Archives

Time to Learn about New Cardiac Drugs-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 application based CE Activity, a pharmacist will be able to:

  • Select the appropriate first and adjunctive therapies for LDL lowering in patients with differing risks according to guideline recommendations
  • Compare and contrast the mechanism of action and potential utility of the new LDL lowering drugs bempedoic acid and inclisirin versus traditional options
  • Describe hypertrophic cardiomyopathy and its risks
  • Identify the mechanism of action and potential utility of mavacamten versus agents currently recommended in guidelines

Release and Expiration Dates

Released:  December 16, 2022
Expires:  December 16, 2025

Course Fee

$17 Pharmacist

ACPE UAN

0009-0000-22-056-H01-P

Session Code

22RW56-TXJ88

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 application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-22-056-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

C. Michael White, PharmD, FCCP, FCP
BOT Distinguished Professor and Chair of Pharmacy Practice
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. White 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

Mary Maple is an 80-year old with angina pectoris, what intensity of statin therapy should she receive and how much should her LDL be reduced?
a) Moderate intensity, 30%
b) High intensity, 50%
c) Low intensity, 20%

Mary Maple is an 55-year old with angina pectoris, what intensity of statin therapy should she receive and how much should her LDL be reduced?
a) Moderate intensity, 30%
b) High intensity, 50%
c) Low intensity, 20%

According to the CTT relationship, whether the intensity of statin was increased or adjunctive therapy with ezetimibe or evolocumab was used, the relationship between LDL lowering and cardiovascular event reduction had the same relationship
a) True
b) False

Does the CTT relationship apply to inclisirin and bempedoic acid or just to statins, ezetimibe, and PCSK9 inhibitors?
a) Yes
b) Unknown
c) No

Which of the following describes the mechanism of action correctly?
a) Inclisiran inhibits the formation of PCSK9 by inserting small interfering RNA into the cell
b) Bempedoic acid blocks the binding of PCSK9 to the LDL receptor
c) Both of the mechanisms are described correctly

Which of the new cholesterol reducing drugs can cause tendon rupture and increased uric acid?
a. Inclisiran
b. Bempedoic acid
c. Both agents

Which of the following agents can be given every six months once steady state concentrations are achieved?
a. Inclisiran
b. Bempedoic acid
c. Both agents

Hypertrophic cardiomyopathy can lead to what adverse events?
a. Atrial and ventricular arrhythmias
b. Stroke
c. Both of these issues

Mavacamten might be able to replace which of the following HCM treatments?
a. Beta-blockers of Non-DHP CCBs
b. ICDs or anticoagulants
c. Disopyramide or septal reduction therapies

Mavacamten should not be used if the left ventricular ejection fraction goes below what value?
a. 20%
b. 30%
c. 40%
d. 50%

Handouts

VIDEO

Law: Tic-Toc, Turn Back the Clock: Pharmacy in the Post-Roe v. Wade Climate-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 application based CE Activity, a pharmacist will be able to:

1.       Review the original Roe v. Wade ruling and its impact on healthcare in the United States
2.       Discuss Dobbs v. Jackson Women’s Health Organization and its impact on Roe v. Wade
3.       Identify the implications of these Supreme Court rulings on pharmacy practice

Release and Expiration Dates

Released:  December 16, 2022
Expires:  December 16, 2025

Course Fee

$17 Pharmacist

ACPE UAN

0009-0000-22-057-H03-P

Session Code

22RW57-JXT85

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 application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-22-057-H03-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

Kelsey Giara, PharmD
Freelance Medical Writer
Pelham, NH

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.

  • Kelsey Giara 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

Pharmacist Post-test

Learning Objectives
After completing this continuing education activity, pharmacists will be able to
• REVIEW the original Roe v. Wade ruling and how it impacted healthcare in the United States
• DISCUSS Dobbs v. Jackson Women’s Health Organization and its impact on Roe v. Wade
• IDENTIFY the implications of these Supreme Court rulings on pharmacy practice

1. What did the original Roe v. Wade ruling do?
A. Made abortion legal in the U.S. at any gestational age for any reason
B. Left it up to individual states in the U.S. to regulate abortion at any gestational age
C. Made abortion legal in the U.S. through the first trimester of pregnancy

2. What did the Planned Parenthood of Southeastern Pennsylvania v. Casey ruling do?
A. Overturned Roe v. Wade and made abortion illegal across the U.S.
B. Provided states the ability to pass more restrictive laws regarding abortion
C. Laid the groundwork for Dobbs v. Jackson Women’s Health Organization

3. What did the Dobbs v. Jackson Women’s Health Organization ruling do?
A. Made abortion illegal in the U.S. at any gestational age for any reason
B. Left it up to individual states in the U.S. to regulate abortion at any gestational age
C. Made abortion illegal in the U.S. after the first trimester of pregnancy

4. Which of the following was the first successful 6-week abortion ban after the Roe v. Wade ruling?
A. Gestational Age Act
B. Partial-Birth Abortion Ban
C. Heartbeat Act

5. Which of the following states would be MOST likely to enforce abortion bans through criminal penalties?
A. Tennessee
B. New Mexico
C. Florida

6. Which of the following is TRUE about EMTALA?
A. It effectively supersedes state law regarding abortion
B. It states that providers must abort ectopic pregnancies
C. It is not enforceable in the case of abortion care

7. Which of the following is TRUE about dispensing intramuscular methotrexate following the overturn of Roe v. Wade?
A. Pharmacists should use clinical judgment to practice corresponding responsibility and follow state laws
B. It is illegal to dispense to a woman of childbearing age unless they have documented psoriatic arthritis
C. Refusing to fill for any reason is illegal, and pharmacists will face fines and imprisonment for discrimination

8. Which of the following is the BEST way to prevent discrimination or perceived discrimination?
A. Ask all women of childbearing age about pregnancy status when they fill teratogenic medications
B. Decline to fill all prescriptions for abortifacient medications for women of childbearing age
C. Ask individuals about their religious beliefs before offering them employment

9. Which of the following is TRUE about federal preemption?
A. It requires physicians to use telehealth to prescribe medication abortion drugs if patients request
B. It supersedes the FDA to prohibit providers from prescribing opioids to women of childbearing age
C. The Women’s Health Protection Act of 2021 may provide federal preemption regarding abortion services

10. A woman presents to the emergency department at your hospital experiencing complications related to a miscarriage during the ninth week of pregnancy. You work in a state where a 6-week abortion ban is in effect, and a provider suspects the individual of having taken medication to end their pregnancy. A coworker insists on reporting this information to authorities because she does not want to be liable for withholding the information from law enforcement. The law does not require the hospital to report individuals to law enforcement for intentionally ending a pregnancy, but your coworker states that the HIPAA Privacy Rule allows this kind of disclosure. What should you do?
A. Assure your coworker that reporting this patient to law enforcement is an unlawful disclosure of PHI
B. Let your coworker report this information to law enforcement and then report your coworker for PHI disclosure
C. Report this patient to law enforcement so that you are not held liable if she is later charged with unlawful abortion

Handouts

VIDEO

What in the World: A Global Look at Healthcare and Drugs-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 application based CE Activity, a pharmacist will be able to:

1.       Describe the key components of global healthcare systems
2.       Discuss the performance indicators of global health systems
3.       Compare pharmaceutical drug spending levels and trends globally
4.       Define medical tourism and analyze its associated risks and benefits

Release and Expiration Dates

Released:  December 16, 2022
Expires:  December 16, 2025

Course Fee

$17 Pharmacist

ACPE UAN

0009-0000-22-055-H04-P

Session Code

22RW55-CBA96

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 application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-22-055-H04-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

Bisni Narayanan, PharmD
Outpatient Pharmacy Services
Yale New Haven Health System
Pharmacy Supervisor- Operations
Hamden, 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. Narayanan 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

World Health Post Test – CE Finale

After completing this continuing education activity, pharmacists will be able to
1. Describe the key components of global healthcare systems
2. Discuss the performance indicators of global health systems
3. Compare pharmaceutical drug spending levels and trends globally
4. Define medical tourism and analyze its associated risks and benefits

Which of the following are key components in global health systems?

a. Wait times, patient satisfaction, propensity to result in personal bankruptcy, number of healthcare professionals employed, accreditation

b. Type of ownership (public vs. private), patient’s financial obligations, extent of coverage (e.g., preventive, inpatient, outpatient care, etc.)

c. Antibiotic resistance, risk of exposure to blood borne diseases, long distance travel, exposure to unusual infections

What is a common problem encountered in the universal payer model that is frequently used as a performance measure?

a. High out of pocket cost of care

b. Long wait times

c. Higher mortality rates

In comparison to other high-income countries, where does the U.S system’s administrative efficiency rank?

a. 9th

b. 10th

c. 11th

A student under your supervision is filling a prescription for a newly approved drug. She asks if it is a biologic and you say no, it is a drug (also called a small molecule) and explain the difference between a drug and a biologic, most of which are specialty medications. She says that she heard that long patent lives on innovative drugs fuel pharmaceutical drug spending. What do you tell her?

a. “You are incorrect. The largest contributor to increased spending for pharmaceuticals is specialty medications”

b. “You are incorrect. The largest contributor to increased spending for pharmaceuticals is COVID-19 therapeutics.”

c. “You are incorrect. The largest contributor to increased spending for pharmaceuticals is over the counter medications.”

Handouts

VIDEO

First-Line Medication Therapy for Type 2 Diabetes: Time for a Change? -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 application based CE Activity, a pharmacist will be able to:

1.      List the American Diabetes Association’s recommended approach to preventing diabetes-related long-term complications.
2.      Identify efficacy and safety data for the newest FDA-approved diabetes medication.
3.      Recall the most recent ADA’s guideline recommendations on medication management of hyperglycemia in type 2 diabetes.

Release and Expiration Dates

Released:  December 16, 2022
Expires:  December 16, 2025

Course Fee

$17 Pharmacist

ACPE UAN

0009-0000-22-058-H01-P

Session Code

22RW58-VXK92

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 application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-22-058-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

Khanh Dang, PharmD, CDCES, FNAP
Associate Clinical Professor
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. Dang 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

First-Line Therapy for Type 2 Diabetes: Time for a Change?

1. What is the MOST IMPORTANT therapeutic goal in the management of diabetes?
a. Reduce the A1c to <7%
b. Prevent the development of long-term complications of diabetes
c. Save money from costly treatments

2. What is the most common cause of mortality in people with uncontrolled type 2 diabetes?
a. Complications of atherosclerotic cardiovascular disease
b. Neuropathic pain
c. Diabetic eye disease

3. Tirzepatide belongs to which of the following drug class?
a. GLP-1 receptor agonists
b. Dual GIP/GLP-1 receptor agonist
c. SGLT2 inhibitors

4. Mr. N, the hypothetical patient from the presentation, is prescribed tirzepatide by his PCP. Which of the following would be expected as a COMMON side effect of tirzepatide?
a. Pancreatitis
b. Neuropathic pain
c. Nausea

5. Which of the following statements is TRUE according to the 2023 American Diabetes Association’s diabetes guidelines?
a. Four areas are equally emphasized: glycemic management, weight management, cardiovascular risk factor management, and cardiorenal protection.
b. Glycemic control is the most important therapeutic goal and prescribers should encourage all patient to strive for a HbA1c lower than 6.
c. Prevention of kidney complications of diabetes should be emphasized above other management strategies.

6. Which of the following drug class is associated with the LOWEST potential for weight loss (hint: see the tables at the end of the presentation)?
a. Biguanide (metformin)
b. SGLT2 inhibitors
c. GLP-1 receptor agonists

Handouts

VIDEO

Immunization: Is Winter Here? – An Update on Monkey Pox and Covid Vaccines-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 application based CE Activity, a pharmacist will be able to:

1. Discuss trends in the epidemiology of the COVID-19 pandemic and Monkeypox outbreak.
2. Discuss current clinical data on the safety and effectiveness of (i) the bivalent COVID-19 booster vaccines and (ii) the JYNNEOS or ACAM2000 vaccines for Monkeypox.
3. Explain whether a person would be eligible for receipt of (i) the bivalent COVID-19 booster vaccines and/or (ii) the JYNNEOS or ACAM2000 vaccines for Monkeypox.

Release and Expiration Dates

Released:  December 16, 2022
Expires:  December 16, 2025

Course Fee

$17 Pharmacist

ACPE UAN

0009-0000-22-059-H06-P

Session Code

22RW59-KXV39

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 application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-22-059-H06-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

Jeffery Aeschlimann, PharmD
Associate Clinical Professor-Infectious Disease Specialty
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. Aeschlimann 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

 

  1. Good news! News reporters and Internet sites began announcing in the spring and summer of 2022 that the global pandemic had ended.  What do you think of that?
    1. YAY! Science prevailed and we obliterated that bad boy and sent it away!
    2. FAKE NEWS. Approximately 2,000 Americans still die each week from (or with) active COVID-19 disease.
    3. CORRECT, but COVID is still a major concern in our socially inclined young adults.

 

  1. What does the data say about adverse effects associated with the bivalent COVID-19 boosters?
    1. The most common adverse effects are systemic (fever, chills, fatigue)
    2. The most common adverse effects are central (headache, mental fogginess)
    3. The most common adverse effects are local (pain, erythema, swelling)

 

  1. Based on current vaccination statistics about populations that have the poorest booster coverage for COVID-19, which of the following population should pharmacists be encouraging to GET VACCINATED!?!
    1. Children age 5 or younger in the Great Lakes regions
    2. People older than 65 in the Pacific northwest
    3. Everybody everywhere
    4. Monkeypox is the name and name-changing is the game. What has the World Health organization decided to call this infection and why?
    5. It will be monk's disease, which will remove some of the stigmatizing language and remind people to live like a monk until the lesions disappear.
    6. It will be mpox, which is intended to dissuade people from using racist and stigmatizing language to describe people infected with this virus.
    7. It will be var-vac-human, reflecting its similarity to variola (smallpox) and vaccinia (viral vaccine for smallpox) and its zoonotic transmission.

 

 

  1. What is eczema vaccinatum?
  2. A complication of the ACAM2000 vaccination that can occur in patients who have eczema/atopic dermatitis, in which vaccinia virus disseminates to cause an extensive rash and systemic illness.
  3. A complication of the JYNNEOS vaccination that can occur in patients who have eczema/atopic dermatitis, in which vaccinia virus disseminates to cause an extensive rash and systemic illness.
  4. A complication of the ACAM2000 vaccination that can occur in patients who have any chronic skin condition, in which vaccinia virus disseminates to cause an extensive rash and systemic illness.

 

 

  1. Andi is a person living with HIV infection who also is prone to keloids. This patient wants the JYNNEOS vaccination for mpox. What is the best course of action?
    1. Administer the vaccine intradermally
    2. Administer the vaccine subcutaneously
    3. Recommend using ACAM2000 instead

 

 

Handouts

VIDEO

LAW: Legal Perspectives on New and Evolving Issues in 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 application based CE Activity, a pharmacist will be able to:

1. Describe recent industry trends and regulatory actions affecting pharmacists’ workplace conditions
2. Explain how a refusal to fill a legitimate prescription might result in civil liability
3. Identify emerging approaches to containing the cost of drugs

Release and Expiration Dates

Released:  December 16, 2022
Expires:  December 16, 2025

Course Fee

$17 Pharmacist

ACPE UAN

0009-0000-22-054-H03-P

Session Code

22RW54-ABC28

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 application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-22-054-H03-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

Jennifer A. Osowiecki, RPh, JD
Cox & Osowiecki, LLC
Suffield, Connecticut  

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.

  • Attorney Osowiecki 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 (for viewing only)

Post Test

Legal Perspectives on New and Evolving Issues in Pharmacy
Post-test
At the conclusion of this CPE activity, participants should be able to:
1. Describe recent industry trends and regulatory actions affecting pharmacists’ workplace conditions
2. Explain how a refusal to fill a legitimate prescription might result in civil liability
3. Identify emerging approaches to containing the cost of drugs

1. When thinking about health-system pharmacists who participated in a survey of well-being, which of the following is TRUE?
A. The majority of pharmacists indicated that their organizations offered resources to improve well-being and that they had used the resources.
B. Pharmacists who had a greater number of non-clinical duties were least likely to report negative effects on well-being.
C. Only a small percentage of these pharmacists—14.5%—were aware of resources offered by their organizations that could help improve well-being.

2. When reading stories published in various newspapers across the country, which of the following may be a limitation in their findings?
A. The people who conducted the “research” are not pharmacists.
B. The “data” is not collected in a structured, evidence-based way.
C. The newspapers rarely fact-check information before publishing.

