Pharmacy Law: Board Hearing Required Before Sanctions?

APRIL 01, 2009
Joseph L. Fink III, BSPharm, JD

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.

Issue of the Case

When a pharmacist is charged with a violation of the law and has had the matter referred to an administrative law judge who concluded that there was no genuine issue of material fact, does the pharmacist subsequently have a right to a hearing on the matter before the state board of pharmacy prior to suspending his license?

Facts of the Case

A pharmacist in a mid-Atlantic state entered into an arrangement with a sales representative from a pharmaceutical manufacturer related to a voucher program the firm used to distribute sample quantities of its medications to patients. After a prescriber issued the request for dispensing the sample quantity of one of the covered medications on a specific form, the form would be presented at the pharmacy for dispensing. The pharmacist was to dispense the medication the same way as with a customary prescription, submitting an attached voucher to the manufacturer for reimbursement of product cost, plus a dispensing fee.

This was how the system was designed to work. In this instance, however, the sales representative would bring the pharmacy bundles of the prescription sample forms. This differed from the planned approach, wherein the patient would present the form at the pharmacy. In a 4-month period, the representative presented 965 forms at the pharmacy, 104 of which formed the basis for a complaint filed by the state attorney general. The sample quantities of medication being dispensed by the pharmacist were not picked up by the patients. Instead, they were either picked up by the representative or mailed to a particular physician, who was not the prescribing physician on the forms that had been presented. Affidavits were presented from the prescribers whose names did appear on the form verifying that they did not sign them.

The attorney general filed a 4-count complaint alleging a variety of statutory and regulatory violations. Sanctions sought in the complaint included suspension of the pharmacist's license and pharmacy permit, as well as imposition of penalties and recovery of investigative costs and attorneys' fees. The pharmacist filed an answer contesting all allegations. The matter was referred to an administrative law judge for a hearing.

The attorney general filed a motion with the administrative law judge for a summary decision, in essence requesting that the hearing officer determine that there were not material issues in dispute and that a ruling could be made based on the filings. The pharmacist filed a cross motion for a partial summary decision. Both parties stipulated certain facts and filed certified statements in support of their positions. Both sides also submitted reports from pharmacists serving as experts on the topic of dispensing medications and handling such requests for dispensing of sample quantities of medications.

The administrative law judge concluded that there was no genuine issue of material fact and granted the motion of the attorney general. The hearing officer concluded that the facts constituted "gross negligence, negligence, and evidence of a lack of professional judgment." He ruled that the pharmacist failed to record the medication in the patients' profiles and failed to offer to counsel them. In the view of the administrative law judge there was, however, a genuine issue of material fact about whether a drug use review had been conducted and whether the pharmacist had failed to record his initials on the prescriptions.

The administrative law judge reported this to the board, which afforded the parties the opportunity to be heard on the issue of the pharmacist's exceptions to the judge's decision and permitted the pharmacist to present evidence.

The board ordered a 5-year suspension of the pharmacist's license, with the first 2 years being an "active suspension" and the remaining 3 years viewed as a probationary period. In addition, investigative costs and attorneys' fees totaling $99,639.75 and a civil penalty totaling $10,000 were assessed. The pharmacist appealed those sanctions to an appellate court, arguing that he never had a chance to address all the issues before the board.

The Court's Ruling

The court ruled in favor of the board, upholding the penalties.

The Court's Reasoning

The court first pointed out that the actions of administrative agencies are entitled to a "strong presumption of reasonableness." It found the decision of the board to be "entirely consistent" with the applicable statutes and regulations and supported by substantial credible evidence. It concluded that the undisputed facts provided ample support for the finding that the pharmacist dispensed the medication under circumstances that should have alerted him to the fact that the prescriptions were not valid.