Lactated Ringers. Apoquel. Doxycycline. These are just a few drugs that members have contacted AVMA about recently with concerns about availability. We’ve heard the reasons drug shortages happen: lack of a manufacturer’s access to high-quality active ingredients, and increased FDA regulation of the drug-production process, to name just a couple. But despite the reasons, it’s unfortunately something members have said is a fact of life. So, what’s a veterinarian to do when shortages happen? Here are some questions to help you get started.
- Is the drug truly in a shortage situation? While you might be used to working with one or two main distributors, there are more veterinary distributors than you might realize. The American Veterinary Distributors Association maintains a directory of their members, many of whom are veterinary supply companies. If the drug is truly in a shortage, the FDA asks that veterinarians report it (AskCVM@fda.hhs.gov; phone: 240-276-9300; fax: 240-276-9115).
- Can the product be prescribed? For example, if the needed mg-strength is not available anymore from the distributor, consider giving the client a prescription to have filled at a pharmacy that has it in stock. Recall that the AVMA Principles of Veterinary Medical Ethics and many individual states require veterinarians to provide a prescription in lieu of dispensing a medically needed product upon the request of a client.
- If the drug is truly in a shortage situation, can you use a different form of the product, or is there a different FDA-approved drug that can be used as an alternative? For example, when doxycycline hyclate was unavailable, doxycycline monohydrate was substituted by some veterinarians. Or, perhaps the drug is available in a less-than-ideal, but still effective and feasible, route of administration. The American Academy of Veterinary Pharmacology and Therapeutics has clinical monographs that can help. Remember that FDA’s rules allow veterinarians to use a different drug in an extralabel fashion – AVMA’s extralabel drug use algorithm is also a helpful resource.
- Is it necessary to have the drug compounded? Recognize that AVMA agrees that compounds might be necessary in some situations (nonfood animals), however also know that unlike drugs that are approved by the FDA, potency, stability, safety and efficacy of compounds are often not documented and may be unknown. Recall that price alone is not a reason for using a compounded product. The AVMA’s Compounding page is a great resource, as is a webinar featuring a board-certified pharmacologist that AVMA held earlier this year (AVMA member login required).
Even though it’s been said drug shortages are a fact of life, the AVMA isn’t giving up. We advocate for access to needed products, including raising awareness of our patients’ needs with legislators and regulators. And as always, we look forward to your comments and feedback on this important topic.