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Harvard University hospital pharmacy fined $775,00 over past pharmacy operations

October 3, 1996

University Health Services (UHS) has entered into a civil settlement with the U.S. Attorney for the District of Massachusetts and the federal Drug Enforcement Administration (DEA) involving past administrative operations at UHS's Pharmacy.

The government had alleged that inadequate pharmacy practices resulted in thefts of codeine-based cough medicine by a former pharmacy technician. The government also claimed that the pharmacy had other administrative record-keeping and inventory control procedures that did not meet the technical requirements of the federal regulations governing pharmacies.

"Once it became clear that one Pharmacy technician had stolen codeine-based cough medicine for his own use, we promptly reported the employee's misconduct to the DEA and fired the employee," UHS Director David S. Rosenthal said. "In addition, at my direction, we began a comprehensive internal investigation of Pharmacy operations. That investigation revealed shortcomings in administrative record-keeping, inventory control, and supervisory procedures. At the same time, the government undertook its own inquiry into Pharmacy operations. Harvard fully cooperated in that inquiry, as the government acknowledges."

Harvard agreed to pay $775,000 to settle the civil claims. Any variation from the federal regulations, regardless of intent, constitutes a violation and is punishable by a substantial civil fine. "Although we disagree with the scope of the government's allegations, we have decided to resolve this civil matter in a way that will avoid very expensive and time-consuming litigation, and allow us to dedicate our resources to further ensure high quality care to the University community," Rowe said.

During the past year, a new Pharmacy director has been appointed; that person answers directly to Rosenthal. A new staff of pharmacists, technicians, and support staff has been hired, and a new computer system with sophisticated record-keeping and cash management systems has been installed. Pharmacy policies and procedures have been carefully reviewed to ensure rigorous compliance with regulations.

"We have now brought the Pharmacy's operations into full compliance with regulatory requirements, as the government also acknowledges," Rosenthal said.

The UHS Pharmacy is a "hospital pharmacy" in that it is licensed to fill prescriptions only for patients affiliated with UHS. It is not a retail operation available to the general public. The Pharmacy processes 300-400 prescriptions per day, or 70,000-75,000 per year. There are five licensed pharmacists, including the new director and assistant director of the Pharmacy, and two technicians and support staff, including several Pharmacy interns.

 

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