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.⁴ A 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. ²⁶ Later studies also confirm that poor leadership and insufficient support can adversely influence accuracy.²²

 

ERRORS: WHAT WE KNOW

 

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

 

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

 

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

 

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

 

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

 

How People Work

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

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

 

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

 

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

 

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

 

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

 

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

 

Self-improvement

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

 

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

 

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

 

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

 

An example is that of a stalled car stuck on a level crossing as a distant train barrels toward it. The driver starts and restarts the engine, when the best way to save his life is to exit the car and run. In pharmacy, fixation errors occur when the provider concentrates on a single aspect of a case or problem to the detriment of other more relevant aspects. To break out of a fixation, individuals must be able to recognize the demand for a new approach to the problem and to produce a solution that works. Individuals who tend to fixate need to learn 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.⁴ As we analyze errors, we must include what we’ve learned in the past, but be open to fresh approaches and ideas.

 

Table 4. Improving Your Own Accuracy

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

 

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

 

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

 

 

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.

 

 

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Introduction

 

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

 

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

 

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

 

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

 

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

 

 

 

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

 

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

 

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

 

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

 

One section of the program assesses dietary supplement use among adults. Results from the 2017-2018 NHANES show that^11,12

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

 

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

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

 

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

 

Table 1. Common Dietary Supplements and Potential Uses^7,17,18

 

Dietary Supplement	Potential Use
Black Cohosh	Menopausal symptoms
Calcium	Dyspepsia Osteoporosis Premenstrual syndrome
Echinacea	Prevention and treatment of the common cold Promotion of wound healing
Elderberry	Prevention of upper respiratory tract infections Reduction in duration and severity of symptoms of the common cold
Folic acid	Folate deficiency Kidney failure Neural tube defects
Ginkgo	Anxiety Dementia Memory improvement Premenstrual syndrome
Ginger	Dysmenorrhea Nausea and vomiting Osteoarthritis
Ginseng	Cognitive function Erectile dysfunction
Iron	Anemia Restless leg syndrome
Magnesium	Constipation Dyspepsia
Melatonin	Sleep disorders
Multivitamin with minerals	General supplementation
Omega-3 fatty acids	Alzheimer’s disease Cardiovascular disease Dementia Depression Reduction of triglycerides
Potassium	Hypokalemia Hypertension Kidney stones
Probiotics	Atopic dermatitis Antibiotic-associated diarrhea Irritable bowel syndrome
St. John’s Wort	Anti-depressant Menopausal symptoms
Turmeric	Allergic rhinitis Osteoarthritis Pruritis
Valerian	Insomnia
Vitamin A	Aging skin Healthy vision
Vitamin B-12	Vitamin B-12 deficiency
Vitamin C	Anemia Antioxidant effects Prevention of the common cold Vitamin C deficiency
Vitamin D	Osteomalacia Osteoporosis Vitamin D deficiency
Vitamin E	Alzheimer's disease Dysmenorrhea Premenstrual syndrome
Zinc	Acne Depression Diabetes Diarrhea Treatment of common cold

 

 

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

 

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

 

Table 2. Examples of Nutrient Depletion Induced by Medications^7,17

 

Nutrient	Medication(s)	Mechanism
Vitamin D	Anticonvulsants	Increase hepatic metabolism
	Bile acid sequestrants	Decrease absorption
	Orlistat	Decrease absorption
Magnesium	Estrogens	Decrease serum levels by increasing uptake into tissues
	Loop diuretics	Increase excretion
	Proton pump inhibitors	Decrease absorption
Vitamin B12	Biguanides	Decrease absorption
	Proton pump inhibitors	Decrease absorption
	H-2 blockers	Decrease absorption
Potassium	Loop diuretics	Increase excretion
	Thiazide diuretics	Increase excretion
	Corticosteroids	Increase excretion

 

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

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

 

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

 

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

 

What is a Dietary Supplement?

 

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

 

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

 

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

 

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

 

Regulation of Dietary Supplements

 

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

 

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

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

 

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

 

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

 

Reporting Issues with Dietary Supplements

 

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

 

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

 

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

 

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

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

 

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

 

Integrity of Dietary Supplements

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

 

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

 

Table 3. Dietary Supplement Certification Organizations

 

Certifying Organization	US Pharmacopeial Convention	NSF International	Consumerlab.com
Website	www.usp.org www.qualitysupplements.org	www.nsf.org	www.consumerlab.com
Services offered	Dietary supplement verification program including GMP facility audits, product QCM process evaluation, and product testing	Product and ingredient certification GMP Certification Certified for Sport	Product reviews Quality Certification Program
Information available on the website	Program information, list of verified products, and educational resources	Program information, product search engine, and educational resources	Product reviews, health condition information
GMP = Good Manufacturing Practice

Source: adapted from reference 33

 

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

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

 

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

 

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

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

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

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

 

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

 

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

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Table 4. Adverse Effects of Common Dietary Supplements^7,17

 

Supplement	Adverse Effects
Black Cohosh	Breast tenderness, diarrhea, gastrointestinal upset, nausea/vomiting
Calcium	Burping, constipation, gastrointestinal upset
Echinacea	Diarrhea, constipation, gastrointestinal upset/pain, heartburn, nausea/vomiting, skin rashes
Ginseng	Gastrointestinal side effects, headache, sleep difficulty
Ginger	Burping, diarrhea, heartburn
Iron	Abdominal pain, constipation, diarrhea, nausea/vomiting
Magnesium	Diarrhea, gastrointestinal irritation, nausea/vomiting
Melatonin	Dizziness, drowsiness, headache
Omega-3 fatty acids	Bad breath, headache, heartburn, nausea, diarrhea, unpleasant taste
Potassium	Abdominal pain, burping, diarrhea, nausea/vomiting
St. John’s Wort	Diarrhea, dizziness, dry mouth, fatigue, headache, insomnia
Turmeric	Constipation, dyspepsia, gastrointestinal reflux, nausea/vomiting
Vitamin C	Abdominal cramping, heartburn, kidney stones (if history of kidney stones)
Zinc	Abdominal cramping, diarrhea, metallic taste, nausea/vomiting