3. A patient presents a prescription for emergency contraception on a Saturday evening. The sole pharmacist on duty refuses to fill it based on his religious beliefs and says he will also be the only pharmacist on duty on Sunday and Monday. Which of the following actions may INCREASE the likelihood of civil litigation?
A. The pharmacist tells the patient nothing other than he belongs to a religious sect that considers emergency contraception an abortifacient and he will not fill it.
B. The pharmacist tells the patient that the chain pharmacy across the street is open for another two hours, stocks the medication, and can fill the prescription.
C. The pharmacist asks the patient if she would like him to call his coworker and ask the coworker to come in within 24 hours to fill this prescription.

4. Which of the following prescriptions (which pharmacists refused to fill to treat COVID) resulted in a lawsuit against Walmart and Hy-vee pharmacies that was ultimately dismissed?
A. ivermectin and hydroxychloroquine
B. sodium hyochlorite and ivermectin
C. hydroxychloroquine and molnupiravir

5. Which of the following would reduce prescription drug costs for Medicare patients?
A. The 340B Program
B. Price disrupters and PBMs
C. Inflation Reduction Act of 2022

6. Which of the following terms and descriptions are matched correctly?
A. Clear Bagging: Having the health system’s specialty pharmacy fill the prescription and transport it directly to the place where it will be given.
B. Brown Bagging: Having a specialty pharmacy ship a medication directly to the hospital or clinic so it can be administered to the patient there.
C. Gold Bagging: Having a patient fill a prescription by whatever means available and bring it to the hospital or doctor’s office for administration.

Handouts

VIDEO

Patient Safety: Seven Secrets for Patient Safety with Dietary Supplements

Learning Objectives

 

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

·       Discuss the importance of knowing about a patient’s dietary supplement usage
·       Identify commonly used dietary supplements, their regulation, and the value of certification
·       Recognize potential medication-dietary supplement interactions
·       Demonstrate the ability to locate different sources of information about dietary supplements

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

·       Discuss the importance of knowing about a patient’s dietary supplement usage
·       Identify commonly used dietary supplements, their regulation, and the value of certification
·       Recognize potential medication-dietary supplement interactions
·       Recognize the need for pharmacist counseling when a patient is taking a dietary supplement

Image of a dinner plate filled with various colored medication capsules.

 

Release Date: January 16, 2023

Expiration Date: January 16, 2026

Course Fee

Pharmacists: $7

Pharmacy Technicians: $4

There is no grant funding for this CE activity

ACPE UANs

Pharmacist: 0009-0000-23-001-H05-P

Pharmacy Technician: 0009-0000-23-001-H05-T

Session Codes

Pharmacist:  23YC01-FKE24

Pharmacy Technician:  23YC01-EFK68

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 0009-0000-23-001-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

Jennifer Salvon, RPh
Clinical Pharmacist
Mercy Medical Center

Springfield, MA

Adjunct Faculty Member
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.

Jennifer Salvon does not have any relationships with ineligible companies and therefore has nothing to disclose.

 

ABSTRACT

Consumer consumption of dietary supplements is at an all-time high. Available products number in the tens of thousands, generating millions in annual spending. Increasing interest in overall health and wellness, preventive medicine, and immune function contribute to the rise in usage. It is a common misconception that dietary supplements are safe because they are “natural.”
Ingestion of dietary supplements poses serious health risks including adverse reactions, drug interactions, and toxicity. Adulterated, mislabeled, and contaminated products exist in the marketplace, further increasing consumer risk. Existing federal regulation and oversight for supplements differs from prescription and over-the-counter medications, occurring primarily on a post-marketing basis. Self-reporting by consumers, healthcare professionals, and industry personnel identifies these issues. Patients often omit dietary supplements from medication histories, leaving healthcare professionals unaware that patients are using them. While misinformation abounds on the Internet, many online clinically-backed sources exist.

CONTENT

Content

Introduction

 

Consuming natural substances to produce a desired effect on the body dates back thousands of years to ancient Egypt, Rome, China, and many other cultures. Records from early Mesopotamia include written formulas using many oils still in use today, including cedar, cypress, and licorice. Around 300 B.C., the Greek philosopher Theophrastus described the medicinal benefits of natural substances in his History of Plants. Throughout the centuries, many philosophers, scientists, and physicians continued collecting, combining, and documenting the use of natural products to treat different illnesses.1

 

As the science of medicine developed, so did the science of pharmacology. Isolation of the active ingredients found in herbal substances lead to the development of synthetic compounds with similar properties. The first synthetic medication, chloral hydrate, derived from chloroform and discovered in the 1800s by German chemist Justus von Lieberg, is still in use today.2

 

Fast forward to modern day, and the interest and use of prescription medications, over-the-counter (OTC) products, and dietary supplements are at an all-time high. In 2020, consumers filled 6.3 billion prescriptions in the United States3 (U.S.) and purchased more than 6 billion OTC products.4 The dietary supplement market reached an unprecedented level in 2020 with a global spend of $61.2 billion. Experts predict it will reach $128.64 billion by 2028.5

 

The COVID-19 pandemic, caused by the SARS-CoV-2 acute respiratory coronavirus, significantly impacted our perception and approach to healthcare.6 More and more people use complementary and alternative approaches to healthcare than ever before.7 For example, sales of elderberry supplements more than doubled and zinc products quadrupled shortly after the pandemic's start.8

 

Pharmacists, widely recognized as drug information experts, and pharmacy technicians routinely field consumers' questions about dietary supplements. Many pharmacists lack the necessary knowledge or don't know where to look to answer these questions. Pharmacy schools educate future pharmacists on prescription and OTC medications with courses about nutrition and dietary supplementation, if offered, available as electives. This continuing education activity presents information about dietary supplements through a series of seven common pharmacy situations and lets learners in on seven secrets they can apply to their practices.

 

 

 

Situation: Continuing education is a professional requirement many pharmacists find tedious. Looking through the UCONN online CE library and seeing a new continuing education activity entitled ‘Seven Secrets of Patient Safety with Dietary Supplements,’ a pharmacist remarks to the pharmacy team, "What a waste, no one even takes dietary supplements."

 

Secret #1: Almost 60% of people in the United States used a dietary supplement in the last 30 days.11,12

 

Dietary supplements crowd the aisles in drug stores, supermarkets, warehouse clubs, and even corner convenience stores. The sheer number of products is staggering. The Dietary Supplement Database (DSLD) is an online, searchable database developed by the Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH). The database contains product labeling information on dietary supplements sold in the United States, including both on and off-market products. DSLD currently lists more than 140,000 labels.9

 

In the early 1960s, the National Center for Health Statistics began a program named the National Health and Nutrition Examination Survey (NHANES). NHANES is a continuous program focusing on various health and nutritional measurements and assesses adults' and children's health and nutritional status in the U.S.10 Scientific and technical journals publish the study results.

 

One section of the program assesses dietary supplement use among adults. Results from the 2017-2018 NHANES show that11,12

  • 57.6% of adults 20 years or older used a dietary supplement in the past 30 days
  • Women (63.8%) had a higher utilization than men (50.8%)
  • Use of dietary supplements increased with age, with women 60 years or older reporting the highest usage at 80.2%
  • Use of multiple dietary supplements increased with age
  • Most common dietary supplements used by all age groups include multivitamin-mineral supplements, vitamin D, and omega-3 fatty acids

 

The Council for Responsible Nutrition (CRN) is a trade association for the dietary supplement and functional food industry. Annually, the CRN performs a survey gathering data on consumer use of dietary supplements. The 2019 survey conducted by the CRN underscored dietary supplement usage with the following results13:

  • 77% of US adults take dietary supplements, including 79% of American women and 74% of males
  • Top reasons for taking supplements included:
    • Energy
    • Immune health
    • Filling nutrient gaps
    • Healthy aging
    • Heart health

 

The COVID-19 pandemic significantly impacted our perception and approach to healthcare.6 As of August 5, 2022, SARS-CoV-2 has infected more than 580 million people worldwide.14 Interest in boosting our overall immunity and protecting ourselves from viral infections has dramatically increased as a result.7 Many vitamins and minerals play essential roles in proper immune function.7,15 Sales of supplements associated with boosting immunity increased over the last two years, including vitamins C and D, zinc, omega-3, garlic, ginger, and turmeric.16

 

Table 1. Common Dietary Supplements and Potential Uses7,17,18

 

Dietary Supplement Potential Use
Black Cohosh Menopausal symptoms
Calcium Dyspepsia

Osteoporosis

Premenstrual syndrome

Echinacea Prevention and treatment of the common cold

Promotion of wound healing

Elderberry Prevention of upper respiratory tract infections

Reduction in duration and severity of symptoms of the common cold

Folic acid Folate deficiency

Kidney failure

Neural tube defects

Ginkgo Anxiety

Dementia

Memory improvement

Premenstrual syndrome

Ginger Dysmenorrhea

Nausea and vomiting

Osteoarthritis

Ginseng Cognitive function

Erectile dysfunction

Iron Anemia

Restless leg syndrome

Magnesium Constipation

Dyspepsia

Melatonin Sleep disorders
Multivitamin with minerals General supplementation
Omega-3 fatty acids

 

 

Alzheimer’s disease

Cardiovascular disease

Dementia

Depression

Reduction of triglycerides

Potassium Hypokalemia

Hypertension

Kidney stones

Probiotics

 

 

Atopic dermatitis

Antibiotic-associated diarrhea

Irritable bowel syndrome

St. John’s Wort Anti-depressant

Menopausal symptoms

Turmeric Allergic rhinitis

Osteoarthritis

Pruritis

Valerian Insomnia
Vitamin A Aging skin

Healthy vision

Vitamin B-12 Vitamin B-12 deficiency
Vitamin C Anemia

Antioxidant effects

Prevention of the common cold

Vitamin C deficiency

Vitamin D Osteomalacia

Osteoporosis

Vitamin D deficiency

Vitamin E Alzheimer's disease

Dysmenorrhea

Premenstrual syndrome

Zinc Acne

Depression

Diabetes

Diarrhea

Treatment of common cold

 

 

Eating a healthy diet is essential for good health and nutrition. The Dietary Guidelines for Americans advise professionals, including policymakers, health care providers, and nutrition educators, about what to eat to meet the body’s nutritional needs. It emphasizes eating a diet rich in nutrient-dense foods, such as fruits and vegetables, as the best way to meet the body’s nutritional needs. The guideline identifies specific populations in which dietary supplementation may be necessary, such as women who are pregnant or lactating and adults older than 50.19

 

In addition to these defined special populations, many pharmacy patients may find it necessary to take specific vitamins or minerals due to medication-induced nutrient deficiencies.

 

Table 2. Examples of Nutrient Depletion Induced by Medications7,17

 

Nutrient Medication(s) Mechanism
Vitamin D Anticonvulsants

 

Increase hepatic metabolism
Bile acid sequestrants

 

Decrease absorption
Orlistat

 

Decrease absorption
Magnesium

 

Estrogens

 

Decrease serum levels by increasing uptake into tissues
Loop diuretics

 

Increase excretion
Proton pump inhibitors

 

Decrease absorption
Vitamin B12

 

 

Biguanides

 

Decrease absorption
Proton pump inhibitors

 

Decrease absorption
H-2 blockers

 

Decrease absorption
Potassium Loop diuretics

 

Increase excretion
Thiazide diuretics

 

Increase excretion
Corticosteroids

 

Increase excretion

 

The pharmacist's dismissal of dietary supplement education is understandable. No one wants to waste precious time on irrelevant continuing education. However, the facts presented here illustrate the need for pharmacist education on dietary supplements.

Pause and ponder: A patient presents information about taking lemon and baking soda tea to prevent COVID-19 infection and asks you if it really works. How would you approach this conversation?

 

Situation: Sunday afternoons sometimes (but not often!) present the opportunity to catch up on administrative activities. While completing an inventory reconciliation of the vitamin section, a technician inquires, "Why does the FDA approve so many different products?" Looking up distractedly from the CII safe count, the pharmacist pauses, then replies in a weary voice, "You know, I’m not sure, probably just to make it more confusing for us."

 

Secret #2: Regulatory oversight of dietary supplements differs from prescription and OTC medications.

 

What is a Dietary Supplement?

 

On the most basic level, a dietary supplement is a substance consumed to add nutrients to a diet or to lower the risk of certain health problems. The use of natural substances has been around for millennia, but it is only within the last five decades that countries worldwide have formalized language and regulations around dietary supplements. Terminology, quality control, and safety assessment differ depending on the country and governing legislative body.20

 

In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA), an amendment to the Food, Drug, and Cosmetic Act. DSHEA defines the term dietary supplement as a product intended for ingestion and containing an ingredient that supplements the diet. Dietary supplement labeling must include the term ‘dietary supplement’ or an equivalent term such as ‘herbal supplement’ or ‘magnesium supplement.’ DSHEA also stipulates that a dietary supplement must be free of contamination, adulteration, and properly labeled.21 We will discuss dietary supplement product integrity and labeling later in this activity.

 

According to DSHEA, dietary supplements include vitamins, minerals, herbs, other botanicals, amino acids, and live microbials (probiotics). Dietary supplements are available in many different formulations including tablets, capsules, soft gels, gel caps, powders, and liquids.21

 

DSHEA defined the term ‘new dietary ingredient’ as an ingredient that meets the above criteria and was unavailable in the U.S. before October 15, 1994. If manufacturers want to market a product containing a new dietary ingredient, they must notify the U.S. Food and Drug Administration (FDA) before marketing. The FDA then reviews the product for safety but not effectiveness.21

 

Regulation of Dietary Supplements

 

The FDA and the Federal Trade Commission (FTC) share regulation and oversight of dietary supplements. The FDA is responsible for the information provided on dietary supplement product labeling, including the package labeling, product inserts, and information available at the point of sale. The FTC monitors dietary supplement advertising, ensuring advertisements are truthful, substantiated, and not misleading. Both agencies have the authority to address violations and work together to ensure their efforts are consistent with one another.22

 

The FDA does not have the authority to approve dietary supplement products before manufacturers market, distribute, and sell them to consumers. Manufacturers are responsible for ensuring the products they produce and distribute meet all quality standards defined by federal law. Quality standards include22

  • Ensuring the safety of the dietary ingredients used in the product
  • Following current Good Manufacturing Practices (cGMP)
  • Meeting all product labeling requirements
  • Ensuring substantiation of all claims made about the product
  • Ensuring products are free of adulteration or misbranding

 

cGMP, defined and regularly updated by the FDA, establish the minimum requirements for manufacturing, packaging, and labeling products to ensure product quality. cGMP includes guidance on obtaining quality ingredients, operating procedures, and quality controls.23 Failure to follow cGMP results in possible product contamination.

 

While the FDA may not have the authority to approve dietary supplements before the product marketing and distribution, it can monitor products via post-marketing surveillance and auditing. The FDA routinely performs manufacturer inspections, monitors the marketplace, and investigates adverse event reports. Follow-up includes working with the manufacturer to bring the product into compliance, issuing warning letters, and recalling products.21

 

Reporting Issues with Dietary Supplements

 

Post-marketing surveillance is essential for documenting and monitoring any issues with dietary supplements. Information about severe reactions and product quality are important issues to report. The FDA Safety Reporting Portal is an online tool used to report safety issues on several categories of products, including pet or livestock foods, tobacco products, animal drugs, and dietary supplements.24

 

The website address for the portal is https://safetyreporting.hhs.gov. Anyone can use the portal to report issues, including consumers, healthcare professionals, manufacturers, and researchers. Generating a new report starts on the home screen. The reporter chooses to file the report as a guest or by creating an account. Creating an account streamlines data entry and allows the reporting individual to save a draft of the report, follow up on a report, and view previous submissions.24

 

Generation of an Individual Case Safety Report ID (ICSR) occurs after report submission. The ICSR allows the reporter to identify the report for future reference including submission of a follow-up report with additional information. FDA reviewers assess the seriousness of the reported issue and assign follow-up. Submission of this information allows the FDA to identify potentially dangerous products and potentially remove them from the market.24

 

Traditionally, insurance companies limit coverage to prescription medications. Recent trends show an expansion of coverage to include some dietary supplements. Insurance coverage of dietary supplements blurs the regulatory differences between prescription medications and dietary supplements. Understanding the differences in oversight is beneficial and allows the pharmacy staff to counsel patients effectively.

Situation: While running back to the pharmacy after a much-needed bathroom break, a pharmacist stops when approached by a customer asking for advice about an iron supplement. Overhearing the inquiry, another customer comments, "You should buy that online; it’s cheaper, and the quality is just as good." The pharmacist nods assent, turns, and hurries back to the pharmacy amid the erupting sounds of chaos behind the counter.

 

Secret #3: Product integrity fluctuates between manufacturers and sources of dietary supplements.

 

Integrity of Dietary Supplements

 

The lack of government oversight opens the door for substandard products to flood the market. Poor ingredient quality, heavy metal or microbial contamination, adulteration, and mislabeling occur regularly. In the current economy, with rising prices, consumers are turning to less expensive options, and cheaper is not necessarily better, especially with dietary supplements.

