From time to time, the U. S. healthcare industry has experienced drug shortages. But the past 20 years have seen a steady increase in the frequency, scope, and impact of these shortages. In recent years, drug shortages have reached critical levels, putting patients at risk and strapping healthcare providers.
Causes for the Crisis
The number of medically necessary drugs that are in short supply has multiplied at an alarming rate since 2005 to its current count of 280, according to the U.S. Food and Drug Administration Center for Drug Evaluation and Research. Causes for the drug shortage are complex. Although generally related to supply and demand, a number of other factors, including a lack of raw materials, patent expirations, higher manufacturing costs, predetermined price controls, and manufacturers’ capacity issues, are contributing to the problem.
Sterile injectable oncology drugs have been most affected due to greater demand brought about by advances in cancer treatments. These drugs are difficult and expensive to produce, and only a few highly specialized companies manufacture them. Other drugs that are considered mainstays of therapy and essential to optimal patient care are also in short supply, including:
- electrolyte additives for intravenous feedings
- critical care medications such as amiodarone, atropine, diazepam, digoxin, dopamine, epinephrine, furosemide, heparin, morphine, norepinephrine, and others.
Current shortages have severely impacted patient care and created challenges for patients and healthcare providers alike. The impact on patients has been profound. Some patients receive less effective substitutes or no treatment at all. Drug shortages have forced delays in treatment or surgeries, increased costs to patients, extended length of stay, and caused complications from unanticipated side effects, especially among critically ill and immunocompromised patients.
Prescribers are forced to order less desirable drugs that can create an opportunity for dosing errors because of the prescriber’s unfamiliarity with the alternative drugs. Pharmacologists and other pharmacy professionals are often forced to spend much of their time searching for available alternatives, negotiating for a share of the short supply available, or helping physicians select the best substitute therapies when drugs-of-choice are out of stock. Meanwhile, physicians and other healthcare providers have had to shift their attention from applying known optimal therapies to rescheduling or delaying treatments until they can research and evaluate possible alternatives.
Some hospitals have resorted to obtaining drugs from outside pharmacies that may not be registered with the FDA, in an attempt to stretch their supply. A “gray market” has begun to flourish, with middlemen controlling supplies and, and in some cases, selling pharmaceuticals that have turned out to be counterfeit at premium prices. Other unsafe practices to stretch the supply, including using drugs past their expiration dates or reusing drug vials on more than one patient, invite contamination.
Not surprisingly, higher costs caused by the shortage result in serious financial losses for hospitals. The American Society of Health-System Pharmacists estimates additional annual costs in labor alone to be $216 million nationwide.
The general consensus among industry professionals is that the drug shortage will not end anytime soon; a majority of hospital pharmacy professionals feel the shortage will only get worse. Developing innovative solutions and best practices to minimize the impact is crucial in order to maintain patient safety and overall quality care and contain costs. President Obama issued an executive order to accelerate some of the steps needed to address these shortages, but Congressional action calling for more effective FDA oversight, a comprehensive early warning system, and cooperation from the pharmaceutical industry has stalled despite the urgent need.
For more details about the drug shortage, read Elsevier/Gold Standard: Impact of Drug Shortages on U.S. Hospitals. For the most comprehensive drug database with up-to-date drug dosing and alternative drug information, look into Elsevier’s Gold Standard Drug Database.