Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.
Facts of the Case
Late in 2004, this board of pharmacy notified pharmacists licensed in the state that its licensees were prohibited from “dispensing drugs, devices, or prescriptions when a prescriber relies on Internet or mail questionnaires to make patient diagnosis and then relies on that diagnosis to prescribe.” The board’s communication emphasized that “a prescriber must perform a physical (hands-on) examination of the patient before a drug, device, or prescription can be dispensed.”
A subsequent visit by a board inspector revealed that some pharmacists had dispensed prescriptions from one particular physician for patients located all around the country. The prescriptions were for erectile dysfunction medications. In fact, the physician was an employee of the same individual who owned the pharmacy.
Available information revealed that the physician issued prescriptions after reviewing questionnaires completed by the patients and submitted by telephone or via the Internet. On occasion, the physician would contact the patients by the same method of communication—telephone or Internet—to clarify information on the questionnaire.
The information uncovered by the pharmacy inspector was reported to the state board of medical licensure, a not uncommon example of interagency cooperation. The medical board investigated, conducted a hearing, and concluded that the act of prescribing based on questionnaires without physical examination constituted unprofessional conduct. The physician was placed on probation for 5 years.
Returning to the pharmacy board, a complaint was issued against the pharmacy where the prescriptions had been dispensed. In total, 63,532 prescriptions were issued by the physician in question, which were deemed invalid by the medical board. The pharmacy board decided to revoke the state permit under which the pharmacy operated, but it stayed (suspended) implementation of the sanction for a 5-year probationary period.
The pharmacy challenged the decision of the board of pharmacy by going to court, advancing several arguments: (1) the board had no authority over these transactions because none of the prescriptions were dispensed to residents of the state where the pharmacy and the board were located; (2) the statutes enacted by the legislature to cover such situations with the physician and the pharmacy were so vague as to be unconstitutional; (3) the pharmacy board had engaged in selective enforcement; and (4) the conclusions reached by the pharmacy board following the investigation and the subsequent hearing were not supported by the evidence the board had before it.
The trial court where this challenge was mounted ruled in favor of the board of pharmacy while making some modifications to the board’s order. The pharmacy appealed to the state court of appeals.
The Court’s Ruling
The appellate court agreed with the trial court’s decision in all 4 areas and, as a result, affirmed the trial court’s modified order upholding the board of pharmacy’s decision.
The Court’s Reasoning
The court decided that the board had jurisdiction over the pharmacy and the activities there, based on the authority conferred on it by the legislature to issue permits to operate pharmacies. The statutes being applied to the facts of this situation were not so vague as to be deemed unconstitutional. The pharmacy had submitted no evidence to support its claim that the board had engaged in selective enforcement of the relevant state statutes and regulations. Finally, the appellate court decided that the board had more than sufficient evidence during its deliberations to conclude that the prescriptions in question were issued without a physical examination of the patient by the prescriber and, therefore, not a lawful basis for dispensing a federal legend medication.
This case reinforces the importance of paying close attention to communications emanating from a state board of pharmacy. Many boards of pharmacy participate in the newsletter production and distribution program led by the National Association of Boards of Pharmacy. Moreover, board of pharmacy Web sites feature updates and interpretations of the relevant statutes and regulations.