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

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.

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

INTRODUCTION

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

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

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

Definitions of “Medication Error”

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

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

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

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

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

Table 1. Definition of Medication Errors

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

Source: Reference 3

Systemic Failures: Avoiding Blame

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

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

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

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

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

QUALITY AND PERFORMANCE IMPROVEMENT APPROACHES

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

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

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

SIDEBAR; What is TALL man Lettering?

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

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

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

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

Source: Reference 11

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

Term	Definition
Tracking	· The ability to assess performance; following the course or trail of someone or something, usually to find them or note their location. In pharmacy, this could include: Product identification and verification, detection of and response to suspicion of illegitimate products Record keeping located in pharmacies, distributers, and providers’ records Patient data sharing to assist with medication reconciliation Recording all variances on unusual incident reports
Trending	· Monitoring the general direction in which something is developing or changing. In pharmacy, monitoring has led to expansion of the pharmacists’ role. Examples include vaccination administration, collaborative practice agreements in certain states, tobacco cessation programs, and point-of-care testing. · A method of estimating future costs of health services by reviewing past trends in cost and utilization of those services.
Root cause analysis	· A full investigation of the causes of unexpected events followed by identification and implementation of appropriate and effective strategies to prevent similar occurrence in the future. · Asking “Why?” until it cannot be answered, often employing a “fishbone diagram” that looks at potential issues with materials, machines, methods, environment, measurements, and people. · It helps pharmacies take a process-driven, system-based approach to address errors.
Workplace re-engineering	· Planned elimination, addition, or distribution of functions or duties in the workplace focused on innovative strategies to develop leaders, engage employees, and foster healthy workplace culture. · Is often influenced by excessive or insufficient labor, poor patient outcomes, or political or economic changes.
Disaster drill or mock code	· An exercise or demonstration that tests the readiness and capacity of a hospital, a community, or other systems to respond to a possible public health emergency or other disaster.

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

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

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

Successful Programs

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

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

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

Table 3. Psychosocial Factors that Influence Work Performance

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

Source: References 6, 22, 23, 24

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

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

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

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

ERRORS: WHAT WE KNOW

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

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

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

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

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

How People Work

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

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

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

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

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

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

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

Self-improvement

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

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

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

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

An example is that of a stalled car stuck on a level crossing as a distant train barrels toward it. The driver starts and restarts the engine, when the best way to save his life is to exit the car and run. In pharmacy, fixation errors occur when the provider concentrates on a single aspect of a case or problem to the detriment of other more relevant aspects. To break out of a fixation, individuals must be able to recognize the demand for a new approach to the problem and to produce a solution that works. Individuals who tend to fixate need to learn to^43,44

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

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

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

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

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

Table 4. Improving Your Own Accuracy

Do this….	And then do this…
Periodically review your errors and near-misses.	Analyze errors to determine if you see a trend like confusing look-alike, sound-alike or spell-alike drugs. Determine if you can take steps to reduce the likelihood of a similar error happening again. Develop and use checklists if errors occur in multi-step processes.
Schedule visual and hearing exams more frequently as you age.	Wear appropriate glasses or hearing aids at work. Ask your employer for assistive devices (supplemental lighting, a magnifier, or a phone amplifier), or secure these yourself.
Solicit feedback from peers and supervisors about ways to reduce your own and others’ errors.	Maintain a quiet, composed demeanor in the workplace.
Address workplace distractions as soon as you become aware of them.	Reduce noise and clutter, improve lighting.
Understand technology’s limitations.	Maintain your skills so that if technology fails, you can revert to the pre-technology work method.
Value relationships with coworkers and promote good organizational dynamics.	Resolve disputes immediately, and retire grudges. Provide feedback to coworkers constructively.
Address developing personal problems (alcohol abuse, marital discord) early.	Engage with your employer’s employee assistance program before your supervisor refers you.
Understand that some people make errors because they lack knowledge.	Address your own knowledge gaps, and promote a culture of learning.
Avoid relying on “workplace re-engineering” or “work task design” to prevent errors; these may fail as the workplace composition and focus changes.	Learn to engage and listen to your “inner pharmacist” or “inner technician” when something is out of the ordinary.

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

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

Reducing Workplace Turbulence

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

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

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

Poka-Yoke

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

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

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

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

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

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

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

CONCLUSION

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

References

Anderson JG, Abrahamson K. Your health care may kill you: medical errors. Building Capacity for Health Informatics in the Future. 234:13-17. DOI 10.3233/978-1-61499-742-9-13. Accessed December 27, 2022. http://ebooks.iospress.nl/publication/46132.
Rogers EE, Griffin E, Carnie W, et al. A just culture approach to managing medication errors. Hosp Pharm. 2017;52(4):308-315.
Aronson, J. (2019). Medication errors: definitions and classification. Accessed December 27, 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2723196/
Grasha AF. Into the abyss: seven principles for identifying the causes of and preventing human erros in complex systems. Am J Health-Syst Pharm. 2000:57:544-564.
Hodgson BB, Kizior RJ. Appendix L. In: Hodgson BB, Kizior RJ, Saunders Nursing Drug Handbook 2013. 1^st edition. St. Louis, Missouri, Saunders/Elsevier; 2012:1290.
Vosper H, Lim R, Knight C, et al. Considering human factors and developing systems- thinking behaviours to ensure patient safety. Clinical Pharmacist. 2018,10:2. Accessed December 27, 2022. https://dspace.lboro.ac.uk/dspace-jspui/bitstream/2134/28474/3/Hignett_Vosper%202018%20ACCEPTED%20%20pharmaceutical-journal.com.pdf
Rosen RK. Medication errors: a 21st-century perspective. Proceedings (Bayl Univ. Med Cent). 2004;17(4):464-467;discussion 467-468.
da Silva BA, Krishnamurthy M. The alarming reality of medication error: a patient case and review of Pennsylvania and National data. J Community Hosp Intern Med Perspect. 2016;6(4):31758.
Quillivan RR, Burlison JD, Browne EK, et al. Patient safety culture and the second victim phenomenon: connecting culture to staff distress in nurses. Jt Comm J Qual Patient Saf. 2016:42(8):377-86.
Rogers, Erin, et al. A Just Culture Approach to Managing Medication Errors. National Center for Biotechnology Information, April 2017. Accessed December 27, 2022. www.ncbi.nlm.nih.gov/pmc/articles/PMC5424837/
Institute for Safe Medication Practices. Look-alike drug names with recommended tall man letters. Accessed December 27, 2022.Available at https://www.ismp.org/recommendations/tall-man-letters-list
“Emergency Preparedness: 3 Steps to Prepare Your Pharmacy.” PBA Health, 12 Mar. 2018, Accessed December 27, 2022. Emergency Preparedness: 3 Steps to Prepare Your Pharmacy (pbahealth.com)
Reorganization. Defined Term. Accessed December 27, 2022. https://definedterm.com/reorganization
Root Cause Analysis Workbook for Community/Ambulatory Pharmacy. Institute For Safe Medication Practices. Accessed December 27, 2022. www.ismp.org/resources/root-cause-analysis-workbook-community-ambulatory
Schwartz, Heidi. Re-Engineering the Workplace For Employee Wellness. January 26, 2015. Facility Executive Magazine. Accessed December 27, 2022. https://facilityexecutive.com/2015/01/employers-will-be-challenged-to-re-engineer-the-workplace-attract-and-retain-people/
“Tracking.” Defined Term. Accessed December 27, 2022. https://definedterm.com/tracking

