AVMA White Paper on Internet Pharmacies

The American Veterinary Medical Association (AVMA) receives two types of calls from veterinarians with respect to internet pharmacies. The first seek to determine guidance with respect to writing prescriptions. AVMA staff indicates the Association has approved a position statement that encourages veterinarians to honor client requests to prescribe rather than dispense a drug. That statement infers that a veterinarian-client-patient relationship exits and the veterinarian has determined that the drug is medically indicated. Staff adds that veterinarians should determine individual state requirements by contacting the State Board of Veterinary Medicine and the State Board of Pharmacy. Some states mandate that a prescription be given under such circumstances.

The second call involves complaints of pharmacy practices that appear to be contrary to FDA and other regulation and inconsistent with best patient care. The fundamental concern identified is that some internet pharmacies are supplying prescription drugs to consumers without the authorization of a veterinarian who has a veterinarian-client-patient relationship. Prescription drugs are regulated by federal and state agencies, including the state where the pharmacy is located and the state to which prescription drugs are sent. Pharmacists are required to have a valid prescription before dispensing prescription drugs. The AVMA assists veterinarians in making reports of their observations to the proper regulatory agencies.

The FDA regulates the drug products sold by pharmacies, not the practice of pharmacy itself. FDA can take action if the drugs are adulterated or misbranded. Adulterated drugs include unapproved drugs and compounded drugs that do not meet FDA’s compounding policies. Misbranded drugs include those prescriptions that are sold without a valid prescription.

The Board of Pharmacy regulates the practice of pharmacy in the state in which the internet pharmacy is located and registered. Boards of Pharmacy in states where consumers receive prescription drugs enforce their requirements for “out of state” pharmacies.

The state Board of Veterinary Medicine regulates the practice of veterinary medicine, including veterinarians who authorize prescription drugs without a veterinarian-client-patient relationship,
as in the case of “pharmacy staff veterinarians” who allegedly authorize prescriptions for animals in other states.

Defining the Problem

The reported problem is the provision of prescription drugs to consumers by some internet pharmacies without the authorization of a veterinarian involved in a veterinarian-client-patient relationship. Prescription drug labels bear the statement “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” The FDA has the responsibility for determining if an animal drug should be marketed over-the-counter or by prescription. An animal drug which is not safe for animal use except under the professional supervision of a licensed veterinarian (because of its toxicity or other potential for harmful effects, or the method of its use, or the collateral measures necessary for its use) is a prescription drug if it is not possible to prepare adequate directions for use under which a layperson can use the drugs safely and effectively.

For clarification, the scope of this issue paper does not include the sale of “ethical products” I.e., those products for which the manufacturer has voluntarily limited the sale to veterinarians as a marketing decision. Some flea and tick control products are ethical products. Unlike prescription drugs, these products are registered by the Environmental Protection Agency or approved by the FDA as an over-the-counter drug, and do not carry government restrictions on the distribution of these products. Manufacturers have chosen to limit their sales to veterinarians. The AVMA Principles of Veterinary Medical Ethics state “it is unethical for veterinarians to use or permit the use of their names, signatures, or professional status in connection with the resale of ethical products in a manner which violates those directions or conditions specified by the manufacturer to ensure the safe and efficacious use of the product.” Reports of fraudulent sales should be directed to the manufacturer.

The numbers of complaints by veterinarians to the AVMA alleging prescription drug law violations by internet pharmacies is steadily growing. Through 2000, the AVMA approach was to provide callers with contact information for the proper regulators (federal and state) to allow them to file a primary complaint. The AVMA is not a regulatory agency. We have no power to investigate or regulate. Only a primary complaint to regulators can be investigated.

Allegations of violations of prescription drug law continued to become more blatant and numerous. In 2001, the AVMA Council on Biologic and Therapeutic Agents (COBTA) spent a significant amount of time on the issue. Discussions with the FDA Center for Veterinary Medicine revealed that relatively speaking, very few complaints had been received by the agency, despite the growing number of calls to the AVMA.

What has the AVMA done?

The AVMA created a “Position Statement on Internet Pharmacies” to guide veterinarians. It appeared with a news story in the June 1 issue of the Journal of the AVMA and has been distributed to Executive Directors of allied organizations in the AVMA House of Delegates.
The AVMA provided a historical account of the association’s experience with complaints of alleged prescription drug law violation to FDA. Written communications on the subject (July 1998-January 2001) were redacted for anonymity and sent to a single designated contact within the headquarters of the FDA Center for Veterinary Medicine. This allowed the agency to experience the number of calls received by the AVMA, the nature of the complaints, and adverse trends in complaints without identifying the veterinarian who called.
The AVMA created a Pharmacy Complaint Form to simplify the reporting process for busy practitioners. Filing primary complaints is the best way to document the problem and prompt appropriate activity by regulatory agencies. The form identifies the key agencies that need to receive a copy of the report. AVMA staff is ready and willing to assist. Since the creation of the form in March 2001, the AVMA has received 45 phone call complaints from veterinarians. To our knowledge, only 11 veterinarians filed the supplied complaint form with the identified regulatory agencies to date. Low reporting percentages continue to be an obstacle to overcome.

