Equipment to Make Non-Sterile Compounding A Breeze

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

LIST the reasons why a compounding lab might consider purchasing machinery and the steps in the evaluation process
IDENTIFY the purpose and function of common compounding equipment (e.g., balances, mixers, mortars and pestles, capsule fillers, ointment mills)
DESCRIBE the principles of accuracy, precision, and calibration as they relate to compounding tools
EXPLAIN regulatory expectations for equipment use, cleaning, and maintenance (USP <795>)

The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy and Pharmaceutical Sciences 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.

As interest in specialized compounding, veterinary preparations, and cannabidiol (CBD)-related products grows, pharmacy compounding laboratories increasingly face decisions regarding automation and equipment acquisition. Although compounding equipment can improve efficiency, reduce repetitive manual labor, enhance dosing accuracy, and potentially decrease contamination risk, selecting appropriate equipment requires a structured and data-driven needs assessment. This continuing education activity reviews the major considerations involved in choosing compounding equipment. Decision makers must evaluate the pharmacy’s scope of services, compounding volume, formulation complexity, regulatory obligations, facility limitations, staff training needs, ergonomic concerns, and financial constraints before investing in equipment. They must consider the United States Pharmacopeia chapters <795>, <797>, and <800>, workflow integration, maintenance requirements, and vendor support. Ergonomics and repetitive strain prevention are also critical factors, noting that automation may be justified even when time savings are modest if employee injury risk can be reduced. This CE covers commonly used compounding equipment categories. For each category, it summarizes mechanisms of action, advantages, limitations, regulatory implications, and practical considerations affecting equipment selection. Ultimately, successful equipment selection depends on aligning technology with the pharmacy’s actual compounding needs rather than purchasing equipment based solely on novelty or perceived efficiency. A thoughtful needs analysis can help pharmacies avoid costly purchasing errors while improving product quality, workflow efficiency, and employee safety.

INTRODUCTION

With the increased interest in specialized, veterinary, and cannabidiol (CBD) compounds, pharmacy staff who work in academia and specialize in compounding occasionally field questions from start-up companies that need help selecting the best equipment for their needs. Most compounders who have these questions are aware of compounding equipment’s advantages; the machines are semi-automatic or automatic, streamlined, safe, and more efficient and faster than humans.^1,2 Saving time means saving money! When used according to the directions, they also produce products with accurate dosing.^1,2

Pharmacy compounders who are considering the purchase of machines always have additional questions. They want to know if specific equipment will decrease human exposure to medications and decrease the likelihood of human error. They also ask if machines can decrease repetitive motions. What is the likelihood of cross contamination? And will the finished products be pharmaceutically elegant? Unfortunately, compounding experts will not have a one-size-fits-all answer. Each compounding lab will need to conduct a needs analysis before considering new equipment. Choosing compounding equipment without a needs analysis is how pharmacies end up with very expensive dust collectors.

CONSIDERATIONS FOR SELECTION

Before purchasing any machine, decision makers need to ask, “What specific problem does this solve, and how often will we have that problem?” The answer to that question must be data driven.

First, decision makers need to define the scope of services the pharmacy provides.³ It’s critical to choose equipment based on type of medications being compounded now (see Table 1), and to also consider how the business may grow in the next few years. When looking at the compounded product types, the employee or employees doing the analysis need to augment the data with the volume or frequency that the pharmacy compounds each type of product.³ Things to think about include peak and average workload, batch compounding as opposed to one-off prescriptions, and the patient’s or customer’s typical turn-around expectations. The goal is to determine which compounds the staff makes often enough and in large enough quantities that automation would be a reasonable consideration.

Table 1. Types of Compounded Products
Nonsterile	Capsules Creams Gels Gummies Ointments Solutions Suspensions Troches
Sterile	Intravenous Ophthalmics
Hazardous drugs (e.g., oncology)

Second, decision makers need to look at the various formulations they compound and assess their complexity. They need to look at each formulation and determine if it requires some kind of special approach. It might be high shear mixing, precise particle size reduction, or homogeneity testing. The high-shear mixing process involves using shear to emulsify, homogenize, disperse, or reduce particle size. This shear force occurs when part of the mixture is pushed in one direction, while the other part is pushed in the opposite direction simultaneously. If the shear force is higher, the particles mix more evenly due to the particle size reduction outcomes, which assists in homogenization. An example of this would be creating a cream or lotion with an oil and water base.⁴ These compounds tend to be more complex than other compounds, and if they are produced in large enough batches, the decision makers may need to look at mixers, electronic mortars and pestles, or homogenizers. Concurrently, they need to look at each compound and ask, “What level of dosing accuracy is required?” If any of these products include drugs with narrow therapeutic indexes or are destined for pediatric or neonatal patients, it's possible that automated dispensing systems, precision balances, or capsule filling machines could be helpful.

Third, it's always important to look at regulatory and compliance considerations.⁵ People who make these decisions need to be fully educated about the United States (U.S.) Pharmacopeia chapters <795>, <797>, and <800>.^6-8 In addition, they need to be aware of their State Board of Pharmacy rules. This means that they should determine if any environmental monitoring, documentation systems, or closed system transfer devices are needed. (A closed system transfer device is a drug transfer system designed to prevent hazardous drugs from escaping into the environment and to block contaminants from entering the system during preparation and administration.) Any equipment that they purchase must be in compliance with the rules and not purchased just to improve production. This is also the time to also ask if the specific piece of equipment will provide traceable documentation. If batch-to-batch consistency is imperative, documentation is an indispensable element of the pharmacy’s quality assurance program.^6-8

Fourth, space and facility constraints are very important.^3,5 Before purchasing any machine, pharmacy staff should look at their available square footage and cleanroom requirements to determine if the machine will even fit.⁵ A good way to do this is to determine the equipment’s size and construct a dummy out of cardboard. Placing it in the workflow will help determine if the machine will work for the specific pharmacy. Many machines are large and will require dedicated space or specific ventilation. A PRO TIP is to ask, “Does it integrate with your existing equipment?”⁵ Integration means that the new machine may need to be able to “talk” to the pharmacy’s software, labeling systems, and barcoding.⁵

Fifth, decision makers need to assess the pharmacy team's current skill levels and determine if the staff will need additional or extensive training.^3,5 If the team's skill level is only basic, or if the pharmacy experiences high employee turnover, it might be important to look for simpler equipment rather than fancier equipment. While conducting this part of the needs assessment, decision makers also need to determine if manufacturer support and training is available and included in the purchase price. If it is not included in the purchase price, the budgeting process will need to reflect the additional cost.

A related concern is how the physical work of compounding affects employees’ bodies over time, referred to as ergonomics. Many compounding tasks—grinding powders with a mortar and pestle, mixing thick creams by hand, filling capsules, drawing up liquids into syringes by the hundreds, and even keyboard strokes—are very repetitive.⁹ Small, precise motions repeated hundreds of times can be more damaging than heavy lifting—because they never give muscles a break.^10,11 Over time, drawing 0.5 mL 300 times is more straining than lifting a heavy box 10 times. Employees may develop wrist pain, hand fatigue, shoulder or neck strain, or long-term injuries that require workman’s compensation.^9,10 A PRO TIP is to replace the question, “Can an employee do this task?” with, “Can an employee do this task all day, every day, without risk of injury?” If a machine can save employees from strain or injury, it might be worth it—even if it doesn’t save much time.

PAUSE AND PONDER: A technician draws up small volumes (0.5–1 mL) into syringes for 2–3 hours straight. Why is this more tiring than it sounds? What small muscles are being overused? What could reduce strain without full automation?

Repetitive hand motions could cause carpal tunnel syndrome, which is caused by compression of the median nerve. This causes pain, numbness, and tingling in the hand.¹²

Sixth, developing a budget isn’t as simple as just determining how much money is available.³ Two questions should drive budgeting:

“Will this machine pay for itself?”
“What happens if it breaks?”

The answers to these questions emanate from an analysis of upfront costs and the long-term anticipated return on investment.³ Sometimes, decision makers overlook hidden costs like maintenance and calibration costs, consumables and proprietary supplies (supplies that are only available from the manufacturer), and service contracts.⁵

During the budgeting process, decision makers should delve into some additional concerns listed in Table 2. A snazzy machine with poor vendor support becomes useless quickly.

Table 2. Vendor Support & Reliability⁵

Is technical support readily available? What is the typical or guaranteed response time?
What is the process for machine cleaning and calibration?
Does the vendor supply replacement parts or can they be purchased elsewhere?
Does the vendor provide training? If so, is it free or associated with a charge?
What happens if the machine fails? What is the backup plan or work-around process?
What is the cost of the service contract and does it include replacement parts?

A final and seventh step is to ask, “What specific problem does this solve, and how often will we have that problem?”

SIDEBAR: Stop Calling It Personal Protective Equipment!^6-8

Experts now discourage the term “personal protective equipment” (PPE) in cleanroom settings because it implies protection of the worker, while the primary goal is protection of the product from contamination. Cleanroom standards (e.g., United States Pharmacopeia <797>) emphasize garbing to maintain aseptic conditions. Using “PPE” can lead to incorrect practices, such as prioritizing self-protection over sterility, potentially increasing the risk of microbial contamination in compounded sterile preparations.

And the USP documents themselves are confusing! USP <800> uses PPE but <795> and <797> used the preferred term “garb”!

So say it! In compounding we garb!

Heads = Machine, Tails = Employee

After completing the seven steps described above, it may be clear that the pharmacy has the volume, money, and justification to purchase a machine.³ However, it's a good idea to play devil's advocate and think about ways to reduce strain without full automation. This is a good brainstorming activity for the entire staff.

Some ways to reduce strain include rotating tasks every 30 to 60 minutes, so that staff members alternate fine motor tasks and non-fine motor tasks, and scheduling micro breaks.⁹ It's also possible to tweak equipment so that there's less strain on employees. Using larger syringes when possible uses less force per draw. Choosing low resistance syringes can decrease strain because they have smoother plunger actions. Employees can also use a syringe holder, or a stabilizing device and training should emphasize ensuring proper hand positioning.⁹

Regardless of the type of equipment being used, compounders should use disposable products when applicable (i.e. weigh boats [a small, shallow, disposable container used in laboratories to hold solids while they are being weighed on a balance], or single use oral syringes) in conjunction with their equipment. They increase infection prevention and patient safety by avoiding cross contamination; they save time and labor by not having to clean and sanitize in between compounds; and there is no maintenance involved. There may also be potential for bulk buying discounts.

Decision makers need to keep one more thing in mind when they select equipment. USP <795> requires compounding pharmacies to clean and maintain the equipment according to written procedures.⁸ The PRO TIP here is that as soon as equipment is purchased, the pharmacy needs to establish and follow such procedures.

Let's look at the types of available equipment.

EQUIPMENT TYPES AND PURPOSES

Weighing and measuring equipment in compounding ensures accurate quantities, which are critical for safety and effectiveness. This includes balances for weighing powders and volumetric measuring devices (e.g., graduated cylinders, syringes) for liquids. Selection depends on the required precision—small volumes or potent drugs demand higher accuracy. Employees must calibrate equipment and use it properly to avoid dosing errors. Inaccurate measurement can lead to subpotent or toxic preparations, making proper technique and maintenance essential in both sterile and nonsterile compounding.

Choosing the right scale depends on the pharmacy’s specific compounding needs. Most quality scales range from $500 to $2,000. Scales come in two types: analogue and digital.

The USP discusses and requires Class A prescription scales on compounding pharmacies.¹³ All state laws require a Class A scale or a scale that is more sensitive in licensed pharmacies, too. This level of mechanical balance is sensitive enough to detect small weight changes, with a sensitivity requirement of 6 mg or less and a minimum weighable quantity of 120 mg (to ensure error will be 5% or less). This means adding 6 mg will move the pointer one division on the scale. Because of this level of precision, Class A balances are considered appropriate for accurately weighing ingredients used in compounded preparations. A Class A balance is defined by how little weight it can detect (again, 6 mg or less)¹³; in case you are wondering, there are no official Class B or C balances in USP compounding—just balances that either meet the standard or don’t.

An analogue scale is a mechanical device that uses physical weights, springs, or balance beams and does not need electricity. It uses the principle of equilibrium, comparing the unknown weight with standard weights.¹⁴ Analogue scales are less costly than digital scales. All older pharmacies had torsion balances, which are a form of analogue scale, which did not require electricity. They were extremely durable and highly accurate when used correctly. In the “old days,” schools of pharmacy taught students how to use these scales. Many schools no longer teach this, considering these scales old-fashioned. Yet a survey that received 372 responses from pharmacies in Missouri found that almost half of those pharmacies (46.8%) owned a torsion balance.¹⁵Almost 60% of pharmacists-in-charge recommended continuing to teach how to use torsion balances.¹⁵Do you still have a torsion balance in your practice?

Over time, mechanical parts may loosen and analogue scales will need recalibration using certified weights. Ideally, a compounder should test the balance with a standard weight set before the scale is used each time and should arrange to have the scale calibrated professionally every one to two years, depending on its amount of use. In addition, parallax error—error that occurs when someone reads a scale or measurement from the wrong angle, rather than looking at it straight on—is possible. The compounder must look at the measurement mark at eye level. Because analogue scales are slow to use and require manual skill and calibration, human reading errors are possible, and today’s compounding pharmacies tend to use digital scales.¹⁴ (But having an analogue scale is handy if the power goes out or a digital scale breaks.)

Digital scales use electronic sensors to measure weight and display the result numerically.^16,17 Usually, these scales use a load cell to convert force (weight) into an electrical signal. A highly sensitive analog-to-digital converter changes the load cell’s electrical signal into a digital value. Next, a microcontroller is a calculator of sorts, changing the signal into an LCD display and telling the user what the item’s weight is. They are fast and easy to read, highly precise (often to milligrams or better), and sometimes include features like taring (resetting the scale to zero after placing a container on it, so employees only measure the substance they add—not the container), calibration alerts, and unit conversion. These features reduce human error. More costly than analogue scales, digital scales need a power source and can be sensitive to environment (vibration, airflow, static).^16,17However, most new balances have a battery backup so they can still be used in case of a power outage.

When choosing scales, pharmacy staff should start by considering how precise their measurements must be (e.g., 1 mg vs. 1.001 g) and the typical quantity—small amounts or several kilograms. Space may matter, so a compact design can help. Many modern scales offer digital features like battery backup, USB, or Ethernet connectivity for data recording, and automatic internal calibration. Analog scales are more affordable and suitable for basic tasks, while digital scales provide greater precision and reliability, making them ideal for more demanding environments.^10,11,14,16

Other types of weighing scales include bench scales, truck scales, pallet scales, floor scales, and dynamic weighing systems.

Mixing and blending equipment ensures ingredients are evenly distributed so each dose is consistent and effective. This includes manual mortar and pestles, electronic mortar and pestles (EMPs), ointment slabs, electronic mixers, and homogenizers. The choice depends on the formulation—thick creams may require more force, while suspensions need uniform particle distribution. Proper mixing prevents “hot spots” (too much drug in one area), “cold spots” (areas with little to no drug), or separation.¹⁸ Equipment should be easy to clean and appropriate for the product to maintain quality and avoid contamination.

