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An Over-The-Counter Lifesaver: Increased Intranasal Naloxone Accessibility

Learning Objectives

 

After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able to

·       DISCUSS naloxone nasal spray’s shift to over-the-counter (OTC) availability
·       DESCRIBE how to use naloxone nasal spray safely and effectively
·       IDENTIFY the pharmacist’s role in OTC naloxone access

 

Watercolor image of person reaching out to help another individual on the ground

 

Release Date: May 20, 2023

Expiration Date: May 20, 2026

Course Fee

Pharmacists $4

Pharmacy Technicians $2

 

There is no grant funding for this CE activity

ACPE UANs

Pharmacist: 0009-0000-23-018-H08-P

Pharmacy Technician: 0009-0000-23-018-H08-T

Session Codes

Pharmacist:   23YC18-FXK23

Pharmacist Technician:  23YC18-KFX48

Accreditation Hours

1.0 hours of CE

Accreditation Statements

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-018-H08-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

 

Disclosure of Discussions of Off-label and Investigational Drug Use

The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

Faculty

Kelsey Giara, PharmD
Adjunct Assistant Professor
University of Connecticut
Storrs, CT

 

 

Faculty Disclosure

In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

Dr. Giara has no financial relationships with ineligible companies and therefore has nothing to disclose.

 

ABSTRACT

Recently, the US Food and Drug Administration approved an over-the-counter naloxone product. This is a welcome change that will hopefully reduce the number of opioid-related deaths in the United States, which have escalated over the last two decades. Used appropriately, naloxone can be lifesaving. In addition, its wide margin of safety contributed to the FDA's decision to move this medication from prescription status to over-the-counter (OTC) status. This continuing education (CE) activity covers important information about naloxone, signs of overdose, and naloxone use by bystanders who observe potential opioid overdoses. It also discusses the legal repercussions of using OTC naloxone. Finally, this CE covers counseling tips that are critical for laypeople who purchase OTC naloxone.

CONTENT

Content

INTRODUCTION

The opioid epidemic has gripped the United States (U.S.) for more than two decades.1 Opioid overdose is the number one cause of death for adults aged 25 to 64 years old, which significantly contributes to the decline in the average lifespan.1 The rise of synthetic opioids (primarily fentanyl) augments the uptick in overdoses, referred to as the “3rd wave” of the opioid epidemic.1,2 In fact, 8 in 10 fatal opioid overdoses in the U.S. now involve synthetics.1 Non-fatal overdose is also significant; for every opioid-induced fatality, up to 8.4 non-fatal overdoses occur.1

 

Prescription opioids are also a noteworthy contributor to the rise in opioid overdose deaths.2 Healthcare providers started prescribing opioids for chronic, non-cancer pain (e.g., arthritis, back pain) in the 1990s.3 In the decades since, patients started receiving increasingly higher doses of prescription opioids for long-term chronic pain management.2,3 In 2015, the amount of opioids prescribed per person was three times higher than it was in 1999.3 Even when patients take opioids as prescribed, they are still at risk of accidental overdose and drug-drug (e.g., benzodiazepines) or drug-alcohol interactions.2 Their household contacts are also at risk.

 

Naloxone—an opioid antagonist—is the only approved treatment to reverse opioid overdose.4 The drug competes for the same receptor sites opioids use, effectively and rapidly reversing their effects (i.e., respiratory depression, sedation, and hypotension).4 Naloxone is available in intranasal, subcutaneous, and intramuscular formulations for outpatient use and intravenous formulations for inpatient use.5,6 Naloxone is a safe antidote for suspected overdose, and its use has caused the number of opioid overdose deaths to decrease in communities where it is readily available.2

 

The U.S. Food and Drug Administration (FDA) has undertaken a series of measures to increase accessibility to this lifesaving medication.7 Until recently, naloxone was only available via prescription. In March 2023, the FDA approved the first naloxone product for over-the-counter (OTC), nonprescription use.6,7 This aims to improve access to naloxone, increase the number of locations where it is available (e.g., drug stores, convenience stores, grocery stores, the Internet), and help reduce opioid overdose deaths across the country.

 

INCREASED ACCESSIBILITY

The FDA first approved naloxone in 1971 as a prescription drug.6 It wasn’t until 2014 that the agency approved the first naloxone auto-injector for use outside of a healthcare setting, followed by a nasal spray formulation in 2015.8 Its status as a prescription-only medication made initial access difficult and inconsistent across the country and various high-risk groups.

 

In the mid-1990s, community-based programs implemented efforts to increase distribution to high-risk individuals.6 Consequently, naloxone dispensing from retail pharmacies increased substantially from 2010 to 2015, with a 1170% increase between 2013 and 2015.6 Naloxone dispensing remains inadequate, however, with only one naloxone prescription dispensed for every 70 high-dose opioid prescriptions.

 

Pharmacist Naloxone Prescribing

It’s common knowledge that pharmacists are highly accessible, trusted healthcare professionals, so their role in naloxone distribution is not surprising. Their accessibility, medication expertise, access to patients’ medical records, and regular patient interaction are valuable tools for increasing naloxone availability.6

 

Many states across the U.S. have enacted naloxone access laws (NALs) to expand pharmacists’ scope of practice through standing orders or collaborative practice agreements, allowing them to distribute naloxone without a patient-specific prescription.6 Studies show that NALs significantly increased naloxone prescribing, but not enough.6 Despite NALs, many pharmacists remain uncomfortable dispensing the drug without a patient-specific order given limited training, lack of understanding state laws, and lack of reimbursement for patient education. Some evidence also exists that pharmacists are afraid of potential legal ramifications.6

 

Shifting to the Other Side of the Counter

The FDA has a specific process for shifting from prescription to OTC approval.9 Prescription products can undergo a full switch or partial switch. A full switch converts the drug product covered under a New Drug Application (NDA) to nonprescription marketing status entirely. A partial switch only converts some of the conditions of use (e.g., indications) to nonprescription status and retains others within prescription status. A full switch requires a sponsor to submit an efficacy supplement to an approved NDA or a 505(b)(2) application, but a partial switch requires an entirely new NDA.9 Ultimately, approval of a prescription-to-OTC switch application depends on the FDA deciding that prescription status is “not necessary for the protection of the public health by reason of the drug’s toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and…the drug is safe and effective for use in self-medication as directed in proposed labeling.”9

 

The FDA has been working to authorize an OTC version of naloxone since 2019 by prioritizing applications and assisting manufacturers pursuing OTC naloxone approval.8 The agency announced in January 2019 that preliminary assessment showed that consumers understood a model drug facts label well for OTC naloxone nasal spray and manufacturers found the label acceptable, a slow but steady step in the right direction.8 In late 2022, the FDA issued a Federal Register notice indicating that certain naloxone products—up to 4 mg nasal spray and up to 2 mg intramuscular or subcutaneous autoinjector—may be approvable for nonprescription use.10 This did not immediately approve naloxone products for safe and effective OTC use, but it did provide the framework for manufacturers to pursue approval.

 

The FDA granted priority review status to the application to approve branded naloxone nasal spray (Narcan) for OTC use.11 It was then the subject of an advisory committee meeting in February 2023 where the committee voted unanimously to approve naloxone for nonprescription marketing.11

 

What’s Next?

It’s important to note that the prescription to OTC switch does not automatically apply to all forms of naloxone. Only branded Narcan 4 mg nasal spray is now granted OTC status, not its generic counterparts.7 Manufacturers of generic products with Narcan listed as their reference listed drug product will need to submit a supplemental application to switch their products to OTC status. Other brand name naloxone nasal spray products of 4 mg or less must also update labeling and apply individually for a switch to OTC status.7

 

Pharmacy teams should also be aware that the drug will not be available on drug store shelves immediately.12 The manufacturer will need to implement manufacturing and supply chain changes to support nonprescription packaging requirements. According to the drug’s manufacturer, pharmacies can expect the OTC formulation to be available in late summer 2023. Until then, the prescription product will be readily available through current access channels.12

 

Cost is also important to consider. The drug’s manufacturer has yet to reveal pricing plans for the OTC version, but it plans to work with public interest groups who are now charging about $47.50 per box.13 Health economists predict that the price of OTC Narcan could land somewhere between $35 and $65, plus a retailer’s markup.13 Unfortunately, this price could be prohibitive for many individuals, especially those who misuse opioids. Some also fear that this could encourage individuals to shoplift the drug, forcing locations to move the product behind the pharmacy counter or behind glass and creating a barrier to those who can afford it but are uncomfortable asking for it.13

 

As for accessing the drug outside of a pharmacy setting (e.g., convenience stores, gas stations), additional barriers may exist. Some states require a special license for non-pharmacy businesses to sell OTC medications, which can effectively create “naloxone deserts” where the drug is not available for purchase. In the state of Connecticut, for example, 28 towns currently do not have stores with permits to sell OTC medications, causing residents to travel to obtain the lifesaving antidote.14 Pharmacy teams should check their state’s law regarding OTC sales to direct interested individuals on where to obtain the drug.

 

NEW OPPORTUNITIES FOR THE PHARMACY TEAM

Naloxone shift to OTC availability may seem to take the load off pharmacy teams when it comes to collaborative practice agreements and NALs, but the pharmacy team should remain heavily involved in naloxone distribution. OTC medications are often not covered by insurance, so pharmacists should stay vigilant about active NALs and collaborative practice agreements to prescribe the drug for people with cost concerns.

 

Assessing Overdose Risk

Prescription or not, a crucial role for pharmacy staff is identifying patients for whom naloxone is appropriate. Anyone exposed to opioids, regardless of the source, is at risk of overdose and should be considered for naloxone.15 This applies to people taking opioids for pain with or without other medications and those who misuse opioids. As the drug is bystander-administered, caregivers of individuals at risk of overdose may also request naloxone and should be educated about its use.15

 

Paying attention to opioid dosing is important when considering patients for naloxone. A dose of 50 morphine milligram equivalents (MME) per day doubles the risk of fatal opioid overdose compared to 20 MME or less.3 Patients taking 90 MME or more daily are 10-times more likely to die from an overdose.3 Other overdose risk factors include15

  • concurrent benzodiazepine and/or alcohol use
  • history of substance use disorder, including opioid addiction
  • comorbid mental illness (e.g., depression, anxiety)
  • filling prescriptions at multiple pharmacies and/or from multiple prescribers
  • receiving a methadone prescription
  • recent emergent medical care for opioid poisoning, intoxication, or overdose
  • recent period of abstinence (e.g., release from incarceration, discharge from an opioid detox or abstinence-based program)
  • renal or hepatic dysfunction
  • comorbid respiratory conditions (e.g., smoking, chronic obstructive pulmonary disease, emphysema, asthma, sleep apnea)

 

Counseling on Naloxone Nasal Spray Use

The FDA deemed naloxone nasal spray safe enough for OTC use, but that doesn’t preclude the need to counsel individuals on its safe and appropriate use. Pharmacists should counsel all patients buying OTC naloxone nasal spray about signs of an opioid overdose, how to administer naloxone, and other important clinical pearls. Signs of an opioid overdose include15

  • pale and/or clammy skin
  • limp body
  • pinpoint pupils
  • blue or purple lips, nose, and/or fingernails
  • vomiting or making gurgling noises
  • unconscious or unarousable
  • breathing very slow or not at all

 

Pharmacists should advise individuals to administer naloxone in the event of suspected overdose even if they are not 100% sure the victim is in fact suffering from an overdose.16 Administering naloxone to someone who is not actually suffering from opioid overdose is better than withholding care from an overdose victim based on uncertainty. See Sidebar: Saving a Life is Scary for additional information to ease concerns regarding naloxone administration.

 

SIDEBAR: Saving a Life Is Scary15,17

Often, individuals are trained and ready to perform lifesaving first-aid procedures like CPR or the Heimlich maneuver, but they are afraid of the implications if things take a turn for the worse. Naloxone administration is subject to these same liability concerns. Individuals may also be concerned about legal repercussions when calling for help at the scene of an overdose. Ensure that individuals know about supporting laws and regulations that protect them to increase comfort and confidence with administering the drug:

  • Good Samaritan*: Protects people who call for emergency medical assistance at the scene of an overdose from being arrested for drug possession.
  • Liability protection/third party administration: Protects naloxone prescribers and bystanders who administer the drug and allows bystanders to obtain naloxone for use on opioid overdose victims.

 

*Some states have Good Samaritan laws that differ from general ones. For example, Ohio places limits on the number of times someone can be granted Good Samaritan immunity and requires that overdose victims seek referral for addiction treatment within 30 days. Pharmacy teams should stay current with state-specific Good Samaritan laws regarding naloxone.

 

Naloxone nasal spray is available in a two-pack of single-use, prefilled devices that cannot be reused.4,5 The device should not be primed. Pharmacists should advise people buying OTC naloxone nasal spray about the following administration steps4,16:

  • Check for a suspected overdose (i.e., yell “wake up,” shake the person gently)
  • If the individual does not wake up, lay them on their back
  • Hold the nasal spray device with a thumb on the bottom of the plunger
  • Insert the nozzle into one nostril and press firmly to administer the dose
  • Call 911 immediately
  • Stay until medical assistance arrives, even if the person wakes up
  • Give another dose if the person does not wake up after 2 to 3 minutes or they become very sleepy again initial arousal
  • Continue giving doses every 2 to 3 minutes until the person wakes up or medical assistance arrives (it is safe to keep giving doses)

 

Naloxone is a relatively safe drug, but it still comes with risks and clinical pearls that cannot be ignored. Abrupt opioid reversal in physically dependent individuals can cause acute withdrawal.4,7 Signs and symptoms include body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia.4 Patients may also become aggressive upon sudden reversal of opioids. Naloxone is only effective in reversing opioid overdoses, not in treating other types of overdoses, so it is crucial that individuals seek emergency medical attention following naloxone administration.

 

CONCLUSION

Naloxone is a vital tool for preventing fatal opioid overdose. Pharmacists should be prepared to identify people at risk of overdose and assess their need for this lifesaving drug, make all individuals aware of its OTC availability, and counsel on its safe and appropriate use.

Pharmacist Post Test (for viewing only)

Learning Objectives
• DISCUSS naloxone nasal spray’s shift to over-the-counter (OTC) availability
• DESCRIBE how to use naloxone nasal spray safely and effectively
• IDENTIFY the pharmacist’s role in OTC naloxone access

1. Which of the following is required for a prescription-to-OTC switch?
A. Evidence that the drug is safe for self-medication
B. Evidence of bioavailability to the prescription product
C. A lower dose than the prescription formulation

2. Which of the following is an appropriate course of action following the naloxone prescription-to-OTC switch?
A. Move all naloxone products to the customer-facing shelves of the pharmacy immediately
B. Warn patients that naloxone nasal spray will be unavailable until late summer 2023
C. Review state NALs and collaborative practice agreements to continue dispensing naloxone

3. Which of the following is TRUE about naloxone nasal spray administration?
A. Bystanders should administer a maximum of 2 doses before emergency care arrives
B. It can cause patients to act aggressively or show signs of withdrawal
C. Bystanders should only use it if they are 100% sure the victim used opioids

4. It’s 2024 and your customer-facing pharmacy shelf is stocked with naloxone nasal spray. A woman presents to the counter with the product stating she knows her father is on opioids for cancer pain, but she is afraid he will accidentally take too many doses. She asks if there is anything important she should know about naloxone nasal spray and expresses that she is concerned she will not know how to identify when he is experiencing an overdose. Which of the following is the BEST counseling point for this individual?
A. The Good Samaritan law will protect you from liability if you administer naloxone on your father and it does not work or he was not actually overdosing on opioids.
B. If your father experiences an overdose, he will show signs of respiratory distress (slowed or stopped breathing) and be unconscious. Even if you are not 100% sure, administer the naloxone anyways.
C. Your father is not at risk of overdose because he is using prescription opioids for cancer pain, so naloxone nasal spray is unnecessary. Use a pill organizer to ensure he uses the opioids as prescribed.

5. Which of the following people are most likely at high risk of opioid overdose?
A. An individual with an expired prescription for methadone who was recently released from incarceration
B. An individual with no opioid use history who takes lorazepam (a benzodiazepine) as needed for panic attacks
C. An individual diagnosed with gout who fills prescriptions for naproxen from both his primary care provider and an urgent care facility

Pharmacy Technician Post Test (for viewing only)

Learning Objectives
• DISCUSS naloxone nasal spray’s shift to over-the-counter (OTC) availability
• DESCRIBE how to use naloxone nasal spray safely and effectively
• IDENTIFY the pharmacist’s role in OTC naloxone access

1. Which of the following is required for a prescription-to-OTC switch?
A. Evidence that the drug is safe for self-medication
B. Evidence of bioavailability to the prescription product
C. A lower dose than the prescription formulation

2. Which of the following is an appropriate course of action following the naloxone prescription-to-OTC switch?
A. Move all naloxone products to the customer-facing shelves of the pharmacy immediately
B. Warn patients that naloxone nasal spray will be unavailable until late summer 2023
C. Review state NALs and collaborative practice agreements to continue dispensing naloxone

3. Which of the following is TRUE about naloxone nasal spray administration?
A. Bystanders should administer a maximum of 2 doses before emergency care arrives
B. It can cause patients to act aggressively or show signs of withdrawal
C. Bystanders should only use it if they are 100% sure the victim used opioids

4. It’s 2024 and your customer-facing pharmacy shelf is stocked with naloxone nasal spray. A woman presents to the counter with the product stating she knows her father is on opioids for cancer pain, but she is afraid he will accidentally take too many doses. She asks if there is anything important she should know about naloxone nasal spray and expresses that she is concerned she will not know how to identify when he is experiencing an overdose. Which of the following is the BEST counseling point for this individual?
A. The Good Samaritan law will protect you from liability if you administer naloxone on your father and it does not work or he was not actually overdosing on opioids.
B. If your father experiences an overdose, he will show signs of respiratory distress (slowed or stopped breathing) and be unconscious. Even if you are not 100% sure, administer the naloxone anyways.
C. Your father is not at risk of overdose because he is using prescription opioids for cancer pain, so naloxone nasal spray is unnecessary. Use a pill organizer to ensure he uses the opioids as prescribed.

5. Which of the following people are most likely at high risk of opioid overdose?
A. An individual with an expired prescription for methadone who was recently released from incarceration
B. An individual with no opioid use history who takes lorazepam (a benzodiazepine) as needed for panic attacks
C. An individual diagnosed with gout who fills prescriptions for naproxen from both his primary care provider and an urgent care facility

References

Full List of References

REFERENCES

  1. Skolnick P. Treatment of overdose in the synthetic opioid era. Pharmacol Ther. 2022;233:108019. doi:10.1016/j.pharmthera.2021.108019
  2. U.S. Department of Health and Human Services. U.S. Surgeon General’s advisory on naloxone and opioid overdose. Updated April 8, 2022. Accessed April 13, 2023. https://www.hhs.gov/surgeongeneral/reports-and-publications/addiction-and-substance-misuse/advisory-on-naloxone/index.html
  3. Centers for Disease Control and Prevention. Opioid prescribing: Where you live matters. July 2017. Accessed April 13, 2023. https://www.cdc.gov/vitalsigns/pdf/2017-07-vitalsigns.pdf
  4. Narcan [prescribing information]. Emergent BioSolutions; 2023.
  5. College of Psychiatric & Neurologic Pharmacists. Naloxone product comparison. Prescribe to Prevent. January 2023. Accessed April 13, 2023. https://prescribetoprevent.org/wp2015/wp-content/uploads/Naloxone-Product-Comparison-2023.pdf
  6. Xu J, Mukherjee S. State laws that authorize pharmacists to prescribe naloxone are associated with increased naloxone dispensing in retail pharmacies. Drug Alcohol Depend. 2021;227:109012. doi:10.1016/j.drugalcdep.2021.109012
  7. U.S. Food and Drug Administration. FDA approves first over-the-counter naloxone nasal spray. March 29, 2023. Accessed April 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray
  8. U.S. Food and Drug Administration. Timeline of selected FDA activities and significant events addressing substance use and overdose prevention. Accessed April 16, 2023. https://www.fda.gov/drugs/information-drug-class/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose
  9. U.S. Food and Drug Administration. Prescription-to-Nonprescription (Rx-to-OTC) Switches. Updated June 28, 2022. Accessed April 16, 2023. https://www.fda.gov/drugs/drug-application-process-nonprescription-drugs/prescription-nonprescription-rx-otc-switches
  10. U.S. Food and Drug Administration. FDA announces preliminary assessment that certain naloxone products have the potential to be safe and effective for over-the-counter use. November 15, 2022. Accessed April 13, 2023. https://www.fda.gov/news-events/press-announcements/fda-announces-preliminary-assessment-certain-naloxone-products-have-potential-be-safe-and-effective
  11. U.S. Food and Drug Administration. FDA approves first generic naloxone nasal spray to treat opioid overdose. April 19, 2019. Accessed April 13, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-naloxone-nasal-spray-treat-opioid-overdose
  12. Emergent BioSolutions. U.S. FDA approves over-the-counter designation for Emergent BioSolutions’ NARCAN® nasal spray, a historic milestone for the opioid overdose emergency treatment. March 29, 2023. Accessed April 14, 2023. https://investors.emergentbiosolutions.com/news-releases/news-release-details/us-fda-approves-over-counter-designation-emergent-biosolutions
  13. The New York Times. Over-the-Counter Narcan Could Save More Lives. But Price and Stigma Are Obstacles. March 29, 2023. Accessed April 26, 2023. https://www.nytimes.com/2023/03/28/health/narcan-otc-price.html
  14. News 8 WTNH. 28 Conn. towns won't be able to sell Narcan drug. April 19, 2023. Accessed April 26, 2023. https://www.wtnh.com/video/28-conn-towns-wont-be-able-to-sell-narcan-drug/8572715/
  15. College of Psychiatric & Neurologic Pharmacists. Naloxone access: A practical guideline for pharmacists. Prescribe to Prevent. 2015. Accessed April 16, 2023. https://prescribetoprevent.org/wp2015/wp-content/uploads/naloxone-access.pdf
  16. Narcan [over-the-counter packaging]. March 2023. Accessed April 16, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208411Orig1s006lbl.pdf
  17. The Network for Public Health Law. Naloxone access and overdose Good Samaritan law in Ohio. September 2018. Accessed April 16, 2023. https://www.networkforphl.org/wp-content/uploads/2020/01/Ohio-Naloxone-Good-Sam-Laws-Fact-Sheet.pdf

 

 

Colon on Fire? Novel Suppression of Ulcerative Colitis InFLAMmation

Learning Objectives

  After completing this application-based continuing education activity, pharmacists will be able to
1. Differentiate UC from Crohn’s disease
2. Describe currently available and novel UC medications under development in the United States
3. Outline the relationship between the types of treatment for UC, patient characteristics and disease severity
4. Identify patient education pearls to address inflammation and advance to remission
After completing this application-based continuing education activity, pharmacy technicians will be able to:
1. Differentiate UC from Crohn’s disease
 2. Describe currently available and novel UC medications under development in the United States
3. Outline the relationship between the types of treatment for UC, patient characteristics and disease severity
4. List symptoms that a patient with UC may share with a pharmacy technician

Woman holding her abdomen with a cartoon picture of the large intestine superimposed

Release Date:

Release Date:  May 15, 2023

Expiration Date: May 15, 2025

Course Fee

FREE

This CE was funded by an educational grant from Bristol Meyer Squibb

ACPE UANs

Pharmacist: 0009-0000-23-014-H01-P

Pharmacy Technician: 0009-0000-23-014-H01-T

Session Codes

Pharmacist:  23YC14-HTX49

Pharmacy Technician:  23YC14-XHT82

Accreditation Hours

2.0 hours of CE

Accreditation Statements

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-014-H01-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

 

Disclosure of Discussions of Off-label and Investigational Drug Use

The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

Faculty

 


Pamela Sardo, PharmD, BS
Freelance Medical Writer
Sardo Solutions
Josephine, TX

Faculty Disclosure

In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

Dr. Sardo worked for Rhythm Pharma until March 2022.  We identified no potential financial or other conflicts of interest.

ABSTRACT

Ulcerative colitis is an idiopathic relapsing/remitting disease that is increasing in incidence and prevalence. It is characterized by inflammation, abdominal cramping, bloody diarrhea, fatigue, and bowel urgency among other symptoms. It often presents in teens and young adults with various degrees of severity and significantly impacts quality of life. Primary treatment objectives include achieving rapid resolution of symptoms, mucosal healing, clinical and endoscopic remission, and improving a patient’s quality of life. In moderate to severe disease, prescribers employ immunosuppressive medications, anti-TNF agents, IL 12/23 antagonists, adhesion molecule inhibitors, JAK inhibitors, and S1P receptor modulators. Two organizations have published joint recommendations regarding these pharmaceuticals’ place in therapy. As more data is published and investigational therapies are approved, the treatment approach will continue to evolve. Ulcerative colitis is incurable, so some patients may require surgery. Optimizing care with a multidisciplinary team, including pharmacy personnel, remains an opportunity in this complex condition.

CONTENT

Content

INTRODUCTION

Fiery inflammation in the bowel can be due to several conditions. In inflammatory bowel disease (IBD), gastrointestinal (GI) tract inflammation episodes are common. Crohn’s disease (CD) and ulcerative colitis (UC) are two IBDs differentiated by location and bowel involvement.1 That’s a point to remember: that IBD is an umbrella term that includes CD and UC. In 10% to 15% of patients, the features of CD and UC are so similar that it is impossible to differentiate between them and misdiagnosis may result.1,2 Besides the GI tract, both CD and UC also may be accompanied by symptoms outside the intestine, called extraintestinal symptoms.

 

DIFFERENTIATING CD AND UC

CD results in patchy ulceration of any portion of the GI tract (see Figure 1) from the mouth to the anus. It frequently affects the terminal ileum and colon, and bleeding is uncommon. Typically, patients experience pain in the lower right abdomen.3 UC, this continuing education’s primary focus, involves inflammation of the colon mucosa. UC often affects the rectum, referred to as proctitis, and bleeding during bowel movements is common. Typically, patients experience pain in the lower left abdomen. It may extend into the left (sigmoid) part of the pelvis or beyond the sigmoid, or include the entire colon, referred to as pancolitis.4 In UC, inflammation leads to edema, ulcers, bleeding, and electrolyte losses.

Figure 1. The Gastrointestinal Tract

Cartoon image showing the entire gastrointestinal tract, from mouth to anus

UC is a chronic idiopathic relapsing/remitting condition (meaning it waxes and wanes) with interactions between the environment, immune system, gut microbiome, and a genetic predisposition to the disease suspected as causes.UC’s incidence and prevalence is increasing worldwide.6 From 1990 to 2017, its incidence increased from 3.7 million individuals to 6.8 million affected individuals worldwide.7 UC is incurable, so treatment goals aim to achieve rapid resolution of symptoms, mucosal healing, and clinical and endoscopic remission. An additional goal is to improve a patient’s quality of life (QoL).6.

 

Individuals with this complex condition have a high level of disability and high healthcare resource utilization. Beyond medical management, 15% to 20% of patients with UC will require surgery. Compared to adults without IBD, adults with IBD experienced $11,029 higher direct costs per patient per year according to one report.8 Documenting this diagnosis in the pharmacy’s profile can help pharmacists and technicians screen for potential problems more efficiently.

 

Differentiating the two forms of IBD drives treatment. Both CD and UC present as similar repetitive episodes of GI inflammation and create significant patient burden. In CD, inflammation or ulceration commonly occurs in the ileum and colon.4 Outside of the intestine, CD may affect the esophagus, duodenum, or stomach, and gallstones may occur. In UC, extraintestinal manifestations may appear most commonly as inflammatory arthropathies (joint disease) and bile duct inflammation and scarring, but may include bone, eye, and skin involvement.9,10 Although IBD’s incidence peaks at age 15 to 29 years, 10% to 15% of new diagnoses occur among adults aged 60 years or older.11 Both forms of IBD are more prevalent among non-Hispanic White people than among people in other racial/ethnic groups.12

 

PAUSE AND PONDER: What support can you provide to a patient who tells you that wherever they go, their first action is to scan for the closest bathroom?

 

UC’S PATHOPHYSIOLOGY AND ASSESSMENT

 

The normal colon is five or six feet long and three inches wide. Its layers of circular and longitudinal muscles and tissues contract to move food and liquid forward. It wraps around the outside of the small intestine, has segments, and looks somewhat flat. A seam runs vertically down the middle so the segments bulge on either side of the seam. As UC becomes chronic, the colon becomes more rigid and short, leading to a pipe-like appearance.9

 

The most important risk factor for UC is a family history of IBD in a first-degree relative.14 Patients with disease extension to the left side of the colon, or extensive colitis, are more likely to need medication, undergo colectomy (removal of a portion of the colon), and develop colorectal cancer.15  Risk factors for colorectal dysplasia (abnormal that are not cancerous but can sometimes lead to cancer) or cancer include disease duration and extent, active inflammation, presence of a stricture (inelastic narrowing of a section of the GI tract), polyps, and family history of colorectal cancer. The bile duct may also become diseased in 3% to 7% of patients with UC.15,16

 

UC’s pathophysiology involves defects in the epithelial barrier, defective immune response, the presence of leukocytes, and microflora imbalance in the colon.17,18 UC’s inflammation deteriorates the epithelium, and exposure to certain intestinal microbes worsens the inflammation.9 Other immune-related factors that affect UC’s pathophysiology and the body’s response include tumor necrosis factor-alpha (TNF-alpha), numerous interleukins, and elevated immune globulin levels.17

 

Two measures are recognized in UC. Gastroenterologists and researchers tend to use the erythrocyte sedimentation rate (ESR) and c-reactive protein (CRP) components of the Truelove and Witts criteria. Researchers frequently measure ESR and CRP before and during treatments as outcome measures. The prescribing information for anti-TNFs, JAK inhibitors, and IL-12/23 antagonists also include ESR and CRP measures. Table 1 illustrates UC disease severity measured by assessment in the modified Truelove and Witts criteria.15

 

 Table 1. Modified Truelove and Witts Criteria15

Parameter Mild Moderate Severe
Bloody stools/day (n) <4 4-6 >6
Pulse (beats/minute) <90 ≤90 >90
Temperature (T) °C

(T°F )

<37.5

(<99.5)

37.5 – 37.8

(99.5 – 100.4)

>37.8

(>100.4)

Hemoglobin (g/dL) >11.5 11.5 – 10.5 <10.5
ESR (mm/hr)

[or CRP mg/l]

<20 (normal) 20 – 30 (<30) >30 (>30)

°C=degree Celsius; CRP = c-reactive protein; ESR = erythrocyte sedimentation rate; °F = degree Fahrenheit

 

In the clinical setting, the simpler Mayo score (see Table 2) is used more widely than Truelove and Witts criteria.19 It reflects stool frequency, rectal bleeding, a physician’s global assessment, and a measure of mucosal inflammation at endoscopy, with a maximum score of 12. Clinical response in UC is defined as19

  • a reduction of Mayo score by at least 3 points and a decrease of 30% from the baseline score, or
  • a decrease of at least 1 point on the rectal bleeding subscale or
  • a total rectal bleeding score of 0 or 1

 

Table 2. Mayo Score for Ulcerative Colitis15,20,19

  Points
Mayo Variables 0 1 2 3
Stool frequency Normal 1-2/day more than normal 3-4/day more than normal 5/day more than normal
Rectal bleeding None Streaks of blood with stool <50% of the time Obvious blood with stool most of the time Blood passed without stool
Mucosa (endoscopic subscore) Normal or inactive disease Mild disease (erythema, decreased vascular pattern, mild friability) Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) Severe disease (spontaneous bleeding, ulcerations)
Physician’s global assessment Normal Mild disease Moderate disease Severe disease

Mayo score = sum of scores for each of the four variables (maximum score 12)

 

 

Beyond clinical response, clinical remission is a desired objective and is defined as a Mayo score of 2 or less and no individual subscore exceeding 1.19 Mucosal healing is defined as a mucosa subscore of 1 or less. Disease activity is a measure used to decide what treatments to prescribe. Mild disease activity is defined as scores of 3 to 5. Moderate and severe disease activity are defined as scores between 6 and 10 and 11 and 12, respectively.19

 

The clinician’s patient assessment must be global (all encompassing).21 During patient interviews, clinicians should inquire about extraintestinal symptoms, which may include joint, mood, ocular, oral, or skin changes. They should order laboratory evaluation for anemia and liver function abnormalities. Clinicians should explore QoL issues, such as impact on school, work, or personal relationships. Treatment plans should incorporate patients’ unmet needs and preferences. Exploring the need for social and emotional support, financial resources, and adequacy of patient education regarding their disease are important.21

 

Throughout treatment, it’s important to assess the patient’s clinical response and remission periodically. Clinicians should monitor cross-sectional imaging, specifically MRI, CT and ultrasound, and surrogate markers, such as fecal calprotectin (FCP; type of white blood cell that migrates to inflamed tissue) and CRP.15,22 A sigmoidoscopy or colonoscopy is recommended within three to six months of initiating treatment to determine the level of suppression of the inflammation, treatment response, or the need to modify the treatment.22

 

THE PATIENT’S JOURNEY

The journey through symptoms, diagnosis, and treatment to quell the fiery inflammation associated with UC can be long and difficult. In one study, one in four individuals with IBD reported GI symptoms to their primary care physician more than six months before receiving a diagnosis.23 Of these individuals, 10.4% reported symptoms five years before receiving a UC diagnosis. Delayed diagnosis often results in disease progression, worsening tissue, and mucosal damage, surgery, colectomy, or colitis-associated cancer.  Patients with a previous diagnosis of irritable bowel syndrome or depression were less likely to receive a timely specialist appointment.23

 

UC is vastly heterogeneous. Table 3 presents two cases with distinct disease journeys.

 

 

Table 3. Two Distinct Patient Journeys24,25

UC Patient Case 1   UC Patient Case 2
9-year-old girl diagnosed after ileocolonoscopy reveals diffuse moderate inflammation UC since age 18
Moderate clinical disease activity, Mayo score = 8 Symptoms included bleeding, severe pain and swelling in lower abdomen, gas, and nausea
Low hemoglobin, low vitamin D Lifestyle: Undergraduate, lifeguard, swim coach
Oral corticosteroids started followed by dose tapering dose and mesalamine started Daily regimen of oral medication, rectal suppositories, nightly enemas
At week 4, active disease remained Symptoms worsened so → ED
IFX started at 10 mg/kg at 0, 2, and 6 weeks Barely able to eat or drink, covered with rash and inflamed eyes
At 26 weeks with IFX, she remained in clinical remission Incontinence in street, bus, and post office
At 1 year, she remained in remission Acute diarrhea with each BM → became homebound
Follow-up flexible sigmoidoscopy demonstrated mucosal healing At age 29, married → then 10 weeks of hospitalization without remission
  Agreed to surgical colectomy → difficult recovery, diarrhea, and intestinal blockages
  Finally exercising, back to work, and monitoring the quantity, texture, and timing of food. Remained on pre-surgical medications.

BM = bowel movement; ED = emergency department; IFX = inFLIXimab

 

UC affects many distinct populations. In the pediatric population with UC, unlike in adults, the clinical condition can present atypically with a more severe, early onset and continuous inflammation of the rectum and colon.26,27,28 In these patients, clinicians should assess disease location and severity. One study indicated 62% of pediatric patients with UC from birth to age 5 years had extensive pancolitis, and 38% and 31% from ages 6 to 11 and from ages 12 to 18, respectively, had pancolitis.27   Children can also experience rectal sparing (a normal/unaffected rectum) and limited distal disease.26,28

 

To optimize management, enhance QoL, and minimize complications in all patients, continued patient engagement is important.29

 

GOALS OF UC MANAGEMENT

 

The UC treatment guidelines recommend goals of therapy to include29

  • induction and maintenance of clinical and endoscopic remission
  • maintaining steroid-free remission
  • improving QoL, and
  • preventing complications, hospitalizations and surgery.

Pursuing these goals can also contribute to minimizing cancer risk.21,30,31 Long-term mucosal healing may reduce the risk of dysplasia.31

 

The Treat-To-Target Approach                                                         

UC is considered relapsing/remitting because it presents as relapses of symptoms and then periods of symptomless response and remission. Beyond symptom remission, a treat-to-target (T2T) approach focuses on32,33

  • minimizing disease activity
  • reducing futures risks and
  • reducing future relapses or complications such as ileal strictures (narrowing), fistulas, functional impairment, or colon cancer.

 

In 2015, the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative recommended that UC treatment goals should address two targets: clinical and endoscopic outcomes.32 IBD experts recommend using measures of inflammation such as FCP.32  FCP detects GI inflammation sensitively and is used to monitor disease activity and predict relapse.

 

PAUSE AND PONDER: Which UC treatments do you see in your practice location most often?

 

UC’s treatment options are plentiful and evolving. Pharmacy team members can collaborate with multidisciplinary professionals regarding patient care for UC. (See SIDEBAR). Pharmacists’ drug therapy and disease management expertise can promote individualized treatment decisions for these complex patients.

 

 

SIDEBAR: Working with the Multidisciplinary Team

Team collaboration can increase patient and provider education, enhance quality of care, and reduce disease burden, and morbidity. Many pharmacists don’t know how to introduce themselves to or work with multidisciplinary teams. Sometimes, team members from other disciplines will call with questions or concerns, and the call opens the door for regular communication. Often, however, pharmacy staff will need to take the initiative and introduce themselves. Here are four tips to working better with the UC care team.

  • Ask patients if they are seeing a nutritionist, primary care provider, gastroenterologist, or behavioral health provider (for stress support). If UC is severe, inquire if they have a surgeon or know their radiologist. Record these providers’ names in the patient record and contact them when questions or concerns arise.
  • Make the patient your ally and be your patient’s ally. When you educate patients well and show them your capabilities, they will report back to their clinicians.
  • When you work with a patient who has UC, let the professional team members know. Sending a quick note to say that, for example, the patient’s adherence was poor and you discussed ways to improve it with the patient sheds light on possible non-response. It also makes clinicians aware that you have skills and you’re not afraid to use them!
  • Don’t be afraid to make team members aware of issues like cost or availability of less expensive options. Often, prescribers have no idea that patients experience sticker shock when they fill their prescriptions.

 

TREATMENT

Medication is a mainstay of treatment for patients with UC. Prescribers may combine, dose-escalate, reduce, or discontinue medications, depending on the patient’s disease severity.

 

Traditional Treatments

When a patient presents with mild to moderate UC, the expert consensus is to start treatment with an oral 5-aminosalicylate (5-ASA; sulfasalazine, mesalamine, and diazo-bonded 5-ASA [the prodrugs, balsalazide and olsalazine, which convert to mesalamine]34) with or without a rectal 5-ASA.34,35 In many cases, rectal dosing improves symptoms; using a suppository, enema, or rectal foam applies the medication exactly where needed. Sulfasalazine, balsalazide, and mesalamine are similarly effective and safe.34 Some patients will respond inadequately and may need to escalate therapy to systemic corticosteroids, immunomodulators (IMM), biologics, or other agents. If symptoms persist, it is important to rule out infection, optimize adherence, increase the oral dose, and add rectal 5-ASA if not yet prescribed.34,35

 

Comparative efficacy studies are helpful to clinicians. One technical review of multiple drugs in mild to moderate UC compared rectal 5-ASAs (5-ASA enemas 1 to 4 g/day or 5-ASA suppositories 1g/day) to rectal corticosteroids (hydrocortisone enema 100mg/day, prednisolone enema 25–30 mg/day, budesonide enema 2 mg/day, beclomethasone 3 mg/day or comparable foam) in 13 trials.36 In mild to moderate ulcerative proctosigmoiditis cases treated for two to eight weeks, rectal 5-ASAs were superior to rectal corticosteroids for induction of clinical remission.36

 

Table 4 lists the broad categories of medications for mild, moderate, or severe UC and dosing information.

 

Table 4. Medications for UC22,37-42

Category Substance Dosage
5 – ASA Mesalamine

 

 

Balsalazide

 

Olsalazine

 

Sulfasalazine

2 – 4.8 g/day (oral)

1 – 2 g/day (rectal)

 

6.75 g/day (rectal)

 

1 g/day (oral)

 

2 – 4 g/day

Corticosteroids Budesonide

 

Budesonide MMX

 

Prednisone

 

Hydrocortisone

 

Methylprednisolone

2 mg/day (rectal)

 

9 mg/day (oral)

 

0.75 – 1 mg/kg/day

 

100 mg IV 4 times/day

 

125 mg IV/day

Thiopurines

Immunosuppressives

Azathioprine

 

6-mercaptopurine

2 – 2.5 (max 3) mg/kg/day

 

1 – 1.5 mg/kg/day

Calcineurin inhibitors Cyclosporine

 

Tacrolimus

2 mg/kg/day IV

 

0.2 mg/kg/day

Anti-TNF agents Adalimumab

 

 

 

Golimumab

 

 

 

Infliximab

160 mg wk 0, 80 mg wk 2, 40 mg wk 4, then 40 mg every 2 wks; may ↑ to 40 mg/wk SUBQ

 

200 mg wk 0, 100 mg wk 2, 50 mg wk 4, then 50 mg every 4 wks; may ↑ to 100 mg if pt>80 kg SUBQ

 

5 mg/kg wk 0, 2, 6, then every 8 wks IV

Adhesion molecule inhibitors

(anti-integrin)

Vedolizumab 300 mg wk 0, 2, 6, then every 8 wks IV
Janus kinase inhibitor Tofacitinib

 

 

 

 

 

 

 

Upadacitinib

5 – 10 mg/day (oral)

First 8 wks: 10 mg twice/day

10 mg twice/day for 8 more wks if partial response

Then 5 mg twice/day

or 22 mg XR/day for 8 weeks; then evaluate

 

45 mg/day for 8 wks then 15 mg/day (oral)

Interleukin 12/23 antagonist Ustekinumab 250 mg to 55 kg IV

390 mg if >55 kg – 85 kg IV

520 mg if >85 kg IV

Then 90 mg SUBQ every 8 wks

Sphingosine 1-phosphate receptor modulator Ozanimod 0.23 mg days 1-4, 0.46 mg days 5-7, then

0.92 mg/day (oral)

G = grams; IV= intravenous; kg=kilogram; mg= milligrams; MMX = Multi-Matrix System technology drug release; SUBQ=subcutaneous; wk= week

 

Sulfasalazine

If sulfasalazine is prescribed, 4 g provides approximately 1.6 g of 5-ASA equivalence.34 Typical doses are 2 tablets 4 times a day.37,43 In some cases, prescribers may initiate therapy with a smaller dose, (e.g., 1 to 2 g daily) to reduce possible GI intolerance and slowly increase as tolerated. They may also try enteric-coated sulfsalazine.37,43 Sulfasalazine is commonly prescribed for individuals with UC and rheumatologic comorbidities.43 Periodic monitoring of complete blood counts (CBC) and liver function tests (LFT) is recommended.