Benedetto AR. Six Sigma: not for the faint of heart. Radiol Manage. 2003;25(2):40-53.
Rodziewicz TL, Houseman B, Hipskind JE. Medical Error Reduction and Prevention. In: StatPearls. Treasure Island (FL): StatPearls Publishing; December 4, 2022.
“Trending.” Defined Term. Accessed December 27, 2022. https://definedterm.com/trending
Agency for Healthcare Research and Quality. Root cause analysis. Accessed December 27, 2022. https://psnet.ahrq.gov/primers/primer/10/root-cause-analysis
“Lessons We Don't Learn: A Study of the Lessons of Disasters, Why We Repeat Them, and How We Can Learn Them.” January 15, 2015. HOMELAND SECURITY AFFAIRS. Accessed December 27, 2022. www.hsaj.org/articles/167
Sutherland A, Ashcroft DM, Phipps DL. Exploring the human factors of prescribing errors in paediatric intensive care units. Arch Dis Child. 2019;104(6):588-595. doi:10.1136/archdischild-2018-315981
Bhangu A, Bhangu S, Stevenson J, Bowley DM. Lessons for surgeons in the final moments of Air France Flight 447. World J Surg. 2013;37(6):1185-1192.
Croft H, Nesbitt K, Rasiah R, Levett-Jones T, Gilligan C. Safe dispensing in community pharmacies: applying the software, hardware, environment and liveware (SHEL) model. Pharmaceutical J. 2017;9(7): DOI: 10.1211/CP.2017.20202919. Accessed December 27, 2022. https://www.pharmaceutical-journal.com/research/safe-dispensing-in-community-pharmacies-applying-the-software-hardware-environment-and-liveware-shell-model/20202919.article
Grasha AF, Schell K. Psychosocial factors, workload, and human error in a simulated pharmacy dispensing task. Perceptual Motor Skills. 2001;92:53-71.
Grasha AF. Understanding medication errors: a cognitive systems approach. Medscape. May 14, 2001. Accessed December 27, 2022. https://www.medscape.org/viewarticle/418538
Grasha AF, Reilley S, Schell K, Tranum D, Filburn J. A cognitive systems perspective on human performance in the pharmacy: implications for accuracy, effectiveness, and job satisfaction. Cincinnati, Ohio: University of Cincinnati,2000, Cognitive Systems Lab Report 062100-R.
Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. ADE Prevention Study Group. JAMA. 1995;274(1):29-34.
Barry R, Murcko AC, Brubaker CE. The Six Sigma Book for Healthcare. Ann Arbor, MI: Chicago Health Administration Press; 2002:19-43.
Grasha AF. Misconceptions about pharmacy workload. Can Pharmaceut J. 2001;134(4):26-35.
Bhasale AL, Miller GC, Reid SE, Britt HC. Analysing potential harm in Australian general practice: an incident-monitoring study. Med J Aust. 1999;170(6):287-288.
Tudor CL, Papachristou N, Gallagher J, et al. Identifications of priorities for improvement of medication safety in primary care: a PRIORTIZE study. BMC Fam Pract. 2016;17(1):160.
Bogner MS. Misadventures in Healthcare. Mahwah, NJ: Lawrence Erlbaum Associates; 2004:1-186
Ashcraft MH. Human memory and cognition (2^nd ed.). New York: Harper Collins, 1994.
Anderson JR. Learning and memory: An integrated approach. New York: John Wiley & Sons, 1995.
Chui MA, Mott DA. Community pharmacists’ subjective workload and perceived task performance: a human factors approach. J Am Pharm Assoc (2003). 2012;52(6):e153-e160.
Vatansever D, Menon DK, Stamatakis EA. Default mode contributions to automated information processing. PNAS. 2017;114(48):12821-12826.
Gouraud J, Delorme A, Berberian B. Autopilot, mind wandering, and the out of the loop performance problem. Front Neurosci. 2017;11:541.
Casey S. Set Phasers on Stun: And Other True Tales of Design, Technology and Human Error. Santa Barbara, CA: Aegean; 1998.
“Insight,” The Free Dictionary. Accessed December 27, 2022. https://medical-dictionary.thefreedictionary.com/insight
Psychestudy. Insight Learning. Accessed December 27, 2022. https://www.psychestudy.com/behavioral/learning-memory/insight-learning
How to Detect Insight Moments in Problem Solving Experiments. Accessed December 27, 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5854655/
Fioratou E, Flin R, Glavin R. No simple fix for fixation errors: cognitive processes and their clinical applications. Anaesthesia. 2010;65(1):61-69.
Leslie I. How mistakes can save lives: one man’s mission to revolutionise the NHS. June 4, 2014. Accessed December 27, 2022. https://www.newstatesman.com/2014/05/how-mistakes-can-save-lives
Jenkins B. Cognitive aids: time for a change? Anaesthesia. 2014;69:655–668.
Grasha AF. Tools for the reflective practitioner: Using self-monitoring, personal feedback and goal setting to reduce error. Health Notes Qual Assur. 2002;19-24.
Tierney M, McLurg D, Macmillan C. Transferring medication order entry from pharmacists to pharmacy technicians. JCPH. 1999;52(4):240-243.
Lapkin S, Levett-Jones T, Chenoweth L, Johnson M. The effectiveness of interventions designed to reduce medication administration errors: a synthesis of findings from systematic reviews. J Nurs Manag. 2016;24(7):845-858. doi:10.1111/jonm.12390
Castro-Rodríguez C, De Lucas-Volle S, González-Roca I, Diaz-Redondo A, Mora-Capín A, Marañón R. Professionals' Perception of a Strategy to Avoid Interruptions During Medication Handling. J Patient Saf. 2023;19(1):29-35. doi:10.1097/PTS.0000000000001082
Soliman-Junior, J., Tzortzopoulos, P., and Kagioglou, M. 2020. “Exploring Mistakeproofing in Healthcare Design.” In: Tommelein, I.D. and Daniel, E. (eds.). Proc. 28th Annual Conference of the International Group for Lean Construction (IGLC28), Berkeley, California, USA, doi.org/10.24928/2020/0034
Van Scyoc K. Process safety improvement--quality and target zero. J Hazard Mater. 2008;159(1):42-48.
Kumar S, Steinebach M. Eliminating US hospital medical errors. Int J Health Care Qual Assur. 2008;21(5):444-471.
China Manufacturing Consultants. 6 Poka Yoke (mistake proofing) techniques that most factories overlook. Accessed December 22, 2022. http://www.cmc-consultants.com/blog/6-poka-yoke-mistake-proofing-techniques-that-most-factories-overlook

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

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

Recognize and define types and leading causes of treatment/medication refusal

Describe the ethical and legal principles associated with medication refusal, covert medication, and surreptitious prescribing

Determine treatment alternatives for patients with dietary, religious, or other restrictions

Identify and implement key components of a medication refusal protocol

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

Recognize and define types and leading causes of treatment/medication refusal

Describe the ethical and legal principles associated with medication refusal, covert medication, and surreptitious prescribing

Determine treatment alternatives for patients with dietary, religious, or other restrictions

Identify and implement key components of a medication refusal protocol

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

LAW: Getting Soft on “Hard” Drugs?

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

INTRODUCTION

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

--Former Baltimore Mayor Kurt L. Schmoke

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

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

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

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

REGULATION OF CONTROLLED SUBSTANCES

Historical Perspective

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

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

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

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

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

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

The Harrison Act required physicians and pharmacists who prescribed or dispensed “narcotics” to be registered and pay a fee of $1 to $24 per year^11,12 (equivalent to $29 to $700 today). The act mandated special order forms and record keeping whenever narcotic drugs were sold. They could only be provided from packages bearing a government stamp.¹²

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

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

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

Later, the 18^th Amendment of the Constitution and the Volstead Act banned the manufacture, transportation, or sale of alcohol in 1919.^10,15 (By this time, many states had already banned the sale of alcohol.) Prohibition was overturned by the 21^st Amendment in 1933.

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

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

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

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

REGULATION OF RECREATIONAL DRUGS – INTERNATIONAL

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

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

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

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

SIDEBAR: Decriminalization and Legalization

Decriminalization is not the same as legalization.

