Having spent the first 24 years of my career as a companion animal veterinarian and practice owner, I have a respectable understanding of the medications we prescribe regularly. I consider myself familiar with the indications, dosages and potential side effects of most of those drugs. In practice, I managed the occasional adverse reaction, but fortunately, such outcomes were uncommon and generally mild.
I hesitate to admit that I didn’t always report adverse events to the manufacturers, and I might have become a bit complacent in discussing side effects with pet owners. Even more humbly, I admit I didn’t always discuss extralabel use with my clients. Because of the lack of veterinary-approved drugs for many diseases we treat, it was just “what we do,” right? Or so I naively believed.
Having spent the past 12 years in industry and currently working as a technical services veterinarian for a veterinary pharmaceutical manufacturer, I now have a different perspective.
3 Questions
Drug manufacturers must notify the U.S. Food and Drug Administration within a defined period of all suspected adverse events associated with their products. The reports are used to monitor the pharmaceuticals’ safety and effectiveness.
In my current role, I review adverse experiences associated with any of the drugs that Norbrook Laboratories makes. I often talk about the events with the prescribing veterinarians or their clients. During my conversations with pet owners, the three most frequent questions I hear are:
- Why didn’t my veterinarian discuss the potential side effects with me?
- Why didn’t my veterinarian recommend bloodwork or monitoring as suggested by the product insert?
- Why didn’t my veterinarian tell me the drug wasn’t approved for such-and-such a condition, species or age?
Dr. Google
Now, I’ve been around the veterinary profession long enough to recognize that clients don’t always remember everything we tell them, and sometimes they misrepresent the facts when speaking with me. On the other hand, I realize they sometimes are quite accurate in their recall. Add to it the fact that they can easily second-guess decisions made in hindsight and after a quick internet search.
The three questions above make for awkward discussions. I always try to point out that no veterinarian would intentionally harm a patient, and I attempt to share how consumers often ignore product information, even when it is provided. To that point, I always ask clients whether they read all the literature from their personal pharmacists. I also explain that every drug has potential side effects and that veterinarians must carefully balance the risks and benefits of every medical decision they make.
Generally, what started with an accusatory undertone proceeds to a more rational conversation that ends in a better understanding and less blame directed at the veterinarian.
Be Forthright
There’s a lesson to be learned here. I urge prescribing veterinarians to discuss the risks and benefits of all pharmaceuticals dispensed or prescribed, make every effort to follow a label’s recommendations, and provide the pet owner with the package insert (or a copy) for reference.
If you don’t provide the information, I assure you your clients will easily find it later, especially if their pet has an adverse effect, and then they’ll look for someone to blame: you, the prescriber.
No less important are the discussions I have with veterinarians. While I believe they always mean well and hope to do the best for patients and clients, they sometimes cut corners or bend the rules for clients out of compassion or in the interest of time.
It’s not uncommon when I investigate an adverse drug experience to learn of an apparent failure to adhere to manufacturer recommendations regarding:
- Blood chemistry testing before use.
- Post-administration monitoring.
- Dosage or administration frequency.
- Indications.
To be clear, we cannot advocate using any product in an extralabel manner. We can certainly discuss the topic legally from veterinarian to veterinarian, but ultimately, the risk lies with the prescribing doctor. Supporting a product used in a manner inconsistent with its label is problematic. Practitioners should carefully explain to clients any deviation from the prescribing information on a drug’s package insert and then document the conversation in the medical record along with, ideally, the informed consent.
I’m not an attorney, but it seems reasonable to me to assume that failing to adequately inform a pet owner about the potential side effects or extralabel use of a drug could increase a veterinarian’s liability should an adverse event occur. It would follow that the small investment in time to take precautionary steps is sound and increases the message of value and care that you wish to convey to your clients. Don’t be complacent and then learn the hard way after an unexpected event.
Ground Rules
I am sure many of you are acutely aware of the concepts I described and maintain appropriate documentation and client consents. For those who don’t, here are eight suggestions from one veterinarian to another. (Please contact your legal adviser for specific recommendations in your state.)
- Always discuss the potential side effects of any drugs you dispense or prescribe with the pet owner.
- Always provide the package insert (or a copy if you dispense drugs into a secondary container).
- Consider using the client information sheets available for most drugs to educate and set reasonable expectations. You might even use your clinic software to print the information with the receipt.
- Label all dispensed drug packaging according to the requirements of your jurisdiction’s veterinary board or regulatory authority.
- Follow manufacturer recommendations for the appropriate use of drugs whenever possible and document any need for deviations.
- When you prescribe extralabel drugs, be sure the client knows why and signs an informed-consent document.
- If a client declines recommended testing before you dispense a drug or monitoring after the drug’s administration, document your recommendations and the response in the medical record with a time-stamped client acknowledgment or consent.
- Report all adverse drug experiences to the manufacturer.
I hope your implementation of these tips prevents uncomfortable situations and awkward conversations.
A VCPR MATTERS
According to the Animal Medicinal Drug Use Clarification Act (bit.ly/48m6WOW), “Any extralabel use of an approved new animal or human drug must be by or on the lawful order of a veterinarian within the context of a veterinarian-client-patient relationship.”