Patient Safety: Catch Me if You Can: Medication Errors and Their Impact

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

1. Describe details of common medication errors in hospital and community pharmacies

2. Differentiate between categories of medication errors

3. Calculate medication error rates

4. List approaches to learn from and prevent medication errors

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

1. Describe details of common medication errors in hospital and community pharmacies

2. Differentiate between categories of medication errors

3. Calculate medication error rates

4. List approaches to learn from and prevent medication errors

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.

Statisticians and risk managers widely consider medication errors to be the most preventable and most common cause of patient injury. By understanding common error scenarios, implementing safety protocols, and leveraging technology, pharmacy professionals can actively reduce risks and enhance the quality of care. This continuing education activity is designed to empower pharmacy professionals with the knowledge and tools needed to understand, measure, and address medication errors effectively.

INTRODUCTION

Ray and Kai are pharmacists that work together in a very busy outpatient clinic pharmacy. On a typical day, they fill around 800 prescriptions, and they usually have help from three technicians. Unfortunately, if anyone calls out sick or with an emergency, they don't have backup coverage.

Several times a week, patients return to the pharmacy and indicate that the prescriptions they received don't seem to be correct. Occasionally, Ray and Kai discover a medication error when patients indicate that their tablets or capsules don't look the same as a previous refill. Just yesterday, a mother returned to the pharmacy because her child’s liquid amoxicillin/clavulanate ran out before it should have. When Kai examined the label, she found a typographical error; it said, “take 5 mL three times a day” when it should have said, “take 2.5 mL three times a day.”

When staff members in this pharmacy identify medication errors, they usually discuss the problem quietly with the involved staff and make a mental note to implement corrective action or pay closer attention. Their pharmacy’s workload, staffing, error rate, and method of dealing with medication errors is not much different than many pharmacies across our nation. Throughout this continuing education activity, this example and others will help learners apply the lessons that experts have learned from analyzing medication errors.

Patient safety is a cornerstone of quality healthcare, and pharmacy professionals have an obligation to ensure patients receive safe and effective medications. Medication errors often stem from communication gaps, system complexities, or improper medication use. These errors not only compromise patient outcomes but also contribute to increased healthcare costs and increase risks of medication-related adverse effects.¹

The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) tallies and analyzes medication error reports from the National Medication Errors Reporting Program, which is administered by the Institute for Safe Medication Practices (ISMP). NCC MERP defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm.” Medication errors occur at various stages of the medication-use process, from prescribing and dispensing to administration and monitoring.² Recognizing these errors and implementing prevention strategies are essential to improving patient safety and advancing pharmacy practice.

OVERVIEW OF MEDICATION ERRORS

To truly appreciate medication errors’ impact on patients, pharmacy team members must recognize common terms and types of errors.

Medication Error Terminology

Several medication errors can arise in clinical and retail settings. To actively prevent patient injury through medication errors, it is important to know what to look for in practice. Terms to be familiar with in all pharmacy practice settings include^3,4:

Adverse drug event (ADE): An injury resulting from medical intervention related to a drug
Adverse drug reaction (ADR): An unintended reaction occurring at the intended drug dose
High-alert medications: Drugs that bear a heightened risk of causing significant patient harm when used in error
Look-alike/sound-alike (LASA) medications: Medications with similar-looking or similar-sounding names and/or shared features of products or packaging, leading to potential confusion
Medication reconciliation: The process of creating the most accurate list possible of all medications a patient is taking—including drug name, dosage, frequency, and route—and comparing that list against the physician's admission, transfer, and/or discharge orders, with the goal of providing correct medications to the patient at all transition points

PAUSE AND PONDER: When an error is identified, how does your pharmacy respond?

Defining and Classifying Medication Errors

Table 1 lists common medication errors that may occur throughout the stages of medication use.⁴

Table 1. Common Medication Errors⁴

Error Type	Description	Examples
Prescribing	Errors occurring when ordering medication	Wrong drug selection, incorrect dose/frequency, illegible handwriting, incomplete prescription, drug interactions
Dispensing	Errors occurring during medication preparation and distribution	Wrong medication, wrong strength, wrong dosage form, incorrect labeling, look-alike/sound-alike drug confusion
Administration	Errors occurring during drug administration to the patient	Wrong route, wrong dose, wrong rate, omission, administering to the wrong patient
Monitoring	Errors occurring due to lack of proper patient monitoring	Failure to monitor for adverse effects, inadequate lab test follow-up, failure to adjust dose for renal/hepatic function

Most medication errors are preventable and can also be classified by the severity of their impact on the affected patient. Leading organizations, such as NCC MERP, have developed taxonomies to classify medication errors in more detail, including nine categories labeled A through I. These categories range from circumstances that have the capacity to cause error (Category A) to errors that result in patient death (Category I). While categories E through I describe varying degrees of harm to the patient, categories A through D involve situations with no patient harm. These classifications help institutions analyze trends and implement targeted interventions.⁵

Figure 1 displays NCC MERP’s medication error classifications with severity levels increasing from top to bottom.⁵

Figure 1. Medication Error Classification⁵

A patient comes in to pick up a prescription at Ray and Kai’s pharmacy and the line is out the door. As Kai retrieves the medication, she quickly confirms the patient’s last name and date of birth. Ray knows the patient and greets him; “Hey Charlie, how are the kids?” Kai then realized the prescription in hand was meant for a different patient by the name of Billy and was in the same bin. The correct medication is retrieved, and the patient safely receives what was actually prescribed, resulting in a near miss, rather than a full medication error.

Later, Ray and Kai sit down to reflect on what could have happened if the mistake hadn’t been caught in time. If the pharmacy dispensed the wrong medication and the patient noticed and brought it back before taking it, this would be an error, no harm situation. However, if the patient took the incorrect medication and experienced harmful adverse effects, it would result in an error, harm situation. In a more severe scenario, if the patient took the wrong medication and had an allergic reaction or other fatal outcome, it would be considered error, death. After discussion, Ray and Kai decide to speak to the staff about the importance of verifying patient information in full at every encounter. They relay a PRO TIP: employees can place prescriptions for patients with similar names in separate bins to avoid confusion.

Even the smallest and most routine tasks, such as verifying a patient’s identity, carry immense responsibility. Every action performed in a pharmacy setting has a direct impact on patient health. A moment of inattention or a skipped step can be the difference between preventing harm and causing irreversible consequences. That’s why it is crucial to approach every task, no matter how routine, with full attention and diligence

Beyond preventing individual mistakes, classifying and analyzing medication errors is a key to improving patient care on a larger scale. Recognizing and labeling these errors—whether they are near misses, errors with no harm, or more serious mistakes—provides valuable insight into when and where they happen. By identifying patterns, pharmacies can implement targeted safety measures to minimize risks.^4,5

ANALYSE, DOCUMENT, PREVENT

Medication Error Rates

To identify and reduce medication errors effectively, individuals and institutions must track their occurrences systemically. One of the most effective ways to achieve this is by calculating the medication error rate, which provides valuable insight into areas requiring improvement.⁶ The formula for calculating the medication error rate is as follows:

<<ADD IMAGE>>

The numerator represents the total number of medication errors recorded during a given period, with each error event counted as one. The denominator consists of all medication orders or doses that were dispensed and administered.⁶ This formula applies across all pharmacy settings, including both community and hospital environments.

For example, a hospital pharmacy dispenses 100,000 doses in a month and identifies 50 medication errors in that month. What is the medication error rate?

Once calculated, error rates are a crucial tool for identifying trends and implementing targeted interventions. By analyzing the data, healthcare teams can pinpoint high-risk areas, set measurable goals, and put corrective measures into action to minimize errors. This proactive approach not only enhances patient safety; it also optimizes pharmacy workflow and overall efficiency.

The pharmacy where Ray and Kai work is accredited. During an accreditation audit, one of the surveyors asks Ray about their medication error rate. Ray is unable to answer. The surveyor pushes a little and asks Ray to provide copies of all incident reports regarding medication errors. Ray finds two or three in which the medication error was serious enough to attract attention from the clinical staff or the clinic's risk manager. When the surveyor explains how to calculate a medication error rate, Ray listens carefully. Needless to say, the surveyor noted the lack of documentation about medication errors as a deficit in the survey and indicated that she did not believe that they only had three medication errors in the past year. When Ray and Kai meet to plan corrective action, they realize that without good documentation, they cannot make this calculation.

To ensure accuracy and reliability, all pharmacy and healthcare organizations must foster a culture of transparency and promote non-punitive error reporting.^6,7 Management must encourage staff to report errors without fear of retribution, allowing institutions to collect comprehensive data and develop effective mitigation strategies. Hospitals and community pharmacies can gain valuable insight into their performance by benchmarking their calculated error rates against institutions of similar size and complexity. Comparing rates with national standards or similar organizations helps ensure adherence to best practices and provides insight into additional potential interventions.⁷

Documenting Medication Errors

Pharmacists and technicians should know how to document and report incidents that occur in their pharmacy properly, usually following policies or procedures put in place by their institution and legal regulations. Unusual incident reports (UIRs) are a formal mechanism for documenting clinically significant medication errors and near misses.

Following identification of an incident and corrective patient measures, all relevant personnel should be notified and asked to record their recall of events. These reports should include key details such as who was involved, when and where the incident occurred, type of error, contributing factors, and corrective actions taken.⁸To prevent recurrence of an incident or find a systemic issue leading to incidents, errors should regularly be recorded regardless of severity or whether it reached the patient or not. A PRO TIP is to maintain a list of errors that should be documented and keep unused UIRs in an accessible place (e.g., pinned on all desktops or stored in designated folders), encouraging staff to fill them out. These forms should be completed in full and a PRO TIP is to include instructions on what steps to take following the incident (i.e., read over and include any forgotten details, ensure all relevant staff is notified). Investigative staff should thoroughly gather data pertaining to the incident, including records, UIRs, patient notes, and physical items used in the event.⁹ Staff should establish a clear chronology of events to determine the root cause and prevent future occurrences.

Pharmacists and technicians should be well-versed in properly documenting and reporting incidents in their pharmacy, usually following institutional policies and legal regulations. UIRs serve as a formal mechanism for recording clinically significant errors and near misses. The following steps are necessary for proper documentation and reporting^8-10:

Identify and respond to the incident
- When an error or near miss occurs, prioritize patient safety by taking corrective actions and notify all relevant personnel, including leadership.
Thoroughly document the incident
- UIRs should capture key details such as
  1. who was involved
  2. when and where the incident occurred
  3. type of error and contributing factors
  4. corrective actions taken and follow-up measures
- All involved personnel should document their recollection of events promptly to ensure accuracy.
Encourage consistent reporting
- To prevent recurrences and identify systemic issues, all errors—regardless of patient impact severity—should be recorded.
- PROTIP: Maintain a list of errors that must be documented and keep unused UIRs easily accessible (i.e., pinned on desktops or stored in a designated folder) to encourage completion.
- Forms should be fully completed, and staff should review their entries for accuracy before submission.
Investigate and analyze the incident
- Investigative staff should collect all relevant data, including UIRs, records, forms, and any physical items used in the event.
- Establish a clear chronology of events to determine the root cause and prevent future occurrences.

UIRs are considered Quality Improvement data in healthcare organizations, making them confidential and generally protected from disclosure under laws like the Patient Safety and Quality Improvement Act.¹¹ Organizations use these reports internally to enhance patient safety and do not share them with patients or lawyers. However, protection can vary based on state laws and institutional policies, so a PRO TIP for organizations would be to highlight their specific policies and require additional training and separate filings to ensure proper procedures to maintain confidentiality.

Individuals must report serious medication errors resulting in patients harm or regulatory violations to state boards of pharmacy and should also report them to accreditation agencies (e.g., Joint Commission) and the FDA through the MedWatch program.⁸ Pharmacy personnel is expected to know how and when to use institution-specific forms and to revise these to simplify and encourage the error reporting process.

Ray and Kai are motivated to track medication errors better. When they dust off their stack of unused UIR forms, they realize that their forms are skeletal and their organization would benefit from a better tool. One of their technicians, Tara, volunteers to look at a number of different forms and identifies four. The staff chooses to “pilot” two, meaning they will document all medication errors that occur over the next three weeks on both forms, and then analyze the results. At the end of the pilot, they choose one form but realize that they need to tailor it to their practice. Tara also notes that they could automate the form and include a picture of the dosage forms that were involved.

Within three months, Ray and Kai realize from the pictures that a full 25% of their errors involve tablets that are white. Ray and Kai can share a PRO TIP with other organizations now. They create a whiteboard that lists most of their white tablets and the tablet markings. The technicians who handle inventory update the whiteboard when they change generics. Additionally, whenever Ray or Kai visually verify a prescription for a white tablet, they note the tablet marking on the prescription. In this way, they eliminate a good number of errors.

Institutions may have different methods for documenting unusual incidents, so it is essential that pharmacy staff know how to access and properly complete these forms. Keeping UIR forms up to date ensures they remain effective and relevant. Attached are three different incident report forms; review them carefully and identify their similarities and differences (see Appendix).^12-14

Accurate medication error reporting is the underpinning of identifying risks and improving patient safety. However, traditional error-reporting systems often capture only a portion of actual incidents and do not usually account for adverse effects. This could be attributed to limitations in error-reporting, including but not limited to underreporting due to fear of punishment, time-consuming processes, and a lack of feedback and follow-up.¹⁵ Research suggests that the use of observation, when appropriate and feasible, could lead to more accurate detection of medication errors in practice.^16,17 When applicable, institutions can use observation in combination with tracking error reports and greatly reduce the frequency of medication errors.

A strong culture of safety in pharmacy practice encourages transparent error reporting and non-punitive responses. Employees should feel comfortable reporting mistakes without fear of disciplinary action, as this fosters a learning environment rather than a blame culture. Encouraging reporting allows institutions to^7,18

identify error trends and implement preventative measures
provide additional training where needed
improve medication safety policies and procedures

All people in positions of authority should encourage pharmacy personnel to report medication errors to their institutions and to the FDA, ISMP, or NCC MERP if appropriate.¹⁹

System-Based Prevention Approaches

Healthcare institutions implement structured systems to enhance workflow efficiency and minimize medication errors. These systems provide standardized protocols, technological advancements, and communications strategies that help pharmacy personnel ensure safe and accurate medication dispensing and administration.

With advancements in technology, healthcare professionals frequently rely on automated systems to assist with medication safety. While these tools greatly reduce the potential for human error, they should be used to complement, not replace, pharmacist and technician expertise. Proper training and implementation of these tools are essential to their effectiveness. Key technologies that reduce medication errors include the following^18,20,21:

Barcode scanning as an additional verification step in the dispensing and administration process ensures that the correct drug, dose, and patient matches the prescription and manufacturer specifications.
Computerized provider order entry (CPOE) and e-prescribing reduce errors by eliminating the risk of misinterpreting handwritten prescriptions. CPOE also alerts prescribers about potential drug interactions, allergies, and dosing errors before orders are processed.
Automated dispensing cabinets, commonly used in hospitals, help regulate medication storage, access, and tracking to prevent unauthorized or incorrect dispensing.

To maximize these systems’ effectiveness, pharmacy staff must remain vigilant, ensuring that they do not blindly trust automation. As recommended by the ISMP, conducting manual double-checks judiciously, selective to certain high-risk tasks or medications, can further enhance patient safety.²²

Familiarizing all staff with institutional standard operating procedures (SOPs) is essential for ensuring consistent and safe practice. These guidelines outline step-by-step procedures for specific pharmacy operations, reducing deviations that could lead to medication errors.²³ When adhered to properly, SOPs standardize processes (minimizing variability and human error), provide clear instructions for handling high-alert medications, and outline best practices for prescription verification, dispensing, and patient counseling.^21,23 For example, a hospital SOP may require two licensed healthcare professionals to verify chemotherapy doses independently before administration. In a community pharmacy, an SOP may require mandatory counseling for first-time prescriptions of high-risk medications, such as opioids or anticoagulants. Having SOPs and checklists readily accessible ensures that pharmacy personnel can reference best practices quickly when dealing with complex or high-risk situations.

SIDEBAR: A Word About CHECKLISTS

When checklists are numerous in quantity and poor in design, pharmacy staff may experience a sense of checklist fatigue, becoming overwhelmed and disengaged with completing them. This could lead to rushed or skipped steps, negatively impacting performance and patient safety. The following lists some strategies to avoid feeling desensitized to the repetitive nature of checklists^22,24,25:

Use checklists selectively by focusing on the most important or highest-risk tasks
Improve the design to be clear, concise, and easy to follow
Avoid unnecessary or redundant steps
Regularly ensure the checklists are up-to-date and effective
Address fatigue with staff and provide training and feedback on the importance of each step

PAUSE AND PONDER: When reviewing a prescription, what red flags should prompt you to double check with a prescriber, pharmacist, or colleague?

PHARMACY PRACTICE CONSIDERATIONS

Each pharmacy practice type has its own unique concerns and considerations with regard to medication error reporting.

Community Pharmacy

In a retail or clinic pharmacy setting, like the one in which Ray and Kai work, pharmacists and pharmacy technicians must exercise caution throughout the prescription filling process to prevent errors. These errors can be minor and initially go unnoticed, but can lead to serious adverse events, hospitalizations, or even fatalities if not promptly identified and addressed.²⁶

The first stage of medication processing—receiving a prescription—creates a significant risk for errors. Whether prescriptions are transmitted electronically, by phone, or handwritten, pharmacy personnel may misread, misinterpret, or fail to recognize important details.²⁷ Especially in high-volume settings, healthcare professionals should prioritize accuracy by seeking prescriber clarification when needed, rather than making assumptions or rushing through interpretation. Errors can also originate from prescribers, and pharmacy personnel should have a high index of suspicion that every prescription is incorrect. Calling to clarify questionable doses or frequencies ensures patient safety and may also prompt prescribers to recognize and correct unintended mistakes.²⁶All three errors that Ray and Kai documented had been serious enough to result in an ADE or ADR. When they looked back at these errors, they realized that for two of them, if they had questioned the patients or called the prescribers, the errors may have been avoided entirely.

Common errors that pharmacists and technicians should be vigilant about in community pharmacy include^1,3,27,28

Misinterpreting abbreviations and symbols: Sloppy abbreviations and symbols can lead to dangerous dosing errors. Table 2 summarizes the Joint Commission’s “DO NOT USE” list of abbreviations that should be displayed in pharmacies.
LASA medications: Medications with similar names can be easily confused if not carefully verified.
Incorrect dosing and strength selection: Errors can occur by selecting the wrong strength of a medication or miscalculating pediatric or weight-based doses.

Table 2. The Joint Commission’s “DO NOT USE” List²⁸

Do Not Use	Potential Problem	Use Instead
U, u	Mistaken for “0” (zero), the number “4” (four) or “cc”	Write “unit
IU	Mistaken for IV (intravenous) or the number 10 (ten)	Write “International Unit”
Q.D., QD, q.d., qd Q.O.D., QOD, q.o.d., qod	Mistaken for each other Period after the Q mistaken for “I” and the “O” mistaken for “I”	Write “daily” Write “every other day”
Trailing zero (X.0 mg) * Lack of leading zero (.X mg)	Decimal point is missed	Write X mg Write 0.X mg
MS MSO₄ and MgSO₄	Can mean morphine sulfate or magnesium sulfate Confused for one another	Write “morphine sulfate” Write “magnesium sulfate”

*Exception: A trailing zero is only allowed when necessary to indicate the exact level of precision, such as in laboratory results, imaging studies that report lesion sizes, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.

Maintaining readily accessible reference lists can help pharmacy personnel cross-check potential medication errors before contacting prescribers. The ISMP has identified numerous LASA pairs that contribute to medication errors and has created lists of commonly confused abbreviations and symbols.²⁹ Additionally, using TALL Man lettering (e.g., capitalizing part of a drug's name in upper case letters to differentiate similar drug names like hydrALAzine vs hydrOXYzine) when documenting or labeling LASA medications can minimize confusion.²⁹

In the hypothetical pharmacy, Ray notes that one of the technicians consistently fills prescriptions for dipyridamole with diphenhydramine. He has pointed this problem out to the technician several times and asked the technician to find the correct medication, but the problem continues. After learning about TALL Man lettering, he realizes that their computer system does not use this simple but useful intervention. He contacts the programmers and asks if they can make the changes, providing the ISMP's list of drugs for which this intervention could prevent many errors. A PRO TIP here is to ask the technician to use a highlighter to highlight the part of the drug name that follows "DIP-" on all drugs that begin with these three letters before filling prescriptions.

Errors often arise during the later stages of prescription processing, including data entry, assembly, and pharmacist verification. Pharmacy personnel may rely too heavily on the auto-populated fields in electronic prescribing systems (e.g., McKesson, PioneerRx), assuming the information is correct without double-checking key details. This could lead to incorrect medication strengths, frequency, or refill quantities, ultimately causing billing issues or improper medication dispensing.^27,20

Dispensing the wrong formulation can occur if pharmacy staff select similar-looking bottles. Barcode scanning technology can help reduce assembly errors by ensuring use of the correct product. Pharmacists must physically inspect medications rather than relying solely on electronic systems. Pharmacy staff should attach medication guides, auxiliary labels, and other patient education materials as necessary. Pharmacy professionals must recognize that technology is a tool, not a replacement for human oversight. Systems may have glitches or auto-fill errors, and staff should remain vigilant to manually verify accuracy when needed. ²⁰

Over the few weeks after the accreditation survey, Ray and Kai see a number of minor medication errors in the pharmacy. During a counseling session, Kai learns that one patient has been taking a diuretic but has not been increasing the amount of potassium in her diet. The patient reports cramping and nausea. Kai realizes that the pharmacy staff stopped using colorful auxiliary labels, assuming that the key counseling points are covered in the multi-page handout that the computer prints with each prescription. Unfortunately, many patients simply throw that multi-page handout into the recycle bin (as did this patient). Kai realizes that using auxiliary labels is an opportunity to improve counseling and to increase the likelihood that patients will take medications correctly.

The final step in the prescription process—dispensing the medication to the patient—requires uninterrupted attention to detail. Staff often overlook or rush this step in busy retail pharmacies, especially under pressure from patients who may be in a hurry. Patients who are eager to leave or have pressing time constraints may create an environment where staff feel rushed to complete the transaction quickly, potentially compromising safety. The Joint Commission requires two patient identifiers before dispensing a medication (e.g., full name and date of birth) to prevent mix-ups.²⁶ Failing to confirm the patient’s identity may result in a patient receiving the wrong prescription, leading to serious consequences.

While not all patients will ask for counseling, it is the pharmacy staff’s responsibility to offer counseling proactively, especially in critical situations. Pharmacy staff must remain alert to identify potential medication errors and recognize when pharmacist intervention is necessary. Pharmacy technicians are essential to this process. In our hypothetical pharmacy, Ray and Kai realize that the way that they've been dealing with medication errors isn't conducive to ideal teamwork. Further, they realize that they need to engage their technician support team so the pharmacist becomes involved in the process earlier when technicians see red flags.

Common errors that require technician awareness and referral to the pharmacist include^2,4,20

misuse or incorrect administration
first-time prescriptions, dose changes, or class switches
high-risk medications or drug interactions
duplicate therapy or overlapping prescriptions

By actively engaging in patient education and ensuring clear communication at the point of dispensing, pharmacy professionals can significantly reduce medication errors and enhance patient safety. A PRO TIP comes from the Indian Health Service where pharmacy staff take a few minutes to remove medication from the bag, read the drug name, open the bottle, shake a few dosage units into the cap, and show it to the patient. Patients may identify medications that look different than they remember, which may signal a change in generic supplier or may identify an error. Although this process sounds time consuming, it actually takes just a few seconds for each bottle, and it prevents adverse outcomes in many cases.

Hospital Pharmacy

Hospital pharmacists and pharmacy technicians have serious responsibilities in ensuring safe medication use among high-risk patient populations. Like patients seen in the community, hospitalized patients often have complex conditions, multiple comorbidities, and require high-alert medications. But any event that precipitates hospitalization increases vulnerability to medication-related adverse events.²¹ Learners should note that many of these interventions apply in community centers as well.

Similar to retail or clinic pharmacy, miscommunication between prescribers and pharmacy personnel remains a leading cause of medication errors in hospitals. Healthcare providers can reduce errors through effective communication, verification, and collaboration. Regularly confirming prescription details and clarifying discrepancies helps prevent errors before they reach patients. Pharmacy staff need to establish trust and employ open communication with prescribers to ensure patient safety in hospitals. A breakdown in interprofessional relationships can lead to medication errors, such as^18,21

incorrect medication selection due to misinterpreted verbal or written orders
dosing errors, particularly in pediatric or renally impaired patients, when key patient information is not communicated
failure to adjust medications in response to changing renal or hepatic function, leading to toxicity or subtherapeutic dosing
missed allergy documentation, resulting in patients receiving medications that trigger adverse reactions

By fostering a culture of open dialogue and verification, hospital pharmacy teams can minimize preventable errors and ensure optimal patient care.

Consider a hospital pharmacy that employs nine pharmacists on three shifts, with a staffing ratio of one pharmacist to two technicians throughout the entire 24 hours. This pharmacy does a better job of documenting medication errors on unusual incident reports, but considerable room for improvement remains. Lisa is the pharmacist who works closely with the Performance and Quality Improvement (QPI) Department. Her liaison in QPI notifies Lisa that of the 46 medication errors reported in the last quarter, eight were associated with orders from a hospitalist, Dr. Backoff, who rotates shifts. The underlying cause seems to be miscommunication. Dr. Backoff is well known for his offensive behaviors; he humiliates people who ask questions, intimidates coworkers using insults or repeatedly bringing up past errors, excludes staff from opportunities to participate, and is generally so critical that people avoid him.³⁰

When staff call Dr. Backoff, he often fails to return the call. Over time, the situation has escalated to the point where staff are afraid to pick up the phone and call him when problems occur. As Lisa works with her QPI liaison, they realize that their workplace has no comprehensive policies and procedures targeting workplace bullying. Without clear guidelines and protocols, people who are targeted by bullies may feel powerless and unwilling to work with their bully.³¹ A PRO TIP is that this organization needs to develop training to address bullying, and Lisa and the QPI liaison need to speak to Dr. Backoff's supervisor immediately. The supervisor can refer Dr. Backoff to employee assistance program or implement corrective and disciplinary action.

Certain medications require heightened safety precautions due to their potential for severe patient harm if misused. The ISMP has a list of high-alert medications that require extra safeguards in hospital settings. An example of these are anticoagulants; even small dosing mistakes could lead to severe bleeding or thrombosis (clotting).³² Due to the serious risks associated with high-alert medications, pharmacy staff pharmacists and pharmacy technicians should double-check and arrange independent verification consistently.²¹

Medication errors frequently occur during transitions of care, including hospital admission, transfers to other facilities (e.g., long-term care, rehabilitation), and discharge to home. These errors can result in unintentional medication discontinuation, dose and frequency errors, or discharge medication miscommunication, significantly increasing patients’ risk of harm.³³One of the most significant risks during transitions of care is unintentional medication discontinuation (mistakenly stopping an essential chronic medication). Dose and frequency discrepancies and miscommunications about discharge medications further increase the risk of ADEs post-hospitalization.³⁴

To prevent these errors proactively, hospital pharmacists and pharmacy technicians should^21,33

conduct a thorough medication reconciliation at the time of admission, ensuring all home medications are accurately documented
maintain clear, updated medication lists through each stage of hospitalization
collaborate to ensure patients and caregivers receive comprehensive discharge counseling, with the technician reminding or prompting pharmacists if this step is missed, and reinforcing medication changes adherence instructions

Lisa’s hospital has a structured transitions of care program. They hire pharmacy students to conduct medication reconciliation under a pharmacist’s supervision. Before pharmacy students can conduct medication reconciliation, they complete a comprehensive training program. Regardless, errors on the medication list still slip through.

Lisa's hospital is not alone with this problem. Many hospitals find that errors occur even after medication reconciliation. A 2024 study of the medication reconciliation process and related medication errors indicates that these processes are “very heterogeneous,” meaning that in some areas, medication reconciliation was very good and in others, not so much.³⁵ They found that error rates were unexpectedly high in some areas. This study looked at 929 prescriptions written for 182 patients. In 91% of cases, the reconciler had not specified the drug form. About 72% of medication administration errors pursuant to a faulty medication reconciliation exercise resulted in patients receiving the wrong release dose formulation (i.e., immediate release as opposed to extended release). The researchers indicated that medication error rates did not improve significantly over the period before they conducted routine medication reconciliation.³⁵

Lisa has heard coworkers talk about medication reconciliation as a useless process and seeing them roll their eyes when they look at a medication reconciliation report that has obvious errors. In the past, pharmacy staff did not consider a mistake on a medication reconciliation list to be a medication error. However, when a serious error slips through, Lisa’s QPI liaison suggests that they began tracking such errors on unusual incident reports. A PRO TIP here is to track errors in medication reconciliation and try to identify the areas where errors are most likely to occur in the medication reconciliation process. At this hospital, Lisa and the QPI liaison were able to confirm that they also had a problem with identification of the correct formulation. Over the following months, they were able to improve by using additional training and revising their medication reconciliation form to force technicians to ask about the formulation or to see the bottle.

PAUSE AND PONDER: Can you think of any processes or policies in your workplace that can be improved to enhance patient safety?

Pharmacist and Technician Responsibilities

Pharmacy professionals have a responsibility to actively communicate with their colleagues and other healthcare providers to prevent errors. Effective collaboration within the healthcare team ensures safe medication practices by¹⁸

clarifying unclear or incomplete prescriptions before dispensing
confirming appropriate dosing adjustments for renal or hepatic impairment
coordinating medication reconciliation during transitions of care to prevent omissions or duplications

Management needs to empower pharmacists and pharmacy technicians to voice concerns regarding potential medication errors. Addressing these concerns professionally and respectfully fosters a culture of teamwork and patient safety.

A key responsibility of pharmacy professionals is to provide clear, understandable medication counseling to patients. However, it is unrealistic to expect that staff can counsel all patients on every detail of their prescription. Instead, pharmacists should prioritize the most critical points, especially on new prescriptions, including³⁶

dosing instructions and adherence importance
common and serious adverse effects
drug interactions and contraindications
proper storage and administration techniques

One effective counseling strategy is the teach-back method, where patients repeat the pharmacist’s instructions back in their own words. This ensures patients fully understand how to use their medication correctly. For example, when dispensing doxycycline, instead of simply stating “Take this with a full glass of water,” a pharmacist using the teach-back method would ask one simple question after explaining how to take the doxycycline: “Can you explain to me how you will take this medication to avoid stomach irritation? I need to be sure I covered everything.”^18,21,26

When a serious medication error occurs, it is crucial to investigate the underlying causes to prevent future occurrences. Root-cause analysis (RCA) is a structured problem-solving method used to analyze errors after they have happened—including what, how, and why it happened—and can help determine what lessons could be learned and how to reduce the risk of recurrence and make care safer.^3,21 For example, if a retail pharmacy dispenses the wrong insulin type and a patient is subsequently hospitalized, an RCA might reveal that the error stemmed from look-alike packaging and a lack of independent verification.

Failure mode and effects analysis (FMEA) is a proactive approach to medication safety, identifying potential failures before they occur. By evaluating processes and pinpointing high-risk areas, institutions can implement safeguards to prevent errors before they reach patients.²¹ For instance, before introducing a new automated dispensing cabinet, an FMEA could help identify potential failure points, such as medication selection due to user interface design, allowing for preventive modifications.

CONCLUSION

Patient safety is a fundamental pillar in pharmacy practice, and reducing medication errors requires a proactive, systematic approach. Errors can occur at any stage of the medication use process, from receiving and interpreting prescriptions to dispensing and patient counseling. Recognizing common errors—such as abbreviations, LASA drugs, incorrect dosing, and transcription mistakes—helps pharmacy professionals to implement safeguards that prevent harm.

Patient Safety: Catch Me if You Can: Medication Errors and Their Impact

Pharmacist Post-test

After completing this continuing education activity, pharmacy technicians will be able to
• Describe details of common medication errors in hospital and community pharmacies
• Differentiate between categories of medication errors
• Calculate medication errors rates
• List approaches to learn from and prevent medication errors

1. Which of the following examples of medication errors is correctly matched with its error type/stage of prescription processing?
A. Wrong route of administration – Prescribing
B. A prescription written with illegible handwriting – Dispensing
C. Failure to adjust dose for renal/hepatic function – Monitoring

2. Which of the following is an example of a high-alert medication that requires extra caution?
A. Normal saline
B. Loratadine
C. Warfarin

3. You need to calculate your pharmacy’s medication error rate for the past calendar week before the staff meeting. There have been eight errors and 6,400 medication orders that were dispensed for this week. What is the medication error rate?
A. 0.13%
B. 0.08%
C. 8.13%

4. Which of the following is a key benefit of encouraging incident reporting systems in pharmacies?
A. Identifying trends to implement system-wide improvements
B. Finding who is responsible and firing them immediately
C. Reducing the daily workload for pharmacy staff

5. Which of the following is an example of why it is important to maintain good relationships with other health professionals?
A. It ensures that pharmacists thoroughly document allergies
B. It facilitates clear communication, reducing risk of errors
C. It allows pharmacy staff to bypass unnecessary verification steps

6. Which of the following best differentiates a prescribing error from a dispensing error?
A. A prescribing error occurs during medication order entry, while a dispensing error occurs during medication preparation or distribution
B. Prescribing errors only occur in hospitals, while dispensing errors only occur in community or outpatient clinic pharmacies
C. A prescribing error is always detected by the pharmacy technician, while a dispensing error is only noticed by the pharmacist

7. A patient started thyroid medication 6 months ago and has been taking the same dose without any follow-up bloodwork. What type of medication error is this?
A. Monitoring error
B. Transition-of-care error
C. Prescribing error

8. Which of the following is the best strategy to prevent look-alike/sound-alike medication errors?
A. Using only brand names during the prescription filling process
B. Using TALL Man lettering and routine barcode scanning
C. Storing similar-sounding medications together for easy access

9. How can you use the medication error rate to identify areas for improvement and enhance patient safety?
A. Analyzing error rate trends to pinpoint problem areas
B. Creating predictive models that estimate future potential error rates
C. Benchmarking error rates against comparable institutions

10. In your very busy pharmacy, you identify that most medication errors are occurring at the point of prescription entry. What is an appropriate response?
A. Provide additional training on prescription verification
B. Add a verification call to the prescriber for all written prescriptions
C. Stop accepting handwritten prescriptions in your pharmacy

Patient Safety: Catch Me if You Can: Medication Errors and Their Impact

Pharmacy Technician Post-test

1. Which of the following medication errors is correctly matched with its error type/stage of prescription processing?
A. Wrong route – Monitoring
B. Illegible handwriting – Dispensing
C. Wrong drug selection – Prescribing

2. When would you classify a medication error as a near miss?
A. An error occurred, but did not reach the patient
B. A potential error was identified, intercepted, and avoided
C. An error occurred and reached patient, but the patient is fine

3. The pharmacist you work with wants to calculate the percentage of prescription orders that were errors in the past calendar week. They ask you to calculate this number, telling you that there have been five errors out of 7,000 medication orders dispensed this week. What is the medication error rate?
A. 0.07%
B. 0.05%
C. 1.40%

4. How can you use the medication error rate to identify areas for improvement and enhance patient safety?
A. Analyzing error rate trends to pinpoint problem areas
B. Creating predictive models that estimate future potential error rates
C. Benchmarking error rates against comparable institutions

5. Which of the following is a common cause of medication errors in community pharmacy?
A. Using auxiliary labels on all medications without reviewing their necessity
B. Providing medication counseling for patients even when they are rushed
C. Misinterpreting prescriptions due to abbreviations or unclear handwriting

6. Which of the following scenarios would prompt you to refer a patient to the pharmacist to prevent a medication error?
A. A patient picking up medication refill for her spouse
B. A patient requesting an early refill on a maintenance medication
C. A patient using new insurance information on a prescription refill

7. Where can you find lists of high-alert medications and look-alike/sound-alike medications?
A. American Pharmacist Association (APhA) practice guidelines
B. Standards of operations forms
C. Institute of Safe Medication Practices

8. Which strategy can help prevent accidental medication discontinuation during transition of care?
A. Medication reconciliation
B. Automatic therapeutic substitution
C. Discharging the patient as fast as possible

9. Which strategy can help prevent medication errors in all pharmacy settings?
A. Using auto-population options on electronic systems as often as possible
B. Encouraging a double-check system for high-risk medications
C. Relying solely on bar-code scanning as the final verification step

10. In a hospital setting, when is there a high chance of medication errors occurring?
A. During surgery
B. During discharge
C. During visitation hours