 

In the literature, many studies exist that analyze dietary supplement product integrity. A study published in 2021 tested multiple bottles of 29 herbal supplements for consistency of ingredient activity and the presence of metal and fungal contaminants. The analysis showed inconsistent ingredient activity not only between bottles of the same product manufactured by the same company, but also between bottles manufactured by different companies. Assaying for metal contamination found zinc in 88% of bottles and nickel in 40% of bottles. In 37 of 58 bottles tested, fungal contamination was present, with 21 bottles having multiple strains.25

 

Another study analyzed 41 dietary supplements for the presence of cadmium, lead, and mercury. Results revealed that 68.3% of samples contained contamination with cadmium and lead, and 29.3% with mercury.26 One research team evaluated 121 dietary supplements along with 49 prescription drugs for levels of toxic element contamination. A small percentage of the dietary supplement products exceeded safety levels for mercury, lead, cadmium, arsenic, or aluminum. None of the prescription products exceeded these safety levels.27

 

Adulterated products contain substances not listed on the product labeling, substitution of inferior materials for active ingredients, or may contain a lesser amount of ingredients. Weight loss, sports enhancement, and sexual function supplements commonly contain banned substances.28

 

The FDA created and currently maintains the Health Fraud Product Database to increase awareness. This database contains information about products cited in warning letters, advisory letters, recalls, public notifications, and press announcements for various issues. Issues cited include products claiming to cure, treat, or prevent a disease and products containing undeclared ingredients or a new dietary ingredient.29 The database is available in the consumer section of the FDA website at https://www.fda.gov/consumers/health-fraud-scams/health-fraud-product-database.

 

On January 2, 2022, the FDA issued a warning letter to the manufacturers of Nasitrol, a nasal spray based on the ingredient iota carrageenan. A review of the product’s website found claims that the product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Federal regulations define products making these claims as drugs and subject to review by the FDA before approval and subsequent marketing. As discussed earlier, this is in direct violation of federal regulations.30

 

In another example, on July 15, 2022, the FDA issued a public notice advising consumers to refrain from purchasing Adam’s Secret Extra Strength Amazing Black, a product promoted for sexual enhancement. Laboratory analysis found that the product contained tadalafil, a prescription medication used for erectile dysfunction.31 Due to the potential for severe side effects such as hypotension, tadalafil administration requires medical supervision by a physician.32

 

A study published in 2018 analyzed FDA warning letters issued from 2007 through 2016, using data from the Health Fraud Product Database. During this time frame, the FDA found 776 adulterated dietary supplements from 146 different companies. A total of 157 products contained more than one unapproved ingredient. Products marketed for sexual enhancement accounted for 45.5% of letters, weight loss 40.9%, and muscle building 11.9%. Unapproved ingredients included sildenafil in sexual enhancement, sibutramine in weight loss, and synthetic steroids or steroid-like ingredients in muscle building supplements.33

 

One way for consumers to know they are purchasing a valid product is by looking for a certified product. The certification process involves an independent, third-party company testing a company’s products, offering quality assurance for dietary supplements. Parameters tested include34

  • Product contains the ingredients stated on the label
  • Presence of harmful ingredients
  • Presence of contamination
  • Proper dissolution
  • cGMP followed during manufacture

 

Three independent, private, third-party certifying organizations operate in the United States: the US Pharmacopeial Convention (USP), NSF International, and Consumerlabs.com. All three companies offer product certification programs for a fee. Each company allows products passing certification to display a seal on product labeling. Table 3 summarizes information about each organization.

 

Table 3. Dietary Supplement Certification Organizations

 

Certifying Organization US Pharmacopeial Convention NSF International Consumerlab.com
Website www.usp.org

www.qualitysupplements.org

 

www.nsf.org www.consumerlab.com
Services offered Dietary supplement verification program including GMP facility audits, product QCM process evaluation, and product testing Product and ingredient certification

GMP Certification

Certified for Sport

Product reviews

Quality Certification Program

Information available on the website Program information, list of verified products, and educational resources Program information, product search engine, and educational resources Product reviews, health condition information
GMP = Good Manufacturing Practice

Source: adapted from reference 33

 

Online product ordering is a convenient shopping option rapidly gaining popularity in recent years, especially during the pandemic. While tempting to order the least expensive product, investigating the source and quality of dietary supplements available online is essential. Proactive training of the entire pharmacy team aids in providing patients with accurate information.

Situation: A weary technician finally finishes ringing out the last customer after two hours straight at the register. A sigh of relief quickly turns into a disgruntled groan as another customer approaches. With a bottle labeled ‘Menopausal Support’ in hand, the customer points to the bottle label and asks, "What does ‘proprietary blend’ mean?" The technician glances over her shoulder, sees the pharmacist engaged in an intense phone conversation, and replies to the customer, "The bottle label clearly lists the ingredients."

 

Secret #4: Federal regulations define required dietary supplement label information. Unfortunately, ambiguity still exists, making it challenging to identify exactly what the product contains.

 

Federal regulations define the information required on dietary supplement product labeling in detailed, specific terms. Product labeling must include35

  • Product name
  • The term ‘dietary supplement’ or similar term (i.e., herbal supplement)
  • Name and location of the manufacturer, along with a domestic address and phone number for reporting serious adverse events
  • Nutrition labeling in the form of a “Supplement Facts” panel with the following information (see Figure 1):
    • Serving size
    • Number of servings per container
    • Listing of each dietary ingredient in the product
    • Amount of dietary ingredient per serving (Exception: ingredients in a proprietary blend)
    • Amount per serving listed as a quantitative amount by weight, as a percentage of the Daily Value, or as both
  • A list of other ingredients not declared on the Supplement Facts label (usually excipients such as preservatives or dyes)
  • Net quantity of contentsImage of a Supplemental Facts label found on dietary products.

Figure 1. Supplemental Facts Label (sourced from reference 36)

One area of ambiguity in dietary supplement product labeling is the listing of a proprietary blend. The term proprietary blend refers to a blend of dietary ingredients unique to a manufacturer and product. Federal labeling regulations allow the listing of proprietary blends on dietary supplement products, however, only the total weight of the blend is required, not the weight of individual ingredients.35 There is no way for the healthcare professional or consumer to know exactly how much of a particular ingredient the proprietary blend contains.

 

Consumerlabs.com cautions consumers about products containing proprietary blends or formulas. In many instances, the blend's name sounds like a desired, expensive ingredient that is only a small part of the formula. Marketing of products containing proprietary blends may mislead the consumer with claims meant to impress the consumer and drive sales of the product.37

 

FDA regulations do allow structure/function claims on dietary supplement labeling. Structure/function claims describe how a nutrient or dietary ingredient may affect or act to maintain the structure or function of the body.35 Examples of structure/function claims include35

  • Calcium builds strong bones
  • Antioxidants maintain cell integrity
  • Fiber maintains bowel integrity

 

If a dietary supplement label contains a structure/function claim it must also contain the following statement: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."35

 

The example in this situation involved a product marketed for menopausal support. Menopausal symptoms affect more than 1 million women in the US annually and include symptoms such as hot flashes and sleep disturbances.38 A search of the DSLD using the term ‘menopausal support’ and filtering for on-market products containing the ingredient ‘proprietary blend’ returned almost 3,000 products.9 This abundance of products illustrates the ambiguity that exists on dietary supplement labeling.

 

Pharmacy technicians are often the first line of contact at the pharmacy. Training and development of pharmacy technicians on the facts surrounding dietary supplements empower technicians, allowing them to answer factual questions and provide effective patient education.

 

Situation: The pharmacy phone constantly rings throughout the day, and today is no exception. The new COVID vaccine is out, and everyone wants to know if the pharmacy has it in stock. Answering yet another call, the technician is surprised when a patient asks to talk to the pharmacist, complaining about dizziness. The pharmacist checks the patient’s profile, finding no underlying causative medication. Further questioning the patient, the pharmacist uncovers the recent addition of melatonin at night for sleep.

 

Secret #5: Like prescription medications, dietary supplements have pharmacologic and physiologic effects on the body, potentially resulting in health risks and side effects.

 

Consumers perceive dietary supplements as safe due to their source from natural substances. While generally well tolerated, dietary supplements affect the body like prescription medications, capable of producing an undesired effect. Lack of regulatory oversight allows products to reach consumers without adequate safety evaluation.

 

Information describing adverse effects of dietary supplements is anecdotal, derived from case reports and reports submitted through the FDA Safety Reporting Portal. Most dietary supplements have not been studied in pregnant or lactating women or children.

 

A study published in 2015 evaluated ten years of emergency room data to assess the number of annual visits resulting from dietary supplement adverse events. The authors calculated an average of more than 23,000 emergency room visits stemmed from the consumption of dietary supplements, resulting in more than 2,000 hospitalizations annually.39

 

Events in older adults accounted for the highest percentage of visits, with 40% of visits due to difficulty swallowing. Incidence in young adults aged 20 to 34 was significant at 28% and primarily involved weight loss and energy products. Side effects reported include heart palpitations, chest pain, and tachycardia.39

 

Unsupervised child ingestions accounted for 21% of visits. Unlike prescription medications, regulations do not require child-resistant packaging for dietary supplements, except for iron-containing products.39 The authors note the numbers evaluated in the study are likely underreported as patients do not always include dietary supplements with the current medication list.39

 

Table 4. Adverse Effects of Common Dietary Supplements7,17

 

Supplement Adverse Effects
Black Cohosh

 

Breast tenderness, diarrhea, gastrointestinal upset, nausea/vomiting
Calcium

 

Burping, constipation, gastrointestinal upset
Echinacea

 

Diarrhea, constipation, gastrointestinal upset/pain, heartburn, nausea/vomiting, skin rashes
Ginseng Gastrointestinal side effects, headache, sleep difficulty
Ginger

 

Burping, diarrhea, heartburn
Iron

 

Abdominal pain, constipation, diarrhea, nausea/vomiting
Magnesium

 

Diarrhea, gastrointestinal irritation, nausea/vomiting
Melatonin

 

Dizziness, drowsiness, headache
Omega-3 fatty acids Bad breath, headache, heartburn, nausea, diarrhea, unpleasant taste
Potassium

 

Abdominal pain, burping, diarrhea, nausea/vomiting
St. John’s Wort

 

Diarrhea, dizziness, dry mouth, fatigue, headache, insomnia
Turmeric

 

Constipation, dyspepsia, gastrointestinal reflux, nausea/vomiting
Vitamin C

 

Abdominal cramping, heartburn, kidney stones (if history of kidney stones)
Zinc

 

Abdominal cramping, diarrhea, metallic taste, nausea/vomiting

 

 

Patients often fail to report usage of dietary supplements and most pharmacy software lacks the ability to note dietary supplement usage in the patient profile. In this situation, the pharmacist took the extra time to further question the patient about dietary supplement usage and successfully identified the causative agent.

 

Pause and Ponder: In what ways could you incorporate activities into the daily workflow to increase awareness of patients’ use of dietary supplements?

 

Situation: Today, the workload in the pharmacy is lighter than usual. With a grateful sigh, the pharmacist sinks onto a stool reaching for a quick snack. Then the phone rings… The caller is a triage nurse from the local hospital to verify a patient’s medication profile. Pulling up the profile, the pharmacist verifies the list of medications, including digoxin. The triage nurse confirms atrial fibrillation as the cause for admission, adding that the patient recently started taking St. John’s Wort for depression.

 

Secret #6: Some dietary supplements affect the CYP450 liver enzymes, potentially altering the pharmacokinetics of medications, leading to treatment failure and/or toxicity.

 

Dietary supplement-drug interactions

 

Drug-drug interactions result in altered absorption, metabolism, or excretion. Drug-dietary supplement interactions occur through the same pathways as those used by FDA-approved drugs. The cytochrome P450 (CYP P450) enzymes in the liver are responsible for the metabolism of most medications.41,42 The ability of a drug to either induce or inhibit these enzymes is a significant factor in drug-drug interactions. The natural ingredients found in dietary supplements are capable of inhibition or induction, also having the potential to interact with medications.

 

St. John’s Wort, an herbal commonly taken for the relief of mild to moderate depression, induces the activity of CYP3A4.43,44 This induction increases the clearance of medications metabolized by CYP3A4. Examples of medications cleared by CYP3A4 include alprazolam, atorvastatin, cyclosporine, oral contraceptives, oxycodone, and warfarin.43,44 Patients need counseling about potential drug interactions with St. John’s Wort.

 

Limited clinical studies evaluating the impact of drug-dietary supplement interactions exist. Many interactions are theoretical, based on limited clinical evidence, animal research, and case reports.

 

Table 5. Examples of Potential Drug-Dietary Supplement Interactions7,17

 

Dietary Supplement Medication Interaction
Calcium

 

 

Quinolone and tetracycline antibiotics Decreased antibiotic efficacy

Take antibiotic 2 hours before or 4-6 hours after calcium

Dolutegravir

Elvitegravir

Reduced serum levels

Take medication 2 hours before or 2 hours after calcium

Ginseng Diabetes medications Increase risk of hypoglycemia
Immunosuppressants Decreased effectiveness of immunosuppressant
Ginkgo

 

Anticoagulants Increased risk of bleeding
Iron

 

Quinolone and tetracycline antibiotics Decreased levels of antibiotics due to decreased absorption

Take antibiotics 2 hours before or 4-6 hours after iron

Magnesium

 

Bisphosphonates Decreased absorption

 

Levodopa/carbidopa Decreased bioavailability of levodopa/carbidopa
Niacin

 

 

 

Statins Increased risk of myopathy or rhabdomyolysis
Thyroid hormones Antagonize the effects of thyroid hormone replacement
Antihypertensive medications Increased risk of hypotension due to niacin’s vasodilating effects
St. John’s Wort Alprazolam Decreased effects of alprazolam
Oral Contraceptives Decreased efficacy

Counsel patients to use other forms of contraception

Digoxin Decreased levels of digoxin
Omeprazole Decreased effects of omeprazole
Valerian CNS depressant drugs Additive sedative effects
Vitamin B6

 

Phenytoin Decrease levels and clinical effects of phenytoin
Vitamin D

 

Atorvastatin Decreased absorption of atorvastatin
Vitamin E

 

Anticoagulants Increased risk of bleeding
Zinc

 

Quinolone antibiotics Decreased levels and effects of antibiotics

Take antibiotic 2 hours prior or 4-6 hours after zinc

 

Pharmacy training emphasizes the importance of drug-drug interactions. It is important to remember that any substance introduced to the body, including food, beverages, and dietary supplements, has the potential to interact with medications.

Situation: It is another busy day in the pharmacy; prescriptions cover the bench, the phone rings constantly, and a pickup queue extends around the corner. A technician nervously approaches the pharmacist about a patient at the counter with a question regarding a supplement. The pharmacist throws down the spatula, muttering angrily about lacking the knowledge and training to answer the question properly. Sighing, he says, "I’ll just Google it."

 

Secret #7: Many websites provide clinically backed information on dietary supplements (and Google is not one of them!).

 

The vast amount of health information available via the Internet with just a few clicks of the keyboard is both a blessing and a curse. Google is now a verb, and a simple search returns millions of results in seconds. While this may seem like a blessing, the curse lies in the searcher's inability to recognize valid, accurate sources of information. In many searches, ads appear as search results adding to the confusion.

 

In addition to the Internet, consumers turn to social media for health information. Social media use increased from 27% in 2009 to 86% in 2019.45 Information posted on social media provides communication about healthcare issues, potentially resulting in improved health care.45 Unfortunately, inaccurate information abounds on the Internet and social media platforms, leading to consumer misinformation.47-49

 

The FDA recently launched a new dietary supplement education initiative geared towards consumers, healthcare professionals, and teachers. The program, Supplement Your Knowledge, presents information about dietary supplements through a series of three videos. Educational materials, including fact sheets and infographics, are available in English and Spanish.50

 

Many government agencies provide free access to information about dietary supplements and their side effects, toxicity, and drug interactions. There are also several paid subscription resources available. Table 6 lists many of the available information options.

