Do Drug Shortages Endanger Patients?

When hospitals run out of essential drugs, the results can be extremely grave. It is happening far more often now than in the past.
A recent perspective in the New England Journal of Medicine (Aug. 26, 2010) highlights a critical shortage of the injectable anesthetic propofol. This drug is used during many surgical and diagnostic procedures because it works quickly, in less than a minute, and gives the anesthesiologist a lot of control over the patient’s sedation. Propofol is very safe when used properly.
Sadly, the country has been experiencing a widespread propofol shortage for months and there is no end in sight. Two of the three companies that supply this anesthetic were faced with massive recalls in part because of contamination. One, Teva, has decided not to resume production of propofol. That means that hospitals and ambulatory surgery centers are running out and having to come up with alternatives that may not be as safe.
In one case, an endoscopy clinic in Nevada tried to stretch its supply of propofol by re-using vials that were intended for single use. The result of this practice was contamination and an outbreak of hepatitis C infection. Nearly 40,000 patients had to be tested for hepatitis B, C and HIV.
Another essential medicine in short supply is epinephrine. This decades-old injectable drug is used in emergencies for patients experiencing life-threatening allergic reactions.
Before people with severe allergies to peanuts or wasps start to panic, we need to point out that it is the prefilled hospital syringes that are hard to find. As far as we can tell, patients can still access EpiPen Auto-Injectors for personal use.
Hospitals and ambulance teams can still get ampoules of epinephrine, but they have to be diluted and the dose must be carefully calculated. In an emergency every second counts. Not having preloaded syringes with the correct dose is a serious shortcoming.
Dozens of other drug shortages have clinicians and surgeons scrambling to find substitutes. What’s behind so many drug shortages? Increasingly the raw material for medicine comes from abroad. Some experts estimate that 80 percent of the chemicals used in our drugs are made outside the U.S. Foreign manufacturers in China, India, Thailand, or Indonesia may not be keeping up with demand.
There have also been large-scale generic recalls because of quality-control issues. Some drug companies in India had to cease export to the U.S. because of quality concerns. That led to shortages of several commonly prescribed drugs.
In some cases, a drug company makes a business decision to stop production. That can leave patients with little if any recourse.
Perhaps Congress needs to scrutinize critical drug shortages from the perspective of homeland security. We don’t want patients and hospitals held hostage by shortfalls, domestic or foreign.