 

Sulfasalazine may be poorly tolerated due to adverse effects such as headache, nausea, diarrhea, and rash.43 Additional adverse events with sulfasalazine include folate metabolism interference, male infertility, and rare cutaneous side effects such as Stevens-Johnson syndrome. Anemia, leukopenia, or thrombocytopenia are also possible. Pneumonitis and hepatitis have been reported.43  Sulfasalazine is contraindicated if a patient has a sulfa allergy. Sulfasalazine tablets are a yellow/orange color; individuals who take it may notice an orange tinge in urine, tears, and sweat that can stain clothing and contact lenses. Auxiliary labels and counseling should emphasize drinking plenty of fluids, taking the drug on an empty stomach, and avoiding antacids.

 

Mesalamine and Balsalazide

Low dose mesalamine may be prescribed initially at less than 2 grams per day(g/d). Some patients need 2 to 3 g/d. Higher doses of 3 g/d or more may be required to induce remission.36 Combining oral and rectal therapy may deliver a higher effective dose of 5-ASA to the involved area and lead to higher rates of induction and maintenance of remission. This approach may avoid escalation to corticosteroids or other agents.36

 

Mesalamine and balsalazide are associated with rare idiosyncratic worsening of colitis.22 Rare interstitial nephritis may also occur. The prescribing information recommends periodic renal function monitoring. Olsalazine is generally less well tolerated than either mesalamine or balsalazide. Headache, nausea, diarrhea, leukopenia and hepatitis are possible. 5-ASA treatments should be avoided in pregnancy.22

 

Steroids and Other Traditional Treatments

Corticosteroids, such as budesonide, are generally prescribed for a short duration or for induction of remission.34 Some experts suggest prescribing oral mesalamine, balsalazide or olsalazine over budesonide because hepatic first-pass metabolism lowers budesonide’s systemic activity.34,44 As the patient’s condition improves, withdrawing the steroids and reaching steroid-free remission (SFR) is important. Long-term corticosteroid use may lead to infection, diabetes mellitus, weight gain, insomnia, osteoporosis, or glaucoma.45 Mood changes, cataracts and delayed wound healing are possible.45

 

Thiopurines and Cyclosporine

Thiopurines, including azathioprine and 6-mercaptopurine, may improve inflammation in patients with UC. They inhibit the proliferation of lymphocytes and are used to maintain remission. Their dosing is weight-based and their onset of action can be slow, taking up to three months.22 They are often used in combination with biologics. Monitoring for drug interactions is necessary. Allopurinol interactions with thiopurines are especially important because allopurinol inhibits thiopurine metabolism.46 The dose of mercaptopurine or azathioprine may need to be reduced to one-third or one-quarter of the normal dose if allopurinol is also prescribed. Prescribers determine dose reductions based on therapeutic response and toxicity.47

 

Even though thiopurines and cyclosporine have been prescribed for many years, remaining aware of their side effects is important. Possible adverse events of thiopurines include nausea, vomiting, fever, leukopenia, thrombocytopenia, pancreatitis, and hepatotoxicity. Rare adverse events may include non-Hodgkin lymphoma. Individuals prescribed calcineurin inhibitors, such as cyclosporine, may experience hypertension, nephrotoxicity, hyperkalemia, infection, lymphoma, or diabetes mellitus.37

 

Additional therapies include biologics and newer small molecules (tofacitinib, ozanimod). Before discussing newer therapies, a short review of step-up and step-down approaches is reasonable. If a patient presents with moderate to severe ulcerative colitis, philosophies differ among gastroenterologists regarding beginning with a step-up versus a step-down approach.36,48

  • The step-up approach begins with the traditional therapies mentioned above and followed by biologics and IMM if symptoms persist, if remission is not achieved, and the patient is considered high-risk. Extensive inflammation and the need for repetitive use of corticosteroids are examples of high-risk status.
  • The step-down approach occurs when prescribers begin with a more intensive treatment with biologics and IMM and then step down to the medications mentioned above if patients improve.

 

Step Up or Step Down?

A 2021 study (N = 1891) examined UC’s clinical presentation in the five years before starting biologic therapy. The researchers analyzed patients’ experiences, comorbidities, morbidity, and treatment burden over time. Figure 2 summarizes participants’ health burden, disease progression, medication burden, and increased comorbidities. Across the study period, the need for treatment with oral corticosteroids, 5-ASA, and other non-biologic immunomodulators (IMM) increased progressively. Due to the increasing burden, the researchers supported early use of biologics (a step-down approach) rather than gradual step-up after failing conventional therapies for adult patients with moderate to severe UC.30 

Figure showing results from the trials mentioned

 

Figure 2. Treatment and Health Experience Beginning Five Years Before First Biologic30

5-ASA = 5-aminosalicylates; ED = emergency department; OC = oral corticosteroids; Pts = patients

 

 

Anti-TNF agents

 

Anti-TNF agents are commonly prescribed for moderate to severe UC due to their effectiveness, length of time on the market, and healthcare professional comfort prescribing them.44 The U.S. Food and Drug Administration (FDA) has approved many anti-TNFs, but has approved only adalimumab, golimumab, or inFLIXimab for treating UC. Usually, prescribers use anti-TNFs after 5-ASA and corticosteroids in patients with mild to moderate severity and the step-up approach to treatment. Prescribers may prescribe the step-down approach, using biologics earlier, in some cases.38 They often employ concomitant IMM to decrease immunogenicity seen with anti-TNFs.38,47

 

Because biologics like anti-TNFs are made with living cells, patients may develop an unintended immune response (immunogenicity) in the form of anti-drug antibodies; if they develop, these antibodies may render the anti-TNF medication less effective. The antibodies may bind to the anti-TNF, interfere with its mechanism of action, reduce the anti-TNF’s serum concentration, increase its clearance, and lead to loss of effectiveness. Antibodies may also occur upon restarting an anti-TNF if a patient starts and stops an anti-TNF over time. It is unknown why some people develop anti-drug antibodies and others do not. The presence of antibodies and reduced response often prompt prescribers to switch the anti-TNF to regain effectiveness, and doing so often works. The addition of an IMM can suppress the antibodies which may reduce the risk of switching therapies or avoiding an anti-TNF dose increase.47

 

Pharmacy team members should remain diligent about look-alike, and sound-alike names of the anti-TNF agents and should remember that doses of anti-TNF agents vary by indication.

 

SIDEBAR: TECH TALK about Look-alike, Sound-alike medications

Medications with names that look-alike and/or sound alike are classified as high-alert medications.

  • Know that inFLIXimab had been confused with riTUXximab, so the Institute for Safe Medication Practices recommends using TALL Man lettering.
  • Prevent medication errors between therapies for UC, such as adalimumab and golimumab, ustekinumab and upadacitinib, or vedolizumab and ustekinumab or adalimumab. Segregate the medications in different locations or consider stickers or other alert methods prior to medication dispensing.

 

 

An Anti-integrin

Integrins are adhesion receptors that mediate cell-to-cell and cell-to-extracellular adhesion. Vedolizumab is a humanized monoclonal antibody that binds to the α4β7 integrin, blocks the interaction of α4β7 integrin, and inhibits lymphocyte migration into inflamed GI tissue.49 With fewer lymphocytes in the GI tract, vedolizumab helps reduce inflammation and UC symptoms. Vedolizumab can be referred to as a B-anti-integrin and an adhesion molecule inhibitor. Patients with steroid-dependent disease have treatment options, including treatment with thiopurines, anti-TNF agents (may be combined with azathioprine or 6-mercaptopurine), or vedolizumab.38

 

Prescribers and patients may ask about outcomes in clinical trials. A vedolizumab study enrolled patients with an inadequate response or intolerance to IMM therapy (i.e., azathioprine or 6-mercaptopurine) and/or an inadequate response, loss of response, or intolerance to an anti-TNF.49 Participants received IV vedolizumab 300 mg or placebo at week 0 and week 2. Concomitant stable dosages of 5-ASA, corticosteroids (prednisone dose of 30 mg/day or less or equivalent), and IMM (azathioprine or 6-mercaptopurine) were permitted through week 6. The percentage of patients achieving a clinical response at week 6 was 47%. The researchers also measured remission and found 17% of participants achieved remission at week 6. Those with a clinical response at week 6, or receiving open-label vedolizumab, were invited to enter a 52-week study with every 8-week dosing. At week 52, 42% of participants achieved clinical remission.49

 

JAK inhibitors

 

Tofacitinib and upadacitinib are referred to as small molecules because their molecular structure is smaller and simpler than the biologics’, which are large three-dimensional structures. The JAK inhibitors are dosed orally and require a loading dose. JAK inhibitors are indicated for adults with moderately to severely active UC who responded inadequately or couldn’t tolerate one or more anti-TNF agents.39 Many individuals are willing to visit an infusion suite for treatment; however, younger patients and those with very busy lifestyles or heavy travel schedules may prefer the small molecule oral drugs for their convenience.

 

When prescribing JAK inhibitors, pretreatment screening should include assessment for hepatitis B and tuberculosis. When patients start biologics or JAK inhibitors, their immune response may decrease, increasing risk of certain infections, such as hepatitis B or tuberculosis. If patients have active hepatitis B or tuberculosis, they need treatment to eradicate those infections before beginning biologics or JAK inhibitors. A risk of bacterial, viral, and herpes zoster infections exists, so prescribers must assess vaccination status before treatment. CBC and lipid panel monitoring is recommended. Prescribing tofacitinib in combination with biologics for UC or with potent IMM, such as azathioprine and cyclosporine, is not recommended.40

 

 

IL-12/23 antagonist

Interleukin 12 (IL-12) and IL-23 are proteins that can cause inflammation. Ustekinumab is a human monoclonal antibody against the shared p40 subunit of IL-12 and IL-23 cytokines. Ustekinumab disrupts inflammation by blocking IL-12/23.41 The FDA has approved this biologic for adults with various forms of psoriasis, CD, and UC. (It is also approved for children 6 and older for various forms of psoriasis.) In UC in adults, it is typically administered as an IV induction dose, followed by subcutaneous maintenance dosing every eight or 12 weeks. Clinicians should screen for hepatitis B and tuberculosis and monitor CBC every six months.41 To minimize the risk of medication errors, pharmacy staff should double-check the prescribed route (IV or subcutaneous). They should also be alert for look-alike, sound-alike issues, to prevent prescription transcribing errors or other confusion between ustekinumab and the JAK inhibitor upadacitinib.

 

Research has documented outcomes for this monoclonal antibody, too. A ustekinumab clinical trial assessed efficacy and safety in adults with UC; the primary endpoint was clinical remission at week 8.41 The researchers randomized participants to a single IV dose of ustekinumab of approximately 6 mg/kg, 130 mg (a lower dose than recommended), or placebo at week 0. Enrollment required previous inadequate response to corticosteroids, IMM, or at least one biologic. At week 8, 19% of participants successfully reached clinical remission.41

 

S1P Modulator

Ozanimod is an oral sphingosine 1-phosphate receptor (S1P) modulator indicated for the treatment of moderately to severely active UC in adults.42 It is also approved for relapsing forms of multiple sclerosis, and the pharmacy team may field questions about this medication’s various indications. Ozanimod binds with high affinity to S1P receptors 1 and 5. It blocks lymphocyte trafficking from lymph nodes, reducing the number of lymphocytes in peripheral blood. Ozanimod may transiently decrease heart rate and cause atrioventricular conduction delays, so a low-dose starter titration pack is available. Prescribers should escalate the dosing slowly to avoid rare but significant bradycardia. Progressive multifocal leukoencephalopathy, a disabling, sometimes deadly adverse event, is rare but possible. Pharmacy teams should counsel patients regarding the need for effective contraception to prevent pregnancy; patients should use contraceptives for three months after discontinuing ozanimod.42

 

An ozanimod clinical trial assessed efficacy and safety using a primary study endpoint of clinical remission at week 10.42 It enrolled adults with moderately to severely active UC if they had an inadequate response, or were intolerant, to specific other treatments. The treatments included oral 5-ASA, corticosteroids, IMM (e.g., 6-mercaptopurine and azathioprine), or a biologic (e.g., anti-TNF and/or vedolizumab). The proportion of patients reaching clinical remission at week 10 was 18% with an ozanimod dose of  0.92 mg once daily. Those achieving a clinical response were invited to be re-randomized to a 52-week study extension. The primary endpoint was the proportion of patients in clinical remission at week 52. The proportion of patients with an ozanimod dose of 0.92 mg once daily with clinical remission at week 52 was 37%.42

 

MEDICATIONS IN DEVELOPMENT

Etrasimod is a once-daily, oral S1P receptor modulator in development for the treatment of UC. Results from the phase 2 OASIS trial and open-label extension study revealed patients with moderately to severely active UC who received etrasimod showed improvements in clinical remission and symptom relief beginning as early as week 2. In the phase 3 ELEVATE UC 52 study, 27% of patients in the etrasimod group achieved clinical remission compared with 7% of patients in the placebo group at 12 weeks.50 Use of etrasimod in UC is not FDA-approved and regulatory authorities have not yet evaluated its safety and efficacy.

 

Risankizumab-rzaa is an IL-23 inhibitor that is FDA-approved for psoriasis and Crohn’s disease. It is in development for treatment of individuals with UC. In the INSPIRE trial, 20.3% of participants with intolerance or inadequate response to conventional or advanced therapies (biologics, JAK inhibitors, and S1P receptor modulators) achieved clinical remission at week 12.51 The FDA has not approved risankizumab in UC or evaluated its safety and efficacy.

 

Considerations for Medications in Therapy

Decision-making regarding UC treatment requires consideration of many factors, including

  • disease and inflammation location, severity, and extent
  • comparative effectiveness and long-term safety of available treatments
  • treatment availability
  • product labeling
  • guideline recommendation
  • prior treatment successes or failures
  • cost, and
  • patient preferences

Since some prescribers may dose escalate to an off-label (higher) dose or off-label shorter dosing interval, pharmacy teams need to remain alert regarding insurance policies that may impact treatment decisions.

 

Safety Information

Each medication’s full prescribing information includes comprehensive safety and efficacy details. The information in this section is not all-inclusive. It’s critical to keep in mind that all UC treatments have limitations. Because most infusions have similar adverse events, Table 5 summarizes select safety information and limitations regarding newer agents used in UC.

 

 

Table 5. Newer Agents: Select Safety Information and Limitations 37,41,42,49,52

Limitations and Safety Considerations Anti-TNF agents Anti-IL-12/23

Agents

JAK Inhibitors Anti-integrin S1PR

modulator

Immuno-suppression
Infection

(herpes zoster)

(upper respiratory)

Venous thrombo-embolism        
Psoriasis      
Major CV adverse event      
Infusion/ injection site reaction  
Malignancy
Tuberculosis  
Worsen CHF        
Lymphoma

(if combine with thiopurines)

   
Lymphocyte abnormalities        
Anemia      
Elevated lipids        
Headache
Nausea  
Fatigue
Liver function test elevations    
Contra-indication if post-MI within 6 months, or unstable angina, stroke or TIA        
Contraindicated if severe untreated sleep apnea        
PML      

MI = myocardial infarction; PML = progressive multifocal leukoencephalopathy; TIA = transient ischemic attack

 

Identifying drug interactions is a key skill for pharmacists. Of note, JAK inhibitors can interact with CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) and CYP2C19 inhibitors (e.g., fluconazole, omeprazole).40 Drug interactions may be a concern with the use of ozanimod and concurrent IMM, tyramine, antiarrhythmics, beta blockers, or calcium channel blockers.42

 

ACG and AGA Guidelines for the Management of Moderate-to-Severe UC

The American College of Gastroenterology (ACG) and the American Gastroenterological Association (AGA) published comprehensive treatment guidelines and interventions for UC.31,44 Both guidelines cover achieving a response, induction of remission, and maintenance of remission. Select highlights presented below are not all-inclusive.

 

For remission induction, ACG recommends the following options31:

  • In moderately active UC, oral budesonide MMX
  • In moderately to severely active UC, oral corticosteroids
  • In moderately to severely active UC, anti-TNF therapy
  • When inFLIXimab is used as induction therapy for patients with moderately to severely active UC, it should include a thiopurine
  • In moderately to severely active UC, or if failed anti-TNF, vedolizumab
  • In moderately to severely active UC, tofacitinib 10 mg orally twice a day for 8 weeks
  • For induction of remission in moderately to severely active UC with previous failure of anti-TNF therapy, tofacitinib

 

For maintenance of remission, ACG recommends the following options31:

  • For previously moderately to severely active UC in remission due to corticosteroid induction, thiopurines
  • Continue anti-TNF therapy after anti-TNF induction in patients with previously moderately to severely active UC
  • Continue vedolizumab in previously moderately to severely active UC now in remission after vedolizumab induction
  • Continue tofacitinib in previously moderately to severely active UC now in remission after induction with tofacitinib

 

The AGA provides the following recommendations for response and remission44:

  • Current evidence supports use of inFLIXimab, adalimumab, golimumab, vedolizumab, and tofacitinib for remission induction and maintenance in moderate-severe UC
  • Thiopurine monotherapy should not be used for induction of remission but may be considered for remission maintenance
  • Meta-analysis suggests that inFLIXimab and vedolizumab may be preferred first-line therapy in biologic-naïve patients, rather than standard-dose adalimumab or golimumab
  • In patients with prior inFLIXimab exposure, particularly those with primary non-response to induction therapy, vedolizumab or tofacitinib may be preferred over adalimumab or golimumab
  • Combination of a biologic agent with an immunomodulator is more effective than monotherapy with either agent
  • In patients with moderate-severe disease activity, at high risk of colectomy, biologic agents with or without an IMM, or tofacitinib, should be used early rather than gradual step-up therapy after failure of 5-ASA
  • Patients in remission with biologic agents and/or IMM, or tofacitinib, after prior failure of 5-ASA, may discontinue 5-ASA

 

PAUSE AND PONDER: What patient support questions may uncover a patient’s adherence challenges?

 

Patient Education Pearls for Patient Counseling

 

Pharmacy teams have numerous opportunities to provide UC patient education. Because the condition appears differently in affected individuals, conversations should align with the individual patient’s situation. Supportive patient education pearls addressing inflammation and advancing opportunities to remission should be individualized from these topics53:

  • UC’s exact cause is unknown
  • UC affects people differs widely
  • UC is a chronic condition and symptoms wax and wane
  • Medications are available to control UC
  • The number of people with UC has been increasing
  • It can occur at any age and in any racial or ethnic group
  • Symptoms will occur in the intestine and may occur outside of the intestine
  • Ulcers in the intestine lining that bleed may lead to low red blood cell count (anemia)
  • Ask the doctor what tests are needed
  • Diet and nutrition plans differ for each patient
  • Managing stress is important
  • Have supportive friends and family
  • Locate restrooms when outside the home
  • Carry extra underclothes, toilet paper or moist wipes
  • Ask for school or work accommodations

 

SIDEBAR: OTC and Alternative Therapies for Patient Discussion34,35,44,54

 

Patients with UC may use these OTC products:

  • Patients with UC may eat less, thinking it will decrease diarrhea. However, they need proteins, water, vitamins, and minerals to promote healing. Patients need vitamin D and calcium for bones if reduce their dairy intake.
  • Bismuth subsalicylate (Pepto Bismol) is an antidiarrheal liquid, chewable tablet, and also swallowable tablet. It helps reduce inflammation in the intestinal lining. Remind patients that it darkens stool and the tongue. That darkening is not a medical concern.
  • Simethicone (Gas-X) is an anti-flatulent that helps form gas bubbles in the digestive tract, making them easier to pass and relieving gas pain.
  • Loperamide (Imodium) should be taken with caution. It slows digestion. Occasional use may be effective, but patients should consult healthcare providers if they contemplate ongoing use.
  • If mild disease persists, such as seen with a Mayo score of 1, the AGA guidelines and some advocacy web sites mention curcumin (a phytochemical from turmeric) or suggest adding curcumin and probiotics for some individuals suffering with UC.
  • Patients with severe disease, frequent bleeding, anemia, or abnormal laboratory results may need folic acid. The usual folic acid dose is 1 mg/day. Asparagus, broccoli, and spinach are also foods that contain folate or folic acid.

Patients who have UC should avoid these OTC products:

  • Patients should consult their healthcare providers whether to avoid aspirin, nonsteroidal anti-flammatories (ibuprofen, naproxen), lactose, sugar substitutes, or preservatives.
  • Patients who take sulfasalazine or mesalamine should not take them with antacids.

 

Many institutions, hospitals and healthcare providers have created UC resources. Table 6 lists  examples of supportive options that can be shared with individuals with UC.

 

Table 6. Patient and Clinician Resources to Support Individuals with UC

Resource Contact
American College of Gastroenterology https://gi.org/topics/ulcerative-colitis/

·       Describes symptoms, tests, diagnosis, risks, surgery and treatments

Cleveland Clinic: Butts and Guts podcast https://my.clevelandclinic.org/podcasts/butts-and-guts

·       Covers a wide range of gastrointestinal issues including management and surgery

·       Use the search term “ulcerative colitis”

Crohn’s and Colitis Foundation (CCF)

 

Help Center (referrals, insurance info)

https://www.crohnscolitisfoundation.org/

info@crohnscolitisfoundation.org

1-888-MY-GUT-PAIN

(888-694-8872- extension 8)

Signs and Symptoms https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/living-with-ulcerative.pdf

Spanish Help Center
https://www.crohnscolitisfoundation.org/es/home

School Accommodation Suggestions

https://www.crohnscolitisfoundation.org/justlikeme/living-with-crohns-and-colitis/school/school-accommodations

Mayo Clinic https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326

·       Includes a video and written materials on diagnosis, symptom management, and treatment

Downloadable Mobile Apps

·       Download from the App Store or Google Play

My IBD Care: tracks symptoms, flares, medical appointments, BMs, medications

Bathroom Scout: Identifies 1.3 million public toilets

MyPlate: Monitors calories, the nutrition content of food

MyColitis: Health tracking of bowel movements, medications, moods, symptoms, tests

 

CONCLUSION

UC is a debilitating chronic IBD that usually requires long-term treatment to control symptoms and prevent disease-related complications. Many treatments are available; however, the effectiveness, safety, and durability of response and remission vary, and careful assessment of these factors must drive a personalized approach to care. Pharmacy teams must recognize that every patient’s disease is different, and results in diverse manifestations. Pharmacists and pharmacy technicians are ideally positioned to collaborate with multidisciplinary teams to support strategies tailored to each patient to optimize care and to help patients maintain a positive outlook.

 

Many unanswered questions remain about UC. Researchers will continue to evaluate treatment advances and explore disease management opportunities while pharmacy teams encourage patients suffering from UC to have routine doctor visits, adhere to their medication regimen, and maintain a healthy lifestyle.

 

 

 

 

Pharmacist Post Test (for viewing only)

Learning Objectives
After completing this continuing education activity, pharmacists will be able to
1. Differentiate UC from Crohn’s disease
2. Describe currently available and novel UC medications under development in the United States
3. Outline the relationship between the types of treatment for UC, patient characteristics and disease severity
4. Identify patient education pearls to address inflammation and advance to remission

1. Which is true regarding the difference between Crohn’s and ulcerative colitis (UC)?
a. Crohn’s disease is limited to inflammation of the colon mucosa
b. Ulcerative colitis can appear anywhere between the mouth and anus
c. Ulcerative colitis involves inflammation of the colon mucosa

2. Which is the usual adalimumab starting dose for a newly diagnosed UC patient?
a. Adalimumab 160 mg at week 0, 80 mg at week 2, 40 mg at week 4
b. Adalimumab 20 mg at week 0, 40 mg at week 2, 50 mg at week 3
c. Adalimumab 200mg at week 0, 90 mg at week 2, 60 mg at week 4

3. Which statement reflects a novel characteristic of ozanimod?
a. Ozanimod is an IL 12/23 monoclonal antibody
b. Ozanimod is an oral S1P modulator
c. Ozanimod is a oral JAK inhibitor

4. When inducing remission, which statement(s) describe(s) ACG recommended UC treatment, patient characteristics, and disease severity?
a. In moderately to severely active UC or if failed anti-TNF, a 5-ASA is recommended
b. In moderately to severely active UC oral corticosteroids may be prescribed
c. In mild-to-moderate UC, lifestyle changes are usually sufficient to induce remission

5. Which are patient education pearls to discuss with a patient suffering with UC?
a. The number of people with UC has been decreasing
b. Intestinal ulcers that bleed will not lead to anemia
c. Many medication options are available to control UC

6. You receive a prescription or order for tofacitinib. Which of the following would be an appropriate dose for a patient who has UC?
a. 5 mg orally once a week
b. 5-10 mg orally daily
c. 10 mg IV every 8 weeks

7. Which statement contains safety information to be aware of with UC treatments?
a. Sulfasalazine carries a risk for venous thromboembolism, herpes zoster, and major cardiovascular adverse events
b. JAK inhibitors may interfere with folate metabolism, affect male fertility, cause rare cutaneous adverse effects
c. Ustekinumab may cause infections, infusion or injection site reactions and may increase the risk of malignancy

8. A 22-year-old college student with newly diagnosed UC is experiencing daily blood in the stool, cramping, and had bowel incontinence on the way to the parking lot after class. Multiple options are available to treat this patient. What are the goals of treatment?
a. To prescribe medication to obtain response in 1 week and remission in 8 days
b. To induce and maintain clinical and endoscopic remission and quality of life
c. To use oral medications only (and avoid infusions) because of her youth and lifestyle

9. A 17-year-old restaurant worker presents with pancolitis. She has no other significant past medical history. She was treated with adalimumab, but the condition is worse with daily blood in the stool, 5 BMs/day, and weight loss of 10 pounds in the past 2 months. She has been reading about UC and is interested in switching to an infusion. Which is a possible IV treatment option?
a. Prednisone
b. Vedolizumab
c. Balsalazide

10. A 30-year-old newly married patient with UC works as a flight attendant. She has pancolitis and was told she is anemic and today has a fever. She comes to the pharmacy before her doctor’s appointment asking which UC medications are oral. Which product names are options to provide this patient?
a. Methylprednisolone
b. Ustekinumab
c. Ozanimod

Pharmacy Technician Post Test (for viewing only)

Pharmacy Technician Learning Objectives
After completing this continuing education activity, the pharmacy technician will be able to
1. Differentiate UC from Crohn’s disease
2. Describe currently available and novel UC medications under development in the United States
3. Outline the relationship between the types of treatment for UC, patient characteristics and disease severity
4. List symptoms that a patient with UC may share with a pharmacy technician

1. Which is true regarding the difference between Crohn’s and ulcerative colitis (UC)?
a. Crohn’s disease is limited to inflammation of the colon mucosa
b. Ulcerative colitis can appear anywhere between the mouth and anus
c. Ulcerative colitis involves inflammation of the colon mucosa

2. Which is the usual adalimumab starting dose for a newly diagnosed UC patient?
a. Adalimumab 160 mg at week 0, 80 mg at week 2, 40 mg at week 4
b. Adalimumab 20 mg at week 0, 40 mg at week 2, 50 mg at week 3
c. Adalimumab 200mg at week 0, 90 mg at week 2, 60 mg at week 4

3. Which statement reflects a novel characteristic of ozanimod?
a. Ozanimod is an IL 12/23 therapeutic
b. Ozanimod is an oral S1P modulator
c. Ozanimod is an oral JAK inhibitor

4. A patient who visits the pharmacy often for medication related to his UC brings a few OTC products to the register. Which of the following might be a problem?
a. Simethicone
b. Naproxen
c. Curcumin

5. Which symptoms might a new patient suffering with UC reveal to a pharmacy technician?
a. cold sores, stomach ulcers, 1 BM/day, miss 1 day of work/year
b. bloody stools, 6 BMs/day, mood changes, had to quit work
c. 1 BM/day, cold sore, dental pain, perfect work attendance

6. You receive a prescription or order for tofacitinib. Which of the following would be an appropriate dose for a patient who has UC?
a. 5 mg orally once a week
b. 5-10 mg orally daily
c. 10 mg IV every 8 weeks

7. Which statement contains safety information to be aware of with UC treatments?
a. Sulfasalazine carries a risk for venous thromboembolism, herpes zoster, and major cardiovascular adverse events
b. JAK inhibitors may interfere with folate metabolism, affect male fertility, cause rare cutaneous adverse effects
c. Ustekinumab may cause infections, infusion or injection site reactions and may increase the risk of malignancy

8. A 22-year-old college student with newly diagnosed UC is experiencing daily blood in the stool, cramping, and had bowel incontinence on the way to the parking lot after class. Multiple options are available to treat this patient. What are the goals of treatment?
a. To prescribe medication to obtain response in 1 week and remission in 8 days
b. To induce and maintain clinical and endoscopic remission and quality of life
c. To use oral medications only (and avoid infusions) because of her youth and lifestyle

9. A 17-year-old restaurant worker presents with pancolitis. She has no other significant past medical history. She was treated with adalimumab, but the condition is worse with daily blood in the stool, 5 BMs/day, and weight loss of 10 pounds in the past 2 months. She has been reading about UC and is interested in switching to an infusion. Which is a possible IV treatment option?
a. Prednisone
b. Vedolizumab
c. Balsalazide

10. A 30-year-old newly married patient with UC works as a flight attendant. She has pancolitis and was told she is anemic and today has a fever. She comes to the pharmacy before her doctor’s appointment asking which UC medications are oral. Which product names are options to provide this patient?
a. Methylprednisolone
b. Ustekinumab
c. Ozanimod

References

Full List of References

REFERENCES

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  2. Guindi M, Riddell RH. Indeterminate colitis. J Clin Pathol. 2004;57(12):1233-1244. doi: 10.1136/jcp.2003.015214
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  29. Armuzzi A, Liguori G. Quality of life in patients with moderate to severe ulcerative colitis and the impact of treatment: A narrative review. Dig Liver Dis. 2021;53(7):803-808. doi: 10.1016/j.dld.2021.03.002
  30. Wang Y, Makadia R, Knoll C, Hardin J, Voss EA, Fife D, Davis K, Sloan S. Understanding patient journey in ulcerative colitis prior to biologic initiation: a 5-year exploration. BMC Gastroenterol. 2021;21(1):121. doi: 10.1186/s12876-021-01708-6.
  31. Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG clinical guideline: ulcerative colitis in adults. J Am Coll Gastroenterol.2019;114:384–413. doi: 10.14309/ajg.0000000000000152
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  45. Rubin WA Jr, Loftus EV Jr, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of corticosteroid therapy for inflammatory bowel disease: a population-based study. Gastroenterology. 2001;121(2):255-260. doi: 10.1053/gast.2001.26279
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  50. Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet. 2023;401(10383):1159-1171. doi: 10.1016/S0140-6736(23)00061-2
  51. Rizankizumab (SKYRIZI®) achieves primary and all secondary endpoints in phase 3 induction study in patients with ulcerative colitis. Abbvie. News Center. March 23, 2023. Accessed April 10, 2023. https://news.abbvie.com/news/press-releases/risankizumab-skyrizi-achieves-primary-and-all-secondary-endpoints-in-phase-3-induction-study-in-patients-with-ulcerative-colitis.htm
  52. Remicade. Prescribing information. Janssen Biotech, Inc. October 2021. Accessed April 8, 2023
  53. Living with Ulcerative Colitis. Crohn’s and Colitis Foundation. December 2018. Accessed April 11, 2023. https://issuu.com/ccfa1/docs/living-with-ulcerative-colitis-brochure-final?fr=sN2ZhYjM3MDAxNzI
  54. Patrick E. Over the counter medication for ulcerative colitis. Ulcer Talk. April 10, 2023. Accessed April 15, 2023https://www.ulcertalk.com/over-the-counter-medication-for-ulcerative-colitis/

 

 

 

Patient Safety: Your Personal Medication Error Rate: Checkpoints and Reality Checks

Learning Objectives

 

After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able to

  • Differentiate systemic approaches to medication errors and individual (personal) responsibilities for medication errors
  • Outline various causes for medications errors that can be traced back to individuals
  • Discuss how unique work habits influence the propensity to make errors
  • Apply methods to reduce an individual’s medication error rate

Cartoon character holding up traffic sign that says 'oops!'

Release Date:

Release Date:  May 1, 2023

Expiration Date: May 1, 2026

Course Fee

Pharmacists: $7

Pharmacy Technicians: $4

There is no grant funding for this CE activity

ACPE UANs

Pharmacist: 0009-0000-23-016-H05-P

Pharmacy Technician: 0009-0000-23-016-H05-T

Session Codes

Pharmacist:  23YC16-XVK33

Pharmacy Technician:  23YC16-TXP82

Accreditation Hours

2.0 hours of CE

Accreditation Statements

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-016-H05-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

 

Disclosure of Discussions of Off-label and Investigational Drug Use

The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

Faculty

Amanda Choi, PharmD
Pharmacist
Backus Hospital
Norwich, CT

Carren Jepchumba, PharmD
Pharmacy Manager
Kroger Health
Indianapolis, IN

Jeannette Wick, RPh, MBA, FASCP
Dir. Office of Pharmacy Professional Development
UConn School of Pharmacy
Storrs, CT


 

Faculty Disclosure

In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

Drs. Choi and Jepchumba and Ms. Wick have no relationships with ineligible companies and therefore have nothing to disclose.

 

ABSTRACT

Pharmacists and pharmacy technicians must be careful not to make
errors, but errors slip through from time to time. Organizations (healthcare systems,
hospitals, and pharmacies) often use systems-based approaches to error
prevention. Pharmacy employees need to know about systems-based approaches,
but they also need to know about approaches they can use themselves to reduce
their own chances of error. This activity describes factors that increase the
likelihood of error and methods that are proven to help individuals focus. We
discuss–and strongly recommend–knowing your limit, tracking and recording errors,
collaborating with coworkers, employing tools that increase accuracy, and
stopping the workflow when things “feel” wrong.

CONTENT

Content

INTRODUCTION

Pharmacists and pharmacy technicians strive to provide safe, high-quality care to people when they are unwell, but sometimes we make errors. No one likes to make an error, and in our field, errors can have devastating consequences: preventable illness and injury, unnecessary hospitalizations, disability, and sometimes even death. Experts who have extrapolated data indicate that medical errors now account for 9.5% of all deaths in the United States, which if true, would make medical mistakes the third leading cause of death after heart disease and cancer.1

Addressing issues systemically has become commonplace in healthcare systems. Most of us know that the first step in resolving medication errors is being able to identify where errors occur and factors that contribute to their occurrence. Tracking in this way allows us to integrate preventive measures into our systems and habits to reduce future occurrence. It’s also important to create safe workplace environments so individuals involved in errors are not afraid to address future errors.2

But external factors aren’t the sole cause of medication errors. Psychosocial and cognitive factors can seriously impact the rates at which errors occur. Individuals who identify their own habits or knowledge gaps that might contribute to errors can take the next step: working on improving.

Definitions of “Medication Error”

To identify and prevent medication errors properly, having a clear, unambiguous definition would be ideal. Unfortunately, everyone seems to use similar—but different—definitions. Each person has a role and individual actions impact the team’s overall performance. Let’s compare a few definitions:

 

An error is a failure to complete a planned action as intended or the use of an incorrect plan of action to achieve a specific endpoint. Bad judgment, ignorance, or inattention might cause this type of error. A pharmacy situation might be when a technician fails to remove expired, very expensive medication and order new stock. When a new patient is admitted to the hospital and needs the medication immediately, the pharmacist hurries to process the order. Assuming that all medication in stock is in-date, the pharmacist approves an intravenous (IV) bag. At final verification, the pharmacist finally notices the medication’s expiration date. With no in-date stock, the pharmacist cannot send the IV. This mistake disrupts patient care. The pharmacy technician failed to keep the inventory in-date and the pharmacist assumed, failed to pay attention, and didn’t double check before proceeding.

 

An error is the enactment of a misconception due to incorrect information or part of a statement that is incorrect. An example in pharmacy might be when a doctor sends a new prescription with a higher-than-expected quantity, fails to update the prescription signatura (sig) or instructions, but tells the patient to take a higher dose. The puzzled pharmacist proceeds to process it. The insurance rejects the claim highlighting the calculated days-supply did not match the quantity indicated. While the pharmacist works on the prescription, the patient comes to the pharmacy to pick up her prescription. The pharmacist cannot contact the doctor who wrote the prescription and the doctor’s colleagues cannot confirm the prescription because they are unsure. The pharmacist decides to dispense a lower quantity per the old instructions so that the insurance will approve it. With the prescription now approved, the pharmacist dispenses the prescription but because the patient follows the doctor’s verbal directions, she runs out sooner than indicated on the prescription. She returns a few days later demanding more. The patient must now contact the insurance, the doctor, and the pharmacist to obtain the prescription that she needs. This could have been avoided if the doctor had noted that the patient would be taking the same drug at an increased dose.

 

An error is the departure from what is ethically acceptable or an incorrect result produced by automation. As healthcare systems increase their use of electronic health records, this problem is  increasing. Most systems are programmed to increase efficiency with the autofill function—meaning the computer will fill a field automatically based on the most common entry—which can increase avoidable errors. Too often, healthcare personnel blindly accept the computer-generated entry or calculations. This can result in a patient being given too much or too little drug and disrupt the quality of care.

 

In summary, medication errors occur in many ways (see Table 1). When a medication error occurs, it reduces the chances of achieving a desired outcome and the margin of safety associated with that outcome. Some medication errors result in adverse drug reactions but many do not. This is because not all adverse events cause adverse drug reactions.3 Many of us have made errors that serendipitously improved something. For example, a person making carrot soup may misread the words “1 garlic clove” and “1 teaspoon of cloves.” The soup will be different—and possibly better—than if the cook used garlic cloves. In medicine, however, errors are rarely “Happy Accidents” and we need to make every effort to reduce and eliminate them.

 

Table 1. Definition of Medication Errors

  • A misconception resulting from incorrect information
  • A wrong action attributable to bad judgment or ignorance or inattention
  • Departure from what is ethically acceptable
  • Inadvertent incorrectness
  • Part of a statement that is not correct
  • The occurrence of an incorrect result produced by a computer
  • Unintentional failures to act or plan (when it’s intentional, it’s a violation, not an error)

Source: Reference 3

Systemic Failures: Avoiding Blame

Many healthcare systems and providers now stress approaches that analyze errors as systemic failures. Systems, by nature, are interrelated units that work together toward the same goal. Most medication errors occur as a result of multiple, compounding events—or collapse of a faulty system—rather than an individual’s isolated act.4,5 It’s amazing how many times a serious error occurs because employees missed the opportunity to catch and rectify an error at multiple points in the patient’s care. Using a systems approach4,6

  • avoids assigning blame
  • explores relationships between various parts of the system, and
  • recognizes that cause and effect may be separated by space or time.

 

Many experts describe systemic failure using a Swiss cheese analogy. The holes in Swiss cheese represent the faults within a system. If an error passes through one of the holes in one slice of Swiss cheese, one would hope that the holes of the next slice of cheese won’t align, blocking the error. If the holes of the Swiss cheese slices all align, that medication error would slip through and reach the patient. Recognizing the placement of each slice—or the placement of each healthcare professional and that professional’s responsibility to be vigilant—can decrease the likeliness that a medication error will occur and it’s also key in identifying systemic failures.7,8

 

This Swiss cheese analogy can be applied to community pharmacy, where pharmacy staff establish multiple checkpoints during the filling process to ensure prescriptions are filled correctly (reviewing, scanning barcodes, tablet appearance, etc.). However, many patient safety cultures tend to look for explanatory causes for trouble and encourage blaming, criticizing, or silencing healthcare providers who make errors.4 For this reason, some experts refer to the individual who makes an error as the “second victim.” Lack of support from colleagues and supervisors can greatly affect involved health care providers’ ability to cope, leading to greater distress or protracted recovery.9

 

Fears of blame and punishment can deter individuals from reporting their errors, which can prevent creation of a culture of safety. Admitting one’s mistakes allows open discussion with peers and performance improvement experts can prevent further patient harm if they identify and fix the systemic “hole” causing the mistake.2,4 Let’s look at systems-based approaches first, and then examine why individual approaches are also critical.

 

QUALITY AND PERFORMANCE IMPROVEMENT APPROACHES

Various workplaces take different approaches to errors, but risk managers have proven certain approaches are more successful than others (see Table 2). The two most common approaches to analyzing medication errors are tracking and trending. Almost every workplace, whether it’s a healthcare facility or some other kind of business—requires employees to complete incident reports if they make an error. A responsible individual (usually someone designated as a quality or performance improvement specialist or a risk manager, although individuals may be interested in looking at their own errors) should look at incident reports over time to determine

  • What type of error or errors are most common
  • If a particular drug or product is involved in multiple incidents and why
  • The time of day or workload volume when the error occurred
  • The individual or individuals involved

 

This amounts to a type of detective work, in which the responsible party investigates medication errors individually and collectively to track and trend predisposing factors. If the data indicates that certain factors are trending (occurring more than once), the workplace can take action to prevent the error from happening again.10 Sometimes the action is as simple as heightening employees’ awareness that errors have occurred. Other times, the workplace might place a sign on a shelf indicating that a product is a look-alike or sound-alike product, mark bottles with bright colors to differentiate them, use TALL man lettering (see SIDEBAR), or conduct training so staff is better educated.

 

SIDEBAR; What is TALL man Lettering?

TALL man lettering is the practice of writing part of a drug's name in upper case letters to help distinguish sound-alike, look-alike drugs from one another. The goal is to differentiate drug names visually and avoid medication errors. The Office of Generic Drugs of the U.S. Food and Drug Administration (FDA) encourages manufacturers to use TALL man lettering labels. Many hospitals, clinics, and health care systems use TALL man lettering in their computerized order entry, automated dispensing machines, medication admission records, prescription labels, and drug product labels. Does your system use TALL man lettering? If not, should it?

 

The Institute for Safe Medication Practices creates a list of TALL man lettering for drug names. Most—but not all—of the drugs on the list are generic products. Find the list here: https://www.ismp.org/recommendations/tall-man-letters-list.

