FDA should act on drug shortages


By guest blogger Michael Cohen:

As noted in a previous post severe drug shortages have cropped up in our nation’s hospitals. This is a major problem and it’s having dangerous repercussions.

We recently surveyed health professionals that work in US hospitals to ask them how the drug shortage is affecting patient care. The survey will be open for a few weeks yet but so far we’ve received over 1,000 returns. The data shows that substantial staff resources are being devoted to investigating shortages, correcting ordering problems, and finding alternatives to suggest to prescribers. Along with treatment delays and dose omissions though, are actual medication errors, mostly due to doctors and nurses being unfamiliar with replacement therapies.

Among the errors have been 10-fold overdoses of epinephrine (adrenalin) that occurred as a result of staff accidentally using an undiluted form of the drug when pre-diluted syringes became unavailable. At least two deaths have been related to a shortage of certain form of morphine injection, where a hydromorphone replacement was used but prescribed at a dose similar to that typically used for morphine. Some prescribers are unaware that hydromorphone injection is about 5-7 times more potent than morphine. Such an overdose can cause respiratory depression or even arrest. One pharmacist reported a 5-fold heparin concentration error when her pharmacy technician accidentally mixed heparin IV incorrectly. The technician wouldn’t have even had to mix the drug before a severe shortage of ready-to-use drug recently arose.

One problem right now is that in most cases drug companies don’t even have to tell FDA when they make a business decision to stop making a drug. I’d like to see FDA have the power to at least require companies to continue making critical items until suitable replacements can be assured. We’ll be sharing survey data with FDA and others to advocate for changes to better avoid shortages that put patients in harms way.

For information on the Institute for Safe Medication Practices' consumer website go www.consumermedsafety.org
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