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

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

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

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

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

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

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

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

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

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

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

U.S. RECREATIONAL DRUG REGULATION

Controlled Substances Act

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

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

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

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

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

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

Scheduling

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

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

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

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

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

DECRIMINALIZATION – STATE AND LOCAL ACTIONS

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

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

Beyond Marijuana

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PROS AND CONS

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

Table 1. Pros and Cons re: Decriminalization of Recreational Drugs^{1,16,54,55,56,57}

Justifications for decriminalization

Justifications for continuing prohibition of recreational drugs

· A sense that the “War on Drugs” is expensive, harmful to society, and not working

· The suggestion that a medical model will be more effective

· Decriminalization will reduce profits for drug traffickers

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

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

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

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

· Risk of endorsing or encouraging risky behaviors

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

· Few non-violent users are actually imprisoned

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

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

· The threat of incarceration is an incentive to seek treatment

· If restrictions are abandoned, other social costs will increase

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

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

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

Where Will This Lead?

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

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

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

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

SUMMARY AND CONCLUDING COMMENTS

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

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

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

Law: Getting Soft on “Hard” Drugs?

Post-test

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

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

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

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

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

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

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

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

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

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

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

Law: Getting Soft on “Hard” Drugs?

Post-test

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

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

References

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

Pet Allergies

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

· Outline the causes of pet allergies in dogs, cats, and other less common species

· Differentiate between allergic sensitization, allergy, and cross sensitivity

· Paraphrase facts that prove that currently, hypoallergenic dogs and cats are a myth

· Compare nonpharmacologic, over the counter, and prescription treatments in terms of dosing, effectiveness, and cost

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

· Outline the causes of pet allergies in dogs, cats, and other less common species

· Differentiate between allergic sensitization, allergy, and cross sensitivity

· Paraphrase facts that prove that currently, hypoallergenic dogs and cats are a myth

· Identify patients whose complaints indicate they may need referral to a pharmacist

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

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

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

Introduction and Epidemiology

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

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

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

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

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

PET ALLERGENS

Allergy Mechanisms

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

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

Characterizing Pet Allergens

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

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

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

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

Table 1. Summary of Characterized Pet Allergens^13-22

Common Name of Animal	Source	Allergen	Family
Dog	Dander, saliva, hair	Can f 1 (major allergen) Can f 2 Can f 4 Can f 6 Can f 3 Can f 5 Can f 7 Can f 8	Lipocalin Lipocalin Lipocalin Lipocalin Albumin Arginine esterase (kallikrein) Epididymal secretory protein E1 or Niemann Pick type C2 protein Cystatin
Cat	Sebaceous, anal, and salivary gland	Fel d 1 (major allergen) Fel d 2 Fel d 4 Fel d 7 Fel d 3 Fel d 5w Fel d 8 Fed d 6w	Uteroglobin Albumin Lipocalin Von Ebner gland protein Cystatin Cat IgA Latherin-like IgM
Horse	Dander, sublingual, submaxillary salivary glands, and urine	Equ c 1 (major allergen) Equ c 2 Equ c 4 Equ c 3 Equ c 6	Lipocalin Lipocalin Latherin Albumin Lysozyme
Chinchilla	Epithelia, saliva, urine	Chi La Chi Lb	Protein kinase inhibitor Lipocalin
Guinea pig	Epithelia, saliva, urine	Cav p 1 (major allergen) Cap p 2 (major allergen) Cap p 3 Cap p 4 Cap p 6	Lipocalin Lipocalin Lipocalin Serum albumin Lipocalin
Gerbil	Epithelial, salvia, urine, sleep bed	Mer un 23kDa Mer un 4	Lipocalin Serum albumin
Siberian hamster	Epithelial, saliva, urine	Phod s 1	Lipocalin
Rat		Rat n 1 (major allergen) Rat n 4 Rat n 7	Lipocalin; alpha-2u-glubulin Serum albumin Immunoglobulin
Mouse		Mus m 1 (major allergen) Mus m 2 Mus m 4 Mus m 7	Lipocalin; urinary prealbumin Unknown Serum albumin Immunoglobulin
Rabbit		Ory c 1 Ory c 2 Ory c 3 Ory c 4	Lipocalin Lipocalin Secretoglobin Lipocalin
Ferret		Mus p 17 Mus p 66	Unknown Serum albumin
Pig	Meat	Sus s 1 Sus s 5 Sus s 6	Serum albumin Lipocalin Serum albumin

Lipocalin Superfamily

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

Serum Albumin Family

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

Secretoglobin Superfamily

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

SIGNS AND SYMPTOMS OF PET ALLERGIES

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

Hypoallergenic Pets

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

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

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

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

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

DIAGNOSIS

Skin Prick Test

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

Serum-specific IgE Test

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

Molecular Diagnosis

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

PET ALLERGY MANAGEMENT

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

Nonpharmacologic Treatment – Avoid & Minimize Allergen Exposure

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

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

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

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

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

But should companion animals be bathed so often?

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

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

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

Pharmacologic Treatment

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

Table 2. Medications to Treat Allergy Symptoms³⁶

Medication	Mechanism of Action	Adverse Effects	Notes
Antihistamines
1^st generation (nonselective, more sedating) * Diphenhydramine, chlorpheniramine, clemastine 2^nd generation (less sedating, less drowsiness): Cetirizine,* desloratadine,* fexofenadine,* levocetirizine,* and loratadine* Azelastine has nasal spray* and eye drop formulation. Epinastine and olopatadine* are formulated as eye drops.	Blocks histamine and its binding to receptors, prevents histamine-caused redness, swelling, itching, and changes in secretions during an allergic response	· Drowsiness · Fatigue · Headache	The 2^nd generation antihistamines are preferred over 1^st generation based on safety and efficacy data.
Corticosteroids
Available as tablets, liquids, nasal spray, topical creams for skin allergies, topical eye drops for conjunctivitis. Some steroids include: beclomethasone, ciclesonide, fluticasone furoate,* mometasone, budesonide,* triamcinolone,* dexamethasone ophthalmic, prednisone, etc.	Anti-inflammatory effect	Short-term use: Weight gain, fluid retention, high blood pressure Long-term use: Growth suppression, diabetes, cataracts of the eye, osteoporosis, muscle weakness Side effects of inhaled steroids: Cough, hoarseness, fungal infection of the mouth	Highly effective for allergies but must be taken regularly. It may take 1 to 2 weeks before the full effect.
Decongestants
Available as nasal sprays, eye drops, liquids, and tablets Some decongestants include: pseudoephedrine,* phenylephrine,* and oxymetazoline* nasal sprays	Shrinks swollen nasal tissues and blood vessels to relieve the symptoms of nasal swelling, congestion, mucus secretion, and redness	· Increased blood pressure · Insomnia · Anxiety, feeling nervous, restlessness	Relieve congestion and are often prescribed with antihistamines for allergies Contraindicated in patients with severe coronary artery disease, severe hypertension, and who concomitantly use monoamine oxidase inhibitors Short-term use only (~5 days). Long-term use can make symptoms worse.
Combination Allergy Drugs
Some combination drugs include: cetirizine/pseudoephedrine,* fexofenadine/ pseudoephedrine,* diphenhydramine/ pseudoephedrine,* loratadine/pseudoephedrine,* pseudoephedrine/triprolidine* for nasal allergies, and naphazoline/pheniramine* for allergic conjunctivitis	Effects from each component	Side effects from each component	Use with caution due to increased risk of adverse effects
Anticholinergic Nasal Spray
Ipratropium bromide nasal spray to control nasal discharge	Antisecretory properties in the nasal mucosa	· Bitterness of the mouth · Dry nose, nosebleeds, or irritation · Dizziness · Headache · Sore throat · Respiratory tract infection	Some patients may feel better right away. For others, it may take 1 to 2 weeks before the medicine helps. It is important for patients to continue use of this medication as instructed.
Mast Cell Stabilizers
Available as eye drops for allergic conjunctivitis and nasal sprays for nasal allergy symptoms Some mast cell stabilizers include cromolyn sodium,* iodoxamide-tromethamine, nedocromil, pemirolast, etc.	Prevents histamine release from mast cells	Throat irritation, coughing, skin rashes For eye drops may cause blurred vision, stinging, and burning	For mild to moderate symptoms Not as effective as steroids
Leukotriene Modifiers
Montelukast*: Indicated for adults and pediatric patients six months or older with perennial allergic rhinitis. May be less effective than loratadine or cetirizine for reducing daytime nasal symptoms	Montelukast binds to leukotriene receptors in the human airway (smooth muscle cells and macrophages), preventing airway edema, smooth muscle contraction, and other respiratory inflammation	· Stomach pain or upset · Headache · Stuffy nose · Cough · Fever · Rash · Irritability	Warn patients to report behavior changes, including suicidal ideation or suicidal behavior Avoid concomitant use of aspirin or NSAIDs in aspirin-sensitive patients
*Indicates over the counter (OTC) medication

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

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

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

Allergy Immunotherapy

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

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

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

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

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

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

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

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

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

What About Cost?