 

Here’s a snapshot from the center of the list:

 

Drug Name with TALL Man Letters Confused with
hydrALAZINE hydrOXYzine – HYDROmorphone
HYDROmorphone hydrOXYzine – hydrALAZINE
hydrOXYzine hydrALAZINEHYDROmorphone
medroxyPROGESTERone methylPREDNISolone – methylTESTOSTERone
methylPREDNISolone medroxyPROGESTERone – methylTESTOSTERone
methylTESTOSTERone medroxyPROGESTERone – methylPREDNISolone
mitoXANTRONE Not specified
niCARdipine NIFEdipine
NIFEdipine niCARdipine
prednisoLONE predniSONE
predniSONE prednisoLONE
risperiDONE rOPINIRole
rOPINIRole risperiDONE

 

Source: Reference 11

Table 2. Common Approaches to Medication Error-Related Performance Improvement

Term Definition
Tracking ·       The ability to assess performance; following the course or trail of someone or something, usually to find them or note their location. In pharmacy, this could include:
  • Product identification and verification, detection of and response to suspicion of illegitimate products
  • Record keeping located in pharmacies, distributers, and providers’ records
  • Patient data sharing to assist with medication reconciliation
  • Recording all variances on unusual incident reports
Trending ·       Monitoring the general direction in which something is developing or changing. In pharmacy, monitoring has led to expansion of the pharmacists’ role. Examples include vaccination administration, collaborative practice agreements in certain states, tobacco cessation programs, and point-of-care testing.

·       A method of estimating future costs of health services by reviewing past trends in cost and utilization of those services.

Root cause analysis ·       A full investigation of the causes of unexpected events followed by identification and implementation of appropriate and effective strategies to prevent similar occurrence in the future.

·       Asking “Why?” until it cannot be answered, often employing a “fishbone diagram” that looks at potential issues with materials, machines, methods, environment, measurements, and people.

·       It helps pharmacies take a process-driven, system-based approach to address errors.

Workplace re-engineering ·       Planned elimination, addition, or distribution of functions or duties in the workplace focused on innovative strategies to develop leaders, engage employees, and foster healthy workplace culture.

·       Is often influenced by excessive or insufficient labor, poor patient outcomes, or political or economic changes.

Disaster drill or mock code ·       An exercise or demonstration that tests the readiness and capacity of a hospital, a community, or other systems to respond to a possible public health emergency or other disaster.

Source: References 12, 13, 14, 15, 16, 19

 

In the event a serious error occurs, workplaces need to go beyond simple steps. One such step is to conduct a root cause analysis (RCA). RCA starts by reviewing what and how an event occurred, and expands the investigation to identify why it happened. Many organizations explain to their employees that RCA is the art of asking “Why” until no more questions beginning with “Why” are possible. Armed with that information, the RCA team can develop workable corrective measures that prevent future events of the type observed. RCA is not flawless, but it ensures that teams of people look at very serious errors and develop approaches that could prevent them in the future.20

 

Finally, errors are more likely to occur when unusual, unexpected, or unanticipated situations arise. For this reason, many organizations run disaster drills and observe them closely. In this way, they can identify areas where their systems are weak and implement corrective measures.21

 

Successful Programs

To create the best possible error prevention program, organizations can look at what has been proven to work. It’s clear that behavior-based programs create better outcomes than technology or any other approach.4 A leading researcher in pharmacy error identified six elements common to the most effective behavior-based programs (See Figure 1).4

 

Figure discussing six elements of performance improvement programs

Efforts that address the system and the individual jointly and individually are prudent. Consider a systemic safety measure: the widespread use of technology that is “smart.” Relying on technology and assuming it never fails may make some individuals become complacent and less vigilant until it is too late.4 Examples in community pharmacy are automated inventory systems and bar-code scanners. A person who enters data into a system—this would be an employee in the inventory management section in most pharmacies or healthcare systems—has a slight chance of entering an incorrect drug name. If no one catches the error, the last chance to prevent an error rests with the pharmacist who verifies that the tablet matches the description in the system before it is dispensed to the patient. The final check—a step that cannot and must not be automated—is an individual responsibility. Taking the extra seconds to verify the drug (while remembering that sometimes technology fails) can save a patient’s life from what could have been a deadly mistake.4

 

Many psychosocial factors also influence work performance. Work-as-imagined (work that is anticipated and described in official policies and procedures compiled by administrators or policy makers) and work-as-done (the way that employees actually accomplish work) are often quite different.22 Factors associated with the process of filling prescriptions are shown in Table 3.

 

 

Table 3. Psychosocial Factors that Influence Work Performance

  • Anxiety or depression
  • Changing workload
  • Competing tasks
  • Determination to “get the job done” despite barriers
  • Distraction or interruption
  • Hurrying
  • Insufficient decision support
  • Insufficient staffing
  • Knowledge gaps
  • Lack of experience
  • Lack of non-technical skills training (examples include communication, decision-making, reasoning, team work, time management)
  • Machinery or hardware that is difficult to operate
  • Perception that an error could lead to criminal charges
  • Rapidly changing or evolving roles
  • Use of “work-arounds” (shortcuts or approaches that differ from procedure) to overcome barriers
  • Vague or incomplete policy or procedure

 

Source: References 6, 22, 23, 24

 

The physical environment (inadequate illumination, environmental distractions, and noise), interruptions in workflow, facility design, technology, poorly designed labels, interpersonal relationships (e.g., number of interfaces with people and the level of stress and conflict caused by those interactions), and workload can adversely affect accuracy. 25,26,27

 

Many pharmacy employees associate high workload with increased error rates. They are often surprised to learn that low-workload conditions are more closely linked with errors than high-workload conditions. Consider a study conducted in 2000 that involved pharmacists, pharmacy technicians, and 21,672 prescriptions. Pharmacy employees made more process errors under low-workload conditions (11.2%) than under high-workload conditions (6.1%) and during periods when the workload trended downward in volume (at the start of a shift or after a break).28,29 In general, pharmacists were more vulnerable to mistakes when processing fewer than 15 prescriptions per hour than when processing more than 25 prescriptions per hour. (Author aside: We include these numbers because the study reported them, not as a hard and fast rule. We acknowledge that everyone has unique working habits, and some people can feel burned out processing fewer prescriptions than others.) A little bit of task tension (from perceived workload) seemed to result in fewer errors while filling prescriptions. However, there may be limits to the increases in task tension that would provide desirable results—too much stress and tension can become a problem. Overall, low levels of objective workload and subjective task tension were associated with more errors.26,30

 

Personal qualities can also play a role. Impulsivity, task frustration, fatigue, perceptual ability, concern for doing well, a lack of physical hardiness, and magnitude of personal effort expended can cause more errors to progress through the verification process unnoticed. Individuals should examine their task-related anxiety and overall job-related depression (a strong predictor of overall job stress often manifesting as constant complaining at work, impatience with coworkers, the need for “mental health days,” difficulty getting up on workdays, or physical illnesses) and address them if possible. Supervisors should examine employees’ task-related anxiety and overall job-related depression to help individuals cope; if not, anxiety and depression will affect job satisfaction and performance.4,22

 

Workplace support is also an important factor and the study mentioned earlier also demonstrated its importance. Pharmacists who had supervisors who they perceived as helping them set task goals and gain appropriate autonomy made fewer errors. Pharmacists who had supervisors who were overly autocratic (meaning domineering or overly involved in supervision) experienced tension that interfered with dispensing prescriptions accurately. Pharmacists who believed the number of breaks they receive was adequate to meet their needs made fewer process errors. 26 Later studies also confirm that poor leadership and insufficient support can adversely influence accuracy.22

 

ERRORS: WHAT WE KNOW

 

Errors are inevitable, but we must be able to recognize when we are prone to making errors to be able to limit them. Everyone has periods of increased errors—for instance during dramatic shifts in workload. Entering the pharmacy during peak hours can be stressful and predispose some individuals more than others to make errors they wouldn’t usually make. When we are flustered, our sense of logic escapes us momentarily.4,26

 

Some individuals make more frequent or predictable errors than others because of different cognitive styles. A classic study found that pharmacists whose cognitive styles include attention to details made fewer errors. It also found that about 12% of pharmacists have difficulty attending to details, and that 12% of pharmacists made 33% of errors.26 By using high-intensity task lights, exaggerated product label names (labels that are large and multicolored), NDC numbers, and specially designed devices for holding prescriptions at eye level during data entry, pharmacy staff who had difficulty being attentive to details made fewer errors.26 An 1999 incident monitoring study found poor communication and failure to check medical records when questions arose also contributed to errors.31 A more recent PRIORITIZE study conducted between September 2013 and November 2014 involving 500 North West London primary care clinicians noted the top three problems relating to medication errors in primary care were incomplete medication reconciliation during transitions of care, inadequate patient education about medication use, and poor discharge instructions.32 Clearly, healthcare providers have some communication problems.

 

A patient case in Pennsylvania illustrates the alarming consequences of poor communication between healthcare providers and fewer medication reconciliations. The patient was first hospitalized for uncontrolled blood pressure and acute kidney injury. At the time of discharge, one of her prescription medications was Norvasc® (a high blood pressure medication). The patient experienced worsening fatigue, slow movements, personality changes, and a ‘stoic’ facial expression with suboptimal blood pressure control. Soon after, she was hospitalized the second time for chest pain and underwent angioplasty. Several weeks later, she was diagnosed with anxiety and depression and was prescribed prescription medications for these conditions. The patient was admitted a third time to the emergency room after a fall with light-headedness and poor ambulation. It was only at the third visit when the medication reconciliation team realized her outpatient pharmacy accidentally dispensed Navane® (generic name as thiothixene, an antipsychotic) instead of Norvasc®. When thiothixene was discontinued, her clinical status improved. This preventable medication error occurred because the pharmacy staff and physician deemed the written prescription legible, when in actuality, it was not.8

 

Typically, people make mistakes or slips most frequently when new to the profession and lacking experience. A long period during which mistakes are rare follows. Eventually everyone develops unique work habits, and error rates tend to increase again, usually as bad habits develop.29,33

 

Finally, humans work on autopilot around 80% of the time. This means that 80% of the time, we don’t fully register what we are doing in our brain; we don’t engage with the task at hand and instead just go through the motions. Pharmacists also have an “inner pharmacist” who should kick in and take them out of autopilot mode when issues out of the ordinary arise.30,34,35 Often, when faced with errors after-the-fact, we clearly recall the circumstances under which they occurred because we wake up from our autopilot. We’ll talk more about autopiloting below.

 

How People Work

Workload in the pharmacy has been traditionally measured as the number of prescriptions dispensed per hour or day, or the number of prescriptions dispensed per pharmacist. Experts predict that the typical pharmacist’s workload has and will increase for two reasons:

  • An increase in demand from an aging population and
  • The addition of pharmacist-provided services (examples include medication therapy management, helping women select oral contraceptives in some states, and immunizations).

 

Instead of only focusing on the numbers, pharmacists, pharmacy technicians, and the organizations that employ them should focus on understanding the individual’s subjective experience of work demands. For pharmacists, verifying patient’s information, performing patient consultation and drug utilization reviews, and verifying prescriptions for accuracy can be demanding to the point that high workload negatively impacts performance. For technicians, similar factors—performing repetitive and mundane tasks, expanding roles, and high-risk assignments—may increase stress or create situations in which they must multi-task. Understanding that work is a process and not a series of discrete events can help maintain the “big picture.”30 That big picture is that pharmacists and pharmacy technicians must promote patient safety; dispensing to keep up with the pharmacy queue—the people who are in line or who have called in—is not prudent.36

 

Over the course of the day, filling many prescriptions is bound to cause a person go on autopilot—which is understandable. Humans are creatures of habit and routine. All humans work on autopilot around 80% of the time.4,34,35 Autopiloting occurs when the brain recognizes a situation and rapidly selects appropriate responses using familiar, predictable behavior context. The brain does this to preserve energy. Essentially, we perform most tasks reasonably well without thinking much about them. Many readers will sigh with recognition when they read this example: many people have left home on a non-work day to go someplace that’s in the general direction of work. They may be surprised to find themselves in their workplace’s parking lot. That’s autopilot. In the retail setting, pharmacy technicians and pharmacists autopilot the most when they are dealing with insurance coding and billing to third-party insurers. Autopiloting is usually safe.37

 

Our autopiloting should stop when we encounter stressful situations that are unfamiliar because our brains don’t know how to react appropriately in unfamiliar situations. In stressful situations, we tend to misapply familiar rules and knowledge. Intense emotion blocks out our sense of logic. In these situations, we have to remember to exercise mindfulness—taking a little bit of time away from the regular work stream to assess the situation calmly and proceed with a plan of action.4

 

It’s also crucial for each worker to know his or her own tendency to make errors and do what is necessary to refocus.4 However, all pharmacy employees must recognize that some people’s propensities and capabilities are hardwired.33 They cannot change their abilities and will approach work the same compulsive way, regardless of training.

 

Using technology to help us work is effective, but technology has limitations.38 Technology makes us lazy and unfamiliar with manual processes that have been automated. It is common for individuals to become complacent because we believe a machine designed for a specific purpose will complete the task correctly for us. We tend to trust that technology will work well all the time. It doesn’t.39 For instance, refilling a carousel cassette with the wrong medication will not prevent the machine from filling the prescription. This error can go undetected unless the pharmacist performs a final check before dispensing to the patient. This emphasizes the importance of the pharmacist’s individual responsibility as mentioned earlier.4,39

 

Self-improvement

While all of us prefer not to make errors, expecting an error rate of zero is unreasonable.4 Errors will happen. As noted above, some people make more errors than others, and a landmark study found that 12% of pharmacists made 30% of reported errors.26 Certainly, we all work with others who seem to make a disproportionate share of the workplace’s errors, and those who seem to be remarkably accurate. Where do you fall on the spectrum?

 

Examining your own error rate requires insight. This term—insight—is used most often in psychiatry and is defined as the patient’s awareness and understanding of the origins and meaning of his or her attitudes, feelings, and behavior, and disturbing symptoms.40 It means understanding of oneself. It has a slightly different meaning in the context of medication errors. In problem solving, it means the sudden perception of the appropriate relationships between things that results in a solution.41,42

 

Some people, and especially those who are error-prone, have poor insight. It may result from fixation, over-reliance on experience and past circumstances, rushing to solve a problem, or using the same approach over and over and expecting different results. Let’s look at each of these individually.

 

Fixation error refers to the tendency for the brain’s perceptual field to narrow and shorten in a crisis.43,44 When this happens, we develop a sometimes stymieing compulsion to fixate on the problem we think we can solve, and ignore almost everything else. During periods of fixation, time becomes distorted; minutes often seem longer than usual. In addition, the fixated individual may not hear input from others. Even the most skilled and experienced professionals can develop a fixation in periods of high stress.43,44

 

An example is that of a stalled car stuck on a level crossing as a distant train barrels toward it. The driver starts and restarts the engine, when the best way to save his life is to exit the car and run. In pharmacy, fixation errors occur when the provider concentrates on a single aspect of a case or problem to the detriment of other more relevant aspects. To break out of a fixation, individuals must be able to recognize the demand for a new approach to the problem and to produce a solution that works. Individuals who tend to fixate need to learn to43,44

  • Ask themselves what is different about the current problem
  • Heighten awareness of the people around them and listen
  • Invite others into the problem solving team to identify alternatives

 

Over-reliance on experience and past circumstances often occurs during emergencies. In this case, the individual tends to rely on past experience (even if it doesn’t apply in the current situation), and have difficulty abandoning assumptions based on that experience. In short, the person applies incident-specific experience to a situation that is probably much broader in nature. An example would be investigating why a patient who has asthma is experiencing exacerbations. If the pharmacist assumes the problem is treatment nonadherence when the actual problem is that the inhaler is faulty or requires skills like visual acuity or manual dexterity that the patient does not possess, the assumption can be deadly. In addition, during emergencies, individuals may have trouble recalling information accurately (elevated cortisol levels tend to change cognition and thinking). Often, using a cognitive aid like a checklist, decision tree, or an algorithm can help clarify thinking and lead to faster—and better—solutions.45

 

It’s interesting that many pharmacy staff members say, “I was rushing,” when they analyze errors, but few studies looked at or identified rushing as a cause. Rushing to problem-solve can increase the likelihood of error. An older study found that physicians linked 10% of errors to rushing or fatigue.31 Experts in medication error science also indicate that rushing contributes to error.46 An older study in Canada looked at a pilot program that transferred order entry responsibilities from pharmacists to pharmacy technicians. At the end of the study, the error rate had increased from 2.5% to 6%. Analysis indicated that technicians were rushing to enter orders, and re-training technicians to slow down and be mindful reduced the error rate to below the baseline level.47 Often, technicians may try to fill more quickly, or pharmacists rush the final verification step of dispensing as the customer line lengthens, and errors occur.

 

One area of growing interest is interruptions and interruption management.48,49 Interruptions have been shown to increase the medication error rate, and some studies suggest a technique called interruption management. They suggest using a “do not interrupt” sign or even a piece of clothing that warns people to stay away until the healthcare professional completes the task. They also recommend using a checklist for multistep processes. At this time, it’s unclear if these interventions help.48,49

 

Finally, many of us have fallen victim to a common dilemma: using the same approach over and over and expecting different results.4 Healthcare practitioners as a rule, do many tasks—even complicated ones—from memory rather than from following a checklist. Over time, and especially when we see our error rates beginning to climb upward, it’s important to look at our own work and consider ways in which we need to adjust or change (see Table 4). We cannot rely on what we did before. Over time, people change, workplaces change, and many of the problem’s underlying elements change.4 As we analyze errors, we must include what we’ve learned in the past, but be open to fresh approaches and ideas.

 

Table 4. Improving Your Own Accuracy

Do this…. And then do this…
Periodically review your errors and near-misses. Analyze errors to determine if you see a trend like confusing look-alike, sound-alike or spell-alike drugs.

Determine if you can take steps to reduce the likelihood of a similar error happening again.

Develop and use checklists if errors occur in multi-step processes.

Schedule visual and hearing exams more frequently as you age. Wear appropriate glasses or hearing aids at work.

Ask your employer for assistive devices (supplemental lighting, a magnifier, or a phone amplifier), or secure these yourself.

Solicit feedback from peers and supervisors about ways to reduce your own and others’ errors. Maintain a quiet, composed demeanor in the workplace.
Address workplace distractions as soon as you become aware of them. Reduce noise and clutter, improve lighting.
Understand technology’s limitations. Maintain your skills so that if technology fails, you can revert to the pre-technology work method.
Value relationships with coworkers and promote good organizational dynamics. Resolve disputes immediately, and retire grudges.

Provide feedback to coworkers constructively.

Address developing personal problems (alcohol abuse, marital discord) early.

 

Engage with your employer’s employee assistance program before your supervisor refers you.
Understand that some people make errors because they lack knowledge. Address your own knowledge gaps, and promote a culture of learning.
Avoid relying on “workplace re-engineering” or “work task design” to prevent errors; these may fail as the workplace composition and focus changes. Learn to engage and listen to your “inner pharmacist” or “inner technician” when something is out of the ordinary.

 

 

When we discuss medication errors, it’s critical to talk about data entry errors because they represent about 25% of all medication errors.25 The pharmacy has many repetitive tasks like data entry or filling prescriptions. Many of these tasks can be completed without conscious awareness. This ‘autopilot’ function contributes to data entry errors like misspellings or errors recorded on the patient’s profile. The vast majority of data entry errors are inconsequential, but some are dangerous.25

 

Many factors could impact the cognitive system directly. Pharmacists and pharmacy technicians can take some simple steps to increase accuracy in the pharmacy. Figure 2 suggests a few, but individuals will find the best solutions are those they develop themselves and tailor to their own habits and circumstances.

 

Figure discussing four error prevention techniques in the pharmacy

 

Reducing Workplace Turbulence

Workplace turbulence occurs when something causes discomfort or decreases workplace stability. Some things that cause workplace turbulence include poor temperature control (it’s either too hot or too cold), noise, clutter, uncertainty, or working with people who have different styles or personalities that are abrasive to you. These things affect accuracy and productivity. If workplace distractions are the problem, making small changes to decrease turbulence can make large differences.29,33

 

If the problems are environmental, ask the appropriate person to help resolve them. Establishing good relationships with the people who provide environmental support—people in building supervision, maintenance, and housekeeping—is imperative. They can often help adjust the ambient temperature or reduce clutter. Learning to work with instead of against or parallel to coworkers and supervisors can improve the environment.4 The key is telling your supervisor how you best hear constructive criticism and delivering constructive criticism to others in a positive way—and in the way they receive it best.

 

Finally, be aware of when you are fatigued or unable to perform at your peak and enlist coworkers' help by asking them to monitor your work.29,33

 

Poka-Yoke

Since the 1960s, many industries have adopted the principles of poka-yoke, also called “mistake-proofing,” to prevent errors.50 Poka-yoke is a systems approach, but unlike many systems approaches, the people closest to the work (not administrators or policy makers) propose the action. Defined broadly, poka-yoke refers to any behavior-shaping constraint in a process that prevents faulty behaviors by the worker. An industrial engineer at Toyota developed this concept, and it encourages workplaces to look at common mistakes and develop processes that make it impossible for workers to make the mistake in the future. Basically, it’s defensive workplace design. It depends on involving the people closest to the work to identify what to mistake-proof and develop ideas to prevent very specific mistakes. In pharmacies, four poka-yoke principles are used often, and can be applied in many more areas.50-52

 

First, workplace managers need to empower employees to pause or even stop the work process entirely if they believe that an error is in process.29 Employees need to be able to ask four questions respectfully:

  • Did we do everything?
  • Did we do everything right?
  • Does it look, sound and feel right?
  • Are these our usual work conditions?

 

Next, everyone in the pharmacy community from manufacturers to distributors to providers who work in direct patient care need to make it easier for people to do the right thing than the wrong thing. A short example can clarify this principle. Years ago at the National Cancer Institute, a collaborating company was developing a new monoclonal antibody (MAB). The MAB was lyophilized and came in a fairly large multidose vial. It needed to be reconstituted with 20 mL of a specific diluent. The manufacturer provided the MAB with a vial of the diluent that contained 30 mL. The astute reader will see the potential for error. In many cases, pharmacists and pharmacy technicians who worked in investigational drug preparation looked at the package, and simply transferred the diluent—all 30 mL of it—into the larger vial. The resultant solution was an incorrect dose. Can you see why? Diluting a 400 mg vial with 20 mL creates a 20 mg/mL solution. Using 30 mL creates a 13.33 mg/mL solution. After investigational drug employees identified and reported this error several times, and the NCI reported it to the manufacturer, the simple poka-yoke fix was implemented. Although it took quite some time to implement the change, eventually the manufacturer packaged the MAB with a vial of diluent that had the correct amount needed in it—20 mL.

 

People who work in pharmacy in any capacity can make it easier to do the right thing than the wrong thing in numerous ways. Let’s discuss four of them.

  • Putting items that will always be used together in that same container, and making sure that the items that are assembled are the correct sizes or doses or quantities, is kitting at work. It results in fewer missing parts, and it also speeds your process. Some experts estimate that it can cut errors by as much as 80%.53 The solution noted above is an example of kitting. Other examples of kitting are creating bowel evacuation kits for patients having colonoscopies, or assembling packages of items that are frequently prescribed together for specific procedures or treatments.
  • Keying simply means that a process can’t be started without a key or tool of some sort. The requirement to remove your ATM card before receiving cash is an application of this principle so people don’t leave their cards in the machine. An example in the pharmacy is a computer that requires the user to insert an ID card to start the system. This increases accuracy and prevents users from signing in early in the day, walking away from the computer, and allowing others to operate under an incorrect sign-in code. Another example of a type of keying is moving pseudoephedrine to behind the counter in the pharmacy. Adding that step—requiring customers to sign for pseudoephedrine and limiting quantities—ensures there is a check in the process. States that have implemented this step have decreased the amount of pseudoephedrine diverted to methamphetamine production significantly.
  • Interlocking uses simple mechanisms so that parts will only fit with other appropriate pieces. These are simple, low cost devices that prevent parts from being assembled incorrectly. An everyday example of poka-yoke for someone who always forgets or loses his keys is to place the keys in the shoes he will wear tomorrow. An example in pharmacy might be providing drugs meant to be administered intrathecally in a device that cannot attach to any intravenous equipment.
  • Tell-tales let you know when you have made an error. Barcoding is a type of telltale. When you scan a barcode and it doesn’t match the barcode on the actual order, it sends you an alert that you’ve made an error.

 

The last poke yoke principle we’ll cover is this: Make mistakes obvious to workers immediately and discretely so they can make on-the-spot corrections, and allow people to take corrective actions or stop the work flow before irreversible damage is done. This small kindness brings errors to the error-maker’s attention, and allows immediate learning.

 

CONCLUSION

Despite our best intentions, some errors escape the confines of the pharmacy. Randomly checking completed work that has apparently passed verification sometimes identifies problem areas. But, some errors are just that—unfortunate events that could not be anticipated and occurred due to a confluence of factors. Even though reaching a medication error rate of zero is improbable, we should still make efforts to acknowledge our professional responsibility in our own work habits. Creating solutions tailored to our habits and circumstances can help reduce error rates and encourage a focus on a workplace culture of patient safety—not the number of prescriptions filled—as the big picture in pharmacy.

 

 

Pharmacist Post Test (for viewing only)

LEARNING OBJECTIVES
After participating in this activity, pharmacists and pharmacy technicians will be able to:
1. Discuss the difference between systemic approaches to medication errors and individual (personal) responsibilities for medication errors
2. Outline various causes for medications errors that can be traced back to individuals
3. Discuss ways in which peoples’ unique work habits influence their propensity to make errors
4. Identify methods to reduce an individual’s medication error rate and apply them appropriately

1. Which of these can INCREASE the chance of making errors?
A. Labeling of common look-alike, sound-alike drugs on shelves
B. Working on autopilot to perform tasks that are very routine
C. Working during a dramatic increase or decrease in workload

2. Which is an example of individual responsibility for medication errors?
A. A hospital administration implements autofill functions in the computer software to improve efficiency
B. A pharmacist provides the final check of a prescription after the prescription bottle comes out of the carousel
C. A manufacturer packages an intramuscular injection and its diluent in proper quantities in the same box

3. Eloise is a pharmacist at your hospital pharmacy. She is a reliable employee and one of the most skilled and experienced members of the pharmacy team. She has good recollection, even in stressful situations, but she tends to fixate when dealing with emergencies. If this situation occurs, which of the following should she perform FIRST?
A. Isolate herself from the people around her so she can think
B. Try to rectify the problem based on her past experiences
C. Take a moment to ask herself what’s different about this problem

4. What have studies of errors in healthcare found to be TRUE?
A. Eventually everyone’s error rate increases after a period of time working in their profession.
B. Addressing the system and individual jointly and individually is useless for analyzing errors.
C. Technology creates better outcomes than behavior-based programs.

5. What was the cause of the medication error in the Pennsylvania patient case described in this CE activity?
A. Poor communication
B. Bad work habits
B. Autopiloting

6. Which one of these is an example of how can individuals can improve their personal medication error rates?
A. Using the same approach over and over for different situations for consistency
B. Pointing out other team members’ mistakes so others will not do the same thing
C. Applying what you know works well while being open to fresh approaches and ideas

7. Mike is a pharmacy technician who works in a community retail pharmacy. He prides himself on being a people-person and receiving good feedback from patients. Last month while chatting with customers, he accidentally reconstituted an antibiotic medication with too much diluent. The pharmacist dispensed it and the patient now has a resistant infection due to receiving suboptimal treatment. As the pharmacist filled out an incident report, he told ML to stop talking with the customers and focus on his work. Since then, ML has become quieter. Patients have noticed his change in demeanor and brought it up with the pharmacist. What do you think the pharmacist should do next?
A. Tell patients that nothing’s wrong with Mike. He’s just focusing on his work because he made an error when he was distracted previously.
B. Ask Mike if he has a moment to talk about last week’s incident, apologize, to him and ask how Mike would prefer to hear criticism in the future.
C. Disregard their concerns – Mike was a chatter box who needed to learn how to limit his talking sooner rather than later.

8. Which of the following statements describe how the workload in the pharmacy should be measured?
A. The number of prescriptions per hour or day
B. The individual’s subjective experience of work demands
C. The number of prescriptions per pharmacist

9. CJ is an experienced pharmacist. With a growing number of tasks, CJ has been struggling to stay afloat. On a busy afternoon, CJ administered multiple immunizations and answered dozens of phone calls. The wait time was longer and longer. CJ made a list of his remaining tasks. He decides to rush through prescriptions to clear the queue. Which of the following could contribute to increased risk of medication error and is within CJ’s control?
A. The growing list of tasks to be done as a pharmacist
B. A particularly busy work day or time of day at the pharmacy
C. Rushing without addressing ways to readjust to accommodate for new tasks

10. Which factors help reduce medication error?
A. Leaving conflicts in the workplace unresolved and unacknowledged
B. Avoiding personal problems until they become a problem at the work place
C. Creating a safe environment for individuals involved in the error

11. Which of the following is a cognitive factor that influences workplace performance?
A. Changing workload
B. Insufficient staffing
C. Attention to detail

12. Which is an example of a SYSTEMIC approach that would increase medication errors?
A. A pharmacist performs final verification of a prescription after final packaging
B. The pharmacy implements automated inventory systems, autofill, and bar code scanners
C. A technician carefully checks for expiration dates and disposes medication accordingly

13. Which of the following would INCREASE an individual’s medication error rate?
A. Relying on technology whenever possible and utilize more “smart technology”
B. Maintaining skills so that if technology fails, you can revert to manual work methods
C. Wearing appropriate glasses, secure assistive devices or hearing aids at work.

14. Which of the following will INCREASE medication errors that are traced back to individuals?
A. Employees routinely examine their task-related anxiety and job-related depression
B. The pharmacy has poor leadership and insufficient support for employees
C. Pharmacy employees believe the number of breaks they receive are adequate

Pharmacy Technician Post Test (for viewing only)

LEARNING OBJECTIVES
After participating in this activity, pharmacists and pharmacy technicians will be able to:
1. Discuss the difference between systemic approaches to medication errors and individual (personal) responsibilities for medication errors
2. Outline various causes for medications errors that can be traced back to individuals
3. Discuss ways in which peoples’ unique work habits influence their propensity to make errors
4. Identify methods to reduce an individual’s medication error rate and apply them appropriately

1. Which of these can INCREASE the chance of making errors?
A. Labeling of common look-alike, sound-alike drugs on shelves
B. Working on autopilot to perform tasks that are very routine
C. Working during a dramatic increase or decrease in workload

2. Which is an example of individual responsibility for medication errors?
A. A hospital administration implements autofill functions in the computer software to improve efficiency
B. A pharmacist provides the final check of a prescription after the prescription bottle comes out of the carousel
C. A manufacturer packages an intramuscular injection and its diluent in proper quantities in the same box

3. Eloise is a pharmacist at your hospital pharmacy. She is a reliable employee and one of the most skilled and experienced members of the pharmacy team. She has good recollection, even in stressful situations, but she tends to fixate when dealing with emergencies. If this situation occurs, which of the following should she perform FIRST?
A. Isolate herself from the people around her so she can think
B. Try to rectify the problem based on her past experiences
C. Take a moment to ask herself what’s different about this problem

4. What have studies of errors in healthcare found to be TRUE?
A. Eventually everyone’s error rate increases after a period of time working in their profession.
B. Addressing the system and individual jointly and individually is useless for analyzing errors.
C. Technology creates better outcomes than behavior-based programs.

5. What was the cause of the medication error in the Pennsylvania patient case described in this CE activity?
A. Poor communication
B. Bad work habits
B. Autopiloting

6. Which one of these is an example of how can individuals can improve their personal medication error rates?
A. Using the same approach over and over for different situations for consistency
B. Pointing out other team members’ mistakes so others will not do the same thing
C. Applying what you know works well while being open to fresh approaches and ideas

7. Mike is a pharmacy technician who works in a community retail pharmacy. He prides himself on being a people-person and receiving good feedback from patients. Last month while chatting with customers, he accidentally reconstituted an antibiotic medication with too much diluent. The pharmacist dispensed it and the patient now has a resistant infection due to receiving suboptimal treatment. As the pharmacist filled out an incident report, he told ML to stop talking with the customers and focus on his work. Since then, ML has become quieter. Patients have noticed his change in demeanor and brought it up with the pharmacist. What do you think the pharmacist should do next?
A. Tell patients that nothing’s wrong with Mike. He’s just focusing on his work because he made an error when he was distracted previously.
B. Ask Mike if he has a moment to talk about last week’s incident, apologize, to him and ask how Mike would prefer to hear criticism in the future.
C. Disregard their concerns – Mike was a chatter box who needed to learn how to limit his talking sooner rather than later.

8. Which of the following statements describe how the workload in the pharmacy should be measured?
A. The number of prescriptions per hour or day
B. The individual’s subjective experience of work demands
C. The number of prescriptions per pharmacist

9. CJ is an experienced pharmacist. With a growing number of tasks, CJ has been struggling to stay afloat. On a busy afternoon, CJ administered multiple immunizations and answered dozens of phone calls. The wait time was longer and longer. CJ made a list of his remaining tasks. He decides to rush through prescriptions to clear the queue. Which of the following could contribute to increased risk of medication error and is within CJ’s control?
A. The growing list of tasks to be done as a pharmacist
B. A particularly busy work day or time of day at the pharmacy
C. Rushing without addressing ways to readjust to accommodate for new tasks

10. Which factors help reduce medication error?
A. Leaving conflicts in the workplace unresolved and unacknowledged
B. Avoiding personal problems until they become a problem at the work place
C. Creating a safe environment for individuals involved in the error

11. Which of the following is a cognitive factor that influences workplace performance?
A. Changing workload
B. Insufficient staffing
C. Attention to detail

12. Which is an example of a SYSTEMIC approach that would increase medication errors?
A. A pharmacist performs final verification of a prescription after final packaging
B. The pharmacy implements automated inventory systems, autofill, and bar code scanners
C. A technician carefully checks for expiration dates and disposes medication accordingly

13. Which of the following would INCREASE an individual’s medication error rate?
A. Relying on technology whenever possible and utilize more “smart technology”
B. Maintaining skills so that if technology fails, you can revert to manual work methods
C. Wearing appropriate glasses, secure assistive devices or hearing aids at work.

14. Which of the following will INCREASE medication errors that are traced back to individuals?
A. Employees routinely examine their task-related anxiety and job-related depression
B. The pharmacy has poor leadership and insufficient support for employees
C. Pharmacy employees believe the number of breaks they receive are adequate

References

Full List of References

 

References

 

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  5. “Lessons We Don't Learn: A Study of the Lessons of Disasters, Why We Repeat Them, and How We Can Learn Them.” January 15, 2015. HOMELAND SECURITY AFFAIRS. Accessed December 27, 2022. www.hsaj.org/articles/167
  6. Sutherland A, Ashcroft DM, Phipps DL. Exploring the human factors of prescribing errors in paediatric intensive care units. Arch Dis Child. 2019;104(6):588-595. doi:10.1136/archdischild-2018-315981
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  8. Croft H, Nesbitt K, Rasiah R, Levett-Jones T, Gilligan C. Safe dispensing in community pharmacies: applying the software, hardware, environment and liveware (SHEL) model. Pharmaceutical J. 2017;9(7): DOI: 10.1211/CP.2017.20202919. Accessed December 27, 2022. https://www.pharmaceutical-journal.com/research/safe-dispensing-in-community-pharmacies-applying-the-software-hardware-environment-and-liveware-shell-model/20202919.article
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  22. Gouraud J, Delorme A, Berberian B. Autopilot, mind wandering, and the out of the loop performance problem. Front Neurosci. 2017;11:541.
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  29. Jenkins B. Cognitive aids: time for a change? Anaesthesia. 2014;69:655–668.
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  31. Tierney M, McLurg D, Macmillan C. Transferring medication order entry from pharmacists to pharmacy technicians. JCPH. 1999;52(4):240-243.
  32. Lapkin S, Levett-Jones T, Chenoweth L, Johnson M. The effectiveness of interventions designed to reduce medication administration errors: a synthesis of findings from systematic reviews. J Nurs Manag. 2016;24(7):845-858. doi:10.1111/jonm.12390
  33. Castro-Rodríguez C, De Lucas-Volle S, González-Roca I, Diaz-Redondo A, Mora-Capín A, Marañón R. Professionals' Perception of a Strategy to Avoid Interruptions During Medication Handling. J Patient Saf. 2023;19(1):29-35. doi:10.1097/PTS.0000000000001082
  34. Soliman-Junior, J., Tzortzopoulos, P., and Kagioglou, M. 2020. “Exploring Mistakeproofing in Healthcare Design.” In: Tommelein, I.D. and Daniel, E. (eds.). Proc. 28th Annual Conference of the International Group for Lean Construction (IGLC28), Berkeley, California, USA, doi.org/10.24928/2020/0034
  35. Van Scyoc K. Process safety improvement--quality and target zero. J Hazard Mater. 2008;159(1):42-48.
  36. Kumar S, Steinebach M. Eliminating US hospital medical errors. Int J Health Care Qual Assur. 2008;21(5):444-471.
  37. China Manufacturing Consultants. 6 Poka Yoke (mistake proofing) techniques that most factories overlook. Accessed December 22, 2022. http://www.cmc-consultants.com/blog/6-poka-yoke-mistake-proofing-techniques-that-most-factories-overlook

 

 

Patient Safety: Medication Refusal: Understanding the Why “They Just Say No”

Learning Objectives

 

After completing this application-based continuing education activity, pharmacists will be able to

Recognize and define types and leading causes of treatment/medication refusal
Describe the ethical and legal principles associated with medication refusal, covert medication, and surreptitious prescribing
Determine treatment alternatives for patients with dietary, religious, or other restrictions
Identify and implement key components of a medication refusal protocol

    After completing this application-based continuing education activity, pharmacy technicians will be able to

    Recognize and define types and leading causes of treatment/medication refusal
    Describe the ethical and legal principles associated with medication refusal, covert medication, and surreptitious prescribing
    Determine treatment alternatives for patients with dietary, religious, or other restrictions
    Identify and implement key components of a medication refusal protocol

     

    Release Date: October 17, 2023

    Expiration Date: October 15, 2026

    Course Fee

    Pharmacists: $7

    Pharmacy Technicians: $4

    There is no grant funding for this CE activity

    ACPE UANs

    Pharmacist: 0009-0000-23-047-H05-P

    Pharmacy Technician: 0009-0000-23-047-H05-T

    Session Codes

    Pharmacist:  20YC80-TRX39

    Pharmacy Technician:  20YC80-XRT42

    Accreditation Hours

    2.0 hours of CE

    Accreditation Statements

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-047-H05-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

     

    Disclosure of Discussions of Off-label and Investigational Drug Use

    The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

    Faculty

    Danielle Haskins, PharmD
    CVS Pharmacy Manager
    Santee, CA

     

    Ming May Zhang, PharmD Candidate 2022
    University of Connecticut School of Pharmacy
    Storrs, CT

    Faculty Disclosure

    In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

    Danielle Haskins and Ming May Zhang  do not have any financial relationships with ineligibile companies.

     

    ABSTRACT

    Based on the principle of informed consent, competent patients always
    have the right to refuse medical treatment. Patients may refuse treatment
    for a variety of reasons, including dietary restrictions, religious reasons, medical
    misconceptions, a desire to avoid adverse effects, and mistrust of the medical
    team. Patient refusals can create serious dilemmas in the healthcare setting. On
    the one hand, clinicians have an ethical and legal obligation to honor patient autonomy.
    On the other hand, a patient’s refusal of treatment often leads to adverse
    medical outcomes, resulting in harm to the patient. Healthcare
    professionals should search for acceptable treatment alternatives that honor patients’
    wishes while meeting their medical needs. Every institution—whether in
    the community, long-term care, or inpatient setting—should have a protocol to
    guide and standardize the approach to managing treatment refusals. In complex
    cases, it may be beneficial to use expert ethics consultations.

    CONTENT

    Content

    ONLY PDF version is Available for this CE

     

     

    Pharmacist Post Test (for viewing only)

    Medication Refusal: Understanding the Why "They Just Say No"
    After participating in this activity, pharmacists and pharmacy technicians will be able to
    1. Recognize and define types and leading causes of treatment/medication refusal
    2. Describe the ethical and legal principles associated with medication refusal, covert medication, and surreptitious prescribing
    3. Determine treatment alternatives for patients with dietary, religious, or other restrictions
    4. Identify and implement key components of a medication refusal protocol

    1. Which of the following is an example of ACTIVE medication refusal?
    a. A patient ingests her medication when the caregiver administers it, but secretly spits it out half an hour later.
    b. A patient states that she does not wish to take her oral medication, then refuses to open her mouth to ingest the medication.
    c. A patient initially refuses to take her medication, but concedes when the caregiver repeatedly asks her to.

    2. A patient states that he is vegetarian and wishes to avoid animal products. Which of the following excipients is INAPPROPRIATE for this patient?
    a. Gelatin
    b. Peanut oil
    c. Mannitol

    3. Which of the following best describes motivational interviewing?
    a. An interviewing style that involves the use of ethics counselors, who help healthcare professionals navigate complicated cases
    b. The process by which patients are educated about a treatment’s risks, benefits, and alternatives
    c. A behavioral technique that motivates patients to change by empowering them and motivating them with their own values

    4. Which of the following statements is FALSE about the practice of covert medication?
    a. It refers to administering medications without a patient’s knowledge, such as by concealing medications in food or drink.
    b. It is justifiable in mentally competent patients who refuse treatment against medical advice.
    c. It may be better received than more aggressive methods, such as forced injections.

    5. A practicing Sikh patient tells you that her religion prevents her from consuming Medication X, which contains animal by-products. She wants to know what alternatives are available, and what she should avoid. Which of the following best describes her reasons for refusing Medication X?
    a. Dietary restriction
    b. Medical misconception
    c. Mistrust of the medical team

    6. A practicing Sikh patient tells you that her religion prevents her from consuming Medication X, which contains animal by-products. She wants to know what alternatives are available, and what she should avoid. Which is the best resource to refer her to?
    a. Pillbox, so she can research medications’ ingredients and avoid those containing animal products
    b. The primary literature and PubMed or GoogleScholar, so she can find the most recent data
    c. The patient should not be referred; Medication X is the most effective option for her illness, and she should take it regardless of her beliefs

    7. Why might an ethics consultation be useful in certain instances of treatment refusal?
    a. Ethics counselors are authorized to make healthcare decisions on behalf of incompetent patients.
    b. Ethics counselors are compensated based on patient outcomes, so they persuade patients to choose the most medically effective option.
    c. Ethics counselors are trained in core ethics and healthcare competencies and can help navigate difficult situations.