Using the traditional mortar and pestle, compounders crush and mix various ingredients to create a fine mixture by hand.¹⁹ They place the ingredients in the mortar (the sturdy bowl made of hard materials) and rub it with the pestle (the club-shaped implement used to pound or grind substances). The process can be time-consuming, and the final product may differ in consistency depending on who wields the mortar! Proper hand positioning in holding the pestle will reveal how skilled the compounder is.¹⁹

EMPs generally retail at about $2,000 to $4,000 each. They increase the potential output of topical compounds.²⁰ Employees can use them to make multiple compounds in small, personalized batches using single use plastic jars and small plastic mixing discs, which remain in the final product jar. Often, topical compounds produced using EMPs have better product quality than those produced by hand.¹⁹ Considered a closed system, these machines also prevent cross contamination. EMPs use a circular or S-shaped blade that spins inside the jar, pushing the cream outwards (toward the jar’s wall). The paddle on each end of the blade creates a forceful, shearing effect and delivers a homogenous and smooth mixture as the process is repeated.²⁰ One limitation to EMPs is they may generate heat during the process, which introduces the possibility that the heat will degrade the active pharmaceutical ingredient.¹⁹ This outcome is highly unlikely because these machines are FAST—they can mix in three to five minutes depending on the product.

A planetary mixer is a closed mechanical mixing device used to blend creams, ointments, gels, and viscous formulations.¹⁹ They produce less heat than EMPs. The name comes from the motion of the mixing blade, which rotates on its own axis while traveling around the bowl, similar to a planet orbiting while spinning. Its dual movement provides thorough, uniform mixing and reduces unmixed areas. These mixers are also very fast. Planetary mixers are especially useful for thicker preparations and larger batches, improving consistency and reducing manual effort.¹⁹ However, they require cleaning between batches and may be less practical for very small quantities.

In the compounding lab, student Carli is watching a demonstration of the planetary mixer. Several of her classmates are bored and visibly distracted, but she is intrigued. At the end of the demonstration, she stays behind and tells her instructor that she found the whole concept interesting. She says that her classmates often make cupcakes for a fundraising event, and when they make buttercream frosting, the powdered sugar goes everywhere. She likes the idea of a closed system that would incorporate butter, sugar, flavoring, and milk with no mess. She says, “Too bad these are so expensive. They’d be great for frosting!” The instructor asks her to think about it and identify the reason why the planetary mixer would make terrible frosting. It takes a minute, but Carli says, “Ah! It’s because when making buttercream frosting, you need to whip air into it. Planetary mixers press all the air out.” The instructor says, “Correct.” Carli’s friend Sydney is nearby and says, “I guess you can’t make meringue from egg whites in a planetary mixer either!” The instructor nods.

An ointment mill is a device used to mix and finely grind ingredients, especially incorporating powders into ointment bases.²² Its main purpose is to reduce particle size and evenly distribute the drug throughout the preparation, producing a smooth, uniform product free of grittiness—that’s called pharmaceutical elegance. This improves both patient comfort and the consistency of dosing.²²Ointment mills reduce particle sizes better than EMPs and compounders who make topicals that contain more than 10% active pharmaceutical ingredient will usually need to use an ointment mill rather than an EMP.²⁰ (If you are wondering, “Why?” see the SIDEBAR.)

SIDEBAR: The EMP to Ointment Mill Switcheroo!

Kyle is a pharmacy student taking an advanced compounding class. A proctologist has ordered a 20% benzocaine ointment for a patient who has anorectal pain. He has laid out his components and has the EMP ready to mix the ointment. He asks the instructor to check his work. She approves his calculations, but says, “You would be better off using the ointment mill. He says, “Why? I didn’t see anything about this in the USP. Is this some kind of FDA regulation?”

She replies, “No universal USP or FDA rule dictates using an ointment mill instead of an EMP if a topical contains more than 10% active pharmaceutical ingredient (API). Compounders often switch to an ointment mill at higher API loads to improve pharmaceutical quality and address rheology issue. (Rheology is the science of how materials flow, spread, deform, or resist movement under force.)”

She goes on to summarize this way:

At low API concentrations, an EMP can usually generate enough shear and mixing energy to disperse powder uniformly.
At higher concentrations (especially insoluble powders such as urea, salicylic acid, ketoprofen, zinc oxide, etc.), the formulation behaves more like a dense suspension than a simple cream.
High solids loading increases
- agglomeration (the situation in which mall powder particles stick together and form clumps)
- grittiness
- poor wetting
- nonuniform particle distribution
- risk of dose variability,
- instability/separation

An ointment mill produces much higher and more controlled shear forces than an EMP. The rollers physically reduce particle size and break agglomerates, improving

content uniformity
smoothness/elegance
skin feel
reproducibility
and potentially, drug release characteristics.

An EMP mainly homogenizes and mixes; an ointment mill both mixes and reduces particle-size.

Most ointment mills use three rollers that rotate in different directions and at different speeds, creating shear forces that break down particles and blend them thoroughly.²² This process, related to particle size reduction, enhances drug absorption and ensures stable, professional-quality ointment. Using an ointment mill is definitely faster them mixing an ointment by hand.²²

Homogenizers create a uniform mixture by reducing particle or droplet size and evenly dispersing ingredients throughout a preparation.²³ They are especially useful for emulsions, suspensions, and creams, where consistent distribution of components is critical for accurate dosing and stability.²³

Homogenizers work by applying intense mechanical forces—such as pressure, turbulence, or shear—to break down particles and droplets.²³ By forcing mixtures through narrow channels at high pressure, homogenizers decrease particle size and increase uniformity, leading to better bioavailability. This process improves texture, enhances absorption, and prevents separation over time. The result is a smooth, stable product with consistent therapeutic properties, achieved through principles related to homogenization.²³

Capsule filling machines efficiently fill empty capsules with precise amounts of powdered or granulated medication.²⁴ They help ensure consistent dosing and uniformity across multiple capsules, which is especially important when preparing individualized prescriptions.²⁴Capsule filling machines may be manual, semi-automatic, or fully automatic.²⁵

These machines typically align empty capsules, separate the caps from the bodies, fill the bodies with the prepared formulation, and then reassemble the capsules.²⁴ By improving speed and accuracy compared to manual filling, they reduce variability and enhance workflow efficiency. Proper use supports uniform drug distribution and dose accuracy, key aspects of content uniformity. Traditionally, compounders use hard or soft gelatin capsules, which remain widely available and inexpensive. They are not vegetarian, however, as gelatin is a meat byproduct, but there are vegetable-based capsules available. In addition, some gelatin capsules are kosher, but some are not. To be kosher, the gelatin capsules must be made from a kosher source and in a supervised, certified process. Capsules that meet vegetarians’ needs and the needs of people who keep kosher are available and made of cellulose. They tend to be more costly than gelatin capsules.²⁴

Of note, 21 U.S.C. § 830 (Controlled Substances Act [CSA] – recordkeeping & reporting) and 21 CFR Part 1310 (DEA regulations on “regulated transactions”) require reporting of certain transactions involving encapsulating machines. These laws define an encapsulating machine as any equipment that will be used to fill capsules with powder, liquid, and others, regardless of the alleged purpose. The CSA legally classifies anyone who sells or distributes these machines as a regulated person and any sale of an encapsulating machine—domestic, import, or export—triggers the requirement to file Form 452 and keep sales records. The purpose of these laws is to scrutinize sales that may be linked to illicit drug production. Note that owning such machines is not illegal; selling them is if the seller does not file a Form 452.

Infuser machines ($100 to $400) extract active ingredients from raw materials into a liquid or oil base.^26,27 The term “infuser machine” is colloquial, meaning that’s what just about everyone calls them, mainly because they have been used heavily by the emerging cannabis industry. The scientific names for these machines include²⁷

solid–liquid extractors
botanical extraction systems
maceration/percolation systems
dynamic extraction devices

The infusing procedure extracts compounds from the solid material to the outlet (the liquid in which it is infused), creating a solution that contain colorants, bioactive compounds, and/or fragrances.²⁷ Compounders use these machines to prepare infused oils or solutions by combining heat, time, and controlled mixing to transfer desirable compounds into the final product.²⁶

These machines work by maintaining consistent temperatures and agitation, which helps improve extraction efficiency and uniformity.²⁶ This process relies on principles of solid-liquid extraction, including diffusion and osmosis, ensuring that the active components are evenly distributed throughout the preparation for consistent potency and quality. They can infuse a variety of flavors and aromas like milk, honey, butter, oil, or glycerin. They are popular with herbalists and THC/CBD manufacturers.²⁶

Interestingly, infusion techniques have become a mainstay of valorization—taking something that would otherwise be considered waste, low-value, or underused and turning it into something more useful or economically valuable.²⁷ In doing so, the process must extract the desirable component while discarding the constituents that are less desirable.²⁸ Some examples include extracting antioxidants from orange peels that would otherwise be discarded; converting agricultural waste into biofuels; using spent grain from breweries to make protein ingredients; and the ever-popular recovering cannabinoids, terpenes, or polyphenols from plant material. Infusion techniques are also very often used in herbal medicine.²⁸

Compounders need to appreciate that extraction efficiency increases as particle size decreases because surface area increases.²⁷ That principle is exactly why many infusion machines grind material finely, heat the oil, stir continuously, or cycle between pressure and vacuum.²⁷

Molds and presses constructed of silicone or stainless steel ensure uniform shape and size. Many are available in standard sizes, but some can be custom-made. They are employed in both manual and automated compounding. They enhance efficiency with regulated compression force-dosage uniformity. They must be cleaned regularly and thoroughly to meet quality assurance standards.

Magnetic stirrers mix liquids using a rotating magnetic field.^29-31 The compounder places a small, coated magnet (“stir bar” or “flea”) in the liquid and then places the container on a plate that has a magnet below it. The stir bar is polytetrafluoroethylene-coated (PTFE which means it is coated in the chemically inert substance we usually know as Teflon). A motor rotates the magnet. The stir bar spins as the field rotates, creating a vortex that mixes the solution uniformly. Some units also include a hot plate for simultaneous heating and mixing. These devices mix the solution consistently, so the final product has uniform dosing and the results are reproducible. Adding heat can make solids dissolve faster and reduce the likelihood of hot spots.^29,30

Magnetic stirrers work best with low- to moderate-viscosity liquids.³⁰ They mix creams, ointments, gels, and high-solid suspensions poorly, so for these, a planetary mixer or overhead mixer (a motorized mixer much like a stand mixer in a home kitchen) are better choices. They are also limited to batches of 2 to 4 liters. In addition, if used improperly (at high speeds or improper conditions) they are prone to stir bar decoupling, meaning the stir bar may fail to respond to the magnet completely.³² In addition, compounders need to be certain that their containers are not too narrow or irregularly shaped.³³ And, magnetic stirriers do not reduce particle size.³⁰ Finally, the PTFE coating can chip or degrade over time and the magnet may weaken, potentially compromising mixing and introducing contamination.^31-34

Filling machines accurately dispense a defined volume or mass of a preparation into containers (bottles, jars, tubes, syringes).³⁵ Compounders usually use them for oral liquids (solutions, suspensions), topical products (creams, gels, lotions), and occasionally syringes or unit-dose containers. Table 3 lists the several types of filling machines.

Table 3. Types of Filling Machines^35,36

Volumetric liquid fillers would be best for low- to moderate-viscosity liquids or well-mixed suspensions; they deliver a fixed volume per cycle. These may be piston fillers—which are very accurate and widely used—or peristaltic pump fillers when sterile or clean products are needed.
Peristaltic fillers move fluid through a tub using rollers that compress the product. The fluid has contact with the tubing only so contamination is unlikely and cleaning is simple—just replace the tubing. These are less precise if the product is viscous, and the tubs may show wear and tear with use.
Auger fillers are used for creams, ointments, and gels. In these devices, a rotating auger screw displaces a controlled amount of the product. These are able to handle higher viscosities than liquid fillers, and they're good for use with jars or wide mouth containers.
Some piston fillers are used for viscous products, especially topicals, and in these machines, a high force piston pushes the product through a nozzle. Piston fillers have better control than augers for some formulations.
Tube filling machines are used for ointments or creams, and they push the product into an aluminum or a plastic tube. The process is to fill, crimp or seal, and then trim the tube.

When using any type of filling machine, compounders need to be aware of some limitations. Filling machines can be influenced by the product’s viscosity, air bubbles, or equipment calibration.^35,37 Of these factors, viscosity is the single most important driver of equipment choice.³⁷ Some machines may develop calibration drift that leads to dosing errors. A PRO TIP is to use gravimetric checks (weight verification) to ensure that their filling machines are accurate.

Compounders need to realize that they need to continuously stir suspensions when using filling machines to ensure that the product is evenly distributed. They must also premix creams in an appropriate mixer like a planetary mixer before using the machine. Another limitation is air incorporation. If for some reason the filling machine is incorporating air into the product, the fills will be inaccurate and the product’s stability uncertain; air incorporation is most likely to occur with foaming liquids, gels, or creams. Finally, each of those machines needs to be cleaned thoroughly in accordance with the device’s manual directions between all formulations.

Some ophthalmic preparations, oral solutions, and suspensions are only stable within a narrow pH range (see the SIDEBAR).^37,38 pH meters are electronic instruments that measure the acidity or alkalinity of a solution by detecting hydrogen ion activity. The typical device has a glass electrode (sensing element), a reference electrode, and a digital meter that converts voltage into pH units. The measurement the device produces uses electrochemical principles described by the Nernst equation, which relates voltage to ion concentration. Compounders need to know that with some devices, pH readings can change with temperature. (Those that have automatic temperature compensation are less likely to have this problem, but the manual will describe the temperature excursions window in which the device is reliable.) Most machines require thorough cleaning and electrode storage in a potassium chloride solution. They are less reliable in viscous solution, non-aqueous, or solution of low-ionic strength. An example of a low-ionic strength solution is preservative-free artificial tears. They have few dissolved ions (like sodium, chloride, potassium) compared with normal saline or buffered IV fluids, which makes them low ionic strength.

SIDEBAR: What is pH? The pHacts!^37,38

pHunny you should ask! pH is a way to describe how acidic or basic (alkaline) a pHluid is.

It is measured on a scale from 0 to 14
A pH of 7 is neutral (like pure water)
A pH below 7 means the substance is acidic (like lemon juice or stomach acid)
A pH above 7 means it is basic or alkaline (like soap or baking soda solution)
The pH of most body fluids is 7.4

A straightforward way to think about it is this: pH tells you how “sour” or “soapy” a liquid would be if you could taste or touch it safely. And not all flavoring can affect pH. Most flavors are acidic and contain citric acid (i.e., lemon or orange), malic acid (apple), or tartaric acid (grape). So flavoring is an active excipient, not just a good taste. Compounders should remember that pharmaceutical-grade flavoring systems are often buffered and standardized.

Slight changes in pH can have remarkable effects on drug dissolution, stability, and propensity to be irritating or gentle.

CONCLUSION

Overall, an efficient compounding company needs well-organized workspaces with designated zones for weighing, mixing, and packaging. Its work areas should be streamlined and well thought out to decrease excess motions and to reduce cross contamination. It is important to follow USP standards closely, and to conduct performance testing. Use best practices with quality assurance checks and regular sanitization and perform maintenance checks regularly and don’t forget to fill out those training, cleaning, and maintenance logs.

When considering a certain machine, managers should ask the manufacturer of the machine for names of companies who have recently purchased the product. Reach out to those companies for feedback on the device. It is also important to let the compounders who are going to use the machine in your compounding company have an opinion.

Automated machines eliminate human error and can reduce cross contamination. They can produce compounds which have better consistencies that can increase absorption and enhance comfort. Most importantly, they allow the compounder to create specialized/customized vehicles with adjusted strengths, which opens up more treatment options for our patients.