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

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

CONCLUSION

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

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

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

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

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

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

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

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

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

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

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

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

Pet Allergies

Pharmacy Technician Post-test

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

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

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

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

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

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

2021-2022 APPA National Pet Owners Survey. Accessed January 17, 2022. https://www.americanpetproducts.org/press_industrytrends.asp
Ownby D, Johnson C. Recent Understandings of Pet Allergies [version 1; peer review: 2 approved]. F1000Research. 2016;5(108)doi:10.12688/f1000research.7044.1
Perzanowski MS, Rönmark E, Platts-Mills TA, Lundbäck B. Effect of cat and dog ownership on sensitization and development of asthma among preteenage children. Am J Respir Crit Care Med. 2002;166(5):696-702. doi:10.1164/rccm.2201035
Ownby DR, Johnson CC, Peterson EL. Exposure to dogs and cats in the first year of life and risk of allergic sensitization at 6 to 7 years of age. JAMA. 2002;288(8):963-72. doi:10.1001/jama.288.8.963
Díaz-Perales A, González-de-Olano D, Pérez-Gordo M, Pastor-Vargas C. Allergy to uncommon pets: new allergies but the same allergens. Front Immunol. 2013;4:492-492. doi:10.3389/fimmu.2013.00492
Curin M, Hilger C. Allergy to pets and new allergies to uncommon pets. Allergol Select. 2017;1(2):214-221. Published 2017 Aug 4. doi:10.5414/ALX01842E
Villas F, Compes E, Fernández-Nieto M, Muñoz MP, Bartolome B, de las Heras M. Bird-egg syndrome caused by Agapornis species (lovebird). J Investig Allergol Clin Immunol. 2009;19(1):71-2.
Quirce S. Asthma in Alergológica-2005. J Investig Allergol Clin Immunol. 2009;19 Suppl 2:14-20.
Ferret allergies: Are ferrets hypoallergenic animals? Accessed July 12, 2022. https://friendlyferret.com/ferret-hypoallergenic-allergies/
Are rabbits hypoallergenic? All your questions answered. Hypoallergenic Home. Accessed July 12, 2022. https://hypoallergenichomes.com/hypoallergenic-pets/rabbits/
Konradsen JR, Fujisawa T, van Hage M, et al. Allergy to furry animals: New insights, diagnostic approaches, and challenges. J Allergy Clin Immunol. Mar 2015;135(3):616-25. doi:10.1016/j.jaci.2014.08.026
Kang SY, Won HK, Park SY, Lee SM, Lee SP. Prevalence and diagnostic values of laboratory animal allergy among research personnel [published online ahead of print, 2021 Jul 11]. Asian Pac J Allergy Immunol. 2021;10.12932/AP-220321-1094. doi:10.12932/AP-220321-1094
Grönlund H, Saarne T, Gafvelin G, van Hage M. The major cat allergen, Fel d 1, in diagnosis and therapy. Int Arch Allergy Immunol. 2010;151(4):265-74. doi:10.1159/000250435
Fernández-Parra B, Bisson C, Vatini S, Conti A, Cisteró Bahima A. Allergy to chinchilla. J Investig Allergol Clin Immunol. 2009;19(4):332-3.
De las Heras M, Cuesta-Herranz J, Cases B, et al. Occupational asthma caused by gerbil: purification and partial characterization of a new gerbil allergen. Ann Allergy Asthma Immunol. 2010;104(6):540-542.
De las Heras M, Cuesta J, De Miguel J, et al. Occupational rhinitis and asthma caused by gerbil. J Allergy Clin Immunol. 2002;109(1):S326.
Hunskaar S, Fosse RT. Allergy to laboratory mice and rats: a review of the pathophysiology, epidemiology and clinical aspects. Lab Anim. 1990;24(4):358-379.
Sathish JG, Sethu S, Bielsky M-C, et al. Challenges and approaches for the development of safer immunomodulatory biologics. Nat Rev Drug Discov. 2013;12(4):306-324.
Phipatanakul W. Rodent allergens. Curr Allergy Asthma Rep. 2002;2(5):412-416.
Gonzáles de Olano D, Pastor Vargas C, Cases Ortega B, et al. Identification of a novel 17-kDa protein as a ferret allergen. Ann Allergy Asthma Immunol.. 2009;103(2):177-178.
Posthumus J, James HR, Lane CJ, et al. Initial description of pork-cat syndrome in the United States. J Allergy Clin Immunol.. 2013;131(3):923-925.
FDA Allergen Extract Sublingual Tablet. Cited 21 February 2022 Accessed https://www.fda.gov/vaccines-blood-biologics/allergenics/allergen-extract-sublingual-tablets.
Jesner S. (2022, June 28). Sublingual immunotherapy faqs. Sublingual Immunotherapy FAQs. Accessed July 8, 2022. https://www.hopkinsmedicine.org/otolaryngology/specialty_areas/sinus_center/sublingual_immunotherapy.html#:~:text=Immunotherapy%20treats%20the%20cause%20of,as%20drops%20under%20the%20tongue.
Malandain H. IgE antibody in the serum--the main problem is cross-reactivity. Allergy. 2004;59(2):229-230. doi:10.1046/j.1398-9995.2003.00395.x
Nicholas CE, Wegienka GR, Havstad SL, et al. Dog allergen levels in homes with hypoallergenic compared with nonhypoallergenic dogs. Am J Rhinol Allergy. 2011;25(4):252-6. doi: 10.2500/ajra.2011.25.3606
Dance A. The race to deliver the hypoallergenic cat. Nature. 2020;588(7836):S7-S9. doi:10.1038/d41586-020-02779-3
Hypoallergenic cats. Blue Cross. (n.d.). Accessed July 8, 2022. https://www.bluecross.org.uk/advice/cat/hypoallergenic cats#:~:text=Despite%20popular%20belief%2C%20hypoallergenic%20cats,how%20much%20protein%20they%20produce
Skin prick tests. FoodAllergy.org. Accessed August 1, 2022. Skin Prick Tests - FoodAllergy.org
de Vos G. Skin testing versus serum-specific IgE testing: which is better for diagnosing aeroallergen sensitization and predicting clinical allergy?. Curr Allergy Asthma Rep. 2014;14(5):430. doi:10.1007/s11882-014-0430-z
Hodson T, Custovic A, Simpson A, Chapman M, Woodcock A, Green R. Washing the dog reduces dog allergen levels, but the dog needs to be washed twice a week. J Allergy Clin Immunol. Apr 1999;103(4):581-5. doi:10.1016/s0091-6749(99)70227-7
Latz K. How Often Should You Bathe Your Dog? Accessed July 13, 2022. https://www.akc.org/expert-advice/health/how-often-should-you-wash-your-dog/
Aalberse RC. Mammalian airborne allergens. Chem Immunol Allergy. 2014;100:243-247. doi:10.1159/000358862
Wood RA, Johnson EF, Van Natta ML, Chen PH, Eggleston PA. A placebo-controlled trial of a HEPA air cleaner in the treatment of cat allergy. Am J Respir Crit Care Med. 1998;158(1):115-120. doi:10.1164/ajrccm.158.1.9712110
Discover ProPlan LiveClear Allergen Reducing Cat Food. Purina. Accessed July 12, 2022. https://www.purina.com/pro-plan/cats/liveclear-cat-allergen-reducing-food
Scolaro KL. Chapter 11: Colds and Allergy. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 20th Edition.
Product Information: SINGULAIR(R) oral tablets, oral chewable tablets, oral granules, montelukast sodium oral tablets, oral chewable tablets, oral granules. Merck & Co (Per FDA); 2012.
Clark J, White ND. Immunotherapy for Cat Allergies: A Potential Strategy to Scratch Back. Am J Lifestyle Med. 2017;11(4):310-313. doi:10.1177/1559827617701389
Allergenics. U.S. Food and Drug Administration. Accessed July 29, 2022. https://www.fda.gov/vaccines-blood-biologics/allergenics
Sublingual Immunotherapy. Johns Hopkins Medicine. Accessed July 13, 2022. https://www.hopkinsmedicine.org/otolaryngology/specialty_areas/sinus_center/sublingual_immunotherapy.html#:~:text=Immunotherapy%20treats%20the%20cause%20of,as%20drops%20under%20the%20tongue.
Abramson MJ, Puy RM, Weiner JM. Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2010;(8):Cd001186. doi:10.1002/14651858.CD001186.pub2
Aasbjerg K, Torp-Pedersen C, Backer V. Specific immunotherapy can greatly reduce the need for systemic steroids in allergic rhinitis. Allergy. 2012;67(11):1423-9. doi:10.1111/all.12023
Ling M, Long AA. Pet dander and difficult-to-control asthma: therapeutic options. Allergy Asthma Proc. 2010;31:385-391.
Cox L, Nelson H, Lockey R, et al. Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol. 2011;127(1 Suppl):S1-55. doi:10.1016/j.jaci.2010.09.034
Goodman MJ, Jhaveri M, Saverno K, Meyer K, Nightengale B. Cost-effectiveness of second-generation antihistamines and montelukast in relieving allergic rhinitis nasal symptoms. Am Health Drug Benefits. 2008;1(8):26-34.
Aboshady OA, Elghanam KM. Sublingual immunotherapy in allergic rhinitis: efficacy, safety, adherence and guidelines. Clin Exp Otorhinolaryngol. 2014 Dec;7(4):241-9. doi: 10.3342/ceo.2014.7.4.241.
Hardin FM, Eskander PN, Franzese C. Cost-effective Analysis of Subcutaneous vs Sublingual Immunotherapy From the Payor's Perspective. OTO Open. 2021 Oct 25;5(4):2473974X211052955. doi: 10.1177/2473974X211052955.

