Will Stronger Stewardship Practices Mean Changes to Compounding Guidelines?
September 22, 2016
Stronger antimicrobial stewardship practices by everyone, in both in human and veterinary medicine, are essential to continue to combat antimicrobial resistance. As proposed federal regulations are set to be in place for the end of 2017 to increase veterinary oversight of antimicrobial use in food animals, it allows the question to be asked, “Will there be a need for increased stewardship with the use of compounding in a veterinary setting?”
Current Guidelines for Compounding
As defined in the Canadian Veterinary Medical Association Antimicrobial Prudent Use Guidelines 2008 for Beef Cattle, Dairy Cattle, Poultry and Swine, compounding is the combining or mixing together of two or more ingredients (of which at least one is a drug or pharmacologically active component) to create a final product in an appropriate form for dosing.
- Compounding of drugs is considered extra-label drug use.
- When no approved products (veterinary or human) exist, veterinarians may prescribe that a drug be compounded for a specific animal or group of animals provided the veterinarian has adequate medical justification for the prescription.
- Compounding does not include mixing drugs with feed in accordance with label directions for approved products.
- Drugs may only be compounded by a veterinarian or pharmacist pursuant to a veterinary prescription in accordance with provincial legislation.
- When dispensing any compounded drug, the veterinarian is responsible for the quality of the ingredients used. Veterinarians must use veterinary or human approved pharmaceutical products as the basis for compounding when available.
- Veterinarians must not prescribe or use active pharmaceutical ingredients (API) of medically important antimicrobials.
- The prescribing veterinarian remains responsible for the outcomes including adverse reactions, which may include lack of efficacy.
- Compounding drugs for inventory and subsequent sale is considered manufacturing and not in compliance with Health Canada regulations and consequently is not permitted.
- A veterinarian shall not use cost as the sole reason for prescribing a compounded antimicrobial drug.
- Cost shall not be used as a basis for using an API instead of an approved pharmaceutical product when compounding.
In 2006, a document called Guidelines for the Legitimate Use of Compounded Drugs in Veterinary Practice – 2006 was produced to summarize and clarify all existing legislation and policy regarding compounded products for use in animals. In the guidelines, it lists a Decision Cascade for veterinarians to follow and choose the level of least risk to the patient and public safety (food animals). (If you are CVMA member, you can access the document use your username and password and login)
Moving Forward: Keeping Antimicrobial Stewardship at the Top of Mind
The use of compounding in companion animal practice will remain a legitimate form of practice moving forward, provided the decision cascade is adhered to.
Veterinarians need to be aware of special concerns in food-producing animals.
- Use of APIs in food animals is currently not compatible with the recommendations of the World Health Organization (2001)
- Use of APIs, in dose form or compounded, in food animals has great potential for food safety problems on a national and international scale
- APIs are not approved through the Health Canada approval process for drugs, have no safety, efficacy or quality control testing, and have no requirement for adverse reaction reporting
- The current system for antimicrobial residue avoidance in food animals in Canada, cgFARAD, never provides advice on withdrawal times for antimicrobial APIs, since there are no stability and quality control data for APIs.
- The compounding of antimicrobials for use in food animals is prohibited by the US Food and Drug Administration.
These concerns support the assumption that while it may currently be permissible for a veterinarian to prescribe compounding of an approved product in both companion and food animal practice, in the future antimicrobial stewardship and prudent drug use will dictate that veterinarians should no longer prescribe the use of APIs, in dose form or compounded, for use in food producing animals.