 

Table 6. Sources of Information about Dietary Supplements

 

Resource Website Information
Dietary Supplement Education Program https://www.fda.gov/food/healthcare-professionals/dietary-supplement-continuing-medical-education-program

 

  • Continuing medical education program
  • Collaboration between FDA and AMA
  • Series of 3 videos about dietary supplements
  • Also contains links to educational materials and other websites with information about dietary supplements
Dietary Supplement Label Database https://dsld.od.nih.gov

 

  • Current and historical label information on dietary supplement products marketed in the United States
  • Useful to determine the contents of dietary supplement products
Food and Drug Administration https://www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-supplements

 

  • Information for consumers on using dietary supplements
  • Links to educational resources and materials, consumer updates, alerts, recalls and other information
Google Scholar

 

https://scholar.google.com/

 

  • Source of information from many avenues including journals, books, and conference proceedings
Lexi-Comp

Natural Products Database

Available via mobile app
  • Requires a paid subscription
  • Alphabetical, searchable natural product database
Memorial Sloane Kettering Cancer Center https://www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine/herbs

 

  • Information on herbs, botanicals, and other products for both consumers and healthcare professionals
  • Dietary supplement monographs
  • IOS app: About Herbs
  • Part of an online integrative medicine resource center
National Cancer Institute Office of Cancer Complementary and Alternative Medicine https://cam.cancer.gov

 

  • Information for consumers and healthcare professionals about CAM as it relates to cancer therapy
  • Information on current NCI CAM research
National Center for Complementary and Integrative Health https://www.nccih.nih.gov

 

  • Information for both consumers and healthcare professionals about complementary health products and practices
National Library of Medicine - Medline Plus https://medlineplus.gov/druginfo/herb_All.html

 

  • Online health information about drugs, herbs, and supplements for consumers
  • Information sourced from the National Center for Complementary and Integrative Health and Natural Medicines Comprehensive Database
Natural Medicines Comprehensive Database https://naturalmedicines.therapeuticresearch.com

 

  • Requires a paid subscription
  • Professional monographs including information about effectiveness, safety, adverse effects, and interactions
  • Information on specific commercial products
  • Interaction checker
  • Patient handouts in English, Spanish and French
Office of Dietary Supplements https://ods.od.nih.gov
  • Information for both consumers and healthcare professionals
  • General supplement information
  • Information on supplements for specific purposes
  • Fact sheets on dietary supplements and their ingredients
PubMed https://pubmed.ncbi.nlm.nih.gov

 

  • Search engine for the National Library of Medicine
  • Source of information from journals
United States Department of Agriculture https://www.nutrition.gov/topics/dietary-supplements

 

  • Links to general information and resources on dietary supplements

 

 

Performing an Internet search via Google may seem like the quickest and easiest way to find the answer to an inquiry. Engaging with the patient, gaining additional information, and knowing where to look ultimately saves time. It is not necessary for one to be an expert in all dietary supplements, just to self-educate one supplement at a time.

 

Pause and Ponder: A patient shares the unfortunate news about a recent cancer diagnosis. He asks you about the use of herbs in the treatment of cancer. What advice would you give? 

Conclusion

You may have noticed a recurring theme throughout this activity. Education. Dietary supplement education is essential to patient safety given the current usage patterns and accessibility of the retail pharmacy team. Education needs to include the entire pharmacy team. Technicians are often the first point of contact at the pharmacy, commonly fielding patient questions. Knowing when to answer questions and when to involve the pharmacist is a necessary skill. Understanding the differences in oversight, the physiological effects of dietary supplement consumption, and the potential for drug interactions allows effective management and counseling of patients. It is important for healthcare providers to solicit information regarding patient consumption of dietary supplements.

 

 

Sidebar: Tips for Counseling Patients about Dietary Supplements

 

Carefully inspect the product to ensure intact product labeling

Ensure the safety seal is intact

Check for an expiration date or best used by date

Check for customer service or return information before ordering

Buy direct from a reputable company; many reputable companies sell through Amazon, avoid 3rd party resellers

Check for the presence of a third-party certification seal

Before purchase, check the company’s website for information on quality standards

Pay attention to the appearance and smell of the product upon opening

Child-resistant packaging is not a requirement for dietary supplements; advise on proper storage of product

Reinforce the importance of including dietary supplements on a current medication list

 

 

 

 

Pharmacist Post Test (for viewing only)

Seven Secrets for Patient Safety with Dietary Supplements

Pharmacist post-test

After completing this continuing education activity, pharmacists will be able to:

1. Discuss the importance of knowing about a patient’s dietary supplement usage (K)
2. Identify commonly used dietary supplements, their regulation, and the value of certification (K, or A?)
3. Recognize potential medication-dietary supplement interactions (K)
4. Demonstrate the ability to locate different sources of information about dietary supplements (A)

1. According to The National Health and Nutrition Examination Survey more than what percentage of adults have used a dietary supplement in the last 30 days?

A. 45%
B. 50%
C. 55%

2. Which of the following is a commonly used dietary supplement?

A. Boswellia
B. Turmeric
C. Quercetin

3. Which government agencies regulate dietary supplements?

A. USDA, FDA
B. FTC, DEA
C. FTC, FDA

4. Patient MW fills a new prescription for bumetanide. Which potential nutrient depletion may occur?

A. Magnesium
B. Vitamin D
C. Vitamin B12

5. While completing an inventory reconciliation of the vitamin section, a technician inquires, ‘Why does the FDA approve so many different products?’ Which of the following is the most appropriate answer?

A. ‘The FDA does not have the authority to approve dietary supplements, the FTC approves dietary supplements, including vitamins.’
B. ‘The FDA does not have the authority to approve dietary supplements before they are marketed, allowing manufacturers to flood the market with products.’
C. ‘You know, I’m not sure, probably just to make it more confusing for us.’

6. Which of the following companies offer independent third-party dietary supplement certification services?

A. Consumer Reports
B. NSF International
C. Certified Naturally Grown

7. Patient ED is a 58-year-old male new to your pharmacy. He provides the pharmacy team with a list of his current medications including:
• Warfarin 3 mg PO QD
• Atorvastatin 10 mg PO QD
• Donepezil 10 mg PO QHS
• Metformin 1,000 mg PO BID
Use of which of the following supplements would be cause for concern in this patient?

A. Ginkgo
B. Omega-3 fatty acids
C. Niacin

8. A patient calls with questions about a supplement recommended by a friend. The name of the supplement is Mind and Memory Essentials, and the patient does not know the product ingredients. Where would you go to find this information?

A. Dietary Supplement Label Database
B. Office of Dietary Supplements
C. United States Department of Agriculture

9. A patient asks you about the potential side effects of taking turmeric. Where would you go to find this information?

A. Google
B. PubMed
C. Office of Dietary Supplements

10. You are verifying a new birth control prescription for a patient, recalling that the patient strongly believes in alternative medicine and dietary supplementation. Thankfully her profile contains a list of dietary supplements. You see St. John’s Wort listed and suspect a drug-supplement interaction. Where would you go to find more information?

A. Natural Medicines Database
B. Google Scholar
C. National Library of Medicine

11. One of your regular patients stops by the counter to ask your opinion on a dietary supplement product purchased on the Internet. What should you assess when looking over the product?

A. Product labeling, color of bottle, structure/function disclaimer, certification
B. Certification, expiration date, product labeling, intact seal
C. Expiration date, product price, certification, product labeling

12. Pharmacy patient ML approaches the pharmacy counter to purchase several bottles of oral glucose tablets. When questioned, the patient reveals the recent occurrence of several hypoglycemic episodes. The patient confirms compliance with taking their prescription for metformin 1 gm PO BID. ML reports no changes in other prescriptions or dietary habits but does state they started taking a dietary supplement a few days ago but cannot recall the name. Which product would you suspect based on the information provided?

A. Vitamin E
B. Valerian
C. Ginseng

Pharmacy Technician Post Test (for viewing only)

Pharmacy Technician

After completing this continuing education activity, pharmacy technicians will be able to:

1. Discuss the importance of knowing about a patient’s dietary supplement usage (K)
2. Identify commonly used dietary supplements (A)
3. Define dietary supplement oversight and different levels of quality (K)
4. Recognize the need for pharmacist counseling when a patient is taking a dietary supplement (K)

1. Why is it important to ask about a patient’s usage of dietary supplements?

A. It is not important to ask about dietary supplement usage.
B. To identify which dietary supplements the pharmacy should feature on the front counter.
C. Dietary supplements potentially interact with prescription medications.

2. Which of the following is a commonly used dietary supplement?

A. Boswellia
B. Turmeric
C. Quercetin

3. Which government agencies regulate dietary supplements?

A. USDA, FDA
B. FTC, DEA
C. FTC, FDA

4. A patient approaches the counter with 2 different magnesium products and asks your opinion on which to purchase. Which of the following is an appropriate answer?

A. Let’s look at these a little closer.
B. Neither, it’s better to buy supplements online.
C. The one that’s on sale.

5. Reasons for dietary supplementation include which of the following?

A. To supplement a poor diet.
B. Promotion of optimal immune health
C. No one needs to take dietary supplements.

6. Which of the following companies offer independent third-party dietary supplement certification services?

A. Consumer Reports
B. NSF International
C. Certified Naturally Grown

7. You are entering a new patient into the pharmacy system. In addition to asking about allergies, demographics, and current medications, what else should you ask?

A. How many hours of sleep do you average a night?
B. Do you take any over-the-counter medications or dietary supplements?
C. How many children do you have and how old are they?

8. You are finally heading out for a lunch break and walk past a pharmacy patient in the aisle looking at 2 different brands of St. John’s Wort. What should you do?

A. Keep going, you already punched out and only have 30 min to eat your lunch.
B. Stop and offer to accompany them to the pharmacy to talk to the pharmacist.
C. Stop and help them make a choice between the products.

9. A patient picks up a medication and purchases a bottle of magnesium at the same time. What should you do?

A. Advise the patient that there may be an interaction between the prescription and the magnesium.
B. Ring out the patient as usual.
C. Touch base with the pharmacist to make sure there are no potential interactions between the products.

10. Where should adverse reactions or issues with dietary supplements be reported?

A. FDA Safety Reporting Portal
B. Federal Trade Commission
C. Office of Dietary Supplements

References

Full List of References

References

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    2. Jones AW. Early drug discovery and the rise of pharmaceutical chemistry. Drug Test Anal. 2011;3(6):337-344. doi:10.1002/dta.301

    3. Aitken M, Kleinrock M. The Use of Medicines in the U.S. Spending and Usage Trends and Outlook to 2025. IQVIA Institute for Human Data Science. May 2021. Accessed August 5, 2022. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-use-of-medicines-in-the-us/iqi-the-use-of-medicines-in-the-us-05-21-forweb.pdf

    4. OTC Sales Statistics. Consumer Healthcare Products Association. Accessed June 22, 2022. https://www.chpa.org/about-consumer-healthcare/research-data/otc-sales-statistics

    5. Dietary Supplements Market Size, Share & COVID-19 Impact Analysis, By Type (Vitamins, Minerals, Enzymes, Fatty Acids, Proteins, and Others), Form (Tablets, Capsules, Liquids, and Powders), and Regional Forecasts, 2021-2028. Fortune Business Insights. Accessed June 22, 2022. https://www.fortunebusinessinsights.com/dietary-supplements-market-102082

    6. Moynihan R, Sanders S, Michaleff ZA, et al. Impact of COVID-19 pandemic on utilisation of healthcare services: a systematic review. BMJ Open. 2021;11(3):e045343. Published 2021 Mar 16. doi:10.1136/bmjopen-2020-045343

    7. Dietary Supplements in the Time of COVID-19. Fact Sheet for Health Professionals. National Institutes of Health, Office of Dietary Supplements. Accessed July 20, 2022. https://ods.od.nih.gov/factsheets/COVID19-HealthProfessional/.

    8. Adams KK, Baker WL, Sobieraj DM. Myth Busters: Dietary Supplements and COVID-19. Ann Pharmacother. 2020;54(8):820-826. doi:10.1177/1060028020928052

    9. US Department of Health and Human Services, National Institutes of Health, Office of Dietary Supplements. Dietary Supplement Label Database (DSLD). Accessed August 5, 2022. https://ods.od.nih.gov/Research/Dietary_Supplement_Label_Database.aspx

    10. About the National Health and Nutrition Examination Survey. National Center for Health Statistics. Accessed July 20, 2022. https://www.cdc.gov/nchs/nhanes/about_nhanes.htm

    11. Mishra S, Stierman B, Gahche JJ, Potischman N. Dietary supplement use among adults: United States, 2017–2018. NCHS Data Brief, no 399. Hyattsville, MD: National Center for Health Statistics. 2021. DOI: https://doi.org/10.15620/cdc:101131external icon

    12. Gahche JJ, Bailey RL, Potischman N, et al. Federal Monitoring of Dietary Supplement Use in the Resident, Civilian, Noninstitutionalized US Population, National Health and Nutrition Examination Survey. J Nutr. 2018;148(Suppl 2):1436S-1444S. doi:10.1093/jn/nxy093

    13. 2019 CRN Consumer Survey on Dietary Supplements. Council for Responsible Nutrition. https://www.crnusa.org/2019survey. Published September 30, 2019. Accessed June 1, 2022.

    14. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/. Accessed August 5, 2022.

    15. Calder PC, Carr AC, Gombart AF, Eggersdorfer M. Optimal Nutritional Status for a Well-Functioning Immune System Is an Important Factor to Protect against Viral Infections. Nutrients. 2020;12(4):1181. Published 2020 Apr 23. doi:10.3390/nu12041181

    16. Hamulka J, Jeruszka-Bielak M, Górnicka M, Drywień ME, Zielinska-Pukos MA. Dietary Supplements during COVID-19 Outbreak. Results of Google Trends Analysis Supported by PLifeCOVID-19 Online Studies. Nutrients. 2020;13(1):54. Published 2020 Dec 27. doi:10.3390/nu13010054

    17. Natural Medicines. Therapeutic Research Center. Accessed August 2, 2022. https://naturalmedicines.therapeuticresearch.com.

    18. Office of Dietary Supplements Dietary Supplement Fact Sheets. Accessed August 2, 2022. https://ods.od.nih.gov/factsheets/list-all/

    19. U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th Edition. December 2020. Available at DietaryGuidelines.gov. https://www.dietaryguidelines.gov/sites/default/files/2021-03/Dietary_Guidelines_for_Americans-2020-2025.pdf

    20. Thakkar S, Anklam E, Xu A, et al. Regulatory landscape of dietary supplements and herbal medicines from a global perspective. Regul Toxicol Pharmacol. 2020;114:104647. doi:10.1016/j.yrtph.2020.104647
    21. FDA 101: Dietary supplements. United States Food and Drug Administration. Accessed July 31, 2022. https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements.
    22. Questions and Answers on Dietary Supplements. U.S. Food and Drug Administration. Accessed July 31, 2022. https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements.

    23. Facts About the Current Good Manufacturing Practices (cGMPs). U.S. Food and Drug Administration. Accessed July 22, 2022.
    https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps

    24. Safety Reporting Portal. Food and Drug Administration. Accessed August 10, 2022. https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=da6dc761-7962-4743-82cd-2e62985492d0

    25. Veatch-Blohm ME, Chicas I, Margolis K, Vanderminden R, Gochie M, Lila K. Screening for consistency and contamination within and between bottles of 29 herbal supplements. PLoS One. 2021;16(11):e0260463. Published 2021 Nov 23. doi:10.1371/journal.pone.0260463

    26. Ćwieląg-Drabek M, Piekut A, Szymala I, et al. Health risks from consumption of medicinal plant dietary supplements. Food Sci Nutr. 2020;8(7):3535-3544. Published 2020 May 19. doi:10.1002/fsn3.1636

    27. Genuis SJ, Schwalfenberg G, Siy AK, Rodushkin I. Toxic element contamination of natural health products and pharmaceutical preparations. PLoS One. 2012;7(11):e49676. doi:10.1371/journal.pone.0049676

    28. Tucker J, Fischer T, Upjohn L, Mazzera D, Kumar M. Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings [published correction appears in JAMA Netw Open. 2018 Nov 2;1(7):e185765]. JAMA Netw Open. 2018;1(6):e183337. Published 2018 Oct 5. doi:10.1001/jamanetworkopen.2018.3337

    29. Health Fraud Product Database. United States Food and Drug Administration. Accessed August 10, 2022. https://www.fda.gov/consumers/health-fraud-scams/health-fraud-product-database

    30. Warning Letter: Amcyte Pharma, Inc. United States Food and Drug Administration. January 03, 2022. Accessed August 12, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amcyte-pharma-inc-623474-01032022

    31. Public Notification: Adam’s Secret Extra Strength Amazing Black contains hidden drug ingredient. United States Food and Drug Administration. July 15, 2022. Accessed August 12, 2022. https://www.fda.gov/drugs/medication-health-fraud/public-notification-adams-secret-extra-strength-amazing-black-contains-hidden-drug-ingredient

    32. Coward, RM, Carson CC. Tadalafil in the treatment of erectile dysfunction. Ther Clin Risk Manag. 2008;4(6):1315-1329. Accessed October 3, 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2643112/pdf/TCRM-4-1315.pdf

    33. Tucker J, Fischer T, Upjohn L, Mazzera D, Kumar M. Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings [published correction appears in JAMA Netw Open. 2018 Nov 2;1(7):e185765]. JAMA Netw Open. 2018;1(6):e183337. Published 2018 Oct 5. doi:10.1001/jamanetworkopen.2018.3337

    34. Akabas SR, Vannice G, Atwater JB, Cooperman T, Cotter R, Thomas L. Quality Certification Programs for Dietary Supplements. J Acad Nutr Diet. 2016;116(9):1370-1379. doi:10.1016/j.jand.2015.11.003

    35. Dietary Supplement Labeling Guide, U.S. Food and Drug Administration. https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide Accessed July 15, 2022.