    8. Patient BT is newly diagnosed with a disease. His doctor recommends Treatment X and describes the treatment’s risks and benefits. BT refuses his doctor’s suggestion. Instead, he decides to try natural OTC products. This is an example of:
    a. Beneficence
    b. Primum non nocere
    c. Autonomy

    9. Patient BT is newly diagnosed with a disease. His doctor recommends Treatment X and describes the treatment’s risks and benefits. BT refuses his doctor’s suggestion. Instead, he decides to try natural OTC products. Which of the following is the LEAST appropriate response to BT?
    a. Inform BT of the risks and benefits of OTC products, and show him how to interpret the Drug Facts labels.
    b. Identify BT’s reason for refusal—ask about his beliefs, perceptions, and concerns. Counsel him accordingly.
    c. Inform BT that you will request an ethics consultation to advise in this situation, which in your opinion is untenable.

    10. Patient WG is prescribed a new medication and told to take one capsule twice a day. WG misunderstands—he takes two capsules once a day, instead. Which of the following best describes WG’s behavior?
    a. Intentional non-adherence
    b. Unintentional non-adherence
    c. Passive refusal

    11. Patient AU tells you, “Dr. S prescribed five different pills for me, but I’m not taking any of them. I’m a regular churchgoer and I know I should love and respect all people, but I don’t have a good feeling about Dr. S. I think she has it out for me. I’m going to get the meds from Dr. G instead.” Based on this statement, AU’s primary reason for refusal is:
    a. Religious refusal
    b. Lack of belief in the medications’ effect
    c. Mistrust of the medical provider

    12. Patient LG is a 5-year-old female who requires a life-saving blood transfusion. Her caretaker refuses to consent to the procedure since it goes against her religious beliefs. Which of the following statements is TRUE of this situation?
    a. The attending physician must request an ethics consultation, since this is legally required for all cases involving a minor.
    b. LG’s caretaker has the ultimate say in her medical decisions but LG’s doctors are ethically obligated do what is beneficial for the patient.
    c. Since LG does not suffer from any brain disorders, she can make her own medical decisions. The medical team only needs LG’s consent, not the caretaker’s.

    Pharmacy Technician Post Test (for viewing only)

    Medication Refusal: Understanding the Why "They Just Say No"
    After participating in this activity, pharmacists and pharmacy technicians will be able to
    1. Recognize and define types and leading causes of treatment/medication refusal
    2. Describe the ethical and legal principles associated with medication refusal, covert medication, and surreptitious prescribing
    3. Determine treatment alternatives for patients with dietary, religious, or other restrictions
    4. Identify and implement key components of a medication refusal protocol

    1. Which of the following is an example of ACTIVE medication refusal?
    a. A patient ingests her medication when the caregiver administers it, but secretly spits it out half an hour later.
    b. A patient states that she does not wish to take her oral medication, then refuses to open her mouth to ingest the medication.
    c. A patient initially refuses to take her medication, but concedes when the caregiver repeatedly asks her to.

    2. A patient states that he is vegetarian and wishes to avoid animal products. Which of the following excipients is INAPPROPRIATE for this patient?
    a. Gelatin
    b. Peanut oil
    c. Mannitol

    3. Which of the following best describes motivational interviewing?
    a. An interviewing style that involves the use of ethics counselors, who help healthcare professionals navigate complicated cases
    b. The process by which patients are educated about a treatment’s risks, benefits, and alternatives
    c. A behavioral technique that motivates patients to change by empowering them and motivating them with their own values

    4. Which of the following statements is FALSE about the practice of covert medication?
    a. It refers to administering medications without a patient’s knowledge, such as by concealing medications in food or drink.
    b. It is justifiable in mentally competent patients who refuse treatment against medical advice.
    c. It may be better received than more aggressive methods, such as forced injections.

    5. A practicing Sikh patient tells you that her religion prevents her from consuming Medication X, which contains animal by-products. She wants to know what alternatives are available, and what she should avoid. Which of the following best describes her reasons for refusing Medication X?
    a. Dietary restriction
    b. Medical misconception
    c. Mistrust of the medical team

    6. A practicing Sikh patient tells you that her religion prevents her from consuming Medication X, which contains animal by-products. She wants to know what alternatives are available, and what she should avoid. Which is the best resource to refer her to?
    a. Pillbox, so she can research medications’ ingredients and avoid those containing animal products
    b. The primary literature and PubMed or GoogleScholar, so she can find the most recent data
    c. The patient should not be referred; Medication X is the most effective option for her illness, and she should take it regardless of her beliefs

    7. Why might an ethics consultation be useful in certain instances of treatment refusal?
    a. Ethics counselors are authorized to make healthcare decisions on behalf of incompetent patients.
    b. Ethics counselors are compensated based on patient outcomes, so they persuade patients to choose the most medically effective option.
    c. Ethics counselors are trained in core ethics and healthcare competencies and can help navigate difficult situations.

    8. Patient BT is newly diagnosed with a disease. His doctor recommends Treatment X and describes the treatment’s risks and benefits. BT refuses his doctor’s suggestion. Instead, he decides to try natural OTC products. This is an example of:
    a. Beneficence
    b. Primum non nocere
    c. Autonomy

    9. Patient BT is newly diagnosed with a disease. His doctor recommends Treatment X and describes the treatment’s risks and benefits. BT refuses his doctor’s suggestion. Instead, he decides to try natural OTC products. Which of the following is the LEAST appropriate response to BT?
    a. Inform BT of the risks and benefits of OTC products, and show him how to interpret the Drug Facts labels.
    b. Identify BT’s reason for refusal—ask about his beliefs, perceptions, and concerns. Counsel him accordingly.
    c. Inform BT that you will request an ethics consultation to advise in this situation, which in your opinion is untenable.

    10. Patient WG is prescribed a new medication and told to take one capsule twice a day. WG misunderstands—he takes two capsules once a day, instead. Which of the following best describes WG’s behavior?
    a. Intentional non-adherence
    b. Unintentional non-adherence
    c. Passive refusal

    11. Patient AU tells you, “Dr. S prescribed five different pills for me, but I’m not taking any of them. I’m a regular churchgoer and I know I should love and respect all people, but I don’t have a good feeling about Dr. S. I think she has it out for me. I’m going to get the meds from Dr. G instead.” Based on this statement, AU’s primary reason for refusal is:
    a. Religious refusal
    b. Lack of belief in the medications’ effect
    c. Mistrust of the medical provider

    12. Patient LG is a 5-year-old female who requires a life-saving blood transfusion. Her caretaker refuses to consent to the procedure since it goes against her religious beliefs. Which of the following statements is TRUE of this situation?
    a. The attending physician must request an ethics consultation, since this is legally required for all cases involving a minor.
    b. LG’s caretaker has the ultimate say in her medical decisions but LG’s doctors are ethically obligated do what is beneficial for the patient.
    c. Since LG does not suffer from any brain disorders, she can make her own medical decisions. The medical team only needs LG’s consent, not the caretaker’s.

    References

    Full List of References

    References

       

      These can be found on the pdf version of the CE

      LAW: Getting Soft on “Hard” Drugs?

      Learning Objectives

       

      After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able to

      ·       DESCRIBE regulation of controlled substances and how it has changed over time
      ·        INDICATE how drugs are regulated internationally
      ·       CHARACTERIZE state and local actions that are loosening the regulation of controlled substances
      ·       DISCUSS the pros and cons of drug decriminalization

       

      Picture of mushrooms on a blank white background

      Release Date:

      Release Date:  April 15, 2023

      Expiration Date: April 15, 2026

      Course Fee

      Pharmacists: $7

      Pharmacy Technicians: $4

      There is no grant funding for this CE activity

      ACPE UANs

      Pharmacist: 0009-0000-23-015-H03-P

      Pharmacy Technician: 0009-0000-23-015-H03-T

      Session Codes

      Pharmacist:  23YC15-XBC24

      Pharmacy Technician:  23YC15-CBX42

      Accreditation Hours

      2.0 hours of CE

      Accreditation Statements

      The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-015-H03-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

       

      Disclosure of Discussions of Off-label and Investigational Drug Use

      The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

      Faculty

      Gerald Gianutsos, PhD, JD
      Emeritus Associate Professor of Pharmacology
      University of Connecticut School of Pharmacy
      Storrs, CT


       

      Faculty Disclosure

      In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

      Dr. Gianutsos has no relationship with ineligible companies and therefore has nothing to disclose.

       

      ABSTRACT

      Early in the 20th Century, what are now called controlled substances were regularly available for retail purchase. Over the course of the last 100 years, the regulation of many drugs has become stricter and, since 1970, are subject to the restraints of the Controlled Substances Act. In 1996, some states began easing restrictions on the use and possession of marijuana. More recently, many municipalities and a few states (and some counties) have decriminalized the possession of an increasing number of controlled substances. This continuing education activity will review the national and international regulatory oversight of controlled substances and discuss the characteristics of some of the recent international, state, and local actions that have reduced penalties and continue the trend towards a more public health emphasis on drug control.

      CONTENT

      Content

      INTRODUCTION

       

      Congress, in order to reduce the black market in illegal drugs, should begin taking incremental steps toward making drugs less of a criminal justice responsibility and more of a public health responsibility.1

      --Former Baltimore Mayor Kurt L. Schmoke

       

      Has the time arrived for the incremental steps that Mayor Schmoke envisioned more than 30 years ago? One does not need to look any further than marijuana, which has been a tightly controlled substance in the U.S. for more than 85 years but is rapidly gaining acceptance as a medical product and a permissible intoxicant.2,3 It is likely that many pharmacists are supportive of this regulatory movement and may even have “experimented” with this Schedule I drug while in school. But what about something like cocaine? “That won’t happen,” you say? Then you should be aware that Oregon passed a law in 2020 that reduced the penalty for the unauthorized possession of less than two grams of cocaine to the payment of a small fine.4

       

      Other states, municipalities, and countries have also begun taking steps towards loosening or eliminating penalties for prohibited recreational substances, in some cases including other drugs currently listed in Schedule I of the Controlled Substances Act (CSA). Is this the start of a new national trend leading to a relaxation of restrictions on previously controlled substance and perhaps even to someday permit retail sales? Will the future of drug control start to look more like the 1890s than the 1990s?

       

      This continuing education activity will review national and international regulation of controlled substances and some changes that governments are enacting or considering to loosen their control. Do these events indicate that society’s view of controlled substances and use disorders—and pharmacy’s role—are evolving?

       

      Pause and Ponder: Will biennial controlled substance inventories and the familiar red “C” go the way of manual typewriters and become relics of a bygone era?

       

      REGULATION OF CONTROLLED SUBSTANCES

       

      Historical Perspective

      In the 19th Century, what we now call controlled substances were readily available in retail locations. In the 1890s, the Sears and Roebuck catalog (that’s the 19th Century Amazon for our younger readers) offered a syringe and a small amount of cocaine for purchase for $1.505 (equivalent to about $50 today). Individuals could also order the tonic, Wine of Coca, a mixture of coca-leaf extract and Bordeaux wine, which was promoted as “a genuine rich wine ... well known throughout Europe for its strengthening and nourishing qualities” at retail for 95 cents.5 In addition to cocaine, consumers could also openly purchase morphine and heroin from catalogs, apothecaries, and physicians. 5

       

      The popularity of cocaine-infused beverages, tonics, and powders grew in the late 1800s, and were generally held to have therapeutic value for a variety of conditions, including headache and fatigue, constipation, nausea, asthma, and impotence.6 Most pharmacy personnel are probably aware that a pharmacist in Atlanta, John Pemberton, took advantage of prohibition being enacted in parts of Georgia and replaced the wine in Wine of Coca with a sugary syrup and added a kola-nut extract containing caffeine in 1886.7 He named the concoction Coca-Cola and described it as a temperance drink.7

       

      Although frequently denied by the company, Coca-Cola contained a small amount of cocaine (and likely the precursor, ecgonine) and became one of the world’s most popular tonic/beverage sold at retail, often at pharmacy soda fountains.6,8 Early in the 20th Century, public opinion about cocaine began to turn negative and the company (by then owned by another pharmacist, Asa Candler), tried to remove cocaine from the beverage but it would not become completely cocaine-free until 1929 when newer extraction methods were developed.6

       

      Recently, the well-known billionaire, Elon Musk, jokingly(?) tweeted “Next I’m buying Coca-Cola to put the cocaine back in.”8 Current legislative changes discussed below suggest that this notion is not so far-fetched.

       

      During the early part of the 20th Century, there were no federal agencies that regulated medical and pharmacy practice, and physicians could freely prescribe cocaine and morphine as treatment for pain.9 Drug abuse became increasingly common and emerged as a significant social and public health issue, and a less permissive attitude towards drugs began to take hold.9

       

      The first federal law to ban the non-medical use of a substance was the Smoking Opium Exclusion Act in 1909; it prohibited the possession, importation, and use of opium for smoking, although it could continue to be used medically.10 A more significant step was the passage of the Harrison Narcotic Tax Act in 1914 which regulated “narcotics” (defined as opiates and cocaine) by imposing a special tax upon anyone who produced, imported, manufactured, sold, dispensed, distributed, or compounded these substances.11 Note that the act was an economic regulation to comply with treaty obligations and did not directly prohibit the use nor sale of opiates and cocaine.1

       

      The Harrison Act required physicians and pharmacists who prescribed or dispensed “narcotics” to be registered and pay a fee of $1 to $24 per year11,12 (equivalent to $29 to $700 today). The act mandated special order forms and record keeping whenever narcotic drugs were sold. They could only be provided from packages bearing a government stamp.12

       

      By using the federal government’s taxing power to restrict the use of opiates to professional practices, the Harrison Act effectively created the first class of prescription drugs.11 (The Food Drug and Cosmetic Act in 1938 formally established prescription-only drugs and the 1951 Durham-Humphrey Act [sponsored by two pharmacist-legislators] gave the U.S. Food and Drug Administration (FDA) authority to designate which drugs would require prescriptions.13)

       

      After 1919, oversight by the Treasury Department expanded to define the scope of professional practice.11 Previously, physicians interpreted terms in the act such as “legitimate medical purposes,” “professional practice,” and “prescribed in good faith” to mean that they could provide narcotics to ease the suffering of withdrawal in addicts who were regarded as having a disease.12 However, the Treasury Department interpreted the Harrison Act to mean that any prescription for an addict for the purpose of relieving the trauma of addiction was illegal, and the Courts supported this position.12 Consequently, the only source available for an addict to obtain narcotics was through illegal means.12

       

      The law also established the first federal narcotics agents, although their enforcement powers were limited. The Federal Bureau of Narcotics (FBN) was established in 1930 and was given the authority to enforce the Harrison Act and other anti-drug laws and later also oversaw the Marijuana Tax Act (see below).14 President Herbert Hoover appointed Harry J. Anslinger to be Commissioner of Narcotics, a position he would hold under four U.S. presidents for more than three decades. He became the face of the government’s hardline approach to eradicate drug abuse.14

       

      Later, the 18th Amendment of the Constitution and the Volstead Act banned the manufacture, transportation, or sale of alcohol in 1919.10,15 (By this time, many states had already banned the sale of alcohol.) Prohibition was overturned by the 21st Amendment in 1933.

       

      By 1930, 30 states had also prohibited the use of marijuana, beginning with California in 1913 and Utah in 1914.16 (Ironically, California became the first state to approve the medical use of marijuana 83 years later.) In 1937, Congress passed the Marihuana Tax Act which was modeled after the Harrison Act.55 The law didn’t specifically criminalize the use or possession of marijuana, but it required practitioners register and pay a tax, and imposed a fine of up to $2000 (about $40,000 today) and five years in prison for non-payment.10,17 There is a widely held feeling that the push for stricter control of marijuana was fueled by non-health concerns. Those concerns included

      • commercial interests
      • anti-immigrant and racial bias
      • exaggerated fear about violence and crime
      • hysteria about the drug’s alleged contribution to moral decay, and
      • pressure from the Federal Bureau of Narcotics

      All of these factors played major roles in the push for stricter control of marijuana.17,18 Such feelings persist today and are part of the effort towards deregulation. The Act was ruled unconstitutional in 1969 in a suit brought by Harvard psychology professor and psychedelic guru, Timothy Leary.19

       

      Today, drugs subject to abuse are regulated by the Controlled Substances Act (CSA), signed into law by then-President Richard Nixon in 1970, which, among other things, established the now-familiar five schedules. This will be discussed further below.

       

      REGULATION OF RECREATIONAL DRUGS – INTERNATIONAL

       

      The United States is a party to three United Nations (U.N.) drug control treaties20:

      • the 1961 Single Convention on Narcotic Drugs
      • the 1971 Convention on Psychotropic Substances, and
      • the 1988 Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

      These are designed to establish effective control over international and domestic trafficking in opiates, coca leaf, cocaine, marijuana, stimulants, depressants, and hallucinogens by limiting the international production and trade of psychotropic substances and their chemical precursors.9,20 The treaties also establish international mechanisms to monitor treaty adherence.20 More than 95% of U.N. Member States are participants in these international treaties.20 Under the CSA, treaty obligations may require the U.S. Attorney General to control or reschedule a substance if existing limits in the U.S. are less stringent than those required by a treaty.9

       

      Despite these international agreements, more than two dozen countries have moved toward some form of decriminalization of recreational drugs.21 The SIDEBAR differentiates decriminalization and legalization.

       

      SIDEBAR: Decriminalization and Legalization

      Decriminalization is not the same as legalization.

       

      When a drug is legalized, it may be restricted but there is no punishment for possession or use. Typically, regulations may exist regarding where and how the legal drug can be produced, sold, and consumed. Criminal or civil penalties may apply if production, sale, or consumption take place outside of regulations (think alcohol).

       

      When a drug is decriminalized, possession and use are still “illegal” but, there are no criminal penalties (e.g., incarceration) for use or possession. Instead, there may be civil penalties (e.g., fines, or mandated treatment or educational programs), and usually, possession limits. In addition, use or possession do not lead to a criminal record that might affect employment, housing, or travel opportunities if a substance is decriminalized. Selling or manufacturing drugs would normally still carry criminal penalties.22

       

       

      Most people will bring up the Dutch city of Amsterdam when discussing lax drug policies. Indeed, people 18 years of age or older can purchase marijuana and other “soft” drugs (magic mushrooms, Salvia, Peyote cactus) legally and openly in coffee shops and other establishments in The Netherlands. .23 Smoking tobacco products are also tolerated in public places except near schools or playgrounds.

       

      Dutch drug policy rests on two principles.23 (Note that Dutch policy applies nation-wide, but most people think of Amsterdam when this topic arises.) One is the fundamental belief that all human beings may decide about matters relating to their own health and includes acceptance of euthanasia for terminally ill patients. The other is that concealing socially negative phenomena does not cause those practices to disappear and instead makes them far more difficult to influence and control.

       

      The Dutch divide drugs into two groups, soft and hard drugs, based on their human health impact. Hard drugs such as cocaine, LSD, morphine, and heroin are forbidden in the Netherlands. Soft drugs are tolerated but strict laws limit quantities, conditions of sale, and use. For example, driving under the influence of a soft drug is treated similarly to driving under the influence of alcohol. Large scale growing, processing, and trading in marijuana is forbidden, but Dutch courts bestow milder penalties than in most other countries.23

       

      Another frequently cited model is Portugal. On July 1, 2001, Portugal became the first country in the world to decriminalize all drugs, including methamphetamine and heroin, removing the distinction between soft and hard drugs.24,25 Possession is decriminalized for personal use within certain limits, depending on the drug.24 Generally, the limits are based on a hypothetical 10-day supply for an average individual.25 Drug use became an administratively sanctionable misdemeanor under the responsibility of the Ministry of Health, rather than involving law enforcement.25 The intent of the law was to focus police resources on those who profit from the drug trade, rather than their victims, while also providing a public health approach to drug users.24

       

      Individuals caught possessing drugs for personal use in Portugal are sent to a commission composed of health experts and a legal expert.26 The commission evaluates the person’s drug use and, if necessary, will refer them to voluntary treatment. (While most treatment is voluntary, in some cases, the commission can choose to issue a fine or mandate some form of therapy.) Additionally, the country expanded access to treatment and harm reduction services like needle exchanges.26

       

      However, selling drugs is still illegal. Portuguese law considers it a crime if someone produces, buys, or transports an illicit drug that is above the legal amount for personal use.24 For example, possession of more than 5 grams of hashish could potentially lead to arrest and prosecution for drug trafficking. A conviction for drug trafficking in Portugal can be subject to between one and five years in prison.24

       

      Beginning January 31, 2023, drug users 18 years of age and older in British Columbia, Canada who possess up to 2.5 grams of illegal drugs for personal use will not be arrested, charged, nor have their drugs confiscated.27 Drugs include heroin, fentanyl, cocaine, methamphetamine, and 3,4-methylenedioxymethamphetamine (MDMA or Ecstasy). While those substances will remain illegal, police will offer users information on available health and social services. The province said it asked for the change in its request to the Canadian government for the drug laws exemption in order "to remove the shame that often prevents people from reaching out for life-saving help."27

       

      Canada’s intent is to use the province as a potential model for similar changes elsewhere in the country as part of a multi-faceted health-based strategy to end Canada’s drug overdose crisis, which reached record highs during the COVID-19 pandemic. The program has some exemptions; it will not apply to drug use on primary and secondary school grounds, child-care facilities, airports, or to members of Canada's military. The pilot program is set to run until January 31, 2026.27

       

      On the other hand, some countries have very harsh drug laws. In Malaysia, you can be fined, jailed, or deported for having drugs in your possession and those who sell drugs can be punished with death.28 Execution is also the penalty for some drug crimes in China, Vietnam, and The Philippines. In Dubai, you can be imprisoned for possession of many prescription drugs that are legal in other parts of the world and failing a drug test can be grounds for incarceration even if the individual is not in possession of any drugs.28 In Russia, even Americans in possession of vape cartridges containing hashish oil can be subject to arrest and detention, as WNBA star Brittney Griner discovered.29

       

      U.S. RECREATIONAL DRUG REGULATION

       

      Controlled Substances Act

      As noted above, in the early 1900s, drugs could be purchased at retail outlets with few, if any, limitations. Strong restrictions emerged later in the 20th Century. In the 1960s, attention was being paid to a medical approach to preventing and treating drug abuse along with a powerful emphasis on law enforcement.9 By 1969, newly elected President Richard Nixon made reducing drug abuse, especially heroin abuse, one of his top priorities.9 Nixon feared that drugs were undermining the integrity of America’s youth and was convinced that abuse and addiction gave rise to crime, the biggest issue in his 1968 campaign.30 Nixon sensed a need to restore control to a broken system and declared a “war on drugs.” Dismissing the current laws as “inadequate and outdated,” he called for a single, modern law to confine drug use to legitimate medical purposes.30

       

      One weapon in the war was the enactment of the CSA.9 The CSA was part (Title II) of an omnibus bill (a proposed law covering a number of diverse or unrelated topics) called the Comprehensive Drug Abuse Prevention and Control Act of 1970. The new legislation offered a more systematic approach to regulation of abused drugs and provided additional law enforcement resources.9

       

      Congress, in enacting the CSA, dealt with two competing interests related to drug regulation.31 They recognized that while improper use of controlled substances can be detrimental to Americans' health and general welfare, many of these substances have a useful and legitimate medical purpose and are necessary to maintain health and well-being. The Act simultaneously aims to protect the public from the dangers of controlled substances while also ensuring access for legitimate purposes.31 To achieve both goals, the statute created two complementary legal schemes. One provision required individuals and entities working with controlled substances to register with the government, report certain information to regulators, and have a responsibility to prevent diversion and misuse of controlled substances.31 The act also contained provisions to prevent trafficking in controlled substances by establishing penalties for the production, distribution, and possession of controlled substances outside the legitimate scope of the registration structure.31 CSA policies that were intended to curtail illegitimate use of these drugs included prescription refill limitations, security standards, recordkeeping requirements, order forms, production quotas, and the registration of importers and exporters of controlled substances.11,30 The new law was, however, not exclusively punitive; it eliminated mandatory minimum sentences for drug crimes.30

       

      Moreover, Title I of the comprehensive act had more of a public health focus.30 It provided authority and funding to permit the Department of Health, Education, and Welfare to deliver prevention and treatment efforts through community mental health centers and public health service hospitals. It authorized the National Institute of Mental Health to increase substance abuse research and training.30 It also protected subjects’ privacy rights under the care of approved researchers.

       

      Over the next few decades, public concern over drug abuse increased and Congress responded by enacting policies that created a harsher system of drug control and served as a basis of the ensuing “War on Drugs.” 30 Congress repeatedly amended the law to address the heightened concern, and it became more punitive and criminally focused and less directed towards rehabilitation and improved treatment.30

       

      A new Federal Agency, the Drug Enforcement Administration (DEA), was created in 1973 to enforce the new law. This was done in part to coordinate federal and state enforcement activities and to reduce inter-agency rivalries.9,30 After the CSA was enacted, there were nearly 500,000 importers, exporters, manufacturers, distributors, and practitioners covered by the law, making the DEA the largest administrative agency in the U.S.11

       

      Scheduling

      The centerpiece of the CSA, as pharmacists are aware, was the creation of a scheduling system that provided a means for assigning regulated substances into one of five categories based upon the drug’s medical risks, therapeutic use, and potential for abuse and dependence.9,31 The classification system also establishes the obligations and penalties of the law.31 The most restrictive category is Schedule I which is comprised of drugs with high potential for abuse, but no accepted medical use.32 The placement of a drug in a schedule is fluid, and drugs can be moved to a different schedule, either up or down, added to the controlled substances list, or deleted.30 Any individual, not just regulatory officials or health care providers, can request that the DEA add, remove, or change a drug’s scheduling.9

       

      In determining into which schedule a drug or other substance should be placed, or whether a substance should be re-scheduled or decontrolled, certain factors must be considered. The DEA is required to seek a scientific and medical evaluation of the substance from the Department of Health and Human Services  to apply what is known as the eight-factor test when determining scheduling.32 These factors are

      (1) Its actual or relative potential for abuse
      (2) Scientific evidence of its pharmacological effect, if known
      (3) The state of current scientific knowledge regarding the drug or other substance
      (4) Its history and current pattern of abuse
      (5) The scope, duration, and significance of abuse
      (6) What, if any, risk there is to the public health
      (7) Its psychic or physiological dependence liability
      (8) Whether the substance is an immediate precursor of a substance already controlled

       

      These criteria help to stratify the seriousness of the public health concern among the controlled substances. Will new regulatory strategies remove these distinctions?

       

      PAUSE AND PONDER: Do the “C” schedules serve a purpose?

       

      DECRIMINALIZATION – STATE AND LOCAL ACTIONS

       

      While the general trend at the federal level for the past five decades has been a toughening of the restrictions on abused drugs, especially opioids, one exception is marijuana. States have led the way by actively relaxing restrictions on marijuana, first by legalizing medical use and later permitting limited non-medical use.

       

      The medical use of marijuana has been legalized in 37 states plus the District of Columbia (D.C.), Puerto Rico, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands.33 The medical marijuana movement began in California in 1996, but it wasn’t until 2012 that Colorado and Washington became the first two states to decriminalize the non-medical use of marijuana (for people 21 years of age or older).33 (California voters had rejected a proposition in 2010.) In the 2022 election, two additional states, Maryland and Missouri, approved the recreational use of marijuana. bringing the total up to 21 (plus D.C.) although similar proposals were rejected in Arkansas, North Dakota, and South Dakota.33

       

      Beyond Marijuana

       

      More recently, states and municipalities have gone beyond marijuana and have decriminalized other controlled substances. In May 2019, Denver, Colorado became the first governmental entity in the U.S. to decriminalize a (non-Cannabis) Schedule I drug, the psychedelic ingredient from mushrooms, psilocybin.34 The proposal was placed on the municipal ballot after garnering almost 9500 petition signatures and was supported by 50.5% of voters in the election.34 Denver was also the first major U.S. city to legalize the possession of small amounts of marijuana in 2005.34

       

      The new ordinance states that the “enforcement of any laws imposing criminal penalties for the personal use and personal possession of psilocybin mushrooms... shall be the lowest law enforcement priority in the City and County of Denver.” It mandates that “no department... shall use any city funds or resources to assist in the enforcement of laws imposing criminal penalties for the personal use and personal possession of psilocybin mushrooms by adults.”35 Adult is defined as an individual 21 years of age or older.

       

      One advocacy group (Decriminalize Denver) noted its support for the ordinance by stating that “Humans have used these mushrooms for thousands of years for healing, rites of passage, spiritual insight, strengthening community, and raising consciousness.” Decriminalize Denver has argued that “One arrest is too many for something with such low and manageable risks for most people, relative to its potential benefits.”34 In contrast, opponents have warned that “Denver is quickly becoming the illicit drug capital of the world” and that the long-term health effects of these drugs are unknown.34

       

      Other municipalities have followed the same path as Denver. Oakland and Santa Cruz, California also decriminalized psilocybin in 2019 and 2020, respectively. In both cases, their respective City Councils took the action rather than mounting a referendum.36,37 The Santa Cruz ordinance is very similar to what was enacted in Denver preventing resources from being used to investigate and arrest people 21 years of age and older solely for the personal use and possession of “entheogenic plants and fungi”37 (a psychoactive, hallucinogenic substance or preparation especially when derived from plants or fungi and used in religious, spiritual, or ritualistic contexts38). Community testimony from people sharing mental health struggles and treatment likely contributed to the Council’s decision. Santa Cruz later extended its policy and banned enforcement actions against individuals using peyote and other mescaline-containing cacti. Oakland also decriminalized mescaline cacti, ayahuasca and ibogaine.39 The City Council in Ann Arbor, Michigan also unanimously approved mushroom decriminalization in 2020.40

       

      Voters in Washington D.C. also approved similar measures in 2020, termed the Entheogenic Plant and Fungus Policy Act, which would decriminalize natural psychedelics including magic mushrooms, ayahuasca, and mescaline, and makes arrests for their possession or use the lowest priority for DC police. Due to D.C.’s unique status, implementation of the act was delayed for Congressional review and approval. D.C. received approval in 2021 but not before one member of Congress threatened to derail the process.41

       

      In late 2021, Seattle became the largest city (to date) to decriminalize Schedule I psychedelic drugs.39,42 The City Council unanimously passed a resolution that “the investigation, arrest, and prosecution of anyone engaging in entheogen-related activities should be among The City of Seattle’s lowest enforcement priorities.” Its City Council asked the city’s police department to codify that practice as departmental policy.39 The resolution was limited to natural substances, notably psilocybin and ayahuasca, and later peyote; it excluded synthetic materials such as LSD.39,42 In support of its approval, the resolution noted both the therapeutic potential of psychedelics and protection of indigenous peoples who use these compounds for cultural and spiritual practices.42 More than 100 additional cities are moving to decriminalize psychedelic mushrooms.43

       

      States are also supporting decriminalization measures and Oregon is at the forefront of these activities. In the 2020 election, voters in the state passed two companion referenda that significantly changed the state’s drug policy. Measure 109 approved the use of a psychedelic mushroom for medical use by authorizing the Oregon Health Authority to create a program to permit licensed service providers to administer psilocybin-producing mushroom and fungi products to individuals 21 years of age or older.44 The new law will allow anyone age 21 or older who passes a screening procedure to access the services for “personal development."45 A client does not need to be diagnosed with or have any particular medical condition to receive psilocybin. Clients would complete a preparatory session and then attend a session at a psilocybin service center where they would receive and consume the psilocybin product under the supervision of the service facilitator.44

       

      Unlike the cities that decriminalized psychedelic drugs for personal use, the Oregon measure took a medical approach with the purpose of improving the physical, mental, and social well-being of people in the state and reducing the prevalence of mental illness conditions among adults who have not been helped by more mainstream therapies.44,46 The measure restricts psilocybin sales to licensed service providers and does not permit sales directly to users. Individual counties can opt out of the program.46

       

      In the 2022 election, Colorado became the second state to approve psychedelics.47 The proposition legalizes regulated access to natural medicines for people 21 years of age or older, including plants or fungi that impact an individual's mental health and provides civil and criminal immunity for providers and users.47

       

      Pharmacy staff should note that there is a growing interest in the potential therapeutic applications of psychedelic drugs to help many psychiatric disorders and these may become FDA-approved pharmaceutical products.48

       

      While several municipalities and states have authorized the decriminalization of mushrooms and other psychedelics and justified their actions due to their healing and spiritual value, there have been other movements to expand decriminalization beyond those with potential medical benefits.

       

      In the same election that decriminalized mushrooms, voters in Oregon approved another measure (110) to become the first state to lighten penalties for possession of both large and small amounts of a wide assortment of scheduled substances.4

       

      Under the new law, the penalty for possession of larger amounts of controlled substances was reduced from a felony offense to a Class A misdemeanor punishable by up to 364 days of imprisonment and a fine of up to $6,250. For possession of smaller amounts of controlled substances, the measure reduced the penalty from a criminal misdemeanor to a new, Class E violation, which is punishable by a $100 fine. In lieu of a fine, a person charged with a violation may instead complete a health assessment at an Addiction Recovery Center.4

       

      The threshold differentiating large from small amount are defined for different substances. For cocaine, the Class E violation applies to unauthorized possession of less than two grams. For oxycodone, it is unauthorized possession of fewer than 40 pills, tablets, or capsules. Someone in possession of less than 1 gram heroin would be subject to the new Class E penalty.4 The new measure also removes penalty enhancements for possession of small amounts of controlled substances where the individual previously had a felony conviction or multiple previous convictions for possession.4,45

       

      The new program is loosely based on Portugal’s model, described above, but was modified in accordance with recommendations from Oregon’s recovery community.26 Oregon’s approach will focus on diversion and harm reduction for people who use drugs while retaining punitive approaches for drug trafficking. A goal of the new program is to improve Oregon’s ranking as one of the worst states at providing treatment for addiction.26 In 2016 and 2017, Oregon ranked first in the country for analgesic drug misuse, second in the U.S. for methamphetamine misuse, and fourth for cocaine and alcohol misuse while ranking 48th in access to treatment.26 In all, almost 10% of the state’s population had a substance use disorder.

       

      The state is expanding its addiction recovery centers and anyone will be able to access them whether or not they have received a citation.26 The funding for expanded services will come from a higher than anticipated yield from marijuana taxes, which has exceeded $100 million per year.26

       

      Oregon’s program has produced mixed results. In the first year after decriminalization took place, police issued approximately 2000 citations, but, despite the waiver of the fine if a person calls the hotline for a health assessment and counseling, only 92 of those ticketed called the hotline and only 19 of them requested resources for services.50 Almost half of people receiving a citation failed to make a court appearance. State health officials reported 473 opioid overdose deaths in the first 8 months of 2021, surpassing the total for all of 2020, and nearly 200 deaths more than the state saw in 2019.50 The state also reported that visits to emergency rooms and urgent care centers for opioid overdose have been increasing. The Oregon Health Authority cites an upturn in fentanyl abuse and a pandemic-related downturn in reporting in 2020 as possible reasons for the disappointing results. In addition, Oregon’s inpatient facilities, detox clinics and recovery-focused nonprofits were adversely affected by issues related to COVID-19 including workforce shortages; there is uncertainty whether providers can adequately expand to meet increased needs.51

       

      Pause and Ponder: Is there a role for pharmacists in improving outcomes?

       

      However, it has also been suggested that the more lenient rules take away the threat of jail time that some individuals need to encourage them to get into recovery while fewer low-level offenders will be forced into court-ordered behavioral health services.51 Portugal takes a more robust approach than Oregon, having “dissuasion commissions” that pressure anyone caught using drugs, including marijuana, to seek treatment. Tools include fines, prohibiting drug users from visiting certain venues or from traveling abroad, seizure of personal property, community work, and having to periodically report to health services or other facilities.50

       

      California, Maine, and New Jersey, among others, have also been considering enacting decriminalization measures.52,53 A bill pending approval in California would decriminalize most psychedelics. The bill would allow people aged 21 and older to possess psilocybin, DMT, ibogaine, mescaline, LSD, and MDMA for personal use and “social sharing.”52 The bill advanced to the final step of Assembly approval when the sponsor removed ketamine from the list of substances due to concerns over date rape. The bill prohibits sharing drugs with anyone under 21 years of age or possessing them on school grounds. It would also allow personal cultivation of mushrooms. Proponents touted the benefits to individuals who would be aided by the use of psychedelics to treat trauma including military veterans. Opponents argued that social sharing could result in more overdoses from contaminated products and give drug dealers a built-in defense.52

       

      PROS AND CONS

       

      Why have states and municipalities chosen to decriminalize drugs? Although a detailed discussion of the benefits and detriments of lax drug policies is beyond the scope of this activity, it is worth briefly examining some of the arguments that have driven the move towards decriminalization. Table 1 describes the pros and cons frequently used to support the various arguments.

       

       

      Table 1. Pros and Cons re: Decriminalization of Recreational Drugs1,16,54,55,56,57

       

      Justifications for decriminalization Justifications for continuing prohibition of recreational drugs
      ·       A sense that the “War on Drugs” is expensive, harmful to society, and not working

      ·       The suggestion that a medical model will be more effective

      ·       Decriminalization will reduce profits for drug traffickers

      ·       More than half of people in prison have untreated substance use disorders and

      o   Imprisonment actually leads to increased illicit drug and medication misuse following a period of incarceration with a much higher risk of drug overdose upon release

      o   Relapse to drug use in someone with an untreated opioid use disorder can be fatal due to loss of opioid tolerance that may have occurred while the person was behind bars

      o   A criminal conviction or a record of imprisonment can significantly hamper a person’s employment prospects and other opportunities

      ·       Risk of endorsing or encouraging risky behaviors

      ·       Decriminalization would drive down the cost of drugs, making them more accessible

      ·       Few non-violent users are actually imprisoned

      ·       A black market will still exist for users under the permitted statutory age

      ·       The current treatment infrastructure is inadequate to accommodate the anticipated increased demand

      ·       The threat of incarceration is an incentive to seek treatment

      ·       If restrictions are abandoned, other social costs will increase

       

      As a proponent for decriminalization, Mayor Schmoke proposed that the abuse of drugs should be “dealt with as a moral and medical problem than as a criminal problem ... a problem for the surgeon general, not the attorney general.”1 The number of people incarcerated for drug-law violations in state and federal prisons in the United States increased 12-fold between 1980 and 2018. Yet there is no statistically significant relationship between state drug imprisonment rates and three markers of state drug problems: self-reported drug use, drug overdose deaths, and drug arrests.57

       

      Pause and Ponder: Should recreational drugs be regulated like alcohol?

       

      Many advocates recommend an approach similar to the policy in Portugal and treat illicit drug use the way most states regulate alcohol and marijuana, by making it legal for stores to sell such drugs to adults.57 In Portugal, which has led the way towards decriminalization, the use of cocaine among young adults (15-34) is 0.3% compared with 2.1% in the European Union (EU) countries.58 Amphetamine and MDMA use are also lower. The overall overdose death rate in Portugal is five times lower than in the EU (which has a lower rate than in the U.S.).58 HIV infection rates among IV drug users have also dropped.58

       

      Where Will This Lead?

      Are the localities decriminalizing recreational drug use an anomaly or do they represent the tip of the iceberg for liberalization of personal drug use? The movement could follow the path taken by marijuana.

       

      States have pursued a pattern of first decriminalizing and/or allowing medical use of marijuana before finally proposing legalization.16,59 States used their experiences with the intermediate steps as a means to anticipate the expected effects of total legalization.16 The liberalized marijuana policies in medical marijuana states exposed the public to more open marijuana use and may have changed attitudes towards the drug, along with a sense that prohibition is too costly.59

       

      Efforts are ongoing to legalize marijuana at the federal level. Congress is currently considering the Marijuana Opportunity Reinvestment and Expungement (MORE) Act. It would remove marijuana from the list of scheduled substances under the Controlled Substances Act and eliminate criminal penalties for an individual who manufactures, distributes, or possesses marijuana.3 It would also establish a process to expunge convictions and conduct sentencing review hearings for individuals previously convicted of federal cannabis offenses. It would establish and fund a grant program to provide resources to administer services for individuals adversely impacted by the War on Drugs, including job training, legal aid, reentry services, and health education programs and would levy a 5% tax on the sale of cannabis products.3

       

      Will legalizing marijuana serve as a model for other C-I drugs to follow? Indeed, a bipartisan bill was recently introduced in the U.S. Senate calling on the DEA to reclassify breakthrough therapies such as psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) as Schedule II drugs.60

       

      SUMMARY AND CONCLUDING COMMENTS

       

      The pendulum of drug control may be swinging closer to the more lenient approach that existed 100 years ago. In a decade, the U.S. moved from no state permitting recreational use of marijuana to almost half of the states doing so, along with decriminalization being debated at the federal level. Will additional recreational drugs follow the same path? Several municipalities and a few states have already made significant strides in that direction. In particular, Oregon and the nation of Portugal have established programs making controlled substances a medical and public health issue rather than a law enforcement issue, although with mixed results. Will the distinction between “hard” and “soft” drugs disappear in the U.S., as more states adopt measures aimed at decriminalizing drugs?

       

      If so, there will be many questions about how pharmacy may be affected. Will drugs for which there is some evidence for medical applications like cannabinoids and psychedelics such as psylocibin, find their way to the pharmacy shelf? If Oregon’s medical model for psychedelics is followed by other states, will it enable new opportunities for pharmacists? Will cocaine and heroin once again be available as OTC products in pharmacies?

       

      It is important for pharmacy staff to stay abreast of regulatory changes in their own states and nationally. They should become part of the conversation about the direction such regulations should take.

       

       

       

      Pharmacist Post Test (for viewing only)

      Law: Getting Soft on “Hard” Drugs?

