Health industry experts this week offered solutions to the widespread prescription drug shortage, calling for regulatory and manufacturing changes to protect patient care.
The meeting comes after HHS officials last week testified during a House Energy and Commerce Subcommittee on Health that a growing shortage of certain medications for life-threatening illnesses could result in a major health crisis.
According to the testimony, 178 drug shortages were reported to FDA in 2010, nearly three times the number reported in 2005. So far in 2011, there have been even more shortages of "medically necessary" drugs, including drugs used to treat lymphoma, leukemia, and breast cancer, as well as antibiotics, anesthetics, and electrolytes for patients on IV feeding tubes.
A recent American Hospital Association (AHA) survey found that roughly 99% of hospitals experienced one or more drug shortages in the first six months of 2011. According to AHA Director of Policy Development Roslyne Schulman, the shortages have caused hospitals to delay treatment and administer less effective medications.
During Monday's meeting, Edward Cox, coordinator of the FDA drug shortage program, said that in 2010:
- 54% of drug shortages were caused by quality or manufacturing issues;
- 21% were caused by delays and capacity issues;
- 11% were caused by discontinuations; and
- 5% were caused by issues with raw materials.
Solving the shortage
Both Republicans and Democrats questioned whether government interference with the forces of supply and demand has exacerbated the shortage, and they stressed continued compromise with the administration going forward. A bill (HR 2245) introduced by Rep. Diana DeGette (D-Colo.) would require drugmakers to alert FDA when they expect a shortage.
Speaking on behalf of the American Academy of Pediatrics, DeWayne Pursley, chief of neonatology at Beth Israel Deaconess Medical Center, suggested that FDA develop a list of critical medications and create a National Critical Medicines Stockpile. Pursley also called for a two-way exchange of real-time shortage information.
Other panelists suggested that drugmakers be required to notify FDA if they expect a drug shortage within six months, which currently is required only for sole-source drugmakers (Lee, Modern Healthcare, 9/26 [subscription required]; Frieden, MedPage Today, 9/26; AHA News, 9/26).