In response to ongoing and new drug shortages, ASA and other drug shortage stakeholders sent a formal communication to Congress urging increased transparency regarding drug shortages, as well as improvements to manufacturing infrastructure.
As covered in the Capitol Hill newspaper, POLITICO in a November 29 article “Drug shortages post-hurricane focus concerns on FDA disclosure policy,” this correspondence describes how “the lack of transparency about drug manufacturing makes it more difficult to take steps to prevent shortages.” As quoted in the article, ASA President James Grant, M.D., said “as a clinician, I spend a lot of time just trying to figure out what we have and what we don't have.”
In the formal communication to Reps. Morgan Griffith (R-VA) and Diana DeGette (D-CO) — the Vice Chairman and Ranking Member, respectively, of the House Energy and Commerce Subcommittee on Oversight and Investigations — stakeholders asked Congress to take immediate action to address the public health crisis caused by persistent shortages of critical medications. The letter highlighted the ongoing shortage of critical medications, including sodium bicarbonate and epinephrine, which has been exacerbated in recent weeks by shortages of small-volume parenteral solutions (SVPs). SVPs are solutions of 100 mL or less used in nearly every hospital in the United States to dilute intravenous medications. The SVP shortage is primarily a result of hurricane-related damage to pharmaceutical manufacturing plants in Puerto Rico. Drug shortages pose a significant threat to the safety and quality of patient care in hospitals and other healthcare settings and may result in delayed treatment and increased risk of adverse reactions and medication errors.
Signatories also called for a comprehensive strategy to manage drug shortages, asking Congress to examine the following questions to address the underlying causes of shortages:
- Should manufacturers be required to disclose to the medical community their manufacturing sites and the products produced in those sites, in terms of volume and percentage of product line?
- Should sole-source products be allowed to be produced in a single plant?
- Should there be redundancy in production of critical products?
- Should the FDA identify a list of “critical medications” that would require manufacturers to develop a reasonable contingency plan in the event of a production interruption or shutdown?
- What incentives could be developed for other manufacturers to increase production when drug shortages occur?
- What can be done to determine the best locations of pharmaceutical plants in addition to ensuring that backup systems can quickly accommodate needs in the event of a disaster, given there are several types of natural disasters that can occur?
This formal communication was sent following a November 6, 2017 stakeholder meeting. Representatives from the clinician community and others convened to identify new opportunities to address the ongoing patient-care challenges associated with drug product shortages. Stakeholders including ASA, the American Hospital Association, Pew Charitable Trusts, the University of Utah Drug Information Services, the American Society of Clinical Oncology, the American Medical Association, the American Society of Parenteral and Enteral Nutrition, the Institute for Safe Medication Practices, and the Society of Critical Care Medicine participated to assess emerging trends, review the impact of the 2012 FDA Safety and Innovation Act (FDASIA), and discuss the challenges faced by healthcare organizations to manage and conserve supplies of critical medications.
At the meeting, stakeholders made 11 recommendations, including the development of a quality rating system for companies that consistently employ high-quality manufacturing standards and a requirement for manufacturers to develop production contingency plans for sole-source drugs. The participants also called for an amendment to Title X of FDASIA that would require additional information — duration and expected timeline for resolving a shortage — when manufacturers report a drug shortage to the FDA. A formal report detailing these recommendations is forthcoming.
ASA is a founding member of the Drug Shortage Summit and continues to monitor drug shortages for members through collaboration with ASHP and the University of Utah Drug Information Service, as well as the FDA. These stakeholders are critical to tracking drugs in short supply and maintain an online resource center that features updates about product availability, recommendations for managing current inventory, and, when available, recommendations for alternative therapies.
See actions ASA has taken on drug shortages.