April 1, 2015
Health System Pharmacists, Others Propose
Drug-Shortage Solutions

Philadelphia—Pharmacists facing the hard truth that they can’t dispense drugs they don’t have might take heart from a new report offering potential solutions to the problem of drug shortages in the United States.

Concerned about under-supply of lifesaving medicines, including antibiotics, chemotherapy, and cardiovascular drugs, a group of healthcare organizations released a new report suggesting ways to address the ongoing issue.

Included in the document are potential solutions considered at a 2014 summit attended by 22 concerned groups, including healthcare professionals and other nonprofit organizations, industry, public interest, and government agencies. The report also summarizes manufacturing, regulatory, and economic issues related to drug shortages.

Organizers of the 2014 Drug Shortages Summit included the American Society of Health-System Pharmacists (ASHP), the American Hospital Association, the American Society of Anesthesiologists, the American Society of Clinical Oncology, the Institute for Safe Medication Practices, and The Pew Charitable Trusts. Earlier summits were held in 2010 and 2013.

While new drug shortages generally have decreased, existing shortages have persisted in significant numbers, according to the report. According to the Government Accountability Office, the nation experienced more than 450 shortages in 2012 alone.

Last year, a survey of 358 pharmacy directors who are ASHP members throughout the U.S. found that 98% of respondents had at least one drug shortage during the previous 12 months, with 70% reporting instances of inadequate supplies of drugs needed to treat patients. More than half, 63%, said their facility had run out of at least one injectable oncology drug during the previous year.

Possible solutions developed at the 2014 summit include the following:

• Encourage manufacturers to foster a corporate quality culture and use an FDA-developed set of metrics to support early collaboration on quality issues that can cause production problems;
• Decrease the overall time for full approvals for facility upgrades by identifying regulatory efficiencies, such as synchronizing reviews by different global agencies;
• Help mitigate losses during plant or line upgrade approvals by allowing for commercialization of trial batches of drugs that meet quality specifications;
• Allow price increases, while increasing contractual penalties for failing to supply a product, to incentivize manufacturer investments in capacity and reliability;
• Commit to the purchase of specified volumes of products vulnerable to shortage, either by a group purchasing organization or through a government program, to provide better guarantees of demand;
• Establish limited and/or shared exclusivity agreements to incentivize companies to produce needed drugs where there are no active producers.
• Reduce waste and avoid contamination by standardizing commonly used doses and concentrations in unit-of-use packaging.

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