References

1. Hodkinson A, Tyler N, Ashcroft DM, et al. Preventable medication harm across health care settings: a systematic review and meta-analysis. BMC Med. 2020;18(1):313. doi:10.1186/s12916-020-01774-9
2. National Coordinating Council for Medication Error Reporting and Prevention. About Medication Errors. Accessed February 2, 2025. https://www.nccmerp.org/about-medication-errors
3. Agency for Healthcare Research and Quality. Glossary. Patient Safety Network. Accessed February 2, 2025. https://psnet.ahrq.gov/glossary-0
4. Technical Series on Safer Primary Care: Medication Errors. World Health Organization. December 13, 2016. Accessed February 2, 2025. https://www.who.int/publications/i/item/9789241511643
5. National Coordinating Council for Medication Error Reporting and Prevention. NCC MERP Index for Categorizing Medication Errors. Updated October 2022. Accessed February 2, 2025. https://www.nccmerp.org/sites/default/files/index-color-2021-draft-change-10-2022.pdf
6. Allan BL. Calculating medication error rates. Am J Hosp Pharm. 1987;44(5):1044-1046.
7. Hughes RG, ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); April 2008.Accessed February 4, 2025. https://pubmed.ncbi.nlm.nih.gov/21328752/
8. Institute of Medicine (US) Committee on Data Standards for Patient Safety, Aspden P, Corrigan JM, Wolcott J, Erickson SM, eds. Patient Safety: Achieving a New Standard for Care. Washington (DC): National Academies Press (US); 2004.Accessed March 21, 2025. https://nap.nationalacademies.org/catalog/10863/patient-safety-achieving-a-new-standard-for-care
9. Lawton R, McEachan RR, Giles SJ, Sirriyeh R, Watt IS, Wright J. Development of an evidence-based framework of factors contributing to patient safety incidents in hospital settings: a systematic review. BMJ Qual Saf. 2012;21(5):369-380. doi:10.1136/bmjqs-2011-000443
10. The Confidentiality of Incident Reports: A Crucial Consideration. SafeQual. Accessed April 30, 2025. https://www.safequal.net/sb/the-confidentiality-of-incident-reports-a-crucial-consideration/
11. U.S. Department of Health and Human Services. Understanding patient safety confidentiality. October 22, 2024. Accessed March 25, 2025. https://www.hhs.gov/hipaa/for-professionals/patient-safety/index.html
12. Clinical incident report sample PDF form. FormsPal. Accessed March 27, 2025. https://formspal.com/pdf-forms/other/clinical-incident-report-sample/
13. 7 Essential Elements of an Incident Report, and a Free Guide. Safety Evolution Blog. August 24, 2022. Accessed March 27, 2025. https://www.safetyevolution.com/blog/7-essential-elements-of-an-incident-report-and-a-free-guide
14. Tariq A, Georgiou A, Westbrook J. Medication incident reporting in residential aged care facilities: limitations and risks to residents' safety. BMC Geriatr. 2012;12:67. Published 2012 Nov 2. doi:10.1186/1471-2318-12-67
15. Flink E, Chevalier CL, Ruperto A, et al. Lessons Learned from the Evolution of Mandatory Adverse Event Reporting Systems. In: Henriksen K, Battles JB, Marks ES, Lewin DI, eds. Advances in Patient Safety: From Research to Implementation (Volume 3: Implementation Issues). Rockville (MD): Agency for Healthcare Research and Quality (US); February 2005.Accessed March 22, 2025. https://www.ncbi.nlm.nih.gov/books/NBK20547/
16. Flynn EA, Barker KN, Pepper GA, Bates DW, Mikeal RL. Comparison of methods for detecting medication errors in 36 hospitals and skilled-nursing facilities. Am J Health Syst Pharm. 2002;59(5):436-446. doi:10.1093/ajhp/59.5.436
17. Cullen DJ, Bates DW, Small SD, Cooper JB, Nemeskal AR, Leape LL. The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv. 1995;21(10):541-548. doi:10.1016/s1070-3241(16)30180-8
18. Alhur A, Alhur AA, Al-Rowais D, et al. Enhancing Patient Safety Through Effective Interprofessional Communication: A Focus on Medication Error Prevention. Cureus. 2024;16(4):e57991. doi:10.7759/cureus.57991
19. Mutair AA, Alhumaid S, Shamsan A, et al. The Effective Strategies to Avoid Medication Errors and Improving Reporting Systems. Medicines (Basel). 2021;8(9):46. doi:10.3390/medicines8090046
20. Odukoya OK, Stone JA, Chui MA. E-prescribing errors in community pharmacies: exploring consequences and contributing factors. Int J Med Inform. 2014;83(6):427-437. doi:10.1016/j.ijmedinf.2014.02.004
21. ASHP guidelines on preventing medication errors in hospitals. Am J Hosp Pharm. 1993;50(2):305-314.
22. Independent double checks: Worth the effort if used judiciously and properly. ISMP. June 6, 2019. Accessed March 25, 2025. https://home.ecri.org/blogs/ismp-alerts-and-articles-library/independent-double-checks-worth-the-effort-if-used-judiciously-and-properly?utm
23. Caetano BDL. SOP management in the pharmaceutical industry. SimplerQMS. Updated January 24, 2025. Accessed February 3, 2025. https://simplerqms.com/pharmaceutical-sop-management/
24. Chance EA, Florence D, Sardi Abdoul I. The effectiveness of checklists and error reporting systems in enhancing patient safety and reducing medical errors in hospital settings: A narrative review. Int J Nurs Sci. 2024;11(3):387-398. Published 2024 Jun 8. doi:10.1016/j.ijnss.2024.06.003
25. Grigg E. Smarter Clinical Checklists: How to Minimize Checklist Fatigue and Maximize Clinician Performance. Anesth Analg. 2015;121(2):570-573. doi:10.1213/ANE.0000000000000352
26. Hong K, Hong YD, Cooke CE. Medication errors in community pharmacies: The need for commitment, transparency, and research. Res Social Adm Pharm. 2019;15(7):823-826. doi:10.1016/j.sapharm.2018.11.014
27. Pervanas HC, Revell N, Alotaibi AF. Evaluation of Medication Errors in Community Pharmacy Settings: A Retrospective Report. J Pharm Technol. 2016;32(2):71-74. doi:10.1177/8755122515617199
28. The Joint Commission. Official “do not use” list. September 2018. Accessed March 21, 2025. https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/patient-safety/do_not_use_list_9_14_18
29. Institute for Safe Medication Practices. FDA and ISMP Lists of Look-Alike Drug Names with Recommended Tall Man (Mixed Case) Letters. 2023. Accessed April 25, 2025. https://online.ecri.org/hubfs/ISMP/Resources/ISMP_Look-Alike_Tallman_Letters.pdf
30. Knapp K, Shane P, Sasaki-Hill D, Yoshizuka K, Chan P, Vo T. Bullying in the clinical training of pharmacy students. Am J Pharm Educ. 2014;78(6):117. doi:10.5688/ajpe786117
31. Customer Harassment, Bullying Affecting Pharmacists’ Ability to Do Their Jobs. US Pharmacist. February 2, 2022. Accessed March 11, 2025. https://www.uspharmacist.com/article/customer-harassment-bullying-affecting-pharmacists-ability-to-do-their-jobs
32. Institute for Safe Medication Practices. ISMP list of high-alert medications. 2018. Accessed February 4, 2025. https://www.ismp.org/sites/default/files/attachments/2018-08/highAlert2018-Acute-Final.pdf
33. Donaldson L, Ricciardi W, Sheridan S, Tartaglia R, eds. Textbook of Patient Safety and Clinical Risk Management. Cham (CH): Springer; 2021.Accessed February 4, 2025. https://pubmed.ncbi.nlm.nih.gov/36315660/
34. Park J, Kim AJ, Cho EJ, et al. Unintentional medication discrepancies at care transitions: prevalence and their impact on post-discharge emergency visits in critically ill older adults. BMC Geriatr. 2024;24(1):1000. doi:10.1186/s12877-024-05517-w
35. Schuster J, Saddawi A, Frisch A, et al. A comprehensive study of prescribing, administering and drug handling medication errors in ten wards of a university hospital after implementation of electronic prescribing, clinical pharmacists or medication reconciliation. Pharmazie. 2024;79(1):11-16. doi:10.1691/ph.2024.3579
36. Center for Medicare & Medicaid Services. Drug diversion toolkit: Patient counseling—a pharmacist’s responsibility to ensure compliance. November 2014. Accessed February 4, 2025. https://www.cms.gov/files/document/patientcounselingbooklet111414pdf

So Much STI Data: Information to help you stay current and informed – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-25-030-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.

1.) A 19-year-old female is at the clinic. She had recent unprotected sexual intercourse with her partner. She has not had any previous STI screenings. Which STIs are indicated for screening at this time?
a. HIV, gonorrhea, and chlamydia
b. Gonorrhea, chlamydia, and syphilis
c. Chlamydia, syphilis, and HPV

2.) Which of the following STIs have shown a continued increase in incidence based on 2023 data?
a. Congenital syphilis
b. Gonorrhea in the population
c. Chlamydia cases in men

3.) After completing gonorrhea treatment, when should a clinician re-screen the patient?
a. 1 month after completing treatment
b. 3 months after completing treatment
c. 1 year after completing treatment

4.) What is the guideline-based treatment recommendation for a 200 lb male patient with a confirmed gonorrhea and chlamydia co-infection?
a. Ceftriaxone 500 mg IM x 1 and azithromycin 1000 mg PO x 1
b. Ceftriaxone 250 mg IM x 1 and doxycycline 100 mg PO BID x 7 days
c. Ceftriaxone 500 mg IM x 1 and doxycycline 100 mg PO BID x 7 days

5.) Which population should receive seven days of treatment with metronidazole for trichomoniasis?
a. Young males 15 – 24 years old
b. Males 25 – 45 years old
c. Females of any age

6.) A pregnant patient is positive for primary syphilis. What is the guideline recommended treatment for her?
a. 2.4 million units benzathine penicillin G IM x 1
b. 2.4 million units benzathine penicillin G IM x 3 weekly doses
c. 100 mg PO doxycycline 2 time daily doses for 28 days
7.) Which of the following is a newly approved type of product that will increase patient access?
a. OTC bacterial Pre-Exposure Prophylaxis
b. OTC home screening tests for STIs
c. OTC HIV Post Exposure Prophylaxis

8.) What should pharmacists warn healthcare providers about regarding possible alternatives during a shortage of Bicillin LA for syphilis?
a. Impact of HIV cases
b. Adverse effects from the frequent use of the medication
c. Antimicrobial resistance

9.) You are working with emergency department physicians to manage a shortage of ceftriaxone. One concern is the treatment of gonorrhea. Which of the following would be a stewardship principle applied to this STI management choice?
a. Use the most recent antibiotic approved for the indication
b. Use alternative based on narrowest effect spectrum and incorporating local resistance data, if known
c. Choose an alternative that will also cover other STIs just in case

Patient Safety: Anticoagulation Stewardship: Identifying Key Data, Avoiding Errors, and Enhancing Safety – RECORDED WEBINAR

Learning Objectives

Differentiate high-priority, practice-changing information from less relevant or conflicting data after reviewing the anticoagulation guidelines, literature and clinical updates.

Recognize common anticoagulation-related errors in pharmacy practice and implement strategies to minimize patient safety risks

Identify red flag situations in anticoagulation management that pose patient safety risks.

Determine the appropriate guidelines or evidence-based resources to guide clinical decision-making and referrals

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-25-029-H05-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.

1. Which of the following BEST represents a high-priority takeaway from current guideline recommendations for DOAC use in atrial fibrillation?
a) DOACs are preferred over warfarin in all patients with AF
b) Apixaban is the only DOAC that does not require renal dosing adjustments
c) DOACs should not be used in patients with mechanical heart valves

2. A 68-year-old male with nonvalvular atrial fibrillation (weight 60 kg, age 78) and SCr 1.4 mg/dL is started on apixaban. Which of the following would be considered a dosing error?
a) apixaban 5 mg BID
b) apixaban 2.5 mg BID
c) warfarin with a target INR of 2–3

3. A 55-year-old female patient with atrial fibrillation (weight 75 kg, SCr 1.6 mg/dL) and recent MI has been taking apixaban 5 mg BID, clopidogrel 75 mg daily, aspirin 81 mg daily, and pantoprazole 40 mg for the past 7 months. Which of the following should be considered a red flag that would prompt pharmacist stewardship at this point?
a) Use of aspirin in combination with DAPT
b) Use of clopidogrel in a patient with CAD
c) Use of apixaban for stroke prevention at the incorrect dose

4. You are managing a patient with cirrhosis (Child-Pugh Class B) who requires anticoagulation for VTE. Which of the following is the most appropriate course of action?
a) Prescribe rivaroxaban using its complete prescribing information recommendation
b) Refer to hepatology/hematology to discuss bleeding risk and treatment alternatives
c) Use warfarin because it’s always the safest anticoagulant in liver disease

5. A patient newly started on warfarin reports they “just stopped eating leafy greens” to be safe. What is the best pharmacist action?
a) Encourage the patient to continue avoiding all vitamin K-containing foods
b) Educate that consistent vitamin K intake is more important than avoiding it
c) Schedule weekly INR checks and adjust the warfarin dose aggressively

Information overload in Chronic Coronary Disease – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-25-028-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.

1. A female patient is interested in lifestyle modification. Which of the following would you recommend?
a. Switch from EVOO to coconut oil
b. Switch from smoking weed to “doing” crystal methamphetamine
c. Limit alcohol to a maximum of 1 drink a day

2. A patient with CCD is determined to have “high risk” of experiencing an ASCVD event. The patient cannot receive high- or even moderate-intensity statins due to a history of significant rises in liver enzymes 8-10 weeks after initiation on two occasions. Which is true of the patient’s recommended lipid regimen?
a. The patient needs high-intensity statin regardless of the liver issues and ezetimibe should be added if the LDL on the statin is over 70mg/dL
b. The patient could receive a low intensity statin + a PCSK9 inhibitor and if the LDL remains over 70mg/dL, ezetimibe can be added
c. The patient could receive a PCSK9 inhibitor and if the LDL remains over 70mg/dL, ezetimibe can be added

3. Why can’t metoprolol tartrate be used to terminate a new onset angina pectoris event?
a. Because the onset of action is 30 minutes, and the maximum effect is felt 2 hours after ingestion
b. Because I am a pharmacist and I said so, that’s why
c. Because metoprolol does not work on the coronary arteries and only coronary dilators can be used for acute angina pectoris events

4. A student is explaining the PPCP process to you. Which of the following statements would you question and ask the student to research?
a. The PPCP process helps structure an assessment to be sure that important drug related problems are all included
b. Major pharmacy organizations agreed upon this process to show regulators, clinicians, patients, payers and insurers our unique patient services
c. “PPCP” is an old term; major professional organizations have replaced it with the subjective-objective-assessment-plan process

5. When would it be useful to recommend nitroglycerin spray instead of sublingual nitroglycerin?
a. In a patient taking an anticholinergic
b. In a patient taking an SSRI
c. In a patient taking benzodiazepines

6. JP is a patient who has rheumatoid arthritis and chronic coronary disease. He has an hsCRP test taken and the level is 7.2 mg/dL. Would this patient be a candidate for colchicine therapy according to the AHA/ACC Guideline and why or why not?
a. Yes, colchicine should be used in all people with elevated hsCRP
b. Yes, colchicine should be used in all patients regardless of hsCRP
c. No, specific disease modifying antirheumatic drug are used in patients with RA

7. AT is a patient with heart failure with reduced ejection fraction, who also has chronic coronary disease. Would an SGLT2 inhibitor or a GLP-1 agonist be preferred for the treatment of this patient?
a. Neither drug should be used at all
b. The SGLT-2 inhibitor would be preferred
c. The GLP-1 agonist would be preferred

8. WC is a patient who just had a PCI procedure but also has atrial fibrillation and is treated with rivaroxaban. What is the proper regimen to prevent stent occlusion?
a. Clopidogrel + aspirin + rivaroxaban for one month, then clopidogrel + rivaroxaban for 5 months, then just rivaroxaban alone thereafter
b. Clopidogrel + aspirin + rivaroxaban for six months, then clopidogrel + rivaroxaban for 6 months, then just rivaroxaban alone thereafter
c. Clopidogrel + aspirin + rivaroxaban for 12 months, then rivaroxaban + clopidogrel then rivaroxaban for 6 months, then rivaroxaban alone

Information overload to action: Decoding academic concepts for pharmacy preceptors- RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-25-026-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.

1. Joey is an IPPE student under your supervision this month. He observes as you meet with a patient who has a question about various options to treat psoriasis. You tell the patient you will get back to him about medications covered by his plan, out of pocket costs, the time burden associated with treatment, and potential adverse effects. Joey wants to help. What can Joey do?
A. Collect information, asking for help if or when he needs it
B. Observe how you collect information but assess independently
C. Collect information only under direct and proactive supervision

2. Phoebe is an APPE student in her first clinical rotation. She aspires to obtain an industry fellowship and hopes to receive the best grade possible on this rotation with the least work. She says, "I don't plan to work in a clinical position, so this is not a priority for me. What is the BEST answer?
A. The PPCP is not just applicable to clinical situations. It structures processes for all kinds of projects, not just clinical challenges.
B. Most students who aspire to work in industry do not get fellowships, and you need to know the PPCP if you land in an actual pharmacy.
C. Say nothing. Allow Phoebe to do minimal work.

3. Rachel is on her last APPE rotation before graduation. YAY! She works up a patient who has a cardiac issue. She collects a lot of appropriate information, and her assessment is almost perfect. She makes one statement that seems "off" to you. She recommends using a medication that is no longer first-line treatment. What is the MOST LIKELY cause for her omission?
A. She relied on only one guideline for evidence
B. She collects too much information and is confused
C. She is hyper-focused on cost, not effectiveness

4. Joey is now an APPE student on a general medicine rotation. You assign him a patient to review for your discussion this afternoon. When Joey joins you, he provides background information on the patient, reports on the physical notes, pertinent laboratory values and his conversation with the patient. What step of the Pharmacist Patient Care Process is Joey demonstrating?
A. Collect
B. Assess
C. Plan

5. Ross, an APPE student on your ambulatory care rotation, is writing up a SMART goal for his patient with diabetes. The goal reads “Reduce the patient’s blood glucose within six months. Patient will start metformin XL 500mg PO daily and follow up with the pharmacy team for titration every seven days. Reduction in the patient’s A1c will lead to better health outcomes and reduce the severity of complications from his diabetes.” What part of the SMART goal is Ross missing?
A. Specific
B. Measurable
C. Realistic

6. What is the performance goal for a “practice ready” APPE student in terms of level of entrustability on each of the entrustable professional activities (EPAs)?
A. Direct supervision
B. Reactive supervision
C. General Direction

Law: Understanding Disabled Pharmacy Patients’ Right to Nondiscrimination-RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-25-027-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.

1. What was Congress’ purpose when it wrote the definition of “individual with a disability”:
A. To make it easier for people with disabilities to be covered by federal law
B. To restrict coverage to people with certain medical diagnoses
C. To only cover people with physical impairments

2. When may a pharmacist refuse to administer the flu shot to a person with HIV?
A. If the patient is in a rehabilitation program for using illegal drugs.
B. If the patient hasn’t made an appointment ahead of time and all patients must make appointments ahead of time.
C. If special gloves are not available for administering shots to people with communicable diseases.

3. A patient enters the pharmacy with a dog, and you are not sure if it’s a service animal or not. Which of the following questions may you ask the patient?
A. What is the nature and extent of your disability?
B. Do you need the dog to be present because of a physical, sensory, psychiatric, intellectual or other mental disability?
C. Is the dog required because of a disability?

4. A patient enters the pharmacy with a dog. When you ask what tasks the dog has been trained to perform, the patient says that it is a comfort animal and has undergone no training. Can you ask the patient to leave and come back without the comfort animal?
A. No, because comfort animals are considered service animals under federal law.
B. Yes, because comfort animals are not protected by federal law.
C. No, because that would be discrimination.

5. A patient enters the pharmacy with a bulldog. When you ask if the patient needs the bulldog because of a disability, the patient says yes. Can you exclude the bulldog?
A. No, because a service animal cannot be excluded based solely on its breed.
B. Yes, because bulldogs are known to be aggressive.
C. Yes, because the patient has not disclosed their specific disability in response to your question.

6. If a patient enters the pharmacy using a mobility device, a pharmacist is permitted to inquire about which of the following?

A. The nature and extent of the patient’s disability.
B. What paperwork the patient has with them to prove that the mobility device has been serviced recently.
C. Whether the mobility device is needed because of the patient’s disability.

THYROID DISEASE: The Basics and the Latest

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

Discuss Thyroid Disease and the typical medications used to treat it
Explain drug-induced hypo/hyperthyroidism, drug interactions, and proper administration of thyroid medications
Explain the lab work and the frequency of monitoring needed for patients treated with levothyroxine
Differentiate hypothyroid disease from subclinical hypothyroid disease and their respective treatment approaches

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

Recall and list the common symptoms of thyroid disease
Identify typical medications used to treat thyroid disease
Recognize when to refer patients to the pharmacist for further consultation

Thyroid hormones, produced by the tiny thyroid gland, influence almost every organ in the body. They control the body’s energy production and metabolic rate; imbalances can have profound health consequences. Thyroid disease is classified as hypothyroidism or hyperthyroidism. In the United States, an estimated 20 million people have thyroid disease. Hashimoto’s thyroiditis, an autoimmune disease resulting in hypothyroidism, accounts for most thyroid disease in the U.S. Prescribers treat it with levothyroxine, which is among the most frequently dispensed medications. Many patients have subclinical hypothyroidism and the decision to treat with levothyroxine is based on a patient’s individual circumstances. Hyperthyroid disorders are less common, and most cases are Graves’ disease, an autoimmune disorder. The 2020 approval of teprotumumab marked a major advancement in the treatment of thyroid eye disease. Pharmacologic treatment of thyroid disease is largely safe and effective with proper management. A knowledgeable pharmacy team can have a positive impact on patient care.

INTRODUCTION

Did the Mona Lisa have hypothyroidism? Discussions around the Mona Lisa’s enigmatic smile have fascinated art lovers for centuries but now some endocrinologists have started a new line of debate. They describe telltale signs, like swollen hands, thinning hair, and a lump in the neck, that point to the famous Mona Lisa exhibiting hypothyroidism. They even suggest that the disease contributed to her mysterious smile. Amusing! When you view the painting do you see the same signs?

Theodor Kocher, a Swiss physician who was award the Nobel Prize in 1909 for his work on the thyroid gland, described the first case of hypothyroidism in the mid-19^th century.¹Effective treatment emerged about 100 years ago, so if the 16^th century Mona Lisa had hypothyroidism, she might have suffered without knowing the cause. Patients with undiagnosed or inadequately treated hypothyroidism are at risk for cardiovascular problems, osteoporosis, and infertility.²

The thyroid gland’s main hormones are responsible for controlling the body’s energy production and metabolic rate and they affect nearly every organ system in the body. Having too little or too much of these hormones can have profound consequences on health.

Millions of Americans are affected by thyroid disease with most cases classified as hypothyroidism or underactive thyroid. Children, whose cognitive and physical development depends on normal thyroid function, can also be affected.³ Levothyroxine is used to treat hypothyroidism and is consistently among the most frequently prescribed medications in the United States (U.S.).⁴ Although less common, hyperthyroid disease is a serious endocrine disorder with profound health consequences if not properly treated.

THYROID GLAND AND FUNCTION

The thyroid gland is a small bow tie shaped endocrine gland that sits at the base of the neck. It produces two main hormones: tetraiodothyronine called thyroxine (T4), and triiodothyronine (T3). T4 and T3 control energy production and metabolic rate and influence nearly every organ system in the body including the brain, bowels, and skin. They regulate protein, carbohydrate, and fat metabolism by stimulating protein production and increasing oxygen needs at the cellular level. They are essential for proper fetal and neonatal development. Thyroid hormones influence body temperature, heart rate, appetite, mood, and digestion.²

Iodine is a constituent of T4 and T3 and sufficient dietary intake of iodine and its adequate uptake by the thyroid gland is necessary for proper thyroid function. The thyroid gland produces mostly inactive hormone in the form of thyroxine, called T4 because it has four iodine atoms. T4 is highly protein bound for transport to the liver where it undergoes deiodination (the removal of one iodine atom) resulting in T3. T3, like T4, is highly protein bound and must be released from its binding protein to be active. Equilibrium is maintained between bound and free T3; as the body demands more biologically active hormone more T3 is released from the binding protein. Free T3 is the main biologically active form of thyroid hormone.²

Hypothalamic-Pituitary-Thyroid Axis

The hypothalamic-pituitary-thyroid axis governs thyroid hormone production by regulating the synthesis and secretion of thyroid stimulating hormone (TSH), also called thyrotropin. The hypothalamus is the part of the brain responsible for monitoring thyroid hormone levels in the body. When the hypothalamus detects low levels of thyroid hormone in the body, it releases a hormone called thyrotropin-releasing hormone (TRH). TRH stimulates the pituitary gland, the small pea-size gland sitting at the base of the brain, to secrete TSH. TSH, in turn, instructs the thyroid gland to produce more T4 and T3. High levels of T4 in the body inhibit TSH secretion while low levels of T4 stimulate TSH secretion. Disease affecting any part of the hypothalamic-pituitary-thyroid axis can result in thyroid hormone imbalances and disease.²

THYROID DISEASE AND ETIOLOGY

Thyroid disease is an endocrine disorder. Primary thyroid disease refers to disease of the thyroid gland. Secondary thyroid disease is far less common and refers to disease affecting the hypothalamus or pituitary gland resulting in thyroid dysfunction. Thyroid disease is classified as either hypothyroidism or hyperthyroidism.

Hypothyroid Disease

Hypothyroid disease occurs when inadequate thyroid hormone is available to the body. It is often referred to as an underactive thyroid and it is the most common form of thyroid disease. Hypothyroid disorders are categorized as either primary hypothyroidism or secondary hypothyroidism. The vast majority of cases are primary hypothyroidism.²

Hashimoto’s Thyroiditis

Hashimoto’s thyroiditis (HT) is the most common cause of primary hypothyroidism in the U.S. Japanese physician Hakaru Hashimoto first described the disease in 1912. It wasn’t until decades later that it was recognized as an autoimmune disorder and it is now considered the most prevalent autoimmune disease.⁵ Many patients do not realize that their hypothyroid condition is caused by this autoimmune disorder.

HT is characterized by infiltration and destruction of thyroid cells by leukocytes (white blood cells). A chronic autoimmune inflammation ensues resulting in atrophy and fibrosis of the thyroid gland that leads to hypothyroidism. Circulating thyroid autoantibodies, anti-thyroperoxidase antibody (anti-TPO Ab), and anti-thyroglobulin antibody (anti-Tg Ab) can be detected but clinicians usually don’t measure them since all treatment of hypothyroidism is similar.⁶

Women are more likely to develop HT and often have a family history, implicating a genetic component. The presence of other autoimmune disorders is common and prevalence is higher among those with chromosomal disorders like Down syndrome.²

Patients may present with thyroiditis (inflammation of the thyroid gland) and symptoms of hypothyroidism, like weight gain and fatigue, but not always. Symptoms can develop gradually and go unnoticed. Laboratory assessment of thyroid function (discussed below) confirms the diagnosis. Individuals diagnosed with HT require lifelong treatment with the thyroid replacement hormone levothyroxine.⁶

HT’s complications can manifest particularly in untreated or undertreated individuals including²:

Lipid disorders (elevated total cholesterol, LDL, and triglycerides)
Anemia
Menstrual abnormalities
Infertility
Hyponatremia
Thyroid associated orbitopathy
Increased risk for papillary thyroid carcinoma

Lipid disorders are of particular concern because they can contribute to coronary artery disease. Anemia is observed in 30% to 40% of patients. Recent research has suggested greater risk for recurrent pregnancy loss in patients with HT and an additional autoimmune disorder, but more research is needed to fully understand the link.⁷

Most complications of HT are rare but prescribers must monitor and treat complications as they arise to optimize patient management.⁸

Researchers have also noted vitamin D deficiency in HT. A randomized, double blind, clinical trial observed that supplementation with vitamin D reduced circulating thyroid autoantibodies.⁵The researchers suggest a possible role for vitamin D in the alleviation of disease activity but acknowledge the need for further studies before introducing this intervention to clinical practice. Despite the need for additional research, treating vitamin D deficiency in patients with HT may be warranted.

Gut microbiota are considered intrinsic regulators of thyroid autoimmunity. Scientists have studied the composition of the microbiota in patients with thyroid autoimmunity and have found it to be altered in HT.⁹Clinical implications of this research are not fully understood, but further research may determine the role these findings may have in HT management.

With early diagnosis, prompt treatment, proper follow-up care, and attention to associated complications, HT’s prognosis is excellent, and patients lead a normal life.¹⁰

Iodine Deficiency Hypothyroidism

Although uncommon in America, iodine deficiency is the leading cause of hypothyroidism worldwide. Adequate iodine intake is necessary for the thyroid gland to function properly, and it is critical for normal fetal and neonatal development. The recommended daily allowance (RDA) for adults is 150 mcg and it increases to 250 mcg in pregnancy and to 290 mcg during lactation. Goiter (an abnormal enlargement of the thyroid gland) is common as the thyroid gland enlarges in an attempt to sequester iodine to make thyroid hormone.^11,63

Universal salt iodization programs have dramatically reduced iodine deficiency-related thyroid disease.¹² Historically, iodine deficient areas in the U.S. included the mountainous regions and the so called “goiter belt” around the Great Lakes. Most Americans now consume adequate amounts of iodine in their diets by using iodized salt and by eating dairy products, eggs, and seafood. However, certain populations may still be at risk, including vegans, pregnant women, and people who don’t use iodized salt.¹¹ Most alternative milk products are low in iodine and processed foods like canned soup and specialty salts–including kosher, Himalayan, and sea salt–rarely provide iodine.¹³ Healthcare practitioners must be aware of iodine deficiency’s consequences, especially during pregnancy.^11,63

Thyroid diets have gained interest among patients and circulate widely on the Internet. These diets promote avoiding particular foods to achieve optimal thyroid function. Certain foods including broccoli, Brussels sprouts, cabbage, cauliflower, and soy contain goitrogens, which are substances that interfere with iodine uptake by the thyroid. For most people in the U.S. who consume adequate amounts of iodine, eating foods containing goitrogens is not a concern. People with iodine deficiency who eat an abundance of these foods may have trouble consuming enough iodine.^13,63

Thyroidectomy and Cancer Treatment Resulting in Hypothyroidism

Thyroidectomy, the surgical removal of the thyroid gland, is sometimes indicated in cancer treatment and in some cases of hyperthyroidism. Thyroidectomy results in hypothyroidism and patients require life-long thyroid hormone replacement with levothyroxine.¹⁴

Most thyroid cancers respond well to treatment, but a small percentage can be very aggressive. Treatment of thyroid cancer often results in hypothyroidism and patients require lifelong treatment with thyroid replacement hormone.¹⁴

Medication-Induced Hypothyroidism

The pharmacy team must be aware that certain medications can affect thyroid function. Table 1 lists common medications that can cause hypothyroidism and hyperthyroidism. The medications that cause hypothyroidism decrease synthesis of T4/T3, inhibit T4/T3 secretion, and/or cause thyroiditis.¹⁵

Table 1. Medications that May Lead to Thyroid Dysfunction
Drug class/medications	Hypothyroidism	Hyperthyroidism
Antidysrhythmic:
Amiodarone	X	X
Bipolar Disorder Medication:
Lithium	X	X
Thyroid Medications:
PTU	X
Methimazole	X
Radioactive Iodine	X
Cancer Medications:
Biological response modifiers:
Interferon	X
Interleukin-2	X
Tyrosine kinase inhibitors:
Sunitinib	X
Sorafenib	X
Checkpoint inhibitors:
Nivolumab	X	X
Pembrolizumab	X	X
Ipilimumab	X	X
Multiple Sclerosis Medication:
Alemtuzumab		X

Medications that cause thyroid disorders are important treatments and, in most cases, they cannot be discontinued; any drug-induced hypothyroidism requires levothyroxine.

Amiodarone structurally resembles thyroid hormone and is often implicated in thyroid dysfunction, mostly hypothyroidism.¹⁶ It is comprised of 37% iodine, so a 200 mg dose provides 75 mg of organic iodide, which is 100 times more than required. Researchers estimate thyroid abnormalities occur in 14% to 18% of patients taking long-term amiodarone but a meta-analysis found that with low doses, the incidence is lower (3.7%).¹⁷ Lithium can inhibit thyroid hormone release resulting in hypothyroidism; it usually occurs in younger women within the first two years of therapy. Antineoplastic agents may cause thyroid dysfunction in 20% to 50% of patients.¹⁸ Pharmacists must educate patients about the need for routine thyroid function assessment when receiving these medications.

Hyperthyroid Disease

Hyperthyroidism is characterized by excessive metabolism and secretion of thyroid hormones. It is less common than hypothyroid disease. Graves’ disease, thyroiditis, multi-nodular goiter, and toxic nodular goiter (benign growths on the thyroid gland that produce thyroid hormone in excess) can also cause hyperthyroid disease. Ingestion of too much external thyroid hormone is another possible cause of hyperthyroidism.¹⁹

Graves’ Disease

Graves’ disease (GD) accounts for most cases of hyperthyroidism. GD is an autoimmune disorder caused by a stimulatory autoantibody against the thyroid receptor for TSH. Most autoantibodies are inhibitory; in GD, the autoantibody is stimulatory. Overstimulation of the thyroid gland results in the overproduction of T4 and T3 leading to hyperthyroidism.¹²

Graves’ disease, like HT, appears to have a genetic link and is often comorbid with other autoimmune disorders. Risk factors for GD include smoking and iodine deficiency. In the case of iodine deficiency, multifocal autonomous growth of the thyroid gland can occur and result in thyrotoxicosis (excess levels of thyroid hormone in the body).²⁰ Women are affected at a higher rate and children can also be affected. GD’s clinical presentation may be dramatic or subtle and goiter may or may not be present. Laboratory assessment of thyroid function is used to help diagnose GD.

Researchers have studied the composition of gut microbiota in patients with GD and similar to findings in HT, have found it to be altered. The researchers suggest the findings from this randomized controlled trial may offer an alternative noninvasive diagnostic methodology for GD.²¹ Further research is needed to elucidate the role microbiota may play in thyroid autoimmunity.

Thyroid Eye Disease

Thyroid eye disease is a progressive, potentially sight threatening ocular disease that is reported in almost half of patients who have GD. It arises from a separate autoimmune process involving autoantibodies that activate an insulin-like growth factor-1 receptor (IGF-1R) mediated signaling complex on cells within the eye orbit. The most common clinical feature is proptosis (bulging eyes) with edema and erythema of the surrounding eye tissue, but patients may also experience a skin manifestation called thyroid dermopathy (a nodular diffuse thickening of the skin on the legs). Patients with thyroid eye disease often complain of dry and gritty ocular sensation, photophobia, excessive tearing, double vision, and pressure sensation behind the eyes. Severe disease occurs in 3% to 5% of patients causing intense eye pain and inflammation, and threatening sight.²²

Recently, the Food and Drug Administration (FDA) approved the monoclonal antibody teprotumumab for treatment of adults with thyroid eye disease, marking a significant advancement in treatment. Prior to this approval, treatment options only included steroids or surgery.²³

Medication Induced Hyperthyroidism

Like medication that can cause hypothyroidism, some medication can cause hyperthyroidism. The pharmacy team must be knowledgeable of the medications that can cause hyperthyroidism that warrant close monitoring of thyroid function (See Table 1). Patients should understand the importance of routine thyroid function assessment when taking medications that can affect thyroid function.

Amiodarone-associated hyperthyroidism is less common than amiodarone-associated hypothyroidism; still, it is estimated to occur in 3% of patients. Onset of amiodarone-induced thyrotoxicosis (elevated levels of free thyroid hormone) can be sudden and require rapid assessment and treatment.¹⁶ Pharmacists must educate their patients about the symptoms of hyperthyroidism and instruct them to report them immediately if encountered.

PAUSE AND PONDER: How many of your patients take medications that might cause thyroid dysfunction? Why is it important to tell these patients that some of their medications might influence the thyroid gland?

PREVALENCE

As many as 20 million Americans are affected by thyroid disease. Clinicians diagnose hypothyroidism in nearly five of 100 Americans aged 12 years and older.²⁴ Thyroid disease affects men, women, and children. Women are disproportionately affected at a 10 to 15 times higher rate, and it’s estimated one in eight women will develop some form of thyroid disease in their lifetime.²⁴

HT is most often diagnosed between the ages of 40 to 60 years. Prevalence increases with age.⁸ Twenty percent of adults older than 75, most of them women, have insufficient levels of thyroid hormone.²⁴ The Colorado Thyroid Disease Prevalence Study,a cross-sectional study conducted more than 20 years ago, reported the prevalence of hypothyroid disease in symptomatic and asymptomatic adults at 9.5%.²⁵ In people not taking thyroid hormone, prevalence was 8.5% and 0.4% for subclinical and overt disease, respectively.¹⁰

Hyperthyroidism is much less common than hypothyroidism. Prevalence of hyperthyroidism in the U.S. is estimated at 1.3%. GD is the most common cause of hyperthyroidism followed by toxic nodular goiter. GD is estimated to affect 1% of the population, mainly women of childbearing age. Incidence increases with age, and it is observed more frequently in Caucasians compared to other races. Mild hyperthyroidism occurs at a higher rate in iodine deficient geographic areas.¹²

SYMPTOMS

Because thyroid hormones affect nearly every organ system in the body thyroid disease’s symptoms are wide ranging and numerous. Symptoms vary depending on the type of thyroid disease and patients may experience few or many symptoms.²⁶ Clinicians should routinely monitor patients for symptoms of thyroid disease, especially those at risk for thyroid disease including elderly women (See Table 2).²⁷

Table 2. Thyroid Disease’s Common Symptoms
	Hypothyroidism	Hyperthyroidism
Whole body	Fatigue, lethargy, cold sensitivity	Hunger, fatigue, weakness, sweating, increased appetite, heat intolerance, insomnia
Mood/behavioral	Depression, irritability, sluggish, brain fog	Nervousness, restlessness, hyperactivity, panic attacks
Cardiac	Bradycardia, elevated cholesterol	Tachycardia, palpitations
Weight	Weight gain	Weight loss
Hair, skin, nails	Hair loss, dry skin/hair, brittle nails	Hair loss, warm skin
Eyes/face	Periorbital edema, puffy face	Proptosis (abnormal protrusion of eyes)
Gastrointestinal	Constipation	Frequent bowel movements
Menstruation/fertility	Heavy or irregular menstrual periods, fertility problems	Amenorrhea, lighter or irregular menstrual periods, fertility problems
Musculoskeletal	Joint/muscle pain	Osteoporosis
Thyroid presentation	May be enlarged	May be enlarged

Weight gain is a common and often first symptom of hypothyroidism. Up to 82% of women with HT have excess body weight and a third suffer from obesity.²⁸ Despite achieving euthyroidism (normal thyroid function) with levothyroxine treatment, many women continue to struggle to lose weight. Caloric reducing diets are often unsuccessful and excess body weight increases risk for comorbidities.²⁹

Food sensitivity and the effects of elimination diets on autoimmune disease have gained interest. An interventional/observational study evaluated the effect of an elimination diet in obese women diagnosed with HT. The researchers observed that women eliminating sensitive foods (foods that may cause an IgG antibody reaction) in addition to caloric reduction had a greater decrease in body mass index (BMI) when compared to women only reducing caloric intake.³⁰Improvement in thyroid function laboratory parameters was also observed in the group eliminating sensitive foods.³¹

LABS TO ASSESS THYROID FUNCTION

Thyroid function is assessed mainly through readily available laboratory blood tests. Results of basic thyroid function laboratory tests largely differentiate and diagnose thyroid disease (See Table 3).