      Post-test

      After completing this activity, pharmacists and pharmacy technicians should be able to
      • DESCRIBE regulation of controlled substances and how it has changed over time
      • INDICATE how drugs are regulated internationally
      • CHARACTERIZE state and local actions that are loosening the regulation of controlled substances
      • DISCUSS the pros and cons of drug decriminalization

      1. What was the first Schedule I drug (after marijuana) to be decriminalized by a U.S. city?
      A. Cocaine
      B. Psilocybin
      C. Heroin

      2. What is the guiding principle behind Amsterdam’s drug policy?
      A. Individuals should be able to decide about matters relating to their own health
      B. It is too expensive to try to crack down on the use of recreational drugs
      C. Individuals need the threat of punishment in order to seek help for addiction

      3. What was the first country to decriminalize all drugs?
      A. Canada
      B. The Netherlands
      C. Portugal

      4. Jose is talking with Mike. Jose says more than half of the people in American prisons have untreated substance use disorders and in these people, incarceration is associated with a much higher risk of drug overdose upon release. Jose also says a criminal conviction can significantly hamper a person’s employment prospects and other opportunities. Mike argues that the threat of incarceration is an incentive to seek treatment and few non-violent users are actually imprisoned. He says that the current treatment infrastructure is inadequate to accommodate the influx of people who would need treatment if Jose’s proposal passes. What positions are they arguing?
      A. Jose is a proponent of legalization of all drugs; Mike is against legalization of drugs.
      B. Jose supports decriminalization of all drugs; Mike is against decriminalization of drugs.
      C. Jose supports legalization of all drugs, while Mike is a proponent of decriminalization.

      5. The first significant regulation of opioids in the U.S. was the Harrison Act. What did this act do?
      A. Empowered the FBI to seize all opioids entering the U.S. at all ports
      B. Required pharmacists who dispensed “narcotics” to be registered and pay a fee
      C. Prohibited the dispensing of cocaine from pharmacies or other healthcare venues

      6. What significant change occurred as a result of the enactment of the CSA?
      A. Possession of marijuana became illegal
      B. The “C” Schedules were established
      C. Public health remedies for addiction were curtailed

      7. Many factors apply to the decision to control drugs under the CSA. Which of the following correctly describes one of these factors?
      A. The CSA may require the DEA to comply with international treaty obligations when assigning a drug to a schedule
      B. Only law enforcement or federal employees may ask the DEA to consider adding or deleting a drug from a schedule
      C. The DEA must request a scientific/medical evaluation from the Centers for Disease Control and Prevention when deciding on scheduling

      8. A young woman is stopped for speeding in Oregon and the officer sees she has a baggie with 12 Oxycontin tablets on the passenger’s seat, and she admits she does not have a prescription. The officer explains that under Oregon’s current laws, she may pay a fine for the unauthorized possession of small amounts of prescription opioids. What can she do in lieu of a monetary penalty?
      A. Perform 20 hours of community service at an addiction recovery center
      B. Attend an educational program about the risks of drug abuse
      C. Complete a health assessment at an addiction recovery center

      9. What was Oregon’s goal in decriminalizing the possession of controlled substances?
      A. Raise revenue by taxing the sale of all recreational drugs
      B. Improve the provision and use of addiction treatment services
      C. Make sales from illegal sources economically unworkable

      10. What would the proposed Marijuana Opportunity Reinvestment and Expungement (MORE) Act do?
      A. Reclassify marijuana from the C-1 category to a C-II drug
      B. Allow Medicare to pay for over-the-counter cannabidiol
      C. Remove marijuana from the list of scheduled substances

      Pharmacy Technician Post Test (for viewing only)

      Law: Getting Soft on “Hard” Drugs?

      Post-test

      After completing this activity, pharmacists and pharmacy technicians should be able to
      • DESCRIBE regulation of controlled substances and how it has changed over time
      • INDICATE how drugs are regulated internationally
      • CHARACTERIZE state and local actions that are loosening the regulation of controlled substances
      • DISCUSS the pros and cons of drug decriminalization

      1. What was the first Schedule I drug (after marijuana) to be decriminalized by a U.S. city?
      A. Cocaine
      B. Psilocybin
      C. Heroin

      2. What is the guiding principle behind Amsterdam’s drug policy?
      A. Individuals should be able to decide about matters relating to their own health
      B. It is too expensive to try to crack down on the use of recreational drugs
      C. Individuals need the threat of punishment in order to seek help for addiction

      3. What was the first country to decriminalize all drugs?
      A. Canada
      B. The Netherlands
      C. Portugal

      4. Jose is talking with Mike. Jose says more than half of the people in American prisons have untreated substance use disorders and in these people, incarceration is associated with a much higher risk of drug overdose upon release. Jose also says a criminal conviction can significantly hamper a person’s employment prospects and other opportunities. Mike argues that the threat of incarceration is an incentive to seek treatment and few non-violent users are actually imprisoned. He says that the current treatment infrastructure is inadequate to accommodate the influx of people who would need treatment if Jose’s proposal passes. What positions are they arguing?
      A. Jose is a proponent of legalization of all drugs; Mike is against legalization of drugs.
      B. Jose supports decriminalization of all drugs; Mike is against decriminalization of drugs.
      C. Jose supports legalization of all drugs, while Mike is a proponent of decriminalization.

      5. The first significant regulation of opioids in the U.S. was the Harrison Act. What did this act do?
      A. Empowered the FBI to seize all opioids entering the U.S. at all ports
      B. Required pharmacists who dispensed “narcotics” to be registered and pay a fee
      C. Prohibited the dispensing of cocaine from pharmacies or other healthcare venues

      6. What significant change occurred as a result of the enactment of the CSA?
      A. Possession of marijuana became illegal
      B. The “C” Schedules were established
      C. Public health remedies for addiction were curtailed

      7. Many factors apply to the decision to control drugs under the CSA. Which of the following correctly describes one of these factors?
      A. The CSA may require the DEA to comply with international treaty obligations when assigning a drug to a schedule
      B. Only law enforcement or federal employees may ask the DEA to consider adding or deleting a drug from a schedule
      C. The DEA must request a scientific/medical evaluation from the Centers for Disease Control and Prevention when deciding on scheduling

      8. A young woman is stopped for speeding in Oregon and the officer sees she has a baggie with 12 Oxycontin tablets on the passenger’s seat, and she admits she does not have a prescription. The officer explains that under Oregon’s current laws, she may pay a fine for the unauthorized possession of small amounts of prescription opioids. What can she do in lieu of a monetary penalty?
      A. Perform 20 hours of community service at an addiction recovery center
      B. Attend an educational program about the risks of drug abuse
      C. Complete a health assessment at an addiction recovery center

      9. What was Oregon’s goal in decriminalizing the possession of controlled substances?
      A. Raise revenue by taxing the sale of all recreational drugs
      B. Improve the provision and use of addiction treatment services
      C. Make sales from illegal sources economically unworkable

      10. What would the proposed Marijuana Opportunity Reinvestment and Expungement (MORE) Act do?
      A. Reclassify marijuana from the C-1 category to a C-II drug
      B. Allow Medicare to pay for over-the-counter cannabidiol
      C. Remove marijuana from the list of scheduled substances

      References

      Full List of References

      References

        REFERENCES
        1. Schmoke KL. An Argument in Favor of Decriminalization. Hofstra Law Rev. 1990; 18(3):501-525. Accessed March 21, 2023. https://scholarlycommons.law.hofstra.edu/cgi/viewcontent.cgi?article=1668&context=hlr
        2. Support for Legal Marijuana Holds at Record High of 68%. Gallup. November 4, 2021. Accessed March 21, 2023. https://news.gallup.com/poll/356939/support-legal-marijuana-holds-record-high.aspx
        3. H.R. 3884. MORE Act of 2020. 116th Congress (2019-2020). Accessed March 21, 2023.
        https://www.congress.gov/bill/116th-congress/house-bill/3884
        4. Lantz M, Nieubuurt B. Measure 110 (2020) Background Brief. State of Oregon Legislative Policy and Research Office. December 9, 2020. Accessed March 21, 2023.
        https://www.oregonlegislature.gov/lpro/Publications/Background-Brief-Measure-110-(2020).pdf
        5. Holzwarth L. The Most Unexpected Items People Used to Buy via Catalog. History Collection. January 31, 2019. Accessed March 21, 2023.
        https://historycollection.com/the-most-unexpected-items-people-used-to-buy-via-catalog/10/
        6. Palermo E. Does Coca-Cola Contain Cocaine? Live Science. December 13, 2016. Accessed March 21, 2023.
        https://www.livescience.com/41975-does-coca-cola-contain-cocaine.html
        7. Hamblin J. Why We Took Cocaine Out of Soda. Atlantic. January 31, 2013. Accessed March 21, 2023.
        https://www.theatlantic.com/health/archive/2013/01/why-we-took-cocaine-out-of-soda/272694/
        8. Browne E. Fact Check: Was There Ever Cocaine in Coca Cola, As Elon Musk Implied? Newsweek. April 29, 2022. Accessed March 21, 2023.
        https://www.newsweek.com/elon-musk-tweet-twitter-coca-cola-cocaine-ingredient-1701864
        9. Sacco LN. Drug Enforcement in the United States: History, Policy, and Trends. Congressional Research Service. October 2, 2014. Accessed March 21, 2023. https://fas.org/sgp/crs/misc/R43749.pdf
        10. War on Drugs. History.com. Updated December 17, 2019. Accessed March 21, 2023.
        https://www.history.com/topics/crime/the-war-on-drugs#:~:text=Drug%20use%20for%20medicinal%20and,had%20not%20yet%20been%20outlawed
        11. Spillane JF. Debating the Controlled Substances Act. Drug Alcohol Depend. 2004;76(1):17-29.
        12. Cantor DJ. The Criminal Law and the Narcotics Problem. J. Crim. L. Criminology & Police Sci. 1961;51(5):512-527. Accessed March 21, 2023.
        https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=4977&context=jclc
        13. U.S. Food and Drug Administration. Milestones of Drug Regulation in the United States. Accessed March 21, 2023.
        https://www.fda.gov/media/109482/download#:~:text=1951%20Durham%2DHumphrey%20Amendment%20defines,prescription%20by%20a%20licensed%20practitioner
        14. Narcotics Enforcement in the 1930s. DEA Museum. Accessed March 21, 2023.
        https://museum.dea.gov/exhibits/online-exhibits/anslinger/narcotics-enforcement-1930s
        15. Volstead Act. Britannica. Accessed March 21, 2023.
        https://www.britannica.com/topic/Volstead-Act
        16. Dills A, Goffard S, Miron J, Partin E. The Effect of State Marijuana Legalizations: 2021 Update. Cato Institute. February 2, 2021. Accessed March 21, 2023.
        https://www.cato.org/policy-analysis/effect-state-marijuana-legalizations-2021-update
        17. Musto DF. The history of the Marijuana Tax Act of 1937. Arch Gen Psychiat. 1972; 26(2): 101-108. Accessed March 21, 2023. http://www.druglibrary.org/schaffer/hemp/history/mustomj1.html
        18. Brecher EM. Marijuana is Outlawed. The Consumers Union Report on Licit and Illicit Drugs. Chapter 56. 1972. Accessed March 21, 2023. https://www.druglibrary.org/schaffer/library/studies/cu/cu56.html
        19. Leary v. United States, 395 U.S. 6 (1969). Accessed March 21, 2023.
        https://supreme.justia.com/cases/federal/us/395/6/
        20. Rosen LW. International Drug Control Policy: Background and U.S. Responses. Congressional Research Service. March 16, 2015.
        https://sgp.fas.org/crs/row/RL34543.pdf
        21. Approaches to Decriminalizing Drug Use & Possession. Drug Policy Alliance. February 2015. Accessed March 21, 2023.
        https://www.unodc.org/documents/ungass2016/Contributions/Civil/DrugPolicyAlliance/DPA_Fact_Sheet_Approaches_to_Decriminalization_Feb2015_1.pdf
        22. Overview: Decriminalisation vs Legalisation. Alcohol and Drug Foundation. Accessed March 21, 2023.
        https://adf.org.au/talking-about-drugs/law/decriminalisation/overview-decriminalisation-legalisation/
        23. Amsterdam Drugs Laws. Amerstam.info. Accessed March 21, 2023.
        https://www.amsterdam.info/drugs/
        24. Silva L. Portugal Drug Laws under Decriminalization: Are Drugs Legal in Portugal? Portugal.com. April11, 2022. Accessed March 21, 2023.
        https://www.portugal.com/op-ed/portugal-drug-laws-under-decriminalization-are-drugs-legal-in-portugal/
        25. Rêgo X, Oliveira MJ, Lameira, C. et al. 20 Years of Portuguese Drug Policy - Developments, Challenges and the Quest for Human Rights. Subst Abuse Treat Prev Policy. 2021;16:Art 59. Accessed March 21, 2023.
        https://substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-021-00394-7
        26. Abraham R. How Oregon’s Radical Decriminalization of Drugs Was Inspired by Portugal. Next City. January 5, 2021. Accessed March 21, 2023.
        https://nextcity.org/urbanist-news/how-oregons-radical-decriminalization-of-drugs-was-inspired-by-portugal?gclid=CjwKCAjwlqOXBhBqEiwA-hhitF2WD4yaDXh2LLfgppfmqe5xh5gl2q00t16uM6l0T8oDrbP38JipShoCN7sQAvD_BwE
        27. BBC. Canada Trials Decriminalising Cocaine, MDMA and Other Drugs. BBC.com. June 1, 2022. Accessed March 21, 2023. https://www.bbc.com/news/world-us-canada-61657095
        28. American Addiction Centers. The 20 Countries with the Harshest Drug Laws in the World. Updated July 16, 2021. Accessed March 21, 2023.
        https://drugabuse.com/blog/the-20-countries-with-the-harshest-drug-laws-in-the-world/
        29. Ganguli T, Abrams J, Bubola E. What We Know About Brittney Griner’s Case in Russia. NY Times. October 25, 2022. Accessed March 21, 2023.
        https://www.nytimes.com/article/brittney-griner-russia.html#:~:text=Griner%2C%2031%2C%20who%20has%20played,a%20professional%20women%27s%20basketball%20team
        30. Courtwright DT. The Controlled Substances Act: How a "Big Tent" Reform Became a Punitive Drug Law. Drug Alcohol Dependence. 2004;76(1):9–15.
        31. Lampe JR. The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress. Congressional Research Service. February 5, 2021. Accessed March 21, 2023.
        https://sgp.fas.org/crs/misc/R45948.pdf
        32. U.S. Drug Enforcement Administration. The Controlled Substances Act. Accessed March 21, 2023.
        https://www.dea.gov/drug-information/csa
        (8 factor) Ref 58
        33. State Medical Cannabis Laws, National Conference of State Legislatures. Accessed March 21, 2023.
        https://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx
        34. Chavez N, Prior R. Denver Becomes the First City to Decriminalize Hallucinogenic Mushrooms. CNN. May 9 2019. Accessed March 21, 2023.
        https://www.cnn.com/2019/05/08/us/denver-magic-mushrooms-approved-trnd
        35. BallotPedia. Denver, Colorado, Initiated Ordinance 301, Psilocybin Mushroom Initiative (May 2019). Retrieved from:
        https://ballotpedia.org/Denver,_Colorado,_Initiated_Ordinance_301,_Psilocybin_Mushroom_Initiative_(May_2019
        Mush 51.
        36. Kennedy M. Oakland City Council Effectively Decriminalizes Psychedelic Mushrooms. NPR. June 5, 2019. Accessed March 21, 2023.
        https://www.npr.org/2019/06/05/730061916/oakland-city-council-effectively-decriminalizes-psychedelic-mushrooms
        37. York JA. Santa Cruz Decriminalizes Natural Psychedelics. Santa Cruz Sentinel. January 29, 2020. Retrieved from: Accessed March 21, 2023.
        https://www.santacruzsentinel.com/2020/01/29/santa-cruz-decriminalizes-natural-psychedelics/
        38. “Entheogen.” Merriam-Webster.com Dictionary, Merriam-Webster. Accessed March 21, 2023.
        https://www.merriam-webster.com/dictionary/entheogen
        39. Adlin B. Seattle Becomes Largest U.S. City to Decriminalize Psychedelics. Marijuana Moment. October 4, 2021. Accessed March 21, 2023.
        https://www.marijuanamoment.net/seattle-becomes-largest-u-s-city-to-decriminalize-psychedelics/
        40. Stanton R. Why Ann Arbor Officials Decided to Decriminalize Psychedelic Mushrooms, Plants. Michigan Live. September 22, 2020. Accessed March 21, 2023.
        https://www.mlive.com/news/ann-arbor/2020/09/why-ann-arbor-officials-decided-to-decriminalize-psychedelic-mushrooms-plants.html
        41. Beaujon A. Magic Mushrooms are Decriminalized in DC as of Today. Washingtonian. March 15, 2021. Accessed March 21, 2023.
        https://www.washingtonian.com/2021/03/15/magic-mushrooms-are-decriminalized-in-dc-as-of-today/
        42. Miller C. Seattle City Council Votes in Favor of Decriminalizing Psychedelic Drugs. King 5. October 7, 2021. Accessed March 21, 2023.
        https://www.king5.com/article/news/local/seattle/seattle-city-council-favor-decriminalize-psychedelic-drugs/281-23bee413-1898-41fd-8850-31ecc38ea621
        43. Kelly D. Denver Dabbles with Magic Mushrooms, but Using them to Treat Mental Health Disorders Remains Underground. LA Times. April 5, 2021. Accessed March 21, 2023.
        https://www.latimes.com/world-nation/story/2021-04-05/denver-dabbles-with-magic-mushrooms-but-using-them-to-treat-mental-health-disorders-remains-underground
        44. Oregon Measure 109, Psilocybin Mushroom Services Program Initiative (2020). Ballotpedia. Accessed March 21, 2023.
        https://ballotpedia.org/Oregon_Measure_109,_Psilocybin_Mushroom_Services_Program_Initiative_(2020)
        45. Acker L. Oregon Becomes First Stat to Legalize Psychedelic Mushrooms. Oregonian. Updated November 4, 2020. Accessed March 21, 2023.
        https://www.oregonlive.com/politics/2020/11/oregon-becomes-first-state-to-legalize-psychedelic-mushrooms.html
        46. McInally M. Many Oregonians Will Have to Vote Again on Psilocybin. Oregon Capital Chronicle. August 8, 2022. Accessed March 21, 2023.
        https://oregoncapitalchronicle.com/2022/08/08/many-oregon-voters-will-have-to-decide-again-on-a-psilocybin-program/
        47. Martin S. In Colorado Election, Voters Legalize Psychedelic Mushrooms for Medicinal Purposes. USA Today. November 11, 2022. Accessed March 21, 2023.
        https://www.usatoday.com/story/news/politics/2022/11/11/colorado-election-magic-mushrooms-health-approved/10669400002/
        48. Nutt D, Erritoze D, Carhart-Harris R. Psychedelic Psychiatry’s Brave New World. Cell. 2020; 181: 21-28.
        49. National Survey on Drug Use and Health. 2016-2017 National Survey on Drug Use and Health National Maps of Prevalence Estimates, by State. Accessed March 21, 2023.
        https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHsaeMaps2017/NSDUHsaeMaps2017.pdf
        50. Selsky A. Oregon's Pioneering Drug Decriminalization Law Draws Mixed Results. KGW8. April 4, 2022. Accessed March 21, 2023.
        https://www.kgw.com/article/news/local/mixed-results-oregon-drug-decriminalization/283-0980d8b1-a514-425a-8989-889b027f5a95
        51. Quinton S. Oregon’s Drug Decriminalization May Spread, Despite Unclear Results. Pew Stateline. November 3, 2021. Accessed March 21, 2023.
        https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2021/11/03/oregons-drug-decriminalization-may-spread-despite-unclear-results
        52. Thompson D. California Advances Decriminalizing Psychedelic Substances. AP News. June 29, 2021.
        Accessed March 21, 2023.
        https://apnews.com/article/california-health-government-and-politics-c3eb439025f5f0b50090c73f22183cd0?utm_id=32439&sfmc_id=4213507
        53. An Act to Make Possession of Scheduled Drugs for Personal Use a Civil Penalty. Maine Legislature Legislative Document 967. First Regular Session, 2021. Accessed March 21, 2023.
        https://legislature.maine.gov/legis/bills/getPDF.asp?paper=HP0713&item=1&snum=130
        54. Weatherburn D. Australian & New Zealand Journal of Criminology. 2014;47(2)176–189. Accessed March 21, 2023.
        https://idhdp.com/media/362647/1408-weatherburn-article.pdf
        55. ProCon.Org. Should Illegal Drugs Legalized? Accessed March 21, 2023.
        https://aclu.procon.org/questions/should-illegal-drugs-be-legalized/
        56. Volkow ND. Addiction Should be Treated, Not Penalized. Neuropsychopharmacology. 2021;46:2048-2050.
        57. Gelb A. Pew Charitable Trust Letter to Chris Christie. June 19, 2017. Accessed March 21, 2023.
        https://www.pewtrusts.org/~/media/assets/2017/06/the-lack-of-a-relationship-between-drug-imprisonment-and-drug-problems.pdf
        58. Atkins S, Mosher C. Oregon Just Decriminalized All Drugs – Here's Why Voters Passed This Groundbreaking Reform. US News. December 10, 2020. Accessed March 21, 2023.
        https://www.usnews.com/news/best-states/articles/2020-12-10/oregon-just-decriminalized-all-drugs-heres-why-voters-passed-this-groundbreaking-reform
        59. History of Recreational Marijuana. ProCon.Org. Accessed March 21, 2023.
        https://marijuana.procon.org/history-of-recreational-marijuana/
        60. DeFuedis N. Congress Takes Another Look at Reclassifying Psilocybin and MDMA. Endpoints News. November 18, 2022. Accessed March 21, 2023.
        https://endpts.com/push-to-reclassify-psilocybin-and-mdma-gains-bipartisan-support/

        Pet Allergies

        Learning Objectives

         

        After completing this application-based continuing education activity, pharmacists will be able to

        ·       Outline the causes of pet allergies in dogs, cats, and other less common species
        ·       Differentiate between allergic sensitization, allergy, and cross sensitivity
        ·       Paraphrase facts that prove that currently, hypoallergenic dogs and cats are a myth
        ·       Compare nonpharmacologic, over the counter, and prescription treatments in terms of dosing, effectiveness, and cost

        After completing this application-based continuing education activity, pharmacy technicians will be able to

        ·       Outline the causes of pet allergies in dogs, cats, and other less common species
        ·       Differentiate between allergic sensitization, allergy, and cross sensitivity
        ·       Paraphrase facts that prove that currently, hypoallergenic dogs and cats are a myth
        ·       Identify patients whose complaints indicate they may need referral to a pharmacist

        Cartoon of boy blowing nose with cat next to him

         

        Release Date: March 15, 2023

        Expiration Date: March 15, 2026

        Course Fee

        FREE

        There is no grant funding for this CE activity

        ACPE UANs

        Pharmacist: 0009-0000-23-008-H01-P

        Pharmacy Technician: 0009-0000-23-008-H01-T

        Session Codes

        Pharmacist:   23YC08-JKT44

        Pharmacist Technician:  23YC08-TKX48

        Accreditation Hours

        2.0 hours of CE

        Accreditation Statements

        The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-008-H01-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

         

        Disclosure of Discussions of Off-label and Investigational Drug Use

        The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

        Faculty

        Yangzhou (Marina) Li, MS, PharmD
        Medical Writing Scientist
        Janssen of Pharmaceutical Companies of Johnson and Johnson,
        Boston, MA

         

        Dylan DeCandia, BS
        PharmD Candidate 2023
        University of Connecticut
        Storrs, CT

        Faculty Disclosure

        In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

        Dr. Li is a full time employee of Janssen Pharmaceutical of Johnson and Johnson and previously worked for Nest Bio and LegendBiotech. Dylan DeCandia does not have any relationships with ineligible companies and therefore has nothing to disclose.

         

        ABSTRACT

        Many American households have pets, and many others would like to have pets but family members have pet allergies. Allergies to cats and dogs are common (an estimated 15% to 30% of people are allergic to companion pets), and allergies to unusual or exotic pets have increased over the last decade. Pet allergy is an allergic reaction to proteins (allergens) found in animals’ skin cells (dander), saliva, urine, or sweat on their fur. Most animal allergens belong to one of three primary protein families. Pet allergies are currently incurable. The treatment goal is to control symptoms and improve patients’ functional status and well-being. Options include nonpharmacologic interventions like cleaning and bathing the pet and pharmacologic management with antihistamines, corticosteroids, anticholinergic nasal sprays, mast cell stabilizers, or leukotriene modifiers. Allergists will consider allergy-specific immunotherapy when medications and/or avoidance measures fail.

        CONTENT

        Content

         

        Introduction and Epidemiology

        The American Pet Products Association (APPA) estimates that approximately 70% of Americans keep pets in their household, equating to 90.5 million homes. Dogs and cats are the most popular and live in around 69.0 and 45.3 million U.S. households, respectively, followed by 11.8 million households for freshwater fish, 9.9 million households for birds, and 3.5 million households for horses.1 Public, residential, leisure, and specific occupational environments (e.g., farms, laboratories, pet shops) have high concentrations of pet allergens because of the high prevalence of community pet-keeping and Americans’ tendency to live indoors. Allergic reactions to pets have been recognized for at least 100 years.2 Risk factors for developing asthma and rhinitis include allergies to furry animals, especially cats and dogs.3 Direct or second-hand pet exposure increases the likelihood of exacerbating disease in pet-sensitive people. However, evidence also shows that early childhood exposure to dogs or cats before one year of age may have protective effects in preventing allergic sensitization.4

        Notably, allergies to unusual or exotic pets have increased over the last decade.5 In many urban areas, apartment complexes prevent owning large pets or charge a fee for owning cats and dogs, leading to the choice of smaller, more unusual animals. Some examples of uncommon pets are rodents (mice, rats [which allegedly make very good pets], guinea pigs, and other mammals like ferrets, pigs), amphibians (axolotl [a Mexican salamander], dart frogs, and fire belly newts), and reptiles (snakes).6 The allergic signs and symptoms or diseases associated with uncommon pets are like those manifested in cat and dog allergies. In addition, patients may present with respiratory symptoms induced by bird allergens and gastrointestinal symptoms after consuming bird eggs; this is called a bird-egg syndrome.7

        Overall, the incidence of specific allergy to exotic or uncommon pets is unknown because literature only includes isolated cases or small series. In the United States, an estimated 15% to 30% of people are allergic to their pets.8 Among people with pet allergies, a fraction is sensitized to more than one animal. Moreover, according to the Asthma and Allergy Foundation of America, cat allergies are reported twice as often as dog allergies. Animals are also recognized as the third leading cause of allergic asthma, after mites and pollens.8 Many people adopt ferrets or rabbits, believing they are hypoallergenic. They are not, and pharmacy staff should be aware of that fact.9,10 The most frequent allergic reactions result from inhalation, contact, or bites.

        This continuing education activity summarizes knowledge of pet allergens, including those from uncommon pets; the allergy reaction mechanism and its signs and symptoms; current advances in diagnosis and treatment methods such as immunotherapy; and recommendations for patient education and counseling.

        Pause and Ponder: When patients ask about medication for pet allergies, what kinds of questions should you ask?

        PET ALLERGENS

        Allergy Mechanisms

        Compared with other conditions’ mechanisms, allergy mechanisms are simple and encompass three specific paths: allergic sensitization, allergy, and cross-reactivity.11

        • Allergic sensitization is the presence of immunoglobulin E (IgE) antibodies to an allergen.
        • Allergy is the occurrence of reproducible symptoms or signs initiated by exposure to a defined stimulus at a dose tolerated by nonallergic persons and mediated by specific immunologic mechanisms. If no symptoms develop, a person could be sensitizing to a particular allergen but not be allergic.
        • Cross-reactivity is the process of IgE antibodies (originally developed against a given allergen) binding to homologous molecules originating from a different allergen source.

        Characterizing Pet Allergens

        Allergies to pets are common. Pet allergy is an allergic reaction to proteins (allergens) found in animals’ skin cells (dander), saliva, urine, or sweat on their fur.5 Allergens within the same protein family can cause cross-reactivity. Most allergens are spread via airborne particles. Dander contains allergens formed in sebaceous gland secretions and saliva. Secretions containing allergens adhere to the hair and stratum corneum of the skin. When an animal sheds, tiny particles disperse into the air and remain buoyant for an extended period of time. After the particles slowly settle onto the floor, furniture, or other items, they can be easily re-dispersed into the air. As a result, pet-sensitive people could experience allergy symptoms in the nose, eyes, and respiratory tract even if the pet is not present.5 Additionally, people can carry pet allergens that settled onto their clothing or hair.

        For cats and dogs, the primary allergen sources are dander and saliva. Similarly, the primary allergen source in rabbits is saliva. In contrast, the primary allergen source is urine in rodents (e.g., mouse, rat,) and Mustelidae (ferrets and minks).

        Rodents are an interesting case study. Most research laboratories experience a very high rate of staff turnover because lab workers develop allergies to rodents. Children who are exposed to rodent urine can develop this allergy, too. Male rodents produce a larger quantity of and more condensed urine than female rodents. This explains why people who commonly come in contact with male rodents are more likely to develop allergic symptoms. Allergy to rodents acts as an occupational hazard for researchers. Mouse urine is the most concentrated of all urines—far more concentrated than any other species.12 One study showed that 30% of people exposed to mice and 13.7% of people exposed to rats suffered from allergy symptoms.12 Symptoms range from conjunctivitis to asthma to skin reactions, which makes working with these animals difficult.

        Most animal allergens belong to one of three primary protein families. Within the three families, lipocalin-like proteins and the serum albumin family are the two most widely studied. Other identified allergens are considered minor, including gelatins, immunoglobulins, and transferrins presented in secretions and dandruff. Knowledge of these allergens’ allergenicity and cross-activity is essential to improve treatment and prevent allergic reactions. Table 1 summarizes partially characterized pet allergens, including those generated by exotic pets, because not all allergens are fully characterized.5

         

        Table 1. Summary of Characterized Pet Allergens13-22

        Common Name of Animal Source Allergen Family
        Dog Dander, saliva, hair Can f 1 (major allergen)

        Can f 2

        Can f 4

        Can f 6

        Can f 3

        Can f 5

        Can f 7

        Can f 8

        Lipocalin

        Lipocalin

        Lipocalin

        Lipocalin

        Albumin

        Arginine esterase (kallikrein)

        Epididymal secretory protein E1 or Niemann Pick type C2 protein

        Cystatin

        Cat Sebaceous, anal, and salivary gland Fel d 1 (major allergen)

        Fel d 2

        Fel d 4

        Fel d 7

        Fel d 3

        Fel d 5w

        Fel d 8

        Fed d 6w

        Uteroglobin

        Albumin

        Lipocalin

        Von Ebner gland protein

        Cystatin

        Cat IgA

        Latherin-like

        IgM

        Horse Dander, sublingual, submaxillary salivary glands, and urine Equ c 1 (major allergen)

        Equ c 2

        Equ c 4

        Equ c 3

        Equ c 6

        Lipocalin

        Lipocalin

        Latherin

        Albumin

        Lysozyme

        Chinchilla Epithelia, saliva, urine Chi La

        Chi Lb

        Protein kinase inhibitor

        Lipocalin

        Guinea pig 

         

        Cav p 1 (major allergen)

        Cap p 2 (major allergen)

        Cap p 3

        Cap p 4

        Cap p 6

        Lipocalin

        Lipocalin

        Lipocalin

        Serum albumin

        Lipocalin

        Gerbil

         

        Epithelial, salvia, urine, sleep bed Mer un 23kDa

        Mer un 4

        Lipocalin

        Serum albumin

        Siberian hamster Epithelial, saliva, urine Phod s 1 Lipocalin
        Rat Rat n 1 (major allergen)

        Rat n 4

        Rat n 7

        Lipocalin; alpha-2u-glubulin

        Serum albumin

        Immunoglobulin

        Mouse Mus m 1 (major allergen)

        Mus m 2

        Mus m 4

        Mus m 7

        Lipocalin; urinary prealbumin

        Unknown

        Serum albumin

        Immunoglobulin

        Rabbit Ory c 1

        Ory c 2

        Ory c 3

        Ory c 4

        Lipocalin

        Lipocalin

        Secretoglobin

        Lipocalin

        Ferret Mus p 17

        Mus p 66

        Unknown

        Serum albumin

        Pig Meat Sus s 1

        Sus s 5

        Sus s 6

        Serum albumin

        Lipocalin

        Serum albumin

        Lipocalin Superfamily

        More than 50% of allergens identified from furry animals belong to the lipocalin superfamily and are found in animal dander, saliva, and urine.23 Lipocalins are large proteins and can induce IgE production in a large proportion of atopic individuals (people who have enhanced immune response to common allergens) who are exposed to the allergen source.24

        Serum Albumin Family

        Serum albumin is a globular protein prone to participation in IgE-mediated cross-reactions.24 Serum albumin is commonly found in pet dander and saliva and causes an allergic reaction by inhalation and ingestion.

        Secretoglobin Superfamily

        Secretoglobins are the most potent allergens in cats (e.g., Fel d 1) and other pets (e.g., rabbit Ory c 3). Produced by the skin, salivary and lacrimal glands, these proteins have an unknown function. Dried saliva and dandruff are spread as airborne particles and cause sensitization in susceptible people.25

        SIGNS AND SYMPTOMS OF PET ALLERGIES

        The most frequently observed pet allergies result from inhalation, contact, and bites. The main allergic symptoms are similar across both common and uncommon pet types. They present as rhinitis, conjunctivitis, urticaria (red, itchy welts that result from a skin reaction), and lower and upper respiratory symptoms, which can be mild to severe and rarely cause anaphylactic shock.5

        Hypoallergenic Pets

        “Hypoallergenic” is defined as possessing decreased risk of causing an allergy in people, which means that hypoallergenic animals could still elicit allergies in humans.9 To make hypoallergenic animals, breeders or researchers combine breeds that produce less allergen (in dogs, breeders use breeds that shed less than other breeds, or have hair rather than fur). However, animals often have different mechanisms of allergenicity, so infrequent shedding does not solve all allergy problems.

        In a dog allergen study, homes that included hypoallergenic dogs had no statistically significant difference in dog allergen levels compared to homes that included non-hypoallergenic dogs. The common allergen in dogs, Can f 1, was reported at similar levels in all groups.25 The frequency of shedding varies in different dog breeds, but all dogs can elicit allergies in humans.

        The main allergen in cats, Fel d 1 protein, comes from their saliva and sweat glands. Because of its small size and adhesiveness, Fel d 1 floats around and sticks to everything, making it almost impossible to remove physically. In fact, Fel d 1 measures in at less than one-tenth the size of ribosome; it’s so small, it easily navigates its way deep into the lungs and can precipitate asthma.26 For this reason, making a completely hypoallergenic cat has proven impossible, however vaccines to decrease the production of Fel d 1 protein have been studied; one vaccine is a combination of recombinant Fel d 1, tetanus toxoid protein, and a snippet of the coat of a plant virus.27 Researchers are unsure as to the purpose of Fel d 1 in cats or why levels of Fel d 1 vary.

        Ferrets—which are related to otters, minks, weasels—are considered hypoallergenic because they are less likely to cause an allergic reaction compared to other animals. However, they can still provoke allergies in people. Allergies to ferrets come from their hair, saliva, and urine. Ferret hair and saliva is usually easy to control because they shed infrequently and do not lick people like dogs and cats often do. However, urine is harder to control and can cause allergies when owners clean crates.9

        Rabbits produce allergens through dander, hair from shedding, and saliva. They tend to shed more often than ferrets, around every three months, so keeping up with cleaning may be difficult. Rabbit hair isn’t naturally allergenic, but when rabbits lick their fur, they transfer a saliva protein that is contaminated with the protein allergen.10

        DIAGNOSIS

        Skin Prick Test

        Allergists (allergy specialists) use skin prick tests together with medical history and physical examinations to rule out or confirm a suspected IgE-mediated animal allergy.28 Manufacturers prepare skin prick tests by extracting natural allergens from animal hair, dander, and urine. The doctor or nurse will prick the patient’s skin on the forearm or upper back and determine if an allergic reaction occurs within 15 minutes. If a patient develops a red, itchy bump where the pet allergen extract is pricked into the skin, the patient is allergic to that pet allergen. Diagnosticians should first use a skin prick test as it is inexpensive, easy to use, and quick to perform. However, allergen concentrations and components are inconsistent, varying among similar commercial tests from different manufacturers. Healthcare providers should be aware that patients’ test results may be inconsistent if they use different skin prick tests at different times.28

        Serum-specific IgE Test

        Allergists can use a serum-specific IgE (blood) test when patients’ symptoms and skin test results are contradictory or when patients’ skin conditions prevent a skin test. Serum-specific IgE tests can only determine if a patient is sensitized to a specific pet allergen, but it cannot determine if a patient is allergic to that allergen. Serum-specific IgE tests are highly sensitive, but prone to false-positive results. From this perspective, serum-specific IgE tests may be less accurate than skin prick tests.29

        Molecular Diagnosis

        Recent scientific advances have allowed molecular diagnosis to differentiate patients who are allergic to a single species or sensitized due to cross-reactivity. This method can aid targeted recommendations for avoidance and assess the choice and composition of immunotherapy.28

        PET ALLERGY MANAGEMENT

        Pet allergies cannot currently be cured. The treatment goal is to control symptoms and improve patients’ functional status and well-being.

        Nonpharmacologic Treatment – Avoid & Minimize Allergen Exposure

        Current recommendations for managing pet allergy symptoms start with exposure avoidance. Starting when animals are young, bathing them at least once weekly can reduce allergens and eliminate reactions in humans who are exposed to them (see SIDEBAR).30 Immediate removal of animals from the household will not alleviate symptoms if the owner has carpeting and other pieces of furniture/items that the pet slept or sat on. Mammalian allergens are stable and can persist in house dust for up to six months.32 Additionally, using high-efficiency particulate air (HEPA) filters and mattress encasement, vacuuming, and chemically treating carpet are alternative methods for reducing exposure to contaminated materials, but may not reduce disease severity.33

        Pause and Ponder: When patients have pet allergies, which symptoms are best treated with antihistamines?

        SIDEBAR: To Bathe or Not to Bathe…26,31

        Bathing a cat or dog regularly appears to reduce the quantity of allergen harbored by the pet. To effectively lower Can f 1 concentrations, owners need to bathe the animal at least twice every week because Can f 1 concentrations rise rapidly, approaching baseline concentrations within three days after washing. Twice-weekly bathing can reduce the amount of recoverable Can f 1 on dogs by more than 80%, but researchers note that ideally, one would bathe the dog two to three times every week. Airborne Can f levels can fall by ruff-ly 40% but will quickly escalate.

        However, the beneficial effects of reducing allergen levels by regular bathing are more likely associated with dogs, because their allergen burden returns faster than that of cats. So, bathing animals reduces the amount of allergen far better than vacuuming.

        But should companion animals be bathed so often?

        Most cats are notoriously averse to bathing, although some breeds like water (i.e., the Bengal). Dogs vary in the response to bathing—some like it, others do not. People who plan to bathe their cats or dogs regularly should do three things:

        • Check with a veterinarian or a breed advocacy group. The American Kennel Club indicates that how often an owner should bathe a dog depends on the dog’s coat type and presence or absence of an undercoat (in the latter case, frequent bathing can affect a dog’s temperature regulation). Bathing an animal is not just about a human’s allergies, the animal’s health and welfare should be a primary concern.
        • Consider the labor and time involved in bathing a pet often, safely, and well.
        • Start when the animal is young.

         

        An allergen reducing cat food (Pro Plan LiveClear) is now available, and its manufacturer indicates it reduces the number of allergens in cat hair and dander by 47% after three weeks of feeding.34 It is produced using eggs that contain an anti-Fel d1 antibody. When cats consume the food, the egg powder binds to and neutralizes Fel d1 in the cat’s saliva.34

        Pharmacologic Treatment

        When avoidance and reducing allergens are not enough, depending on the severity of signs, over the counter (OTC) medications like antihistamines or local/topical steroids may provide temporary relief of allergy symptoms.35 Those symptoms include runny/itchy nose or throat, sneezing, and itchy, red or watery eyes. Combination products that contain both an antihistamine and a decongestant or an analgesic are available but should be used with caution due to the increased risk of adverse effects. Other allergy medications, besides the ones mentioned above, are used less often, including mast cell stabilizers and leukotriene antagonists. Table 2 summarizes common medications (both OTC and prescription) for treating mild to moderate allergy symptoms.35

        Table 2. Medications to Treat Allergy Symptoms36

        Medication Mechanism of Action Adverse Effects Notes
        Antihistamines
        1st generation (nonselective, more sedating) *

        Diphenhydramine, chlorpheniramine, clemastine

        2nd generation (less sedating, less drowsiness):

        Cetirizine,* desloratadine,* fexofenadine,* levocetirizine,* and loratadine*

        Azelastine has nasal spray* and eye drop formulation. Epinastine and olopatadine* are formulated as eye drops.

        Blocks histamine and its binding to receptors, prevents histamine-caused redness, swelling, itching, and changes in secretions during an allergic response ·       Drowsiness

        ·       Fatigue

        ·       Headache

        The 2nd generation antihistamines are preferred over 1st generation based on safety and efficacy data.

         

        Corticosteroids
        Available as tablets, liquids, nasal spray, topical creams for skin allergies, topical eye drops for conjunctivitis.

         

        Some steroids include:

        beclomethasone, ciclesonide, fluticasone furoate,* mometasone, budesonide,* triamcinolone,* dexamethasone ophthalmic, prednisone, etc.

        Anti-inflammatory effect Short-term use:

        Weight gain, fluid retention, high blood pressure

         

        Long-term use:

        Growth suppression, diabetes, cataracts of the eye, osteoporosis, muscle weakness

         

        Side effects of inhaled steroids:

        Cough, hoarseness, fungal infection of the mouth

         

        Highly effective for allergies but must be taken regularly. It may take 1 to 2 weeks before the full effect.
        Decongestants
        Available as nasal sprays, eye drops, liquids, and tablets

         

        Some decongestants include:

        pseudoephedrine,* phenylephrine,* and oxymetazoline* nasal sprays

         

        Shrinks swollen nasal tissues and blood vessels to relieve the symptoms of nasal swelling, congestion, mucus secretion, and redness ·       Increased blood pressure

        ·       Insomnia

        ·       Anxiety, feeling nervous, restlessness

        Relieve congestion and are often prescribed with antihistamines for allergies

         

        Contraindicated in patients with severe coronary artery disease, severe hypertension, and who concomitantly use monoamine oxidase inhibitors

         

        Short-term use only (~5 days). Long-term use can make symptoms worse.

