The Food and Drug Administration warns that the number of drug shortages is at a record high and getting even worse. The agency cites shortages of raw materials, drugmakers discontinuing older, and off-patent drugs in favor of newer and more profitable ones, and large recalls due to quality problems as contributing factors to the problem.
In 2010, the FDA received reports of 178 drug shortages, including cancer drugs, anesthetics used in surgery, “sterile injectables” (medicines that are given intravenously) and “crash cart” drugs used in emergency treatments.
Regulators are seeing a large number of new drug shortages in 2011 as well, according to Valerie Jensen, FDA’s expert on drug shortages. Jensen said the agency is especially concerned about the shortages of injectable drugs, which account for more than half of the shortages reported last year to the FDA. These injectables are oncology drugs, drugs used during surgery and drugs used for emergency treatments. Jensen elaborated “Companies have told us that these injectable drugs are older drugs and not as profitable…They’ve told us it’s a business decision to discontinue production.”
While the FDA reports that the number of prescription drug shortages in the country has nearly tripled in the last six year, recently, several over-the-counter drugs such as Tylenol and Motrin have also been recalled in large quantities, reportedly leading to shortages of these drugs as well (Jensen said the FDA did not have an assessment of non-prescription medicines).
A drug shortage, as defined by the FDA, is a situation in which the total supply of all a drug, and all of its approved alternatives, is not enough to meet demand.
The supply is short for many prescription drugs that consumers take by mouth each day, including medicines to treat Attention Deficit Hyperactivity Disorder. Hospital patients are being hit particularly hard by the shortages.
Drugmakers are not required to report drug shortages to the FDA, but the agency said it is urging companies to voluntarily alert regulators of impending shortages “in the interest of public health.” The FDA is focusing its effort on shortages of the most critical drugs (those that are used to treat or prevent a serious disease or medical condition). The agency said when it finds out in advance from a manufacturer that a shortage could occur, it will approach other companies that also make the drug to see if they can ramp up production. They are also considering the approval of limited imports of foreign versions of drugs that are in short supply.