Table 3. Thyroid Function Tests in Hypothyroidism and Hyperthyroidism³²

	TSH (Thyrotropin)	FT4 (Thyroxine)	T3
Lab reference range*	0.5-4.8 mIU/L	0.7-1.8 ng/dL	80-220 ng/dL
Hypothyroidism
Primary, untreated	High	Low	Low or normal
Secondary to pituitary disease	Low or Normal	Low	Low or normal
Hyperthyroidism
Untreated	Low	High	High
T3 toxicosis	Low	Normal	High

*Reference ranges may vary among laboratories.

TSH is the best measurement to assess thyroid function. A normal TSH essentially rules out thyroid disease, except in the less common cases of disease affecting the hypothalamus or pituitary gland. The American Thyroid Association (ATA) recommends routine screening of TSH in adults beginning at age 35 and repeating the test every five years.²⁷

T4 is the primary thyroid hormone circulating in the blood. T4 is found in the body in two forms: free T4 and bound T4. More than 99% of T4 is bound. Because T4 is converted into T3, free T4 (FT4) is the more important hormone to measure. Any changes show up in T4 first; therefore, FT4 reflects thyroid gland function more accurately.³³ Assessment of T3 is primarily used to diagnose and manage hyperthyroidism. It is rarely assessed in hypothyroidism since it’s the last test to become abnormal.³⁴

Patients with thyroid autoimmunity disease develop thyroid autoantibodies. Measurement of autoantibodies may help diagnosis, but clinicians need not monitor them routinely for disease management. Physicians typically order TSH with reflex to FT4 to assess thyroid function in disease management. Reflex testing allows the laboratory to automatically add the FT4 test to the blood sample based on an abnormal TSH result.³⁵

Clinicians sometime use radioactive iodine uptake (a non-blood test) to assess thyroid function. Because iodine is a necessary component of thyroid hormone, administering radioactive iodine and calculating its uptake by the thyroid can determine if the gland is functioning properly. Very high uptake is associated with hyperthyroidism while low iodine uptake indicates hypothyroidism.³⁴

TREATMENT APPROACHES

Levothyroxine

Levothyroxine sodium tablets (Synthroid and many generics) are synthetic T4 and indicated as replacement therapy in all hypothyroidism, regardless of the cause. Thyroid replacement hormone has a narrow therapeutic index and prescribers must individualize each patient’s levothyroxine dose. It is available in 12 different strengths, making it possible for prescribers to titrate doses carefully and avoid under- or over-treatment. Tablets are color-coded and are available from many manufacturers. (See Table 4.)

Table 4. Various Strengths and Colors of Levothyroxine Tablets

Strength	Color
25 mcg	Orange
50 mcg	White
75 mcg	Violet
88 mcg	Mint green
100 mcg	Yellow
112 mcg	Rose
125 mcg	Brown
137 mcg	Deep blue
150 mcg	Light blue
175 mcg	Lilac
200 mcg	Pink
300 mcg	Green

Variability in levothyroxine absorption may exist across manufacturers. A cohort study in the Netherlands evaluated a forced switch of levothyroxine brand. The researchers concluded that a dose-equivalent levothyroxine brand switch might necessitate a dose adjustment.³⁶ The ATA recommends using a consistent manufacturer. If a brand switch is made, the pharmacy team must inform prescribers; it may necessitate a dose adjustment.³⁷

Sidebar: Tech Tasks for Thyroid Medications

Inform patients about the importance of using a consistent brand of levothyroxine.
Note brand of levothyroxine on each patient’s profile.
Review levothyroxine shipments when restocking to assure consistent brand use.
Tag all bags and inform the patient if a brand switch is made.

Peak therapeutic effect of levothyroxine is seen in four to six weeks. Prescribers often start levothyroxine at low doses and titrate in small increments of 12.5 to 25 mcg every four to six weeks based on TSH testing until achieving euthyroidism.³⁸ Average full replacement dose is 1.6 mcg/kg/day. Current ATA guidelines recommend adjusting the levothyroxine dose to resolve symptoms of hypothyroidism and to keep the TSH level within the range of 0.4 to 4 mIU/L.²⁹ Clinicians should assess thyroid function in patients on stable doses of levothyroxine every six to 12 months and within six to eight weeks of any dose change. Ongoing assessment helps avoid under- or over-replacement.³⁸

Adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism and include the following³⁷:

Anxiety
Diarrhea
Fatigue
Hair loss
Heat intolerance, excessive sweating
Increased appetite
Increased heart rate
Muscle weakness
Nervousness
Palpitations
Weight loss

Over-replacement with levothyroxine can lead to serious consequences and can put elderly patients at risk for cardiac arrhythmias, especially atrial fibrillation.¹⁰Complications of over-replacement include

Accelerated bone loss
Increased cardiac contractility
Increased cardiac wall thickness
Increased heart rate
Osteoporosis
Reduction in bone mineral density

Medications, supplements, food, coffee, and even orange juice can decrease levothyroxine’s absorption.¹⁰Levothyroxine is taken with water one hour before breakfast and any other prescription medications. Calcium, iron, antacids, cholestyramine, and sucralfate can inhibit its absorption and must be separated by at least four hours.³⁷Individuals with celiac disease or gastric bypass surgery may absorb medication inadequately.^40,41

Bedtime dosing of levothyroxine offers an alternative to morning dosing. Randomized controlled trials have found patients taking the medication in the evening had improved thyroid hormone status control.^38,42Patients struggling with morning dosing may find evening dosing easier. The ATA recommends that if levothyroxine is taken at bedtime that it be separated by three hours from the evening meal.⁴³

Because levothyroxine is usually administered for life, dose adjustment is often necessary to optimize therapy throughout a patient’s lifetime.⁴⁴ Situations that necessitate possible dose adjustment of levothyroxine include

Aging (age older than 65)
Diagnosis of new medical conditions
Pregnancy
Start of new medications
Weight changes

The Colorado Thyroid Disease Prevalence study assessed thyroid function, symptoms, and corresponding lipid levels in more than 25,000 participants. Among patients taking thyroid medication, only 60% were within the normal range of TSH. Modest TSH elevations corresponded to changes in lipid levels that may affect cardiovascular health.²⁵ Optimization of levothyroxine therapy requires that the healthcare team recognize the need for dose adjustments throughout a patient’s life.

PAUSE AND PONDER: Among your patients being treated for hypothyroidism, how many also take calcium supplements? How many of these patients know to separate them from levothyroxine by four hours?

Liothyronine

Liothyronine (Cytomel) is synthetic T3. It is not recommended, either alone or in combination with levothyroxine, as first line treatment for hypothyroidism. Combination therapy hopes to mimic thyroid hormone physiology more closely; however, current guidelines do not suggest routine use of this approach.¹⁰ A 2016 randomized, double blind, crossover study evaluated combination therapy in 32 patients and found no clear clinical benefit and observed increased heart rate in patients receiving it.⁴⁵A trial, however, may be indicated in a small group of patients who remain symptomatic despite adequate levothyroxine monotherapy.⁴⁶

Iodine

Patients with iodine deficient hypothyroidism are treated with iodine supplements to correct the deficiency while levothyroxine is used to achieve euthyroidism. When the iodine level has been restored and goiter size has decreased, levothyroxine may be interrupted. Prescribers should reassess thyroid function in four to six weeks.¹¹

Consumption of too much iodine can have a negative impact on thyroid health. The safe upper limit of iodine for adults is 1.1 mg/day.⁶³ Iodine toxicity may lead to thyroiditis, hypothyroidism, hyperthyroidism, and thyroid papillary cancer.⁴⁷ Pharmacists should be aware that drug interactions with potassium iodine exist. It can interact with antithyroid drugs and when potassium iodide is taken with ACE inhibitors or potassium sparing diuretics, serum potassium can increase.¹³

Selenium

Selenium is an important micronutrient in the diet and increases active thyroid hormone production. The RDA for selenium is 55 mcg/day. Selenium supplements are used to treat or prevent selenium deficiency. Doses exceeding 400 mcg/day can be toxic. Signs of toxicity include brittle hair and nails, diarrhea, irritability, and nausea. Extremely high intakes of selenium can cause severe problems, including difficulty breathing, tremors, kidney failure, heart attacks, and heart failure. Most people consume adequate selenium through the diet, which is preferred. Consuming two Brazil nuts daily can provide adequate selenium intake; each nut contains 68 to 91 mcg of selenium, so people should not consume too many. Selenium is also found in oysters, tuna, whole-wheat bread, sunflower seeds, meat, mushrooms, and rye.⁴⁸

Subclinical Hypothyroid Disease

Subclinical hypothyroidism is a common condition occurring in about 15% of older women and 10% of older men.²It is a persistent condition in which TSH levels are elevated but free T4 levels remain normal. Treating subclinical hypothyroidism with levothyroxine results in an improved quality of life for many while others show no benefit and continue to complain of symptoms despite treatment.

The decision to treat subclinical hypothyroidism is being reevaluated after a large European study found no clear benefit with treatment.³ Published in the New England Journal of Medicine in 2017, this double-blind, randomized, placebo-controlled, parallel-group trial concluded levothyroxine provided no apparent benefits in older people with subclinical hypothyroidism.⁴⁹ Investigators are conducting more research to evaluate the effect of discontinuing levothyroxine in subclinical hypothyroidism.⁵⁰ They hope to determine if discontinuing levothyroxine in patients with subclinical hypothyroidism is safe or will reduce quality of life.

For now, prescribers should follow current clinical practice guidelines, which state that they should tailor the decision to treat subclinical hypothyroidism to the individual patient when the serum TSH is less than 10 mIU/L. Prescribers should consider the presence of symptoms and how likely the patient will progress to overt hypothyroidism when making the decision to treat.²⁴

Antithyroid Drugs

The treatment goal for hyperthyroid disease is to lower excessive thyroid hormone levels and achieve euthyroidism. The two antithyroid drugs (ATD) available in the U.S. for the treatment of hyperthyroidism are methimazole (Tapazole) and propylthiouracil (PTU). Hepatotoxicity has been reported with both medications but methimazole has been associated with far fewer cases. Therefore, methimazole is used as first line therapy, except in pregnancy.⁵¹

ATDs inhibit T4 and T3 synthesis by blocking oxidation of iodine in the thyroid gland. PTU also partially blocks peripheral conversion of T4 to T3. Beta-blockers can provide symptomatic relief in patients with hyperthyroidism.

Methimazole is available in 5 mg and 10 mg tablets. The starting dose is 5 mg to 20 mg orally every eight hours. Prescribers must titrate the dose over time to the lowest dose needed to maintain euthyroidism. Maintenance doses range from 5 mg to 30 mg/day administered once daily. Once euthyroidism is achieved, patients usually continue the ATD for another 12 to 18 months. The prescriber should check thyroid function four to six weeks after therapy initiation and then every two to three months once the patient is euthyroid.¹²

PTU’s labeling carries a boxed warning for acute liver failure, and it is reserved for use in those who cannot tolerate other treatments such as methimazole, radioactive iodine, or surgery.⁵² It is also recommended for use in the first trimester of pregnancy because birth defects have been associated with methimazole. PTU is available as a 50 mg tablet. The initial starting dose is 50 mg to 150 mg orally every eight hours and the maintenance dose is usually 50 mg every 8 to 12 hours.⁵³

Minor side effects occur in about 5% of patients receiving an ATD. Side effects include⁵³

Agranulocytosis (severe drop in white blood cells)
Arthralgia
Gastrointestinal distress
Hepatotoxicity
Pruritus
Vasculitis (dangerous inflammation of blood vessels)

Serious side effects are less common at lower doses; patients should be maintained at the lowest possible dose needed to achieve euthyroidism. Although rare, hepatotoxicity and agranulocytosis can be life threatening. Pharmacists should educate patients to report signs of agranulocytosis, such as sudden fever, sore throat, or chills, to their prescribers immediately. Prescribers should obtain a baseline serum liver profile and white blood cell count before starting an ATD. Most side effects occur within the first 90 days of therapy. Vasculitis is more common with longer duration of therapy.

A drawback of ATD therapy is the high relapse rate. A longitudinal cohort study concluded that patients initially treated with an ATD had about a 50% relapse rate and 25% felt they had not fully recovered in six to 10 years.⁵⁴

Recent studies have shown that longer treatment time with an ATD can achieve higher remission rates. A randomized, parallel-group study compared relapse rates in patients receiving longer-term versus conventional-length methimazole therapy in GD. The authors concluded that low-dose methimazole treatment for 60 to 120 months was safe and effective and had a higher remission rate compared to conventional treatment for 18 to 24 months.⁵⁵

Long-term methimazole therapy was also evaluated in juvenile GD in a randomized parallel trial. Patients receiving short-term methimazole therapy were almost three times more likely to relapse than those on long-term therapy. The researchers found long-term methimazole treatment of 96 to 120 months to be safe and effective with a significantly higher four-year cure rate.⁵⁶

Teprotumumab

The FDA’s approval of teprotumumab (TEPEZZA) in January 2020 was the most significant advance in treating thyroid eye disease in decades. Teprotumumab binds to IGF-1R and blocks its activation and signaling. It was shown to improve the course of thyroid eye disease in patients in two separate clinical trials, leading to this monoclonal antibody’s approval.^23,57 Proptosis and diplopia improved, as did eye pain, redness and swelling, and quality of life. Serious adverse events were uncommon. The most common adverse reactions observed were

alopecia
altered sense of taste
diarrhea
dry skin
fatigue
headache
hearing loss
hyperglycemia
muscle spasm
nausea

The FDA approved teprotumumab to be given as an infusion every three weeks for a total of eight doses. Patients completing the course of therapy showed significant improvement in symptoms associated with thyroid eye disease. Infusion reactions are reported in about 4% of patients. Dose is based on weight. The first dose is 10 mg/kg, and then the dose is increased to 20 mg/kg for the remaining seven infusions. Teprotumumab is contraindicated in pregnancy. Women of childbearing age must be counseled on pregnancy prevention during treatment and for six months following the last dose.⁵⁸

PAUSE AND PONDER: Which patients with thyroid disease in your practice might benefit from teprotumumab? What is important to tell them about this new biologic?

Surgery

Thyroidectomy is not used as a first line approach for treating hyperthyroidism. It is reserved for patients who refuse radioactive iodine after relapsing on an ATD, patients who cannot tolerate an ATD, or patients with very large goiter, multinodular goiter, or toxic adenoma. Thyroidectomy destroys the thyroid gland and if indicated, patients require lifelong levothyroxine therapy.

Radioactive Iodine

In the U.S., radioactive iodine is the most common treatment for hyperthyroidism. Radioiodine therapy, like surgery, destroys the thyroid gland requiring patients to be on lifelong levothyroxine therapy.

In the last 20 years, radioiodine has been used less frequently.¹⁹ Many patients report a lower quality of life after receiving radioactive iodine than patients receiving ATD or surgical treatment.⁵⁹ A randomized parallel group trial found that long-term methimazole, when compared to radioiodine, was safe, effective, and not inferior to radioiodine further supporting the use of ATD over radioiodine.⁶⁰

Pregnancy

Undiagnosed or inadequately treated hypothyroidism during pregnancy can lead to miscarriage, preterm delivery, or developmental disorders in children. Levothyroxine is safe in pregnancy, but pregnant patients may require a 30% increase in levothyroxine dose to maintain euthyroidism.During pregnancy, attending healthcare providers should titrate levothyroxine doses against TSH, which has trimester-specific ranges. Postpartum TSH levels are similar to preconception levels, so the dose of levothyroxine should return to the preconception dose following delivery.⁶¹

Iodine is a critical mineral for proper fetal development and iodine needs increase by at least 50% in pregnancy and lactation. Pregnant women should receive a prenatal vitamin containing 150 mcg of iodine during pregnancy and lactation. Unfortunately, prenatal vitamins contain variable and inconsistent amounts of iodine. Close to 40% of marketed prenatal vitamins in the U.S. contain no iodine and when measured, the actual iodine content varied between 33 and 610 mcg.¹¹ Healthcare practitioners must be vigilant in assuring that iodine requirements are met during pregnancy and lactation when iodine requirements increase. The ATA recommends that women receive 150 mcg of supplemental iodine daily during pregnancy and lactation and that all prenatal vitamin/mineral preparations contain 150 mcg of iodine.¹¹

Hyperthyroidism in pregnancy requires special consideration. Care givers must stabilize women undergoing treatment for GD who intend to become pregnant prior to conception. Prescribers should advise women to delay attempts at conception until they achieve a stable euthyroid state, whenever possible.⁶² Additionally they should treat hyperthyroidism during pregnancy with the lowest possible dose of PTU because methimazole has been associated with cases of congenital malformation.

The majority of patients with thyroid eye disease are women of childbearing age. Physicians must explain treatment limitations to patients who are contemplating pregnancy. Teprotumumab is contraindicated in pregnancy. Caregivers must provide contraceptive counseling to women of childbearing age with thyroid eye disease treated with teprotumumab during treatment and for the six months following therapy.²³

Pharmacy Team’s Role

The pharmacy team can have a positive impact on the successful management of patients with thyroid disease by educating and screening patients regarding

Adverse effects associated with their thyroid medications
Importance of medication adherence
Laboratory assessment of thyroid function
Screening for drug interactions
Signs and symptoms of hyperthyroidism and hypothyroidism

CONCLUSION

Thyroid disease affects millions in the U.S. and most cases are well controlled with pharmacological management. Adherence to thyroid disease medications is important. A knowledgeable pharmacy team can promote good practices and provide patient education, having a positive impact on patient care. Proper management allows most patients to have an excellent prognosis and quality of life.

With your newly gained knowledge, take another look at the Mona Lisa. Did Leonardo da Vinci, a man before his time, notice a thyroid disorder that he captured in his famous painting and did it intentionally contribute to her enigmatic smile?

This test is for viewing purposes only. If you would like to submit the test, go to the blue button at the top of the page or Test/Evaluation Site.

Pharmacist Post-test
1. Which of the following statement accurately describes hypothyroid disorders?
A) They are all of autoimmune etiology
B) They require treatment with levothyroxine, regardless of cause
C) They are caused only from disease directly affecting the thyroid gland

2. A woman of childbearing age who follows a strict vegan diet and only uses sea salt is contemplating pregnancy. Which of the following is a risk?
A) Selenium deficiency
B) Vitamin D deficiency
C) Iodine deficiency

3. What is the best laboratory assessment of thyroid function?
A) TSH
B) T3
C) Total T4

4. How often should patients on stable doses of levothyroxine have lab assessment of thyroid function?
A) every 6-12 months
B) every 3-6 months
C) every 24 months

5) A patient newly diagnosed with Hashimoto’s Thyroiditis (HT) is very concerned with her new diagnosis. What statement MOST ACCURATELY describes HT?
A) It is an autoimmune disease that has an excellent prognosis and is treated with lifelong levothyroxine therapy.
B) It is an autoimmune disease that has an excellent prognosis and is treated with liothyronine and levothyroxine.
C) It is subclinical hypothyroidism and she may not need treatment with levothyroxine.

6) A patient stable on methimazole for Graves’ disease remarks that she is considering having a child. Why would you encourage her to speak to her primary care provider?
A) Pregnancy is contraindicated
B) Methimazole is contraindicated and she should be switched to PTU
C) Methimazole is contraindicated and she should be switched to teprotumumab

7) Which medication carries a boxed warning in its labeling for acute liver failure, requiring baseline liver function assessment prior to its start?
A) Methimazole
B) Propylthiouracil
C) Teprotumumab

8) A patient starting methimazole for Graves’ disease asks about symptoms that are common to the condition. Which statement MOST ACCURATELY describes possible symptoms of GD?
A) Symptoms of hyperthyroidism may include rapid heart rate, weight loss, nervousness, hunger, fatigue, and hair loss.
B) Symptoms of hyperthyroidism may include hair loss, fatigue, swelling, puffiness, and depression.
C) Symptoms of hyperthyroidism may include proptosis, anxiety, difficulty breathing, and weight gain.

9) Which statement MOST ACCURATELY reflects symptoms of hypothyroidism?
A) Patients may exhibit many or few symptoms, including fatigue, weight loss, depression, constipation, and hair loss
B) Patients may exhibit many or few symptoms, including fatigue, weight gain, depression, constipation, and hair loss
C) Patients may exhibit many or few symptoms, including insomnia, weight gain, depression, constipation, and hair loss

10) What statement MOST ACCURATELY describes subclinical hypothyroidism?
A) It is a common persistent condition in which TSH levels are elevated and free T4 is high.
B) It is a common persistent condition in which TSH levels are elevated and free T4 is low.
C) It is a common, persistent condition in which TSH levels are elevated and free T4 is normal.

This test is for viewing purposes only. If you would like to submit the test, go to the blue button at the top of the page or Test/Evaluation Site.

Pharmacy Technician Post-test

1. What are common symptoms of hypothyroid disease?
A) Hair loss, proptosis, hunger, fatigue
B) Hair loss, depression, weight gain, fatigue
C) Hair loss, heat intolerance, weight loss, fatigue

2. A patient who started on levothyroxine a year ago is picking up her refill; she remarks that she continues to feel sluggish, fatigue and is still overweight. The patient asks why she is still feeling unwell. What do you tell her?
A) Refer this patient to the pharmacist
B) Assure the patient nothing is wrong
C) Suggest she take a dietary supplement

3. Which medication is used to treat hyperthyroidism?
A) Liothyronine
B) Levothyroxine
C) Methimazole

4. Which medication is used to treat hypothyroidism?
A) Propylthiouracil (PTU)
B) Levothyroxine
C) Methimazole

5. What are common symptoms of hyperthyroid disease?
A) Hunger, weight loss, nervousness, palpitations, frequent bowel movements
B) Weight gain, heat intolerance, excessive sweating, increased heart rate
C) Fatigue, depression, decreased heart rate, cold sensitivity, constipation

6. What are the available dosage strengths for levothyroxine?
A) 12 different tablet strengths ranging in dose from 25-300 mcg in 12.5-25 mcg increments.
B) 8 different tablet strengths ranging in dose from 50-300 mcg in 25-50 mcg increments
C)16 different tablet strengths ranging in dose from 100-300 mcg in 25-50 mcg increments

7. A patient who recently started methimazole calls the pharmacy complaining that suddenly she is feeling feverish with sore throat and chills. What next steps should a pharmacy technician take?
A) Indicate that she probably has a cold
B) Refer her to the pharmacist
C) Tell her to call back if she isn’t better in two days

8. Which mineral is important for thyroid health?
A) Calcium
B) Iron
C) Selenium

9. What medication was recently approved for thyroid eye disease marking a significant advancement in treatment?
A) Propylthiouracil
B) Methimazole
C) Teprotumumab

10. A patient is picking up her levothyroxine refill and was told by her physician that she is anemic. She is purchasing iron supplements too. What is important to communicate to the patient?
A) Iron supplements must be separated by four hours from levothyroxine
B) Iron supplements should not be used with levothyroxine
C) Iron supplements may cause upset stomach and dark stools

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35. Henze M, Brown SJ, Hadlow NC, Walsh JP. Rationalizing thyroid function testing: which TSH cutoffs are optimal for testing free T4?. J Clin Endocrinol Metab. 2017;102(11):4235-4241. doi:10.1210/jc.2017-01322.
36. Flinterman LE, Kuiper JG, Korevaar JC, et al. Impact of a forced dose-equivalent levothyroxine brand switch on plasma thyrotropin: a cohort study. Thyroid. 2020;30(6):821-828. doi:10.1089/thy.2019.0414.
37. Levothyroxine sodium tablets [package insert]. Lloyd, Inc.; 2019.
38. Srivastava S, Sharma G, Rathore M, et al. A crossover study evaluating effect of timing of levothyroxine on thyroid hormone status in patients of hypothyroidism. J Assoc Physicians India. 2018;66(9):37-40.
39. Thayakaran R, Adderley NJ, Sainsbury C, et al. Thyroid replacement therapy, thyroid stimulating hormone concentrations, and long term health outcomes in patients with hypothyroidism: longitudinal study. BMJ. 2019;366:l4892. doi:10.1136/bmj.l4892.
40. Skelin M, Lucijanić T, Amidžić Klarić D, et al. Factors affecting gastrointestinal absorption of levothyroxine: a review. Clin Ther. 2017;39(2):378-403. doi:10.1016/j.clinthera.2017.01.005.
41. Gadiraju S, Lee CJ, Cooper DS. Levothyroxine dosing following bariatric surgery. Obes Surg. 2016;26(10):2538-2542. doi:10.1007/s11695-016-2314-x.
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AI: A New Way to Help Pharmacy Thrive!

The global adoption of artificial intelligence (AI) continues to expand, with AI systems providing essential functions in prediction, recommendation, and decision-making based on their underlying algorithms. Healthcare institutions are exploring how these resources may enhance workflows, improve patient outcomes, and allow clinicians to focus more time on direct patient care. Researchers are exploring AI implementation in numerous areas, including diabetes and heart failure management, medical imaging evaluation, acute kidney injury detection, medication adherence, and electronic health record integration. While AI holds immense potential for transforming healthcare, its implementation faces several challenges. Barriers to AI integration include resource allocation, legal consideration, and securing healthcare provider acceptance. Healthcare professionals must address these barriers for the successful application of AI into daily clinical practice.

INTRODUCTION

Dolly is a pharmacist in an independent pharmacy working 9 to 5 (what a way to make a living!). Her technician, Miley, calls her to the front to talk with Carol, a 60-year-old woman who consistently wears her smartwatch. Miley tells Dolly, “You have to hear this!” Carol reports that while walking her dog, she tripped and landed face down on the pavement. Carol says her smartwatch called out, “It looks like you’ve taken a hard fall,” and asked if it should call 911. Carol didn’t need emergency services, but she was grateful that the watch detected her fall and could help if necessary. If Carol had been unresponsive, the watch would have called 911 automatically. When Carol left, Miley said, “You know Dolly, I am really concerned that artificial intelligence (AI) is going to replace me.” Dolly nodded and said, “I know. I have some concerns, too. It's enough to drive you crazy if you let it.” Dolly realizes she needs to look into AI and its possibilities.

AI is a technology that learns, reasons, and performs tasks to mimic humans.¹ A 2022 Pew Institute survey of 11,004 Americans found that while 55% use AI frequently, awareness of its presence and capabilities varies.² Only 30% of participants demonstrated high AI awareness, with factors such as education level, income, and Internet use influencing their familiarity.² Despite growing adoption, public engagement is mixed, with concerns about AI’s impact fueling debate.

Recently, many media outlets have published articles about AI, and many of those pieces have generated public debate and concern.^3-5 Public engagement in ethical debates about AI’s use and limitations is only reasonable and well advised if individuals understand its strengths and limitations. Despite the widespread adoption of AI technologies among Americans, another Pew Research Center survey reported that only 15% express more excitement than concern about its increased use in daily life, 38% express more concern than excitement, and 46% are mixed, containing both excitement and concern.⁶ Nonetheless, AI’s adoption and market value increases annually. Researchers estimated the AI market size at $40 billion in 2022 and expect it to grow to $1.3 trillion by 2032.⁷

Americans rely on AI in their everyday lives for web searches, task automation, and more—often without even realizing it. Engineers have seamlessly integrated AI into technologies like Siri, Alexa, and Google Home, making everyday tasks more convenient. With almost limitless possibilities, AI continues to evolve and grow, including in the healthcare field.

PAUSE AND PONDER: Take a moment and look at this list. Which of the following are AI powered? You can find the answers at the end of this activity (after the CONCLUSION).

Air conditioners
Automatic washing machines
Basic calculators
Customer service chatboxes
Email services
Facial recognition technology
Media/playlist recommendations
Purchase recommendations
Refrigerators
Social media
Television remote controls
Voice assistants
Wearable fitness trackers

Defining AI

AI systems predict, recommend, and make decisions using machine-based algorithms. Programmers design these systems with a set of rules and human-defined objectives to accomplish a variety of tasks.^8,9 As Table 1 implies, no single definition fully captures AI’s complexity, and its applications are broad.¹

Table 1. Definitions and Possibilities Associated with AI¹

An artificial system…

· performs tasks in predictable and unpredictable conditions with minimal human oversight

· learns and improves its performance from experience and data set exposure

· is developed in software or hardware

· works to complete tasks requiring human-like action, cognition, communication, learning, perception, or planning

· is developed to mimic human cognition and neural networks

· is made with techniques for approximating a cognitive task

· is designed to act rationally

AI Models

AI system designs vary based on the AI model used. Common algorithms include machine learning, neural network, deep learning, natural language processing, and rule-based expert systems. Neural network and deep learning fall under the broader category of machine learning. Table 2 describes how developers tailor each model to accomplish specific tasks in unique ways.¹⁰ It also captures common AI models used in healthcare with examples for their application.

Table 2. Explanations and Examples of AI Model Applications¹⁰^-15
Model	Explanation	Example(s)
Machine Learning	· Fits models to data · Trains models with data sets · Encompasses neural network and deep learning models	· Precision medicine: uses information about a person’s genes and lifestyle to prevent, diagnose, or treat disease · A breast cancer prediction algorithm: interpreted 38,444 mammograms from 9,611 women to predict biopsy malignancy and distinguish between normal and abnormal screenings
Neural Network	· Inspired by and mimics the human brain · Uses nodes that mimic human neurons to process and learn from data · Considers inputs, outputs, and weights of variables	· Google Photos: uses a neural network to categorize images based on face or object recognition
Deep Learning	· Complex model building off the neural network · Uses features and variables used to predict an outcome	· Facial recognition: uses deep learning for security purposes like unlocking smartphones or for tagging people on social media · Enables the identification of individuals as the same person, even with changes to physical appearance, lighting, or visual obstructions
Rule-Based Expert Systems	· If-then format for decision-making processes · Constructs rules in a knowledge domain	· Medical diagnosis: if the patient has a fever and a sore throat, then consider the possibility of strep throat

After some research, Dolly was ready to determine the model AI uses to detect falls. She found that smartwatches rely on machine learning models, including deep learning, to identify falls. Specifically, the technology uses accelerometer (an instrument that detects and measures speed and directional vibrations) and gyroscope (an instrument that detects and measures angular momentum) data from the watch to detect abrupt movements and shifts in motion that could signal a fall.¹⁶

PAUSE AND PONDER: How can healthcare professionals and leaders integrate AI models into healthcare?

AI IN DISEASE MANAGEMENT

Integrating AI into healthcare can transform patient care and streamline workflows.¹⁰ A recent survey reported that 80% to 90% of forecast panelists believe that AI will improve care, simplify patient referrals, and facilitate prior authorizations.⁸ Also, 63% of participants indicated that it is very or highly likely for health systems to adopt AI for pharmacist documentation. AI can specifically help document patient information in electronic health records (EHR).⁸ Some physicians and advanced practice providers are already using AI to improve patient documentation.⁸

Generative AI uses machine models to analyze data patterns and create content like images and text. In healthcare, it enhances patient care and supports whole-person health.⁸This technology can assist with medical image interpretation, inform disease diagnosis, identify care gaps, personalize treatment plans, enable remote patient monitoring, and support early intervention and preventive care.^8,17 In her research, Dolly found a number of applications that could improve patient care.

Diabetes Management

By 2050, statisticians expect that 1.31 billion Americans will have diabetes.¹⁸Diabetes management requires frequent follow-up and comprehensive examinations to monitor blood glucose levels and detect complications.¹⁹ Medical resources are unevenly distributed across the United States (U.S.). Physicians are often concentrated in wealthier and suburban areas, leaving rural regions with limited access to primary and specialty care. Yet, rural populations have a 16% higher prevalence of type 2 diabetes (T2DM) and a 20% higher T2DM-related hospital mortality rate compared to urban populations.²⁰

Effective diabetes management requires a collaborative approach involving endocrinology, nutrition, nephrology, ophthalmology, pharmacy, and podiatry. Since primary care alone is insufficient to handle this complex condition, rural areas face significant challenges in diabetes management.¹⁹By 2034, researchers estimate a shortage of 124,000 doctors in the U.S., with the majority of loss in primary care.²¹ If this prediction is accurate, individuals in rural areas will face growing challenges accessing healthcare. Given the uneven distribution of healthcare resources across various regions, AI advancements may enhance efficiency in diabetes care while diminishing overall health expenditures.^10,19

To achieve better care for all people, clinicians may use predictive models to assess disease progression in T2DM, forecast blood glucose levels, and detect diabetic retinopathy.²²

AI technology may prevent diabetes onset in high-risk patients by ensuring early medical intervention.¹⁹AI technologies may use non-invasive, cost-effective methods capable of early identification and classification of diabetes.

An emerging theory is that machine learning using facial texture features and tongue color analysis could predict diabetes onset and identify those at high risk. In patients with diabetes, skin manifestations are common.²³These manifestations range from acanthosis nigricans (demarcated plaques with grey to brown pigmentation), to dermopathy (spots on the front of lower legs), to skin thickening.²³The pathophysiology of these conditions is not entirely understood. However, aging and diabetes causes increased collagen interlinking. Consequentially, skin changes like thickening and hardening may occur.²³

In Chinese Medicine, practitioners believe face regions reflect the health of internal organs.²⁴ Asian researchers postulated that tongue discoloration, such as a yellow coating, is linked to diabetes, with studies showing a connection between tongue features and glucose metabolism.^25,26 In 2017, researchers conducted a study to determine which model analyzes facial texture and color to detect diabetes most accurately.²⁴ They took facial images, divided them into regions, characterized regions by textures, and analyzed them using eight different models.²⁴ In 2019, Chinese researchers collected tongue images from 570 patients and analyzed their color and texture using AI models. The results demonstrated that these models may effectively associate tongue images with diabetes, but these studies remain preliminary.²⁵

In 2024, 8.7 million Americans or 3.4% of all U.S. adults met laboratory criteria for diabetes but were not aware that they had this condition.²⁷ Delayed diagnosis is a common concern in diabetes, with about 45% of adults worldwide undiagnosed.¹⁸ Current diabetes diagnostic tests include hemoglobin A1C, fasting plasma glucose, 2-hour plasma glucose, and oral glucose tolerance test (OGTT). These four tests are invasive as they require venipuncture.²⁴ Non-invasive diagnostic methods, such as analyzing facial images and tongue color, could help identify diabetic patients who are unaware of their condition.

Dolly is fascinated by this information, but aware that these findings are very preliminary. Recently, one of her favorite patients, Lily, had gained weight rapidly in the early trimesters of pregnancy. Her obstetrician ordered an OGTT. Before the test, Lily fasted, then drank a sugary solution and had her blood sugar levels measured at specific intervals. This process was challenging for Lily, as the sight of blood and having her blood drawn nauseates her. Dolly wishes that non-invasive methods were currently available.

In primary care, AI technologies may create personalized diet and exercise plans for people with diabetes. These plans could align with clinician recommendations and contribute to effective diabetes management.¹⁸

Despite the promise of AI technology in diabetes management, predicting blood glucose levels remains challenging because food and subcutaneously administered insulin absorption rates vary. AI technologies are increasingly embedded into continuous glucose monitoring (CGM) systems to predict blood glucose levels. CGMs track patients’ blood glucose levels in real time and eliminate frequent finger pricks. CGMs provide regular and accurate blood glucose data, offering greater convenience than traditional finger sticks. Regardless, errors may still occur. CGM may report blood glucose levels that differ from actual values by roughly 9%. Differences in actual blood glucose level measurements may be an important consideration for individuals with diabetes and their healthcare providers. Soon, it’s likely that AI will also measure ketone levels; some systems will be integrated into CGMs.²⁹

Another obstacle is when clinicians’ recommendations differ from those generated using AI, as both may be correct. To resolve discrepancies, AI may serve as a tool to support human decision-making. Last, AI technology is designed based on the data it receives. Data quality is important for accurately predicting and managing diabetes.^19,22

Cardiac Care

Like diabetes, heart failure (HF)—the inability of an individual’s heart muscle to pump enough blood—is becoming more prevalent. Common symptoms include shortness of breath, fatigue, and swelling of the legs, ankles, or abdomen.³⁰ Worldwide, approximately 60 million individuals live with HF.³¹ Managing HF requires accurate diagnoses and treatments tailored to individual patients. AI technologies may help diagnose, predict outcomes, classify, and optimize treatment strategies in HF.³²

Researchers have published much information on HF, and information on the use of machine learning to analyze this data is increasing. AI algorithms address challenges like data noise (large amounts of unwanted data that make analysis difficult), false correlations (no relationship between two variables), and statistical power issues (a study’s inability to detect accurate results or effects). By streamlining data analysis, AI complements traditional statistical methods to gather insights into HF.³²

Researchers have created an AI-based diagnostic algorithm for HF. The study enrolled 600 patients with and without HF. The results demonstrated a diagnostic accuracy of 98% and surpassed non-specialist clinicians, who had an accuracy of 76%. In regions with limited access to HF specialists, these AI technologies could be beneficial.^32,33

Patients with HF also face high 30-day readmission rates. Decreasing HF hospital admissions and readmissions is important considering the financial penalties that the Centers for Medicare and Medicaid Services (CMS) impose. CMS reduces hospital payments by a percentage following unplanned 30-day readmissions for patients with HF.³⁴The hospitalization rate has improved from about 367 hospitalizations per 100,000 adults in 2016 to 350 hospitalizations in 2020. However, Healthy People 2030’s target is 330 per 100,000, meaning more improvement is needed.³⁵

Deep learning AI models may help lower hospital readmissions for patients with HF. In a 900-patient cohort study, these technologies outperformed traditional techniques in predicting readmission rates. This AI algorithm used heart sounds, respiratory rate, tidal volume (the amount of air that moves in and out of the lungs during a normal breath), heart rate, and patient activity to make predictions.³²

The rising use of remote monitoring and wearable devices is likely to expand AI’s effectiveness in managing HF. AI-powered smartwatches programmed with electrocardiography features demonstrate acceptable accuracy in detecting HF with reduced ejection fraction. These technologies allow continuous data streams, better prediction in hospital readmission rates, and earlier HF identification.^31,32

Dolly finds that smartwatches can also be useful for patients who have or are at risk for atrial fibrillation (AFib). Carol, the patient whose smartwatch detected a fall, has been worried that she might develop AFib, which causes irregular heartbeats. Last week, the watch detected an episode of AFib. When Carol visited her provider, she brought the printed electrocardiogram showing the episode. This enabled the provider to make informed decisions about next steps, supported by AI technologies.

