Analysis

Pew, Other Groups Identify Potential Measures to Address Drug Shortages

Pew and other health care organizations released a report on February 5, 2015 exploring measures that should be considered to address the ongoing issue of drug shortages in the United States, which impacts lifesaving medicines including antibiotics, chemotherapy, and cardiovascular drugs. The report summarizes manufacturing, regulatory, and economic issues related to drug shortages, as well as potential solutions identified at a 2014 Summit attended by 22 stakeholder groups, including health care professionals, non-profit organizations, industry, public interest, and government agencies.

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

  • Improving quality systems in pharmaceutical manufacturing to better prevent production problems that can lead to shortages by encouraging companies to foster a corporate quality culture, and use FDA’s set of quality metrics to support early collaboration between manufacturers and the agency.
  • Identifying regulatory efficiencies, such as synchronizing reviews by regulators in different countries to shorten the overall time for full approvals for facility upgrades.
  • Allowing for commercialization of trial batches of drugs that meet quality specifications to help mitigate losses during the approval process for upgrades to plants or production lines.
  • Incentivizing manufacturer investments in capacity and reliability by increasing contractual penalties for failing to supply a product, and also allowing price increases.
  • Supporting the market through better guarantees of demand by committing to the purchase of specified volumes of drugs vulnerable to shortage, either by a group purchasing organization or through a government program.
  • Establishing limited and/or shared exclusivity agreements to incentivize companies to produce needed drugs where there are no active producers.
  • Standardizing commonly used doses and concentrations in unit-of-use packaging to reduce waste and avoid contamination.

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

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