    36. Frequently Asked Questions for Industry on Nutrition Facts Labeling Requirements. United States Food and Drug Administration. Accessed August 12, 2022. https://www.fda.gov/media/99158/download

    37. Cooperman, T. 6 Red Flags to Watch Out For When Buying Vitamins & Supplements. October 9, 2021. Accessed August 12, 2022. https://www.consumerlab.com/answers/what-to-watch-out-for-when-buying-vitamins-and-supplements/vitamin-and-supplement-red-flags

    38. Research explores the impact of menopause on women’s health and aging. National Institute of Aging. May 6, 2022. Accessed September 6, 2022. https://www.nia.nih.gov/news/research-explores-impact-menopause-womens-health-and-aging

    39. Geller AI, Shehab N, Weidle NJ, et al. Emergency Department Visits for Adverse Events Related to Dietary Supplements. N Engl J Med. 2015;373(16):1531-1540. doi:10.1056/NEJMsa1504267

    40. Code of Federal Regulations. Title 16, Chapter II, Subchapter E, Part 1700. Amended September 6, 2022. Accessed September 6, 2022. https://www.ecfr.gov/current/title-16/chapter-II/subchapter-E/part-1700/section-1700.14

    41. Zanger UM, Turpeinen M, Klein K, Schwab M. Functional pharmacogenetics/genomics of human cytochromes P450 involved in drug biotransformation. Anal Bioanal Chem. 2008;392(6):1093-1108. doi:10.1007/s00216-008-2291-6

    42. Matura JM, Shea LA, Bankes VA. Dietary supplements, cytochrome metabolism, and pharmacogenetic considerations [published online ahead of print, 2021 Nov 4]. Ir J Med Sci. 2021;10.1007/s11845-021-02828-4. doi:10.1007/s11845-021-02828-4

    43. Chrubasik-Hausmann S, Vlachojannis J, McLachlan AJ. Understanding drug interactions with St John's wort (Hypericum perforatum L.): impact of hyperforin content. J Pharm Pharmacol. 2019;71(1):129-138. doi:10.1111/jphp.12858

    44. Zhou S, Chan E, Pan SQ, Huang M, Lee EJ. Pharmacokinetic interactions of drugs with St John's wort. J Psychopharmacol. 2004;18(2):262-276. doi:10.1177/0269881104042632

    45. Chen J, Wang Y. Social Media Use for Health Purposes: Systematic Review. J Med Internet Res. 2021;23(5):e17917. Published 2021 May 12. doi:10.2196/17917

    46. Moorhead SA, Hazlett DE, Harrison L, Carroll JK, Irwin A, Hoving C. A new dimension of health care: systematic review of the uses, benefits, and limitations of social media for health communication. J Med Internet Res. 2013;15(4):e85. Published 2013 Apr 23. doi:10.2196/jmir.1933

    47. Swire-Thompson B, Lazer D. Public Health and Online Misinformation: Challenges and Recommendations. Annu Rev Public Health. 2020;41:433-451. doi:10.1146/annurev-publhealth-040119-094127

    48. Chou WS, Oh A, Klein WMP. Addressing Health-Related Misinformation on Social Media. JAMA. 2018;320(23):2417-2418. doi:10.1001/jama.2018.16865

    49. Suarez-Lledo V, Alvarez-Galvez J. Prevalence of Health Misinformation on Social Media: Systematic Review. J Med Internet Res. 2021;23(1):e17187. Published 2021 Jan 20. doi:10.2196/17187

    50. Supplement Your Knowledge. Dietary Supplement Education Initiative. United States Food and Drug Administration. May 25, 2022. Accessed July 20, 2022. Reference the Supplement your knowledge program

    Only Skin Deep: The Pharmacist’s Guide to Intradermal Vaccine Administration

    Learning Objectives

     

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

    • DISCUSS the potential benefits of intradermal vaccine delivery
    • IDENTIFY how to administer intradermal injections

       

      Release Date: December 5, 2022

      Expiration Date: December 5, 2025

      Course Fee

      FREE

      There is no grant funding for this CE activity

      ACPE UANs

      Pharmacist: 0009-0000-22-066-H06-P

      Pharmacy Technician: 0009-0000-22-066-H06-T

      Session Codes

      Pharmacist: 22YC66-BXV44

      Pharmacy Technician:  22YC66-VBT84

      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 0009-0000-22-066-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

      Kelsey Giara, PharmD
      Freelance Medical Writer
      Pelham, NH

      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 does not have any relationships with ineligible companies and therefore has nothing to disclose.

       

      ABSTRACT

      Researchers have studied intradermal vaccination for various diseases for over a decade, so it was only a matter of time before pharmacists would be asked to learn this route of administration. This is arguably the most challenging method of vaccine administration, and inaccurate technique could render an immunization ineffective. Given the need for intradermal administration of the monkeypox vaccine, pharmacists should be prepared to offer intradermal vaccination to eligible individuals to increase immunization rates, slow viral spread, and improve outcomes for affected individuals.

      CONTENT

      Content

      INTRODUCTION

      Major developments to vaccines and vaccine administration in recent years have demanded a great deal from pharmacists. The coronavirus disease-19 pandemic asked us to fight misinformation and vaccine hesitancy to educate the public about a new virus and new vaccine technology. We’ve been challenged to keep up with booster recommendations and the increased workflow that comes with vaccine administration. Many of us also taught our pharmacy technicians how to immunize.

       

      Now, with the emergence of monkeypox comes yet another new vaccine with an unfamiliar method of administration (see our FREE monkeypox activity for a more in-depth discussion about this virus). In August 2022, the United States (U.S.) declared monkeypox a public health emergency and ramped up efforts to vaccinate at-risk individuals subcutaneously (a method with which pharmacists are generally familiar).1 Shortly thereafter, the U.S. Food and Drug Administration (FDA) recognized that the country’s supply of monkeypox vaccine was unable to meet the current demand given the rapid spread of the virus.2 Administering the vaccine intradermally only requires one-fifth of the subcutaneous dose, so the FDA issued an emergency use authorization (EUA) allowing healthcare providers to use this method of administration. This effectively increased the total number of available doses by up to five-fold.2

       

      In September 2022, the U.S. Department of Health and Human Services authorized pharmacists, pharmacy interns, and pharmacy technicians, as appropriate, to administer monkeypox vaccines and therapeutics, under certain conditions.3 Pharmacists should be prepared to offer intradermal vaccination to eligible individuals to increase vaccination rates, slow viral spread, and improve outcomes both for this virus and any future viruses for which this applies.

       

      THE ROLE OF INTRADERMAL ADMINISTRATION

      Researchers have studied intradermal vaccination for a range of viral diseases, but only a few things are administered intradermally including4,5

      • tuberculosis skin testing
      • BCG (tuberculosis) vaccine
      • rabies vaccine
      • allergy skin testing

       

      Intradermal administration occurs in the dermis just below the epidermis (see Figure 1).4 The epidermis—the thinnest layer—is made up mostly of epithelial cells, but also contains melanocytes (pigment-producing cells), Merkel cells (for light-touch stimuli), and Langerhans cells (tissue-resident macrophages).5 The dermis is a thicker layer containing cells of the adaptive and innate immune systems including macrophages, mast cells, Langerhans cells, and dermal dendritic cells. Cells of the dermis are essential in processing incoming antigens to decide if they are harmful and activate the immune system accordingly.5

       

       

      Figure 1. Methods of Vaccine Administration

       

      High levels of antigen-presenting cells in the dermis induce a more potent immune response, making this an attractive (and potentially superior) vaccination site.5,6 This significant reactivity in the dermis also prompts a strong immune response to a smaller quantity of vaccine antigen—as little as one-fifth to one-tenth the dose—compared to intramuscular or subcutaneous administration.5,7 For this reason, intradermal administration is dose-sparing and potentially cost saving.5 Intradermal administration also avoids the rare risk of nerve, blood vessel, or joint space injury.7

       

      Clinical studies are evaluating intradermal delivery of other vaccines, but none are currently available in the U.S. aside from monkeypox under the recent EUA.5 In years past, an intradermal influenza vaccine was available, but the manufacturer stopped production after the 2017-2018 flu season for unknown reasons.8 Of all parenteral routes, intradermal injections have the longest absorption time due to the lack of blood vessels and muscle tissue in this area. This is attractive for sensitivity testing, as reactions are easier to visualize and assess for severity.4

       

      While intradermal administration is more efficient and cost-effective, it requires more skill and practice compared to subcutaneous or intramuscular administration.9 If incorrectly administered, the vaccine may enter the subcutaneous tissue instead and be ineffective because the dose is too small.

       

      INTRADERMAL ADMINISTRATION TECHNIQUE

      The most common intradermal injection sites are the volar aspect (inner surface) of the forearm and the upper back below the scapula (shoulder blade).4 Intradermal injection is not the best choice for every patient. Skin should be free of lesions, rashes, moles, or scars that could alter visual inspection of the injection site (or interpretation of test results, when applicable).4 In the case of the monkeypox vaccine, intradermal administration is only authorized for patients 18 years or older without a history of keloids (thick, raised scars).10

       

      Researchers have developed various devices for intradermal drug delivery, but in the absence of specialized devices, individuals can employ the Mantoux technique using a hypodermic needle.5 The Mantoux technique is named for French physician Charles Mantoux who used this method for tuberculosis testing in the early 1900s.11 The optimum needle size for this method is 26 to 27 gauge and ¼ to ½ inch long.4

       

      The Mantoux technique is new to pharmacists (we know because we could only find information about administration technique in nursing resources), so listen up, take notes, and remember that practice makes perfect4,10:

      • Inspect the injection site and select an area that is free from lesions, rashes, moles, or scars. Avoid vaccination in an area where there is a recent tattoo (less than one month old). If tattoos cover both arms, select an area without pigment (ink) if possible. If the tattoo is unavoidable, administer through it.
      • Clean the site with an alcohol or antiseptic swab using a firm, circular motion. Allow the site to dry completely to prevent alcohol from entering the tissue, which can cause stinging and irritation.
      • Using the nondominant hand, spread the skin taut at the injection site. Taut skin provides easy entrance for the needle. This is especially important in older individuals with less elastic skin.
      • Hold the syringe in the dominant hand between the thumb and forefinger at a 5- to 15-degree angle at the selected injection site with the bevel of the needle facing up.
      • Place the needle almost flat against the patient’s skin and insert the needle into the skin no more than 1/8-inch (about 3 mm) to cover the bevel. Keeping the bevel side up allows the needle to smoothly pierce the skin and deliver the medication to the dermis.
      • Once the needle is in place, use the thumb of the nondominant hand to slowly push the plunger to inject the medication.
      • Inspect the injection site for a bleb (small blister) which should appear under the skin. The presence of a bleb indicates that the medication is correctly placed in the dermis. The bleb is desired but not required, so if it doesn't appear, don't panic. Simply adjust your technique for next time.
      • Withdraw the needle at the same angle it was placed so as not to disturb the bleb and to minimize patient discomfort and tissue damage. Safely discard the syringe in a sharps container.

       

      For more visual learners, the Centers for Disease Control and Prevention provides a video demonstrating how to administer a vaccine intradermally at https://www.cdc.gov/wcms/video/low-res/poxvirus/2022/53345334Monkeypox-Vaccine-Administration.mp4.

       

      CONCLUSION

      Vaccines work, that much we know. However, this is only true if they’re accessible, trusted, and used appropriately. Pharmacists can help promote access, education, and vaccine uptake if they have the knowledge and skills to do so. New vaccines and administration recommendations are challenging, but don’t let it get under your skin. We hope this quick-and-dirty overview of intradermal vaccines boosted your confidence and made it easier for you to give it a shot.

       

       

       

      Pharmacist Post Test (for viewing only)

      Only Skin Deep: The Pharmacist’s Guide to Intradermal Vaccine Administration

      Learning Objectives
      • DISCUSS the potential benefits of intradermal vaccine delivery
      • IDENTIFY how to administer intradermal injections

      1. Which of the following is a benefit of intradermal vaccine delivery?
      A. It can deliver a larger vaccine dose
      B. It has the fastest rate of absorption
      C. It avoids the risk of nerve injury

      2. Which of the following makes the dermis a good site for vaccine administration?
      A. High levels of Merkel cells
      B. High levels of antigen-presenting cells
      C. Low levels of Langerhans cells

      3. About how far should you insert the needle to administer an intradermal injection via the Mantoux technique?
      A. 1/8-inch
      B. 1/4-inch
      C. 1/2-inch

      4. Travis Barker comes into your pharmacy asking for an intradermal vaccine. You inspect his forearms full of tattoos and find a small space without ink. You complete intradermal administration and notice a small bubble form under his skin. What does this mean?
      A. You administered the vaccine subcutaneously
      B. You administered the vaccine too close to a tattoo
      C. You administered the vaccine correctly

      5. Which of the following is appropriate technique for intradermal administration?
      A. Insert the needle at a 5- to 15-degree angle with the bevel facing up
      B. Pinch the skin between the thumb and forefinger of the nondominant hand
      C. Remove the needle slowly at a 45-degree angle to reduce discomfort

      Pharmacy Technician Post Test (for viewing only)

      Only Skin Deep: The Pharmacist’s Guide to Intradermal Vaccine Administration

      Learning Objectives
      • DISCUSS the potential benefits of intradermal vaccine delivery
      • IDENTIFY how to administer intradermal injections

      1. Which of the following is a benefit of intradermal vaccine delivery?
      A. It can deliver a larger vaccine dose
      B. It has the fastest rate of absorption
      C. It avoids the risk of nerve injury

      2. Which of the following makes the dermis a good site for vaccine administration?
      A. High levels of Merkel cells
      B. High levels of antigen-presenting cells
      C. Low levels of Langerhans cells

      3. About how far should you insert the needle to administer an intradermal injection via the Mantoux technique?
      A. 1/8-inch
      B. 1/4-inch
      C. 1/2-inch

      4. Travis Barker comes into your pharmacy asking for an intradermal vaccine. You inspect his forearms full of tattoos and find a small space without ink. You complete intradermal administration and notice a small bubble form under his skin. What does this mean?
      A. You administered the vaccine subcutaneously
      B. You administered the vaccine too close to a tattoo
      C. You administered the vaccine correctly

      5. Which of the following is appropriate technique for intradermal administration?
      A. Insert the needle at a 5- to 15-degree angle with the bevel facing up
      B. Pinch the skin between the thumb and forefinger of the nondominant hand
      C. Remove the needle slowly at a 45-degree angle to reduce discomfort

      References

      Full List of References

      References

         
        REFERENCES
        1. U.S. Department of Health and Human Services. Biden-Harris Administration Bolsters Monkeypox Response; HHS Secretary Becerra Declares Public Health Emergency. August 4, 2022. Accessed October 26, 2022. https://www.hhs.gov/about/news/2022/08/04/biden-harris-administration-bolsters-monkeypox-response-hhs-secretary-becerra-declares-public-health-emergency.html
        2. U.S. Food and Drug Administration. Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply. August 9, 2022. Accessed October 26, 2022. https://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply
        3. U.S. Department of Health and Human Services. Notice of Amendment to the January 1, 2016 Republished Declaration under the Public Readiness and Emergency Preparedness Act. October 3, 2022. Accessed October 26, 2022. https://public-inspection.federalregister.gov/2022-21412.pdf
        4. Administering intradermal medications. Open Resources for Nursing (Open RN). Accessed October 26, 2022. https://wtcs.pressbooks.pub/nursingskills/chapter/18-4-administering-intradermal-medication/
        5. Kim YC, Jarrahian C, Zehrung D, Mitragotri S, Prausnitz MR. Delivery systems for intradermal vaccination. Curr Top Microbiol Immunol. 2012;351:77-112.
        6. Hickling JK, Jones KR, Friede M, Zehrung D, Chen D, Kristensen D. Intradermal delivery of vaccines: potential benefits and current challenges. Bull World Health Organ. 2011;89(3):221-226.
        7. Brooks JT, Marks P, Goldstein RH, Walensky RP. Intradermal Vaccination for Monkeypox - Benefits for Individual and Public Health. N Engl J Med. 2022;387(13):1151-1153.
        8. Influenza vaccine. Aetna Clinical Policy Bulletins. Reviewed August 1, 2022. Accessed October 26, 2022. https://www.aetna.com/cpb/medical/data/1_99/0035.html
        9. Miller K. What Is an Intradermal Injection, the New Way the Monkeypox Vaccine Is Being Given? Prevention. August 12, 2022. Accessed October 26, 2022. https://www.prevention.com/health/health-conditions/a40869782/what-is-intradermal-injection/
        10. Centers for Disease Control and Prevention. JYNNEOS Smallpox and Monkeypox Vaccine:
        ALTERNATE REGIMEN Preparation and Administration Summary (Intradermal Administration). Updated September 27, 2022. Accessed October 26, 2022. https://www.cdc.gov/poxvirus/monkeypox/files/interim-considerations/guidance-jynneos-prep-admin-alt-dosing.pdf
        11. Kis EE, Winter G, Myschik J. Devices for intradermal vaccination. Vaccine. 2012;30(3):523-538.