Sepsis Identification

Globally, sepsis—a life-threatening response to an infection—is a leading cause of illness and death.³⁶ Patients with sepsis present with varying degrees of severity, ranging from mild sepsis to septic shock. It can lead to tissue damage, organ failure, and death. Sepsis’s variable presentation makes early detection challenging. However, prompt recognition of sepsis is critical, as every hour without treatment increases the risk of death.³⁶

AI technologies may predict sepsis hours before its onset. Through machine learning and predictive algorithms, AI improves the accuracy of sepsis detection in a clinical setting.^36-38Researchers conducted a prospective, multi-center study of 590,736 patients across five hospitals, with 6,877 included in the analysis.³⁸ During the study, researchers used the Targeted Real-time Early Warning System (TREWS) as a sepsis alert system for providers.³⁸ TREWS is a machine learning-based algorithm that notifies providers when a patient is at high risk for sepsis.

TREWS integration enabled early intervention from providers and reduced the hospital mortality rate by 5.1% when providers responded to the alert within three hours.³⁸ The TREWS intervention group also saw a 4.5% decrease in overall mortality compared to patients whose providers did not respond within three hours. Patients flagged as high risk also experienced reductions in organ failure severity.³⁸ A critical point is provider response time. It is possible that providers who responded more quickly simply had better resources or teams at their disposal.³⁹

This study’s major limitation was the predetermined alert settings, which may have influenced the alerts and their associations with clinical outcomes.³⁸ TREWS notified providers when patients exhibited significant findings related to sepsis. This constraint limits the study’s generalizability, as variations in alert settings may lead to significant differences in the timing of alerts and, potentially, patient outcomes. Future implementation may adopt a less restrictive model, allowing earlier warnings by identifying patients with fewer sepsis-related criteria.³⁸

Alert fatigue—healthcare provider desensitization to safety alerts—may also limit this study’s applicability to clinical practice.³⁸ Alert fatigue often causes individuals to not respond properly to safety alerts and warnings.⁴⁰ TREWS integration may contribute to the alert fatigue phenomenon that plagues the healthcare industry.

Despite this study’s promising results, few large, randomized controlled trials (RCTs) have evaluated AI-based alerts for patients with sepsis.³⁷

Acute Kidney Injury Alert

Acute kidney injury (AKI; a decline in the kidney filtrate rate) impacts approximately 18% of inpatients and greater than 50% of patients in intensive care units.⁴¹ Like managing HF and diabetes, early detection is critical.^41,42Two studies have examined AI in AKI.

Chinese researchers led a double-blind RCT to evaluate the impact of electronic alerts on adults with AKI.⁴¹ They randomized more than 2,000 hospitalized patients to determine whether an AKI alert combined with management strategies improves care and clinical outcomes. The data showed that alerts did not improve kidney function or overall patient outcomes. However, the alerts influenced treatment approaches. Patients in the alerts group received more intravenous fluids (82.6% vs 61.8%), fewer nonsteroidal anti-inflammatory drugs (5% vs 11%), and more AKI documentation at discharge (49.9% vs 27.3%).⁴¹

Another double-blinded, multicenter RCT enrolled more than 6,000 patients. Researchers concluded that the AKI alerts did not reduce the risk of AKI progression, dialysis initiation, or death within 14 days of randomization.⁴²

Both studies found that integrating their specific AKI alert algorithms into EHR did not improve patient outcomes.^41-43However, pairing these alerts with management strategies influenced providers’ treatment decisions. These findings suggest that while changes in treatment strategies may not directly benefit patients, they may help avoid medications that can contribute to AKI.^41,42

Image Interpretation

Beyond its use in facial recognition for social media and security, AI also has the proven potential to analyze medical images. Specifically, AI technologies show promise in oncology for identifying and categorizing cancers, and in managing diabetic retinopathy.

Oncology

Researchers are developing AI models for cancer imaging, aiming to improve tumor detection, characterization, and monitoring.^10,44 These tools identify various cancers and predict patient outcomes very accurately.⁴⁵ They can help minimize oversights and serve as an initial screen to reduce omission errors.

AI tumor characterization involves tumor segmentation (outlining and identifying boundaries of the tumor in images), diagnosis, and staging. AI-driven automated segmentation has the potential to enhance the efficiency, reproducibility, and quality of tumor measurements.⁴⁴ It may also improve the ability to monitor changes in tumors over time. Despite these promising advancements, challenges remain in ensuring accurate detection, characterization, and monitoring.⁴⁴

Diabetic Retinopathy

AI models can detect diabetic retinopathy, a complication of diabetes that progressively impairs vision over time. AI identification of diabetic retinopathy is facilitated through retinal fundus imaging, which has demonstrated high sensitivity and selectivity, as defined in the SIDEBAR.^22,46,47

SIDEBAR: Differentiating Sensitivity and Specificity⁴⁷

Sensitivity

Specificity

· A test’s ability to determine whether an individual with the disease is positive

· High sensitivity: limited false negative results—few cases where the disease is missed

· A test’s ability to determine if an individual who does not have the disease is negative

· High specificity: limited false positive results

· Using a test with low specificity causes many people without the disease to screen as positive and receive treatment

In 2017, researchers enrolled 521 participants across 10 U.S. centers. Each patient underwent a dilated ophthalmoscopy (an eye exam). The AI algorithm accurately identified 36 of 37 positive cases (97% sensitivity) and 162 of 184 negative cases (88% specificity).⁴⁶The researchers concluded thatthe AI system detects mild diabetic retinopathy more effectively than general ophthalmologists or retina specialists. This tool may offer a low-cost solution for diabetic retinopathy screening and help reduce the burden of diabetic eye screenings.⁴⁶

Electronic Health Records

Approximately 80% of clinically relevant healthcare information is unstructured data.⁴⁸Applying a natural language processing (NLP)-based algorithm to the EHR may help hospitals identify patients who need a clinical pharmacist’s review. NLP models possess the ability to engage in speech recognition, text analysis, and translation, with goals centered around language processing. One example of its use is transcribing patient interactions, which may be helpful for medication reconciliation. Similarly, NLP-based systems can prepare reports, such as patient notes within the EHR, and analyze these notes.¹⁰By analyzing notes, the system can also identify patients requiring extensive medication interventions and categorize them as high risk. This classification enables pharmacists to dedicate their efforts to patients most likely to benefit, ultimately enhancing their impact on patient care.⁴⁸

AI models may also detect and alert providers when an ordered medication deviates from its typical use pattern. AI captures information on standard dosages and indications, aiding drug selection, dose recommendations, drug-drug interaction detection, and order entry.⁴⁹ This tool supports pharmacists and other healthcare providers in clinical decision-making to minimize medication-related errors and improve patient outcomes.⁴⁹

Generative AI models may streamline providers’ documentation processes. Clinicians spend approximately 35% of their time documenting patient data and notes.⁵⁰ AI technologies may reduce this workload, allowing providers to focus more on patient care. However, before integrating AI into documentation, leaders must set clear guidelines. For effective use, these guidelines must address concerns such as data security, accuracy, reliability, ethical considerations, and the need for ongoing evaluation of AI programs to ensure regular maintenance and optimization.⁵¹

The possibilities for AI integration in EHR are endless. With proper use, these resources help streamline workflow and increase time providers spend on direct patient care.

PAUSE AND PONDER: What are the opportunities and challenges for AI integration into healthcare?

AI CHALLENGES

A major challenge is AI’s inability to explain how it arrives at its conclusions, referred to as model transparency. Predictive modeling and deep learning procedures are difficult to adopt in clinical environments. The algorithms behind these models often lack transparency and experimental context.^8,22

For clinicians to accept AI, they must understand how models generate recommendations. By detailing internal decisions, behaviors, and actions, AI’s developers can build trust among healthcare providers. Developers must equip clinicians with sufficient information to understand each event’s causes. Subsequently, providers can determine how to incorporate AI recommendations into their clinical decision-making processes.^8,22

Another barrier arises from EHRs’ limitations. Since EHR data is not publicly available, AI technologies may struggle to generate comprehensive recommendations. Also, healthcare organizations often restrict data access to internal use, leaving predictive modeling without sufficient information.²²To address this challenge, some experts propose federated learning. This allows institutions to contribute to a global model while keeping sensitive data within their respective systems.¹⁰ However, as AI processes large volumes of data, the risk of data breaches and unauthorized access increases. Protecting databases from security threats remains a challenge.⁸

Bias presents another obstacle. If data used in AI models is homogenous, the results may be skewed. Developers must ensure that training datasets include a wide range of patient demographics and conditions to prevent biased outcomes.⁸

Cost inhibits widespread adoption of AI. Institutions allocate resources for AI differently. Smaller, rural hospitals may struggle to implement these technologies due to financial constraints.⁸ Also, demonstrating a clear return on investment for AI integration is difficult. The limited cost avoidance data per intervention and impact on patient outcomes makes it challenging for hospital executives to justify AI investments.⁸

Legal and ethical considerations further complicate AI acceptance. Mistakes are inevitable with AI technologies. Who will be held accountable for errors, especially when they impact patient outcomes? Healthcare providers may be reluctant to adopt AI technologies if responsibility for potential AI errors is unclear.^8,10 This also calls into question regulatory compliance. If AI becomes the standard of care, providers who choose not to use these tools may face legal and regulatory consequences.^8,10

Before implementing AI in clinical practice, healthcare institutions must thoroughly test and validate each model. A designated committee containing diverse healthcare professionals should lead the approval process to ensure safe and effective implementation of AI models. This approval process and integration into daily practice may take years.¹⁰

After looking at how AI is used currently, the research underway, and AI’s challenges, Dolly feels confident that she can discuss changes in the workplace and pharmacy processes with Miley.

TAILORING AI TO PHARMACY PRACTICE

Many healthcare providers already recognize the implications of AI integration in healthcare. A recent survey asked pharmacists, “How likely is it the following will occur by the year 2029 in the geographic region where you work?”⁸ Table 3 displays the findings on AI integration in pharmacists’ documentation and medication histories.⁸

Table 3. Forecast Panelists’ Survey Responses to AI Integration in 2029⁸
Response	Percent of Responders
Statement 1: 50% of health systems will adopt technology in the EHR for pharmacist documentation to be completed by generative AI.
Very Unlikely	4%
Somewhat Unlikely	33%
Somewhat Likely	44%
Very Likely	19%
Statement 2: 25% of health systems will use a Chatbot to obtain medication histories.
Very Unlikely	10%
Somewhat Unlikely	33%
Somewhat Likely	43%
Very Likely	14%
AI, artificial intelligence; EHR, electronic health record.

As healthcare professionals acknowledge AI’s expanding function, they must develop a strong understanding of these technologies. Pharmacists and pharmacy technicians, in particular, need a basic knowledge of AI.⁴⁸With this foundation, pharmacists can assess AI models’ strengths and limitations and determine when and how to use them effectively.

To establish a baseline understanding of AI technologies, institutions must integrate education and didactic experiences into training for pharmacy technicians, pharmacy students, and pharmacists.^52,53This will equip healthcare providers with the basic skills needed to evaluate AI models and understand its responsibility in improving patient care.

AI and the Pharmacy Workforce

Like Miley, may pharmacy personnel worry that AI may replace pharmacists and pharmacy technicians. In the United Kingdom, researchers estimate 35% of all jobs—including some pharmacy-related positions—could be automated in the next 10 to 20 years.¹⁰ However, they also predict job losses will amount to less than 5%. This is because of factors like cost of automation technologies, labor market dynamics, and regulatory and social acceptance. These circumstances create major barriers in the widespread adoption of AI across industries and may mitigate actual job loss.¹⁰

In healthcare, similar trends are expected. To date, AI has not eliminated jobs.¹⁰ Pharmacy student enrollment is unlikely to rise, and researchers predict that 20% of first year post-graduate residency spots will remain unfilled after the match. As a result, they anticipate the pharmacy workforce will decline.⁸ This projected reduction has led to expectations that AI will assist with repetitive pharmacy tasks, allowing pharmacists and technicians to focus on responsibilities that require human expertise.

With the integration of AI into healthcare, pharmacists are expected to expand their scope of practice into areas where they can use their skills more and influence outcomes.^8,10 These include managing high-cost medications, bridging gaps in primary care, applying empathy and persuasion, and taking a big-picture approach to patient care. While AI is designed to mimic certain human actions, it is not human. It lacks interpersonal skills and the ability to build relationships. Ultimately, AI will complement pharmacists by streamlining repetitive tasks, addressing workforce shortages, and enabling them to use their unique human intelligence abilities.^8,10

Adverse Drug Reactions

A primary responsibility for pharmacists in medication management is to mitigate patients’ risk of adverse drug reactions (ADRs). EHR systems use AI for ADR prediction and detection. For example, if a prescriber orders amiodarone for a patient who is already taking warfarin, the system is designed to alert healthcare providers that the combination leads to high bleeding risk. Current systems already deliver this alert, and an AI-assisted system may recommend providers decrease the patient’s warfarin dose empirically by 30% to 50%.⁵⁴ However, like any test or algorithm, false positives and negatives can occur, meaning these systems are not foolproof. It is crucial that clinicians and pharmacists do not rely solely on these alerts for detecting ADRs or sending notifications. Instead, they should apply clinical decision-making and rely on their expertise.

A recent study involving 412 patients used a machine learning algorithm to predict the likelihood of ADRs in neonates.⁵⁵ Researchers designed the algorithm to associate a risk score to predict and prevent ADRs, rather than simply display a warning as is done currently for certain medications. The model displayed high predictive accuracies, successfully detecting ADRs in patients with allergic, renal, central nervous system, and hepatic ADRs 78.9% to 90.2% of the time.^49,55These models illustrateAI’s broad application in ADR detection which supports clinical decision-making.

AI also offers opportunities to improve patient adherence. It can trigger patient-specific message alerts, such as medication renewal reminders for both the pharmacist and the patient. This ensures timely prescription refills, helps maintain a consistent medication supply, and supports better medication adherence for improved health outcomes. Wearable devices like smartwatches and smartphones also integrate AI technology that may encourage behavioral changes and enhance adherence.¹⁰ For example, some smartwatches offer a time-to-stand reminder. If individuals have not moved within the first 50 minutes of an hour, the watch will remind them to stand. Simple alerts like these increase movement and encourage behavior changes.

Beyond clinical applications, AI has the potential to transform pharmacy operations. AI technology may request and process prior authorizations (something of great interest to Dolly and Miley), manage the supply chain, optimize pharmacy revenue cycles, and track financial performance.⁸

CONCLUSION

AI technologies are likely to revolutionize healthcare by enhancing clinical decision-making, improving patient outcomes, and streamlining workflows. Through automation of routine tasks and data analysis, AI can help healthcare providers deliver more efficient care. However, significant barriers including algorithm transparency, bias, cost, and accountability concerns must be addressed before AI is widely adopted. Overcoming these challenges requires collaboration among healthcare providers, policy makers, and AI developers. Establishing clear guidelines and validation procedures will help ensure AI technologies are safe and used properly. With proper implementation and education, AI is a powerful tool that enhances healthcare professionals’ abilities. Dolly and Miley now appreciate that it cannot replace human skills like empathy, critical thinking, and personalized communication.

PAUSE AND PONDER: Take a moment and look at this list. Which of the following are AI powered? These are the answers that we promised to provide!

Air conditioner
Automatic washing machine
Basic calculators
Customer service chat box
Email services
Facial recognition
Media/playlist recommendations
Purchase recommendations
Refrigerators
Social media
Television remote control
Voice assistants
Wearable fitness trackers

Answers	Examples
Customer service chat box	· Chatbots answering basic customer service questions
Email services	· Emails automatically categorized as spam
Facial recognition	· Unlocking devices · Password security · Tagging individuals in social media posts
Media/playlist recommendations	· Spotify or Apple Music playlists · Audiobook platforms · Streaming services
Purchase recommendations	· Social media advertisements · Web browser advertisements
Social media	· Facial recognition · “For you” page geared to user interests
Voice assistants	· Siri · Alexa · Google Home
Wearable fitness trackers	· ECG monitoring · Fall detection

PHARMACIST AND PHARMACY TECHNICIAN LEARNING OBJECTIVES
After completing this continuing education activity, learners will be able to
• Recognize artificial intelligence (AI) and the models underlying these technologies
• Describe the implications of AI within the healthcare and pharmacy fields
• List the opportunities and challenges that AI introduces to healthcare and pharmacy services
• Recognize AI’s impact on the pharmacy workforce and its implications in shaping the future of pharmacy practice

1. An artificial intelligence developer uses an algorithm that mimics the human brain and consists of nodes that mimic human neurons to process and learn from data. What model is the developer using?
A. Deep learning
B. Neural network
C. Rule-based expert system

2. Which of the following is the BEST descriptor of a possibility associated with AI?
A. Performs tasks in predictable and unpredictable conditions with minimal human oversight
B. Performs tasks in predictable conditions only with minimal human oversight
C. Performs tasks in unpredictable conditions only with direct human oversight

3. An AI algorithm is designed with the following input and output: “if the patient has diarrhea and vomiting, then consider the possibility of norovirus infection.” What model does this rule represent?
A. Deep learning
B. Neural network
C. Rule-based expert system

4. When generative AI uses machine models to analyze data patterns and create content in healthcare, how might it enhance patient care?
A. It can assist with medical image interpretation, inform disease diagnosis, and identify care gaps.
B. It can replace the clinician’s need to be present at clinic appointments.
C. It can make decisions for clinicians, write treatment plans, and prescribe medications.

5. Effective diabetes management requires a collaborative, specialized approach. Since primary care alone is insufficient to handle this complex condition, which of the following current barriers to diabetes management could AI BEST help overcome?
A. It can help urban areas that have unlimited access to care for diabetes management.
B. It can help rural areas struggling with limited access to care for diabetes management.
C. It can help primary care providers eliminate challenges in diagnosing patients with diabetes.

6. Which of the following represents the MOST significant implication for AI models in cancer imaging?
A. AI models can improve the efficiency, reproducibility, and quality of tumor measurements.
B. AI models can improve the accuracy of tumor detection and consider patient’s medical history.
C. AI models have the potential to enhance the accuracy in detection, monitoring, and make decisions for providers.

7. Which of the following is a CHALLENGE associated with AI use in healthcare?
A. Identifying patients by their unique identifiers may be impossible.
B. Identifying solutions with good specificity and sensitivity is difficult.
C. Identifying who holds responsibility when an error occurs may be unclear.

8. Dr. Smith is interested in integrating AI technologies. He mentions difficulty reading patients’ notes and getting a complete understanding due to residents copying notes from previous days without updating important details. How can AI technologies BEST address this issue?
A. NLP-based systems can transcribe interactions, such as medication reconciliations.
B. NLP-based systems can prepare reports, such as patient notes within the EHR.
C. NLP-based systems can analyze text, such as patient notes within the EHR.

9. The Dolly Hospital is a 100- bed facility located 100 miles from the nearest large city. Which of the following is MOST likely a CHALLENGE for AI integration at this institution?
A. They may struggle to secure the necessary funds.
B. They may struggle to demonstrate a clear return on investment.
C. They may struggle to obtain accurate cost avoidance data.

10. Why is it UNLIKELY that AI will replace pharmacists and cause widespread job loss?
A. Experts anticipate AI has reached its heyday and will be difficult to develop in new ways.
B. Experts anticipate the federal government will implement laws preventing AI use in healthcare.
C. Experts anticipate the pharmacy workforce will decline, making more jobs to be filled.

11. With the integration of AI into healthcare, how is AI expected to complement pharmacists?
A. By assisting with repetitive tasks, allowing pharmacists to focus on responsibilities that require human expertise
B. By assisting with relationship-building, allowing pharmacists to focus on responsibilities that require human expertise
C. By assisting with personalized communication, allowing pharmacists to focus on responsibilities that require human expertise

12. Molly needs to provide discharge medication counseling to a patient but is pressed for time. She sends an AI robot to provide the counseling instead. However, the patient refuses this service. Why is it LIKELY that the patient declined the AI robot’s counseling service?
A. The patient did not want to pay for AI’s automated labor.
B. The patient did not want to accept AI technologies.
C. The patient did not want AI-related errors in counseling.

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17. Manne R, Kantheti SC. Application of Artificial Intelligence in Healthcare: Chances and Challenges. Current Journal of Applied Science and Technology. 2021;40(6): 78-89. doi:0.9734/CJAST/2021/v40i631320
18. Sheng B, Pushpanathan K, Guan Z, et al. Artificial intelligence for diabetes care: current and future prospects. The Lancet. 2024;12(8):569-595. doi:10.1016/S2213-8587(24)00154-2
19. Guan Z, Li H, Liu R, et al. Artificial intelligence in diabetes management: Advancements, opportunities, and challenges. Cell Rep Med. 2023;4(10):101213. doi:10.1016/j.xcrm.2023.101213
20. Dugani SB, Mielke MM, Vella A. Burden and management of type 2 diabetes in rural United States. Diabetes Metab Res Rev. 2021;37(5):e3410. doi:10.1002/dmrr.3410
21. Five key barriers to healthcare access in the United States. UpToDate, Wolters Kluwer. 2022. Accessed February 20, 2025. https://www.wolterskluwer.com/en/expert-insights/five-key-barriers-to-healthcare-access-in-the-united-states
22. Yang CC. Explainable Artificial Intelligence for Predictive Modeling in Healthcare. J Healthc Inform Res. 2022;6(2):228-239. doi:10.1007/s41666-022-00114-1
23. Labib A, Rosen J, Yosipovitch G. Skin Manifestations of Diabetes Mellitus. Endotext [Internet]. 2022. Accessed February 19, 2025. https://www.ncbi.nlm.nih.gov/books/NBK481900/
24. Shi T, Zhang B, Tang YY. An extensive analysis of various texture feature extractors to detect Diabetes Mellitus using facial specific regions. Computers in Biology and Medicine. 2017;83:69-83. doi:10.1016/j.compbiomed.2017.02.005
25. Li J, Yuan P, Hu X, et al. A tongue features fusion approach to predicting prediabetes and diabetes with machine learning. J Biomed Inform. 2021;115:103693. doi:10.1016/j.jbi.2021.103693
26. Tomooka K, Saito I, Furukawa S, et al. Yellow Tongue Coating is Associated With Diabetes Mellitus Among Japanese Non-smoking Men and Women: The Toon Health Study. J Epidemiol. 2018;28(6):287-291. doi:10.2188/jea.JE20160169
27. National Diabetes Statistics Report. CDC. Accessed February 18, 2025. https://www.cdc.gov/diabetes/php/data-research/index.html#:~:text=Total:%2038.4%20million%20people%20have,older%20(48.8%25)%20have%20prediabetes
28. Contreras I, Vehi J. Artificial Intelligence for Diabetes Management and Decision Support: Literature Review. J Med Internet Res. 2018;20(5):e10775. Published 2018 May 30. doi:10.2196/10775
29. Virdi N, Poon Y, Abaniel R, Bergenstal RM. Prevalence, Cost, and Burden of Diabetic Ketoacidosis. Diabetes Technol Ther. 2023;25(S3):S75-S84. doi:10.1089/dia.2023.0149
30. What is Heart Failure? AHA. 2023. Accessed February 18, 2025. https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure
31. Khan MS, Arshad MS, Greene SJ, et al. Artificial intelligence and heart failure: A state-of-the-art review. Eur J Heart Fail. 2023;25(9):1507-1525. doi:10.1002/ejhf.2994
32. Yoon M, Park JJ, Hur T, et al. Application and Potential of Artificial Intelligence in Heart Failure: Past, Present, and Future. Int J Heart Fail. 2023;6(1):11-19. doi:10.36628/ijhf.2023.0050
33. Choi DJ, Park JJ, Ali T, et al. Artificial intelligence for the diagnosis of heart failure. npj Digit Med. 2020;3(54). doi:10.1038/s41746-020-0261-3
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35. Reduce heart failure hospitalizations in adults. Healthy People 2030. Accessed February 18, 2025. https://odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/heart-disease-and-stroke/reduce-heart-failure-hospitalizations-adults-hds-09/data?group=None&from=2016&to=2020&state=United%20States&populations=#edit-submit
36. Haas R, McGill SC. Artificial Intelligence for the Prediction of Sepsis in Adults. CADTH Horizon Scan [Internet]. 2022;2(3). https://www.ncbi.nlm.nih.gov/books/NBK596676/
37. Schinkel M, van der Poll T, Wiersinga WJ. Artificial Intelligence for Early Sepsis Detection: A Word of Caution. Am J Respir Crit Care Med. 2023;207(7):853-854. doi:10.1164/rccm.202212-2284VP
38. Adams R, Henry KE, Sridharan A, et al. Prospective, multi-site study of patient outcomes after implementation of the TREWS machine learning-based early warning system for sepsis. Nat Med. 2022;28:1455-1460. doi:10.1038/s41591-022-01894-0
39. Kennedy JN, Rudd KE. A sepsis early warning system is associated with improved patient outcomes. Cell Rep Med. 2022;3(9):100746. doi:10.1016/j.xcrm.2022.100746
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41. Li T, Wu B, Li L, et al. Automated Electronic Alert for the Care and Outcomes of Adults With Acute Kidney Injury: A Randomized Clinical Trial. JAMA Netw Open.2024;7(1):e2351710. doi:10.1001/jamanetworkopen.2023.51710
42. Wilson FP, Martin M, Yamamoto Y, et al. Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. BMJ. 2021;372:m4786. doi:10.1136/bmj.m4786
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46. Lim JI, Regillo CD, Sadda SR, et al. Artificial Intelligence Detection of Diabetic Retinopathy: Subgroup Comparison of the EyeArt System with Ophthalmologists' Dilated Examinations. Ophthalmol Sci. 2022;3(1):100228. doi:10.1016/j.xops.2022.100228
47. Disease Screening – Statistics Teaching Tools. New York State Department of Health. Accessed February 18, 2025. https://www.health.ny.gov/diseases/chronic/discreen.htm#:~:text=Sensitivity%20refers%20to%20a%20test's,have%20a%20disease%20as%20negative.
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SMARTen Up: Asthma Management Guidelines

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

1. Describe the pathophysiology and severity classifications of asthma

2. Identify the class, mechanism of action, place in therapy, and potential side effects of asthma therapies

3. Recall updates in the 2020 NHLBI Guideline Update

4. State what SMART Therapy is, why it was added to the asthma guidelines, and how to apply it to patient cases

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

1. List the basic symptoms and pathophysiology of asthma

2. Recall how patients are diagnosed with asthma and what the severities are.

3. Recognize common medications used for asthma

4. Explain SMART therapy and the pharmacy technician’s role in SMART

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. Collins and Dr. Hollenbach have no relationship with ineligible companies and therefore have nothing to disclose.

Lindsay Sawtelle acts as a consultant for GSK but there are no conflicts of interest.

Asthma is one of the most common chronic diseases. Patients with asthma may have respiratory symptoms that affect their ability to breathe, daily activities, and quality of life. Understanding asthma and its pathophysiology, diagnosis, severities, and medications are pertinent to managing the disease.

This continuing education activity describes the 2020 update to the Asthma Management Guidelines by the National Heart, Lung, and Blood Institute (NHLBI) expert panel recommendations. Single Maintenance and Reliever Therapy (SMART) is a guideline revision that impacts clinical practice significantly. Pharmacy personnel need to familiarize themselves with the guideline updates to navigate transformations in prescribing that will follow.

INTRODUCTION

Let’s start this continuing education (CE) course with a story. A 13-year-old adolescent, Emily, had asthma exacerbations that were impacting her life. In addition to sitting out at her soccer games, she was having difficulty waking for school because her asthma exacerbations kept her up a few nights a week. Her physician prescribed a budesonide/formoterol (Symbicort) prescription for maintenance and reliever. When she and her mom went to pick up the prescription, their pharmacist told them this prescription was “inappropriate” and “dangerous” at the pick-up counter. This pharmacist likely frightened the patient and her mother. The patient would have been rightfully hesitant to take the prescription as the physician prescribed.

Although the guidelines did not recommend using this combination for reliever and maintenance before 2020, the pharmacist was mistaken. This pharmacist didn’t know about new NHLBI guidelines for SMART therapy. This continuing education activity will explore a recent change to the asthma guidelines that helps aspiring soccer players like our Emily score a goal with their asthma. Staying up to date on guidelines is the only way pharmacists will keep their place as trusted healthcare professionals.

BACKGROUND

All pharmacy team members need to know about asthma because it is a common chronic disease in both children and adults. The Center for Disease Control (CDC) estimates that around 8% of the population has asthma. As a chronic disease affecting the airway and lungs, asthma is characterized by airway inflammation, bronchospasm, and mucus hypersecretion. These findings cause symptoms of difficulty breathing, wheezing, coughing, and chest tightness.¹ Asthma’s symptoms can range from mild to severe and they fluctuate. Symptom worsening is called an asthma attack, flare, or exacerbation.²

Asthma is often diagnosed in childhood but affects people of all ages. It is diagnosed more commonly in males during childhood, but its prevalence is equal in males and females by adulthood.¹ Asthma seems to have a hereditary component, although many genes probably contribute to asthma.³Family history and the presence of eczema are both risk factors for asthma.¹ Other risk factors include exposure to environmental tobacco smoke, air pollutants, or allergens, such as pollen, dust, or workplace chemicals (see the SIDEBAR for information about household pests).¹ Risk factors for asthma are often present in childhood. For example, exposure to cigarette smoke in the womb increases the probability infants will develop asthma. Young children with allergies or who have respiratory infections are also more likely to develop asthma.¹

Asthma Pathophysiology

The bronchial tree is the branched system of cartilaginous tubes responsible for conducting gas to alveoli, the small air sacs that allow gas exchange, in the lungs. The word “tree” is an apt description because the lungs look like an upside-down tree, where the trachea is the trunk, and the bronchioles are the smallest terminal twigs. The bronchioles are the smallest bronchi and they facilitate gas exchange with alveoli, the air sacs in the lungs that exchange gas with the blood.⁴ Each layer of the bronchi has a smaller diameter than the one it stems from and has more smooth muscle fibers, just like the branches of a tree.⁵ Asthma primarily affects airways including the smooth muscle of the bronchi, where inflammation decreases the airway’s size, in turn increasing the work it takes to breathe.³

In allergic asthma, an asthma exacerbation consists of an early phase and a late phase. IgE antibodies are responsible for the first phase.³Environmental triggers cause plasma cells to release IgE antibodies, which bind to mast cells and basophils. Mast cells release cytokines, histamine, prostaglandins, and leukotrienes.³ Ultimately, smooth muscle contracts and the airway tightens, causing bronchoconstriction.⁶ Th2 lymphocytes sustain the inflammation by producing additional cytokines and maintaining the communication between cells.³ The late phase occurs over the next few hours as inflammatory cells localize to the lungs and cause bronchoconstriction and inflammation. The cells involved in this second phase include basophils, eosinophils, helper and memory T-cells, and neutrophils.³ These cells cause inflammation and further edema. Mucus worsens airway obstruction and difficulty breathing. Successful management of an asthma exacerbation requires recognition of both phases.

Hyperresponsiveness of the bronchi is another mechanism of asthma’s pathophysiology. Hyperresponsiveness is excessive bronchoconstriction after inhalation of or exposure to triggers.⁷ Triggers can include smoke, exercise, emotion, cold temperatures, humidity, animals with fur, infections, and non-steroidal anti-inflammatory drugs.^8-11This mechanism of excessive inflammation involves histamine and increased free intracellular calcium that increases smooth muscle contractility.¹² Disease severity and therapeutic intervention are related to bronchial hyperresponsiveness.

Rodent and Cockroaches Sidebar^13-15

The prevalence of asthma is highest in developed countries, especially in urban areas. In urban areas, up to 1 in 4 children may have asthma. Urban areas increase the risk of exposure to cockroaches and rodents, increasing allergen sensitization in these areas, ultimately leading to asthma. Mouse Mus m 1, mouse urinary protein (MUP), rat N 1, and cockroach (Bla g 1 and Bla g 2) are the responsible allergen proteins. Tests have confirmed high levels of these proteins in houses, schools, and daycares in urban locations.

Multifamily homes, high population density, lower socioeconomic status, and poor physical condition of buildings are all settings that foster cockroach and rodent infestation. Sensitization to cockroaches and rodents is associated with wheezing and severe asthma morbidity. Most research done to date has been in children.

Like people, pests need food, water, and shelter to live. They prefer to live in dark and damp areas. Pest mitigation strategies can decrease the likelihood of exposure to rodent and cockroach proteins:

Do not leave food containers open or dirty dishes out in the open.
Do not leave pet food and water out overnight.
Clean regularly. Pick up garbage, crumbs, and clean liquid spills.
Use trash cans with lids, bags that resist breaking, and do not allow them to overflow.
Check for plumbing leaks and moisture problems and fix any issues right away.
Seal cracks and openings around doors, windows, and foundations.
Use bait gel in cracks and traps rather than pesticides.

Structural changes occur in the airway due to chronic inflammation and airway muscle hyperreactivity. This is known as airway remodeling. An asthmatic bronchiole is narrower than a normal bronchiole. Increased swelling, chronic inflammation, and mucus buildup from persistent airflow obstruction cause the narrowing.³ The narrowing of the lumen disrupts the normal replication of epithelial cells, compromising the layer’s structure and function.¹⁶ The hyperresponsiveness of the bronchioles leads to hypertrophied smooth muscle, disrupting the basement membrane. Irreversible obstruction of airflow is a consequence of airway remodeling.¹² Effective treatment of asthma can prevent or delay airway remodeling.

ASTHMA DIAGNOSIS

The first step in diagnosing asthma is a focused medical history and physical examination. Symptoms consistent with asthma include episodes of cough, wheezing, difficulty breathing, and chest tightness. It is also notable if these symptoms worsen at night and awaken the patient, as they did for our patient Emily.¹⁷ The physical exam may show use of accessory muscles when breathing, sounds of wheezing during normal breathing, increased nasal secretion with mucosal swelling, or atopic dermatitis/eczema.¹⁷Noting patient allergies or a family history of asthma helps establish a diagnosis.

Spirometry can be used to evaluate asthma and monitor disease severity; it can also be used to monitor response to therapy in patients aged 5 and older. Of note, it is not common to find many five-year-olds who are capable of reliably performing the test.¹⁷ Spirometry measures the air a patient breathes in and out. Specifically, spirometry measures the forced expiratory volume in 1 second (FEV₁) and the forced vital capacity (FVC).¹⁸

FEV₁: maximum amount of air a patient exhales in one second.
FVC: maximum amount of air exhaled when blowing out as fast as possible

Comparing results against values normalized by age, height, weight, gender, and race is the only way to interpret them. An easy way to interpret results is based on the percent predicted; however, most pulmonologists now use z-scores to interpret spirometry.¹⁹Physicians may have the patient repeat spirometry after taking a bronchodilator to evaluate for airway reversibility.

Clinicians also use spirometry to evaluate if current therapy is controlling asthma effectively. The results of patients’ spirometry tests while on treatment guides doctors to increase or decrease the dose of asthma medications.¹⁸

Airway hyperresponsiveness is measured using a methacholine test. The clinician uses spirometry to find the patient’s FEV₁. The patient then uses a nebulizer and inhales increasingly larger doses of methacholine. The physician takes the FEV₁ before and after each dose. The test is positive if the FEV₁ drops 20% or more from the baseline FEV₁. The test is negative if the maximum methacholine dose does not decrease the FEV₁ by at least 20%.²⁰ Regardless of asthma control and response to therapy, most people with asthma would have a positive methacholine challenge test.

The 2020 NHLBI guideline update includes the conditional recommendation to use fractional exhaled nitrous oxide (FeNO) as a test to diagnose asthma.²¹ Nitric oxide (NO) is a gas produced by cells involved in inflammation. The higher the NO level, the more inflammation in the body. This test is plausible to use as an adjunct for patients aged 5 and older whose asthma diagnosis is uncertain using history, clinical course, and spirometry. Our patient in this CE case would not be a candidate for a FeNO test, as her asthma diagnoses are apparent without one. One should also note that most commercial insurances no longer cover this test.

Asthma Severities

The NHLBI classifies asthma as intermittent, mild persistent, moderate persistent, or severe persistent. Asthma symptoms before treatment determine the classification, but the patient’s classification may change over time. Patients are diagnosed with the asthma classification in which their most severe symptom falls.¹⁷As you look at these classifications, think about Emily and decide where her asthma would fall.

Intermittent Asthma
- Symptoms occur fewer than two days a week and do not interfere with normal activities
- Nighttime symptoms occur fewer than two days a month
- Lung function tests are normal when the patient is not having symptoms
Mild Persistent
- Symptoms occur more than two days a week, but not every day. Attacks interfere with daily activities
- Nighttime symptoms occur three to four times a month
- Lung function tests are normal when the patient is not having symptoms
Moderate Persistent
- Symptoms occur daily and interfere with daily activities
- Nighttime symptoms occur more than once a week, but not daily
- Lung function tests are abnormal
Severe Persistent
- Symptoms occur daily and severely limit daily activities
- Nighttime symptoms occur multiple times weekly
- Lung function tests are abnormal

The severity of asthma drives the treatment recommendations. Asthma classification can change over time. From our case, Emily likely has moderate persistent asthma. She is kept up a few times weekly by nighttime symptoms, interfering with her sleep. She also needs to sit out of soccer games and was having trouble in school due to her lack of sleep. Her symptoms limit her daily activities.

