Over the past two years, our country has been dealing with the worst drug shortage situation I have seen in over 40 years of practicing pharmacy. I first wrote about the situation in July 2010, after hearing from colleagues around the country who were having trouble obtaining needed medications. Nearly two years later, it continues to be a major public health issue.
At times, patients have been unable to obtain otherwise commonly used medications, including critically important drugs for cancer, emergency medications like epinephrine, pain medications including morphine, and even certain mainstay antibiotics or anesthetics used during operations. The recent methotrexate shortage is evidence that this issue can no longer be ignored, as children with otherwise treatable cancer faced being without treatment options. Reasons for the current crisis are many and have been recounted elsewhere so I won’t go into them here. What is amazing to me is that the government has yet to step in.
It’s clearly not just patient inconvenience that’s at stake; it’s truly been a life threatening situation. Besides forcing the use of less desirable, often expensive, unfamiliar alternative drugs — if available, the potential for errors and poor patient outcomes is great. They’re related not just to absent or delayed treatment but also to preventable problems associated with use of alternative drugs or dosage forms. When a familiar drug like morphine becomes unavailable, substituting a different opioid with a different potency creates opportunities for dangerous dosing errors. Nurses and doctors may not be aware of the differences.
A 2010 survey we conducted showed that pharmacists often first learned about a drug shortage when they tried to order a drug and were unable to obtain it due to a backorder situation. The lack of advanced warning of impending shortages has not allowed adequate time for systematically identifying alternatives and assuring proper communication with staff, and training to assure safe use of alternatives. There’s also often been a lack of time to properly adjust various computerized databases that control technologies like electronic prescribing and drug storage, can lead to fatal errors.
Among the fatal error reports we received last year when morphine was in short supply was a recurring situation with a substitute drug called hydromorphone (also known as Dilaudid). This is a drug that is 7-fold more potent than morphine. Sadly, we received several reports from around the U.S. about fatal errors where doctors unfamiliar with hydromorphone thought it was just another form of morphine. They gave hydromorphone at the same dose they normally used for morphine. The overdose caused some patients to stop breathing.
Another issue has been pressure to conserve drugs in short supply. This can lead to unsafe practices, like giving drugs past their expiration date, or using drug vials on more than one patient, which invites contamination and patient exposure to pathogens like hepatitis virus. For example, in a hospital visit I made during a severe shortage of the anesthetic propofol, anesthesiology personnel were reusing single dose vials of propofol for more than one patient. This is a well-known hazard that has been responsible for serious infection outbreaks, such as a highly publicized hepatitis outbreak at a Nevada endoscopy clinic.
We are also seeing many hospitals resort to using outside pharmacies that provide compounded sterile injectables that are no longer available commercially due to shortages. Some of these pharmacies are not registered with FDA and may be in states, including Pennsylvania, where the state board does not provide oversight to assure strict standards are followed. Serious medication errors as well as infection outbreaks have sometimes occurred in these situations. Just yesterday, the FDA alerted health professionals to an incident involving a compounding pharmacy in Florida that made a non-FDA approved eye injection called Brilliant Blue. The drug was recalled after clinicians in several states reported fungal eye infections in patients who were given the dye during eye surgeries.
Risk is also engendered when hospitals use the “gray market” to obtain drugs in short supply. For example, counterfeit supplies of the cancer drug Avastin were recently shipped to at least 12 cancer clinics around the U.S. after being ordered on line. Vials purportedly containing Avastin actually held none of the drug at all. The counterfeit items were traced to the weakly regulated gray market.
So far, other than an executive order by President Obama directing the FDA to step up efforts to address shortages, not much has happened in Washington policy wise that would address the crisis. Things are as bad or even worse at this point than they were two years ago when I first wrote about it.
Last Friday, a coalition of over 30 national organizations representing clinicians, health care facilities, drug manufacturers and patient advocacy groups wrote to Congress to urge that drug shortages be addressed now, before delays and disruptions in patient care become even more widespread.
Bills have been introduced in both the Senate and House but have yet to become law. For example, over a year ago, our own Senator Bob Casey along with colleague Senator Any Klobuchar of Minnesota introduced legislation (S296, Preserving Access to Life-Saving Medications Act) that has never been passed. The letter pointed out that this would authorize the FDA to develop an early warning system that requires manufacturers to notify the agency when they experience a production disruption or discontinue a product. Also, mentioned in the letter was a requirement for manufacturers to develop contingency plans to line up alternate suppliers of raw materials, or encourage redundancies in manufacturing. The group also suggested that Congress establish a generic user fee program to allow the FDA to leverage fees as economic incentives for manufacturers, and to speed the application process for these products. The agency could offer reduced application fees for products in short supply, or discounted fees if a company demonstrates that its contingency plans are sufficient to reduce the risk of a shortage if production is halted. The letter can be viewed here.
More effective FDA oversight, a comprehensive early warning system, and cooperative efforts by the pharmaceutical industry are all attainable goals that could be facilitated through congressional action, all of which are urgently needed given the current drug shortage crisis.
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