care facilities advanced warning of im- pending drug shortages. Another op- tion would be for FDA to establish joint agreements with reputable manufactur- ers in other countries, allowing the Unit- ed States to import drugs in short supply. Many foreign governments have rules and regulations governing the manu- facture of pharmaceuticals. FDA could vet them to ensure they’re enforced,” he said.
Health organizations are examin- ing the causes of the shortage and col- laborating with stakeholders to develop recommendations to prevent shortages and to improve communication about impending drug discontinuations and limited supplies.
The TMA House of Delegates adopted
a recommendation on drug shortages and physician communication made by the TMA Committee on Infectious Dis- eases at TexMed 2011.
The committee said “better tracking of drug shortages and more effective communication are certainly warranted to make health care professionals aware of shortages and allow them to plan accordingly.” The report’s recommendation directs the association to “work with the Ameri- can Medical Association and appropri- ate federal agencies to increase federal monitoring of potential drug shortages and enhance communications with phy- sicians regarding drug shortages and al- ternative treatments.”
The AMA Council on Science and Public Health will present a report on national drug shortages to the AMA House of Delegates at its interim meet- ing next month. Resolution 504, intro- duced by the Florida delegation to AMA at the 2011 Annual Meeting, asks the association to evaluate the problem of drug shortages and report on the role of government regulation, plaintiff lawsuits, pharmaceutical company decisions, and any other relevant factors contributing to the drug shortage. The resolution also asks AMA to make recommendations to prevent national drug shortages. Other groups have weighed in on the drug shortage plaguing the United States. The American Society of Anesthe- siologists (ASA) held a Drug Shortages
Summit last year to address the problem. (See “ASA Drug Shortages Summit Rec- ommendations,” page 27.) TMA Foundation President Russell Kridel, MD, a member of the AMA Coun- cil on Science and Public Health, says that while physicians individually can’t do a lot to reverse the country’s wors- ening drug shortage problem, organized medicine can play a role in affecting positive change.
“It’s incumbent on the FDA and the
government to see that physicians and patients are vulnerable to shortages and the decisions of pharmaceutical compa- nies. Physicians need to have some ad- vance warning that shortages are coming to give us enough time to look at alter- native medications,” he said.
FDA’s role Dr. Speer says drug shortages frustrate physicians because “the best medication for the patient’s condition is no longer
Drug shortage resources
U.S. Food and Drug Administration The FDA Drug Safety and Availability website,
www.fda.gov/drugs/ drugsafety, communicates information on new drug warnings and other safety information, drug label changes, and shortages of medically necessary drug products to consumers and health profes- sionals. To register to receive FDA e-mail drug shortages alerts, visit
www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUp dates. To report drug shortages to FDA, email drugshortages@fda
.hhs.gov. The FDA Center for Drug Evaluation and Research (CDER),
www.fda.gov/drugs, has a Drug Shortage Program to address and respond to actual or potential shortages of medically necessary drugs. Manufacturers may report a shortage, upon which the CDER investigates the problem. Once CDER has verified the shortage, the agency tries to resolve it, although it’s still up to manufacturers to notify FDA.
American Society of Health-System Pharmacists The Drug Shortages Resource Center,
www.ashp.org/shortage, provides information on current shortages, resolved shortages, and drugs no longer available. The site also features guidance on man- aging drug shortages, including purchasing drug products in short supply and sample drug shortages policy. “ASHP Guidelines on Managing Drug Product Shortages in Hospi- tals and Health Systems,” published in the Aug. 1, 2009, issue of the American Journal of Health-System Pharmacy, online at www.ajhp .org, describes the factors contributing to or exacerbating short- ages and features a three-phase approach to contingency planning for management of drug product shortages and includes strategies for prevention.
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