Pause and Ponder: How would asthma attacks occurring nightly affect a patient’s quality of life?

TREATMENT

With the revision to the guidelines in 2020, several things have changed, and pharmacy staff need to be aware of the changes.

Medications

People can manage asthma with appropriate medications. Table 1^22-26 provides additional detail on the mechanism of action, pharmacology, and adverse events associated with preferred medications used to treat asthma. Inhaled corticosteroids (ICS) are the cornerstone of asthma therapy, and this has not changed with the updated guidelines, although use of biologic agents to control asthma is more prominent.²³ ICS may be dosed once or twice daily but more often during symptomatic periods.²⁴ Beclomethasone dipropionate, budesonide, ciclesonide, flunisolide, fluticasone propionate, and mometasone are all commonly used ICS.²²When dosed at equipotent doses, all corticosteroids are equally effective, but some individuals respond better to certain ICS than others.²⁴ The dose of ICS can be titrated for symptom relief and spirometry response, but the dose response is relatively flat after moderate doses.²⁵ A flat dose response is like continuing to eat when you are already full. When you are full, you likely have gotten all the calories you need from a meal, and now you are just increasing your chances of bellyache. Increasing the dose of ICS past moderate strengths does not continue to provide additional relief of asthma symptoms as before, and the risk of side effects increases. Some patients with severe asthma do escalate to high dose ICS.

Table 1. Preferred Medications for Asthma Therapy^22-26

Medication Class	Mechanism of Action	Pharmacology	Adverse events
ICS	Inhibit production and release of signals allowing extravasation of immune cells into the airway. Decrease inflammatory response and airway hyperresponsiveness	· 1-2 Weeks of treatment for full effect · Goal is high pulmonary affinity with low systemic absorption · MDI vs. DPI may affect absorption · Metabolism and active metabolites may contribute to systemic effects	Nasopharyngitis, headache, bronchitis, sinusitis, influenza, respiratory tract infection, back pain, toothache, abdominal pain, cough, oral candidiasis, rhinitis, and throat irritation
Inhaled SABA	Bind to beta-adrenergic receptors in the bronchiole. Ultimately leads to the relaxation of smooth muscle. The difference between short and long- acting agonists is the half-life.	· Onset: Within minutes · Peak: 30 minutes · Bronchodilation: 4-6 hours	Tremor, nervousness and insomnia in children, nausea, fever, bronchospasm, vomiting, headache, pain, dizziness, cough, dry mouth, sweating, chills, dyspepsia
Inhaled LABA		· Onset: 5-30 minutes · Peak: 15 minutes- 3 hours · Bronchodilation >12 hours	Adverse events are same as short acting, but less likely. LABAs are more B2 selective and lipophilic, concentrating their effects in the lungs
Inhaled SAMA	Antagonize acetylcholine at muscarinic (M3) receptors, leading to decreased bronchoconstriction, mucus secretion and edema	· Onset: Within 15 minutes · Peak: 1-2 hours · Bronchodilation: 6-8 hours	Adverse events are related to systemic anticholinergic activity at all muscarinic receptors including urinary retention, dry mouth, headache, dizziness, sinusitis, dyspnea, back pain, cough
Inhaled LAMA		· Onset: 30 minutes · Peak: 3-4 hours · Bronchodilation: 12 to >24 hours
B2: Beta-2 receptor, ICS: inhaled corticosteroids, DPI: dry powdered inhaler, LABA: long-acting beta agonist, LAMA: long-acting muscarinic antagonist, MDI: metered-dose inhaler, SABA: short-acting beta agonist, SAMA: short-acting muscarinic antagonist

Patients use oral systemic corticosteroids for severe exacerbations or if they have a history of severe exacerbations or difficult-to-control asthma.²¹ Oral corticosteroids have many unfavorable adverse events that need to be considered by prescribing physicians.²⁷ An increase in the release of cortisol from the adrenal glands through a negative feedback loop on the hypothalamus-pituitary-adrenal (HPA) axis causes many of these adverse effects.²⁷

Systemic corticosteroid adverse events differ by duration of therapy²⁷:

Short term: hyperglycemia, leukocytosis, mood alteration, sodium and fluid retention, increased weight gain, nocturnal enuresis
Long term: growth retardation, osteoporosis, skin thinning, impaired wound healing, bruising, cataracts, glaucoma, Cushingoid feature, increased weight gain, and immunosuppression

ICS have little systemic absorption and are preferred for asthma control over oral corticosteroids. Patients taking higher doses of ICS have increased risk of systemic absorption and adrenal suppression. It is important to titrate to the lowest effective dose of ICS to avoid systemic absorption and adverse events. Corticosteroids have a dose-response relationship to adverse events.²⁷ Clinicians must monitor for systemic side effects to determine the risk and benefit balance of both oral corticosteroids and ICS.

While corticosteroids treat the inflammatory component of asthma, additional medications are needed to address airway hyperresponsiveness and can be either short or long-acting medications. “Quick-relief” and “relief” medications are common ways to refer to short-acting medications.²² Short-acting beta-agonists (SABAs) and inhaled short-acting muscarinic antagonists (SAMAs) are the two classes of relief medications. Patients use SABAs and SAMAs when experiencing symptoms or before exposure to triggers.

SABAs are highly effective bronchodilators but have short durations of action.²²Typically, all patients with asthma are prescribed SABAs as a “relief” inhaler.²²Albuterol metered-dose inhalers (MDI) are the most used relief inhaler. Albuterol is dosed at one to two puffs every four to six hours as needed to control an asthma exacerbation.²⁸ SABA use is changing in clinical practice. Newer research shows that SABAs are more effective when followed by an ICS.²⁹ Even in patients with infrequent symptoms, a prescription for daily low-dose ICS reduces asthma symptoms and risk. Increased SABA use is associated with worse outcomes. A patient is at risk of severe asthma exacerbations and asthma mortality if they pick up three or more albuterol inhalers a year from the pharmacy, the equivalent of 1.6 puffs per day.²⁹

SAMAs can be used in place of SABAs but are less effective. SAMAs will be used if SABAs are not tolerated as relief therapy. Ipratropium is a commonly used SAMA. Emily, our patient in the CE case, does not have a SAMA prescription because she receives symptom relief when using albuterol. The APPENDIX describes the different types of inhalers and points that technicians can emphasize when patients pick up refills.

Long-acting medications include long-acting beta-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs). LABAs are never used alone in asthma therapy but are companions to inhaled corticosteroids (ICS).²² Patients should take these medications even when asthma symptoms are not present because they are maintenance therapy. All LABA medications have a boxed warning cautioning about the potential for severe asthma exacerbations. Some severe exacerbations, when using LABA monotherapy, have led to death.²² LABAs do not have the same association with severe exacerbations and death when used in a combination with ICS. Salmeterol and formoterol are the most frequently used LABAs.²² The two LABAs differ in their time of onset. Formoterol and salmeterol have an onset of 15 minutes and 45 minutes, respectively. Patients aged 6 and older can use tiotropium as an add-on LAMA in maintenance therapy.³⁰ Table 2^28,30-46gives an overview of the current inhaled therapies available in the US to treat asthma. You will find details about Emily’s long-acting therapy in the section where SMART is explained.

Table 2. Asthma Inhalers ^28,30-46

Class	Drug	Brand	Dosage Forms
ICS	Beclomethasone dipropionate	QVAR Redihaler	MDI
	Budesonide	Pulmicort Flexhaler Generic	DPI Nebulizer
	Ciclesonide	Alvesco	MDI
	Fluticasone propionate	Flovent HFA Flovent Diskus Arnuity Ellipta Armon Air Digihaler	MDI DPI DPI DPI
	Mometasone	Asmanex HFA Asmanex	MDI DPI
SABA	Albuterol	ProAir Ventolin Proventil Generic	DPI, MDI MDI MDI DPI, MDI
	Levalbuterol	Xopenex HFA	MDI
LABA	Formoterol	Perforomist	Nebulizer
LABA	Salmeterol	Serevent	DPI
SAMA	Ipratropium	Atrovent HFA Generic	MDI Nebulizer
LAMA	Tiotropium	Spiriva Respimat	DPI

Many patients require multiple medications for asthma management. Clinicians prescribe combination inhalers—inhalers that have two medications—to increase efficacy, patient adherence and ease of inhaler use. Patients experience less confusion about when and how to use their inhalers when using fewer products. Clinicians can assess patient adherence and correct use of medications when a patient is on combination products. With this information, clinicians can determine if the patient needs education or an increased medication dose. Table 3 ^47-52 shows the many combination products on the market.

Think back to our case. This patient's prescription was for budesonide/formoterol. This therapy is an ICS and LABA combined therapy. The patient previously used a fluticasone inhaler once daily and albuterol as a relief inhaler. This new therapy would give the patient only one inhaler to control her asthma, avoiding inhaler confusion. Also, as patients cannot exactly “feel” the inhaled corticosteroid inhaler making a “difference,” but patients can always feel a change with SABA/LABA therapy—the combination inhalers help patients to experience a positive effect while taking chronic medications.

Table 3 Combination Products ^47-52

Budesonide/formoterol	Symbicort	MDI
Fluticasone/salmeterol	Advair	DPI, MDI
Fluticasone/vilanterol	Breo Ellipta	DPI
Mometasone/formoterol	Dulera	MDI
Budesonide/umeclidinium/ vilanterol	Trelegy Ellipta	MDI

The 2020 NHLBI Guidelines for Asthma Management list the following medications as alternatives to the preferred therapies: leukotriene receptor antagonists (LTRA), cromolyn (Intal), theophylline, and immunotherapies. The guidelines list nedocromil (Tilade) as an alternative therapy, although the FDA has discontinued this medication.^21,53

LTRAs include montelukast and zafirlukast. These medications antagonize the effects of pro-inflammatory chemicals called leukotrienes. LTRAs work to decrease the inflammatory component of asthma.²² Montelukast is indicated in patients aged 1 and older, is only dosed once a day, and does not have many drug interactions.⁵⁴ Montelukast use is discouraged because of side effects and limited efficacy. Montelukast’s labeling includes a boxed warning because of potential neuropsychiatric adverse events.⁵⁴

Cromolyn is a nebulized solution approved for asthma prophylaxis. The approval is for patients aged 2 and older. It inhibits release of histamine and leukotrienes from mast cells.⁵⁵

Theophylline is an oral medication rarely used as maintenance therapy for asthma. It has many side effects and requires titration via blood tests. It is a phosphodiesterase inhibitor and adenosine antagonist. Theophylline ultimately relaxes smooth muscles in the bronchial airway.²²

Immunotherapies are injectable monoclonal antibodies reserved for patients with severe and treatment-resistant asthma. Currently, omalizumab (Xolair) is the only biologic approved for asthma in patients as young as 4 years old.²¹ The NHLBI 2020 guideline update does not contain specific recommendations for the use of biologics. The systematic reviews the panel examined to update the guidelines did not include the use of biologics. Anti-IgE (omalizumab), anti-IL5 (mepolizumab [Nucala], reslizumab [Cinqair]), anti IL5-R (benralizumab [Fasenra]), and anti-IL4 (dupilumab [Dupixent]) are other biologic treatments for asthma. Insurers typically require prescribers to document the patient’s allergen sensitization and phenotyping before approving immunotherapies. Patients will have to try other therapies and either be unresponsive or intolerant of them before trying biologics. Specialist supervision is needed.²²

Step Therapy Rationale

The NHLBI Guidelines recommend a stepwise approach to the treatment of asthma. The recommendation guides initial asthma treatment based on the asthma severity and subsequent therapy if symptoms persist despite changes in asthma therapy.²¹ Table 4 represents a combination of the stepwise therapy recommendations across all age groups in the NHLBI Guidelines.²¹ For simplicity, the figure only shows the preferred medication recommendations. The full step therapy recommendations can be found in the full version of the NHLBI 2020 Update to the Asthma Management Guidelines.

Table 4. Stepwise Approach to the Preferred Treatment of the Management of Asthma²¹

Intermittent Asthma	Management of Persistent Asthma
Step 1	Step 2	Step 3	Step 4	Step 5	Step 6
Individuals Ages 0-4 years
PRN SABA Short daily course of ICS at the start of respiratory tract infection	Daily low-dose ICS PRN SABA	Daily medium-dose ICS PRN SABA	Daily medium dose ICS-LABA PRN SABA	Daily high-dose ICS-LABA PRN SABA	Daily high-dose ICS-LABA + oral systemic corticosteroid PRN SABA
Individuals Ages 5-11 years
SABA	Daily low-dose ICS PRN SABA	Daily and PRN combination low-dose ICS-formoterol	Daily and PRN combination	Daily high dose ICS-LABA PRN SABA	Daily high-dose ICS-LABA + oral systemic corticosteroid PRN SABA
Individuals Ages 12+
SABA	Daily low-dose ICS and PRN SABA or PRN concomitant ICS & SABA	Daily and PRN combination low-dose ICS-formoterol	Daily and PRN combination medium-dose ICS-formoterol	Daily high dose ICS-LABA PRN SABA	Daily high-dose ICS-LABA + oral systemic corticosteroid PRN SABA

In Step 1—which addressed patients with intermittent asthma—patients only use a reliever inhaler to control intermittent asthma symptoms, meaning the patients will only use an inhaler when experiencing symptoms or for pre-treatment before exercise. A clinician would initiate ICS therapy in a patient with mild asthma on Step 2.¹⁷ A patient with moderate asthma would start therapy on Step 3 or Step 4.¹⁷ A patient with severe asthma would start therapy on Step 5 or Step 6.¹⁷

Once treatment has started, a clinician should reassess the patient every two to six weeks to ensure control of asthma symptoms.²¹ If symptoms persist and asthma is uncontrolled, this would be an appropriate time to step-up therapy. Questioning patients about how frequently they use their reliever inhalers, or how many times they forgot to take their inhaler in the past week may help guide clinicians.¹⁷More frequent use of the SABA, including using a reliever inhaler more than two days a week, would favor stepping up therapy. Appropriate use of asthma inhalers is critical to achieving control. Adherence to the regimen and proper technique are required to determine if the patient is using the medication correctly.²¹Pharmacists can play an integral role in educating patients in proper inhaler technique.

Objective measures, like spirometry, can also be used to assess control. Improvements in spirometry readings indicate better control of a patient’s asthma.²¹ Increased healthcare utilization, like emergency room visits for an exacerbation, is another way to determine if a patient’s asthma is under control.¹⁷ An increase in patients’ healthcare utilization suggests poorly controlled asthma. Mitigating the risk of severe exacerbations is another goal of achieving good asthma control.¹⁷Any patient on step 3 or higher should consult with an asthma specialist for treatment.²¹

If a patient has well-controlled asthma after three consecutive months on a medication, the patient also may step down on therapy.²¹ A patient would always only go down one step of treatment. A clinician would schedule follow-up in the same two-to-six-week timeframe to ensure a patient still has asthma control.¹⁷The benefit of stepping down therapy is to lower the patient’s systemic ICS and LABA dose exposure, decreasing the risk of potential adverse events.

2020 NHLBI Asthma Management Guideline Updates

The 2020 NHLBI Guideline update focused on six select topics: intermittent ICS (e.g. SMART), LAMAs, indoor allergen mitigation, immunotherapy in the treatment of allergic asthma, FeNO testing, and bronchial thermoplasty (BT). A major update to the guideline that is changing clinical practice is SMART.

Time to be SMART

The 2020 NHLBI Asthma Management Guidelines recommend SMART in patients with moderate persistent asthma ages 4 and older. Keeping a patient's current regimen would be appropriate if asthma symptoms are well controlled. SMART employs a single ICS+formoterol combination inhaler product dosed daily and as needed for asthma exacerbations. This is a significant change, and all pharmacy staff need to be aware of it! SMART medications are FDA-approved in patients 12 and older. SMART is recommended off label in children aged 4 through 11.

Before the 2020 update, patients with moderate persistent asthma would be on Step 3 or Step 4 therapy. Therapy consisted of a daily ICS inhaler for maintenance and a SABA inhaler for relief—two separate inhalers. If a patient was uncontrolled on ICS, a physician added a LABA to the regimen. SMART potentially transitions patients from three inhalers to one inhaler. An ICS+LABA combination has never been a reliever option before; the only option was SABA. The drastic change in recommendations is why the pharmacist in the CE case, unaware of this change, was hesitant to fill the prescription. It is an extreme change in therapy and based on outdated information, and he was understandably uncomfortable.

It would be reasonable to switch patients who are uncontrolled on their current regimens or have had an exacerbation in the past year.²¹ It is also reasonable to discuss with patients or families who want to streamline their treatment regimens or those with difficulty adhering to their current regimens. Patients with uncontrolled moderate asthma should switch to SMART on the same treatment step they are currently on before moving up. For example, Emily in the CE case was on Step 4 of the 2007 guidelines, a medium-dose ICS and a LABA.¹⁷After being transferred to SMART, her regimen includes a medium-dose ICS-formoterol. This is Step 4 of therapy in the 2020 guidelines.

Along with an ICS, formoterol, a LABA, is being used as the reliever component of the regimen. Using formoterol is entirely different than our previous approaches where SABAs and SAMAs were the reliever medications. Formoterol’s onset is two to three minutes.⁵⁶ Its duration of action is up to 12 hours, creating quick and durable smooth muscle relaxation.⁵⁶ Formoterol is also an ideal drug because patients can use it more than twice daily. The maximum dosage of formoterol varies by age. Each inhalation of SMART will deliver 4.5 mcg of formoterol. Patients aged 4 to 11 can use eight puffs of formoterol daily (36 mcg).²¹Patients aged 12 and older can use twelve puffs of their inhaler per day (54 mcg).²¹

The two ICS currently used in SMART inhalers are budesonide and mometasone.⁵⁷ A patient using a SMART inhaler as needed will also receive the long-term anti-inflammatory effects of an ICS with each use. SMART therapy aims to provide enough long-acting preventive medicine when symptoms occur to prevent them from recurring.⁵⁷

This treatment will be prescribed as one to two puffs once or twice daily for maintenance with one to two puffs as needed every five to 10 minutes for asthma symptoms. Age, asthma severity, and ICS dose in the inhaler determine the dosage and frequency a clinician prescribes.²¹ Pharmacists should ensure the maximum puffs on a patient’s prescription do not exceed the limit for their age.

SMART reduces asthma exacerbations and decreases healthcare utilization while increasing quality of life and asthma control.²¹SMART therapy also decreases patients’ systemic corticosteroid use. Patients who decrease their use of oral corticosteroids and maintain lower doses of ICS reduce the risk of corticosteroid-associated adverse events.⁵⁷

SMART may make asthma treatment easier for patients and families. Patients appreciate this one inhaler approach with a single prescription to refill and pickup.⁵⁷Having a single inhaler decreases confusion about which inhaler is responsible for maintenance and reliever. It also ensures the patients always have the correct inhaler in their possession. SMART may be especially beneficial for patients who regularly skip their maintenance inhaler when they do not have symptoms.⁵⁷ These patients rely on their reliever inhalers. With SMART, if patients only take their reliever inhaler, they still receive anti-inflammatory medication.

Costs, insurance formulary considerations, and intolerance are all reasons SMART may not be appropriate for some patients.²¹ Patients who overuse their SABA reliever inhalers may not be good candidates for SMART. Some patients use their reliever inhalers when they are anxious or feel short of breath, even when this is not asthma related.⁵⁷ These patients are at risk of receiving ICS doses that are too high. Patients who use ICS-salmeterol as their maintenance should not use it as SMART.²¹ Patients using both inhalers will expose themselves to higher and potentially dangerous LABA & ICS doses.

Pharmacists are responsible for reminding patients to use only their maximum daily puffs and to contact a physician if their asthma symptoms require them to exceed this maximum. The pharmacist should also consider the supply a patient will need using the medication for both maintenance and relief doses. Patients may need to pick up multiple inhalers monthly for adequate supply.²¹

Pharmacy technicians will prevent errors if they can recognize SMART. These prescriptions will contain directions for daily use and as-needed use in the same inhaler. An example prescription is budesonide/formoterol 80/4.5, inhale 2 puffs twice daily and 1-2 puffs every 4 hours as needed for asthma exacerbations (maximum 12 puffs daily). Current evidence only recommends formoterol as the LABA in SMART. Knowing this, a technician can be on the lookout for the look-alike sound-alike medication salmeterol in combination inhalers which are not safe to use for SMART. A patient on SMART therapy will likely need all other prescriptions for asthma therapy put on hold. Let’s emphasize this point: Patients with automatic refills of a SABA or other maintenance medication will be at risk of over-treatment if they continue to take their old inhalers with SMART. If a patient with a SMART prescription comes into the pharmacy, it is important for the technician to recognize this to help prevent medication errors.

Pause and ponder: Who makes the ideal candidate for SMART therapy?

Additional Guideline Updates

Intermittent ICS²¹

The NHLBI organized the recommendations for the use of intermittent ICS by age. This update includes SMART.

The guidelines recommend that from birth to age 4, children with recurrent wheezing related to respiratory tract infections (RTI), not currently on asthma therapy and with no symptoms between infections should use a seven-to-ten-day course of daily ICS when the RTI begins.²¹ It recommends combining ICS with as-needed quick-relief SABA therapy. This recommendation aims to decrease exacerbations, systemic corticosteroid use, and healthcare utilization.²¹ Healthcare utilization declines when caregivers have clear instructions for initiating ICS.

Individuals aged 4 to 12 with mild to moderate persistent asthma who are currently taking daily ICS should not increase their regular daily ICS dose for short periods.²¹

Individuals aged 12 and older with mild persistent asthma have two preferred treatments recommended as Step 2 of therapy²¹: either a daily low-dose ICS and as-needed SABA or an as-needed SABA and ICS delivered concomitantly, one after the other.²¹ SMART therapy is the preferred treatment in patients with moderate to severe asthma in patients 4 and older.²¹

LAMAs

The 2020 NHLBI guideline update changed the recommendation for LAMA use in patients 12 years and older with asthma not controlled by ICS therapy. The next appropriate step is to add a LABA to ICS rather than a LAMA, unless the patient is unable to tolerate, has a contraindication, or has an adherence barrier to a LABA.²¹ A prescriber may still add a LAMA onto the ICS+LABA combination for improved symptom control and increased quality of life.²¹ A patient on ICS+LABA and LAMA will require the use of multiple inhalers.

Indoor Allergen Mitigation

Some patients have an identified allergen component of their asthma. Patients may use mitigation strategies like air purifiers, impermeable pillows, mattress covers, and HEPA filters to reduce their risk of allergen exposure.²¹ The 2020 NHLBI guideline update recommends patients use multiple mitigation strategies, as one strategy alone likely will not improve outcomes.²¹ The guideline recommends integrated pest management in patients' homes who are allergic and exposed to rodents and cockroaches.²¹ If an individual does not have an allergy to indoor substances, the 2020 Update does not recommend home mitigation strategies.²¹

Immunotherapy in the Treatment of Allergic Asthma

Immunotherapy includes subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). The 2020 NHLBI guideline update recommends SCIT as an adjunct treatment in patients with demonstrated sensitization to allergens, but not when patients are experiencing asthma symptoms or have severe asthma.²¹

FeNO Testing

The 2020 NHLBI guideline update recommends FeNO measurement in patients older than 4 years with an uncertain asthma diagnosis after a medical examination, complete history, and spirometry testing.²¹

Bronchial Thermoplasty

BT is a procedure that removes muscle tissue from the airway using heat. The benefits in this procedure are small, the risks are moderate, and long-term outcomes are uncertain.²¹ The 2020 NHLBI guideline update conditionally recommends against this procedure.²¹ Patients who may consider BT must have a risk-benefits conversation with their provider.

Conclusion

The update to the 2020 NHLBI Asthma Management Guidelines offers new guidance to clinicians treating patients with asthma. Patients need to go to the pharmacy and pick up their evidence-based treatment without unnecessary intervention—or incorrect and possibly frightening information—from the pharmacist. Pharmacists should expect to see prescriptions of ICS-formoterol written for SMART. The patient case in this CE is an avoidable situation. Staying up to date with the current guidelines is a pharmacists’ responsibility. Technicians should work with patients and pharmacists to put outdated medication prescriptions on hold to avoid further medication errors.

Pharmacy Technician Sidebar: Education on DPI/ MDI/ Nebulizer

Proper inhaler technique is an essential aspect of asthma control. It may seem like a silly statement, but there are different kinds of inhalers and devices. Each inhaler requires patients to use specific inhalation techniques that deliver medications effectively. Some patients may have multiple inhalers, complicating their regimen and increasing the chance for error. Understanding the different types of inhalers highlights the importance of pharmacist counseling for patients who use inhalers. Below are explanations of the differences between using, cleaning, and storing a metered-dose inhaler (MDI), a dry powder inhaler (DPI), and a nebulizer. Pharmacy technicians can point out that every inhaler has an information sheet where patients can find specific and additional instructions. Technicians should encourage patients to read them.

DPI⁵⁸

The DPI contains preset doses of medications in powder form. The medicine is released into the airways with deep, fast breaths. The DPI may be easier than the MDI for patient use. However, patients with really low lung function or small children may not be able to generate enough inspiratory flow to effectively get the medications. Patients do not need to coordinate breathing and using the inhaler with a DPI .

Instructions for use:
- Open the cover. Hold the inhaler as shown on instructions.
- Load a dose of medicine as shown in your instructions. Do not tip or shake the inhaler.
- Stand or sit up straight.
- Holding the inhaler away from your mouth, breathe out completely to empty your lungs.
- Place the mouthpiece of the inhaler in your mouth. Close your lips around it to form a tight seal.
- Take a fast, deep, forceful breath in through your mouth. Take as big of a breath as possible.
- Hold your breath and count to 10.
- Take the inhaler out of your mouth. Breathe out slowly.
- If you need more than one puff, wait 1 minute between puffs. Repeat steps 2-8 for each puff.
- When you finish close the cover. Store in a cool, dry place.
- If the medicine is an inhaled corticosteroid, rinse your mouth with water and spit it out. This helps prevent infection.
- Some multi-dose DPI have a built-in counter to tell you how many doses are left. When the counter gets to “0,” throw it away. Arrange your refill pick-up before it gets to 0.
Instructions to clean the DPI
- Wipe the mouthpiece at least once a week with a dry cloth
- Do not use water to clean to DPI

MDI⁵⁹

The MDI is a canister of medication placed into an actuator inhalation mouthpiece. Every use of the MDI delivers the correct amount of medication.

Instructions for use:
- Take off the cap, shake the inhaler. Prime the inhaler (if needed)
- If a spacer* is used, place the inhaler in the rubber ring on the end of a spacer
- Stand or sit up straight
- Breathe out completely to empty your lungs
- Place the mouthpiece in your mouth and close your lips around it to form a tight seal
- While breathing in, press down firmly on the top of the canister to release one “puff,” or dose of medication. Take as big of a breath as possible, breathing in slowly for 3-5 seconds.
- Hold your breath and count to 10.
- Take the mouthpiece out of your mouth. Release your breath.
- If you need more than one puff, wait 1 minute between puffs. Repeat steps 3-8 for each puff.
- Put the cap back on the inhaler.
- If the medicine is an inhaled corticosteroid, rinse your mouth with water and spit it out.This helps prevent infection.
Important cleaning instructions:
- Do not put the medicine canister in water
- Do not brush or wipe the inside of the inhaler

A “spacer” is a tube or chamber that adds distance between the mouth and the canister of medication. The device increases the ease of administering medication.

Nebulizers⁶⁰

Nebulizers change liquid medication into an aerosol. Nebulizers come in both home and portable sizes. Nebulizers need a power source. They plug into a wall, have chargers, or need batteries replaced. Nebulizers take longer to use than MDI or DPI. They are also more laborious to use and store.

Instructions for use:
- Wash hands well.
- Put together the nebulizer machine, tubing, medicine cup, and mouthpiece or mask as shown in instructions.
- Put the prescribed amount of medicine into the nebulizer cup.
- Place the mouthpiece in your mouth and close your lips around it to form a tight seal. If a child wears a mask, make sure it fits in snugly around the child’s face and covers their mouth and nose.
- Turn on the nebulizer machine. You will be able to see a light mist coming from the back of the tube or from the mask.
- Take normal breaths through the mouth until the medicine cup is empty or the mist stops. This should take about 10 minutes.
- Take the mouthpiece out of your mouth (or the child’s mouth) and turn off the machine.
- If the medicine is an inhaled corticosteroid, rinse your mouth with water and spit it out. This helps prevent infection. If a child uses a mask, wash the face as well.
How to clean and store:
- After each treatment
  - Wash hands well.
  - Wash the medicine cup and mouthpiece/ mask with warm water and mild soap.
  - Do not wash tubing.
  - Rinse well and shake off excess water.
  - Air dry parts on a paper towel.
- Once a week:
  - Disinfect nebulizer parts to help kill any germs. Use the instructions that come with your device.
  - Do not wash or boil the tubing.
  - Air dry parts on a paper towel.
- Between uses:
  - Store nebulizer parts in a dry, clean plastic storage bag.
  - If the same machine is used by more than one person, keep each person’s medicine cup, mouthpiece or mask, and tubing in a separate, labeled bag to prevent the spread of germs and medication errors.
  - Wipe surface with a clean, damp cloth as needed.
  - Replace parts as stated in the instructions or when they appear damaged.

This test is for viewing purposes only. If you would like to submit the test, go to the blue button at the top of the page or Test/Evaluation Site.

1. Which of the following Ig antibodies are responsible for the early phase of allergic asthma?
a. IgA
b. IgD
c. IgE

2. The mother of a 7-year-old patient takes him to the physician because she is concerned that he has asthma. The patient has attacks of wheezing two to three times a week when at recess or playing in the neighborhood. He sits out and cannot seem to catch his breath. The doctor suspects the patient has mild persistent asthma. When the patient is sitting in the office, he has no symptoms. But the doctor still initiates therapy according to the NHLBI guidelines. What objective measure can the doctor use to monitor his response to ICS therapy?
a. Total IgE
b. Spirometry
c. X-Ray

3. A patient presents to the pharmacy with a prescription for mometasone/formoterol (Dulera). What is the class combination used in this inhaler?
a. ICS/LABA
b. ICS/LAMA
c. ICS/SABA

4. A 16-year-old patient presents to the pharmacist complaining of side effects she thinks are related to her tiotropium (Spiriva Respimat inhaler). Her symptoms include extreme dry mouth, headache, and dizziness. The pharmacist asks how she has been using the medication. The patient responds that she uses it twice daily and sometimes when she develops symptoms during the school day. Why is the pharmacist concerned?
a. The patient is overusing her rescue inhaler.
b. These side effects are not related to the therapy.
c. She is using her tiotropium inhaler incorrectly.

5. Match the drug product with the correct mechanism of action.
a. Albuterol/agonist of beta-adrenergic receptors in the bronchiole leading to smooth muscle relaxation
b. Budesonide/agonist of beta-adrenergic receptors in the bronchiole. Ultimately leads to smooth muscle relaxation
c. Ipratropium/agonist of beta-adrenergic receptors in the bronchiole. Ultimately leads to smooth muscle relaxation

6. A 14-year-old patient presents to the physician with worsening shortness of breath and night-time awakenings. She has uncontrolled-moderate persistent asthma. She reports adherence to her medications and uses her inhalers properly. The patient is currently on a medium-dose ICS maintenance therapy and a SABA for rescue. What does the 2020 NHLBI Guideline recommend?
a. Transitioning the patient to SMART therapy
b. Considering bronchial thermoplasty as an option
c. Using an FeNO test to confirm the asthma diagnosis

7. Select the statement that correctly summarizes the 2020 NHLBI Guideline Update for using immunotherapy in the treatment of allergic asthma.
a. All patients with documented allergic asthma should consider SCIT.
b. SCIT is recommended as an adjunctive treatment in select patients.
c. SCIT is recommended in all patients with severe asthma.

8. Tom is an 8-year-old boy with moderate asthma. Tom also has type 2 diabetes and autism. He has frequent asthma exacerbations at school, requiring inhaler use. Tom presents to the doctor because he has been using his albuterol rescue inhaler multiple times during the week. His physician plans to switch his current regimen to SMART. Which of the following is an advantage the patient will have when switching to SMART?
a. Tom will not need to have an inhaler at school to control his exacerbations
b. SMART therapy will help lower Tom’s blood glucose, helping his diabetes
c. Tom will only need to use one type of inhaler, simplifying administration

9. Select the best way to describe SMART therapy.
a. A patient uses a single inhaler made of a SABA/formoterol for asthma maintence and rescue treatment.
b. A patient uses a single inhaler made of an ICS/formoterol for asthma maintenance and rescue treatment.
c. A patient only needs to use a single medication for asthma once a day

10. Lily is 14-year-old girl who has uncontrolled, moderate persistent asthma. She is currently prescribed a medium dose ICS inhaler with a SABA for rescue. When the pharmacist asks how she takes her medications, Lily admits that she forgets to take her ICS most days. In the morning when she wakes up, she doesn’t have symptoms. This leads her to using her SABA around eight times weekly when symptoms occur. Which of the following is a benefit Lily will receive switching to SMART?
a. When Lily forgets her maintence dose, she still receives the ICS anti-inflammatory benefits when using the rescue dose
b. Lily will save money switching to SMART
c. Lily would not benefit from switching to SMART. It would be dangerous for her to switch because she currently overuses her SABA.

This test is for viewing purposes only. If you would like to submit the test, go to the blue button at the top of the page or Test/Evaluation Site.

1. Select the correct symptoms associated with asthma.
a. Sore throat, cough, burning while running
b. Wheezing, coughing, chest tightness
c. Difficulty breathing, sore throat, pain in chest

2. Which of the following can trigger asthma?
a. Smoke
b. Light
c. Salt Water

3. Allie has had worsening asthma over the past 15 years. She has not been great at taking her medications and her asthma has never been controlled. Allie has chronic inflammation and hyperreactivity. Allie has structural changes in her lungs that includes the narrowing of her bronchioles. Allie has non-reversible obstruction. What is the term for Allie’s structural changes in her lungs?
a. Allie has airway remodeling.
b. Allie has overreactive T-cells.
c. Allie has overgrown mast cells.

4. Tyler is a 7-year-old boy presenting to the physician with asthma. When asked about his symptoms, Tyler says they occur every day. Because of his symptoms, Tyler cannot play outside with his friends sometimes. When asked if his symptoms keep him up at night, Tyler guesses once or twice a week, but not every night. What severity of asthma does Tyler have?
a. Mild Persistent Asthma
b. Moderate Persistent Asthma
c. Severe Persistent Asthma

5. Select the correct test that a physician could consider performing to get objective diagnostic information on cooperative patients 5 and older with asthma.
a. Chest X-ray
b. FeNO
c. Spirometry

6. A patient is coming into the pharmacy to pick up a medication for her asthma. Which medication is she picking up?
a. Budesonide/formoterol (Symbicort)
b. Umeclidinium (Incruse)
c. Glycopyrrolate (Seebri NeoHaler)

7. Which of the following represents a preferred asthma medication in the 2020 NHLBI Asthma management Guideline Update?
a. Montelukast
b. Theophylline
c. Budesonide/formoterol

8. David is a 13-year-old boy presenting to the pharmacy to pick up his new inhaler to begin SMART. Which prescription below is a recommended SMART therapy?
a. Fluticasone/salmeterol 250/50 mcg: Inhale 2 puffs two times daily and 1-2 puffs as needed (up to 12 puffs daily).
b. Budesonide/formoterol 80/4.5 mcg: Inhale 2 puffs two times daily and 1-2 puffs as needed (up to 12 puffs daily).
c. Budesonide/formoterol 80/4.5 mcg: Inhale 2 puffs two times daily

9. Select the best way to describe SMART therapy.
a. A patient uses a single inhaler made of a SABA/formoterol for asthma maintenance and rescue treatment.
b. A patient uses a single inhaler made of an ICS/formoterol for asthma maintenance and rescue treatment.
c. A patient only needs to use a single medication for asthma once a day

10. A mom presents with her son with his new prescription for budesonide/formoterol with directions you recognize as SMART. The patient has been picking up his asthma inhalers at your pharmacy for years. What is a step you can take to ensure this patient transitions safely to SMART?
a. Confirm with the mother if the other asthma inhalers should be put on hold.
b. Tell the family about a boxed warning in the product labeling
c. Ask the patient if you can refill the albuterol that appears to be due for a refill.