Equipment to Make Non-Sterile Compounding A Breeze
26-033 P
Posttest

Learning Objectives
After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
1. LIST the reasons why a compounding lab might consider purchasing machinery and the steps in the evaluation process
2. IDENTIFY the purpose and function of common compounding equipment (e.g., balances, mixers, mortars and pestles, capsule fillers, ointment mills)
3. DESCRIBE the principles of accuracy, precision, and calibration as they relate to compounding tools
4. EXPLAIN regulatory expectations for equipment use, cleaning, and maintenance (USP <795>)

1. The staff at a busy compounding lab has analyzed the type and quantities of creams and ointments they make. They have also examined state and federal regulations to ensure they know any limitations on the purchase of new equipment. They are looking at various machines. What is the next question they should ask?
A. Does it integrate with your existing equipment and fit in the available space?
B. Will staff need additional or extensive training to operate these machines?
C. Can an employee do this task all day, every day, without risk of injury?

2. Which of the following is a reason to use disposable supplies in conjunction with compounding machinery?
A. The USP and FDA require the use of disposable supplies when compounding.
B. Disposable supplies prevent cross contamination and increase patient safety.
C. Disposable supplies are less expensive than washing reusable items.

3. What is the main purpose of calibrating a balance before compounding?
A. To ensure the balance is clean
B. To verify accuracy and precision
C. To comply with labeling requirements

4. Which equipment is most appropriate for preparing a homogeneous cream-based ointment?
A. Capsule-filling machine
B. Electronic mortar and pestle
C. Ointment slab

5. Which of the following is a USP <795> requirement for compounding equipment?
A. Replaced the machinery’s moving parts annually
B. Clean and maintain it according to written procedures
C. Use machinery only for large volume sterile preparations

6. Which piece of equipment is primarily used to reduce particle size and achieve uniform mixing in ointments?
A. Class A balance
B. Ointment mill
C. Magnetic stirrer

7. What three elements are essential when using a dynamic extraction device?
A. S-shaped blades, ice, and time
B. Staff skill, herbal API, and heat
C. Heat, time, and controlled mixing

8. Why is it essential to look at marks on a graduated cylinder at eye level?
A. It prevents parallax
B. It eliminates reflection
C. The numbers are small

9. What is the MOST IMPORTANT reason equipment should be easy to clean and appropriate for the product being compounded?
A. To save staff time and costs of cleaning supplies
B. To ensure faster turnaround time between preparations
C. To maintain quality and avoid contamination

10. Your boss is planning to upgrade a certain machine and asks you to list the old one on Facebook Marketplace and craigslist for sale. You immediately think about 21 U.S.C. § 830 and 21 CFR Part 1310. What machine is he going to upgrade and what will you need to file at sale?
A. An old capsule filling machine; Form 452
B. An old planetary mixer; Form DEA 222
C. An old ointment mill; Forms DEA 222 and 106

Equipment to Make Non-Sterile Compounding A Breeze
26-033 T
Posttest

3. What is the main purpose of calibrating a balance before compounding?
A. To ensure the balance is clean
B. To verify accuracy and precision
C. To comply with labeling requirements

4. Which equipment is most appropriate for preparing a homogeneous cream-based ointment?
A. Capsule-filling machine
B. Electronic mortar and pestle
C. Ointment slab

6. Which piece of equipment is primarily used to reduce particle size and achieve uniform mixing in ointments?
A. Class A balance
B. Ointment mill
C. Magnetic stirrer

7. What three elements are essential when using a dynamic extraction device?
A. S-shaped blades, ice, and time
B. Staff skill, herbal API, and heat
C. Heat, time, and controlled mixing

8. Why is it essential to look at marks on a graduated cylinder at eye level?
A. It prevents parallax
B. It eliminates reflection
C. The numbers are small

1. Bauman I. Solid-solid mixing with static mixers. Chem Biochem Eng Q. 2001;15:159–165.
2. Bauman I, Ćurić D, Boban M. Mixing of solids in different mixing devices. Acad Proc Eng Sci. 2008;33:721–731. doi: 10.1007/s12046-008-0030-5.
3. Automation or Human Labor? Here’s What to Consider. September 2, 2021. Accessed April 3, 2026. https://arnoldmachine.com/resources/automation-or-human-labor-here-s-what-to-consider/
4. The Basics of High-Shear Mixing: A Complete Guide. MDX Process. February 3, 2026. Accessed May 7, 2026. www.mdxprocess.com/blog/high-shear-mixing-tips-tricks
5. What to prioritise when evaluating and comparing machines in the pharmaceutical packaging industry. Manufacturing Chemist. June 17, 2024. Accessed April 3, 2026. https://manufacturingchemist.com/what-to-prioritise-when-evaluating-and-comparing-machines
6. United States Pharmacopeia. General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. In: USP–NF. Rockville, MD: United States Pharmacopeial Convention; 2023.
7. United States Pharmacopeia. General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP–NF. Rockville, MD: United States Pharmacopeial Convention; 2023.
8. United States Pharmacopeia. General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. In: USP–NF. Rockville, MD: United States Pharmacopeial Convention; 2023
9. Zamani M, Chan K, Wilcox J. Pharmacy Technicians' Perceptions of Risk Reduction Strategies Implemented in Response to the Repetitive Strain Injury Associated with Sterile Compounding. Int J Pharm Compd. 2021;25(3):182-186.
10. Ergonomic Program. Occupational Safety and Health Administration, Department of Labor. Accessed April 4, 2026. https://www.osha.gov/laws-regs/federalregister/1999-11-23?utm_source=chatgpt.com
11. Winiarski S, Molek-Winiarski, Chomatowska B. From Motion to Prevention: Evaluating Ergonomic Risks of Asymmetrical Movements and Worker Well-Being in an Assembly Line Work. Appl. Sci. 2025;15(2): 560. https://doi.org/10.3390/app15020560
12. Ramsey JG, Musolin K. Ergonomic Evaluation of Pharmacy Tasks. Centers for Disease Control and Prevention. March 2025. Accessed May 7, 2026. file:///C:/Users/Jeannette/Downloads/cdc_53113_DS1.pdf
13. Pharmaceutical Measurement: Sensitivity Requirement, UH PHAR 4330.Accessed April 5, 2026. https://uhphar-4330.herokuapp.com/module/pharmaceutical_measurement/topics/sensitivity_requirement
14. [No author.] Are Analog Scales Accurate? | Precision Weighing Uncovered. Accessed April 4, 2026. https://snuggymom.com/are-analog-scales-accurate/?utm_source=chatgpt.com
15. Bilger R, Chereson R, Salama NN. Should Torsion Balance Technique Continue to be Taught to Pharmacy Students?. Am J Pharm Educ. 2017;81(5):85. doi:10.5688/ajpe81585
16. How Does a Digital Scale Work: Science of Accurate Weighing. Dwinley. Accessed April 4, 2026. https://www.develoscale.com/how-does-a-digital-scale-work/?utm_source=chatgpt.com
17. How Digital Scales Work. transcell. Accessed April 4, 2026. https://transcell.com/how-digital-scales-work/?utm_source=chatgpt.comC1
18. Geometric Dilution and Mixing Accuracy; The “Folding” Technique: Mastering the Science of Uniformity. Council Pharmacy Standards. Accessed April 5, 2026. https://pharmacystandards.org/chpop/section-6-2-geometric-dilution-and-mixing-accuracy/
19. How Compounding Pharmacies Mix Compounds. August 21, 2020. Accessed April 3, 2026. https://blog.bigcountry.pharmacy/how-compounding-pharmacies-mix-compounds
20. Tompson E/ Battle of the Mixers: Unguator® vs Ointment Mill. Total Pharmacy Supply. September 1, 2020. Accessed April 3, 2026. https://totalpharmacysupply.com/blog/battle-of-the-mixers-unguator-vs-ointment-mill?srsltid=AfmBOooAssIl2pWSwGujJukQDV0ttxCidauImm9YbX5rrmXDwrj63QX8
21. McElhiney LF. Equipment, supplies, and facilities required for hospital compounding. Int J Pharm Compd. 2006;10(6):436-441.
22. The Ointment Mill Process. EXAKTUSA. Accessed April 3, 2026. https://exaktusa.com/the-ointment-mill-process/?srsltid=AfmBOoqKC6w7VJeJP08YNZz378oMvJYfFMIX_q5UlZ7g87SGJA8CHtkw
23. What is a Homogenizer and How Does It Work? Maxwell Machine. October 18, 2024. Accessed April 3, 2026. https://www.maxwell-machine.com/what-is-a-homogenizer-and-how-does-it-work
24. How a Capsule Filling Machine Works? URBAN, April 9, 2024. Accessed April 3, 2026. https://www.urbanpackline.com/blog/how-a-capsule-filling-machine-works.html
25. Types of Capsule Filling Machines – Design, Process, and Working Principle.Adinath International. Accessed April 3, 2026. https://www.adinathmachines.com/blog/types-of-capsule-filling-machines-design-process-and-working-principle/
26. 10 Best infuser machines of 2026. Best Product Reviews. May 7, 2026, Accessed May 7, 2026. https://www.bestproductsreviews.com/infuser-machine?msockid=3df02430d43f62fd03fa32e1d580631e
27. Naviglio D, Scarano P, Ciaravolo M, Gallo M. Rapid Solid-Liquid Dynamic Extraction (RSLDE): A Powerful and Greener Alternative to the Latest Solid-Liquid Extraction Techniques. Foods. 2019;8(7):245. Published 2019 Jul 5. doi:10.3390/foods8070245
28. Ahmed S, Alsharif KF, Aschner M, et al. A deep dive into herbal extraction: Techniques, trends, and technological advancements. S Afr J Bot. 2026;188:9-37. doi:10.1016/j.sajb.2025.11.005
29. Magnetic stirrer. In: ScienceDirect Topics. Elsevier. Accessed April 10, 2026. https://www.sciencedirect.com/topics/engineering/magnetic-stirrer
31. Hotplate stirrers: performance and safety considerations. Thermo Fisher Scientific. Accessed April 10, 2026. https://www.thermofisher.com
30. USP General Chapter <795> Nonsterile Compounding. U.S. Pharmacopeia; current revision. Accessed April 10, 2026. https://www.usp.org
32. Stirring and mixing basics. Cole-Parmer. Accessed April 10, 2026. https://www.coleparmer.com
33. Mixing technology: theory and applications. IKA Works, Inc. Accessed April 10, 2026. https://www.ika.com
34. Hotplate Maintenance: Tips and Troubleshooting. Camlab. Stir bar inspection and replacement guidance. VWR International. Accessed April 10, 2026. https://www.camlab.co.uk/blog/how-to-clean-a-hotplate-stirrer
35. Sterile drug products produced by aseptic processing—current good manufacturing practice guidance for industry. FDA; 2004. Accessed April 10, 2026. https://www.fda.gov
36. Peristaltic pump filling systems: principles and applications. Watson-Marlow Fluid Technology Solutions. Accessed April 10, 2026. https://www.wmfts.com/en-us/support/pump-principles/peristaltic-pumps-how-they-work/
37. Holdich RG. Fundamentals of particle technology and liquid handling. AIChE J. 2002;48(1):15-28. doi:10.1002/aic.690480103
38. Marriott JF, Wilson KA, Langley CA, Belcher D. Pharmaceutical Compounding and Dispensing. 2nd ed. Pharmaceutical Press; 2010.

Patient Safety: Blueprints Before Builds: Patient Assessment in Clinical Decision-Making -RECORDED WEBINAR

The University of Connecticut School of Pharmacy and Pharmaceutical Sciences 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 CE Hours (or 0.1 CEUs) for completing the activity ACPE UAN 0009-0000-26-013-H05-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

Blueprint Before Builds: Patient Assessment in Clinical Decision-Making

Post-Test Questions for Enduring Recorded Webinar

26-013

1.Which of the following correctly lists the components of the Pharmacists’ Patient Care Process?

a. Implement, Follow Up, Collect, Determine

b. Organize, Manage, Follow Up, Plan

c. Collect, Assess, Plan, Implement, Follow Up: Monitor and Evaluate

2. Is the medication list an objective or subjective data?

a. Objective

b. Subjective

c. Can be both objective and subjective data

3. What is PQRSTAU?

a. A mnemonic for questions to ask a patient presenting with a chief concern.

b. A mnemonic for the elements of social determinants of health.

c. A mnemonic for items to determine medication appropriateness.

4. What is a potential pitfall in the Assessment step of the Pharmacists’ Patient Care Process?

a. Taking into account the contributions of social determinants of health in the evaluation of the patient’s health status.

b. Understanding that the patient’s most important health priority (ie, the patient’s problem #1) may not be the same as that of the healthcare professional.

c. Not asking the “why” question if a patient has declined a treatment recommendation.

5. What is one strategy that healthcare professionals can utilize to prioritize patient-centered care into the patient assessment and decision-making process?

a. Ask the patient about their goals for their medical condition(s) and overall health and engage in shared decision-making as part of the treatment plan.

b. Remind the patient that you as a healthcare professional know best and encourage them to comply with the treatment plan.

c. Collect data from the patient only to minimize biases from others such as the caregiver or visiting nurse.

6. What are the components of the 4M Framework for Age Friendly Health Systems that can be applied to clinical decision-making when caring for older adults?

a. What Matters, Medications, Mentation, Mobility

b. Monitoring, Motivation, Money, Mindset

c. Medication, Management, Monitoring, Measurement

LAW: The Legal Blueprint: Designing Error-Proof Pharmacy Policies -RECORDED WEBINAR

The University of Connecticut School of Pharmacy and Pharmaceutical Sciences 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 CE Hours (or 0.1 CEUs) for completing the activity ACPE UAN 0009-0000-26-010-H03-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

The Legal Blueprint: Designing Error-Proof Pharmacy Policies

Pharmacist Post-test

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

RECALL the key governing bodies and their roles
RECOGNIZE important details, dates, and timelines for a pharmacy manager
DESCRIBE the duties of pharmacy technicians and interns
DETERMINE the roles and responsibilities of a pharmacy manager
IDENTIFY key pharmacy laws that pharmacy managers should implement in practice

1. Which government agency creates and enforces regulations for all consumer products, including pharmaceuticals?

a. The Food and Drug Administration (FDA)

b. The Drug Enforcement Agency (DEA)

c. The Joint Commission (TJC)

2. According to federal law, pharmacies looking to receive Medicare reimbursement must retain prescription records for how many years?

a. Two

b. Three

c. Ten

3. What state requirements led to local controversy and pharmacy closures in Maine and other rural states?

a. Pharmacy technician ratios

b. Hours of operation

c. Electronic prescribing laws

4. How do interns and technicians differ in their responsibilities?

a. Interns can perform pharmacist tasks including compounding, dispensing medications, and other services with pharmacist supervision

b. Interns can receive refill authorizations from practitioners, given the prescription is identical to the previous refill and not a controlled substance

c. Interns can verify prescriptions filled by other interns or technicians for all medications except controlled substances

5. What technician certification is required in some states, but allows pharmacies in other states to have higher technician:pharmacist ratios?

a. Certified Pharmacy Technician (CPhT)

b. Bachelor of Science

c. Pharmacy Intern License

6. Which of the following BEST describes the pharmacy manager's responsibilities?

a. Licensing statuses of other pharmacy personnel.

b. Maintaining the pharmacy in clean, sanitary order.

c. Managing everything that occurs in their pharmacy.

7. Which of the following are federal compliance training requirements for staff members to complete annually and/or upon hire?

a. Pseudoephedrine, Fraud, Waste, & Abuse, and HIPAA

b. Phenylephrine, Fraud, Waste, & Abuse, and HIPAA

c. Pseudoephedrine, Fraud, Waste, & Abuse, and pharmaceutical calculations

8. Before prescribing contraceptives to a patient, which of the following must pharmacists complete?

a. Review OBRA 1990 policies and procedures to ensure they are following the United States Medical Eligibility Criteria for Contraceptive Use.

b. Complete extra courses for training and screening patients upon request for contraceptives as required by the state.

c. Nothing. After recent law changes pharmacists are eligible to prescribe any contraceptive upon request of the patient.

