Safety Troubles in Hospital Compounding Pharmacies

We wrote yesterday about contamination at the pharmacy of the NIH Clinical Center in Bethesda. Other big hospitals, judging by media reports, also may need to look at their pharmacy operations, especially when they compound ingredients together into custom drugs for patients.

A major hospital in a San Diego, Calif., suburb may have exposed more than 7,300 of its patients to infection risk due to contaminated medications served up in a pharmacy compounding lab. State officials fined Paradise Valley Hospital $17,500 not only for sanitary violations found in inspections but also because a hospital executive with oversight over the compounding lab was found to have falsified records; no patients came down with infections at the hospital due to the lab woes, otherwise the hospital could have been fined up to $75,000, state officials said.

And in Seattle, the flagship University of Washington Hospital between May 2014 and October 2015 produced medications for  surgical IVs, cancer care chemotherapy, and even simple injectable steroids for joint pain in pharmacies so dirty that they failed that state’s health department inspections, a TV station has reported.

I’ve written before about the nightmares connected with failed regulation of compounding pharmacies, which are supposed to produce custom medications in sterile conditions, especially in hospitals for patients with special needs. Some hospitals have turned to their compounding pharmacies to take on more work in response to skyrocketing prices and declining availability of critical medications. A major scandal erupted in Massachusetts when a contaminated, corner-cutting facility there made and shipped thousands of injections of a back-pain drug that killed almost 50 people and sickened dozens of others.

Although regulators have pledged repeatedly to address problems in compounding pharmacies, lawsuits in the civil system also have played a pivotal role before─and likely again─to protect patients.