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14. Sheehan, W. J., Rangsithienchai, P. A., Wood, R. A., Rivard, D., Chinratanapisit, S., Perzanowski, M. S., Chew, G. L., Seltzer, J. M., Matsui, E. C., & Phipatanakul, W. (2010). Pest and allergen exposure and abatement in inner-city asthma: a work group report of the American Academy of Allergy, Asthma & Immunology Indoor Allergy/Air Pollution Committee. The Journal of allergy and clinical immunology, 125(3), 575–581. https://doi.org/10.1016/j.jaci.2010.01.023
15. Indiana Department of Environmental Management. Integrated Pest Management. [Fact Sheet]. Accessed 28 March 22, https://www.in.gov/idem/files/factsheet_ipm.pdf
16. Kudo M, Ishigatsubo Y, Aoki I. Pathology of asthma. Front Microbiol. 2013 Sep 10;4:263.
17. National Institutes of Health (2007). National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (NIH Publication No. 08–5846). Available online: http://www.nhlbi.nih.gov/guidelines/asthma/index.htm.
18. Irvin CG. Pulmonary function testing in asthma. UpToDate. Available at https://www.uptodate.com/contents/pulmonary-function-testing-in-asthma#H341135837. Accessed 3/9/2022.
19. Johnson JD, Theurer WM. A stepwise approach to the interpretation of pulmonary function tests. Am Fam Physician. 2014;89(5):359-366.
20. American Academy of Allergy Asthma & Immunology. Methacholine Challenge Test. Accessed 28 March 2022. https://www.aaaai.org/Tools-for-the-Public/Conditions-Library/Asthma/Methacholine-Challenge-Test
21. National Heart, Lung and Blood Institute (2020). 2020 Focused updates to the Asthma Management Guidelines. Clinician’s Guide. (NIH Publication No. 20-HL-8141). Washington, DC: U.S. Government Printing Office
22. Sharma S, Hashmi MF, Chakraborty RK. Asthma Medications. [Updated 2022 Feb 16]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK531455/
23. Williams DM. Clinical Pharmacology of Corticosteroids. Respir Care. 2018;63(6):655-670. doi:10.4187/respcare.06314
24. Phillips K, Oborne J, Lewis S, et al. Time course of action of two inhaled corticosteroids, fluticasone propionate and budesonide. Thorax 2004;59:26-30.
25. Adams NP, Jones PW. The dose-response characteristics of inhaled corticosteroids when used to treat asthma: an overview of Cochrane systematic reviews. Respir Med. 2006;100(8):1297-1306. doi:10.1016/j.rmed.2006.04.015
26. Ejiofor S, Turner AM. Pharmacotherapies for COPD. Clin Med Insights Circ Respir Pulm Med. 2013;7:17-34. Published 2013 Apr 25. doi:10.4137/CCRPM.S7211
27. Pandya D, Puttanna A, Balagopal V. Systemic effects of inhaled corticosteroids: an overview. Open Respir Med J. 2014;8:59-65. Published 2014 Dec 31. doi:10.2174/1874306401408010059
28. ProAir HFA (albuterol). Package insert. Teva Respiratory, LLC; 2016.
29. Reddel HK, Bacharier LB, Bateman ED, et al. Global Initiative for Asthma Strategy 2021: Executive Summary and Rationale for Key Changes. Am J Respir Crit Care Med. 2022;205(1):17-35. doi:10.1164/rccm.202109-2205PP
30. Spriva Respimat (tiotropium). Package insert Boehringer Ingelheim Pharmaceuticals, Inc; 2017.
31. QVAR (beclomethasone dipropionate HFA). Package insert. Teva Respiratory, LLC; 2014.
32. Pulmicort Flexhaler (budesonide inhalation powder). Package insert. AstraZeneca; 2010.
33. Alvesco (ciclesonide). Package insert. Sunovion Pharmaceuticals, Inc; 2012.
34. Flovent HFA (Fluticasone propionate). Package insert. GlaxoSmithKline; 2010.
35. Flovent Diskus (fluticasone propionate inhalation powder). Package insert. GlaxoSmithKline; 2014.
36. Arnuity ellipta (fluticasone furoate inhalation powder). Package insert. GlaxoSmithKline; 2018.
37. Armonair digihaler (fluticasone propionate). Package insert. Teva Pharmaceuticals; 2020.
38. Asmanex HFA (mometasone furoate). Package insert. Merck & Co., Inc; 2014.
39. Asmanex Twisthaler (mometasone furoate). Package insert. Schering Corporation; 2018.
40. ProAir Respiclick (albuteral sulfate) inhalation powder. Package insert. Teva Respiratory, LLC; 2016.
41. Ventolin HFA (albuterol sulfate). Package insert. GlaxoSmithKline; 2014.
42. Proventil HFA (albuterol sulfate). Package insert. Merck & Co., Inc; 2012
43. Xopenex HFA (levalbuterol tartrate) inhalation aerosol. Package insert. Sunovion Pharmaceuticals Inc; 2017.
44. Performist (formoterol fumarate). Package Insert. Dey Pharma, L.P.; 2010
45. Serevent Diskus (salmeterol xinafoate inhalation powder). Package insert. GlaxoSmithKline; 2006
46. Atrovent HFA (ipratropium bromide). Package insert. BoehringerIngleim International GmbH; 2004.
47. Symbicort (budesonide and formoterol fumarate dehydrate). Package insert. AstraZenexa; 2017
48. Advair Diskus (Fluticasone propionate and salmeterol). Package insert. GlaxoSmithKline; 2008
49. Advair HFA (Fluticasone propionate and salmeterol). Package insert. GlaxoSmithKline; 2017.
50. Breo Ellipta (fluticasone furoate and vilanterol inhalation powder). Package insert. GlaxoSmithKline. 2019.
51. Dulera (mometasone furoate and formoterol fumarate dihydrate). Package insert. Merck & Co., Inc.; 2015.
52. Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder). Package insert; 2020.
53. Federal Drug Agency. Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil - Questions and Answers. Available at https://www.fda.gov/drugs/information-drug-class/phase-out-cfc-metered-dose-inhalers-containing-flunisolide-triamcinolone-metaproterenol-pirbuterol-0. Accessed 3/10/22.
54. Singulair (Montelukast). Package insert. Merck & co., Inc; 2012
55. Intal (cromolyn sodium inhalation solution). Package Insert. King’s Pharmaceuticals, Inc. 2003
56. Anderson GP: Formoterol: pharmacology, molecular basis of agonism, and mechanism of long duration of a highly potent and selective beta 2-adrenoceptor agonist bronchodilator. Life Sci. 1993;52(26):2145-60. doi: 10.1016/0024-3205(93)90729-m.
57. Fliesler N. SMART: A New approach to asthma Management. Boston Children’s Hospital. Available at: https://answers.childrenshospital.org/smart-asthma-inhaler. Accessed 12 March 2022.
58. U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute. (Updated 2021). How to Use a Dry Powder Inhaler. (NIH Publication No. 21-HL-8164). Retrieved from: https://www.nhlbi.nih.gov/health-topics/all-publications-and-resources/how-use-dry-powder-inhaler
59. U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute. (Updated 2021). How to Use a Dry Powder Inhaler. (NIH Publication No. 21-HL-8164). Retrieved from: https://www.nhlbi.nih.gov/health-topics/all-publications-and-resources/how-use-dry-powder-inhaler
60. U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute. (Updated 2021). How to Use a Nebulizer. (NIH Publication No. 21-HL-8163). Retrieved from: https://www.nhlbi.nih.gov/health-topics/all-publications-and-resources/how-use-nebulizer.

LAW: Danger Behind the Counter?

Pharmacists filled 6.7 billion prescriptions in 2022 while also engaging in a growing number of other health-related services. These duties have created a challenging workplace that threatens public safety. Recent media reports have focused attention on the pharmacy workplace environment and the risk of errors. This continuing education activity will review the factors contributing to workplace stress and errors and the efforts by regulatory agencies and pharmacists to address this growing problem.

“No one recognizes the level of stress they’re putting you under. You’re filling a prescription and the phone is ringing, saying, ‘One pharmacy call, two pharmacy calls, three pharmacy calls.’ I would stand there and feel the sweat come up the back of my neck.” - Pharmacist¹

INTRODUCTION

A recent survey found that more than half of United States (U.S.) consumers worry about potential problems with their prescriptions arising from inadequately staffed pharmacies.² Half of consumers worry about receiving the wrong drug, the wrong dose, or the wrong instructions.² Similarly, a 2024 study by the American data analytics, software, and consumer intelligence company J.D. Power found that overall patient satisfaction with pharmacies has declined, especially among chains, with only mail-order pharmacies showing an improvement in patient satisfaction.³ Only 51% of respondents said their pharmacist is trustworthy.³ The most significant problem areas emerging from the study are long wait times, lower levels of customer trust in pharmacists, and difficulty in ordering prescriptions.³ On a more positive note, 97% of American consumers agree that a pharmacist should have responsibility for informing them about the safety and/or effectiveness of their medications.²

It will probably come as no surprise to readers that pharmacists also report dissatisfaction with working conditions, particularly with issues of staffing, patient aggressiveness, and lack of meaningful communication between pharmacy personnel and management.⁴ The most commonly reported root causes for the disgruntlement were inadequate staffing, the use of performance metrics, and workflow design/policies.

Media reports have described pharmacists at chain pharmacies across the U.S. expressing concern that increased demand for prescriptions, vaccines, and other services are occurring without sufficient staff to fulfill those activities, making it nearly impossible for pharmacy staff to do their jobs properly or safely.⁵ A national survey released in 2022 showed that nearly 75% of pharmacist respondents felt they did not have enough time to safely perform clinical duties and patient care. Nearly two-thirds disagreed with the statement that “employer policies facilitate my ability to safely perform patient care/clinical duties.”⁶ The report also found that three-quarters of pharmacists rated their workload as high or extremely high and that job satisfaction was at the lowest point in 20 years.⁶

Has the modern community pharmacy become a danger to the public? This continuing education activity will examine the current sentiment about the pharmacy workplace, and the perceived risk associated with the current working conditions. It will also review legal and policy changes enacted or contemplated by pharmacists, regulatory bodies, and patients to improve the environment.

THE PHARMACY ENVIRONMENT

In 2022, 6.7 billion prescriptions were dispensed in the U.S., a more than 50% increase from the nearly 4 billion prescriptions dispensed in 2009.⁷Some pharmacists may feel that they filled that many by themselves.

Currently, almost 70% of people in the U.S. between 40 and 79 years old take at least one prescription drug; 20% take five or more.⁸In addition to prescriptions, between February 2020 and September 2022, pharmacy staffs administered more than 270 million vaccines, including more than half of all COVID-19 vaccines given in the U.S.⁹ Community pharmacy teams alone accounted for approximately 45% of the total, including more than 8 million COVID-19 vaccines for long term care residents. Pharmacy staffs also provide more than 50 million influenza vaccines per year, supply in excess of 42 million COVID tests, and prescribe and dispense many antiviral medications.⁹ Interventions by pharmacy staffs during this period is conservatively estimated to have averted more than 1 million deaths, 8 million hospitalizations, and saved $450 billion in healthcare costs.⁹

While these data, highlighting pharmacists’ value, should engender a deserved sense of pride, as the opening quote illustrates, pharmacists are also are feeling stress over their workload. Pharmacists interviewed by the Chicago Tribune and the New York Times reporting on pharmacy errors related that they felt flabbergasted by pressures at the workplace to work quickly and meet quotas.^10,11As a result, a chief executive of a state pharmacy association noted that the number of complaints from members related to staffing cuts and worries about patient safety had become “overwhelming.”¹² Similarly, a survey conducted by the California State Board of Pharmacy found that 91% of chain pharmacists indicated that they lacked the staff needed to ensure adequate patient care.¹³The Kansas Board of Pharmacy found similar results with more than half of pharmacists polled responding that they didn’t feel they could perform their jobs safely.¹³ The biggest reasons cited were a lack of adequate staffing and employer-imposed metrics, such as filling a specific number of prescriptions a day or providing service to patients within a set time.¹³

These added pressures are consistent with a reduction in the number of pharmacies. Chain pharmacies in particular have been reducing staffing levels and closing pharmacies while simultaneously burdening workers with additional duties.¹³ Staff who do not fill prescriptions or answer the phone fast enough or fail to solicit enough vaccinations reportedly may face discipline, reassignment, or termination.¹³ A former pharmacy school Dean likened the current working environment to the equivalent of a fast-food operation where workers feel pressured to race through every order.¹³

PAUSE AND PONDER: How has your job stress changed in the last few years? Have you seen errors in the workplace?

Consumers are also noticing problems or at least expressing a lack of confidence in pharmacists' attention to detail and public safety. Their concerns are not unfounded. A recent systematic review of 62 studies reported a pooled prevalence of dispensing errors across community, hospital, and other pharmacy settings of 1.6%.¹⁴ [It is difficult to accurately determine error rates due to differences in how studies are conducted, the definition of “error,” and other factors. Consequently, error rates vary widely among different studies. However, a generally accepted reasonable estimate of dispensing errors is approximately 1% to 2%.^15-17 This would represent approximately 67 to 134 million errors each year at the current prescription volume!]

Many factors may contribute to the occurrence of medication errors. An error may occur at any stage of therapy, including prescribing, transcribing, identifying the product, counseling, use by the patient, or monitoring. Errors can occur across all practice settings.¹⁷ Errors may result from an act of commission (e.g., dispensing the wrong drug or dose) or omission (e.g., failure to properly counsel a patient).^18,19 According to the Academy of Managed Care Pharmacy, the most common dispensing errors are dispensing an incorrect medication, dosage strength, or dosage form; miscalculating a dose; and failing to identify a drug interaction or contraindication.¹⁸Medication errors can cause a range of undesirable outcomes including adverse drug events (dangerous and unintended events), hospitalization, and even death.¹⁷

What’s Workload Got to Do with It?

A few lines of evidence suggest that errors may be associated with workload. Numerous studies have described a relationship between prescription volume and errors.^20-22A survey of pharmacists in Texas in 2001 found that the estimated risk of errors was positively related to the number of prescription orders filled per hour.²⁰

Other studies found that as prescription volume increased beyond 20 to 24 per hour, the number of errors increased significantly.^20-22 An earlier analysis by a prominent researcher also concluded that the rate of pharmacists’ errors increases after they fill more than 24 prescriptions an hour.²³

The potential for errors is no surprise to pharmacists.¹² One pharmacist reportedly wrote an anonymous letter to his State Board of Pharmacy saying, “I am a danger to the public working for (chain pharmacy).”¹²

Not only is the volume of prescriptions filled by a typical pharmacist a concern for its impact on the risk of errors, but the danger is aggravated by some pharmacy chains’ implementation of time guarantees, promising patients that prescriptions will be filled quickly.^1,12 While the guarantee should provide a benefit to the busy consumer, it is also a safety concern, since the haste to fulfill the guarantee may make it more likely that a medication error may occur. As one pharmacist interviewed by the New York Times wrote, “Metrics put unnecessary pressure on pharmacy staff to fill prescriptions as fast as possible, resulting in errors.”¹²One study of 49 community pharmacists, that had a robust response rate of 90.9%, found that the second most frequent source of error was “patient in a hurry.”²⁴

The former Dean quoted above also believes that “at … the huge pharmacies, errors are a cost of doing business.”¹³ One chain store pharmacist told a reporter that she was reprimanded for taking too long to verify prescriptions, even though her extra diligence had caught several serious mistakes.¹³

The major chains have made changes to address the pressures on pharmacists and promote a “better work-life balance” according to one chain spokesperson.¹³ Most now provide half-hour lunch breaks for staff and some have reduced pharmacy hours.¹³ However, pharmacists report that their workloads remain the same and that they are pressured to work through lunch or stay late to finish their tasks.¹³ Moreover, pharmacists report that when their hours were cut, they saw a corresponding decrease in their salary.¹³

PAUSE AND PONDER: What could be done to reduce workplace stress at your pharmacy?

PHARMACY DESERTS

Pharmacists are not the only ones strained when pharmacies close; it also increases the burden on patients who are left without easy access to pharmacies and their medications. This phenomenon, referred to as “pharmacy deserts,” creates disproportionate consequences for certain communities, notably in areas of patients with high levels of social vulnerability.²⁵ Poor access to pharmacies is often associated with lower medication adherence.²⁵

A pharmacy desert may be defined as a low-income urban area with no pharmacy within a mile radius for those with adequate vehicle access or half a mile for those with limited vehicle access. In rural areas, it refers to areas without an available pharmacy within a 10-mile radius for those with access to transportation.²⁶

The number of retail pharmacies in the U.S. declined by almost 4% (from 63,218 to 60,755) between 2018 and 2023.²⁷ The decrease was larger (5.9%) in rural communities. During the five-year period, 184 rural communities lost all of their retail pharmacies (although 195 rural communities gained retail pharmacies). The majority of the pharmacy losses in rural communities were among independent pharmacies.²⁷ Pharmacy closures were also more common in Black and Hispanic/Latino neighborhoods putting a further strain on health care accessibility in these communities.²⁵

EFFORTS TO CHANGE THE WORKPLACE

Recognition that the pharmacy workplace can contribute to staff burnout and risks to the public is growing. This has resulted in different types of reactions among various groups with the goal of improving the work environment.

Action By Pharmacists

Some pharmacists who have been adversely affected by the current working environment have responded. One action that pharmacists have taken is work stoppage with dozens and, at least in one case, hundreds of pharmacy personnel in chain stores calling out of work to protest working conditions.⁵ The pharmacists maintained that the increased focus on vaccinations added to their workload and made it more difficult for them to carry out their other duties and created a potentially unsafe condition. One pharmacist claimed that the chain has “turned into a vaccination clinic first and a pharmacy second” and added that “because immunizations are so profitable, filling prescriptions is almost an afterthought.”⁵ In at least one instance, pharmacist organizers planned to stage a multi-day nationwide walkout, termed “Pharmageddon,” to protest unsafe working conditions.²⁸

PAUSE AND PONDER: Under what conditions would you be supportive of pharmacists striking for better working conditions?

Action By Regulatory Agencies

Governmental and professional organizations that oversee the pharmacy profession have also become concerned with potentially unsafe conditions existing in the nation’s drugstores and have taken steps to change the workplace environment.

If a pharmacy staff member commits an error, a State Board of Pharmacy may take disciplinary action, but the application of the action differs among the states.²⁹ In the typical situation, the Board will learn of the incident when a patient or caregiver files a complaint, which the Board is obligated to investigate.^29,30 Most states do not have specific rules or regulations that specify that errors are actual regulatory violations, and most determinations are made on a case-by-case basis.³⁰

The most common types of punitive action include license suspension, probation, or revocation, and fines.³⁰ In a few states, incarceration is also a possible punitive action.³⁰ The most common bases for dispensing punitive action were to address public safety/health concerns and public complaints. At least two states (Maryland and Massachusetts) appear to take a nonpunitive approach, with a focus on system wide improvements rather than individual responsibility, and with punitive action reserved for pharmacists deemed incompetent.³⁰

A majority of state boards do not require pharmacies to report errors, and most investigations focus on pharmacists, not the conditions in their workplaces.¹² Someboards have instructed pharmacists in public meetings to quit or speak up if they believe conditions are unsafe. However, many pharmacists fear retaliation, knowing they could easily be replaced for doing so.¹²

Pharmacists have also reported that errors are not consistently disclosed, even internally.¹³ These pharmacists claim that small mistakes and those discovered early are routinely hidden or remain unreported especially by pharmacists who have previously made an error.¹³One California chain pharmacist believes that "for every error that gets found out, there will be an error that never gets caught."¹³ Pharmacists also say that even when they do report potentially fatal errors, no one from their companies investigates how they occurred or makes changes to prevent them from repeating.¹³ Obviously these actions put the pubic at risk.

PAUSE AND PONDER: Should the reporting of pharmacy errors to a regulatory body be mandated?

Many pharmacy organizations have advocated for workplace changes to reduce the number of errors, including the elimination of prescription time guarantees.¹⁶ The American Pharmacists Association approved a resolution in 2018 which “encourages the adoption of patient-centered quality and performance measures that align with safe delivery of patient care services, and opposes the setting and use of operational quotas or time-oriented metrics that negatively impact patient care and safety.”⁴

Similarly, the trade group The National Pharmacists Association, advocated for pharmacist dispensing limits more than 30 years ago as a means to promote safety. They recommended that a pharmacist fill no more than 15 prescriptions an hour.²³

The former Dean says, “I don’t think the boards of pharmacy or the colleges of pharmacy or the professional associations are doing enough to address the issues.”¹³However, in one recent event, the Nevada Board of Pharmacy fined and suspended the licenses of two pharmacists who mistakenly provided a pregnant woman with misoprostol instead of the fertility treatment she was prescribed.¹³ The Board also fined their chain pharmacy employer $10,000. However, the pharmacy’s lawyer objected to the fine saying they did nothing wrong, saying that “the only allegation” against the employer “is that they had these pharmacists.”¹³

Trends in State Intervention

Traditionally, state pharmacy boards and other regulatory bodies have considered sanctions after errors have occurred but have generally refused to intervene over workload complaints.¹³ They have seen their role as protecting consumer safety, not to intrude on what has been regarded as business decisions such as staffing metrics and workload.¹³ However, this stance has been changing.

As early as 2017, the Chicago City Council approved legislation that would limit pharmacists to filling a maximum of 10 prescriptions per hour and also required a 30-minute meal and two 15-minute bathroom breaks for pharmacists working at least a 7-hour shift.³¹ A pharmacy also would need to schedule at least 10 pharmacy technician hours per 100 prescriptions filled. The proposal came in response to an investigation by the Chicago Tribune which found that 52% of local pharmacies tested failed to warn a member of the investigative team of potentially serious or fatal drug interactions when presented with a pair of prescriptions.³¹

A few years later the state of Illinois went further, passing notable changes to their Pharmacy Practice Act in 2020 after the Tribune's undercover investigation.³¹The Act prohibits a pharmacy from requiring staff to work more than 12 continuous hours, including breaks, per day. This applies to pharmacists, pharmacy technicians, and student pharmacists. It also requires at least one uninterrupted 30-minute meal break and another 15-minute break for a pharmacist working six or more continuous hours per day.³² The pharmacist may not work more than five continuous hours before being given the opportunity for a meal break and must be given access to a private break room if one is available.³²

The regulation permits the pharmacy to close during the break period but does not require closure. The pharmacist must be available for emergencies if the pharmacy remains open. Technicians and other authorized support staff may continue to perform normal duties while the pharmacist is on break, except for duties that require a pharmacist’s professional judgment. Prescriptions that have received final verification by a pharmacist and do not require counseling may be dispensed during the break period.³² If a mandated break period is not provided, the pharmacy must pay the pharmacist three times the pharmacist's regular hourly rate of pay for each workday with no break.

The Tribune’s investigation also prompted Illinois Senator Richard Durbin to call for nationwide policies to protect consumers, including asking the Centers for Disease Control and Prevention (CDC) to determine the prevalence of the problem and to provide guidance to pharmacy boards. He also asked the CDC to examine how workload, company performance metrics that track prescriptions, and the length of time consumers wait for prescriptions may impact patient safety and pharmacist errors.³³

Many years earlier (2007), North Carolina had passed a law restricting a pharmacist’s workday to no more than 12 continuous hours and required breaks for a shift of six hours or more.³¹

Other states have also considered regulations to reduce pharmacy stress, although many face opposition from employers. Minnesota is also considering a bill to require bathroom and meal breaks after pharmacists complained that they were afraid to drink liquids during a shift because they might not be able to get to the bathroom.³¹ New Hampshire also has enacted a rule permitting a 30-minute break for pharmacists who work more than eight hours. The new rule took more than four years to be implemented due to opposition from the pharmacy industry.³¹

The South Carolina board has discussed how to investigate conditions more thoroughly after a mistake. It also published a statement discouraging quotas and encouraging “employers to value patient safety over operational efficiency and financial targets.”³¹

PAUSE AND PONDER: Do you think that mandated breaks are beneficial in increasing safety in the pharmacy?

California recently instituted workplace regulations that go even further. The “Stop Dangerous Pharmacies Act” enacted in 2024 allows the pharmacist in charge (PIC) to make staffing decisions “to ensure sufficient personnel are present in the pharmacy to prevent fatigue, distraction, or other conditions that may interfere with a pharmacist’s ability to practice competently and safely.”³⁵ The California Board of Pharmacy estimates that pharmacists make 5 million errors in the state per year, prompting the need for workplace changes.³⁶ If the PIC is not available, a pharmacist on duty may adjust staffing according to workload if needed.³⁵ The pharmacist on duty may also close the pharmacy if, in their opinion, staffing at the pharmacy is inadequate to provide patient care in a safe manner.³⁷

In addition, a chain community pharmacy is required to be staffed at all times during normal business hours (defined as 8:00 am to 7:00 pm) with at least one clerk or pharmacy technician fully dedicated to performing pharmacy-related services.³⁵ This requirement is waived if the pharmacy’s average daily prescription volume is less than 75 prescriptions per day. However, the exemption does not apply if the pharmacist is also expected to provide additional pharmacy services such as immunizations or tests.³⁵ The new regulations also expanded duties that can be performed by a technician including accepting prescription transfers and clarifications of prescriptions.³⁵

California also prohibits chain pharmacies from establishing a quota related to the duties for which a pharmacist or pharmacy technician license is required.³⁸ (A quota is defined as “a fixed number or formula related to the duties for which a pharmacist or pharmacy technician license is required, against which the chain community pharmacy or its agent measures or evaluates the number of times either an individual pharmacist or pharmacy technician performs tasks or provides services while on duty” and includes prescriptions filled and “services rendered” to patients.³⁸)

However, California and other states have found that enforcing these rules is challenging.¹³ The California State Board of Pharmacy, for example, is coping with routine violations by retail pharmacies that then fail to provide records to inspectors seeking to verify complaints.¹³

Oklahoma also recently established rules to ensure adequate staffing levels.³⁹ Pharmacists are expected to complete a form whenever they are concerned about inadequate staffing due to inadequate number of support personnel or excessive workload. Each pharmacy must review completed staffing reports and address any issues listed and document any corrective action taken or justification for inaction. The reports must be made available to the Board during inspections. There is also a prohibition against disciplinary action or retaliation against the pharmacist filing the report.³⁹

Virginia also passed temporary emergency regulations banning production quotas and increasing staffing in late 2024.¹³ Other states, including West Virginia, New York, and Illinois have attempted to pass legislation similar to California’s prohibition of the use of quotas for duties performed by pharmacists or technicians, but the legislation failed to pass.³⁶

The Ohio Board of Pharmacy also took steps to address the pharmacy staffing shortage with new rules in 2024.⁴⁰ One new rule requires pharmacies to “ensure sufficient personnel are scheduled to work at all times in order to minimize fatigue, distraction, or other conditions which interfere with a pharmacist’s ability to practice with reasonable competence and safety.” It also calls for staffing levels to be based on “other requirements” related to the practice of pharmacy and not solely based on prescription volume and also bans the use of “quotas” for “ancillary services.” (Quotas are defined as “a fixed number or formula related to the duties of pharmacy personnel, against which the pharmacy or its agent measures or evaluates the number of times either an individual performs tasks or provides services while on duty.^”40)

To alleviate burnout that can lead to mistakes filling prescriptions, Ohio’s new rules will require that all pharmacies give all employees working six hours or more an uninterrupted 30-minute break.⁴⁰ The pharmacy does not need to close during the break if the pharmacist remains on the premises and prescriptions may still be sold but the recipient must be provided with an offer to counsel. A person who wishes to speak with a pharmacist must be told that the pharmacist is on break and that they may wait to speak with the pharmacist or provide a telephone number for contact after the break.

Significantly, the new rules require pharmacies to develop a formal system so pharmacists can request additional staff. They also require pharmacy owners to act promptly on those requests and prohibit owners from retaliating against pharmacists who request extra help. A written response to the request must occur within 14 business days and a copy of the response must be maintained in the pharmacy for three years for inspection by the Board.⁴⁰

Ohio’s Board also reacted to patients reporting delays in receiving their medication.⁴¹ The new rules require new prescriptions to be filled within three business days and those subject to auto refill to be done within five.⁴⁰ (The rule has exemptions for shortages, delays in insurance coverage, and where the prescription requires clarification or raises suspicion about its safety or validity.⁴⁰)

Pharmacy chains opposed the new rules.¹³ One chain wrote that the “Board should stay focused on the regulation of the practice of pharmacy rather than the business of pharmacy.”¹³ Chain representatives acknowledged the challenges their pharmacists have faced but denied allegations of unsafe working conditions. They claimed that metrics based on measurable objectives such as quick prescription turnarounds, short telephone hold times, and vaccination volumes are standard within the industry and meant to assess quality rather than penalize staff.¹³

Another effort to reduce errors being considered by some states is mandatory error reporting.³⁷ Pennsylvania requires healthcare facilities to report all incidents of harm and may be the only state currently doing so.³⁷ In Canada, Nova Scotia became the first jurisdiction to implement a requirement for community pharmacies to anonymously report medication incidents to a national repository in 2010 and several other Canadian provinces have followed.⁴² The stated purpose of the repository is to improve medication safety in the community through evidence-informed recommendations for reducing preventable harm related to medications.⁴²

Another approach to reduce errors in the pharmacy is to free up the pharmacist from certain traditional tasks by placing greater reliance on technicians. A formalized program is termed tech-check-tech (TCT) and enables a trained pharmacy technician to perform the final verification on a prescription for which the pharmacist has previously performed the prospective drug utilization review.⁴³ The TCT concept dates back to at least 1978 and has been well validated in institutional pharmacy settings.⁴⁴ Studies have found that technicians perform at least as well as pharmacists in final verification activities in institutional settings and have demonstrated that utilization of technicians in this way allows pharmacists to devote one to five more hours per day to direct patient services.^43,44 While this expanded role for technicians is becoming common in institutional settings, few states have adopted it for use in the community pharmacy.⁴³

PAUSE AND PONDER: In your workplace, what additional tasks could certified technicians perform?

SUMMARY

To err is human, and pharmacy staff will make errors despite their best efforts. Errors can occur at any step during prescription processing. The error rate is not well validated due to many methodological variables, and estimates vary widely although 1% to 2% is a commonly accepted value. However, even at these low rates, the number of patients affected is large and the consequences, although usually minor, can be catastrophic. Pharmacy staffs, of course, do not want to commit errors and removing the triggers for errors is a worthy goal. Evidence supports the concept that workplace pressures and insufficient staffing, high prescription volume, and interruptions and distractions exacerbate the risk of errors. The trend towards reducing the number of pharmacies while expanding pharmacy services has added additional strains to the health care system. Patients have become more aware of the risks associated with the pharmacy environment and burnout. This has also lessened the public’s perception of pharmacists.

Concerns over errors have spurred a growing number of states to revise their Pharmacy Practice Acts to relieve some of the workload pressure on pharmacists. Typical changes include limits on the length of the workday, mandated breaks, limits on the number of prescriptions a pharmacist can dispense over time, and reconsideration of tracking metrics. However, these changes have encountered resistance by employers and implementation and enforcement are spotty. Other changes include expanding the use of technicians and allowing more time for pharmacists to provide services related to patient care. It remains to be seen whether more regulatory oversight of the workplace will impact the number of errors committed. In the meantime, pharmacists and technicians should be extra vigilant to avoid being the object of the next media investigation that casts the profession in a bad light and hope they do not become “a danger to the public.”

Law: Danger Behind the Counter?
Post-Test
Learning Objectives
After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
1. Identify the occurrence of errors in the pharmacy
2. Characterize the perception of the workplace by patients and pharmacists
3. Describe actions taken by regulatory agencies to improve the pharmacy workplace.
4. Review the utilization of pharmacy personnel.

1. A study by J.D. Power in 2024 evaluated overall patient satisfaction with pharmacies. What percentage of respondents said their pharmacist is trustworthy?
A. About half
B. 75%
C. Nearly all

2. A recent poll in California asked pharmacists about their workplace environment. What did the results show?
A. Most pharmacists are completely or almost completely satisfied with their work-life balance.
B. Most pharmacists felt that management is responsive to their concerns about workplace stress.
C. Most pharmacists felt that pharmacy staffing was inadequate to ensure patient care.

3. Estimates of the frequency of pharmacy errors are inconsistent. Regardless, what is a generally accepted rate of errors?
A. 1 per thousand
B. 1-2 %
C. 5%-10%

4. One source of pharmacy stress is the added responsibility of administering vaccines. What proportion of COVID vaccines did pharmacy staffs administer during the pandemic?
A. 25%
B. 40 %
C. More than 50%

5. Harried pharmacist X makes a dispensing error and patient Y suffers a serious complication. (At least until recently) how would a typical state’s pharmacy board act in this situation?
A. Require the pharmacy to file an incident report about the error.
B. Hold the pharmacy, not the pharmacist, responsible for the error.
C. Take an action only if and after patient Y files a complaint.

6. More than 30 years ago, the National Pharmacists Association advocated for pharmacist dispensing limits. What did it recommend?
A. That a pharmacist fills no more than 15 prescriptions an hour.
B. That a pharmacist fills no more than 30 prescriptions an hour.
C. That a pharmacist fills no more than 300 prescriptions per day.

7. What prompted Chicago and the state of Illinois to enact pharmacy workplace regulations?
A. An increase in the number of complaints by pharmacists to the state board of pharmacy.
B. A pharmacist work stoppage.
C. An investigation by a local newspaper found that pharmacists failed to detect dangerous drug interactions.

8. California enacted the Stop Dangerous Pharmacies Act in 2024. Which of the following is a component of the act?
A. Pharmacists are not permitted to work more than 45 hours per week unless the Board declares a state-wide pharmacist shortage, or the pharmacist is agreeable.
B. It increased the number of technicians a pharmacist is permitted to supervise, based on the prescription volume.
C. The state prohibits chain pharmacies from establishing a quota related to the duties for which a pharmacist or pharmacy technician license is required.

9. You have just been hired as pharmacist in charge of a chain pharmacy in Ohio. What does a new regulation in this state mandate?
A. You are permitted two 15-minute rest breaks and must close the pharmacy during these periods.
B. You cannot be required to work more than 12 continuous hours in one day.
C. You must have at least two certified technicians available at all times so that the pharmacy is open.

10. The tech-check-tech program encourages qualified technicians to perform a task that is normally performed by a pharmacist. What task is recommended?
A. Perform final verification on prescriptions if a pharmacist has previously performed prospective drug utilization review.
B. Contact the prescriber to clarify prescriptions whenever the technician suspects any kind of error.
C. Counsel patients receiving a select group of medications, relying on a script approved by the pharmacist.

REFERENCES

Semuels A. Why Your Pharmacy Experience is Miserable. Time. September 18, 2024.

Accessed from:

https://time.com/7022116/pharmacies-struggling/?utm_medium=email&utm_source=sfmc&utm_campaign=newsletter+brief+default+ac&utm_content=+++20240920+++body&et_rid=273534511&lctg=273534511

Rebelo A. US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs. Wolters Kluver. December 7, 2022. Accessed from:

https://www.wolterskluwer.com/en/news/us-survey-signals-big-shifts-in-primary-care-to-pharmacy-and-clinic-settings

JD Power. As Mail Order Pharmacies Continue to Climb in Customer Satisfaction, Chain Drug Stores Fall Behind, J.D. Power Finds. JD Power. July 30, 2024. Accessed from:

https://www.jdpower.com/sites/default/files/file/2024-07/2024074%20U.S.%20Pharmacy.pdf

American Pharmacists Association. APhA and NASPA Release Eighth PWWR Report and Learnings. March 18, 2024. Accessed from:

https://www.pharmacist.com/APhA-Press-Releases/apha-and-naspa-release-eighth-pwwr-report-and-learnings

Goodkind N. Why Walgreens Pharmacy Workers Are Walking Off the Job. CNN Business. October 10, 2023. Accessed from:

https://www.cnn.com/2023/10/10/economy/walgreens-pharmacy-walkouts/index.html

Schommer JC, Gaither CA, Lee S, et al. 2021 APhA/NASPA National State-Based Pharmacy Workplace Survey. American Pharmacists Association. Final Report April 2022.

Accessed from:

https://naspa.us/wp-content/uploads/2022/05/National-State-Based-Pharmacy-Workplace-Survey-Final-Report-APRIL-2022-FINAL.pdf#page=12.06

Total number of medical prescriptions dispensed in the U.S. from 2009 to 2022.

Statista. Accessed from:

https://www.statista.com/statistics/238702/us-total-medical-prescriptions-issued/

Wittenauer R, Shah PD, Bacci JL, Stergachis A. Locations and Characteristics of Pharmacy Deserts in the United States: A Geospatial Study. Health Aff Sch. 2024; 2(4):qxae035. doi: 10.1093/haschl/qxae035. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11034534/

Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. J Am Pharm Assoc. 2022;62(6):1929-1945.e1. doi: 10.1016/j.japh.2022.08.010. Epub 2022 Aug 18. PMID: 36202712; PMCID: PMC9387064. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC9387064/

10. Roe S, Long R, King K. Pharmacists Miss Half of Dangerous Drug Combinations. Chicago Tribune. December 2016. Retrieved from: https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Gabler E. At Walgreens, Complaints of Medication Errors Go Missing. NY Times. Updated October 13, 2021. Accessed from:

https://www.nytimes.com/2020/02/21/health/pharmacies-prescription-errors.html

12. Gabler E. How Chaos at Chain Pharmacies is Putting Patients at Risk. NY Times. January 31, 2020. Retrieved from:

https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html

Le Coz E. Prescription for Disaster: America's Broken Pharmacy System in Revolt Over Burnout and Errors. USA Today. October 26, 2023. Retrieved from:

https://www.usatoday.com/story/news/investigations/2023/10/26/pharmacy-chains-dangerous-conditions-medication-errors/71153960007/

14. Bond CA Raehl CL. Pharmacists' Assessment of Dispensing Errors: Risk Factors, Practice Sites, Professional Functions, and Satisfaction. Pharmacotherapy. 2001; 21(5): 614-626.

15. Flynn EA, Barker KN, Carnahan BJ. National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies. J APhA. 2001; 43(2): 191-200.

16. Campbell PJ, Patel M, Martin JR, et al. Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993-2015. BMJ Open Qual. 2018;7(4):e000193. doi:10.1136/bmjoq-2017-000193. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173242/

Um IS, Clough A, Tan ECK. Dispensing error rates in pharmacy: a systematic review and meta-analysis. Res Social Adm Pharm. 2024;20(1):1-9. doi:10.1016/j.sapharm.2023.10.003. Retrieved from:

https://www.sciencedirect.com/science/article/pii/S1551741123004552?via%3Dihub

Academy of Managed Care Pharmacy. Medication Errors. July 18, 2019. Retrieved from:

https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/medication-errors

19. James L, BM, Barlow D, McArtney R, et al. Incidence, type and causes of dispensing errors: a review of the literature. Int J Pharm Pract. 2009; 17(1): 9-30. Retrieved from:

https://onlinelibrary.wiley.com/doi/full/10.1211/ijpp.17.1.0004?sid=nlm%3Apubmed

20. Pervanas HC, Revell N, Alotaibi AF. Evaluation of Medication Errors in Community Pharmacy Settings: A Retrospective Report. J Pharm Technol. 2016; 32(2): 71-74.

Kistner UA, Keith MR, Sergeant KA, et al. Accuracy of Dispensing in a High-Volume, Hospital Based Outpatient Pharmacy. Am J Hosp Pharm. 1994;512:793–7.

Allan EL, Barker KN, Malloy M, et al. Dispensing errors and counseling in community practice. Am Pharm 1995; NS35:25–33.

