Pharmacist Loses Control of Patient Records and Controlled Substances

ISSUE OF THE CASE

A prominent pharmacist who opened and operated a community pharmacy for many years closed the business. What are the consequences of her losing custody of the pharmacy’s controlled substances and records?

FACTS OF THE CASE

A pharmacist in charge in a mid-Atlantic state who had more than 30 years of experience in practice with an unblemished record with the board of pharmacy opened a community pharmacy in an urban area to bring services to an underserved community. After 13 years, she decided to close due to declining activity in the pharmacy. She notified the board of pharmacy of her decision and received guidance about how to achieve that shutdown in conformity with board regulations.

While closing the pharmacy and terminating its lease, the pharmacist— who was holder of the pharmacy’s registration—lost custody of the controlled substances on hand and records and failed to inform the board of pharmacy, the DEA, or state-level controlled substances officials.

The state government later filed a professional licensure complaint against her with the board of pharmacy and said that she had “violated each of the statutory and regulatory provisions cited in the state’s complaint.”

An administrative hearing was held before a hearing officer, who accepted the stipulated facts about disappearance of the items in question and her admitted violations. He also heard statements from community leaders about her reputation and standing in the community and in the profession. This testimony was presented as mitigation of the offense and resulting penalties.

He said “there was no evidence…of any intent on the pharmacist’s part to cause harm” and she “demonstrated a credible desire to serve the pharmacy needs of underserved, at-risk patients in the state.”

Nonetheless, he concluded that she had violated 9 regulations and statutes, and he recommended a 2-year suspension of her license to practice pharmacy to be stayed immediately and replaced with a 3-year probationary period for her license. A variety of requirements and stipulations were also part of his recommendations.

The board of pharmacy accepted the hearing officer’s conclusions about the violations of the law but rejected his recommendations about the sanctions. The board instead imposed a 1-year license suspension to be followed by a 3-year period of probation.

The pharmacist filed an appeal requesting that a court review the decision of the licensure agency to increase the severity of the penalty from that recommended by the hearing officer.

THE RULING

The court reviewed the matter in toto and that the decision of the board of pharmacy regarding the penalty.

THE COURT’S REASONING

The court said when reviewing the decision of an administrative agency like this professional licensure board, it focuses on 2 issues: (1) Was the decision supported by “substantial evidence”? (2) Did the board avoid making “errors of law” while reaching its decision?

An earlier case decided at the level of the state Supreme Court described substantial evidence as “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” Further, the appellate court must review the record of the prior proceedings in deciding the matter in a manner “most favorable to the prevailing party below,” in this case, the board.

The court emphasized that the appellate review by the court does not involve weighing the evidence or making its own factual findings. Rather, “it determines whether the evidence presented and considered was adequate to support the board’s factual findings.”

The question is whether a review of the record shows that the administrative board could have fairly and reasonably reached its conclusions. The burden of proof rests with the party challenging the decision.

A state statute mandated that the “findings of fact made by a hearing officer on a complaint are binding on the board…and the board shall make its final decision to affirm or modify the hearing officer’s recommended conclusions of law and proposed sanctions based upon the factual record.”

So the board must make its ultimate decision based on the entire factual record, but there is no requirement that it discuss each facet of the record in its written decision. Minutes of the board members’ deliberation showed that all had read the entire hearing record based on comments they made while discussing the case.

The court said the main concern of the board members was that the pharmacist had “negligently committed multiple violations, despite the fact that she had practiced pharmacy for 36 years and ‘knew or should have known’ what was required of her.”

Finally, the court ruled that the board had “full discretion to impose the penalty that it deems appropriate.”

JOSEPH L. FINK III, BSPHARM, 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.