Harvard to pay $775,000 for lax pharmacy control
The U.S. Attorney in Boston announced recently that Harvard University will pay $775,000 to settle federal claims that the university’s poor security and record keeping allowed staff to steal drugs.
The federal investigation began in November 1995 when the university reported a suspected drug theft from it’s campus pharmacy to the federal Drug Enforcement Administration (DEA) in Washington, DC. The DEA and the U.S. Attorney’s office traced the theft to a technician who was convicted of stealing 7,500 doses of cough syrup containing codeine over a six-month period. U.S. Attorney Donald Stern reports that the technician had improper access to the pharmacy’s computer system, which allowed him to alter records and facilitate his thefts.
The investigation revealed several other irregularities. Stern says employees ignored inventory errors and changed records to hide the discrepancies. Outdated medications were not disposed of properly, he says, but were left in a back room where unauthorized access was easier.
James H. Rowe, Harvard’s vice president for public affairs, confirms the settlement figure but says the university’s own investigation showed less of a problem than the federal officials allege. The thieving technician was fired, and the pharmacy has overhauled its computer and security systems. t
ECRI says be careful, but reusing disposables is OK
If you’re wondering whether it is worth the cost savings to defy the manufacturers’ instructions to throw away "single-use" medical devices, reassurance is now available from ECRI, the nonprofit health device research agency in Plymouth Meeting, PA.
Because it is objective, ECRI is considered the voice of authority in all matters concerning medical equipment. In a recent report on the matter, ECRI’s vice president for legal affairs, Ronni Solomon, JD, says the agency’s research suggests reuse can be safe.1 He notes that the practice is not prohibited by the U.S. Food and Drug Administration in Rockville, MD, the Centers for Disease Control and Prevention in Atlanta, or the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL. "From a malpractice perspective, the practice of reuse is akin to off-label use," he concludes. He advises following these guidelines from the FDA:
1. The device can be adequately cleaned and sterilized.
2. The physical characteristics or quality of the device will not be adversely affected.
3. The device remains safe and effective for its intended use. The facility or surgeon takes on full responsibility to ensure that the disposable device is safe and effective, since the manufacturer has suggested otherwise.
"This approach is a correct one," Solomon says. "When it comes to reuse, risk managers should help to ensure that there is evidence of safety protocols and appropriate oversight mechanisms. A deliberation on ethical issues of disclosure, consent, and access may also be warranted."
Reference
1. Solomon R. The risks and rewards of reuse. The Risk Management Reporter 1996; 15:2. t
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content