        Combination Allergy Drugs
        Some combination drugs include:

        cetirizine/pseudoephedrine,* fexofenadine/ pseudoephedrine,* diphenhydramine/ pseudoephedrine,* loratadine/pseudoephedrine,* pseudoephedrine/triprolidine* for nasal allergies, and naphazoline/pheniramine* for allergic conjunctivitis

         

        Effects from each component Side effects from each component Use with caution due to increased risk of adverse effects
        Anticholinergic Nasal Spray
        Ipratropium bromide nasal spray to control nasal discharge Antisecretory properties in the nasal mucosa ·       Bitterness of the mouth

        ·       Dry nose, nosebleeds, or irritation

        ·       Dizziness

        ·       Headache

        ·       Sore throat

        ·       Respiratory tract infection

        Some patients may feel better right away. For others, it may take 1 to 2 weeks before the medicine helps. It is important for patients to continue use of this medication as instructed.
        Mast Cell Stabilizers
        Available as eye drops for allergic conjunctivitis and nasal sprays for nasal allergy symptoms

         

        Some mast cell stabilizers include cromolyn sodium,* iodoxamide-tromethamine, nedocromil, pemirolast, etc.

        Prevents histamine release from mast cells Throat irritation, coughing, skin rashes

         

        For eye drops may cause blurred vision, stinging, and burning

        For mild to moderate symptoms

        Not as effective as steroids

        Leukotriene Modifiers
        Montelukast*:

        Indicated for adults and pediatric patients six months or older with perennial allergic rhinitis.

        May be less effective than loratadine or cetirizine for reducing daytime nasal symptoms

        Montelukast binds to leukotriene receptors in the human airway (smooth muscle cells and macrophages), preventing airway edema, smooth muscle contraction, and other respiratory inflammation ·       Stomach pain or upset

        ·       Headache

        ·       Stuffy nose

        ·       Cough

        ·       Fever

        ·       Rash

        ·       Irritability

        Warn patients to report behavior changes, including suicidal ideation or suicidal behavior

        Avoid concomitant use of aspirin or NSAIDs in aspirin-sensitive patients

        *Indicates over the counter (OTC) medication

         

        In general, for conditions eligible for self-care, e.g., allergic rhinitis, patients should start taking OTC allergy medications one week before they expect symptoms from a predictable exposure or as soon as possible before allergen exposure (for episodic exposure).35 Prescribers should tailor the pharmacologic therapy and length of treatment based on symptoms and severity. Usually, complete relief takes two to four weeks. Intranasal steroids control nasal symptoms more effectively than antihistamines, as they inhibit multiple cell types and mediators, and should be recommended for moderate or persistent allergic rhinitis. Decongestants are effective in nasal congestion but have little effect on other symptoms. Intranasal and ocular preparations are available for nasal and eye symptoms. Intranasal cromolyn is the preferred initial choice for pregnant or lactating patients, as the body does not absorb it based on the route of administration. As mentioned in the table, fluticasone and triamcinolone nasal sprays are available over the counter.35

        If a patient has persistent allergies, allergy medication is more effective when taken regularly.35 For example, if a patient with moderate or severe persistent allergic rhinitis has completed two to four weeks of treatment with intranasal corticosteroids or oral antihistamine and achieved symptomatic control, healthcare providers can optimize the treatment’s effect by reducing the dose and continuing treatment for one additional month. If a patient’s symptoms are uncontrolled after two to four weeks of OTC treatment, pharmacists should assess the patient’s adherence and refer for prescription therapy if necessary.35

        Pause and Ponder: Which providers in your area provide allergen-specific immunotherapy? What should patients expect if they take this route?

        Allergy Immunotherapy

        Allergen-specific immunotherapy has been used in pet allergies for years and has proven efficacy to help control symptoms and prevent disease progression. Allergists will consider allergy-specific immunotherapy when symptoms are uncontrolled by medications and/or avoidance measures, when adverse drug effects are intolerable, or when patients want to reduce long-term use of allergy medications.37

        The basis for allergen-specific immunotherapy is gradual reprogramming of the immune system to build a tolerance to allergens. This class comes in three forms:

        • Sublingual allergy immunotherapy (SLIT) tablets
        • SLIT drops, and
        • subcutaneous allergy immunotherapy (SCIT)

        As of 2022, the FDA has approved four SLIT tablets to treat allergic rhinitis with or without allergic conjunctivitis caused by ragweed, northern pasture grasses, and dust mites in susceptible individuals; the FDA has not approved SLIT tablets for pet allergies.22

        SLIT drops are made from FDA-approved allergy extracts used to make SCIT shots. However, these extracts are only FDA-approved for injection use under the skin, and they are not approved for use under the tongue. Therefore, SLIT drops are not FDA-approved and are off-label in the United States, and Medicare or Medicaid does not cover these treatments in most cases. Despite not having FDA approval, patients can still receive SLIT drops from some prescribers who prepare a custom-mixed formulation but must pay out of pocket. Research indicates SLIT is safe and effective.39

        The FDA has approved SCIT for cat allergies, but not for other pet allergies. Patients who receive SCIT usually call it “allergy shots.” One systemic review evaluated 88 trials that enrolled 3,459 asthmatic patients and exposed them to SCIT. One case of deterioration in asthma symptoms was avoided for every three patients treated with SCIT (95% CI, 3-5), and one patient would avoid increasing symptomatic medication use for every four patients treated (95% CI, 3-6).40 Another study found that SCIT can reduce the need for systemic steroids in allergic rhinitis patients.41 Usually, the patient receives a solution for injection with 10,000 bioequivalent allergy units (BAUs) per milliliter (standardized extract) of lyophilized cat hair and dander added to glycerol and human serum albumin (0.03%). A clinician administers one to two subcutaneous injections every week starting at low doses (1:10,000 dilution) and titrating up to a seemingly effective maintenance dosing. Then, the prescriber extends the injection interval gradually to every 2 weeks to 4 weeks. For cat allergens, the effective maintenance dose usually falls within the 1000 to 4000 BAU range.42

        SCIT sometimes can cause treatment-related systemic allergic reactions; however, near-fatal or severe reactions are rare, and most reactions are local and mild (swelling, pruritis, and redness at injection site).43 SCIT should not be recommended to patients who have severe uncontrolled heart problems or asthma if they take beta-blockers, which are associated with more frequent reactions, more severe reactions, and reactions that are refractory to epinephrine. Additionally, allergy shots should not be recommended for pregnant women unless discussed with their obstetricians.43

        Both SCIT and SLIT require gradual up-titration of dosages with ongoing and multiple treatments and may take three to five years to reach desensitization. Also, for SCIT, based on its route of administration (subcutaneous injections are invasive), patients will need to visit the doctor's office more frequently and may experience the treatment-associated side effects.

        SLIT has been increasingly recommended because of its ability to modify the immune system for the long term while reducing allergy symptoms. SLIT also showed a safer profile, only associated with mild mouth symptoms, and improved adherence compared to SCIT.44 When compared to traditional allergy treatments, SLIT tablets showed similar clinical efficacy to nasal corticosteroids and greater clinical efficacy than second-generation antihistamines and montelukast.45

        What About Cost?

        In adherent patients, SCIT and SLIT have proven to be an economically viable option. The annual cost of using SCIT depends on patients’ insurance: Medicare ($1021.70), Medicaid ($758.16), and the commercial average ($1722.24). Yearly treatment costs for SLIT are self-pay because treatment is not FDA approved and costs around $679.25.46 Because SLIT drops are administered at home by patients, they tend to be more affordable than the cost of SCIT. Patient preference might be for a once monthly administration, rather than taking oral antihistamines  daily.

        OTC medications are less expensive than immunotherapy, but costs vary. In a comparison of second-generation antihistamines versus montelukast, levocetirizine (Xyzal) had the best efficacy per cost value. Generic fexofenadine (Allegra), although similar in efficacy, was more expensive than levocetirizine.44

        CONCLUSION

        Healthcare providers should counsel patients about reducing allergen exposure and help patients to choose OTC medications for self-care based on individual patient needs and conditions to optimize treatment effects. Pharmacy staff should refer patients to allergists when necessary to identify the cause of their allergy symptoms. If a patient's allergy does not allow him or her to have pets at home and the patient owns a pet, suggest that the patient ask family members or friends about placement before contacting the local animal shelters.

        Pharmacist Post Test (for viewing only)

        Pet Allergies
        Pharmacist Post-test
        After completing this continuing education activity, pharmacists will be able to
        1. Outline the causes of pet allergies in dogs, cats, and other less common species
        2. Differentiate between allergic sensitization, allergy, and cross sensitivity
        3. Paraphrase facts that prove that currently, hypoallergenic dogs and cats are a myth
        4. Compare nonpharmacologic, over the counter, and prescription treatments in terms of dosing, effectiveness, and cost

        1. What is the major allergen in dogs?
        A. Can f 3
        B. Can f 1
        C. Fel d 1

        2. When comparing allergy immunotherapies (SCIT, SLIT) and traditional allergy treatments, how do they differ?
        A. Traditional allergy treatments are more clinically efficacious, SCIT and SLIT therapies should not be considered in treatment
        B. Traditional allergy treatments are more effective, but with the recent FDA approval of SLIT, it should be considered more often
        C. Although not FDA approved, SLIT showed similar clinical efficacy to nasal corticosteroids and more clinical efficacy to second-generation antihistamines in trials

        3. What is the best way to define hypoallergenic animals?
        A. Animals that are less likely to cause allergies in humans.
        B. Animals that cannot cause allergies in humans
        C. Animals that do not cause conjunctivitis, but other common symptoms may still occur

        4. A mother brings her young son to the pharmacy and says that the allergist indicates he has an allergy to their cat. She asks what this means. What is the BEST answer?
        A. Her son has immunoglobulin G (IgG) antibodies to an allergen.
        B. Her son will experience reproducible symptoms when exposed to the cat.
        C. Her son will have symptoms when exposed to any furry animal.

        5. Lance, a college student who lives in a group house, comes in and says that he has tried several medications for allergic symptoms linked to his roommate’s three cats. The medications relieved the symptoms but caused so much drowsiness, he couldn’t study. His allergist is now recommending he start immunotherapy. What is the MOST LIKELY reason the allergist is making this recommendation?
        A. Lances’ symptoms are uncontrolled by medications
        B. Lance is experiencing intolerable adverse effects
        C. Lance want to reduce his use of allergy medications.

        6. Lance returns to the pharmacy to pick up his atenolol for hypertension and he said the allergist has asked him to decide if he wants to take SCIT or SLIT. He asks you which factors he should consider. What is the BEST answer?
        A. Advise him to consider cost, dosing frequency, and route of administration
        B. Advise him to consider cost and convenience alone as they are both effective
        C. Advise him to tell his allergist he is taking a beta blocker, so SLIT is preferred

        7. Emily and her mom come to the pharmacy and they are very excited. They are considering adopting a dog! Emily has asthma and multiple allergies, and the pediatrician has told them she is probably allergic to or will become allergic to dogs. As Mom chatters, she tells you that the 9-year-old dog, Raven, is an Alaskan Malamute (a breed that has a heavy undercoat) that weighs 95 pounds. She said that a friend told her that if she washes the dog two or three times a month, allergies will not be a problem. She says, “I think I can find time to wash a dog twice a month.” What is the MOST IMPORTANT FACT you should bring to her attention?
        A. Before adopting Raven, check with a veterinarian or a breed advocacy group to determine if bathing is a good idea.
        B. Bathing a pet two to three times a month is not frequent enough to reduce the allergen load—you have to bathe them two to three times a week.
        C. Look for a younger Alaskan Malamute—maybe a puppy—so the dog will get used to being bathed so often.

        8. Adele, who is 7 months pregnant, is experiencing an allergic reaction to a visiting ferret. She asks you to recommend an OTC product to reduce her nasal stuffiness and itchy eyes. Which is the BEST product to recommend?
        A. Intranasal cromolyn
        B. Oral levocetirizine
        C. Oral diphenhydramine

        9. Which of the following have similar effectiveness for pet allergies, but different cost effectiveness?
        A. Fluticasone and fexofenadine
        B. Montelukast and loratadine
        C. Levocetirizine and fexofenadine

        10. Which medication class should be used for no longer than five days at a time?
        A. Decongestants
        B. First generation antihistamines
        C. Nasal corticosteroids

        Pharmacy Technician Post Test (for viewing only)

        Pet Allergies

        Pharmacy Technician Post-test

        After completing this continuing education activity, pharmacy technicians will be able to
        • Outline the causes of pet allergies in dogs, cats, and other less common species
        • Differentiate between allergic sensitization, allergy, and cross sensitivity
        • Paraphrase facts that prove that currently, hypoallergenic dogs and cats are a myth
        • Identify patients whose complaints indicate they may need referral to a pharmacist

        1. What is the major allergen in dogs?
        A. Can f 3
        B. Can f 1
        C, Fel d 1

        2. When comparing allergy immunotherapies (SCIT, SLIT) and traditional allergy treatments, how do they differ?
        A. Traditional allergy treatments are more clinically efficacious, SCIT and SLIT therapies should not be considered in treatment
        B. Traditional allergy treatments are more effective, but with the recent FDA approval of SLIT, it should be considered more OFTEN?
        C. Although not FDA approved, SLIT showed similar efficacy to nasal corticosteroids and more clinical efficacy to second-generation antihistamines in trials

        3. What is the best way to define hypoallergenic animals?
        A. Animals that are less likely to cause allergies in humans.
        B. Animals that cannot cause allergies in humans
        C. Animals that do not cause conjunctivitis, but other common symptoms may still occur

        4. A mother brings her young son to the pharmacy and says that the allergist indicates he has an allergy to their cat. She asks what this means. What is the BEST answer?
        A. Her son has immunoglobulin G (IgG) antibodies to an allergen.
        B. Her son will experience reproducible symptoms when exposed to the cat.
        C. Her son will have symptoms when exposed to any furry animal.

        5. Lance, a college student who lives in a group house, comes in and says that he has tried several medications for allergic symptoms linked to his roommate’s three cats. The medications relieved the symptoms but caused so much drowsiness, he couldn’t study. His allergist is now recommending he start immunotherapy. What is the MOST LIKELY reason the allergist is making this recommendation?
        A. Lances’ symptoms are uncontrolled by medications
        B. Lance is experiencing intolerable adverse effects
        C. Lance want to reduce his use of allergy medications.
        Links to LO #4 Answer found on page 10

        6. Lance returns to the pharmacy to pick up his atenolol for hypertension and he said the allergist has asked him to decide if he wants to take SCIT or SLIT. He asks you which factors he should consider. What is the BEST answer?
        A. Advise him to consider cost, dosing frequency, and route of administration
        B. Advise him to consider cost and convenience alone as they are both effective
        C. Advise him to tell his allergist he is taking a beta blocker, so SLIT is preferred

        7. Emily and her mom come to the pharmacy, and they are very excited. They are considering adopting a dog! Emily has asthma and multiple allergies, and the pediatrician has told them she is probably allergic to or will become allergic to dogs. As Mom chatters, she tells you that the 9-year-old dog, Raven, is an Alaskan Malamute (a breed that has a heavy undercoat) that weighs 95 pounds. She said that a friend told her that if she washes the dog two or three times a month, allergies will not be a problem. She says, “I think I can find time to wash a dog twice a month.” What is the MOST IMPORTANT FACT should you bring to her attention?
        A. Before adopting Raven, check with a veterinarian or a breed advocacy group to determine if bathing is a good idea.
        B. Bathing a pet two to three times a month is not frequent enough to reduce the allergen load—you have to bathe them two to three times a week.
        C. Look for a younger Alaskan Malamute—maybe a puppy—so the dog will get used to being bathed all the time.

        8. Adele., who is 7 months pregnant, is experiencing an allergic reaction to a visiting ferret. She asks you to recommend an OTC product to reduce her nasal stuffiness and itchy eyes. Which is the BEST product to recommend?
        A. Intranasal cromolyn
        B. Oral levocetirizine
        C. Oral diphenhydramine

        9. Which of the following have similar effectiveness for pet allergies, but different cost effectiveness?
        A. Fluticasone and fexofenadine
        B. Montelukast and loratadine
        C. Levocetirizine and fexofenadine

        10. Which medication class should be used for no longer than five days at a time?
        A. Decongestants
        B. First generation antihistamines
        C. Nasal corticosteroids

        References

        Full List of References

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        23. Jesner S. (2022, June 28). Sublingual immunotherapy faqs. Sublingual Immunotherapy FAQs. Accessed July 8, 2022. https://www.hopkinsmedicine.org/otolaryngology/specialty_areas/sinus_center/sublingual_immunotherapy.html#:~:text=Immunotherapy%20treats%20the%20cause%20of,as%20drops%20under%20the%20tongue.
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        40. Abramson MJ, Puy RM, Weiner JM. Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2010;(8):Cd001186. doi:10.1002/14651858.CD001186.pub2
        41. Aasbjerg K, Torp-Pedersen C, Backer V. Specific immunotherapy can greatly reduce the need for systemic steroids in allergic rhinitis. Allergy. 2012;67(11):1423-9. doi:10.1111/all.12023
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        44. Goodman MJ, Jhaveri M, Saverno K, Meyer K, Nightengale B. Cost-effectiveness of second-generation antihistamines and montelukast in relieving allergic rhinitis nasal symptoms. Am Health Drug Benefits. 2008;1(8):26-34.
        45. Aboshady OA, Elghanam KM. Sublingual immunotherapy in allergic rhinitis: efficacy, safety, adherence and guidelines. Clin Exp Otorhinolaryngol. 2014 Dec;7(4):241-9. doi: 10.3342/ceo.2014.7.4.241.
        46. Hardin FM, Eskander PN, Franzese C. Cost-effective Analysis of Subcutaneous vs Sublingual Immunotherapy From the Payor's Perspective. OTO Open. 2021 Oct 25;5(4):2473974X211052955. doi: 10.1177/2473974X211052955.

        Human Trafficking: Pharmacy’s Impact on Care

        Learning Objectives

         

        After completing this application-based continuing education activity, pharmacists will be able to

        • Review the history and current laws of human trafficking in the United States
        • Recognize common terms, warning signs, and/or vulnerabilities for human trafficking in pharmacy patients/customers
        • Describe pharmacists’ impact on identifying and supporting victims and survivors of human trafficking
        • Ensure proper referral, treatment, and counseling for common health risks associated with human trafficking

        After completing this application-based continuing education activity, pharmacy technicians will be able to

        • Review the history and current laws of human trafficking in the United States
        • Recognize common terms, warning signs, and/or vulnerabilities for human trafficking in pharmacy patients/customers
        •  Identify signs/signals of human trafficking red flags to notify pharmacists or law enforcement

        Bar code with human silhouettes in between

         

        Release Date: March 1, 2023

        Expiration Date: March 1, 2026

        Course Fee

        Pharmacist $7

        Technician $4

        There is no grant funding for this CE activity

        ACPE UANs

        Pharmacist: 0009-0000-23-006-H99-P

        Pharmacy Technician: 0009-0000-23-006-H99-T

        Session Codes

        Pharmacist:  23YC06-KAB48

        Pharmacy Technician:  23YC06-BAX92

        Accreditation Hours

        2.0 hours of CE

        Accreditation Statements

        The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-006-H99-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

         

        Disclosure of Discussions of Off-label and Investigational Drug Use

        The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

        Faculty

        Sarah Meade, BS
        PharmD Candidate May 2023
        UConn School of Pharmacy
        Storrs, CT

        Jeannette Y. Wick, RPh, MBA
        Director, Office of Pharmacy Professional Development
        UConn School of Pharmacy
        Storrs, CT

         

        Faculty Disclosure

        In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

        Jeannette Wick and Sarah Meade do not have any relationships with ineligible companies and therefore have nothing to disclose.

         

        ABSTRACT

        Americans may widely underestimate human trafficking’s current extent in the United States because of stereotypes about traffickers, victims, and sex workers, and also because many Americans lack knowledge about this topic. Despite the general public’s lack of knowledge, trafficking reports are rapidly increasing in the United States today. Healthcare for trafficking victims and survivors is often complicated due to clinicians’ lack of sensitivity about a patient’s trafficking experiences. Because victims of human trafficking are highly likely to seek medical care while under a trafficker’s control, training healthcare providers to identify, handle, and report suspected human trafficking is critical. Without trafficking education, providers’ biases and misunderstanding of victim trauma may hinder the ability to develop a trusting patient-provider relationship. Pharmacy teams should know how to identify human trafficking while protecting victims’ safely, providing appropriate resources for victims to seek help, and assisting with individualized treatment selection.

        CONTENT

        Content

        Introduction

        Human trafficking is a growing concern globally. Americans may widely underestimate human trafficking’s current extent in the United States (U.S.) because of stereotypes about traffickers, victims, and sex workers, and also because many Americans lack knowledge about this topic. Despite the general public’s lack of knowledge, trafficking reports are rapidly increasing in the United States today. The SIDEBAR defines terms associated with human trafficking.

         

        SIDEBAR. Human Trafficking Definitions1,2

        • Human Trafficking: Recruitment, transfer, transportation, or receipt of people through force, manipulation, fraud, or threats to achieve control over a person for exploitation
        • Sex worker: A person who voluntarily provides sex work regularly or occasionally in commercial exchange for money or goods. Sex work differs from sexual exploitation, or the forcing of a person to commit sexual acts.
        • Survivors: people who have escaped their trafficking situations
        • Survivor-informed practice: Including meaningful input from a diverse community of survivors at all stages of a program or project, including development, implementation and evaluation
        • Traffickers: people using force, manipulation, threats, or fraud to force victims into exploitative situations
        • Trauma-informed care: collaborating with community resources to empower individuals to determine their own futures
        • Venue: The place in which trafficking occurs; human trafficking does not necessarily involve crossing state or international borders
        • Victims: people currently in an exploitative situation

         

        In 2010, Faith Robles, a 14-year-old teenager from Mexico, moved in with her boyfriend’s family in Queens, New York.3 The family promised her a job that would “change her life,” but she did not learn this involved sleeping with men against her will—sometimes up to 30 men daily—until after her boyfriend smuggled her into the U.S. At the time, Robles was unaware that her boyfriend and four of his relatives were involved in a human trafficking ring. After she arrived, the family threatened to kill her family and traffic her sister if she sought help from authorities or did not comply with their demands. Robles was a victim of sex trafficking for three and a half years, suffering multiple beatings, sexual assaults, and a broken jaw following an escape attempt. She was finally able to escape at age 17 when she sought help from police officers.3 Hearing from survivors like Faith Robles has helped healthcare providers develop interventions that are survivor-informed. This continuing education activity will cover several aspects of human trafficking as it relates to pharmacy using evidence collected by reliable organizations and researchers.

         

        Unfortunately, many victims in the U.S. today share stories like Robles’. In August 2022, the Federal Bureau of Investigation (FBI) announced that they located and identified 84 minors who were victims of sex trafficking during a nationwide sex trafficking operation. FBI agents found an additional 141 adult victims. Human trafficking rates continue to increase in the U.S. Reports of human trafficking to the National Center for Missing and Exploited Children Tipline increased from 21.7 million to 29.3 million reports from 2020 to 2021.4 Readers should note that collecting and reporting data on human trafficking has some limitations; many cases of human trafficking are never reported.5 Sometimes it’s because the victims are afraid or under a trafficker’s strict control and cannot seek help. Sometimes, it's because people who might be able to help a victim do not recognize the problem or have no idea how to help. Sometimes, it’s because systems have not looked at the issue, determined what (if anything) the system’s responsibilities are, and established policies and procedures to prevent trafficking and provide help.

         

        Readers should also note that to be considered human trafficking, the trafficker need not move a victim across state or international borders; thinking that movement is a necessary component of human trafficking is a common misperception. Current federal laws only require that the trafficker has met the criteria for the 3 elements of “act,” “means,” and “purpose.”6

        • ACT means that the trafficker has recruited, transported, transferred, harbors, or received a victim
        • MEANS indicates the trafficker has used threat or use of force, coercion, fraud, deception, abuse of a position of vulnerability, payments or benefits, or abduction
        • PURPOSE is very simple; the trafficker’s sole purpose is to exploit the victim

        In short, these requirements indicate that someone who coerces an individual to provide sex or labor against their will in exchange for housing or drugs would be considered a human trafficker, as doing so is exploitation. Someone who moves victims from place to place is also a trafficker, and in some states, people or organizations that knowingly harbor traffickers and their victims would also be complicit in human trafficking.7,8

         

        In 2019, the National Human Trafficking Hotline reported California, Texas, and Florida as the top states for human trafficking with 1,507, 1,080, and 896 reported cases, respectively.9 Human trafficking often occurs along highways that provide access to easy getaways and quick transportation; many traffickers move their victims often to avoid detections. The busiest interstates in the U.S. include I-5 in the West, I-95 in the East, and I-80 stretching from California to New Jersey. The Polaris Project (see SIDEBAR) asserts that common trafficking venues include illicit massage parlors, informal underground businesses, and hotels and motels along major highways. For this reason, the National Association of Truck Stop Operators and large hotel chains, such as Marriott, offer training to help employees identify and report human trafficking victims.10

        Pause and Ponder: How likely is your pharmacy to interact with victims or survivors of human trafficking? Why?

        SIDEBAR. The Polaris Project

        The Polaris Project is a nonprofit social justice organization that fights sex and labor trafficking through the U.S. National Human Trafficking Hotline. Polaris uses survivor-driven trafficking data to improve trafficking identification, provides assistance for victims and survivors, and educates the community. More information on the Polaris Project can be found on its website (https://polarisproject.org/).11

         

        Polaris hosts the National Human Trafficking Hotline around the clock. Readers should make note of this resource, as it will often be the first and safest place to seek help when patients indicate or pharmacy staff suspects that an individual is being trafficked.

         

        Human trafficking is a crime under federal and international law. The International Labor Organization estimates that the human trafficking “industry” generated $32 billion in 2005, making it the third largest source of income for organized crime.12,13 Current estimates are unavailable but would clearly be much larger. Human trafficking victims can come from any background and may live for years under their trafficker’s control. Victims may be trafficked by their own family, friends, or acquaintances with or without the victim’s knowledge.14,15

         

        Human traffickers prey on others in reprehensible ways.16 Policy makers, public health groups, and researchers have tried to understand the motives behind human trafficking to identify factors that would help develop anti-trafficking interventions. Many publications indicate traffickers become involved primarily for financial gain because the profits associated with human trafficking can be enormous. Many of the interventions currently employed identify traffickers by tracking large quantities of cash and banking patterns. Recent research has found that in some cases, traffickers make considerably less money than expected. These traffickers may be motivated by cultural norms, ideology, or religions that devalue human life. Traffickers may be former victims who go on to recruit and control others. And some traffickers simply have sociopathic tendencies.16

         

        Traffickers use various tactics to manipulate victims, including14

        • Debt-bondage
        • Emotional manipulation
        • Lies or deceit
        • Subjecting victims to unstable or unpredictable conditions
        • Physical, sexual, or psychological violence
        • Threats against family members
        • Transporting victims to unfamiliar places to create a language barrier
        • Withholding documents

         

        Pre-trafficking vulnerabilities for victims include poverty, trauma, domestic violence, learning difficulties, lack of educational or work opportunities, loss of family, community- or gender-based violence, and natural disasters.2 Human trafficking survivors with vulnerabilities are at higher risk of re-victimization. The SIDEBAR describes types of human trafficking.

         

        SIDEBAR. Types of Human Trafficking15,17,18

        All forms of human trafficking include exploitation, abuse of vulnerable situations, psychological violence, and deprivation of freedom. Added physical and/or sexual violence is also common. Specific types of trafficking may include one or more of the following:

        • Sex trafficking: forcing someone to sell sex; more commonly affects women but often happens to children of both sexes
        • Forced labor: involuntary servitude, often in industries with large numbers of workers and little regulation; most common element of modern-day slavery
        • Domestic servitude: jobs related to domestic help; often hidden in plain sight
        • Debt bondage: begins with debt that the victim is unable to pay immediately; employer exploits the victim by adding additional expenses to increase debt
        • Other forms: forced marriage, organ removal for sale, and enforced crime

         

        Readers should note that human trafficking differs from human smuggling. In human smuggling, the purported purpose is to transport or hide individuals who lack proper documentation (e.g., passports, driver’s licenses, or other identification) and circumvent officials without regard to immigration laws (a transportation-based crime). The people smuggled across borders often have chosen to be smuggled as a means to reach an otherwise inaccessible destination. Victims of human trafficking are generally held in circumstances against their will. Nevertheless, traffickers may also use victims’ immigration status and threaten to deport victims to coerce victims to do as they are told. In some cases, smuggling may lead to trafficking.

         

        With 30% to 88% of U.S. trafficking victims seeking healthcare at least once during captivity, life-saving identification of trafficking victims in healthcare settings is crucial.19 Several researchers have attempted to estimate how many victims seek healthcare, but because of the nature of the topic and the risk associated with disclosure, it’s been difficult. Two studies shed some light on victims’ contact with healthcare providers. In a meta-analysis of 420 victims, 50% to 98% of victims reported seeking healthcare services in diverse medical settings while they were captive.20A second study found that roughly 63% of victims had visited emergency departments (ED) and identified hospitals and ED as their most frequent source of care.21 Trafficking victims tend to use complaint-based episodic acute care services (e.g., minute clinics, urgent care centers, and ED) more often than long-term comprehensive primary care services.22 Each visit represents an opportunity to identify potential behaviors, injuries, or actions that may signal victimization. Several studies have documented that healthcare professionals tend to have limited recognition and knowledge of human trafficking.23,24

         

        No data is available about victims’ use of pharmacies, but pharmacy employees in community settings are likely to encounter human trafficking victims. Pharmacists and technicians should be prepared to recognize human trafficking signs for quick, appropriate, and life-saving action.

         

        History of Human Trafficking in the United States

        Let’s return to Faith Robles. Fortunately, Ms. Robles pressed charges against her boyfriend and his family for the damages and trauma she endured during captivity. In 2020, a judge sentenced Robles’ boyfriend and his family to prison terms of between 25 and 40 years under charges of “sex trafficking, sex trafficking conspiracy, sex trafficking of minors, interstate prostitution, alien smuggling, and money laundering conspiracy.”3 However, if Robles had reported her case in the early 1970s, she would not have been able to press charges; the federal government did not incorporate human trafficking crimes into U.S. law until recently.

         

        The first U.S. law for human trafficking was the 1974 Child Abuse Prevention and Treatment Act (CAPTA). CAPTA required states to establish child abuse reporting laws as a condition of receiving federal funds.25 Mandated reporters and agencies to which people who observe or suspect abuse are to report vary by state law, but generally states require reporting in some capacity. Healthcare providers should always check their states’ applicable laws periodically so they know exactly what the state requires.

         

        Mandated reporters are personnel who must report suspected or confirmed exploitation, abuse, or neglect of vulnerable populations. Alabama, Colorado, Connecticut, Hawaii, Oregon, Vermont, and Washington state laws specifically list pharmacists as mandated reporters for child victims. Other states list mandated reporters as “healthcare personnel” or people responsible for the care and/or treatment of child victims. Most states do not require mandatory reporting by healthcare personnel for victims 18 years old or older unless the adult is elderly or in some way vulnerable. States that do not require healthcare providers to report adult victims may do so because of the victims’ heightened safety risk, vulnerability, mistrust in authorities, and fear of their traffickers.26 Federal law does not currently require states to mandate reporting for adults or provide funding to meet reporting requirements.

         

        The Trafficking Victims Protection Act (TVPA) of 2000 created the first comprehensive federal law to address human trafficking. The TVPA offered immigration relief for human trafficking victims, creation of public educational programs for prevention of future trafficking, and increased prosecution of trafficking.25,27 In January 2023, Congress reauthorized this Act. TVPA reauthorization added some additional coverage28:

        • It increases protections for child survivors of human trafficking
        • It provides funding for state welfare agencies to identify and assist child victims of human trafficking and work more closely and efficiently with the juvenile justice system
        • It eliminates barriers to services for child victims of human trafficking: consent from a parent or guardian is no longer necessary to apply for ID and other forms of identification, making it easier for children to apply for benefits and services
        • It expands support for research concerning social media’s impact on human trafficking

         

        In 2013, the U.S. Department of Health and Human Services (HHS) created the Stop, Observe, Act, and Respond (SOAR) program to provide human trafficking training to healthcare and related professionals. The program includes victim identification and implementation of best practices for necessary reporting, referrals, communication, and treatment. In 2018, the HHS required public posting of best practices on the HHS website for entities receiving federal grants.29 SOAR’s program for individuals and groups are available at https://nhttac.acf.hhs.gov/soar/soar-for-individuals/soar-online.

         

        In 2015, the Justice for Victims of Trafficking Act (JVTA) improved U.S. trafficking response. The law strengthened victim resources, including increasing individuals’ criminal liability if they buy commercial sex from victims, creation of the survivor-led U.S. Advisory Council on Human Trafficking, and a national strategy for combating human trafficking.30

         

        Current human trafficking reporting laws are inconsistent due to variations among states; federal law does not clearly define a “mandated reporter” and does not require healthcare providers to report trafficking victims 18 years old or older.25 The American Hospital Association; the law firm of Jones Day; and the Health, Education, Advocacy, Linkage (HEAL) Trafficking network have collated state-specific reporting requirements for healthcare providers on the HEAL Trafficking website (https://healtrafficking.org/wp-content/uploads/2021/01/Human-Trafficking-and-Health-Care-Providers_Legal-Requirements-for-Reporting-and-Education-02_25_21.pdf).26

         

        Pause and Ponder: What policies do you currently have in place to identify victims?

         

        Healthcare Providers & Human Trafficking

        Human trafficking victims are often in situations that compromise their health and safety. Most trafficked people seek healthcare from licensed providers at some point during their exploitation. Pharmacists and pharmacy technicians in outpatient settings may interact with victims without realizing their situation. Healthcare providers should be able to recognize possible victims and survivors confidently and take appropriate action to intervene if needed2; however, most health professionals report that they are unfamiliar with how to identify or respond to a trafficked person effectively.31

         

        The Pharmacy Team in Action

        Pharmacists’ involvement on the healthcare team is increasing and expanding from dispensing drugs to include medication and disease management and more expansive responsibilities. Pharmacy is unique because the available healthcare counseling is highly accessible by the public.

         

        For safety and reporting, pharmacy team members should generally trust their instincts in a suspicious situation, especially when patients2,31,32

        • Act as if under control of another person, i.e., another person accompanies the patient, speaks for them, or there is a lack of rapport between the patient and accompanying individual
        • Report a history of frequent address changes, vagueness about where they live and/or medical history
        • Are present at a time when they should be in school
        • Have poor or concerning physical appearance suggesting captivity, neglect, and/or physical harm, i.e., poor hygiene or inappropriate clothing for current weather conditions or for their age (i.e., clothing is more promiscuous or revealing than normal for a teen)
        • Present with illnesses or injuries not easily explained, especially repeated or partially treated concerns
        • Exhibit signs and symptoms of self-harm, suicidal ideation, depression, or drug or alcohol misuse

         

        Many state laws require pharmacists to counsel patients on new prescriptions. Prescription filling patterns that may signal trafficking include frequent sexually transmitted infection (STI) treatment, no insurance coverage, cash-only payments, prescriptions routinely lost or stolen, or a medical history of prescriptions from acute care clinics rather than a primary care physician.33 Victims may be hesitant to access healthcare because of safety concerns and are more likely to self-treat using over the counter (OTC) medications. Table 1 lists frequently used or misused OTC products for self-treatment, and this information may assist pharmacists and pharmacy technicians with screening for potential victims. Upon suspicion of trafficking, pharmacists should try to screen the patient privately.

         

        Table 1. OTC Products Frequently Used or Misused for Self-Treatment of Trafficking-Associated Medical Concerns34,35

        Health Concern OTC Products
        Mental health and substance abuse St. John’s Wort

        Dextromethorphan

        Diphenhydramine

        Pseudoephedrine

        Phenylephrine

        Sexual intercourse or urinary tract infection Condoms

        Levonorgestrel (Plan B)

        Miconazole

        Pregnancy tests

        Phenazopyridine

        Genital anti-itch creams

        Physical abuse Painkillers (i.e. acetaminophen, ibuprofen, aspirin)

        First aid items (i.e., bandages, gauzes, antiseptics, Neosporin)

         

        Privacy is essential to obtaining accurate and sensitive information that a victim might otherwise not be comfortable with sharing, especially for victims who fear for their safety and accompanied by an abuser. When pharmacy team members try to speak to the patient alone, they should remain calm and ask for privacy cautiously. The pharmacy team may emphasize the importance of privacy to the accompanying individual, perhaps by saying, “I’m going to step in here and speak to [patient’s name] alone because these are deeply personal health issues.” Note that this approach doesn’t ask a question—which might give the trafficker wiggle room to argue—but instead states a fact in a neutral manner. However, pharmacy staff should not push if they experience push-back from the suspected trafficker. Most pharmacies have a separate space for consultation or vaccinations that they may use when patients need privacy or to review sensitive information.

         

        Pause and Ponder: What are some ways your pharmacy team can work to improve health outcomes for victims and survivors of human trafficking?

         

        Avoiding Bias + Using the Correct Language

        Pharmacy team members should be aware of their language when speaking to victims; personal biases may perpetuate stereotypes and influence clinical decision making for therapy or diagnoses.

         

        Well-intentioned but poorly informed organizations or people can perpetuate stereotypes that are not evidence-based or all-encompassing. Understanding bias and perpetuated stereotypes reduces barriers to optimal healthcare. Stereotypes associated with trafficking including victim appearance, location, traffickers, or current situations prevent victims from escaping and/or receiving treatment.1 Table 2 addresses common stereotypes or myths associated with human trafficking in the United States. Pharmacy team members should question, acknowledge, and resolve their personal biases towards trafficking to reduce stigmatizing language and shame.

         

        Table 2. Common Human Trafficking Myths vs Reality1,36

        Myth Reality
        Human trafficking victims are always undocumented foreign women or children. Victims can be any age, sex, ethnicity, or legal status. Sensationalized imagery of victims in the media, such as on TV or in the news, creates bias and provides an inconsistent narrative. Researchers estimate as many as half of all victims and survivors are male, but healthcare professionals are less likely to identify males as victims.
        All commercial sex is human trafficking. Commercial sex is not human trafficking if the patient is an adult and gives informed consent for all activities involved.
        Traffickers always hold victims against their will. Victims may stay involved in trafficking due to lack of resources to leave, fear for their safety, or manipulation by the trafficker. Victims may face shame from their trauma, including cultural attitudes about prostitution, debt, poor health conditions because of captivity, or working conditions.
        Labor trafficking is only an issue in developing countries. Labor trafficking occurs in the U.S. but is reported less often than sex trafficking.
        Human trafficking is always a violent crime. Human trafficking rarely includes physical force such as kidnapping. Most traffickers manipulate victims through psychological means such as defrauding, manipulating, or threatening vulnerable populations.
        If individuals consented to be in their initial situation, they are not victims of trafficking. Initial consent to commercial sex or labor prior to force, manipulation, or fraud is irrelevant if the situation becomes one of coercion and exploitation later.

         

        Healthcare providers should always use strength-based language to avoid victim blaming. For example, providers should refrain from using the term “child pornography,” and instead refer to it as “child sexual abuse materials.”1 For sex trafficking victims, they should refer to sexual acts during captivity as “exploitation” rather than “prostitution.”

        Victims may experience intense shame surrounding their experiences that limits their ability to seek medical attention. Healthcare equity for trafficking victims starts with establishing trust. To gain trust, providers should identify and eliminate unconscious biases to improve service accessibility and health outcomes.

         

        HEALTH CONSEQUENCES FOR VICTIMS

        Traffickers often expose victims to numerous health risks before, during, and after exploitation and may restrict victims’ access to care. A key indicator of human trafficking is delayed care. Many patients have reasons to delay care (e.g., lack of insurance, no transportation, or difficult access to care), but delayed care in combination with other flags may indicate a patient is in trouble.37,38 Victims’ lack of access to proper care and poor environmental conditions may lead to deterioration or exacerbation of conditions.39

         

        Mental Health and Addiction

        Due to mental exhaustion from trauma, most victims face debilitating mental health issues. Victims may present with signs and symptoms of posttraumatic stress disorder (PTSD), depression, anxiety, dissociation, and substance use disorders. Serious symptoms warranting need for behavioral health therapy may include

        • Difficulty sleeping
        • Feeling detached or withdrawn
        • Guardedness
        • Hopelessness
        • Recurrent thoughts of trauma
        • Sudden emotional reaction when reminded of trauma
        • Suicidal ideation
        • Tendency to startle easily

         

        Drug or alcohol addiction may exacerbate victim vulnerability, be used as a coping mechanism, or be a part of the trafficker’s tactic to keep victims hostage. An anti-trafficking service provider reported that 66% of victims claimed their substance use led to being trafficked, while 4.5% claimed their substance use began after being trafficked.40 Substance use throughout victimization occurred in 84.3% of victims, with the most common substances used being alcohol, marijuana, cocaine, and opioids.40 Due to high mortality rates from opioid overdoses, patients who are or have been trafficked warrant screening for opioid addictions.

         

        Healthcare providers need to engage in trauma-informed care when helping victims of human trafficking.41 The experience of trauma overwhelms the victim’s ability to cope and healthcare providers need to recognize trauma’s impact on victims. They need to employ a trauma-informed approach. A trauma-informed approach has four components41:

        • Realizing trauma’s pervasive impact and the potential paths victims can follow for recovery
        • Recognizing trauma’s signs and symptoms in individuals, families, staff, and others involved in the system
        • Responding in a manner that fully integrates knowledge about trauma into policies, procedures, and practices
        • Taking care to communicate in ways that actively avoid retraumatization

         

        A trauma-informed approach means collaborating with community resources to empower individuals to determine their own futures.41 Using the NHTRC hotline is a good way to initiate contact with community resources, as its staff is trained to help healthcare providers determine and identify the next best steps when trafficking is suspected or reported.

         

        The Substance Abuse and Mental Health Services Administration (SAMHSA) supplies additional information on child trauma-informed care for patient and provider use (https://www.samhsa.gov/childrens-awareness-day/child-traumatic-stress-resources).40

         

        Unprotected Sexual Intercourse

        Victims of sex trafficking are at elevated risk for STIs and unwanted pregnancies. Pharmacists should attempt to counsel victims of sex trafficking on proper testing or screening, including the common signs and symptoms of various STIs, types of tests, and when and how to test. The CDC lists specific STI treatment guidelines on its website (https://www.cdc.gov/std/treatment-guidelines/default.htm).42

         

        Monkeypox (now called Mpox) has been an emerging concern particularly for men who have sex with men. Monkeypox presents as a painful rash accompanied by fever, lethargy, muscle aches, and headaches.43 More information on monkeypox presentation, treatment and prevention can be found in UConn’s You Asked For It CE titled, “Go Bananas: Peel Away the Unknowns of Monkeypox.”

