Coverage of the actions taken by the AVMA Executive Board in April began in the May 15 issue and concludes in this issue with the news reports on pages 1781 to 1789.
Statements cover Internet pharmacies to compounding
posted May 15, 2005
The Executive Board approved two new position statements, three revised positions, and rescission of an existing position as recommended by the AVMA Council on Biologic and Therapeutic Agents. In addition, the board approved a drug-related position statement submitted by the AVMA Aquatic Veterinary Medicine Committee.
The board approved rescission of the 1991 AVMA position statement on Professional Labeling. That position enabled the AVMA and the Animal Health Institute to submit a citizens' petition requesting that the commissioner of the Food and Drug Administration implement a series of changes in the regulatory process for approving new animal drugs. Since then, changes in laws, regulations, and FDA policies have allowed many of those requests to be implemented, so the primary intent of the position statement was fulfilled.
Veterinarians' use of drugs would be enhanced, however, if labels contained relevant pharmacodynamic and pharmacokinetic information allowing veterinarians to use drugs in an extralabel manner to meet specific patient needs. Therefore, the board approved a position on Drug Labeling, which states:
Labels that accompany animal drugs should provide relevant pharmacokinetic and pharmacodynamic data necessary for the rational design of dosing regimens specific for the individual patient.
Six minor revisions to the AVMA Guidelines for Veterinary Prescription Drugs were approved to improve the clarity and accuracy of the document. AVMA members can access the guidelines at www.avma.org/noah/members/policy/polrxdrugs.asp.
Language was inserted into the first of eight recommendations that comprise the AVMA position statement on Internet Pharmacies, to direct clients to obtain a prescription from a veterinarian before approaching a pharmacy. The revised recommendation #1 states the following:
- Drug therapy, when medically indicated, should be initiated by the attending veterinarian in the context of a veterinarian-client-patient relationship. Clients that wish to purchase their prescription drugs from a pharmacy rather than the veterinarian, should be advised to first obtain a prescription from their veterinarian before contacting a pharmacy. The veterinarian may choose to either issue the prescription in writing for the client, or contact the pharmacy electronically or by phone.
To access the full position statement on Internet Pharmacies, go to www.avma.org/policies/internet_pharmacies.asp.
Two position statements cover the practice of drug compounding. The board approved revisions to the existing position on Compounding and a proposed new position on Compounding from Unapproved (Bulk) Substances.
To enhance what it considered an otherwise good position statement titled Compounding, COBTA recommended the addition of a working definition. The revised position was approved, including the definition, which states:
Compounding is the manipulation of a drug, other than in accordance with the FDA approved label, to make a different formulation of the drug to meet the needs of a specific patient.
To access the full position on compounding, go to the compounding area on the AVMA Web site at www.avma.org/compounding/position_statements.asp.
COBTA developed the position on Compounding from Unapproved (Bulk) Substances to cover situations in which no FDA-approved drug is commercially available, or it is medically insufficient to use for compounding to relieve pain and suffering in specific nonfood-animal patients. The new position states:
Compounding from Unapproved (Bulk) Substances
Compounding of drugs from unapproved (bulk) substances for use in non-food animals is medically necessary in certain situations and should be allowed through regulatory discretion, if such compounded products are used under the conditions for extra-label use of approved drugs delineated in the regulations written to implement AMDUCA. Such compounding should be allowed only if effective regulatory mechanisms are in place and implemented to assure that such compounding is patient specific and is performed only in the context of a veterinarian-client-patient relationship.
An AVMA position statement on Extralabel Use of Veterinary Feed Directive Drugs for Minor Species, developed by the Aquatic Veterinary Medicine Committee, was approved by the Executive Board. The committee developed it to encourage the FDA Center for Veterinary Medicine to amend its Compliance Policy Guide so that it applies to extralabel use not only of over-the-counter medicated feeds but also of medicated feeds containing Veterinary Feed Directive drugs. The CPG establishes conditions under which extralabel use of medicated feeds will be permitted in minor species. As more VFD drugs are approved, it will become increasingly important for them to be available for extralabel use in minor species. The new position states:
Extralabel Use of Veterinary Feed Directive Drugs for Minor Species
The AVMA believes that veterinarians, their clients and patients would be well served should the Food and Drug Administration, Center for Veterinary Medicine amend the Compliance Policy Guide 615.115 (Extralabel Use of Medicated Feeds for Minor Species) regarding extralabel use of medicated feeds for minor species to include not only over-the-counter (OTC) drugs but also Veterinary Feed Directive (VFD) drugs.