Prescription drug shortages: Some solutions
Across the country, ongoing critical prescription drug shortages continue to jeopardize patient access to medications and treatments. These shortages are multifaceted and are the result of a number of issues, including manufacturing delays or natural disasters like Hurricane Maria, creating further hardship for patients and providers alike. As the Food and Drug Administration (FDA) has repeatedly noted, drug shortages are a complex issue caused by quality problems, manufacturing delays, and capacity difficulties, and one that requires a multi-stakeholder solution.
As the sourcing and purchasing partners for America’s acute and long-term healthcare providers, healthcare group purchasing organizations (GPOs) play an important role in helping healthcare stakeholders prevent and mitigate drug shortages. And in pursuit of finding a multi-stakeholder solution, the Healthcare Supply Chain Association (HSCA) and its GPO members participated in a drug shortage working group composed of leading healthcare provider organizations – including hospitals, health-system pharmacists, physicians, GPOs, and other supply chain stakeholders – to develop policy proposals to help prevent and address drug shortages in a comprehensive manner. Together the group worked to develop key policy steps the FDA could take, including:
FDA should encourage early drug shortage alerts and ongoing multi-stakeholder communications.
FDA should encourage all stakeholders in the market, including providers, manufacturers, wholesalers, GPOs, and others, to communicate with the FDA as soon as a potential shortage situation is identified, and continue to share information as available. FDA and others should continue working to improve inter-agency communication and cross-agency coordination in shortage situations, such as the injectable narcotic shortage that occurred earlier this year, which required involvement of both the FDA and the Drug Enforcement Administration (DEA). Encouraging early and ongoing communication is critical for mitigating risk and reducing the likelihood of shortage situations.
FDA should enhance transparency requirements for drug shortage information.
FDA should require the reporting of accurate and timely information regarding shortages, including anticipated duration, supplier information about what drugs are manufactured at which plants and where those plants are located, and other disclosures, to ensure that all stakeholders take the most effective steps toward addressing drug shortages and ensuring uninterrupted, quality care for patients. The goal for policy solutions should be to ensure that all parties operate under good, complete and timely information.
FDA should strengthen drug shortage disclosures.
Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA) should be strengthened to require notifications to include disclosure of the problem causing the interruption, the extent of the shortage, and the expected duration of the shortage. Failure to provide timely notice of a drug shortage should result in a monetary penalty for the manufacturer. Also, manufacturers should be required to report current or anticipated supply concerns, including issues pertaining to the production or acquisition of raw materials. The information provided should be collated and organized by the FDA into a source on its website and easily accessible by the public.
FDA should expand its drug shortage list.
The FDA should expand its list of drug shortages to incorporate shortages included on other lists – such as the drug shortage list maintained by American Society of Health-System Pharmacists (ASHP) – to ensure a comprehensive and current list of drug shortages is being used. A more complete list can be used to help determine appropriate prioritization and will include more information that is needed to mitigate shortages – e.g., information on 503B compounders. The FDA’s list fails to take into account drugs that are in shortage based on their administration form and dosage, and does not include drugs that are experiencing significant regional shortages. An expanded list would enable feedback from providers that are on the front line.
HSCA, its member GPOs, and all other members of the drug shortage working group will continue to work together to find solutions and ensure consistent patient access to essential medications.
Todd Ebert, R.Ph., is the president and CEO of Healthcare Supply Chain Association (HSCA).