Four Characteristics of High Quality Compounding Pharmacies

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Compounded medications are often essential for treating the wide variety of species and size variety within each species that we see in veterinary medicine. However, since compounded products aren’t FDA-approved there are risks to using them including concerns of strength, stability, and sterility (if applicable) as well as questionable safety and efficacy. Using a high-quality compounding pharmacy is the best way to decrease the change of problems occurring when a compound is needed. There are four areas of evaluation when considering quality.

1. General practices

2. Staff skill level

3. Familiarity with veterinary medicine

4. Pharmacy culture

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1. General Practices

This refers to the pharmacy policies and procedures that are in place. This includes the following:

· A pharmacy should have policies and procedures that are in line with legal requirements and best practices. These should align with what is actually done in the pharmacy.

· The pharmacy should be maintained in a clean and organized manner.

· The staff should work well together and understand roles and responsibilities.

2. Staff Skill Level

Simply because someone is a pharmacist or a licensed pharmacy technician does not mean that they have extensive compounding experience. In most cases, a highly skilled compounding pharmacist or technician got to that point through working in a compounding pharmacy and choosing to pursue additional education and training on the topic. The following processes should be in place:

· A well-defined process and competency check in place for training new staff

· A periodic reevaluation of current staff

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3. Familiarity with Veterinary Medicine

Concepts pertaining to providing medications for animal patients are not core competencies in pharmacy school or pharmacy technician training programs. While core compounding concepts are the same for both human and veterinary compounding, the formulations that are prepared, acceptable inactive ingredients and other clinical considerations will be different. The best-quality compounds for animal patients are likely to come from compounding pharmacies with pharmacists that have at least a baseline knowledge of veterinary pharmacy concepts.

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4. Pharmacy Culture

The culture f the compounding pharmacy should be such that they are a collaborative member of the care team. This means that they are interested in engaging with clients and veterinarians to problem solve and determine possible options for difficult cases. These pharmacies will welcome requests for novel formulations but will critically evaluate the appropriateness prior to agreeing to prepare them. Veterinarians should feel confident that they can reach out to the pharmacist and suggest potential formulation ideas and that the pharmacist will provide insight on the appropriateness from their perspective including if the requested formulation is likely inappropriate.

Two Questions to Ask Pharmacies

There are several ways to evaluate compounding pharmacies to see if they meet the above criteria. However, time is often of the essence, so I have two questions I ask pharmacies to check for potential red flags. The first looks at legal compliance, and the second looks at clinical considerations.

The first question is, “Will you make cyclosporine 100mg capsules?” Cyclosporine is available in 100 mg capsules as the veterinary product Atopica® as well as a human generic product. Therefore, if a compounding pharmacy is duplicating the commercially available products, that’s illegal. If they say they can’t make 100 mg but could make 98 mg, that’s potentially worse because it shows they know the law and are intentionally trying to circumvent it.

The second question is, “Will you make transdermal enrofloxacin?” Enrofloxacin is a fluoroquinolone which is a highly important antibiotic class in human medicine. Therefore, it warrants judicious use from an antimicrobial standpoint. Transdermal compounds are popular due to their ease of administration in cats, but very few drugs are reliably absorbed by this route. Therefore, it’s a bad idea clinically to use transdermal antibiotics since they are more likely to reach low levels and cause resistance than to reach levels effective for treating the infection. There is nothing illegal about compounding transdermal enrofloxacin, but it’s a poor clinical decision that a pharmacist should have concerns about given what we know about antimicrobial stewardship.

Pharmacies that answer “no” to both questions, go on my short list of go-to options for compounded products. Pharmacies that answer yes become red flags because if either of these raise concerns, I start wondering what else might be going on that could be problematic.

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Conclusion

When you are in need of a compounded product, doing your research to find a high-quality pharmacy is the best way to decrease the risk of problematic compounds. A bit of time may be required up front, but it can pay off to have a couple pre-screened compounding pharmacies identified ahead of time.

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