New report explores measures to address shortages of lifesaving medicines

Feb 6 2015

As shortages of lifesaving medicines, including antibiotics, chemotherapy, and cardiovascular drugs continue to plague the United States, a group of health care organizations released a report exploring measures that should be considered to address this ongoing issue. The report summarizes manufacturing, regulatory, and economic issues related to drug shortages, as well as potential solutions that were considered at a 2014 Summit attended by 22 stakeholder groups, including health care professionals and other non-profit organizations, industry, public interest, and government agencies.

The 2014 Drug Shortages Summit was organized by the American Hospital Association (AHA), the American Society of Anesthesiologists® (ASA®), the American Society of Clinical Oncology (ASCO), the American Society of Health-System Pharmacists (ASHP), the Institute for Safe Medication Practices (ISMP), and The Pew Charitable Trusts. Previous summits were held in 2010 and 2013.

Presentations during the Summit validated a number of existing efforts to address drug shortages, including a provision in the Food and Drug Administration (FDA) Safety and Innovation Act that requires manufacturers to report supply disruptions for certain medications to the agency. Although new drug shortages are on the decline, existing shortages have persisted in significant numbers. According to the Government Accountability Office, the U.S. experienced more than 450 shortages in 2012 alone.

The Summit report explores the potential manufacturing, economic, and regulatory causes of drug shortages, and considers several possible solutions that merit further exploration, including:

• Improve quality systems to better prevent production problems that can lead to shortages by encouraging companies to foster a corporate quality culture, and use of an FDA-developed set of quality metrics to support early collaboration between manufacturers and the agency on quality issues.

• Identify regulatory efficiencies, such as synchronizing regulatory reviews by different global agencies to shorten the overall time for full approvals for facility upgrades.

• Allow for commercialization of trial batches of drugs that meet quality specifications to help mitigate losses during plant or line upgrade approvals.

• Incentivize manufacturer investments in capacity and reliability by increasing contractual penalties for failing to supply a product, and also allowing price increases.

• Support the market through better guarantees of demand by committing to the purchase of specified volumes of products vulnerable to shortage, either by a group purchasing organization or through a government program.

• Establish limited and/or shared exclusivity agreements to incentivize companies to produce needed drugs where there are no active producers.

• Standardize commonly used doses and concentrations in unit-of-use packaging to reduce waste and avoid contamination.

While no single solution or "silver bullet" to end drug shortages was identified, Summit participants agreed that these potential solutions merited further exploration.

Source: Pew Health Group