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The FDA found fungus, insects, and poor compounding practices at the National Institutes of Health (NIH) Pharmacy; the pharmacy compounds and supplies clinical-trial medications.
At NIH (Bethesda, Maryland), the Pharmaceutical Development Section produces and manages experimental drugs for the agency's Clinical Center with up to 46 ongoing trials receiving materials from the facility. NIH has suspended use of all these products, and they are also monitoring six patients who received injections of the protein albumin from a batch in which at least two vials were contaminated with fungus.
FDA investigated the NIH facility on May 19-29 in response to an anonymous complaint and issued reports dated May 29 and June 2, outlining numerous problems with quality control and staff training, including the following:
- Pharmacy employees wearing garments that left parts of their arms, faces, or necks exposed.
- Some pharmacy employees resting their arms on work surfaces.
- One lab worker had exposed facial hair.
- Poor maintenance procedures.
- Some parts of the facility were cleaned with materials that could not kill fungal or bacterial spores.
- Some of the labs rarely tested water quality.
- Some of the labs rarely monitored airflow systems.
- Two "cleanrooms" had insects in the light fixtures.
"It's troubling that an institution of NIH's caliber had such serious deficiencies," stated Michael Carome of Public Citizen; "These clearly could have put patients at risk of harm."
An employee discovered the fungal contamination, but the FDA does not know whether it was this person who registered the anonymous complaint with the FDA; the NIH does have a system for employees to report problems to supervisors.
Currently, there are about 250 patients enrolled in NIH clinical trials that use treatments supplied by the closed facility. It was stated that fewer than 50 of these people may need these drugs immediately, and, if no alternative sources for the drugs can be found, NIH director Francis Collins will personally review each patient's case to determine whether medical need justifies giving the person a drug manufactured by the NIH lab.
The New York Times (6/5, A16) reported that the FDA findings and the response are part of "a spate of mistakes with potentially lethal substances in government laboratories," noting problems at the Defense Department and NIH labs.
NBC News (6/5, Fox) in its report says "it's not the first hygiene disaster at NIH," mentioning Klebsiella pneumoniae in 2011, and the discovery of smallpox "forgotten in a storage locker."
One cannot help but wonder why these events continue to occur in ALL practice sites. One thing is apparent and that is the lack of training of pharmacists in this area of practice. This really needs to be changed and continues to support the requests to include curriculum changes in colleges, continuing education programs, and current literature to get up-to-speed and to keep up-to-date.
Back to the original questions, "Is NIH Clinical Center a model compounding pharmacy"? I don't think so!
See the FDA-issued '483 at:
http://www.cc.nih.gov/phar/pdfs/483.pdf
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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