National Medication Shortages

Over the last ten years, the number of drug shortages has increased, straining out health care system. The American Society of Health System Pharmacists (ASHP) and the Food and Drug Administration (FDA) monitor drugs distributions and track drug shortages.

The Food and Drug Administration defines drug shortages as "products used to prevent or treat a serious life-threatening disease or medical condition for which there is not other available source with sufficient supply of that product or alternative drug available."

The ASHP describes a drug shortage as "a supply issue that affects hot the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative drug available". Two very different definitions. Drug shortages can happen for a number of reasons, including little to no access to raw materials, issues with manufacturing noncompliance to regulatory standards, along with business and economic variables.

Barack Obama signed the FDA Safety and Innovation Act (FDASIA), which gave the FDA authority to regulate drug shortages. Under this act, manufacturers of biologics and all prescription drugs that are covered must provide notice to the FDA if a delay or interruption in production is foreseen. This act also gives the FDA the right to conduct expedited reviews of drug applications and/or expedited inspections, in an effort to alleviate the burden of a drug shortage.

Drug shortages can lead to rising health care costs, increased safety risks, and an overall burden to health care providers. It can also lead to non-traditional distributors to enter the market, purchase the remaining supply of the drug, and sell to hospitals and health clinics at an inflated price. The alternative drug that would take its place would probably have more side effects than the prior medication along with reduced efficacy.

Although the number of new drug shortages has declined since 2011 as a result of work by many groups, including FDA, shortages continue to pose a real challenge to public health. This is especially the case when the shortage involves a critical drug to treat cancer, to provide parenteral nutrition, or to address another serious medical condition, such as a shortage of blood pressure medications.