The FDA, government, and manufacturers fight drug shortages

November 28, 2011

Drug manufacturer

Drug shortages have tripled over the last five years.

Over the last five years, drug shortages have tripled from 61 medications in short supply in 2005 to 178 medications in 2010. Drug shortages can be caused by a number of factors, including:

  • Shortages of important raw materials
  • Changes in inventory and distribution
  • Quality and manufacturing problems
  • Discontinuations for business reasons
  • Unexpected increased demand

When healthcare professionals hear about drug shortages, many immediately think about oncology agents. This is no surprise, since most drug shortages are generic sterile injectables, which include a large number of the oncology drugs. Shortages of injectable medications are partially due to quality issues, such as contamination with impurities and stability changes. One of the other main reasons that most drug shortages are related to sterile injectables is due to industry consolidation. Sterile injectables are produced by a limited number of manufacturers. When one of them has to halt or slow down production, it's not easy for the others to make up the difference. This is generally due to capacity issues. It's important to note that drug shortages are not limited to just injectables. Nearly every dosage form has recently been affected, ranging from oral tablets to topical patches.

Combating the drug shortage issue.

The U.S. Food and Drug Administration (FDA) recently stated that in order to put an end to the crisis, solutions must come from all segments of the drug supply chain. Increased communication is needed among manufacturers, wholesalers, stakeholders, and the FDA. They should focus on the extent of specific shortages and when the drug will be available again. The Preserving Access to Life-Saving Medications Act was introduced this year in Congress to help address the issues leading to shortages. The bill proposes that prescription drug manufacturers be required to alert the FDA at the first sign of a potential interruption in the production of a drug. The FDA would then be required to identify drugs that may be subject to shortages, and to work with other manufacturers regarding their findings. The majority of the national pharmacy, medical, drug manufacturer, and patient safety organizations support this proposed act.

Humana's RightSourceRx aids patients during a drug shortage.

Drug shortages can ultimately affect patients' lives. In critical care scenarios, a shortage could be a life-threatening event. For community pharmacy customers, a drug shortage can introduce an unnecessary inconvenience. Humana's RightSourceRx mail-order pharmacy is taking initiatives to reduce the burden on their patients. RightSourceRx will inform its patients when a drug shortage is realized and contact the members' doctors to provide other options. RightSourceRx will also give members the choice of filling at a local pharmacy if the medication is unavailable to RightSourceRx, but is available through local pharmacies. Drug shortages usually affect all lines of business that are supplied by the drug manufacturer, including both retail and mail-order pharmacies.

References:

Koh HK. U.S. Department of Health & Human Services website.

American Hospital Association

American Pharmacists Association

For more information, contact your Humana representative today.