         

        In female patients of childbearing age who have had recent unprotected sexual intercourse, pharmacists may recommend OTC emergency contraceptive pills (ECPs), or an intrauterine device (IUD) or “morning after” pill if allowed by state law.

         

        Copper IUDs are a highly effective emergency contraceptive when inserted up to five days after sexual intercourse. This extended period for use and high efficacy rate may be beneficial for victims of human trafficking who may not have immediate access to emergency contraceptives, but IUD insertion can be expensive, and the trafficker may not allow the victim to see a qualified provider. The most common side effects for IUDs are heavy menstrual bleeding, spotty menstruation, or abdominal discomfort. Because victims of sex trafficking may have increased risk for STIs, victims should generally be tested and/or treated for STIs prior to IUD insertion and monitored after insertion.44

         

        ECPs contain either levonorgestrel or ulipristal acetate (UPA) with 1.2% and 1.2-2.1% efficacy, respectively. UPA-containing ECPs are more effective between 72 and 120 hours post-intercourse than levonorgestrel-containing ECPs. Side effects may include nausea, vomiting, fatigue, and irregular vaginal bleeding.44

         

        More information on emergency contraception eligibility criteria and safety is located on the World Health Organization’s (WHOs) website.44 In any emergency contraceptive, efficacy decreases as the time between intercourse and treatment increases. Pharmacists should inform patients that contraceptives do not induce abortions.

         

        Physical Abuse

        Victims may be vulnerable to physical abuse in captivity. Common signs of physical abuse are bruises, wounds, fractures, internal injuries, chronic pain, or head, neck and back injuries. Physical abuse may also present as substantial weight loss, dehydration, malnutrition, increased vulnerability to illness, and insomnia. Physical abuse is a medical emergency; if a patient’s safety is in danger, the pharmacy must report the situation to authorities immediately if the patient is a minor. States may require pharmacists to report abuse of an adult under state-specific mandatory reporting laws.

         

        Acting on Human Trafficking

        Upon suspicion or confirmation of trafficking, pharmacy technicians should alert the pharmacist and pharmacists should try to see the patient alone when possible. All involved staff must remain vigilant about everyone’s safety and avoid directly challenging the victim and/or accompanying individual. Direct confrontation, or raising the suspicion of an accompanying individual, can put a victim at risk of additional harm. It’s critical to note repeatedly that intervention can be dangerous. Most authorities indicate that the best action is to call the National Human Trafficking Hotline at 1(888) 3737-888 or call 911.38

         

        In instances that involve language barriers, pharmacists should advise the accompanying individual that professional interpreters may be needed instead of relying on ad hoc interpreters (untrained children [who should only be used in emergencies], friends, family, or untrained staff).45-51 The reasons for working alongside interpreters (and interpreters prefer healthcare providers use the term “working alongside” rather than “using” to reflect that this is a collaborative endeavor) are evidence-based. Ad hoc interpreters are more likely to make mistakes, violate confidentiality rules, and increase risk of adverse outcomes. Professional interpreters are also fluid speakers and need not stop and think or reformulate language before translating. Untrained interpreters often leave out the niceties of language—niceties that increase trust and cultural understanding between patient and provider. When using an interpreter, the clinician should address the patient directly and seat the interpreter next to or slightly behind the patient. 45-51 Readers who want to learn more about the nuances of professional interpretation may be interested in What’s in a Word? A Guide to Understanding Interpreting and Translation, available online for free at https://www.ncihc.org/assets/documents/publications/Whats_in_a_Word_Guide.pdf.

         

        Pharmacists and technicians should be patient, compassionate, and sensitive to build trust and gather sufficient information. Since 2011, the Institute of Medicine and the U.S. Department of Health and Human Services have recommended screening for intimate partner violence and abuse by asking patients, “Do you feel safe at home?” at each visit.52 In 2013, the U.S. Preventive Services Task Force also made this recommendation. Although the question was meant to identify intimate partner violence, it has identified other types of abuse. This question surprises many patients, and many healthcare practitioners find it uncomfortable to ask. Pharmacy staff might ask this question, but it probably should not be the first question to the suspected victim. Saving this and similar questions should come after establishing some rapport with the patient and the patient seems comfortable. Regardless, patients may not answer truthfully or at all, but just asking the question let’s victims know that someone cares, and help is available.52 When interviewing patients, pharmacists should ask “trauma-informed” questions but consider the harmful effect of reliving traumatic experiences.2 Table 3 provides additional appropriate example questions when screening patients for human trafficking.

         

        Table 3. Example Screening Tool for Suspicion of Human Trafficking2,14,17

        • Are you limited as to who you can talk to and when?
        • Do you have the freedom to leave your current job?
        • Do you have to ask permission for necessities, such as eating or using the bathroom?
        • Do you owe your employer money or other debts?
        • Has anyone ever physically hit, threatened, or raped you or anyone you work with for any reason?
        • Has anyone ever forced you into sexual intercourse for work?
        • Has anyone threatened your family?
        • Has anyone threatened you with deportation?
        • Is someone else controlling your money or finances?
        • Is someone else in control of where you are allowed to go?
        • Is someone else in control of your identification documents, including your birth certificate or passports?
        • Was someone else in control of your travel arrangements to the U.S.?
        • What is your working or living condition like?

         

        Healthcare providers may be unable to help patients involved in human trafficking—affected individuals may be too afraid to engage. Individuals need to be able and willing to help themselves. Providers should also offer patients choices; if the patient does not verbalize immediate danger, pharmacists can gently discuss reporting to police, non-government organizations, or helplines. When patients do not want to act, healthcare providers should prioritize care for the patient’s health conditions, gain the victim’s trust, and document clearly. Pharmacy teams should write down any information that may be helpful in an investigation, including time of day, address, and vehicle information, if available.

         

        Providers must always consider security risks. Pharmacy staff should never attempt to confront a potential human trafficker or victim directly. They should try to arrange follow-up with patients and document their contact information. Pharmacists may also ask for consent to call the patient’s primary care provider.

         

        That said, pharmacy teams need to follow statutory and healthcare organization procedures at all times. Again, the National Human Trafficking Resource Center (NHTRC) hotline is available for pharmacy teams to use and pharmacy personnel can call the hotline for guidance. The NHTRC helps providers identify local resources and coordinate with social service organizations. It’s hotline is available 24/7 at 1 (888) 3737-888 or text HELP or INFO to “BeFree” (233733). Pharmacists may choose to submit an anonymous tip online on the NHTRC website (https://humantraffickinghotline.org/report-trafficking).33 If the patient is a minor or in imminent danger, a staff member should stay with the patient, remain calm, and contact 911 or the local police department when it is safe to do so.

         

        Providers should do their best to ensure proper self-care after a stressful or intense situation.

         

        Conclusion

        Faith Robles is now a spokeswoman, advocate, and aftercare provider for victims of human trafficking which demonstrates that victims, when they can access help, can survive and flourish.53 Pharmacy teams should remain vigilant when encountering suspicious circumstances. Trafficking victims may have multiple health issues because of their trauma and abuse. Pharmacy team members can easily recognize signs of human trafficking through prescription, disease, or behavioral patterns. Individualized screening and determination of the type of trafficking involved is necessary for treatment recommendations and referrals. Pharmacy teams should address victims’ concerns while considering the patient’s health, safety, and personal hardships. Pharmacies may advocate for federal and/or local legislation focused on trafficking prevention and education to drive large-scale change.

        Pharmacist Post Test (for viewing only)

        PHARMACIST POSTTEST

        Learner Questions for Pharmacists
        Learning Objectives
        At the end of this continuing education activity, pharmacists will be able to
        • Review the history and current laws of human trafficking in the United States
        • Recognize common terms, warning signs, and/or vulnerabilities for human trafficking in pharmacy patients/customers
        • Describe pharmacists’ impact on identifying and supporting victims and survivors of human trafficking
        • Ensure proper referral, treatment, and counseling for common health risks associated with human trafficking

        1. Which of the following statements describes the Trafficking Victims Protection Act (TVPA) of 2000?
        a. TVPA was the first law to address child trafficking reporting laws
        b. TVPA offers immigration relief for victims and survivors of human trafficking
        c. TVPA created the US Advisory Council on Human Trafficking

        2. Which of the following is a federal law and a state-specific law that addresses healthcare providers’ responsibilities regarding human trafficking?
        a. Reporting of human trafficking victims 17 years old or younger
        b. Specific definitions of “mandated reporters”
        c. Mandated human trafficking training for healthcare workers

        3. Which act included increased individuals’ criminal liability if they buy commercial sex from victims?
        a. The Child Abuse Prevention and Treatment Act (CAPTA)
        b. The Stop, Observe, Act, and Respond (SOAR) to Health and Wellness Act
        c. The Justice for Victims of Trafficking Act (JVTA)

        4. Which action may result in increased harm for human trafficking victims when accompanied by an individual?
        a. Asking to see the patient alone during private exams because your state requires prescription counseling
        b. Allowing the accompanied individual to act as an interpreter when there is a language barrier
        c. Staying aware of your own safety when encountering a victim and accompanying individual
        5. Which of the following situations during counseling may suggest a patient may be a victim of human trafficking?
        a. A 37-year-old female patient approaches the consulting window alone asking to pick up her birth control prescription 2 days earlier than allowed by insurance
        b. A patient calls the pharmacy asking about selection of vaginal itch creams and pregnancy tests three separate times within one month
        c. A smiling 9-year-old patient accompanied by his legal guardian picking up a new prescription for an albuterol inhaler for the child

        6. When heightening awareness of human trafficking, what do healthcare providers need to know?
        a. Human trafficking victims are likely to seek healthcare at least once during captivity
        b. Human trafficking victims are predominately female adults aged 25 to 34
        c. Traffickers often force victims into trafficking through physical force such as kidnapping

        7. A young woman visits the pharmacy accompanied by a man who seems to hover and intervene in your conversations with the woman. You are able to gently pry her away and interview her in the counseling room. She tearfully says that 4 days ago she had unprotected sexual intercourse with a man who told her he may have an STI after they had sex. Which emergency contraceptive would you choose for her?
        a. Ulipristal acetate (UPA) emergency contraceptive pills
        b. Levonorgestrel emergency contraceptive pills
        c. Refer her for a copper intrauterine device

        8. A young male who is unkempt and has a prescription for an antibiotic used to treat syphilis listens intently as you counsel him on how to take the medication. You ask him how he has been feeling in general in an attempt to build trust. He says that his clothes have gotten tight, has missed school because he sleeps heavily all night and oversleeps often, and he periodically experiences headache, fatigue, dizziness and thirst. Which symptom set may indicate he may be a victim of human trafficking?
        a. His clothes have gotten tight
        b. Oversleeping
        c. Headache, fatigue, dizziness and thirst

        9. Alex, Ben, and Carrie each describe symptoms that seem to suggest opioid addictions. Alex, 17, says that he has used heroin since he was 12. Ben, 42, says that he currently has little access to opioids and needs treatment to reduce craving. Carrie, 15, says that she uses alcohol when her “friend” cannot find opioids for her. Which patients are most in need of screening for possible human trafficking?
        a. Alex and Ben
        b. Ben and Carrie
        c. Carrie and Alex

        10. The lead technician comes to you and says that she tried to complete medication reconciliation for a young woman. She is 16 years old and has just been admitted to the emergency department for abdominal pain that started with a diagnosis of chlamydia two weeks ago. Now, she may have pelvic inflammatory disease. The patient does not speak English. The woman’s companion said that he would translate for her because she has antisocial personality disorder. Choose the BEST way to approach this dilemma.
        a. Say, “Are you aware that your actions seems suspicious? Either let us talk to her in private or we are going to call the police”
        b. Say, “We have called a translator, and we’ll speak to [patient’s name] alone because these are deeply personal health issues.”
        c. Say, “You have a choice here. We can use the hospital translator with or without you present, and you can take your friend and leave AMA.”

        Pharmacy Technician Post Test (for viewing only)

        Learner Questions for Pharmacy Technicians
        At the end of this continuing education activity, the pharmacy technician will be able to
        • Review the history and current laws of human trafficking in the United States
        • Recognize common terms, warning signs, and/or vulnerabilities for human trafficking in the pharmacy
        • Identify signs/signals of human trafficking red flags to notify pharmacists or law enforcement

        1. Which of the following statements describes the Trafficking Victims Protection Act (TVPA) of 2000?
        a. TVPA was the first law to address child trafficking reporting laws
        b. TVPA offers immigration relief for victims and survivors of human trafficking
        c. TVPA created the US Advisory Council on Human Trafficking

        2. Which of the following is a federal law and a state-specific law that addresses healthcare providers’ responsibilities regarding human trafficking?
        a. Reporting of human trafficking victims 17 years old or younger
        b. Specific definitions of “mandated reporters”
        c. Mandated human trafficking training for healthcare workers

        3. Which act included increased individuals’ criminal liability if they buy commercial sex from victims?
        a. The Child Abuse Prevention and Treatment Act (CAPTA)
        b. The Stop, Observe, Act, and Respond (SOAR) to Health and Wellness Act
        c. The Justice for Victims of Trafficking Act (JVTA)

        4. Which of the following is a pre-trafficking vulnerability for victims?
        a. Natural disasters
        b. High insurance copays
        c. Well-paying occupation

        5. Which of the following types of trafficking matches its definition below?
        a. Forced Labor: involuntary servitude, often from industries with large numbers of workers and little regulation
        b. Domestic servitude: begins with debt that cannot be paid immediately; employer exploits the victim by adding additional expenses to increase debt
        c. Debt bondage: forcing someone to sell sex
        6. Which of the following OTC products are human trafficking victims most likely to use or misuse?
        a. Esomeprazole (Nexium)
        b. Oxymetazoline (Sinex)
        c. Acetaminophen (Tylenol)

        7. Which statement below is a common myth regarding human trafficking in the United States?
        a. Labor trafficking exists in the United States, but public health officials less often report labor trafficking compared to sex trafficking
        b. All commercial sex is human trafficking
        c. Human trafficking rarely uses physical force such as kidnapping

        8. Select the patient interaction that should prompt you to inform your pharmacist of potential human trafficking.
        a. A young adult patient who hands you a handwritten list of their prescriptions and medical history
        b. An adolescent whose breath smells of alcohol and is dressed in shorts and a tank top for 10⁰F weather in January
        c. A female patient asking to fill her birth control 2 days earlier than her insurance will cover because she’s going on vacation to Miami tomorrow
        9. Three patients confirm that they are human trafficking victims but state that they are not in imminent danger and ask you not to contact authorities. You MUST contact the authorities for one patient under federal law. Which one is it?
        a. An 18-year-old patient who has not showered in 3 weeks
        b. An 11-year-old patient accompanied by her father
        c. A 23-year-old patient taking medications for his anxiety disorder
        10. Upon suspicion of human trafficking, which of the following is an appropriate intervention for pharmacy technicians?
        a. Directly confront the individual accompanying the victim and tell them to stay where they are while you get the pharmacist
        b. When alone with the patient, start a discussion with in-depth questions about their trauma for a more detailed background
        c. Prioritize everyone’s safety, inform the pharmacy team of the situation, and call the authorities when appropriate

        References

        Full List of References

        REFERENCES

          References

           

          1. Jessica L. Peck, Jordan Greenbaum & Hanni Stoklosa (2021): Mandated Continuing Education Requirements for Health Care Professional State Licensure: The Texas Model, Journal of Human Trafficking, DOI: 10.1080/23322705.2021.1981708 [Epub ahead of print]
          2. Hunt J, Witkin R, Katona C. Identifying human trafficking in adults. BMJ. 2020; 371 doi:10.1136/bmj.m4683 [Epub ahead of print]
          3. Rasmussen A. 'I Will Never Forgive You': Sex Trafficking Survivor Helps Put Her Captors Behind Bars. CrimeFeed. Published July 2022. Accessed January 5, 2023. https://www.investigationdiscovery.com/crimefeed/id-shows/on-tv0/in-pursuit-with-john-walsh/articles/raymond-dean-holley-easter-sunday-child-sex-abuse-fugitive
          4. Chen S. FBI locates 121 minors, 141 adults in nationwide human trafficking bust. Axios. Published August 15, 2022. Accessed January 5, 2023. https://www.axios.com/2022/08/15/fbi-human-trafficking-operation-recovery
          5. Gaps in Reporting Human trafficking incidents result in significant undercounting. National Institute of Justice. August 4, 2020. Accessed January 5, 2023. https://nij.ojp.gov/topics/articles/gaps-reporting-human-trafficking-incidents-result-significant-undercounting
          6. The Trafficking Victims Protection Act of 2000. U.S. Department of Health & Human Services, Office on Tafficking in Persons. Accessed January 5, 20232. https://www.acf.hhs.gov/archive/otip/policy-guidance/state-letter-01-13
          7. Van Steenwyk J. Human trafficking: What landlords & property managers must know. All Property Management web site. Accessed January 5, 2023. https://www.allpropertymanagement.com/blog/post/human-trafficking-facts-for-landlords/
          8. Landlords Coercing Tenants Unable to Pay Rent to Provide Sex: Sex Trafficking or Not? Polaris web site. Accessed January 5, 2023. https://polarisproject.org/blog/2020/05/landlords-coercing-tenants-unable-to-pay-rent-to-provide-sex-sex-trafficking-or-not/
          9. Where does human trafficking happen? DeliverFund. Published June 9, 2022. Accessed January 5, 2023. https://deliverfund.org/the-human-trafficking-problem-in-america/where-does-human-trafficking-happen/
          10. Datta M. Sex trafficking in the US: Four questions answered. Phys.org. Published March 8, 2019. Accessed January 5, 2023. https://phys.org/news/2019-03-sex-trafficking.html
          11. The Polaris Project. About Us. Accessed January 5, 2023. https://polarisproject.org/about-us/.
          12. Dovydaitis T. Human trafficking: the role of the health care provider. J Midwifery Womens Health. 2010;55(5):462-467.
          13. Feingold D. Human trafficking. Foreign Policy. 2005; 150:26-30.
          14. Zimmerman C, Borland R. Caring for Trafficked Persons: Guidance for Health Providers. International Organization for Migration. 2009. Accessed January 5, 2023. https://www.iom.int/caring-trafficked-persons-guide-health-providers
          15. Polaris. Human Trafficking Trends in 2020 An analysis of data from the U.S. National Human Trafficking Hotline. Accessed January 5, 2023. https://polarisproject.org/wp-content/uploads/2022/01/Human-Trafficking-Trends-in-2020-by-Polaris.pdf
          16. Clark MC. Questioning the Notion of Financial Gain as the Primary Motivation of Human Traffickers. Anti-Trafficking Rev. 2022;18:180-184.
          17. Leslie J. Human trafficking: Clinical assessment guideline. J Trauma Nursing. 2018;25(5):282-289.
          18. Human trafficking vs human smuggling. US Immigration and Customs Enforcement. Published Summer 2017. Accessed January 5, 2023. www.ice.gov/sites/default/files/documents/Report/2017/CSReport-13-1.pdf
          19. Stoklosa H, Showalter E, Melnick A, Rothman EF. Health Care Providers’ experience with a protocol for the identification, treatment, and referral of human-trafficking victims. J Human Trafficking. 2016;3(3):182-192.
          20. Armstrong S, Greenbaum VJ. Using Survivors' Voices to Guide the Identification and Care of Trafficked Persons by U.S. Health Care Professionals: A Systematic Review. Adv Emerg Nurs J. 2019;41(3):244-260. doi:10.1097/TME.0000000000000257
          21. Lederer LJ, Wetzel CA. The health consequences of sex trafficking and their implications for identifying victims in healthcare facilities. Ann Health Law. 2014;23(1);61-87.
          22. Wallace C, Lavina I, Mollen C. Share our stories: An exploration of the healthcare experiences of child sex trafficking survivors. Child Abuse Negl. 2021;112:104896. doi:10.1016/j.chiabu.2020.104896
          23. McAmis NE, Mirabella AC, McCarthy EM, et al. Assessing healthcare provider knowledge of human trafficking. PLoS One. 2022;17(3):e0264338. doi: 10.1371/journal.pone.0264338
          24. Recknor FH, Gemeinhardt G, Selwyn BJ. Health care provider challenges to the identification of human trafficking in health care settings: a qualitative study. J Human Trafficking. 2018;4(3):1-18. doi: 10.1080/23322705.2017.1348740
          25. Jones Day White Paper. Human Trafficking and Health Care Providers: Legal Requirements for Reporting and Education. Published August 2020. Accessed January 5, 2023. https://healtrafficking.org/wp-content/uploads/2021/01/Human-Trafficking-and-Health-Care-Providers_Legal-Requirements-for-Reporting-and-Education-02_25_21.pdf.
          26. Kirschner F, Godspeed T, Baker C, Lynch S, Jones H. Human trafficking and Health Care Providers: Legal Requirements for Reporting and Education. HEAL Trafficking: Health, Education, Advocacy, Linkage. Accessed January 5, 2023. https://healtrafficking.org/2021/01/legal-requirements-for-reporting-and-education/
          27. Federal law. National Human Trafficking Hotline. Accessed January 5, 2023. https://humantraffickinghotline.org/what-human-trafficking/federal-law.
          28. Delgado A. The trafficking victims protection act is signed into law. January 9, 2023. Accessed February 17, 2023. https://www.ecpatusa.org/blog/2023/1/4/trafficking-victims-protection-act-signed-into-law
          29. The SOAR to Health and Wellness Act of 2018, Pub L. No. 115-398 § 132 Stat. 5329 (2018).
          30. Human trafficking laws & regulations. US Department of Homeland Security. Accessed January 5, 2023. https://www.dhs.gov/human-trafficking-laws-regulations.
          31. Nordstrom B. Multidisciplinary Human Trafficking Education: Inpatient and Outpatient Healthcare Settings. J Human Trafficking. 2020;8(2):184-194
          32. Indicators of Human Trafficking. Homeland Security Blue Campaign. Accessed January 5, 2023. https://www.dhs.gov/blue-campaign/indicators-human-trafficking
          33. Palombi L, Ochten H, Patz C. The Pharmacists’ Role in Identifying and Supporting Victims of Human Trafficking. Human Trafficking. 2019;5(3):255-266.
          34. Terrie Y. Promote the Safe and Proper Use of OTC Drugs . Pharmacy Times . 2019;85(4).
          35. Trygstad T, DiMaggio T, Ogurchak J, Arakelians S, Gallagher A, James D. 2022 Survey of Pharmacists' OTC Recommendations. OTC Guide. (2022):3-60. Accessed January 5, 2023. https://cdn.sanity.io/files/0vv8moc6/pharmacytimes/86326ebdabcad93c75193a50a94fb30cf4e10661.pdf/2022OTCGuide_EditorialPagesOnly-R1%20(2).pdf
          36. Myths & Facts. National Human Trafficking Hotline. Published May 3, 2019.Accessed January 5, 2023. https://humantraffickinghotline.org/what-human-trafficking/myths-misconceptions
          37. Baldwin SB, Eisenman DP, Sayles JN, Ryan G, Chuang KS. Identification of human trafficking victims in health care settings. Health Hum Rights. 2011;13(1):E36-E49.
          38. Schuette, B., (2015). Michigan attorney general. Human trafficking “Red Flags” for health care professionals. Accessed December 5, 2022. https://www.michigan.gov/ag/-/media/Project/Websites/AG/human-trafficking/Updated-Red-Flags-for-Responders/Red_Flags_-_Health_Care_598573_7.pdf?rev=827954e5cf9647ca9fc9369046759735
          39. Stoklosa H, MacGibbon M, Stoklosa J. Human trafficking, mental illness, and addiction: Avoiding diagnostic overshadowing. AMA Journal of Ethics. 2017;19(1):23-34.
          40. Resources for Child Trauma-Informed Care. Substance Abuse and Mental Health Services Administration. Accessed January 5, 2023. https://www.samhsa.gov/childrens-awareness-day/child-traumatic-stress-resources
          41. Zarnello L. Implementing trauma-informed care across the lifespan to acknowledge childhood adverse event prevalence: best clinical practices. Nurse Pract. 2023;48(2):14-21. doi:10.1097/01.NPR.0000000000000002
          42. Workowski K, Bachmann L, Chan P, et.al. STI treatment guidelines. Centers for Disease Control and Prevention. Published July 22, 2021. Accessed January 5, 2023. https://www.cdc.gov/std/treatment-guidelines/default.htm
          43. MPox. Ceneters for Disease Control and Prevention. Accessed January 5, 2023. https://www.cdc.gov/poxvirus/monkeypox/index.html
          44. World Health Organization. Emergency contraception. Published November 9, 2021. Accessed January 5, 2023. https://www.who.int/news-room/fact-sheets/detail/emergency-contraception
          45. Juckett G, Unger K. Appropriate use of medical interpreters. Am Fam Physician. 2014;90(7):476-480.
          46. Karliner LS, Jacobs EA, Chen AH, Mutha S. Do professional interpreters improve clinical care for patients with limited English proficiency? A systematic review of the literature. Health Serv Res. 2007;42:727-754.
          47. Flores G, Laws MB, Mayo SJ, et al. Errors in medical interpretation and their potential clinical consequences in pediatric encounters. Pediatrics. 2003;111:6-14.
          48. Jacobs EA, Lauderdale DS, Meltzer D, Shorey JM, Levinson W, Thisted RA. Impact of interpreter services on delivery of health care to limited-English-proficient patients. J Gen Intern Med. 2001;16:468-474.
          49. What's in a Word? A Guide to Understanding Interpreting and Translation in Healthcare. Los Angeles, CA: National Health Law Program; 2010. Accessed January 5, 2023. https://www.ncihc.org/assets/documents/publications/Whats_in_a_Word_Guide.pdf
          50. Jackson JC, Nguyen D, Hu N, Harris R, Terasaki GS. Alterations in medical interpretation during routine primary care. J Gen Intern Med. 2011;26:259-264.
          51. Nápoles A, Santoyo-Olsson J, Karliner L, Gregorich SE, Pérez-Stable EJ. Inaccurate language interpretation and its clinical significance in the medical encounters of Spanish-speaking Latinos. Med Care. 2015;53:940-947.
          52. Scott M. Doctors asking about domestic violence is important, but daunting. December 16, 2015. Accessed February 7, 2023. https://whyy.org/segments/doctors-asking-about-domestic-violence-is-important-but-daunting/
          53. Dahlia's Hope. Accessed January 5, 2023. https://www.dahliashope.org/

           

          HIV Pre- and Post-Exposure Prophylaxis in Adolescents and Young Adults

          Learning Objectives

           

          After completing this application-based continuing education activity, pharmacists will be able to

          • Discuss the prevalence of HIV/AIDS in humans and associated stigma in the adolescent and young adult population
          • Identify risk factors for HIV infection in adolescent and young adults
          • Review pre-/post-exposure prophylaxis methods for HIV prevention in the adolescent/young adult population
          • Maximize the pharmacists’ role in HIV prevention in the adolescent/young adult population

          After completing this application-based continuing education activity, pharmacy technicians will be able to

          • Recall the prevalence of HIV/AIDS in humans and associated stigma in the adolescent and young adult population
          • List high-risk activities for HIV exposure
          • Describe available patient assistance programs & cost assistance programs for pre- and post-exposure HIV prophylaxis
          • Identify antiretrovirals used for pre-/post-exposure HIV prophylaxis in the adolescent and young adult population

          Image showing tablets with 'PrEP' inscribed upon them.

           

          Release Date: February 15, 2023

          Expiration Date: February 15, 2026

          Course Fee

          FREE

          There is no grant funding for this CE activity

          ACPE UANs

          Pharmacist: 0009-0000-23-004-H02-P

          Pharmacy Technician: 0009-0000-23-004-H02-T

          Session Codes

          Pharmacist:  23YC04-ABC34

          Pharmacy Technician:  23YC04-CBA43

          Accreditation Hours

          1.5 hours of CE

          Accreditation Statements

          The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-004-H02-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

           

          Disclosure of Discussions of Off-label and Investigational Drug Use

          The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

          Faculty

          Mikayla Arriaga,
          PharmD Candidate May 2023
          UConn School of Pharmacy
          Storrs, CT

          Saba Azam
          PharmD Candidate May 2023
          UConn School of Pharmacy
          Storrs, CT

          Daniela Barisano
          PharmD Candidate May 2023
          UConn School of Pharmacy
          Storrs, CT

          Jennifer Girotto, PharmD, BCPPS, BCIDP
          Assistant Professor and Assistant Department Head
          UConn School of Pharmacy
          Storrs, CT

          Ying Han, PharmD
          Staff Pharmacist CVS
          Cheshire, CT

          Diana Levytska
          PharmD Candidate May 2023
          UConn School of Pharmacy
          Storrs, CT

           

           

          Faculty Disclosure

          In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

          Drs. Han and Girotto, and Ms. Azam, Arriaga, Barisano, and Levytska do not have any relationships with ineligible companies and therefore have nothing to disclose.

           

          ABSTRACT

          Human immunodeficiency virus (HIV) attacks the body’s immune system by destroying white blood cells (WBCs). When uncontrolled, destruction of WBCs makes patients more susceptible to opportunistic infections throughout the body. Adolescents and young adults aged 13 to 24 years are among one of the largest groups at risk for acquiring HIV, accounting for a fifth of new HIV infections. Risk factors for HIV infection include unsafe sexual practices and injection drug-use. Patients can employ many preventive strategies to decrease risk of acquiring HIV infection. These include using condoms during sex, avoiding needle sharing, and taking prophylactic antiretrovirals. Using an antiretroviral effective against HIV routinely before exposure—referred to as pre-exposure prophylaxis (PrEP)—reduces the likelihood of acquiring HIV. Providers prescribe PrEP to patients who are not infected with HIV who engage in high-risk activities. Post-exposure prophylaxis (PEP) differs from PrEP in that patients take antiretrovirals within 72 hours after a possible HIV exposure (i.e., through blood contact or sexual activity). It is important that healthcare providers counsel and educate young patients about PEP and PrEP to prevent them from becoming infected with HIV. Living with HIV remains highly stigmatized. Recognizing and actively addressing stigma through healthcare team interventions is critical to ensure the well-being of affected patients.

          CONTENT

          Content

          INTRODUCTION

          Human immunodeficiency virus (HIV) attacks the body’s immune system by destroying CD4 helper T cells. These cells are required for adaptive immunity (acquired immunity that adapts to real-time pathogen exposure), as they stimulate key players in the unimpaired immune response. Once patients are infected with HIV, starting potent combination antiretroviral therapy immediately can decrease morbidity and extend life. If the virus remains unchecked and progresses, patients develop high viral loads (the amount of virus in an infected person’s blood expressed as the number of viral particles/mL of blood) and slowly deplete their CD4 helper T cells, elevating risk for opportunistic infections (e.g., pneumocystis pneumonia, bacterial infections such as pneumococcal disease, disseminated mycobacterium avium infections).1

           

          While HIV remains a persistent problem in the United States (U.S.) across all age groups, young people are disproportionately affected. A 2018 report stated 15,820 adults and adolescents diagnosed with HIV died in the U.S. and its six dependent areas.2 Several groups have tracked HIV infections in youths and presented startling statistics. According to the Centers for Disease Control and Prevention (CDC), individuals aged 13 to 24 years accounted for 21% of all new HIV diagnoses in 2018.2 Even more concerning, experts estimate that more than 40% of HIV-infected youth are undiagnosed.3 Although public health officials and healthcare systems have made efforts to improve access to care, recent data suggests that effective HIV prevention and treatment are not reaching those who could most benefit from them (e.g., men who have sex with men [MSM], transgender persons, Black and Hispanic/Latinx people).4

           

          HIV infection is most likely to occur through male-to-male sexual contact (81%), heterosexual contact (10%), and injection drug use (5%).5 Data from the Youth Risk Behavior Survey shows that high school students engage in behaviors that increase risk of acquiring HIV5:

          • Low rates of condom use: 45.7% report not using a condom during their last sexual encounter
          • Low perception of risk: 90.6% of sexually active students report never being tested for HIV
          • Substance use/abuse and sex: 21.2% report drinking alcohol or using drugs before last sexual intercourse
          • Multiple sexual partners: 8.6% report sexual intercourse with four or more partners
          • High rates of sexually transmitted infections (STIs): about half of all reported STIs are in those aged 15 to 24 years

           

          Sexual exploration is a normal part of adolescent development and sexual activity can be both unplanned and unwanted. In 2011-2013, 47% and 44% of 15- to 19-year-old males and females, respectively, had engaged in sexual intercourse.6 The onset of sexual activity during adolescence coupled with a propensity for substance use experimentation and low rates of condom use increase adolescents’ vulnerability to infection with HIV and other STIs.5 Therefore, sexual education including material on HIV and acquired immunodeficiency syndrome (AIDS) is crucial to prevent HIV infection among adolescents and young adults.

           

          HIV’s greater risk and prevalence in adolescents requires focused clinical attention. Early HIV diagnosis and treatment in adolescence and young adulthood reduces risk for HIV transmission and increases the likelihood of a functional lifestyle similar to that of non-infected individuals. There are many HIV prevention methods, including

          • pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) to prevent HIV infection
          • avoiding risky behaviors that can result in HIV exposure/infection
          • testing and treatment to reduce mother-to-child HIV transmission

           

          National U.S. data shows that from 2012 to 2018, among commercially insured individuals at high risk for HIV/AIDS, 13% of patients aged older than 35, 9.6% of individuals aged 25 to 34, but only 2.7% of patients aged 16 to 24 had received PrEP. 2 The low prescribing rate among youths may be related to healthcare providers’ lack of knowledge about PrEP or discomfort with prescribing PrEP.2 Thus, healthcare providers who care for adolescents and young adults need education on discussing sexual health with pointed discussion about STI and HIV prevention and recommending or prescribing PrEP when appropriate.5

           

          PRE-EXPOSURE PROPHYLAXIS

          Taking antiviral medications to reduce the risk of acquiring HIV in the event of exposure is referred to as PrEP. Studies have shown PrEP is highly effective when used consistently (i.e., taken as directed) before HIV exposure during sex or injection drug use.7,8 Specifically, the CDC indicates PrEP can reduce the risk of contracting HIV from sex by about 99% and from injecting drugs by 74% to 84%.7

           

          The most updated “Preexposure Prophylaxis for the Prevention of HIV Infection in the U.S.” clinical practice guidelines state that clinicians should offer PrEP to adolescents who weigh more than 35 kg (77 lbs) who fit the following criteria9:

          • HIV negative, but participate in sexual behaviors that put them at risk for HIV infection (e.g., recent STI, sex with an HIV-positive partner, inconsistent condom use)
          • HIV negative, but inject drugs

           

          The guidelines also define clinical eligibility by the potential medication regimen9:

          • All PrEP regimens (oral and injectable)
            • Negative HIV test result within the last 7 days
            • No signs/symptoms of acute HIV infection
            • No contraindicated medications or conditions
          • Oral daily regimens only (not injectable cabotegravir)
            • Negative hepatitis B virus infection
            • Adequate renal function (discussed below)

           

          PAUSE & PONDER:  How can you identify patients in your practice who may benefit from PrEP?

           

          Oral PrEP Regimens

          Two emtricitabine-based oral regimens are U.S. Food and Drug Administration (FDA) approved for HIV PrEP. The first to be approved was emtricitabine/tenofovir disoproxil fumarate (DF; brand name Truvada) in 2012.10 The FDA expanded the indication for HIV PrEP to at-risk adolescents (age 12 years and older) and adults weighing at least 35 kg in 2018 based on the Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 (Project PrEPare) study. This study identified the safety and feasibility of antiretroviral PrEP for adolescents aged 15 to 17 years in the U.S.11 For HIV prevention, patients take one tablet daily containing 200 mg emtricitabine and 300 mg tenofovir DF.10 Individuals must have a creatinine clearance (CrCl) of 30 mL/min or greater to take Truvada or its generic.10

           

          Preliminary evidence also suggests adult MSM who have infrequent sexual activity can take 2 doses of emtricitabine/tenofovir DF on an “on-demand” basis. Although not FDA approved for this indication, CDC guidelines recommend patients take 2 tablets (total dose emtricitabine 400 mg/tenofovir DF 600 mg) two to 24 hours prior to sexual activity, then one tablet each day for the next 2 days (i.e., 24 and 48 hours after initial dosing). In cases of continued sexual activity, patients should continue taking one tablet daily until 48 hours after the last sexual event.9 This dosing may be ineffective for other patient populations, as drug concentrations in colorectal tissues allows for more missed doses than vaginal concentrations.9

           

          In 2019, the FDA approved a second oral combination for HIV PrEP: emtricitabine 200 mg and tenofovir alafenamide (AF) 25 mg (brand name Descovy) for at-risk adolescents (age 12 years and older) and adults weighing at least 35 kg.12,13 This indication excludes women who have receptive vaginal sex because clinical trials did not assess this patient population. Individuals must have a CrCl of 60 mL/min or greater to take Descovy.13

           

          Both oral PrEP medication regimens offer the same level of protection (for indications evaluated), are dosed once daily, and have many similar adverse effects. However, emtricitabine-tenofovir DF has a higher risk of acute kidney injury and bone mineral density decline due to the tenofovir DF component.14 Serious adverse events from both medications are uncommon. Table 1 lists common and severe adverse effects associated with oral PrEP regimens. Although hepatotoxicity monitoring is not routinely recommended, pharmacists should advise patients to contact a provider if they experience signs and symptoms of liver dysfunction, including decreased appetite, nausea, stomach pain, yellowing of the skin or eyes, darkened urine, and light-colored stool.9 Both oral regimens include a Boxed Warning in their labeling for the possibility of severe acute exacerbations of hepatitis B and the need to use them in individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use.10,13

           

          Table 1. Adverse Effects Associated with Available Oral PrEP Medications9,10,13

          Common
          Emtricitabine/tenofovir DF Headache, abdominal pain, and mild weight loss
          Emtricitabine/tenofovir AF Diarrhea
          Severe (both regimens)
          Adverse Effect Monitoring/Counseling
          Acute kidney injury/failure or worsening of chronic renal failure Evaluate kidney function before treatment (SCr, CrCl, eGFR) and monitor for signs and symptoms of kidney dysfunction (e.g., significantly reduced urine output)
          Lactic acidosis Monitor for clinical symptoms (physical discomfort, rapid breathing or problems breathing, muscle pain, and confusion), no routine labs suggested
          Bone issues associated with decreased BMD (e.g., pain, softening, thinning, fracture risk) Generally asymptomatic; refer to prescriber for fractures, pain, or other concerning bone-related symptoms. Recommend healthy diet with more vegetables and food rich in calcium, vitamin D and K. If needed, over the counter calcium supplement is recommended.
          Abbreviations: AF, alafenamide; BMD, bone mineral density; CrCl, creatinine clearance; DF, disoproxil fumarate; eGFR, estimated glomerular filtration rate; SCr, serum creatinine

           

          Injectable PrEP

          In December 2021, the FDA approved the first injectable therapy for HIV PrEP—cabotegravir extended-release injectable suspension (brand name Apretude)—for adolescents (12 years and older) and adults at risk of sexually-transmitted HIV infection who weigh at least 35 kg.15 The CDC released their HIV PrEP guidelines just prior to injectable cabotegravir’s approval, which may lead to confusion.9 Injectable cabotegravir is approved for adolescents and adults weighing at least 35 kg, but the guidelines only recommended it for adult persons.9,15 Also, injectable cabotegravir is approved to prevent sexually-acquired HIV, but CDC guidelines state that providers should evaluate people at risk due to injection drug use to see if they also are indicated for PrEP due to sexual activity and therefore eligible for injectable cabotegravir.9,15

           

          A provider administers two loading doses of cabotegravir 600 mg intramuscularly one month apart, followed by 600 mg intramuscularly every two months.15 There is a 7-day grace period for dosing. If patients are unable or do not receive their scheduled dose within seven days of when it is due, providers should consult the product information to assess if the patient remains a good candidate and restart dosing as recommended. If there is concern that the patient may not tolerate intramuscular cabotegravir, providers may opt to prescribe oral cabotegravir 30 mg daily as a trial for four weeks.15 If patients take the oral lead-in, the first injection should be scheduled within three days of the last oral dose and the second injection should still occur one month after the first.15

           

          The most common adverse effects of extended-release cabotegravir are injection site reactions (especially after the first few doses), fever, gastrointestinal upset (e.g., diarrhea, nausea, abdominal pain, decreased appetite), headache, myalgia, rash, fatigue, and sleep-related issues.9,15 Warnings and precautions for this medication include depressive disorders, hepatotoxicity, and hypersensitivity reactions.15 Cabotegravir’s labeling includes a Boxed Warning stating patients must have a confirmed negative HIV test before starting the drug and before each injection, as people with undiagnosed HIV who took cabotegravir have developed drug-resistant HIV variants.15 People who become infected with HIV while taking cabotegravir must stop the injections and switch to a complete HIV treatment regimen.15 It is also important to counsel patients that the drug will remain at low concentrations in their system for a long time (median times 44 and 67 weeks for men and women, respectively) even after discontinuing the drug.9 This low drug concentration could increase the risk of resistant virus if the patient is to become infected with HIV in that period.

           

          The FDA’s approval of a long-acting injectable for PrEP is significant progress toward ending the HIV epidemic, as it is the first therapy to prevent HIV that is not a daily oral pill. For PrEP to be effective, it requires a high level of patient adherence, but it is challenging for many patients to remember a daily medication.15 Cabotegravir extended-release injections every two months will be crucial in increasing PrEP adherence in high-risk individuals.15

           

          Ending the HIV epidemic requires adherence to published HIV testing recommendations, sexual health assessments, and STI screening and appropriate prevention education.2 Clinicians—including pharmacists—should be aware of the need for monitoring and follow up with HIV PrEP, listed in Figure 1. Pharmacists, as the most accessible healthcare professionals, can provide and reinforce education on sexual health (e.g., STI and HIV prevention) and recommend PrEP to those who may benefit. They should also encourage that patients combine different prophylaxis methods (e.g., condoms with PrEP) to improve protection based on CDC guidelines.9

          Figure showing different screening intervals for oral regimens versus injectable cabotegravir.

