Oversight of certain drugs used at hospitals hasn’t been tightened since a 2012 meningitis outbreak that killed 64 people and hospitalized 751 more was caused by a contaminated batch of injections.
Compounded drugs — pharmaceuticals made for specific patients, that are synthesized at standalone pharmacies are still not always federally inspected, according to a new Department of Health and Human Services Inspector General report. Such drugs are synthesized at standalone pharmacies that specialize in making them and that are located outside of hospitals.
Compounded sterile preparations are especially dangerous because of its contents, the manufacturing process and the fact that they are injected directly into the bloodstream.
The oversight bodies, the Centers for Medicare & Medicaid Services and four hospital accreditation organizations, don’t review contracts between hospitals and standalone pharmacies and don’t have proper training or access to information on the topic.
“Despite outsourced compounded injections’ being responsible for the 2012 fungal meningitis outbreak, none of the oversight entities plan to change how their oversight addresses hospital contracts with standalone compounding pharmacies,” the inspector general said.
Though compounded drugs are intended for specific patients, hospitals will often contract standalone pharmacies to manufacture the medicine in bulk. It is the hospital executives’ responsibility to oversee the contracts, though most don’t specifically inspect the drugstores. Neither do the oversight bodies.
“Contracting with standalone pharmacies for [compounded sterile preparations] gets limited attention from the oversight entities,” the inspector general said. Only one of the five oversight bodies reviews the contracts between the pharmacies and the hospitals.
Oversight is essential, however, as 92 percent of Medicare-participating hospitals use compounded sterile preparations, and 80 percent of those contract with at least one standalone pharmacy.
Additionally, a 2013 law allowed standalone drugstores voluntarily to register with the Food and Drug Administration as a compounded medicine manufacturer. If a pharmacy doesn’t self-identify with the FDA, there’s no guarantee that the medicine is subject to oversight.
“Standalone compounding pharmacies that register with FDA are subject to FDA inspection,” the IG said. “Because most hospitals do not inspect the standalone pharmacies with which they contract, a satisfactory FDA inspection might be the only indicator of the conditions at a standalone pharmacy.”
Without that oversight, mistakes, like meningitis-causing injections, are more likely.
Also, three of the oversight bodies do not ensure that standalone pharmacies used by hospitals are registered with the FDA. The other two only do occasionally.
“None of the entities plan to change how they assess these contracts in light of FDA’s new initiative to register and inspect standalone compounding pharmacies,” the report said.
Oversight bodies do, however, inspect compounded drug synthesis conducted directly at Medicare-participating hospitals.
Oversight entities don’t always specifically address compounded pharmaceuticals, unless a problem is apparent or was apparent in prior hospital inspections. Essentially, oversight is conducted on a case-by-case basis.
Additionally, the oversight bodies’ staff lacks proper training and knowledge on the subject.
“In fact, experts we spoke with said that only a trained pharmacist would be able to perform a comprehensive review of these recommended practices,” the inspector general said.
Nonetheless, one of the oversight entities didn’t have access to a pharmacist. The other four either had one on staff or enrolled one as a consultant, but wouldn’t always employ them for every survey of hospitals.
Keeping a pharmacist on staff directly isn’t practical, either, since oversight of hospitals requires so many other technical experts.
A properly trained team, however, could assist the oversight bodies.
“Surveyors need the appropriate knowledge of this highly technical aspect of hospital operations,” the inspector general said. “However, we found that oversight entities provide limited training specific to compounding to their surveyors.”
In fact, two oversight entities don’t provide any compounding-specific training to their surveyors at all.
In other words, hospitals are using compounded drugs that aren’t guaranteed proper oversight, which increases the likelihood of a mistake that could result in the outbreak of a deadly disease.