Hendren J. Overwork Threatens Druggists” Accuracy. LA Times. February 27, 2000. Retrieved from:

https://www.latimes.com/archives/la-xpm-2000-feb-27-mn-3125-story.html

Lopes J, Joaquim J, Matos C, Pires T. Medication errors in Community Pharmacy: Potencial Causes and strategies for Prevention. Clin Therap. 2015; 37(8 Supp): E119 (Abstract). Retrieved from:

https://www.clinicaltherapeutics.com/article/S0149-2918(15)00648-7/fulltext

Catalano G, Khan MMM, Chatzipanagiotou OP, Pawlik TM. Pharmacy Accessibility and Social Vulnerability. JAMA Netw Open. 2024;7(8):e2429755. doi:10.1001/jamanetworkopen.2024.29755. Retrieved from:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822776

Trend: What is a Pharmacy Desert? TelePharm. Retrieved from:

https://blog.telepharm.com/what-is-a-pharmacy-desert

Constantin J, Ullrich F, Mueller, KJ. Rural and Urban Pharmacy Presence – Pharmacy Deserts. RUPRI Center for Rural Health Policy Analysis Rural Policy Brief. August 2022. Retrieved from:

https://rupri.public-health.uiowa.edu/publications/policybriefs/2022/Pharmacy%20Deserts.pdf

Constantino AK. Some Pharmacy Staff from Walgreens, Other Chains Are Walking Out Again — Here’s What You Need To Know. CNBC. October 29, 2023. Retrieved from:

https://www.cnbc.com/2023/10/29/pharmacy-staff-from-walgreens-chains-like-cvs-to-walk-out-again.html

Adams AJ, Frost TP. Expunging Board of Pharmacy Disciplinary Actions. Innov Pharm. 2023;14(1):10.24926/iip.v14i1.5219. doi: 10.24926/iip.v14i1.5219. PMID: 38035318; PMCID: PMC10686669. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC10686669/#:~:text=Boards%20of%20pharmacy%20have%20the,practice%20restrictions%2C%20fines%20and%20reprimands.

Holdsworth M, Wittstrom K, Yeitrakis T. Current Approaches to Punitive Action for Medication Errors by Boards of Pharmacy. Ann Pharmacother. 2013;47(4):475-81. doi: 10.1345/aph.1R668. Epub 2013 Apr 2. PMID: 23548647.

Long R. Chicago Moves Closer To Easing Pharmacist Workload. Chicago Tribune. October 10, 2017, Updated June 14, 2024. October 26, 2023. Retrieved from:

https://www.chicagotribune.com/2017/10/10/chicago-moves-closer-to-easing-pharmacist-workload/

Illinois Statutes Ch 225. § 85/15.1. Pharmacy working conditions. Retrieved from:

https://www.ilga.gov/legislation/ilcs/documents/022500850K15.1.htm

Long R, Roe S. After Tribune Investigation, Durbin Pushes Interactive Drug Protection for Consumers. Cap Gazette. December 16, 2016. Retrieved from:

https://www.capitalgazette.com/ct-drug-interactions-durbin-pharmacy-20161216-story.html

21 NC Admin Code 46 .2512. Pharmacist Work Conditions. Retrieved from:

https://regulations.justia.com/states/north-carolina/title-21/chapter-46/section-2500/section-46-2512/

California. Stop Dangerous Pharmacies Act (AB 1286). 2024. Retrieved from:

https://www.pharmacy.ca.gov/publications/ab1286_faqs.pdf

California State Board of Pharmacy. Medication Error Reduction and Workforce Chair Report. November 16, 2022. Retrieved from:

https://www.pharmacy.ca.gov/meetings/agendas/2022/22_nov_med_mat.pdf

California Board of Pharmacy Considers New Legislation Regarding Pharmacy Workplace Conditions. Quarles Newsletter. December 19, 2022. Retrieved from:

https://www.quarles.com/newsroom/publications/california-board-of-pharmacy-continues-to-tackle-concerns-surrounding-pharmacy-workplace-conditions

California Business and Professional Code. 4113.7. Retrieved from:

https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=4113.7.&lawCode=BPC

Oklahoma Admin Code. Section 535:15-3-16 - Adequate Staffing Rules for Pharmacists and Pharmacies. Retrieved from:

https://casetext.com/regulation/oklahoma-administrative-code/title-535-oklahoma-state-board-of-pharmacy/chapter-15-pharmacies/subchapter-3-pharmacies/section-53515-3-16-adequate-staffing-rules-for-pharmacists-and-pharmacies

Ohio Board of Pharmacy. Outpatient Pharmacies Minimum Standards. Updated May1, 2024. Retrieved from:

https://www.pharmacy.ohio.gov/documents/licensing/tddd/general/outpatient%20pharmacy%20minimum%20standards.pdf

41. Schladen M. New Ohio Pharmacy Rules to Take Effect in May. Ohio Cap J. April 1, 2024. Retrieved from:

https://ohiocapitaljournal.com/2024/04/01/new-ohio-pharmacy-rules-to-take-effect-in-may/

The National Incident Data Repository for Community Pharmacies (NIDR)

Information and Frequently Asked Questions. Institute for Safe Medication Practices Canada. September 2023. Retrieved from:

https://ismpcanada.ca/wp-content/uploads/NIDR-faq.pdf

Frost TP, Adams AJ. Tech-Check-Tech in Community Pharmacy Practice Settings. J Pharm Technol. 2017;33(2):47–52. doi: 10.1177/8755122516683519. Epub 2016 Apr 1. PMCID: PMC5998445. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC5998445/#:~:text=TCT%20enables%20a%20specially%20trained,in%20an%20automated%20dispensing%20system.

REFERENCES

Semuels A. Why Your Pharmacy Experience is Miserable. Time. September 18, 2024.

Accessed from:

https://time.com/7022116/pharmacies-struggling/?utm_medium=email&utm_source=sfmc&utm_campaign=newsletter+brief+default+ac&utm_content=+++20240920+++body&et_rid=273534511&lctg=273534511

Rebelo A. US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs. Wolters Kluver. December 7, 2022. Accessed from:

https://www.wolterskluwer.com/en/news/us-survey-signals-big-shifts-in-primary-care-to-pharmacy-and-clinic-settings

JD Power. As Mail Order Pharmacies Continue to Climb in Customer Satisfaction, Chain Drug Stores Fall Behind, J.D. Power Finds. JD Power. July 30, 2024. Accessed from:

https://www.jdpower.com/sites/default/files/file/2024-07/2024074%20U.S.%20Pharmacy.pdf

American Pharmacists Association. APhA and NASPA Release Eighth PWWR Report and Learnings. March 18, 2024. Accessed from:

https://www.pharmacist.com/APhA-Press-Releases/apha-and-naspa-release-eighth-pwwr-report-and-learnings

Goodkind N. Why Walgreens Pharmacy Workers Are Walking Off the Job. CNN Business. October 10, 2023. Accessed from:

https://www.cnn.com/2023/10/10/economy/walgreens-pharmacy-walkouts/index.html

Schommer JC, Gaither CA, Lee S, et al. 2021 APhA/NASPA National State-Based Pharmacy Workplace Survey. American Pharmacists Association. Final Report April 2022.

Accessed from:

https://naspa.us/wp-content/uploads/2022/05/National-State-Based-Pharmacy-Workplace-Survey-Final-Report-APRIL-2022-FINAL.pdf#page=12.06

Total number of medical prescriptions dispensed in the U.S. from 2009 to 2022.

Statista. Accessed from:

https://www.statista.com/statistics/238702/us-total-medical-prescriptions-issued/

Wittenauer R, Shah PD, Bacci JL, Stergachis A. Locations and Characteristics of Pharmacy Deserts in the United States: A Geospatial Study. Health Aff Sch. 2024; 2(4):qxae035. doi: 10.1093/haschl/qxae035. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11034534/

Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. J Am Pharm Assoc. 2022;62(6):1929-1945.e1. doi: 10.1016/j.japh.2022.08.010. Epub 2022 Aug 18. PMID: 36202712; PMCID: PMC9387064. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC9387064/

10. Roe S, Long R, King K. Pharmacists Miss Half of Dangerous Drug Combinations. Chicago Tribune. December 2016. Retrieved from: https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Gabler E. At Walgreens, Complaints of Medication Errors Go Missing. NY Times. Updated October 13, 2021. Accessed from:

https://www.nytimes.com/2020/02/21/health/pharmacies-prescription-errors.html

12. Gabler E. How Chaos at Chain Pharmacies is Putting Patients at Risk. NY Times. January 31, 2020. Retrieved from:

https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html

Le Coz E. Prescription for Disaster: America's Broken Pharmacy System in Revolt Over Burnout and Errors. USA Today. October 26, 2023. Retrieved from:

https://www.usatoday.com/story/news/investigations/2023/10/26/pharmacy-chains-dangerous-conditions-medication-errors/71153960007/

14. Bond CA Raehl CL. Pharmacists' Assessment of Dispensing Errors: Risk Factors, Practice Sites, Professional Functions, and Satisfaction. Pharmacotherapy. 2001; 21(5): 614-626.

15. Flynn EA, Barker KN, Carnahan BJ. National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies. J APhA. 2001; 43(2): 191-200.

16. Campbell PJ, Patel M, Martin JR, et al. Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993-2015. BMJ Open Qual. 2018;7(4):e000193. doi:10.1136/bmjoq-2017-000193. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173242/

Um IS, Clough A, Tan ECK. Dispensing error rates in pharmacy: a systematic review and meta-analysis. Res Social Adm Pharm. 2024;20(1):1-9. doi:10.1016/j.sapharm.2023.10.003. Retrieved from:

https://www.sciencedirect.com/science/article/pii/S1551741123004552?via%3Dihub

Academy of Managed Care Pharmacy. Medication Errors. July 18, 2019. Retrieved from:

https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/medication-errors

19. James L, BM, Barlow D, McArtney R, et al. Incidence, type and causes of dispensing errors: a review of the literature. Int J Pharm Pract. 2009; 17(1): 9-30. Retrieved from:

https://onlinelibrary.wiley.com/doi/full/10.1211/ijpp.17.1.0004?sid=nlm%3Apubmed

20. Pervanas HC, Revell N, Alotaibi AF. Evaluation of Medication Errors in Community Pharmacy Settings: A Retrospective Report. J Pharm Technol. 2016; 32(2): 71-74.

Kistner UA, Keith MR, Sergeant KA, et al. Accuracy of Dispensing in a High-Volume, Hospital Based Outpatient Pharmacy. Am J Hosp Pharm. 1994;512:793–7.

Allan EL, Barker KN, Malloy M, et al. Dispensing errors and counseling in community practice. Am Pharm 1995; NS35:25–33.

Hendren J. Overwork Threatens Druggists” Accuracy. LA Times. February 27, 2000. Retrieved from:

https://www.latimes.com/archives/la-xpm-2000-feb-27-mn-3125-story.html

Lopes J, Joaquim J, Matos C, Pires T. Medication errors in Community Pharmacy: Potencial Causes and strategies for Prevention. Clin Therap. 2015; 37(8 Supp): E119 (Abstract). Retrieved from:

https://www.clinicaltherapeutics.com/article/S0149-2918(15)00648-7/fulltext

Catalano G, Khan MMM, Chatzipanagiotou OP, Pawlik TM. Pharmacy Accessibility and Social Vulnerability. JAMA Netw Open. 2024;7(8):e2429755. doi:10.1001/jamanetworkopen.2024.29755. Retrieved from:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822776

Trend: What is a Pharmacy Desert? TelePharm. Retrieved from:

https://blog.telepharm.com/what-is-a-pharmacy-desert

Constantin J, Ullrich F, Mueller, KJ. Rural and Urban Pharmacy Presence – Pharmacy Deserts. RUPRI Center for Rural Health Policy Analysis Rural Policy Brief. August 2022. Retrieved from:

https://rupri.public-health.uiowa.edu/publications/policybriefs/2022/Pharmacy%20Deserts.pdf

Constantino AK. Some Pharmacy Staff from Walgreens, Other Chains Are Walking Out Again — Here’s What You Need To Know. CNBC. October 29, 2023. Retrieved from:

https://www.cnbc.com/2023/10/29/pharmacy-staff-from-walgreens-chains-like-cvs-to-walk-out-again.html

Adams AJ, Frost TP. Expunging Board of Pharmacy Disciplinary Actions. Innov Pharm. 2023;14(1):10.24926/iip.v14i1.5219. doi: 10.24926/iip.v14i1.5219. PMID: 38035318; PMCID: PMC10686669. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC10686669/#:~:text=Boards%20of%20pharmacy%20have%20the,practice%20restrictions%2C%20fines%20and%20reprimands.

Holdsworth M, Wittstrom K, Yeitrakis T. Current Approaches to Punitive Action for Medication Errors by Boards of Pharmacy. Ann Pharmacother. 2013;47(4):475-81. doi: 10.1345/aph.1R668. Epub 2013 Apr 2. PMID: 23548647.

Long R. Chicago Moves Closer To Easing Pharmacist Workload. Chicago Tribune. October 10, 2017, Updated June 14, 2024. October 26, 2023. Retrieved from:

https://www.chicagotribune.com/2017/10/10/chicago-moves-closer-to-easing-pharmacist-workload/

Illinois Statutes Ch 225. § 85/15.1. Pharmacy working conditions. Retrieved from:

https://www.ilga.gov/legislation/ilcs/documents/022500850K15.1.htm

Long R, Roe S. After Tribune Investigation, Durbin Pushes Interactive Drug Protection for Consumers. Cap Gazette. December 16, 2016. Retrieved from:

https://www.capitalgazette.com/ct-drug-interactions-durbin-pharmacy-20161216-story.html

21 NC Admin Code 46 .2512. Pharmacist Work Conditions. Retrieved from:

https://regulations.justia.com/states/north-carolina/title-21/chapter-46/section-2500/section-46-2512/

California. Stop Dangerous Pharmacies Act (AB 1286). 2024. Retrieved from:

https://www.pharmacy.ca.gov/publications/ab1286_faqs.pdf

California State Board of Pharmacy. Medication Error Reduction and Workforce Chair Report. November 16, 2022. Retrieved from:

https://www.pharmacy.ca.gov/meetings/agendas/2022/22_nov_med_mat.pdf

California Board of Pharmacy Considers New Legislation Regarding Pharmacy Workplace Conditions. Quarles Newsletter. December 19, 2022. Retrieved from:

https://www.quarles.com/newsroom/publications/california-board-of-pharmacy-continues-to-tackle-concerns-surrounding-pharmacy-workplace-conditions

California Business and Professional Code. 4113.7. Retrieved from:

https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=4113.7.&lawCode=BPC

Oklahoma Admin Code. Section 535:15-3-16 - Adequate Staffing Rules for Pharmacists and Pharmacies. Retrieved from:

Ohio Board of Pharmacy. Outpatient Pharmacies Minimum Standards. Updated May1, 2024. Retrieved from:

https://www.pharmacy.ohio.gov/documents/licensing/tddd/general/outpatient%20pharmacy%20minimum%20standards.pdf

41. Schladen M. New Ohio Pharmacy Rules to Take Effect in May. Ohio Cap J. April 1, 2024. Retrieved from:

https://ohiocapitaljournal.com/2024/04/01/new-ohio-pharmacy-rules-to-take-effect-in-may/

The National Incident Data Repository for Community Pharmacies (NIDR)

Information and Frequently Asked Questions. Institute for Safe Medication Practices Canada. September 2023. Retrieved from:

https://ismpcanada.ca/wp-content/uploads/NIDR-faq.pdf

Frost TP, Adams AJ. Tech-Check-Tech in Community Pharmacy Practice Settings. J Pharm Technol. 2017;33(2):47–52. doi: 10.1177/8755122516683519. Epub 2016 Apr 1. PMCID: PMC5998445. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC5998445/#:~:text=TCT%20enables%20a%20specially%20trained,in%20an%20automated%20dispensing%20system.

REFERENCES

Semuels A. Why Your Pharmacy Experience is Miserable. Time. September 18, 2024.

Accessed from:

https://time.com/7022116/pharmacies-struggling/?utm_medium=email&utm_source=sfmc&utm_campaign=newsletter+brief+default+ac&utm_content=+++20240920+++body&et_rid=273534511&lctg=273534511

Rebelo A. US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs. Wolters Kluver. December 7, 2022. Accessed from:

https://www.wolterskluwer.com/en/news/us-survey-signals-big-shifts-in-primary-care-to-pharmacy-and-clinic-settings

JD Power. As Mail Order Pharmacies Continue to Climb in Customer Satisfaction, Chain Drug Stores Fall Behind, J.D. Power Finds. JD Power. July 30, 2024. Accessed from:

https://www.jdpower.com/sites/default/files/file/2024-07/2024074%20U.S.%20Pharmacy.pdf

American Pharmacists Association. APhA and NASPA Release Eighth PWWR Report and Learnings. March 18, 2024. Accessed from:

https://www.pharmacist.com/APhA-Press-Releases/apha-and-naspa-release-eighth-pwwr-report-and-learnings

Goodkind N. Why Walgreens Pharmacy Workers Are Walking Off the Job. CNN Business. October 10, 2023. Accessed from:

https://www.cnn.com/2023/10/10/economy/walgreens-pharmacy-walkouts/index.html

Schommer JC, Gaither CA, Lee S, et al. 2021 APhA/NASPA National State-Based Pharmacy Workplace Survey. American Pharmacists Association. Final Report April 2022.

Accessed from:

https://naspa.us/wp-content/uploads/2022/05/National-State-Based-Pharmacy-Workplace-Survey-Final-Report-APRIL-2022-FINAL.pdf#page=12.06

Total number of medical prescriptions dispensed in the U.S. from 2009 to 2022.

Statista. Accessed from:

https://www.statista.com/statistics/238702/us-total-medical-prescriptions-issued/

Wittenauer R, Shah PD, Bacci JL, Stergachis A. Locations and Characteristics of Pharmacy Deserts in the United States: A Geospatial Study. Health Aff Sch. 2024; 2(4):qxae035. doi: 10.1093/haschl/qxae035. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11034534/

Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. J Am Pharm Assoc. 2022;62(6):1929-1945.e1. doi: 10.1016/j.japh.2022.08.010. Epub 2022 Aug 18. PMID: 36202712; PMCID: PMC9387064. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC9387064/

10. Roe S, Long R, King K. Pharmacists Miss Half of Dangerous Drug Combinations. Chicago Tribune. December 2016. Retrieved from: https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Gabler E. At Walgreens, Complaints of Medication Errors Go Missing. NY Times. Updated October 13, 2021. Accessed from:

https://www.nytimes.com/2020/02/21/health/pharmacies-prescription-errors.html

12. Gabler E. How Chaos at Chain Pharmacies is Putting Patients at Risk. NY Times. January 31, 2020. Retrieved from:

https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html

Le Coz E. Prescription for Disaster: America's Broken Pharmacy System in Revolt Over Burnout and Errors. USA Today. October 26, 2023. Retrieved from:

https://www.usatoday.com/story/news/investigations/2023/10/26/pharmacy-chains-dangerous-conditions-medication-errors/71153960007/

14. Bond CA Raehl CL. Pharmacists' Assessment of Dispensing Errors: Risk Factors, Practice Sites, Professional Functions, and Satisfaction. Pharmacotherapy. 2001; 21(5): 614-626.

15. Flynn EA, Barker KN, Carnahan BJ. National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies. J APhA. 2001; 43(2): 191-200.

16. Campbell PJ, Patel M, Martin JR, et al. Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993-2015. BMJ Open Qual. 2018;7(4):e000193. doi:10.1136/bmjoq-2017-000193. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173242/

Um IS, Clough A, Tan ECK. Dispensing error rates in pharmacy: a systematic review and meta-analysis. Res Social Adm Pharm. 2024;20(1):1-9. doi:10.1016/j.sapharm.2023.10.003. Retrieved from:

https://www.sciencedirect.com/science/article/pii/S1551741123004552?via%3Dihub

Academy of Managed Care Pharmacy. Medication Errors. July 18, 2019. Retrieved from:

https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/medication-errors

19. James L, BM, Barlow D, McArtney R, et al. Incidence, type and causes of dispensing errors: a review of the literature. Int J Pharm Pract. 2009; 17(1): 9-30. Retrieved from:

https://onlinelibrary.wiley.com/doi/full/10.1211/ijpp.17.1.0004?sid=nlm%3Apubmed

20. Pervanas HC, Revell N, Alotaibi AF. Evaluation of Medication Errors in Community Pharmacy Settings: A Retrospective Report. J Pharm Technol. 2016; 32(2): 71-74.

Kistner UA, Keith MR, Sergeant KA, et al. Accuracy of Dispensing in a High-Volume, Hospital Based Outpatient Pharmacy. Am J Hosp Pharm. 1994;512:793–7.

Allan EL, Barker KN, Malloy M, et al. Dispensing errors and counseling in community practice. Am Pharm 1995; NS35:25–33.

Hendren J. Overwork Threatens Druggists” Accuracy. LA Times. February 27, 2000. Retrieved from:

https://www.latimes.com/archives/la-xpm-2000-feb-27-mn-3125-story.html

Lopes J, Joaquim J, Matos C, Pires T. Medication errors in Community Pharmacy: Potencial Causes and strategies for Prevention. Clin Therap. 2015; 37(8 Supp): E119 (Abstract). Retrieved from:

https://www.clinicaltherapeutics.com/article/S0149-2918(15)00648-7/fulltext

Catalano G, Khan MMM, Chatzipanagiotou OP, Pawlik TM. Pharmacy Accessibility and Social Vulnerability. JAMA Netw Open. 2024;7(8):e2429755. doi:10.1001/jamanetworkopen.2024.29755. Retrieved from:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822776

Trend: What is a Pharmacy Desert? TelePharm. Retrieved from:

https://blog.telepharm.com/what-is-a-pharmacy-desert

Constantin J, Ullrich F, Mueller, KJ. Rural and Urban Pharmacy Presence – Pharmacy Deserts. RUPRI Center for Rural Health Policy Analysis Rural Policy Brief. August 2022. Retrieved from:

https://rupri.public-health.uiowa.edu/publications/policybriefs/2022/Pharmacy%20Deserts.pdf

Constantino AK. Some Pharmacy Staff from Walgreens, Other Chains Are Walking Out Again — Here’s What You Need To Know. CNBC. October 29, 2023. Retrieved from:

https://www.cnbc.com/2023/10/29/pharmacy-staff-from-walgreens-chains-like-cvs-to-walk-out-again.html

Adams AJ, Frost TP. Expunging Board of Pharmacy Disciplinary Actions. Innov Pharm. 2023;14(1):10.24926/iip.v14i1.5219. doi: 10.24926/iip.v14i1.5219. PMID: 38035318; PMCID: PMC10686669. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC10686669/#:~:text=Boards%20of%20pharmacy%20have%20the,practice%20restrictions%2C%20fines%20and%20reprimands.

Holdsworth M, Wittstrom K, Yeitrakis T. Current Approaches to Punitive Action for Medication Errors by Boards of Pharmacy. Ann Pharmacother. 2013;47(4):475-81. doi: 10.1345/aph.1R668. Epub 2013 Apr 2. PMID: 23548647.

Long R. Chicago Moves Closer To Easing Pharmacist Workload. Chicago Tribune. October 10, 2017, Updated June 14, 2024. October 26, 2023. Retrieved from:

https://www.chicagotribune.com/2017/10/10/chicago-moves-closer-to-easing-pharmacist-workload/

Illinois Statutes Ch 225. § 85/15.1. Pharmacy working conditions. Retrieved from:

https://www.ilga.gov/legislation/ilcs/documents/022500850K15.1.htm

Long R, Roe S. After Tribune Investigation, Durbin Pushes Interactive Drug Protection for Consumers. Cap Gazette. December 16, 2016. Retrieved from:

https://www.capitalgazette.com/ct-drug-interactions-durbin-pharmacy-20161216-story.html

21 NC Admin Code 46 .2512. Pharmacist Work Conditions. Retrieved from:

https://regulations.justia.com/states/north-carolina/title-21/chapter-46/section-2500/section-46-2512/

California. Stop Dangerous Pharmacies Act (AB 1286). 2024. Retrieved from:

https://www.pharmacy.ca.gov/publications/ab1286_faqs.pdf

California State Board of Pharmacy. Medication Error Reduction and Workforce Chair Report. November 16, 2022. Retrieved from:

https://www.pharmacy.ca.gov/meetings/agendas/2022/22_nov_med_mat.pdf

California Board of Pharmacy Considers New Legislation Regarding Pharmacy Workplace Conditions. Quarles Newsletter. December 19, 2022. Retrieved from:

https://www.quarles.com/newsroom/publications/california-board-of-pharmacy-continues-to-tackle-concerns-surrounding-pharmacy-workplace-conditions

California Business and Professional Code. 4113.7. Retrieved from:

https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=4113.7.&lawCode=BPC

Oklahoma Admin Code. Section 535:15-3-16 - Adequate Staffing Rules for Pharmacists and Pharmacies. Retrieved from:

Ohio Board of Pharmacy. Outpatient Pharmacies Minimum Standards. Updated May1, 2024. Retrieved from:

https://www.pharmacy.ohio.gov/documents/licensing/tddd/general/outpatient%20pharmacy%20minimum%20standards.pdf

41. Schladen M. New Ohio Pharmacy Rules to Take Effect in May. Ohio Cap J. April 1, 2024. Retrieved from:

https://ohiocapitaljournal.com/2024/04/01/new-ohio-pharmacy-rules-to-take-effect-in-may/

The National Incident Data Repository for Community Pharmacies (NIDR)

Information and Frequently Asked Questions. Institute for Safe Medication Practices Canada. September 2023. Retrieved from:

https://ismpcanada.ca/wp-content/uploads/NIDR-faq.pdf

Frost TP, Adams AJ. Tech-Check-Tech in Community Pharmacy Practice Settings. J Pharm Technol. 2017;33(2):47–52. doi: 10.1177/8755122516683519. Epub 2016 Apr 1. PMCID: PMC5998445. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC5998445/#:~:text=TCT%20enables%20a%20specially%20trained,in%20an%20automated%20dispensing%20system.

REFERENCES

Semuels A. Why Your Pharmacy Experience is Miserable. Time. September 18, 2024.

Accessed from:

https://time.com/7022116/pharmacies-struggling/?utm_medium=email&utm_source=sfmc&utm_campaign=newsletter+brief+default+ac&utm_content=+++20240920+++body&et_rid=273534511&lctg=273534511

Rebelo A. US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs. Wolters Kluver. December 7, 2022. Accessed from:

https://www.wolterskluwer.com/en/news/us-survey-signals-big-shifts-in-primary-care-to-pharmacy-and-clinic-settings

JD Power. As Mail Order Pharmacies Continue to Climb in Customer Satisfaction, Chain Drug Stores Fall Behind, J.D. Power Finds. JD Power. July 30, 2024. Accessed from:

https://www.jdpower.com/sites/default/files/file/2024-07/2024074%20U.S.%20Pharmacy.pdf

American Pharmacists Association. APhA and NASPA Release Eighth PWWR Report and Learnings. March 18, 2024. Accessed from:

https://www.pharmacist.com/APhA-Press-Releases/apha-and-naspa-release-eighth-pwwr-report-and-learnings

Goodkind N. Why Walgreens Pharmacy Workers Are Walking Off the Job. CNN Business. October 10, 2023. Accessed from:

https://www.cnn.com/2023/10/10/economy/walgreens-pharmacy-walkouts/index.html

Schommer JC, Gaither CA, Lee S, et al. 2021 APhA/NASPA National State-Based Pharmacy Workplace Survey. American Pharmacists Association. Final Report April 2022.

Accessed from:

https://naspa.us/wp-content/uploads/2022/05/National-State-Based-Pharmacy-Workplace-Survey-Final-Report-APRIL-2022-FINAL.pdf#page=12.06

Total number of medical prescriptions dispensed in the U.S. from 2009 to 2022.

Statista. Accessed from:

https://www.statista.com/statistics/238702/us-total-medical-prescriptions-issued/

Wittenauer R, Shah PD, Bacci JL, Stergachis A. Locations and Characteristics of Pharmacy Deserts in the United States: A Geospatial Study. Health Aff Sch. 2024; 2(4):qxae035. doi: 10.1093/haschl/qxae035. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11034534/

Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. J Am Pharm Assoc. 2022;62(6):1929-1945.e1. doi: 10.1016/j.japh.2022.08.010. Epub 2022 Aug 18. PMID: 36202712; PMCID: PMC9387064. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC9387064/

10. Roe S, Long R, King K. Pharmacists Miss Half of Dangerous Drug Combinations. Chicago Tribune. December 2016. Retrieved from: https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Gabler E. At Walgreens, Complaints of Medication Errors Go Missing. NY Times. Updated October 13, 2021. Accessed from:

https://www.nytimes.com/2020/02/21/health/pharmacies-prescription-errors.html

12. Gabler E. How Chaos at Chain Pharmacies is Putting Patients at Risk. NY Times. January 31, 2020. Retrieved from:

https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html

Le Coz E. Prescription for Disaster: America's Broken Pharmacy System in Revolt Over Burnout and Errors. USA Today. October 26, 2023. Retrieved from:

https://www.usatoday.com/story/news/investigations/2023/10/26/pharmacy-chains-dangerous-conditions-medication-errors/71153960007/

14. Bond CA Raehl CL. Pharmacists' Assessment of Dispensing Errors: Risk Factors, Practice Sites, Professional Functions, and Satisfaction. Pharmacotherapy. 2001; 21(5): 614-626.

15. Flynn EA, Barker KN, Carnahan BJ. National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies. J APhA. 2001; 43(2): 191-200.

16. Campbell PJ, Patel M, Martin JR, et al. Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993-2015. BMJ Open Qual. 2018;7(4):e000193. doi:10.1136/bmjoq-2017-000193. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173242/

Um IS, Clough A, Tan ECK. Dispensing error rates in pharmacy: a systematic review and meta-analysis. Res Social Adm Pharm. 2024;20(1):1-9. doi:10.1016/j.sapharm.2023.10.003. Retrieved from:

https://www.sciencedirect.com/science/article/pii/S1551741123004552?via%3Dihub

Academy of Managed Care Pharmacy. Medication Errors. July 18, 2019. Retrieved from:

https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/medication-errors

19. James L, BM, Barlow D, McArtney R, et al. Incidence, type and causes of dispensing errors: a review of the literature. Int J Pharm Pract. 2009; 17(1): 9-30. Retrieved from:

https://onlinelibrary.wiley.com/doi/full/10.1211/ijpp.17.1.0004?sid=nlm%3Apubmed

20. Pervanas HC, Revell N, Alotaibi AF. Evaluation of Medication Errors in Community Pharmacy Settings: A Retrospective Report. J Pharm Technol. 2016; 32(2): 71-74.

Kistner UA, Keith MR, Sergeant KA, et al. Accuracy of Dispensing in a High-Volume, Hospital Based Outpatient Pharmacy. Am J Hosp Pharm. 1994;512:793–7.

Allan EL, Barker KN, Malloy M, et al. Dispensing errors and counseling in community practice. Am Pharm 1995; NS35:25–33.

Hendren J. Overwork Threatens Druggists” Accuracy. LA Times. February 27, 2000. Retrieved from:

https://www.latimes.com/archives/la-xpm-2000-feb-27-mn-3125-story.html

Lopes J, Joaquim J, Matos C, Pires T. Medication errors in Community Pharmacy: Potencial Causes and strategies for Prevention. Clin Therap. 2015; 37(8 Supp): E119 (Abstract). Retrieved from:

https://www.clinicaltherapeutics.com/article/S0149-2918(15)00648-7/fulltext

Catalano G, Khan MMM, Chatzipanagiotou OP, Pawlik TM. Pharmacy Accessibility and Social Vulnerability. JAMA Netw Open. 2024;7(8):e2429755. doi:10.1001/jamanetworkopen.2024.29755. Retrieved from:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822776

Trend: What is a Pharmacy Desert? TelePharm. Retrieved from:

https://blog.telepharm.com/what-is-a-pharmacy-desert

Constantin J, Ullrich F, Mueller, KJ. Rural and Urban Pharmacy Presence – Pharmacy Deserts. RUPRI Center for Rural Health Policy Analysis Rural Policy Brief. August 2022. Retrieved from:

https://rupri.public-health.uiowa.edu/publications/policybriefs/2022/Pharmacy%20Deserts.pdf

Constantino AK. Some Pharmacy Staff from Walgreens, Other Chains Are Walking Out Again — Here’s What You Need To Know. CNBC. October 29, 2023. Retrieved from:

https://www.cnbc.com/2023/10/29/pharmacy-staff-from-walgreens-chains-like-cvs-to-walk-out-again.html

Adams AJ, Frost TP. Expunging Board of Pharmacy Disciplinary Actions. Innov Pharm. 2023;14(1):10.24926/iip.v14i1.5219. doi: 10.24926/iip.v14i1.5219. PMID: 38035318; PMCID: PMC10686669. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC10686669/#:~:text=Boards%20of%20pharmacy%20have%20the,practice%20restrictions%2C%20fines%20and%20reprimands.

Holdsworth M, Wittstrom K, Yeitrakis T. Current Approaches to Punitive Action for Medication Errors by Boards of Pharmacy. Ann Pharmacother. 2013;47(4):475-81. doi: 10.1345/aph.1R668. Epub 2013 Apr 2. PMID: 23548647.

Long R. Chicago Moves Closer To Easing Pharmacist Workload. Chicago Tribune. October 10, 2017, Updated June 14, 2024. October 26, 2023. Retrieved from:

https://www.chicagotribune.com/2017/10/10/chicago-moves-closer-to-easing-pharmacist-workload/

Illinois Statutes Ch 225. § 85/15.1. Pharmacy working conditions. Retrieved from:

https://www.ilga.gov/legislation/ilcs/documents/022500850K15.1.htm

Long R, Roe S. After Tribune Investigation, Durbin Pushes Interactive Drug Protection for Consumers. Cap Gazette. December 16, 2016. Retrieved from:

https://www.capitalgazette.com/ct-drug-interactions-durbin-pharmacy-20161216-story.html

21 NC Admin Code 46 .2512. Pharmacist Work Conditions. Retrieved from:

https://regulations.justia.com/states/north-carolina/title-21/chapter-46/section-2500/section-46-2512/

California. Stop Dangerous Pharmacies Act (AB 1286). 2024. Retrieved from:

https://www.pharmacy.ca.gov/publications/ab1286_faqs.pdf

California State Board of Pharmacy. Medication Error Reduction and Workforce Chair Report. November 16, 2022. Retrieved from:

https://www.pharmacy.ca.gov/meetings/agendas/2022/22_nov_med_mat.pdf

California Board of Pharmacy Considers New Legislation Regarding Pharmacy Workplace Conditions. Quarles Newsletter. December 19, 2022. Retrieved from:

https://www.quarles.com/newsroom/publications/california-board-of-pharmacy-continues-to-tackle-concerns-surrounding-pharmacy-workplace-conditions

California Business and Professional Code. 4113.7. Retrieved from:

https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=4113.7.&lawCode=BPC

Oklahoma Admin Code. Section 535:15-3-16 - Adequate Staffing Rules for Pharmacists and Pharmacies. Retrieved from:

Ohio Board of Pharmacy. Outpatient Pharmacies Minimum Standards. Updated May1, 2024. Retrieved from:

https://www.pharmacy.ohio.gov/documents/licensing/tddd/general/outpatient%20pharmacy%20minimum%20standards.pdf

41. Schladen M. New Ohio Pharmacy Rules to Take Effect in May. Ohio Cap J. April 1, 2024. Retrieved from:

https://ohiocapitaljournal.com/2024/04/01/new-ohio-pharmacy-rules-to-take-effect-in-may/

The National Incident Data Repository for Community Pharmacies (NIDR)

Information and Frequently Asked Questions. Institute for Safe Medication Practices Canada. September 2023. Retrieved from:

https://ismpcanada.ca/wp-content/uploads/NIDR-faq.pdf

Frost TP, Adams AJ. Tech-Check-Tech in Community Pharmacy Practice Settings. J Pharm Technol. 2017;33(2):47–52. doi: 10.1177/8755122516683519. Epub 2016 Apr 1. PMCID: PMC5998445. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC5998445/#:~:text=TCT%20enables%20a%20specially%20trained,in%20an%20automated%20dispensing%20system.

REFERENCES

Semuels A. Why Your Pharmacy Experience is Miserable. Time. September 18, 2024.

Accessed from:

https://time.com/7022116/pharmacies-struggling/?utm_medium=email&utm_source=sfmc&utm_campaign=newsletter+brief+default+ac&utm_content=+++20240920+++body&et_rid=273534511&lctg=273534511

Rebelo A. US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs. Wolters Kluver. December 7, 2022. Accessed from:

https://www.wolterskluwer.com/en/news/us-survey-signals-big-shifts-in-primary-care-to-pharmacy-and-clinic-settings

JD Power. As Mail Order Pharmacies Continue to Climb in Customer Satisfaction, Chain Drug Stores Fall Behind, J.D. Power Finds. JD Power. July 30, 2024. Accessed from:

https://www.jdpower.com/sites/default/files/file/2024-07/2024074%20U.S.%20Pharmacy.pdf

American Pharmacists Association. APhA and NASPA Release Eighth PWWR Report and Learnings. March 18, 2024. Accessed from:

https://www.pharmacist.com/APhA-Press-Releases/apha-and-naspa-release-eighth-pwwr-report-and-learnings

Goodkind N. Why Walgreens Pharmacy Workers Are Walking Off the Job. CNN Business. October 10, 2023. Accessed from:

https://www.cnn.com/2023/10/10/economy/walgreens-pharmacy-walkouts/index.html

Schommer JC, Gaither CA, Lee S, et al. 2021 APhA/NASPA National State-Based Pharmacy Workplace Survey. American Pharmacists Association. Final Report April 2022.

Accessed from:

https://naspa.us/wp-content/uploads/2022/05/National-State-Based-Pharmacy-Workplace-Survey-Final-Report-APRIL-2022-FINAL.pdf#page=12.06

Total number of medical prescriptions dispensed in the U.S. from 2009 to 2022.