9. A shopper, not a registered patient, comes to your pharmacy counter and asks your technician to purchase hypodermic needles. How is your technician taught to proceed?

a. Any patient can receive hypodermic needles with a prescription. Because the patient is presenting without one, they cannot receive any needles.

b. Many states limit the sale of over-the-counter needle sales; the technician may sell needles over-the-counter up to that limit.

c. Your technician can sell hypodermic needles over-the-counter, but it can only be to regular patients that you recognize with special diagnoses. Notify the patient they can receive needles if they have their prescriptions transferred from their regular pharmacy.

10. In terms of pharmacy, what was the original goal of OBRA 1990?

a. Retrospective DURs could help the federal government make more money and cut financial deficits.

b. Improving the quality of dispensing for medicaid beneficiaries.

c. Develop a series of record keeping requirements for pharmacy licensing.

Load-Bearing Walls: Getting Cardiovascular Therapy Right the First Time -RECORDED WEBINAR

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

Identify high-risk cardiovascular medications that are most commonly associated with preventable adverse drug events amid transitions of care

Describe evidence-based principles for precise cardiovascular medication dosing, including clinically relevant pharmacokinetic considerations that influence drug and dose selection

Explain the benefits and limitations of clinical decision support tools in cardiovascular pharmacotherapy

Recognize common system-level and cognitive factors contributing to cardiovascular medication near misses and adverse effects

The University of Connecticut School of Pharmacy and Pharmaceutical Sciences 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 CE Hours (or 0.1 CEUs) for completing the activity ACPE UAN 0009-0000-26-009-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

1. Which of the following medications would be considered high risk for error during the medication reconciliation process?

Apixaban
Citalopram
Fexofenadine

2. Upon daily chart review, you identify that Jack has an AKI and review his medications for necessary adjustments. Which of the following is most appropriate regarding his apixaban?

Continue to hold anticoagulation given increased bleeding risk
Stop apixaban and start rivaroxaban 15mg daily instead
Consider transitioning to heparin via aPTT measurement until AKI resolves

3. The team decides to start Jack on oral amiodarone 400mg TID x 3 days, 200 mg TID x 3 days, then 200 mg daily. Which of the following is most important for the pharmacist to ensure at discharge?

Ensure the prescription is sent to the patient's home pharmacy for easy refills
Confirm that thyroid function tests are ordered and assessed before starting the amiodarone
Suggest starting sotalol instead for better rate control

4. Which strategy can optimize clinical decision support for high-risk cardiac medications?

Prevent ordering of any anticoagulant except apixaban to ensure standardization
Integrate most recent SCr values and dosing recommendations into sotalol orders
Block order entry of amiodarone by prescribers if all baseline labs are not checked

5. The Epic medical record has the advantage of having access from outside health systems. The VAMC has a secure medical record that cannot be accessed. Jack gets most of his care and his medications at the VA. Which of the following factors increases his risk for experiencing medication errors?

Fragmented medical records
Use of a single pharmacy
Poor insurance coverage

6. Jack's SCr is stable but remains elevated. Following diuresis, he is found to be cachectic and euvolemic with a “dry" weight of 58 kg. You recommend decreasing his apixaban to 2.5 mg BID but receive pushback from the provider as "this was his home dose." What kind of bias does this reflect?

Anchoring bias
Automation bias
Availability bias

Immunization: Our Best Shot – Tips and Tools to Vaccinate Older Adults – 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 0009-0000-24-047-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.

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.

Immunization: Our Best Shot - Tips and Tools to Vaccinate Older Adults

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

• Recognize appropriate vaccine recommendations for the older adult population
• Identify potential barriers to vaccinations
• Analyze current methods used to improve vaccination rates
• Discuss ways to improve vaccine compliance in your patient population

1. How many vaccines does the CDC strongly recommend for older adults?
a. Just two: influenza and COVID
b. Three: influenza, COVID, and RSV
c. Six-ish!!! (It depends)

2. New patient, ES, age 60, has recently moved to Connecticut from Ontario, Canada. The patient reports receiving Zostavax 1 month ago. Which of the following recommendations regarding the administration of Shingrix is correct?
a. Shingrix is contraindicated in those who have received Zostavax.
b. It is recommended to administer the Shingrix vaccine immediately.
c. It is recommended to wait at least 8 weeks after receiving Zostavax.

3. Which of the following situations might act as a barrier to vaccine uptake in older adults?
a. The nearest pharmacy and healthcare facilities are miles away and not on a bus route.
b. Other people at the senior center have had COVID, the flu, or shingles recently and been quite ill.
c. Pharmacy staff asks pleasantly and often if they might be ready to be vaccinated.

4. Which of the following is an example of a contextual influence as defined by the Vaccine Hesitancy Determinants Matrix?
a. Personal experience with vaccinations
b. Communication and media environment
c. Mode of vaccine administration

5. Which of these programs is a federal program that uses digital outreach, television, print, and radio to decrease vaccine hesitancy among older adults?
a. Risk Less, Do More
b. It’s a Sure Shot
c. No Shot in the Dark

6. You’re monitoring vaccine uptake in your community and it is alarmingly low. You decide to use the S-H-A-R-E method of encouraging vaccine uptake. What does the R stand for?
a. Remind patients that getting a vaccine-preventable disease is costly
b. Remind patients that vaccines protect them and their loved ones
c. Remind patients that you have the vaccines they need in stock

Share the tailored reasons why the recommended vaccine is right for the patient
Highlight positive experiences with vaccines (anecdotal or in practice) to strengthen confidence
Address patient questions and concerns about the vaccine
Remind patients that vaccines protect them and their loved ones
Explain the potential costs of getting the disease

Right Fit, Tight Seal: Building Better Cancer Care -RECORDED WEBINAR

The University of Connecticut School of Pharmacy and Pharmaceutical Sciences 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 CE Hours (or 0.1 CEUs) for completing the activity ACPE UAN 0009-0000-26-012-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.

Right Fit, Tight Seal: Building Better Cancer Care

26-012 P Home study

Posttest Questions

Cancer patients are often met with varying degrees of fear and stigma which can negatively impact their outcomes. Which of the following is the best method to mitigate these concerns?
1. Affirming that cancer is a medical condition rather than the consequence of poor personal choices
2. Encouraging patients to hold questions and concerns until you complete all aspects of medication counseling
3. Requesting that family and friends remain out of these counseling discussions as to not violate HIPPA

Patients and healthcare professionals alike often encounter overlapping barriers in their pursuit of obtaining and providing quality care. What are some common barriers?
1. Treatment complexity, adherence and tolerability, cost and accessibility
2. Workplace burnout, annual salary, insurance approvals
3. Image and self-worth, fear and misconception, treatment burden

The current lifetime probability of developing any cancer in the United States is one in three people. Which age group is most commonly affected?
1. Children and adults 0 to 30 years of age
2. Adults 30 to 49 years of age
3. Those 50 years of age and older

Which of the following barriers to care do both patients and providers share as concerns?
1. Managing adverse events and assessing their impact on quality of life
2. Alleviating patient fears with education and defining goals of therapy
3. Navigating drug-drug interactions with complex treatment regimens

A large population of the United States remains uninsured or underinsured. What options are available for these populations to help patients afford treatment?
1. 340b programs, grants, free drug programs
2. 340b programs, Mark Cuban Cost Plus Drug, free drug programs
3. Manufacturer copay cards, discount cards, Medicare payment plan (M3P)

A Medicare patient has a high copay for his oncology drugs. He calls Medicare and asks if he can use an American Cancer Society grant, a free drug program, or a Manufacturer Copay Card. Which programs does the Medicare representative say are OK to use?
1. An American Cancer Society grant, a Free Drug Program
2. A Free Drug Program, a Manufacturer Copay Card
3. A Manufacturer Copay Card, an American Cancer Society grant

LAW: Behind the Counter Crimes: Fraud and Diversion in Pharmacy

Healthcare fraud places an enormous strain on the healthcare system, with loss estimates ranging in the hundreds of billions of dollars. Federal laws and regulations exist to prevent and address fraud in healthcare. Pharmacy team members must understand healthcare regulations to maintain accurate, legal, and ethical practice and to identify and address suspected fraud. Medication diversion poses substantial risk to patients, healthcare workers, and healthcare facilities. It can carry significant financial and legal consequences. Although diversion has traditionally been associated with controlled medications, the incidence of non-controlled diversion has been rising. These medications may be desirable due to their potential for resale, physiological effects, or role in opioid use disorder. Identifying red flags, implementing preventive practices, and reporting suspected diversion appropriately can help to minimize diversion and prevent potential harm.

INTRODUCTION

Meet Charlie. Charlie is a newly licensed pharmacist who is excited to start his new job at a busy community pharmacy. During his training, a more experienced coworker, Hazel, instructs Charlie to override insurance claim rejections. She shows him the prior authorization override code to submit claims. She tells him, “You don’t actually need to contact the prescriber and have them obtain prior authorization for it to work. It’s just a workaround everyone does.”

The next day, the insurance program rejects a prescription for Reimbursitol because it requires prior authorization. Its cash price is more than $1,000, and Charlie dreads informing the patient. Hazel tells Charlie to enter the override code, even though they have not contacted the provider and the insurer has not approved the prior authorization. The claim goes through, and the pharmacy receives payment for Reimbursitol. Charlie is eager to fit in and lacks experience, and this workaround streamlines his workflow, so he follows this process for several prescriptions over the next few weeks.

Healthcare fraud imposes an enormous burden on the healthcare system. Experts estimate that fraud accounts for 3% to 10% of healthcare expenses annually, resulting in billions of dollars lost each year.¹ In 2024, the United States (U.S.) spent $5.3 trillion on healthcare, or about $15,474 per person. A large share of this spending was divided among the following²

Medicare: $1.118 billion (21%)
Medicaid: $932 billion (18%)
Private health insurance: $1.645 billion (31%)
Out-of-pocket spending: $557 billion (11%)

Based on these figures, fraud could account for losses of $159 billion to $530 billion in just one year.

Not only does fraud affect healthcare on a national level, but it directly impacts pharmacies. For example, in 2019, an independent pharmacy chain allegedly submitted false claims to Medicare and Medicaid for prescription medications by switching from a lower cost to a higher cost product without a medical need or prescription. Investigators allege that pharmacy staff switched patients from an inexpensive to an expensive medication and billed federal healthcare programs for reimbursement of the high-cost item. This change in therapy inflated the complexity of the product dispensed, which was not medically necessary and resulted in larger reimbursement payments, In some cases, the pharmacy dispensed the expensive item and billed federal payors without a valid prescription. The case resolved in 2022 with the pharmacy paying $2.05 million and implementing training programs regarding fraud and compliance.^3,4

The water can sometimes seem muddy when it comes to billing practices and legal regulations. Understanding the laws and regulations that govern healthcare can enable pharmacy team members to identify, report, and prevent fraud and abuse, rather than falling victim to unsavory practices.

FRAUD, ABUSE, AND WASTE: WHAT'S THE DIFFERENCE?

Although fraud, waste, and abuse are often grouped together, each carries a distinct definition, intent standard, and regulatory implication.

Fraud is an intentional deception or misrepresentation that could result in an unauthorized benefit. It is intentionally wrongful and considered criminal.^5,6 An example of fraud is billing for services that were not provided.⁷

Abuse is provider practices that are inconsistent with accepted practices, resulting in an unnecessary cost to the health care system. There is usually not criminal intent, but it still leads to financial loss by the payor.^5,6 An example of abuse is billing for medically unnecessary services.⁷

Waste is misuse or inappropriate use of resources that results in unnecessary costs to the healthcare system. It is not associated with deceptive intentions.⁶ An example of waste is ordering excessive or unnecessary tests or services.

See the SIDEBAR for a quick overview of additional law terminology.

SIDEBAR: A (Very) Brief Law Terminology Refresher^8,9

Law: A broad term for all rules that govern conduct, such as statutes, ordinances, and regulations. For example, the Controlled Substance Act is a federal law regulating agents with potential for abuse.

Act or statute: Both refer to a specific type of law. An act is a formal, written law passed by a legislative body, such as Congress or state legislature. A statute refers to the written law itself, typically as it is codified in the U.S. Code. For example, the False Claims Act began as a bill in January 1863. When President Lincoln signed it in March 1863, it became law. It is currently published in the official U.S. federal code as 31 U.S.C. §§ 3729–3733.

Ordinance: A local law in place to ensure public safety, health, and general welfare. Ordinances often regulate fire and safety regulations, housing standards, parking regulations, snow removal, littering, public streets and sidewalks, and zoning. Examples of ordinances pertaining to pharmacy include zoning, signage, and operating hours.

Regulation: A rule issued by administrative agencies that have legislative authority over a specific area to enforce rules or statutes. For example, the state board of pharmacy may regulate how many CE hours pharmacists and technicians must complete each year, or for how many years documentation must remain on the pharmacy premises.

Table 1 offers a brief side-by-side look at civil versus criminal law.

Table 1. Overview of Criminal Law vs. Civil Law^10-12

	Criminal Law	Civil Law
Objective	Punish wrongdoing and protect society	Settle disputes between individuals or entities
Initiating party	State/federal government (prosecutor)	Private party (plaintiff)
Burden of proof*	Very high: beyond a reasonable doubt	Lower standard: Preponderance of the evidence (must be proven more than 50% likely that plaintiff’s claims are true)
Potential penalties	Jail/prison, fines	Financial compensation
Examples	Theft, assault, arson, murder	Breach of contract, personal injury, property disputes
Pop Culture Example (TV)	Law & Order	Judge Judy

*Burden of proof is the responsibility to present enough evidence to win the case and meet the applicable legal standard. It usually lies with the party initiating the case. In other words, the prosecutor or plaintiff must find the defendant guilty rather than the defendant proving their innocence.

COMPLIANCE IN ACTION: FEDERAL LAWS AND REGULATIONS

Several federal laws and regulations are in place to prevent and address fraud. The False Claims Act (FCA), Anti-Kickback Statute (AKS), Physician Self-Referral Law (Stark Law), and HIPAA establish important compliance requirements for healthcare.