        Ketamine and Its Kissing Cousins

        Learning Objectives

         

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

        ·       Identify patient populations in which ketamine use is justified based on its FDA approved indications and for off-labeled use where it has been sufficiently studied
        ·       Compare the different formulations of ketamine and its “kissing cousins”
        ·       Describe potential risks associated with ketamine use

         

        Image depicting chemical structure of ketamine.

        Release Date:

        Release Date: October 22, 2022

        Expiration Date: October 22, 2025

        Course Fee

        Pharmacists: $7

        Pharmacy Technicians: $4

        There is no grant funding for this CE activity

        ACPE UANs

        Pharmacist: 0009-0000-22-062-H08-P

        Pharmacy Technician: 0009-0000-22-062-H08-T

        Session Codes

        Pharmacist:  22YC62-FXK22

        Pharmacy Technician:  22YC62-KXT46

        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 0009-0000-22-062-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

        Alexis Hicks, PharmD.
        CVS Health
        West Hartford, CT

        Canyon Hopkins, PharmD.
        Medical Professional Ethos Cannabis
        Pittsburgh, PA

        Alexis Redfield, PharmD.
        CVS
        Vernon, CT

        Ashley Walsh, PharmD.
        Mohegan Pharmacy
        Uncasville, 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. Hicks, Hopkins, Redfield, and Walsh do not have any relationships with ineligible companies and therefore have nothing to disclose.

         

        ABSTRACT

        Ketamine is Food and Drug Administration-approved as a general anesthetic. Researchers found higher dose ketamine therapy had a more desirable adverse effect profile than the previously used anesthetic phencyclidine (PCP). N-methyl-D-aspartate (NMDA) antagonism from subanesthetic ketamine doses produces dissociative and analgesic effects. As such, prescribers are exploring off-label uses for ketamine in patients with agitation, depression, and pain while considering potential risks to multiple organ systems. Ketamine has the potential to cause complications and providers need to monitor patients closely. Illicit and inappropriate use by abusers and untrained law enforcement officers highlight ketamine’s potentially harmful effects. Educating patients and healthcare providers is vital to allow potential benefits while minimizing harm.

        CONTENT

        Content

        Introduction

         

        Consider this: It’s 10:30 PM on a Friday night, 30 minutes before you leave for the weekend. Suddenly, from across the emergency department you hear, “Get OFF me! No, I have not t-t-taken anything! If you come ANY CLOSER, things are going to get physical!” Not a moment later, an order pops up for ketamine hydrochloride 500 mg intramuscularly (IM) for severe agitation. Concerned, a colleague asks you, “Is this safe? Is this effective? I have never seen a dose this high before. Isn’t this just for horses?”

         

        Ketamine made its debut in human clinical practice in the 1960s when several chemists at Parke Davis Company were searching for an anesthetic with similar effects to phencyclidine (PCP). PCP, ketamine’s notorious kissing cousin, was a promising new anesthetic in the 1950s because of its dissociative effects. However, the chemists quickly became unimpressed with its adverse effect profile (i.e., long-lasting psychoactive effects after anesthesia). Humans experienced intense prolonged emergence delirium following PCP anesthesia, relegating its use to veterinary practice.1 Chemists searched for a better anesthetic and found ketamine, which has similar dissociative effects without PCP’s negative consequences. Ketamine is a more desirable anesthetic because it has a shorter half-life (2.5 hours) compared to PCP (21 hours) and it causes less delirium.1,2

         

        Prescribers have begun using ketamine for several off-label uses and patients have also started using the drug or structural analogs in a variety of formulations illicitly. Pharmacists and technicians can ensure ketamine’s safe use by keeping current with new formulations and indications, both approved and unapproved. This continuing education activity will dive into the clinical and social consequences of ketamine use.

         

        What’s Ketamine?

        Ketamine is a schedule III-controlled substance approved by the U.S. Food and Drug Administration (FDA) for use as a general anesthetic for diagnostic and surgical procedures.2 Ketamine is commercially available in the United States as a solution/injection under its brand (Ketalar) and as generic ketamine.2 Healthcare providers most often use intravenous (IV) ketamine, but it may be used IM or compounded into an oral solution. 

         

        Healthcare providers also use ketamine off-label for analgesia, agitation, and major depressive disorder. These indications emanate from ketamine’s mechanism of action: it acts specifically on the N-methyl-D-Aspartate (NMDA) receptor as a non-competitive antagonist to block glutamate binding.3 Glutamate, a major excitatory neurotransmitter, binds to receptors throughout the nervous system. The NMDA receptor is an ionotropic receptor responsible for the brain’s neuroplasticity, memory, learning, and recovery.4-6 Blocking this receptor with high ketamine doses (ranging from 0.5 to 2 mg/kg) results in dissociation, decreases in spinal reflexes, and produces a cataleptic state (loss of voluntary movements and reduced consciousness) that is applicable to its current clinical use in anesthesia.2 However, at low doses, ketamine can produce analgesia and stimulate new pathways within the brain that reduce depressive symptoms and improve mood.

         

        Although ketamine has useful applications in medicine, prescribers must be aware of the adverse effects and risk factors associated with use and should consider how these effects apply to their patients before initiating the medication. Ketamine adversely impacts multiple organ systems (see Table 1), including but not limited to the cardiovascular system. Increases in blood pressure and heart rate are important cardiovascular effects associated with ketamine therapy.2 These cardiovascular effects make it a drug of choice for anesthesia induction in patients with cardiovascular shock, where it anesthetizes patients while improving blood pressure and improving organ perfusion. However, clinicians must avoid ketamine use in patients with preexisting hypertensive conditions or other patients who have limited baroreceptor buffering capacity (baroreceptor buffering is the body’s ability to sense blood pressure) because of those same effects mentioned above.6

         

        Table 1. General Adverse Effects of Ketamine2,6

        System Adverse effects
        Cardiovascular Cardiac arrhythmias, increased blood pressure,* increased heart rate
        Central nervous system Prolonged emergence from anesthesia,* psychosis,* dissociation,* drug dependence, increased intracranial pressure
        Dermatologic Injection site irritation
        Gastrointestinal Nausea,* vomiting, anorexia
        Genitourinary Lower urinary tract dysfunction, bladder dysfunction
        Respiratory Laryngospasm,* respiratory depression,* apnea
        Immunologic Anaphylaxis
        Other Hypersalivation, diplopia (double vision), nystagmus (uncontrollable rapid eye movement)

        *Common or serious adverse effects of ketamine use

         

        Further contraindications include hypersensitivity to ketamine or its components.7 The American College of Emergency Physicians (ACEP) does not recommend ketamine use in patients with schizophrenia or in children younger than three months of age. The ACEP also advises against solely using ketamine as an anesthetic in procedures involving the pharynx, larynx, and bronchial tree. This recommendation primarily applies to patients with airway instability because ketamine can cause laryngospasms.5 Table 2 lists additional considerations in special populations.

        Table 2. Special Population Considerations with Ketamine2,6-8

        Special population Concerns Recommendation
        Pregnancy Crosses the placenta; may have potential risk to fetus Avoid use; evaluate benefits vs risk
        Breastfeeding Compatibility and safety unknown Avoid breastfeeding to children with respiratory risk factors
        Pediatrics Can be given with anticholinergics to minimize hypersalivation Refer to pediatric dosing. Avoid in infants < 3 months of age
        Elderly May be sensitive to dissociative adverse effects Refer to adult dosing
        Kidney dysfunction No additional concerns Refer to dosing parameters
        Liver dysfunction Hepatobiliary dysfunction with recurrent use Refer to dosing parameters; monitor LFTs with repeated ketamine use
        LFTs = liver function tests

         

        Healthcare providers should monitor patients' vital signs closely during treatment with ketamine. Anesthesiologists and pharmacists must continuously watch patients undergoing surgical or diagnostic procedures for proper induction and maintenance of dissociative effects.2 In patients who must take repeated doses of ketamine (e.g., for chronic pain management or psychiatric disorders), healthcare providers should order liver function tests at baseline and every one to two days during treatment.2,6,9,10

         

        Ketamine’s Kissing Cousins

        As shown in Figure 1, ketamine is structurally related to many compounds. The drugs in Figure 1 antagonize the NMDA receptor and exhibit a dissociative effect.1 PCP is one of the most notoriously abused drugs. Compared with ketamine, PCP is 10 times more potent and has a longer duration of action due to its strong affinity for the NMDA receptor. Both ketamine and PCP can replicate schizophrenia’s positive, negative, and cognitive symptoms and exacerbate underlying schizophrenia. But because ketamine has lower potency and a shorter duration of action, it induces fewer severe psychiatric effects than PCP.1

        Image depicting the molecular structure of ketamine and structurally related drugs.

        Figure 1. Molecular structure of ketamine and structurally related dissociative drugs11

                   

        Although ketamine’s labeling includes many precautions, it is an emerging option because of its therapeutic benefits. Xi Biopharmaceuticals is developing a sublingual wafer to treat acute pain while Janssen Pharmaceuticals has developed a nasal spray formulation for treatment resistant depression.12,13 Table 3 compares the current ketamine formulations that are FDA-approved or under investigation.

         

        Table 3. Ketamine Counterparts12-14

         Cousins Formulation Use & Dose Approval or Trial Phase
        Ketalar (ketamine hydrochloride) Injectable Anesthesia

        0.25 – 0.35 mg/kg followed by CIVI 1 mg/kg/hr

        FDA-approved
        Wafermine (ketamine) Sublingual Wafer Acute Pain

        25 mg, 50 mg & 75 mg PRN for 12 hrs

        End-of-Phase 2 Clinical Trials
        Spravato (esketamine) Nasal Spray Treatment Resistant Depressive Disorder

        28 mg, 56 mg, 84 mg twice a week

        FDA-approved
        ABBREVIATION: CIVI = continuous intravenous infusion

         

        ABUSE, ADDICTION, DEPENDENCE

         

        Why is Ketamine Dangerous?

        Long-term ketamine abuse is associated with memory, attention, and judgment impairment. The actual risk of ketamine abuse in the general population is low compared to other substances of abuse, but patients with polysubstance abuse disorder tend to use it.15 A study examining polysubstance abuse conducted in New York City found that polydrug use occurred because of an unexpected opportunity to use ketamine after already consuming other drugs. Researchers also determined that polysubstance abusers purposefully used ketamine with another substance to achieve an individually desired effect. Oftentimes polydrug-using events occurred within a group and each member contributed something: ketamine, knowledge, other drugs, or space to use drugs.16

         

        Currently, ketamine is only commercially available as an injectable liquid. Dealers illegally sell ketamine as a recreational injectable substance or a white powder that resembles cocaine. The Department of Justice and Drug Enforcement Administration report that illegally distributed ketamine is diverted or stolen from veterinary clinics or smuggled into the United States from Mexico.17 Dealers can then synthesize ketamine into a powder or sell it as an injectable liquid.18 Prices average from $20-$25 per dose (50 mg to 100 mg).19 Drug abusers find ketamine’s dissociative sensations and hallucinations appealing. Users can inject liquid ketamine, or snort or smoke powdered ketamine.17 Ketamine is a popular drug to facilitate physical or sexual assault because it is a colorless, tasteless, and odorless liquid making it difficult for victims to detect. Additionally, ketamine is known to cause impaired coordination, confusion, and memory loss.20

         

        Ketamine’s IV administration started in the early 1990s. Injection events occur most frequently in large cities with high rates of homelessness, like New York City and Los Angeles.18 Researchers conducted a study with 213 people who abused IV ketamine.18 Among these users, 84% admitted to abusing ‘harder’ drugs first, with heroin predominating. Users reported their first ketamine injection happening among a group of people. This group often included people well known to them who provided knowledge and the materials for injecting.18

         

        What attracts people to a dissociative drug with unknown psychoactive effects? Exactly that: the unknown. With most abused drugs, the user understands the effects they will experience. When someone takes ketamine, the reaction to each dose is unknown. Some users seek variety. Ketamine users have described an out of body experience that expands internal and external realms and realities.18 On the other hand, abusers also describe a “K-Hole”—an experience that they describe as near-death that results when they ingest too much ketamine.17

         

        Timothy Wyllie, a spiritualist, describes ketamine doses as a curve over time through realms. He describes the domains abusers experience as they dose ketamine21:

        • The realm “I,” for internal reality, occurs at doses 30 to 75 mg roughly 10 minutes after injection.
        • The extraterrestrial reality realm, “They,” occurs at doses 75 to 150 mg approximately 15 minutes after injection.
        • The realm “We,” for network creation realm, occurs at doses from 150 to 300 mg mg approximately 15 minutes after injection.
        • An unknown realm exists at doses of more than 300 mg.

        The doses studied for depression fall in the realm of internal reality. At these doses, users can see areas needing self-improvement that they were unaware they had the ability to fix. Drug users prefer subanesthetic doses but those that are higher than doses studied for treating depression. As the dose increases, users become so far removed from reality that “extraterrestrial” experiences begin.21

         

         

        KETAMINE USES

         

        Anesthesia

        Patients unable to maintain and protect their airways require endotracheal intubation. Healthcare providers use ketamine as a sedative to facilitate rapid sequence induction and intubation (RSII), by inducing an anesthetized state, prior to paralyzing the patient. The decision to intubate is based on the patient’s Glasgow Coma Score.22,23 A score of 8 or less qualifies a patient to receive endotracheal intubation.23 Healthcare providers follow a RSII strict algorithm, shown in Table 4, detailing the order in which medications should be administered based upon the onset and duration of action.

        Table 4. Algorithm of Rapid Sequence Induction & Intubation22,23

        Step of RSII What and Why Medications Used
        Premedication* Airway manipulation causes a sympathetic activation due to a pressor response. This sympathetic response leads to an increase in intracranial pressure and mean arterial pressure. alfentanil, fentanyl, lidocaine, sufentanil
        Sedation Used to induce an anesthetic state before a paralytic is used and the airway manipulated. Crucial that a patient is properly sedated before paralyzed. Also known as induction agents: etomidate, ketamine, midazolam, propofol
        Paralytics± Neuromuscular blocking agents are given to relax pharyngeal and diaphragmatic muscles allowing for an endotracheal tube to be placed. rocuronium, succinylcholine, vecuronium

        *: Based upon time constraints/needs this step may be omitted

        ±: It is imperative to confirm a patient is properly sedated before beginning paralysis because if the patient is awake, they may feel the tube insertion

         

        The drugs used in RSII possess unique characteristics, including IV use, quick onset, and short duration of action.23 Traditionally, etomidate has been the gold standard for RSII, but ketamine is quickly becoming a commonly used alternative.23 Table 5 highlights the differences between etomidate and ketamine.

         

        Table 5. Comparison of Etomidate and Ketamine22,23

          Etomidate Ketamine
        Dose for Induction 0.3 mg/kg 1.5 mg/kg or 0.1-0.5 mg/kg/min with 10% given as induction bolus
        Onset of Action 10-15 seconds < 30 seconds
        Duration of Action 4-10 minutes 10-15 minutes
        Benefits Stable hemodynamic profile, decreases metabolic rate, decreases cerebral blood flow, increases generalized seizure threshold Sedative and analgesic properties,* cardiovascular and respiratory stimulation, and smooth muscle relaxation (beneficial in reactive airway disease, hypotensive, volume depleted, and septic patients)
        Risks Adrenal suppression, do not use in septic shock, lowers focal seizure threshold, increased incidence of ARDS Potentiates effect of epinephrine, increases cardiac oxygen demand, may increase ICP,** emergent reactions, infusion related respiratory depression, hypersalivation
        ABBREVIATIONS: ARDS = acute respiratory distress syndrome, ICP = intracranial pressure

         

        * Ketamine can be used as a combined premedication and induction step

        ** Data is conflicting, however, may not be suitable for patients with head trauma

         

        The differences between etomidate and ketamine create a significant role in RSII for both drugs, but for different presenting conditions. Ketamine is gaining popularity for its use in septic patients, hypotensive patients, and those with reactive airway diseases. Choosing etomidate is preferable for patients with a hemodynamically stable profile and patients with traumatic brain injury where it could be cerebroprotective.

         

        Analgesia (pain)

         

        Ketamine’s use in pain management is controversial due to limited data, but this dataset is growing.15,24 Before considering subanesthetic ketamine doses, prescribers should collaborate with patients and other clinical team members to try other approved pain regimens.25 Using ketamine for its analgesic properties should be based on patient-specific criteria. The prescriber must assess the patient’s treatment goals, current medical conditions, pain types, and available protocols.

