ASHP (American Society of Health-System Pharmacists), together with five other healthcare organizations, today sent a letter to Reps. Morgan Griffith (R-Va.) and Diana DeGette (D-Colo.) - the Vice Chairman and Ranking Member, respectively, of the House Energy and Commerce Subcommittee on Oversight and Investigations - asking Congress to take immediate action to address the public health crisis caused by persistent shortages of critical medications.
An ongoing shortage of critical medications, including sodium bicarbonate and epinephrine, 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.
In the letter, the signers -; the American Hospital Association, the American Society of Anesthesiologists, the American Society of Clinical Oncology, the American Society of Parenteral and Enteral Nutrition, and the Institute for Safe Medication Practices -; call for a comprehensive strategy to manage drug shortages. The healthcare groups ask 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?
"The scarcity of information available on what drugs are manufactured at which plants and where those plants are located is extremely problematic," said ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. "This lack of transparency hinders healthcare organizations' efforts to take a proactive approach to drug shortages and puts patients at extreme risk for serious harm. Addressing this critical patient care issue is a top priority for ASHP, and we are actively working with the FDA, Congress, and other key stakeholders on behalf of our members and their patients."
The signers also participated in a meeting at ASHP headquarters in Bethesda, Md., on Monday, November 6, to identify new opportunities to address the ongoing patient-care challenges associated with drug product shortages. Joined by representatives from the American Medical Association and the Society of Critical Care Medicine, participants assessed emerging trends, reviewed the impact of the 2012 FDA Safety and Innovation Act (FDASIA), and discussed the challenges faced by healthcare organizations to manage and conserve supplies of critical medications. Staff from the Food and Drug Administration Drug Shortages Program, the University of Utah Drug Information Service, and the U.S. Department of Health and Human Services Office of Emergency Management also participated in the meeting.
Representatives from the healthcare groups 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.
ASHP collaborates with the University of Utah Drug Information Service to track drugs in short supply and maintains an online resource center that features updates about product availability, recommendations for managing current inventory, and, when available, recommendations for alternative therapies.