False Claims Act (FCA)

The False Claims Act (FCA; 31 U.S.C. §§ 3729–3733) is a civil federal statute dating back to 1863 in response to contractor fraud during the American Civil War.¹³ Still in effect today, the FCA allows the federal government to recover losses through civil lawsuits for false or fraudulent claims, seek financial penalties, and pursue criminal charges for that conduct.¹⁴

Knowingly submitting false claims or conspiring to submit false claims violates the FCA.¹³In the healthcare setting, the FCA applies whenever a federal payor is involved, such as Medicare or Medicaid. Examples of healthcare-related FCA violations include submitting false or fraudulent claims for payment, billing for services not rendered, and upcoding (billing for a more expensive service than was actually obtained by the patient).¹⁵

Civil liability under the FCA does not require a specific intent to defraud. In its definition, the FCA uses the term “knowingly” to include individuals who knew the claim was false, deliberately ignored that it was false, or ignored signs that it was false. Violations carrying civil liability consist of recklessness or deliberate ignorance and do not require intent. In other words, an individual who “looks the other way” or “should have known” may be violating the FCA.¹⁶

Civil penalties under the FCA are up to three times the government’s loss plus inflation-related fines ($11,000 for Medicare or Medicaid fraud) per claim. Because each item or service billed counts as a claim, losses and fines can accumulate quickly.¹⁶ The FCA includes a whistleblower provision (“qui tam”), which allows private citizens to submit a claim on the government's behalf for a share of recoveries, usually between 15% to 30%.³ Whistleblowers can be business partners (current or former), hospital or office staff, patients, or competitors.^13,16

In addition to seeking civil penalties under the FCA, the government may also bring criminal charges where appropriate. More severe cases—those with intentional fraud—may face criminal prosecution. Criminal penalties include imprisonment and criminal fines.¹⁶

Anti-Kickback Statute (AKS)

The Anti-Kickback Statute (AKS; 42 U.S.C. § 1320a-7b(b)) ensures that healthcare providers make clinical decisions objectively and appropriately based on patient need, not financial incentive. This federal criminal law prohibits knowingly and willfully offering, paying, soliciting, or receiving remuneration to entice or reward referrals. It also prohibits creating federal healthcare business involving items or services that are reimbursable by programs like Medicare, Medicaid, or other federal health programs. Remuneration is considered anything of value, and in this instance, it covers a wide range. Examples include–but are not limited to–free rent, hotel stays, meals, bribes, rebates, and excessive compensation.¹⁶

The AKS applies to both the party offering the kickback and the party receiving it. This means that it is illegal to accept payment for referring patients, and it is illegal to pay to have patients referred.¹⁶

AKS violations carry both criminal and civil penalties that can be extensive and overlapping. Violations of the AKS are classified as felony crimes under federal law and can result in jail time.¹⁶ Criminal penalties can include fines up to $25,000 per violation and/or up to a 5-year prison term. Civil penalties fall under the Civil Monetary Penalties Law and carry penalties of up to $50,000 per kickback plus up to three times the remuneration value.

Furthermore, AKS violations may also create liability under the FCA and incur the penalties associated with FCA violations. In addition to the criminal and civil penalties, AKS violations can result in ineligibility to participate in federal health care programs.^14,16

Physician Self-Referral Law (Stark Law)

The Physician Self-Referral Law (42 U.S.C. § 1395nn), often called the Stark Law, is a civil law that prohibits physicians from referring Medicare or Medicaid patients for designated health services (DHS) to parties with which the physician or an immediate family member has a financial relationship, unless an exception applies. Simply put, physicians should not profit by referring patients to services in which they have a financial stake.¹⁶ See Table 2 for a list of DHS.

Table 2. Stark Law Designated Health Services (DHS)¹⁷

1. Clinical laboratory services

2. Physical therapy

3. Occupational therapy

4. Outpatient speech-language pathology

5. Radiology and certain other imaging

6. Radiation therapy

7. Durable medical equipment and supplies

8. Parenteral and enteral nutrients, equipment, and supplies

9. Prosthetics, orthotics, and prosthetic devices and supplies

10. Home health services

11. Outpatient prescription drugs

12. Inpatient and outpatient hospital services

The Stark Law is a strict liability statute, meaning that a violation can exist even without specific intent to break the law. Any violation—even an accidental one—is a violation of the Stark Law.¹⁶

Civil penalties include fines and ineligibility to participate in federal healthcare programs.¹⁶Although the Stark Law addresses physician referrals, pharmacists and technicians may be indirectly affected. For example, if a physical refers Medicare or Medicaid patients to a pharmacy which he or she has a financial interest, it may violate the Stark Law, unless an exception applies. A complete list of regulatory exceptions to the Stark Law is beyond the scope of this activity; however, exceptions that may apply to a pharmacy setting include the in-office ancillary services exception, bona fide employment relationships, and fair market value compensation arrangements.^18,19Pharmacy team members can contact their legal or compliance departments if concern exists regarding Stark Law and/or its exceptions.

Health Insurance Portability and Accountability Act (HIPAA)

While HIPAA is often perceived as primarily protecting patient privacy, it includes fraud provisions. It is a crime to knowingly use, obtain, or disclose protected health information (PHI). Criminal penalties for HIPAA violations, addressed under 42 U.S.C. § 1320d–6, can be substantial and vary depending on the nature and extent of the violation. A basic violation can result in fines up to $50,000 and/or up to 1 year in prison. When committed under false pretenses, the fines increase to no more than $100,000 and/or up to 5 years in prison. The intent to sell, transfer, or use PHI for personal gain increases the fines even further to a maximum of $250,000 and/or 10 years in prison.^20,21

Understanding the functions of key regulatory bodies can illustrate the many moving parts involved in governing healthcare. The SIDEBAR summarizes these organizations briefly.

SIDEBAR: Regulatory and Enforcement Agencies^7,22-27

The U.S. Department of Justice (DOJ) is the federal agency responsible for ensuring justice. It enforces federal laws, prosecutes cases, oversees federal law enforcement agencies such as the Federal Bureau of Investigation (FBI) and Drug Enforcement Agency (DEA), and manages prisons. The DOJ is headed by the Attorney General.

The Federal Bureau of Investigation (FBI) reports to the DOJ. It enforces federal criminal law and conducts investigations, and can investigate corruption, fraud, and organized crime.

The U.S. Drug Enforcement Administration (DEA) enforces controlled substance laws and regulations, including the manufacture and distribution of controlled prescription drugs.

The Office of the Inspector General (OIG) is a federal agency that aims to counteract fraud, abuse, and waste while maximizing efficiency and accountability in the Department of Health and Human Services programs. The OIG can audit, investigate, and inspect federal programs, especially Medicare and Medicaid programs, which comprise a large portion of the federal budget.

The Centers for Medicare and Medicaid Services (CMS) is a federal agency within the U.S. Department of Health and Human Services. CMS oversees and regulates federal healthcare programs such as Medicare, Medicaid, and State Children’s Health Insurance Program (SCHIP). CMS collaborates with individuals, groups, and law enforcement organizations to prevent and determine fraud and abuse.

State boards regulate healthcare professions by overseeing licensing and renewals, enforcing professional standards, and inspecting facilities. They may also take disciplinary action when standards are not met. There are many state healthcare boards, but only the following disciplines have prescribing authority or direct access to medications: pharmacy, nursing, medical, osteopathic, dentistry, optometry, podiatry, and veterinary.

From Laws to Practice: Examples of Pharmacy Fraud and Abuse

Remember Charlie? A month into his new job, he takes this CE program, reviews the earlier claims, and realizes that he entered override codes even though prior approval was never obtained. Charlie becomes worried that he might have followed bad advice.

PAUSE AND PONDER: Did Charlie knowingly commit fraud, or did he make a mistake after receiving misleading guidance? What responsibilities does Charlie have to correct past claims or disclose potential issues?

Fraud in healthcare can be committed by an individual, group, or organization.⁷ In the pharmacy setting, fraudulent activity often involves improper billing or reimbursement practices.

Pharmacy Billing and Reimbursement Fraud

Several types of billing fraud can occur in the pharmacy, such as billing for prescriptions that were never dispensed (“phantom claims”), dispensing a different quantity than prescribed without documentation, or refilling prescriptions without authorization. Additional fraudulent billing practices include billing for a brand-name drug while dispensing a generic (or billing for a more expensive generic than what was dispensed), adding medications to prescriptions without dispensing them, and submitting claims without an invoice to document purchase.²⁸

What does this look like in pharmacy practice? Here are two real-life examples involving mismatched quantities coming in versus quantities going out: A pharmacy did not have documentation supporting the medication quantities billed to Medicaid as compared to the quantities purchased from vendors over four years. The case settled for $1,333,660. Another pharmacy had similar documentation gaps; the case settled for $42,521.²⁸

See the SIDEBAR for more real-world examples of fraudulent healthcare schemes and consequences.

SIDEBAR: From the Headlines: Health Care Fraud Cases Involving Pharmacists^29-36

Between 2017 and 2022, a pharmacist submitted fraudulent claims to Medicare for medications that were never dispensed in violation of the FCA. He created fake patient profiles and fraudulent prescription entries, resulting in more than $1 million in Medicare payments to the pharmacy. In 2023, the pharmacist plead guilty to one count of healthcare fraud and was sentenced to 2 years in federal prison (after facing a maximum of 10 years). He was also ordered to pay $1.138 million in fines and restitution, and the state board of pharmacy ordered that he surrender his license.

From June 2014 to June 2020, a pharmacist defrauded Medicare and Kentucky Medicaid by billing for prescriptions that patients never received in violation of the FCA. The pharmacist also submitted inflated reimbursement claims by billing for expensive diabetic test strips while dispensing a less expensive item. The pharmacy collected $627,614 from the healthcare payors for the fraudulent prescriptions and $102,441 for the fraudulent test strip claims. She was sentenced to 20 months in prison with 2 years’ probation after release. She was also ordered to pay $730,056 in restitution, and she surrendered her license.

A pharmacist who owned a pharmacy and served as the pharmacist-in-charge coordinated a healthcare fraud scheme with two co-schemers, resulting in more than $300 million in fraudulent Medi-Cal (California’s version of Medicaid) claims. In early 2022, Medi-Cal suspended its prior authorization requirements while transitioning to a new payment system. From May 2022 to March 2023, the pharmacy billed Medi-Cal $306,521,392 for high-reimbursement, non-contracted generic drugs that normally would have required prior authorization and received approximately $204,032,151 in payments. Investigators allege that these medications were not medically indicated, often weren’t dispensed, and involved kickbacks to the two co-schemers. The co-schemers allegedly received more than $36 million in kickbacks, which the pharmacist referred to as “consulting services.” One co-schemer was a nurse practitioner who received kickbacks for writing the fraudulent prescriptions without evaluating patients, medical records, or medical necessity. The state charged her with two counts of healthcare fraud. The other co-schemer was involved in laundering money from the fraudulent payments and has been charged with one count of healthcare fraud. In August 2024, the pharmacist pleaded guilty to two counts of healthcare fraud. At the time of this writing, he is awaiting sentencing and facing a maximum of 10 years in jail for each count of healthcare fraud. This conduct not only violated the FCA by submitting claims for services not performed but also violated the AKS.

Medical Provider Healthcare Fraud

Healthcare providers may also commit fraud. Examples can include double billing (submitting multiple claims for the same service), phantom billing (billing for a service, visit, or supplies that was never received), unbundling (billing components of a service separately), or upcoding.²²

Patient or Individual Fraud

Although not the focus of this activity, pharmacy staff should be aware of fraudulent schemes involving patients or individuals. Examples include forged or altered prescriptions, doctor shopping (seeing multiple providers to obtain prescriptions for controlled substances), diversion (selling one’s prescription medication), health care provider impersonation (billing for services or supplies without a license to do so), and benefit card abuse (using someone else’s health care card or allowing someone else to use it).²² Awareness of these patterns may help pharmacy staff recognize fraudulent activities.

Speak Up! Don’t Look Away: Addressing Fraud and Abuse

Prompt reporting of suspected fraud is critical to maintain compliance with laws and regulations, and to maintain the financial viability of the healthcare system. There are several ways to report suspected fraud or abuse.⁷

In some cases, self-reporting may result in less severe penalties.²⁸ If one realizes the billing process was questionable, the very first step is to stop submitting problematic claims. Next, individuals should consider obtaining legal counsel specializing in healthcare fraud to evaluate legal practices or risks. Individuals should determine how much money was collected in error and return overpayments. If an investment or suspicious relationship is involved, end it! If appropriate, individuals should consider self-disclosure to CMS or OIG.⁷

So, what does Charlie do? He reports his concern to the pharmacy manager, who audits the claims and corrects the errors. Charlie and the pharmacy team receive additional training to prevent future mistakes. Hazel’s intent and the extent of her use of override codes—and those she influenced—were evaluated during the internal audit. No legal action is taken because the issue was caught early, reported internally, and corrected. Additionally, there was not intent to defraud—it appears to be negligent error.

The pharmacy manager uses the incident as a choose-your-own misadventure learning example. She discusses the following potential outcomes with Charlie:

If Charlie had continued billing incorrectly even though he knew or suspected it was wrong, he could have been subject to consequences including criminal charges, civil charges, or license suspension/revocation.
If the manager ignored Charlie’s concerns, the pharmacy and/or manager could have faced a federal investigation and penalties. Charlie could have been protected by whistleblower protection laws if he chose to file a file a qui tam case.
If the miscoding practices were discovered during a third-party audit, consequences could have included civil penalties and a criminal investigation (to determine intent) for the individuals involved and the pharmacy.
If Charlie had recognized and reported the miscoding right away, it would have triggered an internal investigation with possible disciplinary action for Hazel. It also would have eliminated Charlie’s liability.

Contact Information: How to Report Suspected Fraud or Abuse

If a beneficiary (patient) wants to report:

CMS Hotline: 1-800-MEDICARE (1-800-633-4227)

OIG Hotline: 1-800-HHS-TIPS (1-800-447-8477)

https://oig.hhs.gov/fraud/report-fraud/index.asp

U.S. Department of Health and Human Services

Office of Inspector General

ATTN: OIG Hotline Operations

PO Box 23489

Washington, DC 20026

Complaints specific to Medicare Part C or Part D: 1-877-7SafeRx (1-877-772-3379)

If a Medicare or Medicaid provider wants to report:

OIG Hotline: 1-800-HHS-TIPS (1-800-447-8477)

https://oig.hhs.gov/fraud/report-fraud/index.asp

U.S. Department of Health and Human Services

Office of Inspector General

ATTN: OIG Hotline Operations

PO Box 23489

Washington, DC 20026

Contact MAC (Medicare Administrative Claiming) (https://www.cms.gov/mac-info) or Medicaid State Agency

MAC can also address billing procedures, errors, or questionable practices

The OIG hotline is anonymous; however, providing contact information is preferred so that follow up can occur.⁷

DIVERSION AWARENESS FOR PHARMACY STAFF

Diversion is the unauthorized acquisition, use, or distribution of drugs.³⁸ It can occur with medications that fall under the Controlled Substance Act, such as opioids, benzodiazepines, and/or stimulants, and non-controlled medications.³⁹ Diversion can happen at any point in the supply chain and by either healthcare workers or patients.⁴⁰ This activity will focus on diversion by healthcare workers.

Diversion of Controlled Substances

Addiction often drives controlled substance diversion in healthcare environments, with opioids identified as the most frequently diverted medications.³⁸ Table 3 lists commonly diverted controlled substances. Diversion of controlled substances can cause significant harm to the patient, healthcare worker, and healthcare facility.

Table 3. Commonly Diverted Controlled Substances^38,40

Drug class	Examples
Opioids	codeine, fentanyl, hydromorphone, meperidine, morphine, oxycodone, methadone, hydrocodone combinations
Benzodiazepines	alprazolam, clonazepam, lorazepam
Stimulants	amphetamines, methylphenidate

Diversion of controlled medications by a healthcare worker can result in patient harm in several ways. Consider a hypothetical situation in which a healthcare worker tampers with a vial of an injectable controlled substance. The worker removes half of the contents for her own use and replaces the remainder with another clear liquid, which may or may not be sterile, using a technique that is definitely not sterile. Patient harm can result due to^41-43

An inadequate control of pain or anxiety from a subtherapeutic dose.
Risk of infection if the product administered is contaminated due to the addition of a nonsterile diluent or needle sharing. For example, two outbreaks occurred in 2018 due to contamination:
- An emergency department nurse in Washington diverted a medication and it resulted in 12 cases of hepatitis C
- A cancer center nurse diverted medication in New York leading to 6 cases of Sphingomonas paucimobilis bacteremia.
Risk of allergy or intolerance if the patient receives a drug other than the one prescribed due to diversion of the prescribed agent.
Potential for adverse outcomes, such as errors and complications, if a patient receives direct care from a healthcare worker who is actively and acutely impaired, as this impairment will significantly compromise clinical judgement.