         

        Ketamine is not discussed in available pain guidelines. Some literature recommends its use after unsuccessful trials of at least two opioids. Data supporting ketamine’s use in both acute and chronic pain management is mixed in its findings.26,27 Most trials conclude ketamine can reduce acute pain exacerbations but note that prescribers must be cautious of its adverse effects.15 Data from small trials indicate using ketamine to overcome opioid withdrawal and opioid-induced-hyperalgesia (neuropathic pain) may be possible. Ketamine has a unique ability to counteract the unfavorable responses patients might experience on chronic high-dose opioids by its mechanism of action.24,28 Overstimulated opioid receptors from high dose opioid use causes more hyperalgesia. Several small case reports describe patients on high-dose chronic opioid therapy who reduced their opioid doses after low-dose ketamine administration.29

         

        An open labeled audit determined that IV ‘burst’ ketamine therapy improved analgesia in neuropathic pain and painful bone metastases. Researchers enrolled 39 cancer patients who were refractory to opioid therapy. Patients received bursts of low-dose ketamine (100 to 500 mg/day) over three to five days and reported somatic and neuropathic pain relief for up to eight weeks.15

         

        Limited evidence supports oral ketamine’s effect in chronic pain and most studies that examine its use are case reports or non-comparative trials. Compared to IV administration, lower oral ketamine concentrations are associated with analgesic effects. Oral ketamine has been associated with higher serum levels of its metabolite, norketamine. This metabolite seems to contribute to oral ketamine’s analgesic effects due to its shorter half-life and ability to reach much higher peak plasma concentrations than after IV administration. However, researchers have not extensively explored this in current literature.29

         

        Healthcare providers and patients face many hurdles when using ketamine for pain relief. Prescribers should avoid high ketamine doses that may cause a range of serious adverse effects. Unlike opioids, ketamine has a ceiling effect and maximum dose. Oral ketamine administration has a low bioavailability and is directly linked with a high rate of adverse effects.15,27

         

        Agitation

        Due to ketamine’s dissociative properties, clinicians are increasingly using ketamine for treating pre-hospital and in-hospital agitation. Lacking a uniform definition for agitation, healthcare providers, institutions, and organizations may use different criteria to choose medication intervention in an agitated patient. Although the picture of agitation may change depending on the situation, validated scales like the Altered Mental Status Scale (AMSS) can define agitation’s severity.30 The AMSS translates agitation into a quantifiable, real concept. The line between agitation and delirium is often unclear but has major ramifications for a patient’s treatment and outcome.30 For example, excited delirium, an agitation subtype, classifies a patient’s agitation past the emotional component and includes psychomotor, metabolic, and contributing disease states as possible reasons for agitation.30

         

        As with most psychiatric disorders, identifying and treating agitation has been suboptimal. Since the 1980s, a popular cocktail of medications, known among emergency department physicians as the “B-52” order, has been the mainstay of agitation treatment in psychiatric facilities and emergency departments.31 When examining the B-52 order’s components, it is easy to see the correlation between the regimen and the American jet-powered strategic bomber from which it derives its name: Benadryl 50 mg IM, haloperidol 5 mg IM, lorazepam 2 mg IM.31 The B-52 order serves as a reminder of the suboptimal approach traditionally taken when confronted with an agitated patient.

         

        Ketamine’s different routes of administration have benefits and disadvantages. Although less invasive, oral ketamine takes a longer time to reach the therapeutic range, something that is undesirable in an overly aggressive patient. Intravenous administration has the quickest onset but is the most invasive. Securing IV access may not always be possible. The IM route is the most often used method for agitation control for its quick “on/off” onset and duration of action, and its applicable dosage form.

         

        A review explains ketamine’s uses and benefits in comparison to other, more traditional agitation treatments.30 In terms of agitation efficacy, ketamine provides the same, if not better, response when compared to its more traditional counterparts.30 Ketamine has a significantly faster onset of action when compared to haloperidol (5 minutes versus 17 minutes) and requires less redosing (5% of patients re-dosed versus 20% of patients re-dosed, respectively).30 However, ketamine continues to show a higher incidence of adverse effects when compared to its anti-psychotic counterpart (percent incidence calculated from six studies where adverse events were recorded as a secondary outcome):30

        • emergence reaction 12.3% (8/65 patients)
          • An “emergence reaction” is an often hostile, psychiatric episode brought about by ketamine use
        • hypersalivation 31.8% (22/69 patients)
        • nausea and vomiting 8.5% (7/82 patients)
        • respiratory complications 7.6% (9/118 patients)

         

        Although studies report a higher incidence of adverse reactions when using ketamine for agitation, it is important to consider study limitations: small patient populations, co-administration of drugs, and lack of adverse event reporting (only half of 12 studies included adverse reactions).30 If used properly, ketamine can be a safe, quick-acting drug to stop agitation when compared to traditional treatments.

         

        Some law enforcement agencies use ketamine. However, when they use ketamine improperly, or when adverse effects arise, ketamine can have dangerous consequences. Over a four-day period during late August of 2020 in Colorado, police gave 23-year-old Elijah McClain and 25-year-old Elijah McKnight excessive ketamine doses for agitation.32 McClain died from cardiac arrest and McKnight survived but required life support in the hospital.32 It is inappropriate to allow untrained police officers to inject ketamine as a law enforcement tool. However, police defend using ketamine saying suspects with mental health issues or suspects taking drugs can be belligerent and dangerous. A Minnesota whistleblower lawsuit filed by a former emergency medical services worker claims police pressured them to allow ketamine use uneccessarily.32 In Minneapolis, ketamine used by police rose from four incidents per year in 2015 to 62 in 2017.32 This marked increase in ketamine use is upsetting many healthcare professionals. Dr. Mary Dale Peterson, president of the American Society of Anesthesiologists, says that ketamine can have “dangerous complications,” just like any other anesthetic. Dr. Peterson points out that justifiably using ketamine occurs very rarely.32

         

        Whistleblowers cite complications from unwarranted ketamine use are associated with emergence reactions, and improper dosages.32 McClain died when he was given a ketamine dose for a 200-pound man but only weighed 143 pounds.32 Pharmacists can play a role in educating other healthcare professionals about proper dosing and management of ketamine’s serious adverse effects.

         

        Major Depressive Disorders

        Generally, major depressive disorder’s (MDD) treatment focuses on pathophysiology and regulates serotonin, norepinephrine, and dopamine.32 Medications such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibits (SNRIs), tricyclics, tetracyclics, and serotonin modulators all target an increase in synaptic neurotransmitter levels.32 Unfortunately, these drugs are not consistently effective for all patients, require an 8-week trial period, and have unfavorable adverse effects. For many providers and their patients, MDD treatment can feel like an awful waiting game—one that they sometimes lose.

         

        Ketamine is becoming increasingly popular for its use in treating refractory depression. However, it requires healthcare providers to understand how it works to avoid putting patients into a “K-hole.” It offers a different approach to the current FDA-approved drugs for MDD. Ketamine prevents glutamate reuptake; excess glutamate produces an antidepressant effect. Ketamine, at subanesthetic doses, produces euphoria, and improves symptoms within 24 hours after infusion.4,14,32,33 Depressive symptoms improve rapidly, but the effects last only a few days to weeks. As a result, ketamine is most useful as an adjunctive treatment option. Patients feel better for a brief period, giving their antidepressants a chance to start working.

         

        In addition, prescribers have few options for patients with MDD who have suicidal behaviors and ideation. Ketamine seems promising for patients at an elevated risk for self-harm. The Ketamine for Rapid Reduction of Suicidal Thoughts in Major Depression trial examined ketamine’s potential benefits for 80 suicidal patients with MDD. The results of this randomized controlled study showed that ketamine was superior to midazolam in improving the Scale for Suicidal Ideation (SCI). Patients’ SCI scores improved 4.96 points within 24 hours after a ketamine infusion of 0.5 mg/kg over 40 minutes.32 This suggests clinical use of ketamine as an adjuvant agent for acute episodes of suicide ideation in patients maintained on guideline recommended therapy for MDD may be appropriate. However, patient safety remains a concern (e.g., dissociative effects, abuse potential, respiratory, and cardiovascular effects).

         

        As mentioned earlier, esketamine (Spravato) is ketamine’s S-enantiomer and FDA-approved for treatment-resistant depression.33 In the TRANSFORM-1 randomized controlled trial, the antidepressant/esketamine groups did not have a statistically significant change in Montgomery-Asberg Depression Rating Scale (MADRS) total score (from baseline to study day 28) when compared to the antidepressant placebo group.34,35 However, the changes based on the MADRS were clinically meaningful and showed that esketamine has a beneficial role in treatment-resistant depression when used as an adjuvant agent.36,37 The combination of esketamine with an antidepressant produced desirable outcomes while minimizing adverse effects. Although adverse effects were low, several adverse effects are possible: vertigo, nausea, vomiting, anxiety, sedation, abuse potential, increased blood pressure, dissociation, and suicidal thoughts/behaviors.33

         

        CONCLUSION

        To paraphrase the father of toxicology, Paracelsus, it’s all about the dose. Ketamine is the poster child drug for this statement. Ketamine has the potential to be an important adjuvant therapy for the treatment of a range of conditions. Those listed in this CE—anesthesia, analgesia, and major depressive disorder—are currently the most studied disorders where ketamine and its derivatives may be useful. Due to ketamine’s dissociative and analgesic effects through NMDA antagonism, there may be additional future potential uses for ketamine in pain control and psychiatric disorders. Simply, ketamine treats not only the physical manifestations of these conditions but the emotional component that providers can easily overlook. However, the current data sets are small, many use rating scales instead of final health outcomes, and a larger and longer term series of trials are required to fully determine the place of ketamine in the treatment armamentarium for patients.

         

        Pharmacists and other healthcare providers will need to distinguish between therapeutic use and addiction. Often, these lines are muddled. Providing education is a first step to preventing abuse. Usually, addiction is a manifestation of an untreated, or undertreated, medical condition. Pharmacist intervention helps patients and healthcare providers to make the safest, most informed decisions possible to ensure the best possible outcomes.

         

        Pharmacist Post Test (for viewing only)

        Pharmacist Post-Test
        Objectives:
        1. Identify patient populations in which ketamine use is justified based on its FDA approved indications and for off-labeled use where it has been sufficiently studied
        2. Compare the different formulations of ketamine and its “kissing cousins”
        3. Describe potential risks associated with ketamine use

        1. Patient AV has a GCS score of 8 and requires intubation. He presents with volume depletion, hypotension, and sepsis. What drug would the anesthesiologist probably use for sedation?
        a. Fentanyl
        b. Etomidate
        c. Ketamine

        2. In which patients would you avoid recommending ketamine?
        a. Patients with reactive airway disease
        b. Patients with sepsis or hypotension
        c. Patients with traumatic brain injury

        3. Which formulation of esketamine is FDA-approved for treatment resistant depressive disorder?
        a. Injectable
        b. Nasal spray
        c. Infusion

        4. What is the most commonly used route of administration when using ketamine for agitation?
        a. IV
        b. IM
        c. PO

        5. A clinician asks you about ketamine’s adverse effects. What would you say to start?
        a. Ketamine can cause cardiac arrythmias.
        b. Ketamine can decrease blood pressure.
        c. Ketamine can worsen peptic ulcers.

        6. What is the correct order of administration for RSII medications?
        a. Premedication, sedative, paralytic
        b. Premedication, paralytic, sedative
        c. Sedative, premedication, paralytic

        7. When should prescribers monitor liver function in patients who receive repeated ketamine doses?
        a. At baseline and every 1 to 2 months
        b. At baseline and every 1 to 2 weeks
        c. At baseline and every 1 to 2 days

        8. What is a “K-hole?”
        a. A networking experience
        b. A near-death experience
        c. An extraterrestrial experience

        9. What is a limitation of using ketamine in MDD?
        a. Depressive symptoms improve slowly
        b. Requires an 8-week trial period first
        c. Effects last only a few days to weeks

        10. A police officer asks you to discuss ketamine and asks why you refer to similar drugs as “kissing cousins.” How would you explain it?
        a. They all have similar potency and antagonize NMDA receptor
        b. They are used in similar doses and act as a NMDA receptor agonist
        c. They are structurally similar and antagonize NMDA receptor

        Pharmacy Technician Post Test (for viewing only)

        Technician Post-Test
        Objectives:
        1. Identify patient populations in which ketamine use is justified based on its FDA approved indications and for off-labeled use where it has been sufficiently studied
        2. Compare the different formulations of ketamine and its “kissing cousins”
        3. Describe potential risks associated with ketamine use

        1. In which patient should prescribers avoid using ketamine?
        a. patient with serious peptic ulcer
        b. patient older than 3 months old
        c. patient with uncontrolled hypertension

        2. What ketamine dose results in dissociation?
        a. 0.1 to 0.5 mg/kg
        b. 0.5 to 2 mg/kg
        c. 2 to 3.5 mg/kg

        3. What is a risk associated with using ketamine in RSII?
        a. adrenal suppression
        b. increase ARDS incidence
        c. emergent reactions

        4. What ketamine formulation is currently available by prescription?
        a. sublingual tablet
        b. injectable solution
        c. 24-hour patch

        5. What risk is associated with ketamine use?
        a. exacerbates underlying schizophrenia
        b. lowers focal seizure threshold
        c. increases incidence of ARDS

        6. What is a key difference between PCP and ketamine?
        a. PCP has a shorter duration of action than ketamine
        b. PCP is 10 time more potent than ketamine
        c. PCP has less severe psychiatric effects than ketamine

        7. What is a benefit of using ketamine for agitation in comparison to haloperidol?
        a. faster onset
        b. more redosing
        c. fewer side effects

        8. What is ketamine’s FDA-approved indication?
        a. agitation
        b. analgesia
        c. anesthesia

        9. What can be expected when people use oral ketamine?
        a. high bioavailability
        b. high rate of adverse effects
        c. low plasma peak concentrations

        10. What is ketamine’s role in RSII?
        a. premedication
        b. sedative
        c. paralytic

        References

        Full List of References

        References

           
          1. Li L, Vlisides PE. Ketamine: 50 Years of modulating the mind. Front Hum Neurosci. 2016;10:612. Published 2016 Nov 29. doi:10.3389/fnhum.2016.00612

          2. Ketalar. Prescribing information. Par Pharmaceutical; 2022. Accessed July 25, 2022. https://www.parpharm.com/pdfs/catalog/sterile/Ketalar_PI_20220613.pdf

          3. Institute of Medicine (US) Forum on Neuroscience and Nervous System Disorders. Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System: Workshop Summary. Washington (DC): National Academies Press (US); 2011.

          4. Aleksandrova LR, Phillips AG, Wang YT. Antidepressant effects of ketamine and the roles of AMPA glutamate receptors and other mechanisms beyond NMDA receptor antagonism. Journal of Psychiatry Neuroscience. 2017;42(4):222-229. DOI: 10.1503/jpn.160175.