 

 

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

 

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

 

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

 

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

 

Dietary supplement-drug interactions

 

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

 

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

 

Limited clinical studies evaluating the impact of drug-dietary supplement interactions exist. Many interactions are theoretical, based on limited clinical evidence, animal research, and case reports.⁷ 

 

Table 5. Examples of Potential Drug-Dietary Supplement Interactions^7,17

 

Dietary Supplement	Medication	Interaction
Calcium	Quinolone and tetracycline antibiotics	Decreased antibiotic efficacy Take antibiotic 2 hours before or 4-6 hours after calcium
	Dolutegravir Elvitegravir	Reduced serum levels Take medication 2 hours before or 2 hours after calcium
Ginseng	Diabetes medications	Increase risk of hypoglycemia
	Immunosuppressants	Decreased effectiveness of immunosuppressant
Ginkgo	Anticoagulants	Increased risk of bleeding
Iron	Quinolone and tetracycline antibiotics	Decreased levels of antibiotics due to decreased absorption Take antibiotics 2 hours before or 4-6 hours after iron
Magnesium	Bisphosphonates	Decreased absorption
	Levodopa/carbidopa	Decreased bioavailability of levodopa/carbidopa
Niacin	Statins	Increased risk of myopathy or rhabdomyolysis
	Thyroid hormones	Antagonize the effects of thyroid hormone replacement
	Antihypertensive medications	Increased risk of hypotension due to niacin’s vasodilating effects
St. John’s Wort	Alprazolam	Decreased effects of alprazolam
	Oral Contraceptives	Decreased efficacy Counsel patients to use other forms of contraception
	Digoxin	Decreased levels of digoxin
	Omeprazole	Decreased effects of omeprazole
Valerian	CNS depressant drugs	Additive sedative effects
Vitamin B6	Phenytoin	Decrease levels and clinical effects of phenytoin
Vitamin D	Atorvastatin	Decreased absorption of atorvastatin
Vitamin E	Anticoagulants	Increased risk of bleeding
Zinc	Quinolone antibiotics	Decreased levels and effects of antibiotics Take antibiotic 2 hours prior or 4-6 hours after zinc

 

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

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

 

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

 

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

 

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

 

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

 

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

 

Table 6. Sources of Information about Dietary Supplements

 

Resource	Website	Information
Dietary Supplement Education Program	https://www.fda.gov/food/healthcare-professionals/dietary-supplement-continuing-medical-education-program	Continuing medical education program Collaboration between FDA and AMA Series of 3 videos about dietary supplements Also contains links to educational materials and other websites with information about dietary supplements
Dietary Supplement Label Database	https://dsld.od.nih.gov	Current and historical label information on dietary supplement products marketed in the United States Useful to determine the contents of dietary supplement products
Food and Drug Administration	https://www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-supplements	Information for consumers on using dietary supplements Links to educational resources and materials, consumer updates, alerts, recalls and other information
Google Scholar	https://scholar.google.com/	Source of information from many avenues including journals, books, and conference proceedings
Lexi-Comp Natural Products Database	Available via mobile app	Requires a paid subscription Alphabetical, searchable natural product database
Memorial Sloane Kettering Cancer Center	https://www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine/herbs	Information on herbs, botanicals, and other products for both consumers and healthcare professionals Dietary supplement monographs IOS app: About Herbs Part of an online integrative medicine resource center
National Cancer Institute Office of Cancer Complementary and Alternative Medicine	https://cam.cancer.gov	Information for consumers and healthcare professionals about CAM as it relates to cancer therapy Information on current NCI CAM research
National Center for Complementary and Integrative Health	https://www.nccih.nih.gov	Information for both consumers and healthcare professionals about complementary health products and practices
National Library of Medicine - Medline Plus	https://medlineplus.gov/druginfo/herb_All.html	Online health information about drugs, herbs, and supplements for consumers Information sourced from the National Center for Complementary and Integrative Health and Natural Medicines Comprehensive Database
Natural Medicines Comprehensive Database	https://naturalmedicines.therapeuticresearch.com	Requires a paid subscription Professional monographs including information about effectiveness, safety, adverse effects, and interactions Information on specific commercial products Interaction checker Patient handouts in English, Spanish and French
Office of Dietary Supplements	https://ods.od.nih.gov	Information for both consumers and healthcare professionals General supplement information Information on supplements for specific purposes Fact sheets on dietary supplements and their ingredients
PubMed	https://pubmed.ncbi.nlm.nih.gov	Search engine for the National Library of Medicine Source of information from journals
United States Department of Agriculture	https://www.nutrition.gov/topics/dietary-supplements	Links to general information and resources on dietary supplements

 

 

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

 

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

Conclusion

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

 

 

Sidebar: Tips for Counseling Patients about Dietary Supplements

 

Carefully inspect the product to ensure intact product labeling

Ensure the safety seal is intact

Check for an expiration date or best used by date

Check for customer service or return information before ordering

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

Check for the presence of a third-party certification seal

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

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

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

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

 

 

 

 

Download CE Activity

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 0009-0000-23-026-H05-T, 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.

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.

• Sara Miller, Kyra Durfee and Gabriela Scala have no relationships with ineligible companies and therefore nothing to disclose.