The American College of Veterinary Pharmacists is an association of independent community pharmacy practitioners who have made substantial commitments of resources to be able to provide veterinarians with pharmaceutical options to increase compliance and improve outcomes for their patients. ACVP pharmacists work with veterinarians in their area to solve special problems arising from discontinued products, individual dosing needs, inconvenient dosage forms, flavoring incompatibilities and a number of other challenges.
Over recent months, the ACVP has been pleased to be a part of the American Veterinary Medicine Association’s Council on Biologic and Therapeutic Agents (COBTA). Participation on COBTA has provided a valuable opportunity to expand the professional partnerships between pharmacists and veterinarians at the association level, and to promote understanding between members of each group.
The ACVP pharmacists with whom you work can assist you in understanding federal and state regulations that affect pharmacy practice. There are actually three levels of standards which pharmacists must consider in determining their practice standards.
First are federal guidelines. Guidelines are not laws, but they provide a basis for legislation and inform pharmacists of practices that will draw investigation. In the United States, these guidelines are established by the US Food and Drug Administration (FDA). An example of a guideline would be taken from the FDA Compliance Policy Guide (CPG) which states that the FDA will seriously consider enforcement if, for example, a pharmacy compounds drugs for third parties who resell to individual patients.
Secondly, in both the US and Canada, actual laws governing pharmacy practice are enacted and enforced on the state or provincial level. State regulations are based on federal guidelines and include the prohibition of compounding medications which are commercially available.
Ethical conduct is the third criterion for evaluation of pharmacy practice standards, and these are exemplified by the ACVP Standards of Practice which must be met by members of the ACVP. Ethical standards of pharmacy include a triad of care similar to that followed by veterinarians – that pharmacists work within the bounds of a valid prescriber-pharmacist-patient relationship. Veterinarians should be aware of these standards of practice in order to better understand what to look for in finding a pharmacy partnership. If you encounter a specific pharmacy practice that concerns you, you may consult pharmacy regulations in your state or province or utilize the Prescribing and Dispensing Complaint Form which is available from the AVMA or the ACVP. These forms report specific suspected violations of regulations and should be submitted to the AVMA, the state board of pharmacy where a drug has been dispensed and where a drug has been shipped, and to the FDA. These forms also provide valuable information for tracking violations, and types of violations to ensure appropriate follow-up.
In addition to the guidelines, regulations, and standards mentioned above, veterinarians should note that pharmacists may not compound a medication based only on cost considerations. An ACVP Pharmacist will not compound a medication for an animal if that medication is commercially available. In the case of medically necessary changes in dosage or dosage form, a prescription may be written and presented to a ACVP pharmacist who will be happy to work with the veterinarian to meet the medication need. Also, when administered to an animal patient, all use of human approved drugs is extra-label. (There is no such thing as a compounded OTC product for use in animals.) Only a veterinarian can authorize extra-label use of approved drugs. All human approved drugs dispensed for animals require a prescription from a veterinarian within the context of an established veterinary-client-patient relationship regardless of whether they are legend or OTC drugs. ACVP pharmacists will not provide medications for animals without a valid and ethical prescription.