Human Trafficking: Pharmacy’s Impact on Care

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

Review the history and current laws of human trafficking in the United States

Recognize common terms, warning signs, and/or vulnerabilities for human trafficking in pharmacy patients/customers

Describe pharmacists’ impact on identifying and supporting victims and survivors of human trafficking

Ensure proper referral, treatment, and counseling for common health risks associated with human trafficking

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

Review the history and current laws of human trafficking in the United States

Recognize common terms, warning signs, and/or vulnerabilities for human trafficking in pharmacy patients/customers

Identify signs/signals of human trafficking red flags to notify pharmacists or law enforcement

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

Introduction

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

SIDEBAR. Human Trafficking Definitions^1,2

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

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

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

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

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

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

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

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

SIDEBAR. The Polaris Project

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

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

Web site: https://humantraffickinghotline.org/en in English
Web site: https://humantraffickinghotline.org/es in Spanish
1-888-373-7888
TTY: 711
Text* 233733

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

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

Traffickers use various tactics to manipulate victims, including¹⁴

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

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

SIDEBAR. Types of Human Trafficking^15,^17,18

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

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

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

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

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

History of Human Trafficking in the United States

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

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

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

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

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

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

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

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

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

Healthcare Providers & Human Trafficking

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

The Pharmacy Team in Action

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

For safety and reporting, pharmacy team members should generally trust their instincts in a suspicious situation, especially when patients^2,31,32

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

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

Table 1. OTC Products Frequently Used or Misused for Self-Treatment of Trafficking-Associated Medical Concerns^34,35

Health Concern	OTC Products
Mental health and substance abuse	St. John’s Wort Dextromethorphan Diphenhydramine Pseudoephedrine Phenylephrine
Sexual intercourse or urinary tract infection	Condoms Levonorgestrel (Plan B) Miconazole Pregnancy tests Phenazopyridine Genital anti-itch creams
Physical abuse	Painkillers (i.e. acetaminophen, ibuprofen, aspirin) First aid items (i.e., bandages, gauzes, antiseptics, Neosporin)

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

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

Avoiding Bias + Using the Correct Language

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

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

Table 2. Common Human Trafficking Myths vs Reality^1,36

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

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

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

HEALTH CONSEQUENCES FOR VICTIMS

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

Mental Health and Addiction

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

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

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

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

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

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

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

Unprotected Sexual Intercourse

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

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

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

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

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

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

Physical Abuse

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

Acting on Human Trafficking

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

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

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

Table 3. Example Screening Tool for Suspicion of Human Trafficking^2,14,17

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

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

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

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

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

Conclusion

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

PHARMACIST POSTTEST

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

REFERENCES

References

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

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

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

Discuss the prevalence of HIV/AIDS in humans and associated stigma in the adolescent and young adult population

Identify risk factors for HIV infection in adolescent and young adults

Review pre-/post-exposure prophylaxis methods for HIV prevention in the adolescent/young adult population

Maximize the pharmacists’ role in HIV prevention in the adolescent/young adult population

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

Recall the prevalence of HIV/AIDS in humans and associated stigma in the adolescent and young adult population

List high-risk activities for HIV exposure

Describe available patient assistance programs & cost assistance programs for pre- and post-exposure HIV prophylaxis

Identify antiretrovirals used for pre-/post-exposure HIV prophylaxis in the adolescent and young adult population

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

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

INTRODUCTION

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

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

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

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

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

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

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

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

PRE-EXPOSURE PROPHYLAXIS

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

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

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

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

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

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

Oral PrEP Regimens

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

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

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

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

Table 1. Adverse Effects Associated with Available Oral PrEP Medications^9,10,13

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

Injectable PrEP

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

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

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

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

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

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

Tech Talk: Helping Patients Afford PEP and PrEP^17-21

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

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

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

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

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

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

POST-EXPOSURE PROPHYLAXIS

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

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

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

Table 2. HIV PEP Recommendations Based on Renal Function^{25, 26, 27}

Adolescents and young adults aged ≥ 13 years with:

Medication

Normal renal function

(CrCl ≥ 60 mL/min)

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

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

Renal dysfunction

(CrCl ≤ 59 mL/min)

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

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

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

and

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

≥25 kg:

CrCl ≥50 mL/minute: No adjustment necessary.

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

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

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

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

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

with

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

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

CrCl, creatinine clearance; DF, disoproxil fumarate

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

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

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

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

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

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

Table 3. HIV PEP Required Laboratory Monitoring²⁸

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

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

HIV-RELATED STIGMA

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

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

Stigma Language Guide: addresses how to talk about HIV in a way that can help empower those living with the condition (https://www.cdc.gov/stophivtogether/library/stop-hiv-stigma/fact-sheets/cdc-lsht-stigma-factsheet-language-guide.pdf)
Stigma Scenarios: Support in Action: provides examples of situations showing HIV stigma and ways to take action (https://www.cdc.gov/stophivtogether/hiv-stigma/stigma-scenarios.html)

CONCLUSION

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

PHARMACIST POSTTEST

Pharmacist Posttest:

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

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

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

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

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

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

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

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

PHARMACY TECHNICIAN POSTTEST

Pharmacy Technician Posttest:

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

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

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

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

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

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

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

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

REFERENCES

References:

Centers for Disease Control and Prevention. About HIV. Updated June 30, 2022. Accessed September 14, 2022. https://www.cdc.gov/hiv/basics/whatishiv.html
Zhou, Mo, et al. Pre-exposure prophylaxis (PrEP) prescriptions among individuals at high risk for HIV in the United States, 2012-2018. IDWeek 2021; September 29-October 3, 2021. . Accessed October 18, 2022. Available at 1799149-1632773807.pdf (rackcdn.com)
Hosek S, Henry-Reid L. PrEP and adolescents: The role of providers in ending the AIDS epidemic. Pediatrics. 2020;145(1):e20191743. doi:10.1542/peds.2019-1743
Impact on Racial and Ethnic Minorities. HIV.gov Web site. https://www.hiv.gov/hiv-basics/overview/data-and-trends/impact-on-racial-and-ethnic-minorities.Accessed October 18, 2022
Szucs LE, Lowry R, Fasula AM, et al. Condom and contraceptive use among sexually active high school students - Youth risk behavior survey, United States, 2019. MMWR Suppl. 2020;69(1):11-18. doi:10.15585/mmwr.su6901a2.
Martinez GM, Abma JC. Sexual Activity, Contraceptive Use, and Childbearing of Teenagers Aged 15-19 in the United States. NCHS Data Brief. 2015;(209):1-8.
Centers for Disease Control and Prevention. Pre-exposure prophylaxis (PrEP). Updated July 5, 2022. Accessed September 14, 2022. https://www.cdc.gov/hiv/clinicians/prevention/prep.html
Pre-Exposure Prophylaxis. HIV.gov. Updated January 7, 2022. Accessed April 2, 2022. https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis
Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States—2021 update: A clinical practice guideline. March 2018. Accessed March 2, 2022. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf
Truvada [prescribing information]. Gilead Sciences; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf
Hosek SG, Landovitz RJ, Kapogiannis B, et al. Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men aged 15 to 17 years in the United States. JAMA Pediatrics. 2017;171(11):1063-1071. doi:10.1001/jamapediatrics.2017.2007
U.S. Food and Drug Administration. FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic. October 3, 2019. Accessed March 2, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic

Descovy [prescribing information]. Gilead; 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf
Havens PL, Stephensen CB, Van Loan MD, et al. Decline in bone mass with tenofovir disoproxil fumarate/emtricitabine is associated with hormonal changes in the absence of renal impairment when used by HIV-uninfected adolescent boys and young men for HIV preexposure prophylaxis. Clin Infect Dis. 2017;64(3):317-325. doi:10.1093/cid/ciw765
Apretude [prescribing information]. ViiV Healthcare; 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215499s000lbl.pdf
Velloza J, Kapogiannis B, Bekker LG, et al. Interventions to improve daily medication use among adolescents and young adults: what can we learn for youth pre-exposure prophylaxis services?. AIDS. 2021;35(3):463-475. doi:10.1097/QAD.0000000000002777
Centers for Disease Control and Prevention. Paying for PrEP. Updated June 6, 2022. Accessed September 14 ,2022. https://www.cdc.gov/hiv/basics/prep/paying-for-prep/index.html
New York State Department of Health. Payment options for post-exposure prophylaxis following non-occupational exposures including sexual assault (nPEP). May 2013. Accessed April 1, 2022. https://www.health.ny.gov/diseases/aids/providers/standards/docs/payment_options_npep.pdf
New York State Department of Health. Payment options for adults and adolescents for post exposure prophylaxis (PEP) following sexual assault. October 2021. Accessed April 25, 2022. https://www.health.ny.gov/diseases/aids/general/pep/docs/sexual_assault.pdf
Centers for Disease Control and Prevention. Paying for PEP. Updated July 13, 2022. Accessed February 24, 2022. https://www.cdc.gov/hiv/basics/pep/paying-for-pep.html
NASTAD. Pharmaceutical Company Patient assistance programs and cost-sharing assistance programs for pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). May 2021. Accessed February 23, 2022. https://nastad.org/sites/default/files/2021-11/PDF-PrEP-PEP-Pharma-Co-Patient-Assistance.pdf
DeHaan E. Post-exposure prophylaxis (PEP) to prevent HIV infection. National Center for Biotechnology Information. Published June 2020. Accessed April 14, 2022. https://www.ncbi.nlm.nih.gov/books/NBK562734/
Leonard J. HIV symptoms timeline: Stages, preventing progression, and outlook. Medical News Today. Updated November 22, 2020. Accessed March 15, 2022. https://www.medicalnewstoday.com/articles/316056
Post-exposure prophylaxis. HIV.gov. Updated April 28, 2021. Accessed February 14, 2022. https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/post-exposure-prophylaxis
CATIE. Post-exposure prophylaxis (PEP). 2019. Accessed March 15, 2022. https://www.catie.ca/fact-sheets/prevention/post-exposure-prophylaxis-pep
26. Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007, p 82.
Epivir (lamivudine) [prescribing information]. Shire Pharmaceuticals Group plc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf
Centers for Disease Control and Prevention. Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV—United States, 2016. Accessed March 13, 2022. https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf

Stop the Bite: Uncover the Answers to Malaria and Dengue Fever

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

RECALL symptoms associated with dengue fever and malaria
DESCRIBE emerging information about dengue and malaria vaccines
ASSOCIATE dengue fever and malaria vaccines for specific patients

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

RECALL symptoms associated with dengue fever and malaria
DESCRIBE emerging information about dengue and malaria vaccines
MATCH  dengue fever and malaria vaccines by storage requirements

Malaria and dengue (pronounced deng-ee) fever are not new diseases, but given the emergence of new vaccines, it is critical that pharmacists and pharmacy technicians increase their familiarity with them. These illnesses are both transmitted by mosquitos, but malaria is caused by Plasmodium parasites while dengue fever is a viral disease caused by dengue virus. The United States is not a malaria- or dengue-endemic country, but travel to other countries puts people at risk of these conditions. Pharmacy teams should be prepared to identify potential cases and refer patients for appropriate vaccination or treatment when appropriate.

INTRODUCTION

Malaria cases in 2020 totaled an estimated 241 million, leading to more than 600,000 deaths, mostly in Africa.¹ Direct costs of malaria prevention and treatment in the United States (U.S.) total about $12 billion annually, excluding the toll it takes on affected individuals and their families.¹ The World Health Organization (WHO) reports that between 100 to 400 million people are infected with dengue fever each year.² About 80% of cases are mild and asymptomatic, but dengue fever can progress to “severe dengue,” which is classified as a medical emergency requiring immediate medical care.^2,3

Mosquitos, Malaria, and Dengue – Oh My!

Plasmodium parasites—common to tropical areas (e.g., Africa, South America, the Caribbean Islands, South Asia)—cause malaria.¹ Most commonly, malaria is transmitted through the bite of infected mosquitoes, specifically the Anopheles species, during local outbreaks. There is also a term coined “airport malaria,” describing disease that is transported from an infected country to a non-infected country.⁴ Congenital malaria occurs when mothers infected with the disease transmit parasites to the child during pregnancy or birth.⁴ Although rare, prompt diagnosis is crucial to ensure infected neonates and infants survive. Transfusion-transmitted malaria is also possible where blood recipients can be infected with malaria accidently. There are no approved tests to screen blood donations for malaria, only questioning of prospective donors.⁴ Although rare in the U.S., complications are severe and organizations should take action to prevent potentially-infected individuals from donating.

Patients with malaria generally present with fever, chills/sweating, headache, and weakness within 10 to 15 days of infection.⁵ Diarrhea, abdominal pain, and cough are also possible. As malaria progresses, patients develop a classic paroxysm (i.e., symptoms that come and go) comprising three stages⁶:

15-to-60-minute cold stage (shivering and feeling cold)
2-to-6-hour hot stage (fevers up to nearly 106°F; flushed, dry skin; and often headache, nausea, and vomiting)
2-to-4-hour sweating stage (rapid drop in fever and sweating)

Missed or delayed malaria diagnosis can lead to potentially fatal complicated disease manifesting as severe anemia, renal failure, altered consciousness, and multisystem organ failure.⁶ Clinicians diagnose malaria via a blood smear test. Although rapid and polymerase chain reaction (PCR) tests are available, medical professionals confirm diagnosis through microscopic blood smear examination.⁷

Dengue fever is a viral disease caused by mosquitos—mainly females from the Aedes aegypti and Ae. albopictus species—carrying dengue virus (also known as DENV).² Four DENV serotypes exist, so it is possible to contract the disease four times. The virus can be transmitted through mosquito bite, from pregnant mother to child, and via infected blood products/organ donations and infusions. Transovarial transmission within mosquitoes (from parent to offspring) has also been noted.²

Most dengue cases are asymptomatic or mild and fatalities are rare, but increasing severity can be life-threatening.^2,3 Providers should suspect dengue when a high fever (104°F or greater) is accompanied by any two of the following symptoms^2,3:

severe headache
pain behind the eyes
muscle/joint/bone pain
nausea/vomiting
swollen glands
rash

This febrile phase lasts about 2 to 7 days, and most people recover after about a week.^2,3 Severe dengue is a potentially fatal complication due to plasma leakage, fluid accumulation, respiratory distress, severe bleeding, or organ impairment.² Patients are at risk of severe dengue symptoms about 3 to 7 days after initial symptoms appear.² As fever drops to below 100°F, patients enter a “critical phase” for 24 to 48 hours. Warning signs to watch for during the critical phase include²

severe abdominal pain
rapid breathing
blood in vomit, stool, gums, or nose
persistent vomiting
restlessness/fatigue

Clinicians use commercially available PCR or rapid diagnostic tests to confirm dengue diagnosis.² Enzyme-linked immunosorbent assays are also available to confirm active or previous infections.

