Legislation introduced in February could ease U.S. drug shortages

March 15, 2011

The American Society of Health-System Pharmacists and 3 other healthcare industry groups are working to transform regulations to ease U.S. drug shortages.

The American Society of Health-System Pharmacists (ASHP) and 3 other healthcare industry groups are working to transform regulations to ease U.S. drug shortages.

In January, representatives from ASHP, the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the American Hospital Association (AHA) met with aides to U.S. Sen. Amy Klobuchar (D-Minn.) to discuss key points from the groups' November Drug Shortages Summit that should be included in federal legislation.

The result was the introduction of S.296, The Preserving Access to Life-Saving Medicines Act, on February 7, sponsored by U.S. Senators Klobuchar and Bob Casey (D-Pa.). The bill would increase the authority of FDA to prevent drug shortages.

The recommendations

The group suggested several options that could be included in new legislation, including a requirement for advance notification of supply or production problems by both single-source and multisource manufacturers; changes to FDA regulations for reporting interruptions in single-source, medically necessary product supplies at least 12 months in advance of planned action; and revision of FDA's definition of "medically necessary" to allow for inclusion of factors on the impact of medication use.

Among the key items in the S.296 Act:

Consequences of shortages

The shortages of important drugs over the past year have caused disruption in patient care and resulted in negative publicity. "These disruptions include canceled or delayed medical treatments and procedures, as well as adverse events caused by medications that may have the potential for greater harm than the first-line therapy that is unavailable due to a shortage," an ASHP statement pointed out.

Last year, the Institute for Safe Medication Practices (ISMP) published examples of near-misses, errors, and adverse outcomes associated with drug shortages in its September 23 acute-care edition of ISMP Medication Safety Alert! The drug shortages that compromised patient safety included propofol, neuromuscular blocking agents, morphine, epinephrine, heparin, fosphenytoin, chemotherapy, and antibiotics.