The AVMA has been receiving a growing number of complaints and queries from members about Internet dispensing services. The Council on Biologic and Therapeutic Agents recognized the need to develop guidance for AVMA members.
On page 1690 is the new AVMA Position Statement on Internet Pharmacies, developed by the council and approved by the Executive Board in April. It is a combination of the AVMA's previous, brief Internet position statement (as published in the 2001 AVMA Directory) and concepts the council first presented to the board last fall.
Some Internet pharmacy practices are acceptable, others are not. To guide practitioners through this web, the AVMA developed the Internet Pharmacies position statement. And to increase the reporting of irregularities, the Association created a pharmacy complaint form. The AVMA encourages veterinarians who are concerned about rogue pharmacies to report questionable practices to the appropriate regulators.
Rogue pharmacies are those whose practices appear to be contrary to the regulations of the FDA, state pharmacy acts, or other authorities and are inconsistent with best patient care.
Drugs are regulated at the state and federal levels. At the federal level, the FDA mandates that a valid veterinarian-client-patient relationship must exist for prescription drugs and for extralabel use, something that many states also require.
The pharmacy complaint form simplifies the reporting process. One of the regulators to whom it directs veterinarians to send the completed form is the FDA-CVM. Many practitioners have the misconception that the FDA regulates the practice of pharmacy. Although that is not true, the agency does regulate the drug products sold by pharmacies, and it can take action if drugs are adulterated or misbranded. Adulterated drugs include unapproved drugs and compounded drugs that do not meet the FDA's compounding policies. Misbranded drugs include prescription drugs that are sold without a valid prescription.
The complaint should also be sent to the state board of veterinary medicine if an Internet pharmacy staff veterinarian prescribed drugs without a veterinarian-client-patient relationship. If a pharmacist/agent dispensed prescription drugs without authorization, the complaint should go to the state board of pharmacy.
The new principles remind veterinarians that, in keeping with the AVMA Principles of Veterinary Medical Ethics, they should honor client requests to prescribe rather than dispense a drug. In some states, this is a legal requirement. The client may fill the prescription at any pharmacy.
For prescriptions involving drugs labeled for human use, veterinarians may want to advise clients who choose to fill them through the Internet to select a VIPPS pharmacy—one that is certified by the National Association of Boards of Pharmacy and has its seal of approval.
The national pharmacy association developed the Verified Internet Pharmacy Practice Sites (VIPPS) program in 1999 in response to public concern over the safety of Internet pharmacy practices. VIPPS pharmacy sites are designated by a hyperlink seal.
To be VIPPS certified, a pharmacy must comply with the licensing and inspection requirements of the state in which it is located and in each state where it dispenses pharmaceuticals. These pharmacies must also demonstrate compliance with criteria that include patient rights to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists.
Dr. Donald J. Klingborg, chairman of the Council on Biologic and Therapeutic Agents, said, "Our focus is simply what needs to be accomplished to provide best patient care for animals. It is clear that rogue Internet pharmacies have different interests, and that their activities have the very real potential to harm our animal patients.
"The position statement recently approved by the Executive Board is an important step in protecting the health of animals as the Internet pharmacy industry evolves."
AVMA Position Statement on Internet Pharmacies
(Approved by Executive Board, April 2001)
The following recommendations are offered as a guide to prescribing and client purchases:
- Drug therapy, when medically indicated, should be initiated by the attending veterinarian in the context of a valid veterinary-client-patient relationship.
- Drugs may be dispensed or prescribed. Veterinarians should honor client requests to prescribe rather than dispense a drug (AVMA Principles of Veterinary Medical Ethics). The client has the option of filling a prescription at any pharmacy.
- Clients might be advised to select an Internet pharmacy certified by the National Association of Boards of Pharmacy (email@example.com) whose VIPPS program and its accompanying seal of approval identify to the public those online pharmacies that are appropriately licensed and prepared to practice pharmacy via the Internet.
- Veterinarians asked by pharmacies to approve prescriptions they have not initiated should do so only if they have a valid veterinarian-client-patient relationship and if the prescription is appropriate.
- It is within the veterinarian's (not the pharmacy's) purview to determine the medical criteria whereby a drug is indicated.
- As with any prescription, a written record should be maintained.
- Prescribing veterinarians should assure that information regarding the proper use of the prescribed drug and the risks associated with its use are communicated to the client, regardless of the drug source.
- Use of drugs of foreign origin that lack FDA approval generally is not permitted.