Do you use a compounding pharmacy?
This could be you…
In March 2015, a compounding pharmacy and others were sued by two owners of a racehorse which died after it was administered a drug compounded by the pharmacy. The owners did not include the prescribing veterinarian in the original suit. Later in the year, the pharmacy took the highly unusual and surprising action of filing a third-party complaint against the veterinarian who called the prescription in to the pharmacy. That veterinarian is now a party to the complex and expensive litigation as a result of an action many veterinarians do on a regular basis.
This case brings to mind the importance of understanding and managing your risk associated with using a compounding pharmacy. The purpose of this alert is to make you aware of this risk and to provide some tips to help you avoid similar claims during your career. Working with compounding pharmacies is at times a medically necessary and beneficial component of veterinary practice, and it is important to understand the risks. To reduce the likelihood of allegations of veterinary negligence and board complaints related to compounded preparations, understand the risks involved and implement best practices to manage those risks.
Facts to Help Understand Your Risk
Compounding Pharmacies are not all the same. To ensure that a compound pharmacy is utilizing quality products and following best practices, there are questions that you should consider asking. Professional veterinary organizations such as AVMA and AAEP have materials that suggest a variety of questions and methods to screen compounding pharmacies, and they also provide compounding guidelines.
Compounding pharmacies may not carry product liability insurance that covers compounded drugs or sufficient compounding-specific liability insurance. Standard pharmacist professional liability insurance forms may exclude compounding activity. If you use a compounded product, depending upon the specific circumstances, you could become a target in litigation if compounding pharmacies and the pharmacists involved do not have insurance or sufficient levels of insurance. Perhaps more importantly, the veterinarian may become the target of the compounding pharmacy in an attempt to shift blame for the adverse effect.
How to Reduce Your Risk
Practitioners today operate in a dynamic environment. The FDA is in the process of revising its compounding guidelines. Individual states may have different regulations and laws. Build and maintain healthy relationships with compound pharmacies that are committed to compliance at both the state and federal levels. To protect yourself, stay current with guidelines from professional veterinary groups such as AVMA and AAEP. Make compounding decisions that are medically driven in the interests of patient care. It’s not appropriate to select a compounded drug for economic reasons (versus medical reasons) based on FDA’s Extra-label Drug Use Rules and policy statements.
The PLIT recommends that if you choose to use a compounding pharmacy, you use a pharmacy that is committed to compliance with all FDA regulations and policy, and stands behind the products they compound. And in light of recent claims, you may want to request a certificate of insurance for product liability insurance and compounding-specific pharmacist professional liability coverage from any compounding pharmacy with which you work. This will show evidence of coverage and the policy limits.
We wanted to inform you about a situation that could happen to you if you use a compounding pharmacy. Know the risks involved, and implement best practices to manage those risks and to reduce the likelihood of allegations of veterinary negligence and board complaints against you.
Burton and Domaschko vs. Wickliffe Pharmaceutical, Inc., et. al.
AVMA’s Veterinary Compounding
AAEP’s Equine Veterinary Compounding Guidelines