Pharmacy Law: Board Hearing Required Before Sanctions?

Pharmacy Times, Volume 0,0

In this case, a pharmacist is sanctioned for dispensing sample quantities of medications.

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 aviolation of the law and has had thematter referred to an administrativelaw judge who concluded that therewas no genuine issue of material fact,does the pharmacist subsequentlyhave a right to a hearing on the matterbefore the state board of pharmacyprior to suspending his license?

Facts of the Case

A pharmacist in a mid-Atlantic stateentered into an arrangement with asales representative from a pharmaceuticalmanufacturer related to a voucherprogram the firm used to distributesample quantities of its medicationsto patients. After a prescriber issuedthe request for dispensing the samplequantity of one of the covered medicationson a specific form, the formwould be presented at the pharmacyfor dispensing. The pharmacist wasto dispense the medication the sameway as with a customary prescription,submitting an attached voucher to themanufacturer for reimbursement ofproduct cost, plus a dispensing fee.

This was how the system wasdesigned to work. In this instance,however, the sales representativewould bring the pharmacy bundles ofthe prescription sample forms. Thisdiffered from the planned approach,wherein the patient would present theform at the pharmacy. In a 4-monthperiod, the representative presented965 forms at the pharmacy, 104 ofwhich formed the basis for a complaintfiled by the state attorney general.The sample quantities of medicationbeing dispensed by the pharmacistwere not picked up by the patients.Instead, they were either picked upby the representative or mailed to aparticular physician, who was not theprescribing physician on the formsthat had been presented. Affidavitswere presented from the prescriberswhose names did appear on the formverifying that they did not sign them.

The attorney general filed a 4-countcomplaint alleging a variety of statutoryand regulatory violations. Sanctionssought in the complaint included suspensionof the pharmacist's license andpharmacy permit, as well as impositionof penalties and recovery of investigativecosts and attorneys' fees. The pharmacistfiled an answer contesting all allegations.The matter was referred to anadministrative law judge for a hearing.

The attorney general filed a motionwith the administrative law judge for asummary decision, in essence requestingthat the hearing officer determinethat there were not material issues indispute and that a ruling could be madebased on the filings. The pharmacistfiled a cross motion for a partial summarydecision. Both parties stipulatedcertain facts and filed certified statementsin support of their positions.Both sides also submitted reports frompharmacists serving as experts on thetopic of dispensing medications andhandling such requests for dispensingof sample quantities of medications.

The administrative law judge concludedthat there was no genuine issueof material fact and granted the motionof the attorney general. The hearingofficer concluded that the facts constituted"gross negligence, negligence,and evidence of a lack of professionaljudgment." He ruled that the pharmacistfailed to record the medication inthe patients' profiles and failed to offerto counsel them. In the view of theadministrative law judge there was,however, a genuine issue of materialfact about whether a drug use reviewhad been conducted and whether thepharmacist had failed to record hisinitials on the prescriptions.

The administrative law judge reportedthis to the board, which afforded theparties the opportunity to be heard onthe issue of the pharmacist's exceptionsto the judge's decision and permittedthe pharmacist to present evidence.

The board ordered a 5-year suspensionof the pharmacist's license, withthe first 2 years being an "active suspension"and the remaining 3 yearsviewed as a probationary period. Inaddition, investigative costs and attorneys'fees totaling $99,639.75 and a civilpenalty totaling $10,000 were assessed.The pharmacist appealed those sanctionsto an appellate court, arguingthat he never had a chance to addressall 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 theactions of administrative agencies areentitled to a "strong presumption ofreasonableness." It found the decisionof the board to be "entirely consistent"with the applicable statutes andregulations and supported by substantialcredible evidence. It concludedthat the undisputed facts providedample support for the finding that thepharmacist dispensed the medicationunder circumstances that should havealerted him to the fact that the prescriptionswere not valid.