          Adolescents and young adults face many barriers that lower adherence rates, including lack of awareness of HIV risk, lack of parental understanding or support, safety and adverse effect concerns, and high cost. Pharmacists and pharmacy technicians have various responsibilities to combat these barriers. Pharmacists should help patients and caregivers understand the importance of taking PrEP medications as prescribed. Adherence education can include individualized counseling on medication use, adverse effect monitoring and management, reminder text messages, and computer- and phone-based support. Pharmacy staff can also help make these medications more affordable by working with other healthcare providers and insurance companies to access patient assistance programs and navigate prior authorization (see Tech Talk SIDEBAR).16

          Tech Talk: Helping Patients Afford PEP and PrEP17-21

          Most insurance companies (including Medicaid) are required to cover a PrEP option free of cost. Patients requiring PEP after a sexual assault may also be qualified for full or partial reimbursement. For example, New York state Medicaid will pay for PEP medications for non-occupational health exposures, including sexual assault. The CDC provides location-specific resources to help patients: https://www.cdc.gov/hiv/basics/pep/paying-for-pep.html. After a potential HIV exposure at work, patients usually receive workers’ compensation or their workplace health insurance pays for PEP. If patients cannot obtain insurance coverage, pharmacy technicians can collaborate with healthcare providers to prepare applications for PEP or PrEP through patient assistance programs.

           

          Patients in need of financial assistance—including those without insurance—may be eligible to receive free or low-cost PEP or PrEP medications. Manufacturers offer patient assistance programs to provide low-cost or free medications to people with low incomes. Companies have variable criteria that patients must meet to be eligible for enrollment. Applying to these programs take about five to ten minutes, and pharmacy staff should encourage prompt completion to avoid treatment delays. Patients covered under Medicaid or Medicare do not qualify for patient assistance programs or cost-sharing assistance programs.

           

          Generic versions of emtricitabine-tenofovir DF are less expensive than brand name products and are not usually available through company patient assistance programs or cost-sharing assistance programs. However, patients may qualify for support from the Patient Assistance Foundation, Needy Meds, and/or state PrEP assistance programs. Programs like Gilead's Advancing Access Form and NASTAD’s Patient Assistance Tool list step-by-step instructions on the forms themselves. Many brand name medications are covered by their respective pharmaceutical companies. For more information on patient assistance programs for HIV PrEP medications, please refer to https://nastad.org/prep-access/prep-assistance-programs.

           

           

          All medications approved for HIV PrEP are available by prescription only. Technicians who recognize these drugs can ensure the pharmacy dispenses and packages them appropriately (in their original packages to reduce the risk of contaminating the contents) and encourage adolescents and young adults to consult with the pharmacist as necessary (e.g., if they have questions, or would like education).

           

          PrEP medications require high adherence rates from patients. Technicians might identify patients’ difficulties with adherence during a patient’s medication reconciliation in the hospital or while speaking with a patient in the community pharmacy. Red flags include late refills or failure to pick up a refill, or presenting with prescription vials that have pills remaining when they should have already taken them all.

          PAUSE AND PONDER: How can pharmacy technicians help patients receive free or low-cost PEP and PrEP medications?

           

          POST-EXPOSURE PROPHYLAXIS

          Providers prescribe PEP to HIV-negative patients to prevent HIV infection after a possible exposure. After exposure to HIV, it takes two to four weeks for the virus to establish itself permanently in the body. After exposure, the body's immune system has a small window during which the viral load is small enough to be eradicated. Successful HIV PEP kills the virus before it can establish residency in the patient’s body.22 Patients must start a potent combination of HIV antiretrovirals immediately—ideally within 2 hours but no later than 72 hours after exposure.22 Every hour matters so the sooner the patient starts PEP, the lower the chance of becoming HIV infected. PEP requires a prescription from a healthcare provider and is highly effective (exceeding 80%) in preventing HIV.23

           

          PEP is only for emergency situations and should not take the place of other regular HIV prevention methods. Pharmacy staff should advise patients who frequently require PEP to talk to their provider to see if they qualify for PrEP. Some situations requiring HIV PEP include unplanned and/or unprotected sex or sexual assault, workplace exposures (e.g., a patient’s blood accidentally splashes into a healthcare worker’s eye), or needlestick injury with a contaminated needle.24

           

          Antiretroviral therapy for PEP involves a combination of three antiretroviral medications. According to the CDC, eligible patients should receive 28 days of PEP therapy.25 Table 2 lists the preferred antiretroviral regimens for PEP. Clinicians and patients with additional concerns or questions regarding optimal therapy options can call the National Clinical Consultations Center PEPline at (888) 448-4911.

           

          Table 2. HIV PEP Recommendations Based on Renal Function25, 26, 27

          Adolescents and young adults aged ≥ 13 years with: Medication
          Normal renal function

          (CrCl ≥ 60 mL/min)

          1) emtricitabine 200 mg/tenofovir DF 300 mg once daily with

          2) raltegravir 400 mg twice daily or dolutegravir 50 mg once daily*

          Renal dysfunction

          (CrCl ≤ 59 mL/min)

          1) zidovudine: Renally adjusted doses are based on oral doses of 160 mg/m2/dose every 8 hours and IV dose of 120 mg/m2/dose every 6 hours.

          GFR ≥10 mL/minute/1.73 m2 and continuous renal replacement therapy: No dosage adjustment required

          GFR <10 mL/minute/1.73 m2, intermittent hemodialysis, and peritoneal dialysis: Administer 50% of dose every 8 hours

           and

          2) lamivudine: <25 kg: There are no dosage adjustments provided in the manufacturer’s labeling; consider reducing the dose or increasing the dosing interval; use with caution and monitor closely.

          ≥25 kg:

          CrCl ≥50 mL/minute: No adjustment necessary.

          CrCl 30 to 49 mL/minute: 150 mg once daily.

          CrCl 15 to 29 mL/minute: 150 mg first dose, then 100 mg once daily.

          CrCl 5 to 14 mL/minute: 150 mg first dose, then 50 mg once daily.

          CrCl <5 mL/minute: 50 mg first dose, then 25 mg once daily.

          No additional dosing is required after routine (4 hour) hemodialysis or peritoneal dialysis.

           with

          3) raltegravir 400 mg twice daily or dolutegravir 50 mg once daily*

          *Dosing is the same for both normal renal function and renal dysfunction

          CrCl, creatinine clearance; DF, disoproxil fumarate

          PAUSE & PONDER: What are the most important counseling points for pharmacists to relay to patients about PEP and PrEP?

          Headache, gastrointestinal effects (e.g., nausea, diarrhea, vomiting), and fatigue are common adverse effects of PEP regimens. In addition, clinicians should note some medication-specific adverse effects and contraindications28:

          • Tenofovir is contraindicated in patients with renal dysfunction (≤ 30 mL/min for DF formulation, ≤ 60 mL/min with AF formulation)
          • Emtricitabine can cause a hyperpigmented rash or skin discoloration
          • Raltegravir and dolutegravir should be administered either two hours before or six hours after cation-containing products (e.g., calcium, magnesium, iron, multivitamins) because they can reduce the medications’ absorption (it is important to ask patients about these specifically, as they can be obtained over-the-counter)
          • Zidovudine can cause anemia and neutropenia
          • Lamivudine should not be administered with emtricitabine
          • Tenofovir, emtricitabine, and lamivudine can be used in patients infected with hepatitis B, but patients will need liver function monitoring upon discontinuation because withdrawal may cause or exacerbate acute hepatitis

           

          Patients respond differently to medications and not everybody experiences adverse effects. If patients develop life-threatening adverse effects, they need emergency attention. Subsequently, primary prescribers will need to adjust treatment plans as needed.

           

          Pharmacists must emphasize the importance of patients taking PEP medications as prescribed and remind patients picking up these prescriptions to follow up with their providers. Further, counseling should include that these medications should be taken at the same time every day to optimize effectiveness. It is also important to counsel patients taking medications for PEP, that if they miss any doses, the likelihood of becoming infected with HIV is greater.22 Technicians should be sure to ask patients who receive PEP if they would like to talk to the pharmacist. One possible communication could be, “This is important medication, and the pharmacist may be able to answer questions you don’t even know you have!” Prompts like this can provide patient privacy while encouraging them to spend some time with the pharmacist.

           

          Prescribers monitor patients on PEP at baseline and during the months following exposure. It is important to reinforce that patients require testing for HIV after they complete the medication regimen to ensure it was effective. Table 3 describes the CDC-recommended laboratory monitoring schedule for HIV PEP.28

           

          Table 3. HIV PEP Required Laboratory Monitoring28

          Monitoring Reason(s) Time Period
          HIV antigen/antibody Ensure the patient does not already have HIV (ineligible for PEP) and make sure PEP is effective after use Baseline, 4-6 weeks after exposure, and at 3 months after exposure*
          Hepatitis B and C Pre-existing hepatitis infection may change therapy recommendations or monitoring Baseline
          Serum creatinine Evaluate baseline kidney function for initial therapy choice and determining correct dosing if significant impairment exists and ensure that PEP is not causing kidney injury Baseline and 4-6 weeks after exposure if receiving emtricitabine/tenofovir and integrase-based regimen (e.g., bictegravir, cabotegravir, dolutegravir, elvitegravir, raltegravir)
          Alanine transaminase and aspartate aminotransferase Liver function could affect therapy decisions, especially if baseline hepatitis exists Baseline and 4-6 weeks after exposure if receiving emtricitabine/tenofovir with an integrase inhibitor (e.g., bictegravir, cabotegravir, dolutegravir, elvitegravir, raltegravir)
          Pregnancy test Pregnancy status should be incorporated into therapy decisions Baseline and 4-6 weeks after exposure
          Bacterial STIs Identify any potential co-infections and ensure optimal, prompt therapy Baseline (if not done at baseline or if symptomatic, complete at 4-to-6-week follow-up)

          *additional testing at 6 months indicated if Hepatitis C acquired during exposure

           

          HIV-RELATED STIGMA

          HIV remains a highly stigmatized condition in both adults and adolescents. HIV stigma is discrimination based on negative attitudes and beliefs about the disease and the people who have it. Due to HIV’s long-standing history of prejudice and labeling, patients may have feelings of shame, fear of disclosure, isolation, and despair. This discourages individuals living with HIV from accessing treatment or staying in care, often affecting their health. Additionally, state laws concerning minors’ rights to give informed consent to receive HIV diagnosis or treatment vary across the U.S. Mental and behavioral health is often neglected, which can increase the burden on people living with HIV infection.

           

          It is important that the healthcare team recognizes and actively addresses this stigma using interventions that ensure the well-being of affected patients. The CDC lays out two guidelines to help address the issues of problematic language and minors’ ability to consent:

           

          CONCLUSION

          Adolescents and young adults who participate in high-risk behaviors (e.g., unprotected sex, injectable drug use) are at increased risk for contracting HIV. HIV PrEP and PEP are important medical advances that decrease the risk of HIV infection for uninfected patients. CDC guidelines provide up-to-date recommendations on the medications used for PrEP and PEP. Pharmacists who dispense these medications should be prepared to educate and counsel adolescent and young adult patients at risk of HIV on the appropriate use of PrEP and PEP. Pharmacy technicians can provide significant assistance to patients obtaining HIV PrEP and PEP to ensure these medications are affordable. They can also be vigilant to refer patients obtaining these prescriptions to the pharmacist for important counseling and education.

           

          Pharmacist Post Test (for viewing only)

          PHARMACIST POSTTEST

          Pharmacist Posttest:

          Learning Objectives
          1. Discuss the prevalence of HIV/AIDS in humans and associated stigma in the adolescent and young adult population
          2. Identify risk factors for HIV infection in adolescent and young adults
          3. Review pre-/post-exposure prophylaxis methods for HIV prevention in the adolescent/young adult population
          4. Maximize the pharmacists’ role in HIV prevention in the adolescent/young adult population

          1. GB is a 17-year-old who volunteers at a local nursing home after school. She recently experienced a needlestick injury with a contaminated needle. She asks you if she is eligible to receive PEP. Within how many hours after the injury should GB receive PEP?
          A. 96 hours
          B. 72 hours
          C. 128 hours

          2. Which of the following barriers contributes to lower PrEP adherence rates in adolescents and young adults?
          A. Lack of HIV risk awareness
          B. Parental involvement in therapy
          C. Disregard for safety and adverse effects

          3. According to the 2021 Preexposure Prophylaxis for the Prevention of HIV Infection in the U.S. clinical practice guidelines, clinicians should offer PrEP to minors who fit into which of the following categories:
          A. HIV negative, cisgender women who use condoms regularly
          B. Sexually active, HIV negative MSM with HIV-positive partners
          C. People living with HIV who inject drugs and have history of STIs

          4. According to the CDC’s guidelines which PEP medication is appropriate for a patient with a CrCl of 50 mL/min?
          A. Zidovudine
          B. Cabotegravir
          C. Emtricitabine

          5. Which of the following is TRUE regarding high school students’ behaviors that increase HIV risk?
          A. Most are tested for HIV at every pediatrician appointment
          B. About half report not using a condom during their last sexual intercourse
          C. About half report drinking alcohol prior to their last sexual encounter

          6. A prescriber reaches out to you for help determining the most appropriate PEP therapy for a 15-year-old female who was sexually assaulted 12 hours ago. She has normal renal function and weighs 100 lbs. She takes hormonal birth control pills regularly and reports good adherence. Which of the following is the BEST recommendation?
          A. Zidovudine 300 mg/lamivudine 150 mg + raltegravir 400 mg twice daily for 2 weeks
          B. Cabotegravir 30 mg daily for 4 weeks, then 600 mg intramuscularly once
          C. Emtricitabine 200 mg/tenofovir 300 mg + dolutegravir 50 mg once daily for 4 weeks

          7. Which of the following is TRUE regarding cabotegravir extended-release injectable suspension for PrEP?
          A. Patients require a confirmed negative HIV test each injection
          B. Patients with injection site reactions can take cabotegravir 30 mg orally instead
          C. Patients must self-inject intramuscularly every 3 months

          Pharmacy Technician Post Test (for viewing only)

          PHARMACY TECHNICIAN POSTTEST

          Pharmacy Technician Posttest:

          Learning Objectives
          1. Recall the prevalence of HIV/AIDS among adolescents and young adults and its associated stigma
          2. List high-risk activities for HIV exposure
          3. Describe available patient assistance programs & cost assistance programs for pre- and post-exposure HIV prophylaxis
          4. Identify antiretrovirals used for pre-/post-exposure HIV prophylaxis in the adolescent and young adult population

          1. AB comes into the pharmacy to pick up over-the-counter calcium supplements. You see that she recently started taking PEP for an HIV exposure at work. Which of the following PEP medications would alert you to refer AB to the pharmacist?
          A. Raltegravir
          B. Zidovudine
          C. Lamivudine

          2. Who defines the criteria that patients must meet for patient assistance programs?
          A. Pharmacists at community pharmacies enforce standardized criteria for all programs
          B. Manufacturers or pharmaceutical companies each determine their own criteria
          C. Medicare enforces standardized criterion for all patient assistance programs

          3. GB is a 17-year-old who volunteers at a local nursing home after school. She recently experienced a needlestick injury with a contaminated needle. Within how many hours after the injury should GB receive PEP?
          A. 96 hours
          B. 72 hours
          C. 128 hours

          4. What is the suggested duration of HIV PEP therapy?
          A. 28 days
          B. 6 weeks
          C. 4 months

          5. According to the American Academy of Pediatrics, what percentage of youth with HIV are undiagnosed?
          A. More than 60%
          B. More than 40%
          C. Less than 30%

          6. Which of the following is TRUE regarding high school students’ behaviors that increase HIV risk?
          A. Most are tested for HIV at every pediatrician appointment
          B. About half report drinking alcohol prior to their last sexual encounter
          C. About half report not using a condom during their last sexual intercourse

          7. Which of the following BEST describes insurance coverage and patient assistance programs for PrEP?
          A. Most patients with insurance should have zero co-pay for at least one form of PrEP
          B. Patient assistance programs generally only cover generic forms of PrEP
          C. Uninsured patients do not qualify for any patient assistance programs for PrEP

          References

          Full List of References

          REFERENCES

            References:

            1. Centers for Disease Control and Prevention. About HIV. Updated June 30, 2022. Accessed September 14, 2022. https://www.cdc.gov/hiv/basics/whatishiv.html
            2. Zhou, Mo, et al. Pre-exposure prophylaxis (PrEP) prescriptions among individuals at high risk for HIV in the United States, 2012-2018. IDWeek 2021; September 29-October 3, 2021. . Accessed October 18, 2022. Available at 1799149-1632773807.pdf (rackcdn.com)
            3. Hosek S, Henry-Reid L. PrEP and adolescents: The role of providers in ending the AIDS epidemic. Pediatrics. 2020;145(1):e20191743. doi:10.1542/peds.2019-1743
            4. Impact on Racial and Ethnic Minorities. HIV.gov Web site. https://www.hiv.gov/hiv-basics/overview/data-and-trends/impact-on-racial-and-ethnic-minorities.Accessed October 18, 2022
            5. Szucs LE, Lowry R, Fasula AM, et al. Condom and contraceptive use among sexually active high school students - Youth risk behavior survey, United States, 2019. MMWR Suppl. 2020;69(1):11-18. doi:10.15585/mmwr.su6901a2.
            6. Martinez GM, Abma JC. Sexual Activity, Contraceptive Use, and Childbearing of Teenagers Aged 15-19 in the United States. NCHS Data Brief. 2015;(209):1-8.
            7. Centers for Disease Control and Prevention. Pre-exposure prophylaxis (PrEP). Updated July 5, 2022. Accessed September 14, 2022. https://www.cdc.gov/hiv/clinicians/prevention/prep.html
            8. Pre-Exposure Prophylaxis. HIV.gov. Updated January 7, 2022. Accessed April 2, 2022. https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis
            9. Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States—2021 update: A clinical practice guideline. March 2018. Accessed March 2, 2022. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf
            10. Truvada [prescribing information]. Gilead Sciences; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf
            11. Hosek SG, Landovitz RJ, Kapogiannis B, et al. Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men aged 15 to 17 years in the United States. JAMA Pediatrics. 2017;171(11):1063-1071. doi:10.1001/jamapediatrics.2017.2007
            12. U.S. Food and Drug Administration. FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic. October 3, 2019. Accessed March 2, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic
            1. Descovy [prescribing information]. Gilead; 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf
            2. Havens PL, Stephensen CB, Van Loan MD, et al. Decline in bone mass with tenofovir disoproxil fumarate/emtricitabine is associated with hormonal changes in the absence of renal impairment when used by HIV-uninfected adolescent boys and young men for HIV preexposure prophylaxis. Clin Infect Dis. 2017;64(3):317-325. doi:10.1093/cid/ciw765
            3. Apretude [prescribing information]. ViiV Healthcare; 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215499s000lbl.pdf
            4. Velloza J, Kapogiannis B, Bekker LG, et al. Interventions to improve daily medication use among adolescents and young adults: what can we learn for youth pre-exposure prophylaxis services?. AIDS. 2021;35(3):463-475. doi:10.1097/QAD.0000000000002777
            5. Centers for Disease Control and Prevention. Paying for PrEP. Updated June 6, 2022. Accessed September 14 ,2022. https://www.cdc.gov/hiv/basics/prep/paying-for-prep/index.html
            6. New York State Department of Health. Payment options for post-exposure prophylaxis following non-occupational exposures including sexual assault (nPEP). May 2013. Accessed April 1, 2022. https://www.health.ny.gov/diseases/aids/providers/standards/docs/payment_options_npep.pdf
            7. New York State Department of Health. Payment options for adults and adolescents for post exposure prophylaxis (PEP) following sexual assault. October 2021. Accessed April 25, 2022. https://www.health.ny.gov/diseases/aids/general/pep/docs/sexual_assault.pdf
            8. Centers for Disease Control and Prevention. Paying for PEP. Updated July 13, 2022. Accessed February 24, 2022. https://www.cdc.gov/hiv/basics/pep/paying-for-pep.html
            9. NASTAD. Pharmaceutical Company Patient assistance programs and cost-sharing assistance programs for pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). May 2021. Accessed February 23, 2022. https://nastad.org/sites/default/files/2021-11/PDF-PrEP-PEP-Pharma-Co-Patient-Assistance.pdf
            10. DeHaan E. Post-exposure prophylaxis (PEP) to prevent HIV infection. National Center for Biotechnology Information. Published June 2020. Accessed April 14, 2022. https://www.ncbi.nlm.nih.gov/books/NBK562734/
            11. Leonard J. HIV symptoms timeline: Stages, preventing progression, and outlook. Medical News Today. Updated November 22, 2020. Accessed March 15, 2022. https://www.medicalnewstoday.com/articles/316056
            12. Post-exposure prophylaxis. HIV.gov. Updated April 28, 2021. Accessed February 14, 2022. https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/post-exposure-prophylaxis
            13. CATIE. Post-exposure prophylaxis (PEP). 2019. Accessed March 15, 2022. https://www.catie.ca/fact-sheets/prevention/post-exposure-prophylaxis-pep
            14. 26. Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007, p 82.
            15. Epivir (lamivudine) [prescribing information]. Shire Pharmaceuticals Group plc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf
            16. Centers for Disease Control and Prevention. Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV—United States, 2016. Accessed March 13, 2022. https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf

             

             

             

             

             

            Stop the Bite: Uncover the Answers to Malaria and Dengue Fever

            Learning Objectives

             

            After completing this knowledge-based continuing education activity, pharmacists will be able to

            • RECALL symptoms associated with dengue fever and malaria
            • DESCRIBE emerging information about dengue and malaria vaccines
            • ASSOCIATE dengue fever and malaria vaccines for specific patients

            After completing this knowledge-based continuing education activity, pharmacy technicians will be able to

            •      RECALL symptoms associated with dengue fever and malaria
            •      DESCRIBE emerging information about dengue and malaria vaccines
            •      MATCH  dengue fever and malaria vaccines by storage requirements

            Cartoon representation of a mosquito.

             

            Release Date: February 1, 2023

            Expiration Date: February 1, 2026

            Course Fee

            Pharmacists: $4

            Pharmacy Technicians: $2

            There is no grant funding for this CE activity

            ACPE UANs

            Pharmacist: 0009-0000-23-002-H06-P

            Pharmacy Technician: 0009-0000-23-002-H06-T

            Session Codes

            Pharmacist:  23YC02-MTX44

            Pharmacy Technician:  23YC02-XTM62

            Accreditation Hours

            0.5 hours of CE

            Accreditation Statements

            The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-002-H06-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

             

            Disclosure of Discussions of Off-label and Investigational Drug Use

            The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

            Faculty

            Jessica Bylyku, BS
            PharmD Candidate 2024
            UConn School of Pharmacy
            Storrs, CT

                                                      

            Kelsey Giara, PharmD
            Freelance Medical Writer
            Pelham, NH

             

            Melody White
            PharmD Candidate 2025
            UConn School of Pharmacy
            Storrs, CT

            Faculty Disclosure

            In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

            Dr. Giara, Jessica Bykylu and Melody White do not have any relationships with ineligible companies and therefore have nothing to disclose.

             

            ABSTRACT

            Malaria and dengue (pronounced deng-ee) fever are not new diseases, but given the emergence of new vaccines, it is critical that pharmacists and pharmacy technicians increase their familiarity with them. These illnesses are both transmitted by mosquitos, but malaria is caused by Plasmodium parasites while dengue fever is a viral disease caused by dengue virus. The United States is not a malaria- or dengue-endemic country, but travel to other countries puts people at risk of these conditions. Pharmacy teams should be prepared to identify potential cases and refer patients for appropriate vaccination or treatment when appropriate.

            CONTENT

            Content

            INTRODUCTION

            Malaria cases in 2020 totaled an estimated 241 million, leading to more than 600,000 deaths, mostly in Africa.1 Direct costs of malaria prevention and treatment in the United States (U.S.) total about $12 billion annually, excluding the toll it takes on affected individuals and their families.1 The World Health Organization (WHO) reports that between 100 to 400 million people are infected with dengue fever each year.2 About 80% of cases are mild and asymptomatic, but dengue fever can progress to “severe dengue,” which is classified as a medical emergency requiring immediate medical care.2,3

             

            Mosquitos, Malaria, and Dengue – Oh My!

            Plasmodium parasites—common to tropical areas (e.g., Africa, South America, the Caribbean Islands, South Asia)—cause malaria.1 Most commonly, malaria is transmitted through the bite of infected mosquitoes, specifically the Anopheles species, during local outbreaks. There is also a term coined “airport malaria,” describing disease that is transported from an infected country to a non-infected country.4 Congenital malaria occurs when mothers infected with the disease transmit parasites to the child during pregnancy or birth.4 Although rare, prompt diagnosis is crucial to ensure infected neonates and infants survive. Transfusion-transmitted malaria is also possible where blood recipients can be infected with malaria accidently. There are no approved tests to screen blood donations for malaria, only questioning of prospective donors.4 Although rare in the U.S., complications are severe and organizations should take action to prevent potentially-infected individuals from donating.

             

            Patients with malaria generally present with fever, chills/sweating, headache, and weakness within 10 to 15 days of infection.5 Diarrhea, abdominal pain, and cough are also possible. As malaria progresses, patients develop a classic paroxysm (i.e., symptoms that come and go) comprising three stages6:

            1. 15-to-60-minute cold stage (shivering and feeling cold)
            2. 2-to-6-hour hot stage (fevers up to nearly 106°F; flushed, dry skin; and often headache, nausea, and vomiting)
            3. 2-to-4-hour sweating stage (rapid drop in fever and sweating)

             

            Missed or delayed malaria diagnosis can lead to potentially fatal complicated disease manifesting as severe anemia, renal failure, altered consciousness, and multisystem organ failure.6 Clinicians diagnose malaria via a blood smear test. Although rapid and polymerase chain reaction (PCR) tests are available, medical professionals confirm diagnosis through microscopic blood smear examination.7

             

            Dengue fever is a viral disease caused by mosquitos—mainly females from the Aedes aegypti and Ae. albopictus species—carrying dengue virus (also known as DENV).2 Four DENV serotypes exist, so it is possible to contract the disease four times. The virus can be transmitted through mosquito bite, from pregnant mother to child, and via infected blood products/organ donations and infusions. Transovarial transmission within mosquitoes (from parent to offspring) has also been noted.2

             

            Most dengue cases are asymptomatic or mild and fatalities are rare, but increasing severity can be life-threatening.2,3 Providers should suspect dengue when a high fever (104°F or greater) is accompanied by any two of the following symptoms2,3:

            • severe headache
            • pain behind the eyes
            • muscle/joint/bone pain
            • nausea/vomiting
            • swollen glands
            • rash

             

            This febrile phase lasts about 2 to 7 days, and most people recover after about a week.2,3 Severe dengue is a potentially fatal complication due to plasma leakage, fluid accumulation, respiratory distress, severe bleeding, or organ impairment.2 Patients are at risk of severe dengue symptoms about 3 to 7 days after initial symptoms appear.2 As fever drops to below 100°F, patients enter a “critical phase” for 24 to 48 hours. Warning signs to watch for during the critical phase include2

            • severe abdominal pain
            • rapid breathing
            • blood in vomit, stool, gums, or nose
            • persistent vomiting
            • restlessness/fatigue

             

            Clinicians use commercially available PCR or rapid diagnostic tests to confirm dengue diagnosis.2 Enzyme-linked immunosorbent assays are also available to confirm active or previous infections.

             

            Global Implications  

            Beyond clinical symptoms, malaria and dengue fever inflict social and financial loss for diagnosed individuals and the countries tasked with treating affected populations. Some examples of the indirect burden of these mosquito-borne diseases include1

            • expenses for traveling and receiving treatment
            • absences from work/school
            • burial expenses in cases of death
            • purchases of medication and supplies
            • public health interventions (e.g., insecticide spraying, bed nets)
            • opportunity loss for tourism

             

            Populations at increased risk of contracting malaria include infants, children younger than 5 years, pregnant women, immunosuppressed patients, and migrant workers or traveling populations.5 There is also concern that certain mosquitoes are resistant to insecticide, and by migrating throughout the world they can spread malaria to urban populations.8 Researchers have identified Anopheles gambiae mosquitoes, originally found in India and Iran, as insecticide-resistant. These are projected to put nearly 126 million people in African cities at risk for contracting malaria.8

             

            Populations most vulnerable to contracting dengue fever include pregnant women and children.3 Many asymptomatic or mild dengue cases go unreported. WHO reports most of the dengue burden occurs in Asia, and the number of cases has steadily increased to just over 5 million in 2019.2

             

            PREVENTION AND TREATMENT

            Following prevention and treatment guidelines are crucial to lower transmission rates of dengue fever and malaria.

             

            Dengue Fever

            WHO states that countries should be aware of community mosquito presence and develop active mosquito and virus surveillance to prevent further disease spread.2 They should also remain knowledgeable about the number of infected individuals.

             

            The dengue vaccine (Dengvaxia) has been licensed in other countries since 2015, but the U.S. Food and Drug Administration (FDA) approved the vaccine in 2019.2 WHO recommends people aged 9 to 45 years be vaccinated, but Dengvaxia is only FDA approved for patients 9 to 16 years old with a history of previous infection who live in high-risk areas. As a live-attenuated vaccine, it is contraindicated in individuals with severe immunodeficiency.2 Children receiving Dengvaxia need a 3-dose series administered subcutaneously with doses separated by 6 months.9 Providers should store the vaccine in the refrigerator.10 After reconstitution, it should be administered immediately or stored in the refrigerator and used within thirty minutes.

             

            WHO and the FDA only recommend Dengvaxia for patients with a history of dengue virus infection.10,11 This is based on clinical trial evidence that the vaccine is efficacious and safe in patients with a history of previous DENV infection because a subsequent infection is more serious and life-threatening than the first.11 They also advise countries using the vaccine to control viral spread to implement pre-vaccination screening to confirm previous infection.

             

            As no dengue-specific treatment is available, providers should treat infected patients symptomatically with acetaminophen, rest, and fluids.2 Patients with dengue fever should avoid non-steroidal anti-inflammatory drugs (e.g., ibuprofen, aspirin) because they thin the blood. Given the risk of hemorrhage in this disease, blood thinners may exacerbate the problem.2

             

            Malaria

            WHO recommends that countries engage in vector control and surveillance for the spread of malarial disease.5 Malaria vaccines have been in development for decades, but no malaria vaccine is available in the U.S.12 In 2021, however, WHO recommended a new malaria vaccine (Mosquirix) for children aged older than 5 months who live in areas with moderate to high transmission of P. falciparum.13 The vaccine is only recommended for children as malaria is one of the main killers of children younger than 5 years in countries with moderate or high rates of malaria.14 WHO also recommends giving the vaccine seasonally in countries where malaria transmission is high during certain seasons.13

             

            Initial Mosquirix pilot studies are ongoing, and more widespread vaccine rollout is expected in 2023. For now, people in the U.S. traveling to malaria-endemic countries continue to use oral medications as chemoprophylaxis (i.e., to prevent the disease), including atovaquone/proguanil, chloroquine, doxycycline, mefloquine, primaquine, and tafenoquine.15

             

            Clinicians administer Mosquirix as a 4-dose schedule.16 The vaccine’s adverse effects are pain and swelling at the injection site and fever.17 Providers should store the vaccine in the refrigerator. After reconstitution it should be administered immediately or stored in the refrigerator and used within 6 hours.16

             

            Malaria treatment involves the use of antimalarial drugs based on four main factors15:

            • Infection severity: Malaria infection is either considered uncomplicated (effectively treated with oral antimalarials) or severe (requiring aggressive intravenous antimalarial therapy).
            • Infecting Plasmodium species: P. falciparum and P. knowlesi infections can cause rapidly progressive severe illness or death, necessitating urgent therapy initiation, while other species are less likely to cause severe disease. P. vivax and P. ovale infections also require treatment for hypnozoites (parasites that lay dormant in the liver and then re-awaken to become active infectants).
            • Drug susceptibility: In addition to disease severity differences, Plasmodium species also have different drug susceptibilities, so providers select an antimalarial therapy based on the species of the infecting parasite. If the species cannot be determined, patients must initiate antimalarial treatment against chloroquine-resistant P. falciparum as soon as possible.
            • Previous antimalarial use: Patients using antimalarial medication as chemoprophylaxis, should not receive that same drug or drug combination to treat malaria infection unless no other options are available.

             

            CONCLUSION

            Pharmacists and pharmacy technicians should be familiar with the signs and symptoms of malaria and dengue fever to inform patients when these conditions are suspected and about their appropriate treatment. Pharmacy teams who suspect a case of malaria or dengue fever should refer patients for medical attention and contact their local or state health department.

             

             

             

             

            Pharmacist Post Test (for viewing only)

            PHARMACIST POSTTEST

            Learning Objectives
            ● RECALL symptoms associated with dengue fever and malaria
            ● DESCRIBE emerging information about dengue and malaria vaccines
            ● OPTIMIZE dengue fever and malaria vaccines for specific patients

            1. Which of the following is TRUE?
            A. Dengue fever symptoms are always severe and most patients die
            B. Malaria presents as a cold stage, hot stage, and sweating stage
            C. Pain behind the eyes is a warning sign for malaria

            2. Which of the following is TRUE regarding the malaria vaccine?
            A. WHO recommends it for children 5 months and older who live in endemic areas
            B. It is FDA approved for patients 9 to 16 years old with a history of previous infection
            C. Clinicians administer it as a 3-dose series with each dose separated by 6 months

            3. A patient comes to the pharmacy indicating she and her family are being transferred to a country where dengue is common. She wants to have her three children who are ages 3, 5, and 7 vaccinated for dengue before they move. What is the BEST thing to tell her?
            A. We should schedule your children to be vaccinated about six weeks before you plan to move so they develop antibodies before you actually relocate.
            B. We only vaccinate children who have already had dengue because a second infections is more serious and life-threatening than the first.
            C. Wait until you arrive in the country because they will want to do pre-vaccination screening to confirm your children have not been infected previously.

            Pharmacy Technician Post Test (for viewing only)

            PHARMACY TECHNICIAN POSTTEST

            Learning Objectives
            ● RECALL symptoms associated with dengue fever and malaria
            ● DESCRIBE emerging information about dengue and malaria vaccines
            ● CLASSIFY dengue fever and malaria vaccines by storage requirements

            1. Which of the following is TRUE?
            A. Dengue fever symptoms are always severe and most patients die
            B. Malaria presents as a cold stage, hot stage, and sweating stage
            C. Pain behind the eyes is a warning sign for malaria

            2. Which of the following is TRUE regarding the malaria vaccine?
            A. WHO recommends it for children 5 months and older who live in endemic areas
            B. It is FDA approved for patients 9 to 16 years old with a history of previous infection
            C. Clinicians administer it as a 3-dose series with each dose separated by 6 months

            3. A patient at your pharmacy is receiving the dengue fever vaccine. The patient’s mother asks you if they can use the restroom before the pharmacist administers the vaccine. You look over to see that the pharmacist has just finished reconstituting Dengvaxia for this patient. Which of the following is the BEST response?
            A. Advise the mother not to leave the pharmacy waiting area, as the pharmacist needs to administer this vaccine immediately or it will expire
            B. Advise the mother to take her daughter to the restroom, and the pharmacist can administer this vaccine within 6 hours as long as it’s refrigerated
            C. Advise the mother to take her daughter to the restroom but return within 30 minutes, and ensure the pharmacist refrigerates the reconstituted vaccine

            References

            Full List of References

            REFERENCES

            1. Centers for Disease Control and Prevention. Malaria’s Impact Worldwide. Updated December 16, 2021. Accessed November 30, 2022. https://www.cdc.gov/malaria/malaria_worldwide/impact.html
            2. World Health Organization. Dengue and severe dengue. Updated January 10, 2022. Accessed November 1, 2022. https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue
            3. Centers for Disease Control and Prevention. Dengue. Updated August 3, 2022. Accessed November 1, 2022. https://www.cdc.gov/dengue/index.html
            4. Centers for Disease Control and Prevention. Parasites – Malaria. Updated August 19, 2022. Accessed November 1, 2022. https://www.cdc.gov/parasites/malaria/index.html
            5. World Health Organization. Malaria. Updated July 26, 2022. Accessed November 1, 2022. https://www.who.int/news-room/fact-sheets/detail/malaria
            6. Crutcher JM, Hoffman SL. Chapter 83: Malaria. In: Baron S, ed. Medical Microbiology. 4th ed. University of Texas Medical Branch at Galveston; 1996. Accessed November 1, 2022. https://www.ncbi.nlm.nih.gov/books/NBK8584/
            7. Stanford Health Care. Malaria diagnosis. Accessed November 1, 2022. https://stanfordhealthcare.org/medical-conditions/primary-care/malaria/diagnosis.html
            8. American Society of Tropical Medicine and Hygiene. Invasive mosquitos – Anopheles stephensi in Ethiopia. November 1, 2022. Accessed November 30, 2022. https://astmhpressroom.wordpress.com/annual-meeting-2022/anopheles-stephensi-in-ethiopia/
            9. Centers for Disease Control and Prevention. Dengue Vaccine VIS. Updated December 17, 2021. Accessed November 29, 2022. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/dengue.html
            10. Dengvaxia [prescribing information]. Sanofi Pasteur; 2019.
            11. Ask the Experts: Dengue. Immunize.org. Updated February 16, 2022. Accessed November 21, 2022. https://www.immunize.org/askexperts/experts_dengue.asp
            12. Centers for Disease Control and Prevention. Malaria: Vaccines. Updated October 7, 2021. Accessed December 2, 2022. https://www.cdc.gov/malaria/malaria_worldwide/reduction/vaccine.html
            13. Q&A on RTS,S malaria vaccine. World Health Organization. Updated April 21, 2022. Accessed November 30, 2022. https://www.who.int/news-room/questions-and-answers/item/q-a-on-rts-s-malaria-vaccine
            14. UNICEF. Millions more children to benefit from malaria vaccine as UNICEF secures supply. August 16, 2022. Accessed November 22, 2022. https://www.unicef.org/press-releases/millions-more-children-benefit-malaria-vaccine-unicef-secures-supply
            15. Centers for Disease Control and Prevention. Treatment of Malaria: Guidelines for Clinicians (United States). Updated September 30, 2022. Accessed November 30, 2022 https://www.cdc.gov/malaria/diagnosis_treatment/clinicians1.html
            16. Mosquirix (Product Information). European Medicines Agency. Updated January 8, 2022. Accessed November 30, 2022. https://www.ema.europa.eu/en/documents/outside-eu-product-information/mosquirix-product-information_en.pdf
            17. World Health Organization. Malaria: The malaria vaccine implementation programme (MVIP). March 2, 2020. Accessed November 30, 2022. https://www.who.int/news-room/questions-and-answers/item/malaria-vaccine-implementation-programme

             

             

            Over the Counter Hearing Aids: Breaking Sound Barriers in Community Pharmacy-RECORDED WEBINAR

            About this Course

            This course is a recorded (home study version) of the CE Finale Encore Webinars.

             

            Learning Objectives

            Upon completion of this knowledge based CE Activity, a pharmacist will be able to:

            1. Describe the signs and symptoms of mild to moderate hearing loss 
            2. Recognize how patient-specific barriers restrict access to hearing health care  
            3. Discuss strategies to assist patients with appropriate OTC hearing aid selection 

            Release and Expiration Dates

            Released:  December 16, 2022
            Expires:  December 16, 2025

            Course Fee

            $17 Pharmacist

            ACPE UAN

            0009-0000-22-060-H01-P

            Session Code

            22RW60-XYW84

            Accreditation Hours

            1.0 hours of CE

            Additional Information

             

            How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.

            Accreditation Statement

            The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

            Pharmacists and Pharmacy Technicians are eligible to participate in this knowledge-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-22-060-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

            Grant Funding

            There is no grant funding for this activity.

            Faculty

            Katherine MacDonald, PharmD
            Pharmacist
            UConn Student Health & Wellness
            Storrs, CT

            Faculty Disclosure

            In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

            • Dr. MacDonald has no relationships with ineligible companies

            Disclaimer

            The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

            Content

            Post Test

            Post Test

            1.Which of the following symptoms is indicative of mild to moderate hearing loss

             

            1. Recent treatment for an ear infection
            2. Difficulty maintaining conversation in quiet environments
            3. Watching TV with subtitles on

             

              

            1. M.M., a 75-year-old female, arrives at the pharmacy to pick up her celecoxib prescription (which she takes for arthritis) and to return the ITC-style OTC hearing aids she purchased two weeks ago. When you ask why she's returning the hearing devices, she expresses that she "doesn't need them" as much as she thought, then adds "they feel ok when they're in, but I'm nervous that like they're going to just pop out of my head." Which alternative style of OTC hearing aid might better address M.M.'s needs and priorities?

             

            1. Completely-in-Canal
            2. Behind-the-Ear
            3. Personal Sound Amplification Product

             

            3.D.J. is a regular patient at your pharmacy; today he's joined by his niece. You know that he has difficulty hearing, especially in the busy pharmacy, and make a mental note to remove your mask and speak slowly while you're talking to him. As D.J. and his niece wait for his prescription to be filled, D.J.'s niece points out the OTC hearing aid display by the counter and suggests that "something like that would be perfect for you!" D.J. remarks that he "isn't some bionic action figure and can hear just fine." What is D.J.'s greatest barrier to accessing OTC hearing aids? 

             

            1. Severe hearing loss
            2. No perceived need
            3. Accessibility

             

            1. Which medication is most likely to cause hearing loss?
            2. Gentamycin
            3. Hydrochlorothiazide 
            4. Ibuprofen 
            5. Methotrexate 

             

             

            1. C.S. is a 72-year-old female with moderate hearing loss. Her past medical history also includes diabetes and recent total knee replacement surgery. After her knee replacement, she moved into assisted living and “is excited to meet more of my neighbors and maybe even sign up for a pottery class.” C.S. noticed that OTC hearing aids are available at her local pharmacy and believes that they could help her be more involved in her new community. Which of the following patient-specific characteristics will influence the outcomes of OTC hearing aid use?

             

            1. Limited mobility 
            2. Age
            3. Self-efficacy

             

             

            1. Individuals with untreated hearing loss are more likely to experience which of the following?
            2. Social isolation
            3. Improved cognition
            4. Reversible hearing loss

             

             

            1. Pharmacists are expected to play a new and important role as healthcare providers as hearing aids hit the shelves of community pharmacies. Which of the following best describes how pharmacists will participate in OTC hearing aid provision?

             

            1. Diagnose underlying causes of hearing loss
            2. Administer hearing tests to interested individuals
            3. Employ effective communication strategies

             

             

             

            Handouts

            VIDEO