What is the AVMA doing?

While veterinarians may be understandably frustrated by the apparent lack of adequate enforcement by appropriate regulatory authorities, we believe the profession is approaching a critical mass of complaints that will make the issue a priority for regulators. We believe the ongoing documentation of the problem through the first-hand complaints of veterinarians is necessary and constructive. Only documentation of the scope of the egregiousness of the activity will push this issue into the arena of the regulatory official who must content with human drug issues, and in the case of the FDA, food safety initiatives including BSE prevention. To this end, AVMA helps veterinarians to use the Pharmacy Complaint Form to register their observations with the correct parties.
As a supportive measure, AVMA staff summarizes every phone call complaint received from veterinarians and faxes them to the designated FDA contact. Despite the importance of first-hand reporting by the veterinarian to the proper authorities, it is our experience that only 20%-25% of veterinarians who call the AVMA with a complaint actually take the next step and file the Pharmacy Complaint Form. Low reporting percentage continues to be an obstacle to overcome. Remember that the staff summary reports lack veterinarians’ names and cannot be investigated by the FDA, but they serve to inform the agency of the number of veterinarians who complain to the AVMA and do not report to regulators. It lessens the divide between what the AVMA is hearing and what the FDA is hearing but it is not as good as first-hand reports. We are sharing our knowledge of this subject through initiatives like this white paper.

What AVMA activities are planned?

The AVMA will continue to facilitate reporting to the proper regulatory agencies, including a single point through the FDA. Reports document the breadth and seriousness of concern, serve to heighten priority of the issue within the agencies, and allow the agencies to look into the problem we are experiencing.
Communicate the importance of requiring proper authorization for prescription animal drugs. The AVMA is developing a white paper that describes why the provision of prescription drugs to consumers without the authorization of a veterinary who has a veterinarian-client-patient relationship is illegal and not in the best interest of the patient. It could serve as an effective cover letter accompanying the Pharmacy Complaint Form.
Discuss our concerns with the National Association of Boards of Pharmacy. As the name suggests, the NABP is an association of state Boards of Pharmacy. The Association is not a regulatory authority, but it represents an assembly of state officials whose mission is to assure that pharmacies comply with the state regulations designed to protect health. We hope to heighten awareness of our concern with the practices of some internet pharmacies that dispense prescription animal drugs without adequate authorization and determine if the association can assist in communication and educational efforts to curb the practices of rogue pharmacies. We will attempt to identify a singular contact with each state Board of Pharmacy to receive the Pharmacy Complaint Form.
Discuss our concerns with the Society of Veterinary Hospital Pharmacists, an association of pharmacists who have chosen to serve veterinary medicine often as pharmacists within Colleges and Schools of Veterinary Medicine. The Society understands prescription drug requirements and the field of veterinary medicine. We would like to heighten awareness of our concerns and seek the society’s input.
Determine if the Federal Trade Commission has jurisdiction over the practices of individual veterinarians and practices with respect to the provision of prescription drugs to clients. At least one internet pharmacy is abetting reporting to the Federal Trade Commission of veterinarians who, in their interpretation, refuse prescriptions for inappropriate reasons, asserting this falls within the agency’s consumer protection laws.
Establish a single area within the AVMA web site (www.avma.org) to collect and consolidate pertinent AVMA information on this subject.
Continue to communicate through the Journal of the AVMA and electronic AVMA Bulletin.
Reassess during the AVMA Council on Biologic and Therapeutic Agents meeting October 13, 2001.

What the AVMA cannot do?

AVMA cannot forward complaints based on a veterinarian’s desire to retain the business income from dispensed products. Drugs may be dispensed or prescribed. Veterinarians should honor client requests to prescribe rather than dispense a drug. The client has the option of filling a prescription at any pharmacy.
AVMA cannot become involved in the enforcement of contractual matters or marketing policies.
The AVMA cannot become involved in any activity that might be perceived as using the association’s influence to affect trade.

How can you help?

File a complaintif you believe you have observed abuse of prescription drug law that is contrary to best patient care. Use the Pharmacy Complaint Form to get started.
Share accurate information in newsletters and on list serves and web sites, and encourage reporting of perceived illegal activity.
Offer suggestions of other possible AVMA strategies.
Contact Dr. Elizabeth Curry-Galvin at the AVMA at (800) 248-2862, ext. 290.