As the drug shortage story continues to unfold, it's become clear that the shortages constitute a significant public health crisis. The number of drugs in short supply has nearly tripled, from 61 in 2005 to 178 in 2010, according to the Food and Drug Administration (FDA) (http://1.usa.gov/nsthgW). And according to a survey of community hospitals conducted in June by the American Hospital Association (http://bit.ly/qc6hcE), nearly all (99.5%) reported experiencing shortages of one or more drugs in the previous six months, and almost half reported shortages of 21 or more drugs.
In the survey, the areas most commonly reporting shortages were surgery and anesthesia, emergency care, cardiovascular care, gastrointestinal and nutritional care, and pain management. Thirty-five percent of hospitals reported that the shortages had resulted in adverse outcomes.
Planning for these shortages has generally been impossible: three out of four hospitals surveyed reported that they never or rarely receive advance notice of drug shortages, and 51% were rarely told the expected duration of a shortage.
The shortages have greatly increased hospital expenditures as companies in the "gray market" (where drugs bought outside the normal channels are sold at exorbitant prices) have raced to exploit the situation. For example, according to Jason Kane, writing for the PBS Newshour blog (http://to.pbs.org/no25Ag), a blood pressure medication that usually sells for $25.90 was offered by a gray market seller for $1,200. Such price gouging will cost hospitals $400 million to $500 million this year, according to the blog post. Even after such exorbitant prices are paid, however, patients' health will still be at risk because gray market drugs can be unreliable. In 2009, for example, the FDA reported cases in which insulin didn't work because of improper handling on the gray market. Gray market vendors sometimes also sell counterfeit drugs and diluted medications.
Nurses have been particularly affected by this crisis for several reasons. First, the vast majority of drugs in short supply are sterile injectable drugs, and electrolytes in particular have been scarce. Nurses also have to watch "patients suffer needlessly… because substitute medications [are] not as effective or… no substitutes exist," according to the Emergency Nurses Association.
Jean A. Proehl, an emergency clinical nurse specialist and editor of the Advanced Emergency Nursing Journal, told AJN that "in the case of a propofol shortage, we were forced to use different and sometimes less effective drugs for ventilated patients. In one instance, the substitute medication proved difficult to titrate to an appropriate level of sedation and the patient extubated himself."
Ezekiel J. Emanuel, oncologist and professor of medical ethics and health policy at the University of Pennsylvania, was quoted in an August 6 New York Times article as saying that the primary cause has been greed on the part of pharmaceutical companies: "Most shortages… appear to be the consequence of corporate decisions to cease production" because of low profits, mainly from generic drugs, "or interruptions in production… which manufacturers do not appear to be in a rush to fix."
A number of measures have been proposed to solve the problem. Increasing funding for the FDA would help, because the agency has only four staff members working on the drug shortage, according to a report in the September 3 issue of the Economist. Mike Cohen of the Institute for Safe Medication Practices has recommended that a national pedigree law "with legislative teeth" be enacted to tighten regulation of the gray market. The Preserving Access to Life-Saving Medications Act (S 296), a bill that would require pharmaceutical companies to notify the FDA of possible shortages, has been introduced in the Senate. And because of the crucial role low generic drug prices have played in causing this crisis, Emanuel has suggested that "when a drug becomes generic, Medicare should stop paying, and it should be covered by a private pharmacy plan." An up-to-date listing of drugs that are in short supply is provided by the FDA at http://1.usa.gov/cXo7Cl.—David Carter