Global Implications

Beyond clinical symptoms, malaria and dengue fever inflict social and financial loss for diagnosed individuals and the countries tasked with treating affected populations. Some examples of the indirect burden of these mosquito-borne diseases include¹

expenses for traveling and receiving treatment
absences from work/school
burial expenses in cases of death
purchases of medication and supplies
public health interventions (e.g., insecticide spraying, bed nets)
opportunity loss for tourism

Populations at increased risk of contracting malaria include infants, children younger than 5 years, pregnant women, immunosuppressed patients, and migrant workers or traveling populations.⁵ There is also concern that certain mosquitoes are resistant to insecticide, and by migrating throughout the world they can spread malaria to urban populations.⁸ Researchers have identified Anopheles gambiae mosquitoes, originally found in India and Iran, as insecticide-resistant. These are projected to put nearly 126 million people in African cities at risk for contracting malaria.⁸

Populations most vulnerable to contracting dengue fever include pregnant women and children.³ Many asymptomatic or mild dengue cases go unreported. WHO reports most of the dengue burden occurs in Asia, and the number of cases has steadily increased to just over 5 million in 2019.²

PREVENTION AND TREATMENT

Following prevention and treatment guidelines are crucial to lower transmission rates of dengue fever and malaria.

Dengue Fever

WHO states that countries should be aware of community mosquito presence and develop active mosquito and virus surveillance to prevent further disease spread.² They should also remain knowledgeable about the number of infected individuals.

The dengue vaccine (Dengvaxia) has been licensed in other countries since 2015, but the U.S. Food and Drug Administration (FDA) approved the vaccine in 2019.² WHO recommends people aged 9 to 45 years be vaccinated, but Dengvaxia is only FDA approved for patients 9 to 16 years old with a history of previous infection who live in high-risk areas. As a live-attenuated vaccine, it is contraindicated in individuals with severe immunodeficiency.² Children receiving Dengvaxia need a 3-dose series administered subcutaneously with doses separated by 6 months.⁹ Providers should store the vaccine in the refrigerator.¹⁰ After reconstitution, it should be administered immediately or stored in the refrigerator and used within thirty minutes.

WHO and the FDA only recommend Dengvaxia for patients with a history of dengue virus infection.^10,11 This is based on clinical trial evidence that the vaccine is efficacious and safe in patients with a history of previous DENV infection because a subsequent infection is more serious and life-threatening than the first.¹¹ They also advise countries using the vaccine to control viral spread to implement pre-vaccination screening to confirm previous infection.

As no dengue-specific treatment is available, providers should treat infected patients symptomatically with acetaminophen, rest, and fluids.² Patients with dengue fever should avoid non-steroidal anti-inflammatory drugs (e.g., ibuprofen, aspirin) because they thin the blood. Given the risk of hemorrhage in this disease, blood thinners may exacerbate the problem.²

Malaria

WHO recommends that countries engage in vector control and surveillance for the spread of malarial disease.⁵ Malaria vaccines have been in development for decades, but no malaria vaccine is available in the U.S.¹² In 2021, however, WHO recommended a new malaria vaccine (Mosquirix) for children aged older than 5 months who live in areas with moderate to high transmission of P. falciparum.¹³ The vaccine is only recommended for children as malaria is one of the main killers of children younger than 5 years in countries with moderate or high rates of malaria.¹⁴ WHO also recommends giving the vaccine seasonally in countries where malaria transmission is high during certain seasons.¹³

Initial Mosquirix pilot studies are ongoing, and more widespread vaccine rollout is expected in 2023. For now, people in the U.S. traveling to malaria-endemic countries continue to use oral medications as chemoprophylaxis (i.e., to prevent the disease), including atovaquone/proguanil, chloroquine, doxycycline, mefloquine, primaquine, and tafenoquine.¹⁵

Clinicians administer Mosquirix as a 4-dose schedule.¹⁶ The vaccine’s adverse effects are pain and swelling at the injection site and fever.¹⁷ Providers should store the vaccine in the refrigerator. After reconstitution it should be administered immediately or stored in the refrigerator and used within 6 hours.¹⁶

Malaria treatment involves the use of antimalarial drugs based on four main factors¹⁵:

Infection severity: Malaria infection is either considered uncomplicated (effectively treated with oral antimalarials) or severe (requiring aggressive intravenous antimalarial therapy).
Infecting Plasmodium species: P. falciparum and P. knowlesi infections can cause rapidly progressive severe illness or death, necessitating urgent therapy initiation, while other species are less likely to cause severe disease. P. vivax and P. ovale infections also require treatment for hypnozoites (parasites that lay dormant in the liver and then re-awaken to become active infectants).
Drug susceptibility: In addition to disease severity differences, Plasmodium species also have different drug susceptibilities, so providers select an antimalarial therapy based on the species of the infecting parasite. If the species cannot be determined, patients must initiate antimalarial treatment against chloroquine-resistant P. falciparum as soon as possible.
Previous antimalarial use: Patients using antimalarial medication as chemoprophylaxis, should not receive that same drug or drug combination to treat malaria infection unless no other options are available.

CONCLUSION

Pharmacists and pharmacy technicians should be familiar with the signs and symptoms of malaria and dengue fever to inform patients when these conditions are suspected and about their appropriate treatment. Pharmacy teams who suspect a case of malaria or dengue fever should refer patients for medical attention and contact their local or state health department.

PHARMACIST POSTTEST

Learning Objectives
● RECALL symptoms associated with dengue fever and malaria
● DESCRIBE emerging information about dengue and malaria vaccines
● OPTIMIZE dengue fever and malaria vaccines for specific patients

1. Which of the following is TRUE?
A. Dengue fever symptoms are always severe and most patients die
B. Malaria presents as a cold stage, hot stage, and sweating stage
C. Pain behind the eyes is a warning sign for malaria

2. Which of the following is TRUE regarding the malaria vaccine?
A. WHO recommends it for children 5 months and older who live in endemic areas
B. It is FDA approved for patients 9 to 16 years old with a history of previous infection
C. Clinicians administer it as a 3-dose series with each dose separated by 6 months

3. A patient comes to the pharmacy indicating she and her family are being transferred to a country where dengue is common. She wants to have her three children who are ages 3, 5, and 7 vaccinated for dengue before they move. What is the BEST thing to tell her?
A. We should schedule your children to be vaccinated about six weeks before you plan to move so they develop antibodies before you actually relocate.
B. We only vaccinate children who have already had dengue because a second infections is more serious and life-threatening than the first.
C. Wait until you arrive in the country because they will want to do pre-vaccination screening to confirm your children have not been infected previously.

