million nationally. On top of that, three specific drug shortages — dextrose sy- ringes, epinephrine injection, and suc- cinylcholine injection — affected more than 80 percent of health systems. Sev- enty percent of respondents described the resources available to manage drug shortages as “less than good.” Access the ASHP study online at www
.ajhp.org/site/DrugShortages.pdf?fm_ preview=1.
American Hospital Association (AHA)
survey data complement ASHP’s find- ings. AHA revealed that nearly all 820 hospital respondents reported at least one drug shortage in the six months leading up to the study, and nearly half reported 21 or more shortages during that period. The ASHP survey had simi- lar findings; 47 percent of large hospitals experienced 30 or more shortages. Health care organizations, including
AHA, want Congress to establish an early warning system of drug shortages and mandate that manufacturers report drug interruptions or discontinuations to FDA. U.S. Sens. Amy Klobuchar (D-Minn.) and Bob Casey (D-Penn.) introduced legislation to that effect in February. The Preserving Access to Life-Saving Medi- cations Act requires prescription drug manufacturers to give early notification to FDA of any incident that would likely result in a drug shortage. Incidents may include changes to raw material supplies, adjustments to manufacturer production capabilities, and certain business deci- sions such as mergers, withdrawals, or changes in output. The bill also directs FDA to provide up-to-date public noti- fication of any shortage and the actions the agency would take to address it. “Physicians, pharmacists, and patients
are currently among the last to know when an essential drug will no longer be available; that’s not right,” said Sena- tor Klobuchar in a press release. “As we move forward, it is important that we have better coordination between the pharmaceutical industry, the FDA, and health care providers so patients don’t lose access to the medications they de- pend on.”
The bill is pending in the Senate Committee on Health, Education, Labor, and Pensions.
ASA Drug Shortages Summit recommendations
Stakeholders, including representatives from health professional organizations, pharmaceutical manufacturers, government agen- cies, and suppliers, attended the 2010 American Society of Anes- thesiologists Drug Shortages Summit. They discussed the scope and causes of drug shortages and developed recommendations to address issues associated with drug shortages. The summit’s recommendations include:
• Explore expanding Food and Drug Administration (FDA) author- ity to require manufacturer notification of market withdrawals;
• Define and implement evidence-based and other criteria for identifying critical drug therapies that are vulnerable to drug shortages;
• Explore providing incentives to manufacturers that produce criti- cal drug products or upgrade manufacturing plants to meet or exceed good manufacturing practices in exchange for guarantee of continued production of these therapies;
• Establish an expedited approval pathway for those unapproved drugs (pre-1938 therapies) deemed critical therapies;
• Increase collaboration with industry, the Drug Enforcement Administration, and FDA to establish a process that would more readily modify active pharmaceutical ingredients quotas in re- sponse to drug shortages of controlled substances; and
• Establish improved processes to extend product stability for products in short supply.
To read the full Drug Shortages Summit report and recommen-
dations, visit
www.asahq.org/For-Members/Advocacy. Click on the Federal Legislative and Regulatory Activities link to be directed to the Drug Shortages page.
October 2011 TEXAS MEDICINE 27
Shortages’ impact on anesthesiology Dr. Butler says the drug shortage greatly affects anesthesiology, among other spe- cialties. In April, the American Society of Anesthesiologists (ASA) surveyed its members on drug shortages. Ninety percent of the 1,373 respon-
dents reported a current shortage of at least one anesthesia drug. Ninety-eight
percent reported a shortage of at least one anesthesia drug in the past year. The drugs most frequently in short sup- ply were propofol (89 percent), succinyl- choline (80 percent), and thiopental (60 percent). Dr. Butler says many of the scarce drugs specific to his specialty are ster- ile injectables, which also were part of the nationwide shortage last year, ac-
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