Public Policy Concern –
Drug Shortages are Critical

04/03/2012

In 2010, more than 200 drug shortages were reported by the Food and Drug Administration (FDA) and have continued into 2012. The shortages have occurred across drug classes including critical drugs used in surgery, anesthesia, emergency care and oncology. The current shortages throughout the industry appear to be the result of a significant expansion in the scope and volume of drug products without a corresponding expansion in drug manufacturing capacity. Some companies are leaving the injected generic drug market because profits margins are low.  Companies do not have to notify customers or the FDA that they have stopped manufacturing a drug.

The American Hospital Association recently surveyed hospitals to assess how shortages impacted their operations. With 820 hospitals responding, almost 100 percent reported a shortage in the last six months and nearly half of the hospitals reported 21 or more drug shortages.  Hospitals have proactively taken actions to improve patient safety by accumulating inventory, having routine dialogue with pharmacy and medical staff, adding substitutes to the formulary, contracting with multiple suppliers and continuously monitoring of manufacturing and production of drugs.

This is a public policy concern and we must work together for a solution that could include streamlining approval of drugs in shortage and removing obstacles to assist the FDA in this approval process. We must improve communication among all stakeholders and align goals so our patients receive the best medication for their treatment.

We must act quickly to solve this continuing drug shortage crisis and implement policies to prevent future drug and medication shortages. In many cases, companies raise the prices due to the shortages and only three states (Kentucky, Maine and Texas) have price-gouging laws related to medicines. Consequently, the drug prices are escalating in many states.
Common sense needs to prevail as ultimately all stakeholders’ priorities should be ensuring what is best for patients.