PHARMACY TECHNICIAN POSTTEST

Learning Objectives
● RECALL symptoms associated with dengue fever and malaria
● DESCRIBE emerging information about dengue and malaria vaccines
● CLASSIFY dengue fever and malaria vaccines by storage requirements

3. A patient at your pharmacy is receiving the dengue fever vaccine. The patient’s mother asks you if they can use the restroom before the pharmacist administers the vaccine. You look over to see that the pharmacist has just finished reconstituting Dengvaxia for this patient. Which of the following is the BEST response?
A. Advise the mother not to leave the pharmacy waiting area, as the pharmacist needs to administer this vaccine immediately or it will expire
B. Advise the mother to take her daughter to the restroom, and the pharmacist can administer this vaccine within 6 hours as long as it’s refrigerated
C. Advise the mother to take her daughter to the restroom but return within 30 minutes, and ensure the pharmacist refrigerates the reconstituted vaccine

REFERENCES

Centers for Disease Control and Prevention. Malaria’s Impact Worldwide. Updated December 16, 2021. Accessed November 30, 2022. https://www.cdc.gov/malaria/malaria_worldwide/impact.html
World Health Organization. Dengue and severe dengue. Updated January 10, 2022. Accessed November 1, 2022. https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue
Centers for Disease Control and Prevention. Dengue. Updated August 3, 2022. Accessed November 1, 2022. https://www.cdc.gov/dengue/index.html
Centers for Disease Control and Prevention. Parasites – Malaria. Updated August 19, 2022. Accessed November 1, 2022. https://www.cdc.gov/parasites/malaria/index.html
World Health Organization. Malaria. Updated July 26, 2022. Accessed November 1, 2022. https://www.who.int/news-room/fact-sheets/detail/malaria
Crutcher JM, Hoffman SL. Chapter 83: Malaria. In: Baron S, ed. Medical Microbiology. 4^th ed. University of Texas Medical Branch at Galveston; 1996. Accessed November 1, 2022. https://www.ncbi.nlm.nih.gov/books/NBK8584/
Stanford Health Care. Malaria diagnosis. Accessed November 1, 2022. https://stanfordhealthcare.org/medical-conditions/primary-care/malaria/diagnosis.html
American Society of Tropical Medicine and Hygiene. Invasive mosquitos – Anopheles stephensi in Ethiopia. November 1, 2022. Accessed November 30, 2022. https://astmhpressroom.wordpress.com/annual-meeting-2022/anopheles-stephensi-in-ethiopia/
Centers for Disease Control and Prevention. Dengue Vaccine VIS. Updated December 17, 2021. Accessed November 29, 2022. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/dengue.html
Dengvaxia [prescribing information]. Sanofi Pasteur; 2019.
Ask the Experts: Dengue. Immunize.org. Updated February 16, 2022. Accessed November 21, 2022. https://www.immunize.org/askexperts/experts_dengue.asp
Centers for Disease Control and Prevention. Malaria: Vaccines. Updated October 7, 2021. Accessed December 2, 2022. https://www.cdc.gov/malaria/malaria_worldwide/reduction/vaccine.html
Q&A on RTS,S malaria vaccine. World Health Organization. Updated April 21, 2022. Accessed November 30, 2022. https://www.who.int/news-room/questions-and-answers/item/q-a-on-rts-s-malaria-vaccine
UNICEF. Millions more children to benefit from malaria vaccine as UNICEF secures supply. August 16, 2022. Accessed November 22, 2022. https://www.unicef.org/press-releases/millions-more-children-benefit-malaria-vaccine-unicef-secures-supply
Centers for Disease Control and Prevention. Treatment of Malaria: Guidelines for Clinicians (United States). Updated September 30, 2022. Accessed November 30, 2022 https://www.cdc.gov/malaria/diagnosis_treatment/clinicians1.html
Mosquirix (Product Information). European Medicines Agency. Updated January 8, 2022. Accessed November 30, 2022. https://www.ema.europa.eu/en/documents/outside-eu-product-information/mosquirix-product-information_en.pdf
World Health Organization. Malaria: The malaria vaccine implementation programme (MVIP). March 2, 2020. Accessed November 30, 2022. https://www.who.int/news-room/questions-and-answers/item/malaria-vaccine-implementation-programme

Over the Counter Hearing Aids: Breaking Sound Barriers in Community Pharmacy-RECORDED WEBINAR

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Pharmacists and Pharmacy Technicians are eligible to participate in this knowledge-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs) for completing the activity ACPE UAN 0009-0000-22-060-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

Post Test

1.Which of the following symptoms is indicative of mild to moderate hearing loss

Recent treatment for an ear infection
Difficulty maintaining conversation in quiet environments
Watching TV with subtitles on

M.M., a 75-year-old female, arrives at the pharmacy to pick up her celecoxib prescription (which she takes for arthritis) and to return the ITC-style OTC hearing aids she purchased two weeks ago. When you ask why she's returning the hearing devices, she expresses that she "doesn't need them" as much as she thought, then adds "they feel ok when they're in, but I'm nervous that like they're going to just pop out of my head." Which alternative style of OTC hearing aid might better address M.M.'s needs and priorities?

Completely-in-Canal
Behind-the-Ear
Personal Sound Amplification Product

3.D.J. is a regular patient at your pharmacy; today he's joined by his niece. You know that he has difficulty hearing, especially in the busy pharmacy, and make a mental note to remove your mask and speak slowly while you're talking to him. As D.J. and his niece wait for his prescription to be filled, D.J.'s niece points out the OTC hearing aid display by the counter and suggests that "something like that would be perfect for you!" D.J. remarks that he "isn't some bionic action figure and can hear just fine." What is D.J.'s greatest barrier to accessing OTC hearing aids?

Severe hearing loss
No perceived need
Accessibility

Which medication is most likely to cause hearing loss?
Gentamycin
Hydrochlorothiazide
Ibuprofen
Methotrexate

C.S. is a 72-year-old female with moderate hearing loss. Her past medical history also includes diabetes and recent total knee replacement surgery. After her knee replacement, she moved into assisted living and “is excited to meet more of my neighbors and maybe even sign up for a pottery class.” C.S. noticed that OTC hearing aids are available at her local pharmacy and believes that they could help her be more involved in her new community. Which of the following patient-specific characteristics will influence the outcomes of OTC hearing aid use?

Limited mobility
Age
Self-efficacy

Individuals with untreated hearing loss are more likely to experience which of the following?
Social isolation
Improved cognition
Reversible hearing loss

Pharmacists are expected to play a new and important role as healthcare providers as hearing aids hit the shelves of community pharmacies. Which of the following best describes how pharmacists will participate in OTC hearing aid provision?

Diagnose underlying causes of hearing loss
Administer hearing tests to interested individuals
Employ effective communication strategies

Immunization: Is Winter Here? – An Update on Monkey Pox and Covid Vaccines-RECORDED WEBINAR

Upon completion of this application based CE Activity, a pharmacist will be able to:

1. Discuss trends in the epidemiology of the COVID-19 pandemic and Monkeypox outbreak.

2. Discuss current clinical data on the safety and effectiveness of (i) the bivalent COVID-19 booster vaccines and (ii) the JYNNEOS or ACAM2000 vaccines for Monkeypox.

3. Explain whether a person would be eligible for receipt of (i) the bivalent COVID-19 booster vaccines and/or (ii) the JYNNEOS or ACAM2000 vaccines for Monkeypox.

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs) for completing the activity ACPE UAN 0009-0000-22-059-H06-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

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

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

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

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

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

First-Line Medication Therapy for Type 2 Diabetes: Time for a Change? -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 up to 1.0 CE Hours (or 0.1 CEUs) for completing the activity ACPE UAN 0009-0000-22-058-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

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

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

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

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

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

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

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

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 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 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 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

Introduction

SIDEBAR. Types of Human Trafficking15,17,18

History of Human Trafficking in the United States

Healthcare Providers & Human Trafficking

The Pharmacy Team in Action

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

Avoiding Bias + Using the Correct Language

Table 2. Common Human Trafficking Myths vs Reality1,36

HEALTH CONSEQUENCES FOR VICTIMS

Acting on Human Trafficking

Conclusion

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 Post Test (for viewing only)

SIDEBAR. Types of Human Trafficking^15,^17,18

For safety and reporting, pharmacy team members should generally trust their instincts in a suspicious situation, especially when patients^2,31,32

Table 2. Common Human Trafficking Myths vs Reality^1,36