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Drug Shortages: Legislative opportunities

13 Nov 2019 1:27 PM | MSHP Office (Administrator)

Author: Sarah Cox, PharmD, MS

Impact of Drug Shortages:

The number of drugs impacted by shortages nearly tripled over a five-year period (2007-2012).1

Today, drug shortages continue to pose a threat to health-systems and patients. A survey conducted in collaboration with ASHP and sent to 1300 directors of pharmacy nationwide, indicated that 99% of health-systems had experienced at least one shortage in the past 6 months and about a third or respondents stated having shortages with over 30 different drugs. Costs were estimated to be near $216 million from labor resources allocated to preventing or preparing for shortages.2 Another survey of directors of pharmacy estimated that drug shortages account for one to five percent of medication errors.3

Resources for Your Health-System to Manage Drug Shortages:

While drug shortages are not new and health-systems already have put processes in place in attempt to prevent and address shortages, there are many resources available to aide in this process.

  1. ASHP Drug Shortages List: Includes a master list of current drug shortages and the date the shortage was updated. This list is very user friendly and allows browsing or searching for a specific drug. Clicking on the drug of choice will bring up a new web page with details about the products impacted (including NDC), reason for the shortage, available products, and estimated resupply dates
  2. ASHP Guidelines on Managing Drug Product Shortages: This resource provides strategies health-systems can take to preventing, planning for, and responding to drug shortages.
  3. ASHP Drug Shortages Roundtable Report: This document describes some background on drug shortages including common causes and potential remedies.
  4. ASHP Additional Resources: Webpage includes additional links to best practices, guidelines, tools, and publications on drug shortages including links to the FDA Drug Shortage site and CDC Vaccine Shortage site.

Legislative Efforts:

The FDA Safety and Innovation Act (FDASIA) was enacted in 2012 and included a requirement that drug manufacturers notify the Food and Drug Administration (FDA) “of any change in production that is reasonably likely to lead to reduction in supply.” While this legislation did lead to a reduction in the number of drug shortages, additional legislation may help reduce shortages even further.

The Mitigating Emergency Drug Shortages Act was introduced by Senator Susan Collins (R-ME) and Senator Tina Smith (D-MN) on October 29, 2019. ASHP played a role in developing the objectives for this piece of legislation including:

  • “Requiring manufacturers to disclose the root causes and expected duration shortages
  • Extending reporting requirements to include contract manufacturers and active pharmaceutical ingredients
  • Requiring manufacturers to develop contingency plans to ensure an ongoing supply
  • Developing recommendations to incentivize manufacturers to enter the market for drugs in shortage; and
  • Examining the national security risks of shortages.”4

Take Action:

To advocate for this legislation, go to ASHP’s online advocacy center, contact your representative, and ask them to co-sponsor S. 2723.

References:

  1. Public Health Threat Continues Despite Efforts to Help Ensure Product Availability. United States Government Accountability Office, Washington DC. 2014;pp14-194.
  2. Kaakeh R, Sweet BV, Reilly C, et al. Impact of Drug Shortages on National Survey Reveals High Level of Fristration, Low Level of Safety. Am J Health Syst Pharm. 2011;68(19):1811-1819.
  3. Caulder CR, Mehta B, Bookstaver PB, et al. Impact of Drug Shortages on Health-System Pharmacies in the Southeaster United States. Hosp Pharm. 2015;50(4):279-286.
  4. Issue Update: ASHP Influencing the National Conversation on Drug Shortages. https://ashsp.ac360.aristotleactioncenter.com/#/alertId/03de88de-d2d9-4f57-bf2d-b37fe4bc57b5/ October 24, 2019. 

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