Diversion also poses personal and professional harm to the healthcare worker, including the risk of overdose. Diversion and administration of injectable agents present the potential for infection due to unsterile or unsanitary self-injection techniques or contamination, along with transmission of bloodborne illnesses. Professional risks include felony prosecution, civil charges, and license suspension or revocation. The worker is also liable for fraudulent documentation in the medical record and fraudulent billing if the patient or insurance provider was billed for a medication that the patient did not receive.⁴²

Additionally, the risks associated with the diversion of controlled substances extend to the employer or healthcare organization. Regulatory and legal consequences include the ramifications of fraudulent billing, liability for damages, and diminished community confidence in the healthcare system.⁴¹

Behavioral patterns of healthcare workers may be associated with potential medication diversion. Red flags include^38,44

Unexpected absences or late arrivals
Disappearance from the worksite (frequent extended bathroom breaks or excessive time in the medication storeroom)
Extra time at work (appearance on scheduled days off, seeking overtime, early arrivals, staying late)
Consistently removing controlled substances towards the end of a shift
Erratic productivity
Errors with insufficient explanation
Poor relationships with colleagues, including isolation or avoidance
Insistence upon personal administration of injected medications to patients
Trends with waste: too much or too little, delaying waste documentation procedures until the end of shift, or documenting waste with a variety of healthcare colleagues
Trends with work areas: offering to work in non-assigned areas, preferring patients with controlled medications, or prioritizing work alongside new employees or orientees
Creating false orders or “prefill” orders

Diversion of Non-Controlled Substances

Let’s check in on Charlie. A few weeks go by, and Charlie is settling into his job. He has become more comfortable with the skills and responsibilities required in his position and is adapting to the workplace culture. He notices that Hazel likes to do things her way and on her own. When Charlie tries to unpack the refrigerated delivery one morning, she takes over, telling him “I always do this. It’s too hot to leave the refrigerated items out, and I’m the fastest at putting them away.” He also notices that she’s frequently on the closing shift. When he offers to stay late so she can go home on time, Hazel says “I’ve got it. My roommate borrowed my car and is picking me up late anyway, so I might as well be the one who stays.”

Recently, Charlie has had trouble filling prescriptions for a popular injectable GLP-1 receptor agonist medication. It seems that the pharmacy can’t keep it in stock, even though the ordering system shows several recent deliveries. Hazel often tells patients the medication is on backorder.

When reviewing two GLP-1 receptor agonist prescriptions marked as “returned to stock,” Charlie can’t find the product in the refrigerator. Hazel says they were restocked earlier, adding that she will adjust the inventory herself. Charlie also notices documentation that two additional boxes were “damaged due to temperature excursion,” but he doesn’t remember a recent refrigerator breakdown.

PAUSE AND PONDER: Does Hazel’s behavior demonstrate red flags? Why are discrepancies with non-controlled, high-cost medications concerning?

The incidence of non-controlled diversion has been rising. Because non-controlled medications may not be as tightly regulated as controlled medications, they may be easier to acquire through illegal means. Individuals may divert non-controlled medications, especially high-cost products, for their own use, resale, or to supply friends or family members who can’t afford the cost.³⁹

High-cost medications that are commonly diverted include antiretrovirals and oncology medications. Other agents often diverted are performance-enhancing agents (such as erythropoietin) and psychoactive medications (such as cyclobenzaprine, quetiapine, and trazodone).³⁹ The sedative and anxiolytic effects of atypical antipsychotics have increased their desirability for misuse or diversion. These medications can be used alone for insomnia or anxiety or in combination with other illicit substances for either calming or enhancing effects.⁴⁵

Another potential area for diversion involves medications used in the management of opioid use disorder, including diphenhydramine (for histamine-induced pruritus), ondansetron (for withdrawal-related nausea and vomiting), and naloxone (for overdose reversal).³⁹

Picking up the Pieces: Prevention and Reporting

In a perfect world, medications would make their way to patients without illegal interception by an intermediary. But this world—the real world—isn’t a perfect one, and diversion happens. How should the pharmacy team handle it?

At the end of the month, Charlie is reviewing a routine inventory variance report for high-cost medications. When he completes a physical count of the items in stock, Charlie finds that the pharmacy is short four boxes of the GLP-1 receptor agonist medication. The system shows two prescriptions that were billed and later reversed to “never picked up,” and two boxes that were documented as “temperature excursion — product damaged.” However, the refrigerator logs do not show temperature fluctuations for that time.

PAUSE AND PONDER: How should Charlie address this discrepancy?

The strongest defense is a good offense. Some strategies for preventing and detecting diversion include³⁸

Establishing a diversion program. This is a big task, and it can be challenging to find the time, energy, and resources when it is simply tacked on as an additional responsibility to an existing job description. Ideally, a position (or positions) would be dedicated solely to this role.
Establishing to whom the program reports internally—compliance, risk management, legal, pharmacy, nursing, and so on. This will vary depending on the size and structure of the organization.
If appropriate, including members across all disciplines in the organization, such as pharmacy, nursing, anesthesiology, medical directors, security, risk management, compliance, legal, human resources, occupational health, and employee assistance programs. Organizations can consider creating a subset Response Team for initial investigations.
Having policies for diversion monitoring, investigation, and events.
Conducting audits to identify and investigate discrepancies sooner rather than later. Early action may minimize risk to patients, employees, and the organization.

Monitoring for diversion of non-controlled medications may require a more nuanced strategy. Because these medications aren’t regulated as stringently as their controlled counterparts, they may be more easily diverted. The above recommendations apply for assessing non-controlled diversion, along with a few additional points³⁹

Identify non-controlled medications at risk for diversion and consider storing them like controls—locked and routinely inventoried.
Monitor inventory, especially noting excessive restocking and unexpected unavailability.
If appropriate and/or feasible, utilize diversion analytics software programs to identify access, dispensing, and behavior patterns.
For facilities with automated dispensing cabinets, review reports for overrides (who and what), canceled transactions, inventories, and discrepancies. Investigate any outliers.
Establish a confidential reporting system for employees.
Investigate and respond to all suspicious findings.
Educate employees about commonly diverted non-controlled medications and the steps provided by the facility to prevent, identify, and report suspected diversion.
Use staff feedback and facility data to evaluate and adjust the process as needed.

Charlie brings the discrepancy to the pharmacy manager, who begins an official internal audit. The audit shows that the claim reversals and inventory adjustments for the missing GLP-1 receptor agonist medications were completed with Hazel’s credentials. Security footage from two closing shifts shows Hazel placing small, boxed items from the refrigerator into her personal bag after other staff had left during times that correspond with the claim reversal.

PAUSE AND PONDER: How does reporting differ for controlled versus non-controlled discrepancies? What consequences could one expect for Hazel’s actions?

Controlled diversion requires reporting at local, state, and federal levels. Local law enforcement should be contacted, and the appropriate state licensing boards should be notified.^38,40,46 The state health department should be notified if patient risk occurs, such as tampering or product contamination.⁴³ If the diversion occurred after the prescription was filled and dispensed, it should be reported to the state Medicaid agency–even if it was filled using private insurance or cash. Incidents with diversion are often linked to other acts of fraud, waste, or abuse involving Medicaid, and reporting each occurrence may help to identify other activities.⁴⁰

Under federal regulations, DEA registrants (such as pharmacies) must notify the appropriate DEA field division office within one business day after discovery of significant loss of a controlled substance, and DEA Form 106 must be filed within 45 days.⁴⁷ Additionally, the FDA Office of Criminal Investigations (FDA-OCI) holds federal jurisdiction and can assist facilities when drug tampering of a controlled substance is involved.³⁸

Although controlled diversion carries stricter federal regulations, noncontrolled diversion is unethical, unprofessional, and can lead to significant legal and financial consequences, including license suspension. Incidents of non-controlled diversion usually are addressed by an internal investigation and documentation, state board notification, and local law enforcement notification.⁴⁶ Staff should correct insurance claims if applicable. Notification to the DEA is not required for non-controlled diversion.

How is the loss addressed at Charlie’s pharmacy? The pharmacy manager places Hazel on administrative leave and begins an investigation. Law enforcement is contacted regarding suspected internal theft of prescription medications. The compliance and legal departments are notified, the loss is documented, and the affected insurance claims are reviewed.

CONCLUSION

Where does this leave Charlie?

The next Saturday night, Charlie closes the pharmacy and meets with his new friend, Harry, who also works at the pharmacy.

“Well, this has been…” Charlie pauses to find the right words.

“Interesting,” volunteers Harry.

The two colleagues reflect on the past several weeks. They agree that they have both learned a lot in a short amount of time. They now understand the importance of accurate billing practices and prompt reporting of miscoding errors, and they appreciate that management implemented training to prevent future errors. They are also aware of medications with potential for diversion, along with behavioral red flags that may suggest suspicious activity. Charlie has even volunteered to spearhead a diversion program that encompasses both controlled and non-controlled products, including inventory assessment and staff education.

Together, they can look forward to stronger pharmacy practices related to billing accuracy, diversion prevention, and regulatory compliance.

Behind the Counter Crimes: Fraud and Diversion in Pharmacy
26-021 Pharmacist Post-test

After completing this continuing education activity, pharmacists will be able to
• Define fraud, waste, and abuse in healthcare
• Explain key federal laws and regulations that govern fraud and diversion
• Identify medications at increased risk for medication diversion and red flags associated with diversion
• Apply fraud and diversion prevention and reporting strategies

1. Which of the following is an example of healthcare fraud?
A. Billing for services not provided
B. Billing for medically unnecessary services
C. Ordering excessive or unnecessary services

2. What is the purpose of the FCA?
A. To ensure that healthcare providers make clinical decisions objectively based on patient need rather than financial incentive
B. To prohibit physicians from referring federally insured patients for designated health services with which the physician or an immediate family member has a financial relationship
C. To allow the federal government to recover losses and penalize fraud for false claims

3. To whom does the Anti-Kickback Statute (AKS) apply?
A. Only the party offering the kickback
B. Only the party accepting the kickback
C. The parties offering and accepting the kickback

4. What is “phantom billing”?
A. Submitting multiple claims for the same service
B. Billing for a service, visit, or supplies patients never received
C. Billing components of a service separately

5. Which class of controlled medications is most frequently diverted?
A. Opioids
B. Benzodiazepines
C. Stimulants

6. Which of the following is a behavioral red flag for diversion by a healthcare worker?
A. Consistent productivity when present (but frequent absences)
B. Extra, unnecessary time at work (i.e., arriving early or staying late)
C. Strong team relationships with co-workers

7. Jordan is initiating a diversion control program for both controlled and non-controlled medications. What are strategies he should include?
A. Keep the program secret so he can catch potential diverters without warning.
B. Leave existing storage and inventory procedures unchanged for non-controlled medications.
C. Develop policies, conduct audits, monitor inventory and investigate any outliers.

8. To maximize pharmacist productivity while generating extra income, a busy community pharmacy’s management team instructs its staff skip patient counseling but to bill insurance for Medication Therapy Management sessions. Which of the following is TRUE?
A. The pharmacy is engaging in fraudulent billing because it is submitting claims for services not provided.
B. The pharmacy is not engaging in fraudulent billing because staff is following the directions issued by the management team.
C. The pharmacy is not engaging in fraudulent billing because none of the staff are personally benefitting from financial gain from the billing practices.

9. Continuing from the case in question 8: A staff pharmacist grows concerned that these billing practices may be illegal. What should she do next?
A. Stop billing suspicious claims, obtain counsel, report to CMS or OIG, consider initiating a whistleblower case
B. Continue billing suspicious claims, document that she is following instructions from management
C. Continue billing suspicious claims, ask management for a “raise” since she is generating extra income for the business

10. Trixie is a pharmacist in a busy community pharmacy. On September 1, she completes a routine inventory the controlled substances and discovers a discrepancy of 30 tablets of oxycodone. This is considered a significant loss. By what day must the pharmacy file DEA Form 106?
A. September 2
B. September 8
C. October 15

Behind the Counter Crimes: Fraud and Diversion in Pharmacy
26-021 Pharmacy Technician Post-test

After completing this continuing education activity, pharmacy technicians will be able to
• Define fraud, waste, and abuse in healthcare
• Explain key federal laws and regulations that govern fraud and diversion
• Identify medications at increased risk for medication diversion and red flags associated with diversion
• Apply fraud and diversion prevention and reporting strategies

1. Which of the following is an example of healthcare waste?
A. Billing for services not provided
B. Billing for medically unnecessary services
C. Ordering excessive or unnecessary services

2. In which document would you find the whistleblower provision (“qui tam”), which allows private citizens to bring a claim on the government's behalf for a share of recoveries?
A. The Anti-Kickback Statute (AKS)
B. The False Claims Act (FCA)
C. Stark Law

3. What does the Anti-Kickback Statute do?
A. Ensures that healthcare providers make clinical decisions objectively based on patient need, rather than financial incentive
B. Prohibits physicians from referring federally insured patients for designated health services which the physician or an immediate family member has a financial relationship
C. Allows the federal government to recover losses and penalize fraud for false claims

4. What is “double billing”?
A. Submitting multiple claims for the same service
B. Billing for a service, visit, or supplies that was never received
C. Billing components of a service separately

5. Which of the following is a controlled medication that is frequently diverted?
A. Oxycodone
B. Naproxen
C. Quetiapine

6. Which of the following is a behavioral red flag for medication diversion by a healthcare worker?
A. Reliable attendance at work
B. Errors with insufficient explanation
C. Consistent productivity

7. Tina is a pharmacy technician at a busy community pharmacy. Lately the pharmacy has been dispensing expensive brand-name prescriptions, even when inexpensive generic equivalents are available. There is no documented medical need requiring the brand item. The pharmacy bills Medicare for the more expensive brand medication and receives a significantly higher reimbursement than it would for the generic. Which of the following best describes this billing practice?
A. The pharmacy is engaging in fraudulent billing practices because the pharmacy is intentionally billing for a more expensive product that is not medically necessary.
B. The pharmacy is not engaging in fraudulent billing practices because none of the staff are receiving kickbacks for this practice.
C. The pharmacy is not engaging in fraudulent billing practices because the brand and generic are interchangeable products.

8. Continuing from question 7: When Tina asks her supervisor about this, she is told that Medicare reimburses more for brand items, so the pharmacy profits more by this billing practice. Tina suspects this isn’t legal. What should she do?
A. Nothing. This is a management decision; she is just following directions.
B. Quietly ask other coworkers if they think this practice is legal.
C. Report the suspicious activity to her supervisor’s supervisor, CMS or OIG.

9. Tootsie is a pharmacy technician whose primary responsibility is inventory management. She cannot account for more than $37,000 in stock over the last four months. She lists the product for which more than 10% of inventory has disappeared and notifies her supervisor that several high-cost medications may be being diverted. Which of the following is the BEST strategy for this pharmacy team to use to prevent medication diversion?
A. Perform quarterly inventory when an employee reports suspicious activity
B. Continue to store medications at high risk for diversion in an unsecured location
C. Monitor the inventory of medications at high risk for diversion at least weekly

10. Faith is the pharmacy technician who has been designated the “controlled substances custodian.” She inventories all controlled substances weekly and prepares the orders to replenish stock. On September 1, she returns from a week off. She determines that the wholesaler delivered three bottles of oxycodone on August 25 but they are not in the safe. She realizes this meets the definition of a significant loss. She notifies her supervisor, who says they must file DEA Form 106. On which of the following days would it be TOO LATE file a DEA Form 106?
A. It’s already too late! The form must be filed by September 1.
B. They can file Form 106 on December 31; it is due by year’s end.
C. They need to file the form before October 15.

