Authorizing Technician Activity When No Pharmacist Is Present

Issue of the Case

The pharmacist-in-charge, also the pharmacy owner, was out of town, but an order came in for a compounded chemotherapy medication that was needed the same day, so he authorized a technician to prepare it with no pharmacist present to supervise. Should this have led to professional sanctions from the board of pharmacy?

Facts of the Case

A pharmacy owner was out of town for a continuing education seminar, so he lined up another pharmacist to cover his practice for the day. However, the spouse of the replacement pharmacist became ill, and that pharmacist did not show up as planned. A pharmacy technician called the owner to advise him of the predicament. The owner’s instructions were to close the pharmacy for business but to leave the doors open so that staff members could explain to patients that prescriptions could not be picked up because there was no pharmacist on duty.

The technician also notified the owner that a call had come in from a physician who needed a chemotherapy medication compounded that day. The owner initially directed that the medication should not be prepared but later changed his mind, instructing the technician to prepare the medication and deliver it to the physician’s office.

There was no evidence that the patient suffered any adverse consequences from administration of the compounded medication. However, word reached the board of pharmacy that someone at the pharmacy was practicing without a license and that no pharmacist was present when the medication was prepared. The board dispatched an investigator, who filed a report that was the basis for dual action by the board: action against the pharmacist’s license to practice and action against the pharmacy’s permit to operate.

During a hearing on the matter, the pharmacist-owner testified that he thought he did the right thing under the circumstances by directing the technician to prepare the medication. Moreover, he would do the same thing again, for the benefit of the patient, if a similar situation arose, even though he knew he was violating the law by doing so. He emphasized that he was exercising his professional judgment to violate the law because that was in the best interest of the patient.

The result of the hearing was that the pharmacist’s license to practice and the pharmacy’s permit to operate were placed on probation for 1 year, subject to a number of terms and conditions. The pharmacist and the pharmacy sought review of the board’s decision in the local trial court, but that court upheld the 1-year probation in both instances. The matter was then taken to the state court of appeals for review.

The Ruling

The appellate court upheld the 1-year probationary period for both the pharmacist and the pharmacy.

The Court's Reasoning

The attorney for the pharmacist argued that his actions were justified by his exercise of professional judgment when he authorized the technician to prepare the medication. He had the patient’s best interests in mind and no one complained, nor did the compounded medication cause any harm. The court responded to that argument by stating, “The regulations in question are not suggestions for use. They are mandatory rules established and designed to protect the public.” The court said there was no excuse for the pharmacist’s flagrant disregard of the regulations.

The pharmacist argued that despite his physical absence when the medication was compounded, he had not neglected his duties as pharmacist-in-charge. He attempted to justify his knowing violation of the regulations by arguing that he was exercising professional judgment under extraordinary circumstances, that he had the patient’s care in mind, and that he “knew” the compounding would be properly done by the technician and checked by the prescriber’s office. The court responded that the pharmacist’s “decision to pick and choose which mandatory regulations he believes himself to be bound by in his expertise is nothing short of the sort of arrogance that the regulations are designed to guard the public against.”

The pharmacist also argued that the discipline imposed was disproportionate to the offense. The court responded that the severity of the discipline to be imposed is at the discretion of the board, saying, “A part of the expertise of the members of the board consists of the ability, drawn from their knowledge of industry practices and standards, to assess the gravity of the licensee’s infractions and to fit the sanction to the offense.”

In sum, the appellate court upheld the imposition of the 1-year probation on both the pharmacist’s license and the pharmacy’s permit.

Joseph L. Fink, BPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.