Statista. Accessed from:

https://www.statista.com/statistics/238702/us-total-medical-prescriptions-issued/

Wittenauer R, Shah PD, Bacci JL, Stergachis A. Locations and Characteristics of Pharmacy Deserts in the United States: A Geospatial Study. Health Aff Sch. 2024; 2(4):qxae035. doi: 10.1093/haschl/qxae035. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11034534/

Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. J Am Pharm Assoc. 2022;62(6):1929-1945.e1. doi: 10.1016/j.japh.2022.08.010. Epub 2022 Aug 18. PMID: 36202712; PMCID: PMC9387064. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC9387064/

10. Roe S, Long R, King K. Pharmacists Miss Half of Dangerous Drug Combinations. Chicago Tribune. December 2016. Retrieved from: https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Gabler E. At Walgreens, Complaints of Medication Errors Go Missing. NY Times. Updated October 13, 2021. Accessed from:

https://www.nytimes.com/2020/02/21/health/pharmacies-prescription-errors.html

12. Gabler E. How Chaos at Chain Pharmacies is Putting Patients at Risk. NY Times. January 31, 2020. Retrieved from:

https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html

Le Coz E. Prescription for Disaster: America's Broken Pharmacy System in Revolt Over Burnout and Errors. USA Today. October 26, 2023. Retrieved from:

https://www.usatoday.com/story/news/investigations/2023/10/26/pharmacy-chains-dangerous-conditions-medication-errors/71153960007/

14. Bond CA Raehl CL. Pharmacists' Assessment of Dispensing Errors: Risk Factors, Practice Sites, Professional Functions, and Satisfaction. Pharmacotherapy. 2001; 21(5): 614-626.

15. Flynn EA, Barker KN, Carnahan BJ. National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies. J APhA. 2001; 43(2): 191-200.

16. Campbell PJ, Patel M, Martin JR, et al. Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993-2015. BMJ Open Qual. 2018;7(4):e000193. doi:10.1136/bmjoq-2017-000193. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173242/

Um IS, Clough A, Tan ECK. Dispensing error rates in pharmacy: a systematic review and meta-analysis. Res Social Adm Pharm. 2024;20(1):1-9. doi:10.1016/j.sapharm.2023.10.003. Retrieved from:

https://www.sciencedirect.com/science/article/pii/S1551741123004552?via%3Dihub

Academy of Managed Care Pharmacy. Medication Errors. July 18, 2019. Retrieved from:

https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/medication-errors

19. James L, BM, Barlow D, McArtney R, et al. Incidence, type and causes of dispensing errors: a review of the literature. Int J Pharm Pract. 2009; 17(1): 9-30. Retrieved from:

https://onlinelibrary.wiley.com/doi/full/10.1211/ijpp.17.1.0004?sid=nlm%3Apubmed

20. Pervanas HC, Revell N, Alotaibi AF. Evaluation of Medication Errors in Community Pharmacy Settings: A Retrospective Report. J Pharm Technol. 2016; 32(2): 71-74.

Kistner UA, Keith MR, Sergeant KA, et al. Accuracy of Dispensing in a High-Volume, Hospital Based Outpatient Pharmacy. Am J Hosp Pharm. 1994;512:793–7.

Allan EL, Barker KN, Malloy M, et al. Dispensing errors and counseling in community practice. Am Pharm 1995; NS35:25–33.

Hendren J. Overwork Threatens Druggists” Accuracy. LA Times. February 27, 2000. Retrieved from:

https://www.latimes.com/archives/la-xpm-2000-feb-27-mn-3125-story.html

Lopes J, Joaquim J, Matos C, Pires T. Medication errors in Community Pharmacy: Potencial Causes and strategies for Prevention. Clin Therap. 2015; 37(8 Supp): E119 (Abstract). Retrieved from:

https://www.clinicaltherapeutics.com/article/S0149-2918(15)00648-7/fulltext

Catalano G, Khan MMM, Chatzipanagiotou OP, Pawlik TM. Pharmacy Accessibility and Social Vulnerability. JAMA Netw Open. 2024;7(8):e2429755. doi:10.1001/jamanetworkopen.2024.29755. Retrieved from:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822776

Trend: What is a Pharmacy Desert? TelePharm. Retrieved from:

https://blog.telepharm.com/what-is-a-pharmacy-desert

Constantin J, Ullrich F, Mueller, KJ. Rural and Urban Pharmacy Presence – Pharmacy Deserts. RUPRI Center for Rural Health Policy Analysis Rural Policy Brief. August 2022. Retrieved from:

https://rupri.public-health.uiowa.edu/publications/policybriefs/2022/Pharmacy%20Deserts.pdf

Constantino AK. Some Pharmacy Staff from Walgreens, Other Chains Are Walking Out Again — Here’s What You Need To Know. CNBC. October 29, 2023. Retrieved from:

https://www.cnbc.com/2023/10/29/pharmacy-staff-from-walgreens-chains-like-cvs-to-walk-out-again.html

Adams AJ, Frost TP. Expunging Board of Pharmacy Disciplinary Actions. Innov Pharm. 2023;14(1):10.24926/iip.v14i1.5219. doi: 10.24926/iip.v14i1.5219. PMID: 38035318; PMCID: PMC10686669. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC10686669/#:~:text=Boards%20of%20pharmacy%20have%20the,practice%20restrictions%2C%20fines%20and%20reprimands.

Holdsworth M, Wittstrom K, Yeitrakis T. Current Approaches to Punitive Action for Medication Errors by Boards of Pharmacy. Ann Pharmacother. 2013;47(4):475-81. doi: 10.1345/aph.1R668. Epub 2013 Apr 2. PMID: 23548647.

Long R. Chicago Moves Closer To Easing Pharmacist Workload. Chicago Tribune. October 10, 2017, Updated June 14, 2024. October 26, 2023. Retrieved from:

https://www.chicagotribune.com/2017/10/10/chicago-moves-closer-to-easing-pharmacist-workload/

Illinois Statutes Ch 225. § 85/15.1. Pharmacy working conditions. Retrieved from:

https://www.ilga.gov/legislation/ilcs/documents/022500850K15.1.htm

Long R, Roe S. After Tribune Investigation, Durbin Pushes Interactive Drug Protection for Consumers. Cap Gazette. December 16, 2016. Retrieved from:

https://www.capitalgazette.com/ct-drug-interactions-durbin-pharmacy-20161216-story.html

21 NC Admin Code 46 .2512. Pharmacist Work Conditions. Retrieved from:

https://regulations.justia.com/states/north-carolina/title-21/chapter-46/section-2500/section-46-2512/

California. Stop Dangerous Pharmacies Act (AB 1286). 2024. Retrieved from:

https://www.pharmacy.ca.gov/publications/ab1286_faqs.pdf

California State Board of Pharmacy. Medication Error Reduction and Workforce Chair Report. November 16, 2022. Retrieved from:

https://www.pharmacy.ca.gov/meetings/agendas/2022/22_nov_med_mat.pdf

California Board of Pharmacy Considers New Legislation Regarding Pharmacy Workplace Conditions. Quarles Newsletter. December 19, 2022. Retrieved from:

https://www.quarles.com/newsroom/publications/california-board-of-pharmacy-continues-to-tackle-concerns-surrounding-pharmacy-workplace-conditions

California Business and Professional Code. 4113.7. Retrieved from:

https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=4113.7.&lawCode=BPC

Oklahoma Admin Code. Section 535:15-3-16 - Adequate Staffing Rules for Pharmacists and Pharmacies. Retrieved from:

Ohio Board of Pharmacy. Outpatient Pharmacies Minimum Standards. Updated May1, 2024. Retrieved from:

https://www.pharmacy.ohio.gov/documents/licensing/tddd/general/outpatient%20pharmacy%20minimum%20standards.pdf

41. Schladen M. New Ohio Pharmacy Rules to Take Effect in May. Ohio Cap J. April 1, 2024. Retrieved from:

https://ohiocapitaljournal.com/2024/04/01/new-ohio-pharmacy-rules-to-take-effect-in-may/

The National Incident Data Repository for Community Pharmacies (NIDR)

Information and Frequently Asked Questions. Institute for Safe Medication Practices Canada. September 2023. Retrieved from:

https://ismpcanada.ca/wp-content/uploads/NIDR-faq.pdf

Frost TP, Adams AJ. Tech-Check-Tech in Community Pharmacy Practice Settings. J Pharm Technol. 2017;33(2):47–52. doi: 10.1177/8755122516683519. Epub 2016 Apr 1. PMCID: PMC5998445. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC5998445/#:~:text=TCT%20enables%20a%20specially%20trained,in%20an%20automated%20dispensing%20system.

REFERENCES

Semuels A. Why Your Pharmacy Experience is Miserable. Time. September 18, 2024.

Accessed from:

https://time.com/7022116/pharmacies-struggling/?utm_medium=email&utm_source=sfmc&utm_campaign=newsletter+brief+default+ac&utm_content=+++20240920+++body&et_rid=273534511&lctg=273534511

Rebelo A. US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs. Wolters Kluver. December 7, 2022. Accessed from:

https://www.wolterskluwer.com/en/news/us-survey-signals-big-shifts-in-primary-care-to-pharmacy-and-clinic-settings

JD Power. As Mail Order Pharmacies Continue to Climb in Customer Satisfaction, Chain Drug Stores Fall Behind, J.D. Power Finds. JD Power. July 30, 2024. Accessed from:

https://www.jdpower.com/sites/default/files/file/2024-07/2024074%20U.S.%20Pharmacy.pdf

American Pharmacists Association. APhA and NASPA Release Eighth PWWR Report and Learnings. March 18, 2024. Accessed from:

https://www.pharmacist.com/APhA-Press-Releases/apha-and-naspa-release-eighth-pwwr-report-and-learnings

Goodkind N. Why Walgreens Pharmacy Workers Are Walking Off the Job. CNN Business. October 10, 2023. Accessed from:

https://www.cnn.com/2023/10/10/economy/walgreens-pharmacy-walkouts/index.html

Schommer JC, Gaither CA, Lee S, et al. 2021 APhA/NASPA National State-Based Pharmacy Workplace Survey. American Pharmacists Association. Final Report April 2022.

Accessed from:

https://naspa.us/wp-content/uploads/2022/05/National-State-Based-Pharmacy-Workplace-Survey-Final-Report-APRIL-2022-FINAL.pdf#page=12.06

Total number of medical prescriptions dispensed in the U.S. from 2009 to 2022.

Statista. Accessed from:

https://www.statista.com/statistics/238702/us-total-medical-prescriptions-issued/

Wittenauer R, Shah PD, Bacci JL, Stergachis A. Locations and Characteristics of Pharmacy Deserts in the United States: A Geospatial Study. Health Aff Sch. 2024; 2(4):qxae035. doi: 10.1093/haschl/qxae035. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11034534/

Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. J Am Pharm Assoc. 2022;62(6):1929-1945.e1. doi: 10.1016/j.japh.2022.08.010. Epub 2022 Aug 18. PMID: 36202712; PMCID: PMC9387064. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC9387064/

10. Roe S, Long R, King K. Pharmacists Miss Half of Dangerous Drug Combinations. Chicago Tribune. December 2016. Retrieved from: https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Gabler E. At Walgreens, Complaints of Medication Errors Go Missing. NY Times. Updated October 13, 2021. Accessed from:

https://www.nytimes.com/2020/02/21/health/pharmacies-prescription-errors.html

12. Gabler E. How Chaos at Chain Pharmacies is Putting Patients at Risk. NY Times. January 31, 2020. Retrieved from:

https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html

Le Coz E. Prescription for Disaster: America's Broken Pharmacy System in Revolt Over Burnout and Errors. USA Today. October 26, 2023. Retrieved from:

https://www.usatoday.com/story/news/investigations/2023/10/26/pharmacy-chains-dangerous-conditions-medication-errors/71153960007/

14. Bond CA Raehl CL. Pharmacists' Assessment of Dispensing Errors: Risk Factors, Practice Sites, Professional Functions, and Satisfaction. Pharmacotherapy. 2001; 21(5): 614-626.

15. Flynn EA, Barker KN, Carnahan BJ. National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies. J APhA. 2001; 43(2): 191-200.

16. Campbell PJ, Patel M, Martin JR, et al. Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993-2015. BMJ Open Qual. 2018;7(4):e000193. doi:10.1136/bmjoq-2017-000193. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173242/

Um IS, Clough A, Tan ECK. Dispensing error rates in pharmacy: a systematic review and meta-analysis. Res Social Adm Pharm. 2024;20(1):1-9. doi:10.1016/j.sapharm.2023.10.003. Retrieved from:

https://www.sciencedirect.com/science/article/pii/S1551741123004552?via%3Dihub

Academy of Managed Care Pharmacy. Medication Errors. July 18, 2019. Retrieved from:

https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/medication-errors

19. James L, BM, Barlow D, McArtney R, et al. Incidence, type and causes of dispensing errors: a review of the literature. Int J Pharm Pract. 2009; 17(1): 9-30. Retrieved from:

https://onlinelibrary.wiley.com/doi/full/10.1211/ijpp.17.1.0004?sid=nlm%3Apubmed

20. Pervanas HC, Revell N, Alotaibi AF. Evaluation of Medication Errors in Community Pharmacy Settings: A Retrospective Report. J Pharm Technol. 2016; 32(2): 71-74.

Kistner UA, Keith MR, Sergeant KA, et al. Accuracy of Dispensing in a High-Volume, Hospital Based Outpatient Pharmacy. Am J Hosp Pharm. 1994;512:793–7.

Allan EL, Barker KN, Malloy M, et al. Dispensing errors and counseling in community practice. Am Pharm 1995; NS35:25–33.

Hendren J. Overwork Threatens Druggists” Accuracy. LA Times. February 27, 2000. Retrieved from:

https://www.latimes.com/archives/la-xpm-2000-feb-27-mn-3125-story.html

Lopes J, Joaquim J, Matos C, Pires T. Medication errors in Community Pharmacy: Potencial Causes and strategies for Prevention. Clin Therap. 2015; 37(8 Supp): E119 (Abstract). Retrieved from:

https://www.clinicaltherapeutics.com/article/S0149-2918(15)00648-7/fulltext

Catalano G, Khan MMM, Chatzipanagiotou OP, Pawlik TM. Pharmacy Accessibility and Social Vulnerability. JAMA Netw Open. 2024;7(8):e2429755. doi:10.1001/jamanetworkopen.2024.29755. Retrieved from:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822776

Trend: What is a Pharmacy Desert? TelePharm. Retrieved from:

https://blog.telepharm.com/what-is-a-pharmacy-desert

Constantin J, Ullrich F, Mueller, KJ. Rural and Urban Pharmacy Presence – Pharmacy Deserts. RUPRI Center for Rural Health Policy Analysis Rural Policy Brief. August 2022. Retrieved from:

https://rupri.public-health.uiowa.edu/publications/policybriefs/2022/Pharmacy%20Deserts.pdf

Constantino AK. Some Pharmacy Staff from Walgreens, Other Chains Are Walking Out Again — Here’s What You Need To Know. CNBC. October 29, 2023. Retrieved from:

https://www.cnbc.com/2023/10/29/pharmacy-staff-from-walgreens-chains-like-cvs-to-walk-out-again.html

Adams AJ, Frost TP. Expunging Board of Pharmacy Disciplinary Actions. Innov Pharm. 2023;14(1):10.24926/iip.v14i1.5219. doi: 10.24926/iip.v14i1.5219. PMID: 38035318; PMCID: PMC10686669. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC10686669/#:~:text=Boards%20of%20pharmacy%20have%20the,practice%20restrictions%2C%20fines%20and%20reprimands.

Holdsworth M, Wittstrom K, Yeitrakis T. Current Approaches to Punitive Action for Medication Errors by Boards of Pharmacy. Ann Pharmacother. 2013;47(4):475-81. doi: 10.1345/aph.1R668. Epub 2013 Apr 2. PMID: 23548647.

Long R. Chicago Moves Closer To Easing Pharmacist Workload. Chicago Tribune. October 10, 2017, Updated June 14, 2024. October 26, 2023. Retrieved from:

https://www.chicagotribune.com/2017/10/10/chicago-moves-closer-to-easing-pharmacist-workload/

Illinois Statutes Ch 225. § 85/15.1. Pharmacy working conditions. Retrieved from:

https://www.ilga.gov/legislation/ilcs/documents/022500850K15.1.htm

Long R, Roe S. After Tribune Investigation, Durbin Pushes Interactive Drug Protection for Consumers. Cap Gazette. December 16, 2016. Retrieved from:

https://www.capitalgazette.com/ct-drug-interactions-durbin-pharmacy-20161216-story.html

21 NC Admin Code 46 .2512. Pharmacist Work Conditions. Retrieved from:

https://regulations.justia.com/states/north-carolina/title-21/chapter-46/section-2500/section-46-2512/

California. Stop Dangerous Pharmacies Act (AB 1286). 2024. Retrieved from:

https://www.pharmacy.ca.gov/publications/ab1286_faqs.pdf

California State Board of Pharmacy. Medication Error Reduction and Workforce Chair Report. November 16, 2022. Retrieved from:

https://www.pharmacy.ca.gov/meetings/agendas/2022/22_nov_med_mat.pdf

California Board of Pharmacy Considers New Legislation Regarding Pharmacy Workplace Conditions. Quarles Newsletter. December 19, 2022. Retrieved from:

https://www.quarles.com/newsroom/publications/california-board-of-pharmacy-continues-to-tackle-concerns-surrounding-pharmacy-workplace-conditions

California Business and Professional Code. 4113.7. Retrieved from:

https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=4113.7.&lawCode=BPC

Oklahoma Admin Code. Section 535:15-3-16 - Adequate Staffing Rules for Pharmacists and Pharmacies. Retrieved from:

Ohio Board of Pharmacy. Outpatient Pharmacies Minimum Standards. Updated May1, 2024. Retrieved from:

https://www.pharmacy.ohio.gov/documents/licensing/tddd/general/outpatient%20pharmacy%20minimum%20standards.pdf

41. Schladen M. New Ohio Pharmacy Rules to Take Effect in May. Ohio Cap J. April 1, 2024. Retrieved from:

https://ohiocapitaljournal.com/2024/04/01/new-ohio-pharmacy-rules-to-take-effect-in-may/

The National Incident Data Repository for Community Pharmacies (NIDR)

Information and Frequently Asked Questions. Institute for Safe Medication Practices Canada. September 2023. Retrieved from:

https://ismpcanada.ca/wp-content/uploads/NIDR-faq.pdf

Frost TP, Adams AJ. Tech-Check-Tech in Community Pharmacy Practice Settings. J Pharm Technol. 2017;33(2):47–52. doi: 10.1177/8755122516683519. Epub 2016 Apr 1. PMCID: PMC5998445. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC5998445/#:~:text=TCT%20enables%20a%20specially%20trained,in%20an%20automated%20dispensing%20system.

REFERENCES

Semuels A. Why Your Pharmacy Experience is Miserable. Time. September 18, 2024.

Accessed from:

https://time.com/7022116/pharmacies-struggling/?utm_medium=email&utm_source=sfmc&utm_campaign=newsletter+brief+default+ac&utm_content=+++20240920+++body&et_rid=273534511&lctg=273534511

Rebelo A. US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs. Wolters Kluver. December 7, 2022. Accessed from:

https://www.wolterskluwer.com/en/news/us-survey-signals-big-shifts-in-primary-care-to-pharmacy-and-clinic-settings

JD Power. As Mail Order Pharmacies Continue to Climb in Customer Satisfaction, Chain Drug Stores Fall Behind, J.D. Power Finds. JD Power. July 30, 2024. Accessed from:

https://www.jdpower.com/sites/default/files/file/2024-07/2024074%20U.S.%20Pharmacy.pdf

American Pharmacists Association. APhA and NASPA Release Eighth PWWR Report and Learnings. March 18, 2024. Accessed from:

https://www.pharmacist.com/APhA-Press-Releases/apha-and-naspa-release-eighth-pwwr-report-and-learnings

Goodkind N. Why Walgreens Pharmacy Workers Are Walking Off the Job. CNN Business. October 10, 2023. Accessed from:

https://www.cnn.com/2023/10/10/economy/walgreens-pharmacy-walkouts/index.html

Schommer JC, Gaither CA, Lee S, et al. 2021 APhA/NASPA National State-Based Pharmacy Workplace Survey. American Pharmacists Association. Final Report April 2022.

Accessed from:

https://naspa.us/wp-content/uploads/2022/05/National-State-Based-Pharmacy-Workplace-Survey-Final-Report-APRIL-2022-FINAL.pdf#page=12.06

Total number of medical prescriptions dispensed in the U.S. from 2009 to 2022.

Statista. Accessed from:

https://www.statista.com/statistics/238702/us-total-medical-prescriptions-issued/

Wittenauer R, Shah PD, Bacci JL, Stergachis A. Locations and Characteristics of Pharmacy Deserts in the United States: A Geospatial Study. Health Aff Sch. 2024; 2(4):qxae035. doi: 10.1093/haschl/qxae035. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11034534/

Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. J Am Pharm Assoc. 2022;62(6):1929-1945.e1. doi: 10.1016/j.japh.2022.08.010. Epub 2022 Aug 18. PMID: 36202712; PMCID: PMC9387064. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC9387064/

10. Roe S, Long R, King K. Pharmacists Miss Half of Dangerous Drug Combinations. Chicago Tribune. December 2016. Retrieved from: https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Gabler E. At Walgreens, Complaints of Medication Errors Go Missing. NY Times. Updated October 13, 2021. Accessed from:

https://www.nytimes.com/2020/02/21/health/pharmacies-prescription-errors.html

12. Gabler E. How Chaos at Chain Pharmacies is Putting Patients at Risk. NY Times. January 31, 2020. Retrieved from:

https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html

Le Coz E. Prescription for Disaster: America's Broken Pharmacy System in Revolt Over Burnout and Errors. USA Today. October 26, 2023. Retrieved from:

https://www.usatoday.com/story/news/investigations/2023/10/26/pharmacy-chains-dangerous-conditions-medication-errors/71153960007/

14. Bond CA Raehl CL. Pharmacists' Assessment of Dispensing Errors: Risk Factors, Practice Sites, Professional Functions, and Satisfaction. Pharmacotherapy. 2001; 21(5): 614-626.

15. Flynn EA, Barker KN, Carnahan BJ. National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies. J APhA. 2001; 43(2): 191-200.

16. Campbell PJ, Patel M, Martin JR, et al. Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993-2015. BMJ Open Qual. 2018;7(4):e000193. doi:10.1136/bmjoq-2017-000193. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173242/

Um IS, Clough A, Tan ECK. Dispensing error rates in pharmacy: a systematic review and meta-analysis. Res Social Adm Pharm. 2024;20(1):1-9. doi:10.1016/j.sapharm.2023.10.003. Retrieved from:

https://www.sciencedirect.com/science/article/pii/S1551741123004552?via%3Dihub

Academy of Managed Care Pharmacy. Medication Errors. July 18, 2019. Retrieved from:

https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/medication-errors

19. James L, BM, Barlow D, McArtney R, et al. Incidence, type and causes of dispensing errors: a review of the literature. Int J Pharm Pract. 2009; 17(1): 9-30. Retrieved from:

https://onlinelibrary.wiley.com/doi/full/10.1211/ijpp.17.1.0004?sid=nlm%3Apubmed

20. Pervanas HC, Revell N, Alotaibi AF. Evaluation of Medication Errors in Community Pharmacy Settings: A Retrospective Report. J Pharm Technol. 2016; 32(2): 71-74.

Kistner UA, Keith MR, Sergeant KA, et al. Accuracy of Dispensing in a High-Volume, Hospital Based Outpatient Pharmacy. Am J Hosp Pharm. 1994;512:793–7.

Allan EL, Barker KN, Malloy M, et al. Dispensing errors and counseling in community practice. Am Pharm 1995; NS35:25–33.

Hendren J. Overwork Threatens Druggists” Accuracy. LA Times. February 27, 2000. Retrieved from:

https://www.latimes.com/archives/la-xpm-2000-feb-27-mn-3125-story.html

Lopes J, Joaquim J, Matos C, Pires T. Medication errors in Community Pharmacy: Potencial Causes and strategies for Prevention. Clin Therap. 2015; 37(8 Supp): E119 (Abstract). Retrieved from:

https://www.clinicaltherapeutics.com/article/S0149-2918(15)00648-7/fulltext

Catalano G, Khan MMM, Chatzipanagiotou OP, Pawlik TM. Pharmacy Accessibility and Social Vulnerability. JAMA Netw Open. 2024;7(8):e2429755. doi:10.1001/jamanetworkopen.2024.29755. Retrieved from:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822776

Trend: What is a Pharmacy Desert? TelePharm. Retrieved from:

https://blog.telepharm.com/what-is-a-pharmacy-desert

Constantin J, Ullrich F, Mueller, KJ. Rural and Urban Pharmacy Presence – Pharmacy Deserts. RUPRI Center for Rural Health Policy Analysis Rural Policy Brief. August 2022. Retrieved from:

https://rupri.public-health.uiowa.edu/publications/policybriefs/2022/Pharmacy%20Deserts.pdf

Constantino AK. Some Pharmacy Staff from Walgreens, Other Chains Are Walking Out Again — Here’s What You Need To Know. CNBC. October 29, 2023. Retrieved from:

https://www.cnbc.com/2023/10/29/pharmacy-staff-from-walgreens-chains-like-cvs-to-walk-out-again.html

Adams AJ, Frost TP. Expunging Board of Pharmacy Disciplinary Actions. Innov Pharm. 2023;14(1):10.24926/iip.v14i1.5219. doi: 10.24926/iip.v14i1.5219. PMID: 38035318; PMCID: PMC10686669. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC10686669/#:~:text=Boards%20of%20pharmacy%20have%20the,practice%20restrictions%2C%20fines%20and%20reprimands.

Holdsworth M, Wittstrom K, Yeitrakis T. Current Approaches to Punitive Action for Medication Errors by Boards of Pharmacy. Ann Pharmacother. 2013;47(4):475-81. doi: 10.1345/aph.1R668. Epub 2013 Apr 2. PMID: 23548647.

Long R. Chicago Moves Closer To Easing Pharmacist Workload. Chicago Tribune. October 10, 2017, Updated June 14, 2024. October 26, 2023. Retrieved from:

https://www.chicagotribune.com/2017/10/10/chicago-moves-closer-to-easing-pharmacist-workload/

Illinois Statutes Ch 225. § 85/15.1. Pharmacy working conditions. Retrieved from:

https://www.ilga.gov/legislation/ilcs/documents/022500850K15.1.htm

Long R, Roe S. After Tribune Investigation, Durbin Pushes Interactive Drug Protection for Consumers. Cap Gazette. December 16, 2016. Retrieved from:

https://www.capitalgazette.com/ct-drug-interactions-durbin-pharmacy-20161216-story.html

21 NC Admin Code 46 .2512. Pharmacist Work Conditions. Retrieved from:

https://regulations.justia.com/states/north-carolina/title-21/chapter-46/section-2500/section-46-2512/

California. Stop Dangerous Pharmacies Act (AB 1286). 2024. Retrieved from:

https://www.pharmacy.ca.gov/publications/ab1286_faqs.pdf

California State Board of Pharmacy. Medication Error Reduction and Workforce Chair Report. November 16, 2022. Retrieved from:

https://www.pharmacy.ca.gov/meetings/agendas/2022/22_nov_med_mat.pdf

California Board of Pharmacy Considers New Legislation Regarding Pharmacy Workplace Conditions. Quarles Newsletter. December 19, 2022. Retrieved from:

https://www.quarles.com/newsroom/publications/california-board-of-pharmacy-continues-to-tackle-concerns-surrounding-pharmacy-workplace-conditions

California Business and Professional Code. 4113.7. Retrieved from:

https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=4113.7.&lawCode=BPC

Oklahoma Admin Code. Section 535:15-3-16 - Adequate Staffing Rules for Pharmacists and Pharmacies. Retrieved from:

Ohio Board of Pharmacy. Outpatient Pharmacies Minimum Standards. Updated May1, 2024. Retrieved from:

https://www.pharmacy.ohio.gov/documents/licensing/tddd/general/outpatient%20pharmacy%20minimum%20standards.pdf

41. Schladen M. New Ohio Pharmacy Rules to Take Effect in May. Ohio Cap J. April 1, 2024. Retrieved from:

https://ohiocapitaljournal.com/2024/04/01/new-ohio-pharmacy-rules-to-take-effect-in-may/

The National Incident Data Repository for Community Pharmacies (NIDR)

Information and Frequently Asked Questions. Institute for Safe Medication Practices Canada. September 2023. Retrieved from:

https://ismpcanada.ca/wp-content/uploads/NIDR-faq.pdf

Frost TP, Adams AJ. Tech-Check-Tech in Community Pharmacy Practice Settings. J Pharm Technol. 2017;33(2):47–52. doi: 10.1177/8755122516683519. Epub 2016 Apr 1. PMCID: PMC5998445. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC5998445/#:~:text=TCT%20enables%20a%20specially%20trained,in%20an%20automated%20dispensing%20system.

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Rebelo A. US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs. Wolters Kluver. December 7, 2022. Accessed from:

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JD Power. As Mail Order Pharmacies Continue to Climb in Customer Satisfaction, Chain Drug Stores Fall Behind, J.D. Power Finds. JD Power. July 30, 2024. Accessed from:

https://www.jdpower.com/sites/default/files/file/2024-07/2024074%20U.S.%20Pharmacy.pdf

American Pharmacists Association. APhA and NASPA Release Eighth PWWR Report and Learnings. March 18, 2024. Accessed from:

https://www.pharmacist.com/APhA-Press-Releases/apha-and-naspa-release-eighth-pwwr-report-and-learnings

Goodkind N. Why Walgreens Pharmacy Workers Are Walking Off the Job. CNN Business. October 10, 2023. Accessed from:

https://www.cnn.com/2023/10/10/economy/walgreens-pharmacy-walkouts/index.html

Schommer JC, Gaither CA, Lee S, et al. 2021 APhA/NASPA National State-Based Pharmacy Workplace Survey. American Pharmacists Association. Final Report April 2022.

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https://naspa.us/wp-content/uploads/2022/05/National-State-Based-Pharmacy-Workplace-Survey-Final-Report-APRIL-2022-FINAL.pdf#page=12.06

Total number of medical prescriptions dispensed in the U.S. from 2009 to 2022.

Statista. Accessed from:

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Wittenauer R, Shah PD, Bacci JL, Stergachis A. Locations and Characteristics of Pharmacy Deserts in the United States: A Geospatial Study. Health Aff Sch. 2024; 2(4):qxae035. doi: 10.1093/haschl/qxae035. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11034534/

Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. J Am Pharm Assoc. 2022;62(6):1929-1945.e1. doi: 10.1016/j.japh.2022.08.010. Epub 2022 Aug 18. PMID: 36202712; PMCID: PMC9387064. Accessed from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC9387064/

10. Roe S, Long R, King K. Pharmacists Miss Half of Dangerous Drug Combinations. Chicago Tribune. December 2016. Retrieved from: https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Gabler E. At Walgreens, Complaints of Medication Errors Go Missing. NY Times. Updated October 13, 2021. Accessed from:

https://www.nytimes.com/2020/02/21/health/pharmacies-prescription-errors.html

12. Gabler E. How Chaos at Chain Pharmacies is Putting Patients at Risk. NY Times. January 31, 2020. Retrieved from:

https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html

Le Coz E. Prescription for Disaster: America's Broken Pharmacy System in Revolt Over Burnout and Errors. USA Today. October 26, 2023. Retrieved from:

https://www.usatoday.com/story/news/investigations/2023/10/26/pharmacy-chains-dangerous-conditions-medication-errors/71153960007/

14. Bond CA Raehl CL. Pharmacists' Assessment of Dispensing Errors: Risk Factors, Practice Sites, Professional Functions, and Satisfaction. Pharmacotherapy. 2001; 21(5): 614-626.

15. Flynn EA, Barker KN, Carnahan BJ. National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies. J APhA. 2001; 43(2): 191-200.

16. Campbell PJ, Patel M, Martin JR, et al. Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993-2015. BMJ Open Qual. 2018;7(4):e000193. doi:10.1136/bmjoq-2017-000193. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173242/

Um IS, Clough A, Tan ECK. Dispensing error rates in pharmacy: a systematic review and meta-analysis. Res Social Adm Pharm. 2024;20(1):1-9. doi:10.1016/j.sapharm.2023.10.003. Retrieved from:

https://www.sciencedirect.com/science/article/pii/S1551741123004552?via%3Dihub

Academy of Managed Care Pharmacy. Medication Errors. July 18, 2019. Retrieved from:

https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/medication-errors

19. James L, BM, Barlow D, McArtney R, et al. Incidence, type and causes of dispensing errors: a review of the literature. Int J Pharm Pract. 2009; 17(1): 9-30. Retrieved from:

https://onlinelibrary.wiley.com/doi/full/10.1211/ijpp.17.1.0004?sid=nlm%3Apubmed

20. Pervanas HC, Revell N, Alotaibi AF. Evaluation of Medication Errors in Community Pharmacy Settings: A Retrospective Report. J Pharm Technol. 2016; 32(2): 71-74.

Kistner UA, Keith MR, Sergeant KA, et al. Accuracy of Dispensing in a High-Volume, Hospital Based Outpatient Pharmacy. Am J Hosp Pharm. 1994;512:793–7.

Allan EL, Barker KN, Malloy M, et al. Dispensing errors and counseling in community practice. Am Pharm 1995; NS35:25–33.

Hendren J. Overwork Threatens Druggists” Accuracy. LA Times. February 27, 2000. Retrieved from:

https://www.latimes.com/archives/la-xpm-2000-feb-27-mn-3125-story.html

Lopes J, Joaquim J, Matos C, Pires T. Medication errors in Community Pharmacy: Potencial Causes and strategies for Prevention. Clin Therap. 2015; 37(8 Supp): E119 (Abstract). Retrieved from:

https://www.clinicaltherapeutics.com/article/S0149-2918(15)00648-7/fulltext

Catalano G, Khan MMM, Chatzipanagiotou OP, Pawlik TM. Pharmacy Accessibility and Social Vulnerability. JAMA Netw Open. 2024;7(8):e2429755. doi:10.1001/jamanetworkopen.2024.29755. Retrieved from:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822776

Trend: What is a Pharmacy Desert? TelePharm. Retrieved from:

https://blog.telepharm.com/what-is-a-pharmacy-desert

Constantin J, Ullrich F, Mueller, KJ. Rural and Urban Pharmacy Presence – Pharmacy Deserts. RUPRI Center for Rural Health Policy Analysis Rural Policy Brief. August 2022. Retrieved from:

https://rupri.public-health.uiowa.edu/publications/policybriefs/2022/Pharmacy%20Deserts.pdf

Constantino AK. Some Pharmacy Staff from Walgreens, Other Chains Are Walking Out Again — Here’s What You Need To Know. CNBC. October 29, 2023. Retrieved from:

https://www.cnbc.com/2023/10/29/pharmacy-staff-from-walgreens-chains-like-cvs-to-walk-out-again.html

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https://pmc.ncbi.nlm.nih.gov/articles/PMC10686669/#:~:text=Boards%20of%20pharmacy%20have%20the,practice%20restrictions%2C%20fines%20and%20reprimands.

Holdsworth M, Wittstrom K, Yeitrakis T. Current Approaches to Punitive Action for Medication Errors by Boards of Pharmacy. Ann Pharmacother. 2013;47(4):475-81. doi: 10.1345/aph.1R668. Epub 2013 Apr 2. PMID: 23548647.

Long R. Chicago Moves Closer To Easing Pharmacist Workload. Chicago Tribune. October 10, 2017, Updated June 14, 2024. October 26, 2023. Retrieved from:

https://www.chicagotribune.com/2017/10/10/chicago-moves-closer-to-easing-pharmacist-workload/

Illinois Statutes Ch 225. § 85/15.1. Pharmacy working conditions. Retrieved from:

https://www.ilga.gov/legislation/ilcs/documents/022500850K15.1.htm

Long R, Roe S. After Tribune Investigation, Durbin Pushes Interactive Drug Protection for Consumers. Cap Gazette. December 16, 2016. Retrieved from:

https://www.capitalgazette.com/ct-drug-interactions-durbin-pharmacy-20161216-story.html

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https://regulations.justia.com/states/north-carolina/title-21/chapter-46/section-2500/section-46-2512/

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California State Board of Pharmacy. Medication Error Reduction and Workforce Chair Report. November 16, 2022. Retrieved from:

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California Board of Pharmacy Considers New Legislation Regarding Pharmacy Workplace Conditions. Quarles Newsletter. December 19, 2022. Retrieved from:

https://www.quarles.com/newsroom/publications/california-board-of-pharmacy-continues-to-tackle-concerns-surrounding-pharmacy-workplace-conditions

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https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=4113.7.&lawCode=BPC

Oklahoma Admin Code. Section 535:15-3-16 - Adequate Staffing Rules for Pharmacists and Pharmacies. Retrieved from:

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The National Incident Data Repository for Community Pharmacies (NIDR)

Information and Frequently Asked Questions. Institute for Safe Medication Practices Canada. September 2023. Retrieved from:

https://ismpcanada.ca/wp-content/uploads/NIDR-faq.pdf

Frost TP, Adams AJ. Tech-Check-Tech in Community Pharmacy Practice Settings. J Pharm Technol. 2017;33(2):47–52. doi: 10.1177/8755122516683519. Epub 2016 Apr 1. PMCID: PMC5998445. Retrieved from:

https://pmc.ncbi.nlm.nih.gov/articles/PMC5998445/#:~:text=TCT%20enables%20a%20specially%20trained,in%20an%20automated%20dispensing%20system.

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Faculty Disclosure

ABSTRACT

CONTENT

Content

Appendices 1-3

Pharmacist Post Test (for viewing only)

Pharmacy Technician Post Test (for viewing only)

References

Full List of References

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Faculty Disclosure

ABSTRACT

CONTENT

Content

Pharmacist Post Test (for viewing only)

Pharmacy Technician Post Test (for viewing only)

References

Full List of References

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Faculty Disclosure

ABSTRACT

CONTENT

Content

Pharmacist and Pharmacy Technician Post Test (for viewing only)

References