1. National Healthcare Anti-Fraud Association. The Challenge of Health Care Fraud. Accessed January 21, 2026. https://www.nhcaa.org/tools-insights/about-health-care-fraud/the-challenge-of-health-care-fraud/
2. Centers for Medicare and Medicaid Services. National Health and Expenditure Data. Accessed January 21, 2026. https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/nhe-fact-sheet
3. U.S. Department of Justice, Office of Public Affairs. False Claims Act Settlements and Judgments Exceed $2 Billion in Fiscal Year 2022. Published February 7, 2023. Accessed January 19, 2026. https://www.justice.gov/archives/opa/pr/false-claims-act-settlements-and-judgments-exceed-2-billion-fiscal-year-2022
4. U.S. Department of Justice, United States Attorney’s Office, Eastern District of Wisconsin. Milwaukee Pharmacy Chain to Pay Over $2 Million to Resolve Allegations It Violated the False Claims Act. January 28, 2022. Accessed March 6, 2026. https://www.justice.gov/usao-edwi/pr/milwaukee-pharmacy-chain-pay-over-2-million-resolve-allegations-it-violated-false
5. Centers for Medicare and Medicaid Services. Common types of healthcare fraud. Accessed January 20, 2026. https://www.cms.gov/files/document/overviewfwacommonfraudtypesfactsheet072616pdf
6. Office of Inspector General. What is considered fraud, waste, or abuse? Accessed January 21, 2026. https://oig.usaid.gov/node/221
7. Centers for Medicare and Medicaid Services. Medicare Fraud and Abuse: Prevent, Detect, Report. Accessed January 19, 2026. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Fraud-Abuse-MLN4649244.pdf
8. News from New Hampshire and NPR. Ask Civics 101: What Are The Differences Between Laws, Regulations, Ordinances, And Statutes. Published August 6, 2021. Accessed February 10, 2026. https://www.nhpr.org/nh-news/2021-08-06/ask-civics-101-what-are-the-differences-between-laws-regulations-ordinances-and-statutes
9. Abogados Gold. Difference Between Statute and Act: Key Distinctions Explained. Accessed March 16, 2026. https://abogadosgold.com/statute/statute-vs-act/#google_vignette
10. United States Courts. Glossary of Legal Terms. Accessed February 12, 2026. https://www.uscourts.gov/glossary
11. American Bar Association. Glossary. Accessed February 12, 2026. https://www.americanbar.org/groups/legal_services/flh-home/flh-glossary/
12. Grand Canyon University. Understanding the Differences Between Civil and Criminal Law. Published on Jan 5, 2026. Accessed February 12, 2026. https://www.gcu.edu/blog/criminal-justice-government-and-public-administration/civil-criminal-law
13. U.S. Department of Justice, Civil Division. The False Claims Act. Updated January 15, 2025. Accessed January 19, 2026. https://www.justice.gov/civil/false-claims-act
14. U.S. Department of Health and Human Services, Office of Inspector General. Federal Anti-kickback Statute. Published December 12, 2011. Accessed January 22, 2026. https://oig.hhs.gov/newsroom/oig-podcasts/federal-anti-kickback-statute/
15. U.S. Department of Health and Human Services, Office of Inspector General. False Claims Act. Published December 19, 2011. Accessed January 20, 2026. https://oig.hhs.gov/newsroom/oig-podcasts/false-claims-act/
16. U.S. Department of Health and Human Services, Office of Inspector General. Fraud & Abuse Laws. Accessed January 20, 2026. https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/#:~:text=As%20you%20begin%20your%20career,fines%20can%20add%20up%20quickly.
17. Centers for Medicare and Medicaid Services. Physician Self-Referral. Accessed January 25, 2026. https://www.cms.gov/medicare/regulations-guidance/physician-self-referral?redirect=/physicianselfreferral/
18. Cornell Law School Legal Information Institute. 42 CFR § 411.357 - Exceptions to the referral prohibition related to compensation arrangements. Accessed March 14, 2026. https://www.law.cornell.edu/cfr/text/42/411.357#:~:text=There%20are%20several%20exceptions%20to%20the%20referral,in%20writing%20and%20signed%20by%20both%20parties
19. Cornell Law School Legal Information Institute. 42 CFR § 411.355 - General exceptions to the referral prohibition related to both ownership/investment and compensation. Accessed March 14, 2026. https://www.law.cornell.edu/cfr/text/42/411.355
20. Cornell Law School Legal Information Institute. 42 U.S. Code § 1320d-6 - Wrongful disclosure of individually identifiable health information. Accessed January 26, 2026. https://www.law.cornell.edu/uscode/text/42/1320d-6
21. U.S. Department of Justice. Scope of Criminal Enforcement Under 42 U.S.C. § 1320d-6. Published June 1, 2005. Accessed March 7, 2026. https://www.justice.gov/sites/default/files/olc/opinions/attachments/2014/11/17/hipaa_final.htm#:~:text=(3)%20discloses%20individually%20identifiable%20health,6(b)(3).
22. Federal Bureau of Investigation. Health Care Fraud. Accessed January 20, 2026. https://www.fbi.gov/investigate/white-collar-crime/health-care-fraud
23. U.S. Department of Health and Human Services, Office of Inspector General. About OIG. Accessed February 2, 2026. https://oig.hhs.gov/about-oig/
24. United States Drug Enforcement Administration. What we do. Accessed February 2, 2026. https://www.dea.gov/what-we-do
25. U.S. Department of Justice. Organization, Mission and Functions Manual. Accessed March 3, 2026. https://www.justice.gov/doj/organization-mission-and-functions-manual#:~:text=The%20Department%20of%20Justice%20(DOJ)%20has%20a,Treating%20everyone%20with%20fairness%2C%20dignity%2C%20and%20compassion
26. FBI. Federal Bureau of Investigation. Mission and Priorities. Accessed March 5, 2026. https://www.fbi.gov/about/mission
27. Arizona State Board of Pharmacy. About Our Mission. Accessed March 8, 2026. https://pharmacy.az.gov/about
28. Office of the Inspector General. Texas Health and Human Services. OIG identifies common pharmacy violations. March 7, 2023. Accessed February 4, 2026. https://oig.hhs.texas.gov/about-us/news/oig-identifies-common-pharmacy-violations#:~:text=The%20OIG%20often%20sees%20similar%20errors%20repeated,documentation%20of%20an%20invoice%20supporting%20the%20purchase
29. U. S. Department of Justice. Pharmacy Owner Sentenced for $1M Health Care Fraud Scheme. Published June 12, 2024. Accessed March 10, 2026. https://www.justice.gov/archives/opa/pr/pharmacy-owner-sentenced-1m-health-care-fraud-scheme
30. U. S. Department of Justice. Pharmacist Pleads Guilty to Medicare Fraud Scheme.
Published April 5,2023. Accessed March 10, 2026. https://www.justice.gov/archives/opa/pr/pharmacy-owner-sentenced-1m-health-care-fraud-scheme
31. California State Board of Pharmacy. Before the Board of Pharmacy. Accessed March 10, 2026. https://www.pharmacy.ca.gov/enforcement/fy2223/ac227573#:~:text=same%20as%20revocation.-,2.,of%20the%20Decision%20and%20Order.
32. My News LA. Former LA Pharmacist Sentenced to Prison for Medicare Fraud. Published June 12, 2024. Accessed March 11, 2026. https://mynewsla.com/crime/2024/06/12/former-la-county-pharmacist-sentenced-to-prison-for-medicare-fraud-2/
33. U.S. Department of Justice. Former Eastern Kentucky Pharmacist Sentenced for Healthcare Fraud. Published Wednesday, October 23, 2024. Accessed March 10, 2026. https://www.justice.gov/usao-edky/pr/former-eastern-kentucky-pharamacist-sentenced-healthcare-fraud
34. AOL. Former Kentucky pharmacist gets prison time in Medicare fraud, must repay $730,055. Published October 23, 2024. Accessed March 10, 2026. https://www.aol.com/news/former-kentucky-pharmacist-gets-prison-155735871.html
35. U.S. Department of Justice. Montclair Pharmacist Charged with Submitting Over $300 Million in Fraudulent Claims to Medi-Cal in Medication Reimbursement Scam. Published June 27, 2024. Accessed March 10, 2026. https://www.justice.gov/usao-cdca/pr/montclair-pharmacist-charged-submitting-over-300-million-fraudulent-claims-medi-cal
36. U.S. Department of Justice. Orange County Man Charged in Federal Complaint Alleging He Helped $270 Million Medi-Cal Scam Involving Medication Reimbursement. Published June 30, 2025. Accessed March 11, 2026. https://www.justice.gov/usao-cdca/pr/orange-county-man-charged-federal-complaint-alleging-he-helped-270-million-medi-cal
37. U.S. Department of Justice. Case Summaries. 2025 National Health Care Fraud Takedown. Patricia Anderson. Accessed March 11, 2026. https://www.justice.gov/criminal/criminal-fraud/health-care-fraud-unit/2025-national-hcf-case-summaries
38. Colorado Department of Public Health and Environment. Drug diversion in health care settings. Accessed February 26, 2026. https://cdphe.colorado.gov/healthcare-associated-infections-hais/drug-diversion-in-health-care-settings
39. Institute for Safe Medication Practices. Drug diversion prevention beyond controlled substance medications. ISMP Medication Safety Alert. 2024;29(5):1-4. Published March 7, 2024. Accessed February 17, 2026. https://www.ismp.org/sites/default/files/newsletter-issues/20240307.pdf
40. Centers for Medicare and Medicaid Services. Prescription Drug Diversion Resource Guide. Published June 2014. Accessed February 27, 2026. https://www.cms.gov/files/document/wprescripdrugdiversionresguide062614fpdf
41. American Society of Health-System Pharmacists. Diversion Prevention. Accessed February 26, 2026. https://www.ashp.org/pharmacy-practice/resource-centers/pain-management-and-moud-resource-center/diversion-prevention
42. Berge KH, Dillon KR, Sikkink KM, Taylor TK, Lanier WL. Diversion of drugs within health care facilities, a multiple-victim crime: patterns of diversion, scope, consequences, detection, and prevention. Mayo Clin Proc. 2012;87(7):674-682. doi:10.1016/j.mayocp.2012.03.013
43. Centers for Disease Control and Prevention. Clinician Brief: Drug Diversion. Published March 18, 2024. Accessed February 28, 2026. https://www.cdc.gov/injection-safety/hcp/clinical-overview/
44. Institute for Safe Medication Practices. Drug diversion—A direct and indirect threat to patient safety. ISMP Medication Safety Alert! Community/Ambulatory Care Edition. 2022;21(10). Accessed March 7, 2026. https://www.ismp.org/sites/default/files/newsletter-issues/community202210.pdf
45. Vanderbilt University Medical Center. Why do antipsychotic medications have street value? Published Feb 17, 2016. Accessed March 2, 2026. https://www.vumc.org/poison-control/toxicology-question-week/feb-17-2016-why-do-antipsychotic-medications-have-street-value
46. National Association of Boards of Pharmacy. Drug distributor accreditation criteria. Accessed March 7, 2026. https://nabp.pharmacy/programs/accreditations/drug-distributor/criteria/#policies-and-procedures
47. U.S. Department of Justice Drug Enforcement Administration. Theft/Loss Reporting. Accessed February 27, 2026. https://www.deadiversion.usdoj.gov/21cfr_reports/theft/theft-loss.html

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 United States (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 U.S., 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 (mice and rats) 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, and 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, 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 formulations. 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 sprays, 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 · 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 OTC.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 antihistamines 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. The U.S. Food and Drug Administration (FDA) characterizes allergen-specific immunotherapies as biologics because they are produced from living cells, not synthesized by chemists, and regulated under the Center for Biologics Evaluation and Research (CBER).³⁸ 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 U.S., 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 dose. 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 1,000 to 4,000 BAU range.⁴²

S'CIT 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 for pet allergies, 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

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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.

Delving Beyond the Shelving Podcast Episode #2: Private Equity and PBMs

Delving Beyond the Shelving Episode #2: Private Equity and PBMs
Posttest 26-038
Pharmacists and Pharmacy Technicians

1. Which of the following companies has Sycamore Partners invested in?
a. CVS Caremark
b. Playa Bowls
c. Abercrombie and Fitch

2. Public scrutiny for private equity firms is often associated with which of the following practices?
a. Cutthroat business practices leading to strenuous and substandard working conditions
b. Lack of funding leading to unsatisfactory hiring practices and poorly staffed retailers
c. Private equity firms ignore SEC regulations leading to audits and employee-related lawsuits

3. Walgreens failed to invest in what type of business, leading to its downfall. What type of business was it?
a. Primary care clinics
b. Pharmacy benefit manager
c. Pharmacy manufacturers

4. Walgreen’s investment in what company set them back billions of dollars?
a. Caremark
b. VillageMD
c. Aetna

5. Which of the following is a consequence of the current pharmacy payor system?
a. Mass pharmacy closures across the country
b. Decreased drug pricing for patients
c. Formulary incorporating most available medications

6. Which of the following is an example of potential positive reform to the pharmacy payor system?
a. Keeping the current system and modeling successful pharmacies
b. Developing reasonable dispensing and service reimbursement
c. Lower reimbursement rates to save taxpayer money

7. What action can individual pharmacists perform to impact legislative changes?
a. Make time at work to tell prescribers that things are not going well
b. Contact local legislators and explain how PBMs affect your pharmacy
c. Call PBM pharmacy service lines and provide example of corporate greed

8. Which statement is most closely related to current changes in pharmacy PBM legislation?
a. Legislation is rapidly changing; the system will change for the better soon
b. State governments are laying the groundwork to challenge PBMs
c. The federal government is targeting some PBMs in Congressional hearings

Delving Beyond the Shelving Episode #2: Private Equity and PBMs
Posttest 26-038
Pharmacists and Pharmacy Technicians

1. Which of the following companies has Sycamore Partners invested in?
a. CVS Caremark
b. Playa Bowls
c. Abercrombie and Fitch

3. Walgreens failed to invest in what type of business, leading to its downfall. What type of business was it?
a. Primary care clinics
b. Pharmacy benefit manager
c. Pharmacy manufacturers

4. Walgreen’s investment in what company set them back billions of dollars?
a. Caremark
b. VillageMD
c. Aetna

1#. Walgreens Shareholders Approve $10 Billion Private Equity Buyout. Yahoo Finance. July 11, 2025. Accessed July 15, 2025.
https://finance.yahoo.com/news/walgreens-private-10-billion-deal-225338615.html?guccounter=1

2#. Sycamore Partners Acquires 51% Interest in Mast Global Fashions. Sycamore Partners. November 3, 2011. Accessed July 15, 2025. https://www.sycamorepartners.com/news/article/25

3#. Private Equity Funds. United States Securities and Exchange Commission. Accessed July 16, 2025.
https://www.investor.gov/introduction-investing/investing-basics/investment-products/private-investment-funds/private-equity

4#. What Private Equity Firms Are and How They Operate. ProPublica. August 3, 2025. Accessed July 16, 2025. https://www.propublica.org/article/what-is-private-equity

5#. 10 Top Private Equity Firms by Total Equity. Investopedia. Updated July 16, 2025. Accessed July 17, 2025. https://www.investopedia.com/articles/markets/011116/worlds-top-10-private-equity-firms-apo-bx.asp
6#. Why Is Private Equity Gaining Popularity? Forbes. May 9, 2024. Accessed July 17, 2025.
https://www.forbes.com/councils/forbesfinancecouncil/2024/05/09/why-is-private-equity-gaining-popularity/

8#. Walgreens Boots Alliance, Inc. (WBA). Yahoo Finance. Accessed July 17, 2025. https://finance.yahoo.com/quote/WBA/

9#. Walgreens Boots Alliance Enters into Definitive Agreement to Be Acquired by Sycamore Partners. Walgreens Boots Alliance. March 6, 2025. Accessed July 15, 2025.
https://investor.walgreensbootsalliance.com/news-releases/news-release-details/walgreens-boots-alliance-enters-definitive-agreement-be-acquired

10#. Walgreens Shareholders Approve $10 Billion Private Equity Buyout. Forbes. July 11, 2025. Accessed July 15, 2025.
https://www.forbes.com/sites/brucejapsen/2025/07/11/walgreens-shareholders-approve-10-billion-private-equity-buyout/

11#. Walgreens Boots Alliance Accelerates VillageMD Investment and Large-Scale Rollout of Primary Care Clinics. Walgreens Boot Alliance. Accessed July 18, 2025.
https://www.walgreensbootsalliance.com/news-media/press-releases/2021/walgreens-boots-alliance-accelerates-villagemd-investment-and-large

12#. How Walgreens went from pharmacy behemoth to distressed retailer. Reuters. March 7, 2025. Accessed July 15, 2025.
https://www.reuters.com/business/healthcare-pharmaceuticals/walgreens-pharmacy-behemoth-distressed-retailer-2025-03-07/

13#. Walgreens Net Worth 2010-2025 | WBA. Macrotrends. Accessed July 16, 2025.
https://www.macrotrends.net/stocks/charts/WBA/walgreens/net-worth

14#. Walgreens narrows profit outlook for 2024, takes $6B hit in Q2 from VillageMD investment. Fierce Healthcare. March 28, 2024. Accessed July 19, 2025.
https://www.fiercehealthcare.com/retail/walgreens-takes-6b-hit-q2-villagemd-investment#:~:text=Walgreens'%20VillageMD%20bought%20the%20urgent,through%20over%207%2C400%20provider%20locations.