          5. Vyklicky V, Korinek M, Smejkalova T, et al. Structure, function, and pharmacology of NMDA receptor channels. Physiol Res. 2014;63(Suppl 1):S191-S203. doi:10.33549/physiolres.932678

          6. Godwin SA, Burton JH, Gerardo CJ, et al. American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2014;63(2):247-258.e18. doi:10.1016/j.annemergmed.2013.10.015[PubMed 24438649]

          7. Ellingson A, Haram K, Sagen N, Solheim E. Transplacental passage of ketamine after intravenous administration. Acta Anaesthesiol Scand. 1977;21(1):41-44.[PubMed 842268]

          8. Visser E, Schug SA. The role of ketamine in pain management. Biomed Pharmacother. 2006;60(7):341-348. doi:10.1016/j.biopha.2006.06.021

          9. Zhu X, Kohan LR, Goldstein RB. substantial elevation of liver enzymes during ketamine infusion: a case report. A Pract. 2020;14(8):e01239. doi:10.1213/XAA.0000000000001239

          10. Wilkinson ST, Sanacora G. Considerations on the Off-label Use of Ketamine as a Treatment for Mood Disorders. JAMA. 2017;318(9):793-794. doi:10.1001/jama.2017.10697

          11. Ho JH, Dargan PI. Arylcyclohexamines (Ketamine, Phencyclidine, and Analogues). In: Critical Care Toxicology. Brent J, Burkhart K, Dargan P, Hatten B, Megarbane B, Palmer R, eds. Springer; 2016. https://doi.org/10.1007/978-3-319-20790-2_124-1

          12. Lodge D, Mercier MS. Ketamine and phencyclidine: the good, the bad and the unexpected. Br J Pharmacology. 2015;172(17):4254-4276. doi:10.1111/bph.13222

          13. Study of Wafermine™ for post-bunionectomy or abdominoplasty pain. ClinicalTrials.gov identifier: NCT03246971. Updated July 23, 2018. Accessed Jul 25, 2022. https://clinicaltrials.gov/ct2/show/study/NCT03246971

          14. Treating major depressive disorder: a quick reference guide. American Psychiatric Association. Published October 2010. Accessed July 25, 2022. https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd-guide.pdf

          15. Visser E, Schug SA. The role of ketamine in pain management. Biomed Pharmacother. 2006;60(7):341-348. doi:10.1016/j.biopha.2006.06.021

          16. Lankenau SE, Clatts MC. Patterns of polydrug use among ketamine injectors in New York City. Subst Use Misuse. 2005;40(9-10):1381-1397. doi:10.1081/JA-200066936

          17. Drug Fact Sheet: Ketamine. Department of Justice and Drug Enforcement Administration. Published April 2020. Accessed July 25, 2022. https://www.dea.gov/sites/default/files/2020-06/Ketamine-2020.pdf

          18. Lankenau SE, Sanders B, Bloom JJ, et al. First injection of ketamine among young injection drug users (IDUs) in three U.S. cities. Drug Alcohol Depend. 2007;87(2-3):183-193. doi:10.1016/j.drugalcdep.2006.08.015

          19. Average Cost of Illicit Street Drugs. AddictionResource.net. Updated June 21, 2021. Accessed July 25, 2022. https://www.addictionresource.net/cost-of-drugs/illicit/

          20. Świądro M, Stelmaszczyk P, Lenart I, Wietecha-Posłuszny R. The Double Face of Ketamine-The Possibility of Its Identification in Blood and Beverages. Molecules. 2021;26(4):813. Published 2021 Feb 4. doi:10.3390/molecules26040813

          21. Morris, H. Hamilton’s Pharmacopeia Ketamine: Realms and Realities. [Video]. Vice TV. December 26, 2017. Accessed July 25, 2022. https://www.vicetv.com/en_us/video/hamiltons-pharmacopeia-ketamine-realms-and-realities/59cd5d0b7752d1ac3e90aacf

          22. Kurdi MS, Theerth KA, Deva RS. Ketamine: Current applications in anesthesia, pain, and critical care. Anesth Essays Res. 2014;8(3):283-290. doi:10.4103/0259-1162.143110

          23. Scarponcini TR, Edwards CJ, Rudis MI, Jasiak KD, Hays DP. The role of the emergency pharmacist in trauma resuscitation. J Pharm Pract. 2011;24(2):146-159. doi:10.1177/0897190011400550

          24. Lee M, Silverman SM, Hansen H, Patel VB, Manchikanti L. A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011;14(2):145-161.

          25. Johnstone-Petty, M. Ketamine use for complex pain in the palliative care population. J Hosp Palliat Nurs. 2018;20(6):561-567. doi: 10.1097/NJH.0000000000000488.

          26. Mercadante S, Caruselli A., Casuccio A. The use of ketamine in a palliative-supportive care unit: a retrospective analysis. Ann Palliat Med. 2018;7(2): 205-210. doi: 10.21037/apm.2018.01.01

          27. Bell RF, Kalso EA. Ketamine for pain management. Pain Rep. 2018;3(5):e674. Published 2018 Aug 9. doi:10.1097/PR9.0000000000000674

          28. Lalanne L, Nicot C, Lang JP, et al. Experience of the use of Ketamine to manage opioid withdrawal in an addicted woman: a case report. BMC Psychiatry. 2016;16(1):395. doi:10.1186/s12888-016-1112-2

          29. Blonk MI, Koder BG, Van Den Bemt PMLA, Huygen FJPM. Use of oral ketamine in chronic pain management: a review. Eur J Pain. 2012;14(5): 466-472. https://doi-org.ezproxy.lib.uconn.edu/10.1016/j.ejpain.2009.09.005

          30. Linder LM, Ross CA, Weant KA. Ketamine for the acute management of excited delirium and agitation in the prehospital setting. Pharmacotherapy. 2018;38(1):139-151. doi:10.1002/phar.2060

          31. Lulla AA, Singh M. The Art of the ED Takedown. emDOCs.net - Emergency Medicine Education. Published March 4, 2015. Accessed July 25, 2022. http://www.emdocs.net/the-art-of-the-ed-takedown/

          32. Young R, McMahon S. Some States Allow Authorities to Use Ketamine to Subdue Suspects in The Field. But Is It Safe? Some States Allow Authorities to Use Ketamine to Subdue Suspects in The Field. But Is It Safe? | Here & Now. Published September 8, 2020. Accessed July 25, 2022. https://www.wbur.org/hereandnow/2020/09/08/ketamine-police-safety-elijah-mcclain

          33. Ketamine. In: Lexi-Drugs. Lexi-Comp, Inc. Updated July 20, 2022. Accessed July 25, 2022. http://usj-ezproxy.usj.edu:2099/lco/action/doc/retrieve/docid/patch_f/7135?cesid=a8n33eDrj1M&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dketamine%26t%3Dname%26acs%3Dfalse%26acq%3Dketamine#rfs

          34. Montgomery-Asperg Depression Rating Scale. Accessed July 27, 2022. https://www.mdcalc.com/calc/4058/montgomery-asberg-depression-rating-scale-madrs

          35. Fedgchin M, Trivedi M, Daly EJ, et al. Efficacy and safety of fixed-dose esketamine nasal spray combined with a new oral antidepressant in treatment-resistant depression: results of a randomized, double-blind, active-controlled study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019;22(10):616-630. doi:10.1093/ijnp/pyz039

          36. Spravato. Prescribing information. Janssen Pharmaceutical Companies; 2019. Accessed July 25, 2022. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf

          37. Fedgchin M, Trivedi M, Daly EJ, et al. Efficacy and safety of fixed-dose esketamine nasal spray combined with a new oral antidepressant in treatment-resistant depression: results of a randomized, double-blind, active-controlled study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019;22(10):616-630. doi:10.1093/ijnp/pyz039

          The Mediterranean Diet’s Effect on Health

          Learning Objectives

           

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

          ·       Review the Mediterranean diet’s history and essential components
          ·       Discuss the relationship between culture, associated foods, and proven health benefits
          ·       Describe the relationship between the Mediterranean diet and the human microbiome
          ·       Discuss the pharmacist’s role as a resource for disseminating accurate, concise information to patients about the Mediterranean diet

          Release Date:

          Release Date: October 17, 2022

          Expiration Date: October 17, 2025

          Course Fee

          FREE

          There is no grant funding for this CE activity

          ACPE UANs

          Pharmacist: 0009-0000-22-063-H99-P

          Pharmacy Technician: 0009-0000-22-063-H99-T

          Session Codes

          Pharmacist:  19YC53-HKX42

          Pharmacy Technician:  19YC53-PWK93

          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 0009-0000-22-063-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

           Jill Fitzgerald, PharmD
          Former Director (retired) of Pharmacy Professional Development,
          University of Connecticut School of Pharmacy,
          Storrs, CT

          Sonya Kremenchugsky, PharmD,

          Zachary McPherson, PharmD,
          Pharmacist, Walgreens, CT

          Morgan Miller, PharmD
          Dispensary Pharmacist
          Bluepoint Wellness
          Branford, 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. Fitzgerald, Kremenchugsky, McPherson, and Miller do not have any relationships with ineligible companies and therefore have nothing to disclose.

           

          ABSTRACT

          CONTENT

          Content

          Pharmacist Post Test (for viewing only)

          Pharmacist Post-Test
          1. Ancel Keys was considered an icon in:
          a. Coronary heart disease
          b. Cardiovascular nutrition
          c. Influencing diet

          2. Why did Ancel Keys become interested in studying cholesterol?
          a. He was a vegetarian, which is notoriously a low-cholesterol diet
          b. He was Italian and thought everyone should eat like Italians do
          c. He noticed a significant increase in heart disease mortality

          3. What did Ancel Keys observe while traveling to Europe in the 1950s?
          a. Individuals born and raised in France or Germany experienced almost no cardiovascular disease or dyslipidemia
          b. There was a stark difference in the foods consumed and the health in Mediterranean countries compared to the United States
          c. In both France and Germany, the wealthy had high rates of cardiovascular disease, but the working class poor people had almost no cardiovascular problems

          4. At what meeting did Keys present his ideas?
          a. World Health Organization
          b. UNESCO
          c. PREDIMED

          5. What percentage of calories come from a carbohydrate source for the Mediterranean diet?
          a. 20%-30%
          b. 45%-55%
          c. 60%-70%

          6. What disease states can benefit from the Mediterranean diet?
          a. Kidney disease, diabetes, asthma, Crohn’s, ulcerative colitis
          b. Ulcerative colitis , cardiovascular disease, GERD, asthma
          c. Cardiovascular disease, diabetes, hypertension, kidney disease

          7. What is the human microbiome?
          a. The human microbiome is the complete population of all microbial organisms in and on our body
          b. The human microbiome is the microbial composition in our gastrointestinal tract, their genes and the environment that they live in within our bodies
          c. The human microbiome is the complete species list of all organisms that could pose a potential threat to our bodies

          8. Which disease states are likely to benefit from the microbiome?
          a. Kidney disease, diabetes, asthma, Crohn’s
          b. Ulcerative colitis , cardiovascular disease, GERD, migraines
          c. Cardiovascular disease, celiacs disease, obesity

          9. Which of the following is NOT a function of the microbiome?
          a. The microbiome strengthens the impermeability of the intestine
          b. The microbiome helps produce sex hormones to provide optimal fertility
          c. The microbiome contributes to immune system function

          10. Which of the following food groups provides the most amount of microbes to our bodies?
          a. Grains and cereals
          b. Meats
          c. Fruits and vegetables

          11. What is the effect of Bifidobacterium and Lactobacillus in the microbiome?
          a. They create the perfect environment for bacteria to grow by enhancing the pH and water saturation throughout the GI tract
          b. They defend the intestines against opportunistic pathogens
          c. They stimulate the growth of other beneficial species

          12. Which of the following is a major factor contributing to intestinal and extra intestinal diseases?
          a. Inadequate fluid intake
          b. Dysbiosis
          c. High sugar intake

          13. What is the effect of re-diversifying a dysbiotic microbiome?
          a. New disease states will occur
          b. Loss of function in the microbiome
          c. Prevention of intestinal diseases

          14. Which of the following best describes the Mediterranean Diet?
          a. Low carbohydrate, low fat, high animal protein diet
          b. High carbohydrate, high fat, low animal protein diet
          c. Low carbohydrate, high fat, high animal protein diet

          15. The Historic Centre of Florence is an example of a ____________________.
          a. UNESCO Intangible Cultural Heritage
          b. UNESCO Cultural Heritage
          c. UNESCO Natural Heritage

          16. What was the purpose of the PREDIMED trial?
          a. To test the efficacy of the Mediterranean diet on decreasing all-cause mortality
          b. To test the efficacy of the Mediterranean diet on cardiovascular health
          c. To test the efficacy of the Mediterranean diet on the composite endpoint

          17. What did the Aging and Adherence to the Mediterranean Diet find?
          a. An association between adherence to the Mediterranean Diet and adherence to medication
          b. An inverse association between adherence to the Mediterranean Diet and adherence to medication
          c. An inverse association between adherence to the Mediterranean Diet, polypharmacy and cardiometabolic disorders

          18. Which of the following is an example of a typical meal based on the normative Mediterranean diet?
          a. Bread with olive oil, charcuterie, cheese, a glass of wine
          b. Bread with olive oil, lentil salad, a glass of wine
          c. Bread with olive oil, grilled chicken, lentil salad

          19. Which of the following can help pharmacists and pharmacy technicians analyze a patient’s diet?
          a. The Cardiac Rehabilitation UK Mediterranean Diet Scorecard
          b. The Oldways Diet online site
          c. The Mayo Clinic’s webpage on eating

          20. Select the statement that is TRUE:
          a. The Mediterranean diet builds on inexpensive food that the poor, working class people ate traditionally.
          b. If researchers look at other regions of the world, no similar diets or health implications exist.
          c. Most pharmacists and techs instinctively follow a Mediterranean diet and can explain it to patients.

          Pharmacy Technician Post Test (for viewing only)

          Technician Post-Test
          1. Ancel Keys was considered an icon in:
          a. Coronary heart disease
          b. Cardiovascular nutrition
          c. Influencing diet

          2. Why did Ancel Keys become interested in studying cholesterol?
          a. He was a vegetarian, which is notoriously a low-cholesterol diet
          b. He was Italian and thought everyone should eat like Italians do
          c. He noticed a significant increase in heart disease mortality

          3. What did Ancel Keys observe while traveling to Europe in the 1950s?
          a. Individuals born and raised in France or Germany experienced almost no cardiovascular disease or dyslipidemia
          b. There was a stark difference in the foods consumed and the health in Mediterranean countries compared to the United States
          c. In both France and Germany, the wealthy had high rates of cardiovascular disease, but the working class poor people had almost no cardiovascular problems

          4. At what meeting did Keys present his ideas?
          a. World Health Organization
          b. UNESCO
          c. PREDIMED

          5. What percentage of calories come from a carbohydrate source for the Mediterranean diet?
          a. 20%-30%
          b. 45%-55%
          c. 60%-70%

          6. What disease states can benefit from the Mediterranean diet?
          a. Kidney disease, diabetes, asthma, Crohn’s, ulcerative colitis
          b. Ulcerative colitis , cardiovascular disease, GERD, asthma
          c. Cardiovascular disease, diabetes, hypertension, kidney disease

          7. What is the human microbiome?
          a. The human microbiome is the complete population of all microbial organisms in and on our body
          b. The human microbiome is the microbial composition in our gastrointestinal tract, their genes and the environment that they live in within our bodies
          c. The human microbiome is the complete species list of all organisms that could pose a potential threat to our bodies

          8. Which disease states are likely to benefit from the microbiome?
          a. Kidney disease, diabetes, asthma, Crohn’s
          b. Ulcerative colitis , cardiovascular disease, GERD, migraines
          c. Cardiovascular disease, celiacs disease, obesity

          9. Which of the following is NOT a function of the microbiome?
          a. The microbiome strengthens the impermeability of the intestine
          b. The microbiome helps produce sex hormones to provide optimal fertility
          c. The microbiome contributes to immune system function

          10. Which of the following food groups provides the most amount of microbes to our bodies?
          a. Grains and cereals
          b. Meats
          c. Fruits and vegetables

          11. What is the effect of Bifidobacterium and Lactobacillus in the microbiome?
          a. They create the perfect environment for bacteria to grow by enhancing the pH and water saturation throughout the GI tract
          b. They defend the intestines against opportunistic pathogens
          c. They stimulate the growth of other beneficial species

          12. Which of the following is a major factor contributing to intestinal and extra intestinal diseases?
          a. Inadequate fluid intake
          b. Dysbiosis
          c. High sugar intake

          13. What is the effect of re-diversifying a dysbiotic microbiome?
          a. New disease states will occur
          b. Loss of function in the microbiome
          c. Prevention of intestinal diseases

          14. Which of the following best describes the Mediterranean Diet?
          a. Low carbohydrate, low fat, high animal protein diet
          b. High carbohydrate, high fat, low animal protein diet
          c. Low carbohydrate, high fat, high animal protein diet

          15. The Historic Centre of Florence is an example of a ____________________.
          a. UNESCO Intangible Cultural Heritage
          b. UNESCO Cultural Heritage
          c. UNESCO Natural Heritage

          16. What was the purpose of the PREDIMED trial?
          a. To test the efficacy of the Mediterranean diet on decreasing all-cause mortality
          b. To test the efficacy of the Mediterranean diet on cardiovascular health
          c. To test the efficacy of the Mediterranean diet on the composite endpoint

          17. What did the Aging and Adherence to the Mediterranean Diet find?
          a. An association between adherence to the Mediterranean Diet and adherence to medication
          b. An inverse association between adherence to the Mediterranean Diet and adherence to medication
          c. An inverse association between adherence to the Mediterranean Diet, polypharmacy and cardiometabolic disorders

          18. Which of the following is an example of a typical meal based on the normative Mediterranean diet?
          a. Bread with olive oil, charcuterie, cheese, a glass of wine
          b. Bread with olive oil, lentil salad, a glass of wine
          c. Bread with olive oil, grilled chicken, lentil salad

          19. Which of the following can help pharmacists and pharmacy technicians analyze a patient’s diet?
          a. The Cardiac Rehabilitation UK Mediterranean Diet Scorecard
          b. The Oldways Diet online site
          c. The Mayo Clinic’s webpage on eating

          20. Select the statement that is TRUE:
          a. The Mediterranean diet builds on inexpensive food that the poor, working class people ate traditionally.
          b. If researchers look at other regions of the world, no similar diets or health implications exist.
          c. Most pharmacists and techs instinctively follow a Mediterranean diet and can explain it to patients.

          References

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          References