More Drug Shortages in Fungal Meningitis Aftermath
Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Ameridose -- the sister firm of the NECC, the compounding pharmacy whose tainted products are at the heart of the outbreak -- has shut down, and at the FDA's urging recalled the more than 2,000 products it sold nationwide. The FDA yesterday admitted that these actions will worsen the ongoing shortage of six important drugs hospitals need to help critically ill patients.
Currently, 226 drugs are in short supply. Last year, 99% of U.S. hospitals reported drug shortages. And these are important drugs, says Joseph Hill, director of federal legislative affairs for the American Society of Health-System Pharmacists.
"In the last five years we have seen a significant spike in the number and severity of shortages," Hill says. "It is really alarming when you look at the classes of drugs involved: cancer drugs, heart drugs, pain drugs, and anesthetics. Imagine not being able to perform an emergency surgery."
Compounding pharmacies do not make most of the drugs that are in shortage. But they make an increasing number of them, says David Miller, RPh, CEO of the International Academy of Compounding Pharmacists (IACP).
"What we have seen is on a large scale, important drugs being in shortage -- and not for short periods, but in the months-to-years range," Miller says. "Compounding pharmacies help with that. Now, instead of filling short-term needs, compounding pharmacies are being looked to on a larger scale."
How many compounding pharmacies are doing this? The FDA does not know.
"We do not have this data," says FDA public information officer Sarah Clark-Lynn via email.
"It is important to note that compounded drugs can serve an important public health need if a patient has a particular medical need that cannot be met with an FDA-approved drug," Clark-Lynn says. "Compounded drugs that are prepared improperly pose potential health risks to the patients who take them. When such compounding occurs on a large scale, more patients are exposed to those risks."
Compounding Pharmacy Safety
It's impossible for a hospital running out of crucial drugs to know if a compounder is safe, says Michael Cohen, RPh, president of the Institute for Safe Medication Practices (ISMP).
"I cannot to this day clearly see anything that articulates what pharmacies are provided with the oversight to ensure that they're making these drugs safely and what pharmacies are not," Cohen testified before the FDA's September 2011 workshop on drug shortages.
A full year before the fungal meningitis outbreak, Cohen warned the panel that unsterile drugs made by compounders already had caused infections and deaths -- and that the oversight needed to prevent future disasters was "not happening."