15#. Private Equity Labor Scorecard. Private Equity Stakeholder Project. November 2023. Accessed July 17, 2025. https://pestakeholder.org/pe-labor-scorecard/

16#. The risks of a private equity takeover of Walgreens. Private Equity Stakeholder Project. March 7, 2025. Accessed July 17, 2025. https://pestakeholder.org/news/the-risks-of-a-private-equity-takeover-of-walgreens/

17#. Understanding Drug Tiers. Patient Advocate Foundation. Accessed July 18, 2025.

Understanding Drug Tiers

18#. What Pharmacy Benefit Managers Do, and How They Contribute to Drug Spending. The Commonwealth Fund. March 17, 2025. Accessed July 18, 2025.
https://www.commonwealthfund.org/publications/explainer/2025/mar/what-pharmacy-benefit-managers-do-how-they-contribute-drug-spending

19#. Trends in Retail Prices of Prescription Drugs Widely Used by Older Americans, 2006 to 2020. AARP. January 2024. Accessed July 18, 2025. https://www.aarp.org/content/dam/aarp/ppi/topics/health/prescription-drugs/trends-in-retail-prices-of-prescription-drugs-widely-used-by-older-americans-2006-to-2020.doi.10.26419-2fppi.00219.001.pdf

20#. Anderer S. Nearly 1 in 3 US Pharmacies Have Closed Since 2010, Widening Access Gaps. JAMA. February 4, 2025. Accessed July 17, 2025. doi: 10.1001/jama.2024.26875.

21#. The Powerful Companies Driving Local Drugstores Out of Business. The New York Times. October 19, 2024. Accessed July 18, 2025. https://www.nytimes.com/2024/10/19/business/drugstores-closing-pbm-pharmacy.html#:~:text=This%20has%20been%20happening%20all,dozens%20of%20patients%20and%20pharmacists.

22#. Annual Report 2025. Walgreens Boot Alliance. Accessed July 15, 2025. https://investor.walgreensbootsalliance.com/static-files/1dda9c7b-8315-4527-b4b3-c8cc6b4d7e09

23#. The Real Reason Walgreens Collapsed. The Big News Letter. March 13, 2025. Accessed July 20, 2025. https://www.thebignewsletter.com/p/the-real-reason-walgreens-collapsed

24#. SF 383 – Regulation of Pharmacy Benefit Managers (LSB1492SV.3). Legislative Service Agency. June 6, 2025. Accessed July 20, 2025. https://www.legis.iowa.gov/docs/publications/FN/1528921.pdf

#25 Kicker: What it is, How it Works, and Types. Investopedia. Updated April 26, 2022. Accessed August 6, 2025.

Delving Beyond the Shelving Podcast: Episode #1: Decongesting Phenylephrine Rumors

POST TEST QUESTIONS
Pharm Fresh podcast Episode 1: Decongesting Phenylephrine Rumors
26-019 P

1. What is the formal name of the FDA’s “recipe book” for approved over-the-counter products?
a. OTC Monograph
b. FDA Approved OTCs
c. Monograph of Federal Approvals

2. When was Hatton and Hendeles’ first Citizens Petition for phenylephrine?
a. 2007
b. 2009
c. 2015
*

3. What was Hatton and Hendeles goal in the first Citizens Petition?
a. The FDA should remove oral phenylephrine from the market due to safety issues
b. The FDA should increase the recommended daily dose of oral phenylephrine
c. The FDA should move oral phenylephrine behind the counter with pseudoephedrine

4. Which law enacted in the 2000s was believed to cause increases in phenylephrine sales?
a. Family Smoking Prevention and Tobacco Control Act of 2009
b. Food and Drug Administration Amendments Act of 2007
c. Combat Methamphetamine Act of 2005

5. All phenylephrine routes of administration are effective in current therapies EXCEPT:
a. Ophthalmic
b. Intranasal
c. Oral

6. Which disease state indicates an intranasal phenylephrine product over an oral decongestant such as pseudoephedrine?
a. Uncontrolled Hypertension
b. Nasal Polyps
c. Rhinitis Medicamentosa

7. Which condition limits some congestion self-treatments to 3 days or less?
a. Uncontrolled Hypertension
b. Nasal Polyps
c. Rhinitis Medicamentosa

8. A mother presents to the pharmacy with her 9-year-old child. She states the child is congested, despite using Flonase for the last 2 months for allergies. As the pharmacist, what do you recommend to this patient?
a. Flonase Sensimist. She has exhausted the regular Flonase product and continued use might irritate the child’s nasal passages
b. Neti Pot. The patient has exhausted all Flonase products and non-pharmacological treatment may benefit this patient.
c. Recommend the patient to see their pediatrician. Over-the-counter treatment is no longer indicated in this patient.

POST TEST QUESTIONS
Pharm Fresh podcast Episode 1: Decongesting Phenylephrine Rumors
26-019 T

1. What is the formal name of the FDA’s “recipe book” for approved over-the-counter products?
a. OTC Monograph
b. FDA Approved OTCs
c. Monograph of Federal Approvals

2. When was Hatton and Hendeles’ first Citizens Petition for phenylephrine?
a. 2007
b. 2009
c. 2015
*

5. All phenylephrine routes of administration are effective in current therapies EXCEPT:
a. Ophthalmic
b. Intranasal
c. Oral

6. Which disease state indicates an intranasal phenylephrine product over an oral decongestant such as pseudoephedrine?
a. Uncontrolled Hypertension
b. Nasal Polyps
c. Rhinitis Medicamentosa

7. Which condition limits some congestion self-treatments to 3 days or less?
a. Uncontrolled Hypertension
b. Nasal Polyps
c. Rhinitis Medicamentosa

P5#. FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review. U.S. Food and Drug Administration. November 07, 2024. Accessed January 14, 2025. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after

P8#. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. Federal Register. November 11, 2024. Accessed January 15, 2025. https://www.federalregister.gov/d/2024-25910

P35#. OTC Drug Review Process | OTC Drug Monographs. U.S. Food and Drug Administration. October 10, 2023. Accessed January 29, 2025. https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs

P36#. FAQs About the OTC Review. Consumer Healthcare Products Association. Accessed February 10, 2025. https://www.chpa.org/about-consumer-healthcare/faqs/faqs-about-otc-review#:~:text=Each%20panel%20was%20charged%20with,of%20Federal%20Regulations%20(CFR)

P9#. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for OTC Nasal Decongestant Drug Products. Federal Register. August 1, 2006. Accessed January 15, 2025. https://www.federalregister.gov/d/E6-12265

P4#. Code of Federal Regulations Title 21. National Archives. Last amended June 3, 2025. Accessed May 5, 2025. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-10/subpart-B/section-10.30

P7#. Hendeles L, Hatton R. Supplement to Oral Phenylephrine Citizen's Petition (FDA 2015-P-4131). May 2022. Accessed January 15, 2025. https://downloads.regulations.gov/FDA-2015-P-4131-0007/attachment_1.pdf

P3#. Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. U.S. Food and Drug Administration. July 14, 2025. Accessed January 12, 2025. https://www.fda.gov/drugs/information-drug-class/legal-requirements-sale-and-purchase-drug-products-containing-pseudoephedrine-ephedrine-and

P20#. Oral Phenylephrine as a Nasal Decongestant in the Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic (CCABA) OTC Monograph. 2023 Nonprescription Drugs Advisory Committee Meeting. U.S. Food and Drug Administration. September 11-12, 2024. Accessed January 18, 2025. https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-september-11-12-2023-meeting-nonprescription-drugs-advisory-committee-meeting-announcement#event-materials.

P19#. Hendeles L, Hatton R. Citizen’s petition 2015-P-4131-0001 requesting a final rule removing oral phenylephrine from the final monograph for OTC nasal decongestant products. November 4, 2015. https://downloads.regulations.gov/FDA-2015-P-4131-0001/attachment_1.pdf. Accessed May 6, 2025.

P17#. FDA Response to 2015 Citizens Petition. U.S. Food and Drug Administration. November 8, 2024. Accessed January 22, 2025.

P33#. Interim Response FDA-2015-P-4131. U.S. Food and Drug Administration. May 6, 2016. Accessed January 20, 2025. https://downloads.regulations.gov/FDA-2015-P-4131-0004/attachment_1.pdf

P1#. Phenylephrine, a Common Decongestant, Is Ineffective, Say FDA Advisors. It’s Not Alone. October 05, 2023. Accessed January 10, 2025. https://medicine.yale.edu/news-article/phenylephrine-a-common-decongestant-is-ineffective-say-fda-advisors-its-not-alone/

P6#. Food and Drug Administration Center for Drug Evaluation and Research Final Summary Minutes of the Nonprescription Drugs Advisory Committee Meeting. October 2, 2023. Accessed January 14, 2025. https://www.fda.gov/media/172701/download

P32#. Anderson T, Suda K, Gellad W. Trends in Phenylephrine and Pseudoephedrine Sales in the US. March 5, 2024. DOI: 10.1001/jama.2023.27932.

P10#. CVS Health to no longer sell decongestants with phenylephrine as the only active ingredient. NBC News. October 19, 2023. Accessed January 15, 2025.
https://www.nbcnews.com/business/consumer/cvs-health-pull-decongestants-phenylephrine-shelves-rcna121310

P37#. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. U.S. Food and Drug Administration. April 1, 2020. Accessed February 8, 2025. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market

P11#. Phenylephrine Nasal Spray. MedlinePlus. November 15, 2016. Accessed January 16, 2025. https://medlineplus.gov/druginfo/meds/a616049.html#:~:text=Phenylephrine%20comes%20as%20a%200.125,to%2012%20years%20of%20age.

P16#. Phenylephrine (Topical). Memorial Sloan Kettering Cancer Center. December 12, 2022. Access January 17, 2025. https://www.mskcc.org/cancer-care/patient-education/medications/adult/phenylephrine-topical

P12#. Phenylephrine (ophthalmic route). Mayo Clinic. Accessed January 16, 2025.
https://www.mayoclinic.org/drugs-supplements/phenylephrine-ophthalmic-route/description/drg-20067902

P13#. Phenylephrine (intravenous route). Mayo Clinic. Accessed January 16, 2025.
https://www.mayoclinic.org/drugs-supplements/phenylephrine-intravenous-route/description/drg-20110237

P14#. Morelli A, Ertmer C, Rehberg S, Lange M. Phenylephrine versus norepinephrine for initial hemodynamic support of patients with septic shock: a randomized, controlled trial. November 18, 2008. Accessed January 16. 2025. https://ccforum.biomedcentral.com/articles/10.1186/cc7121.

P15#. Cooper B. Review and update on inotropes and vasopressors. January 2008. Accessed January 17, 2025. DOI: 10.1097/01.AACN.0000310743.32298.1d

P24#. Johnson D, Hricik J. The pharmacology of Alpha-Adrenergic Decongestants. Pharmacotherapy. November-December 1993. Accessed January 20, 2025. https://pubmed.ncbi.nlm.nih.gov/7507588/

P25#. Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. American Heart Association. November 13, 2017. Accessed January 20, 2025. https://www.ahajournals.org/doi/10.1161/hyp.0000000000000065

P26#. Label: SUDAFED SINUS CONGESTION 24 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release. DailyMed. Last updated March 20, 2023. Accessed January 20, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d389347d-eaa3-4571-9b84-21e662db622d

P27#. Is Rinsing Your Sinuses With Neti Pots Safe? U.S. Food and Drug Administration. Last updated April 28, 2025. Accessed March 5, 2025.
https://www.fda.gov/consumers/consumer-updates/rinsing-your-sinuses-neti-pots-safe#:~:text=Some%20children%20are%20diagnosed%20with,might%20not%20tolerate%20the%20procedure

P28#. Rhinocort (budesonide) Nasal Spray Label. U.S. Food and Drug Administration. December 28, 2010. Accessed March 5, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020746s026lbl.pdf

P23#. Pseudoephedrine Capsules and Tablets. Cleveland Clinic. Last reviewed February 2024. Accessed January 20, 2025.
https://my.clevelandclinic.org/health/drugs/20768-pseudoephedrine-capsules-and-tablets

P29#. Label: NASACORT ALLERGY 24HR- triamcinolone acetonide spray, metered. DailyMed. Last updated July 1, 2024. Accessed March 5, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bff57a5-cce0-401c-a0fe-23c65c1b7ddc

P30#. FLONASE (fluticasone propionate) nasal spray label. U.S. Food and Drug Administration. December 28, 2010. Accessed March 5, 2025.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020121s045lbl.pdf

P31#. Label: FLONASE SENSIMIST ALLERGY RELIEF- fluticasone furoate spray, metered. Updated December 19, 2024. Accessed March 5, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=107100af-7ca2-44e8-b067-c0ab0a19a6dc

P21#. Hermelingmeier K, Weber R, Hellmich M. Nasal irrigation as an adjunctive treatment in allergic rhinitis: A systematic review and meta-analysis. September-October 2012. Accessed May 5, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC3904042/

P22#. Reinikainen L, Jaakkola J. Significance of humidity and temperature on skin and upper airway symptoms. December 13, 2003. DOI: 10.1111/j.1600-0668.2003.00155.x.

P34#. Hatton R, Hendeles L. What we have learned from trying to remove oral phenylephrine from the market. January 29, 2025. Accessed March 5, 2025. https://doi.org/10.1002/jac5.2080
P35# Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Overthe-Counter Human Use. November 7, 2024. Accessed August 3, 2025. https://www.regulations.gov/document/FDA-2024-N-4734-0001.

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

About this Course

Learning Objectives

Additional Information

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

CONTENT

Posttest

Handouts

About this Course

Learning Objectives

Additional Information

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

CONTENT

Posttest

Handouts

About this Course

Learning Objectives

Additional Information

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

CONTENT

Posttest

Handouts

About this Course

Learning Objectives

Additional Information

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test

About this Course

Learning Objectives

Additional Information

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

CONTENT

Posttest

Handouts

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