Summit Sheds Light on Escalating Drug Shortages

Experts warn the nation’s dwindling drug supply could worsen if critical barriers are not addressed.

The United States is in the grips of a drug shortage that threatens to severely impact patient safety. Unless drug manufacturers, regulators, and health care providers collaborate immediately to find a solution, the problem will become exponentially worse.

That was the consensus of experts who convened at the Drug Shortages Summit in November. A summary report of the event, released yesterday by the American Society of Health-System Pharmacists (ASHP), outlines the scope and magnitude of drug shortages and identifies major barriers to ending them.

The summit, organized by ASHP, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices, brought together a diverse group of stakeholders. Attendees included representatives from health professional associations, drug manufacturers, and supply chain entities, as well as the FDA and other regulatory agencies.

The report reflects a concerted joint effort on behalf of all stakeholders, and includes the following recommendations for limiting the impact of drug shortages:

• Expanding FDA authority to require manufacturer notification of shortages and market withdrawals
• Providing incentives (eg, tax credits) to manufacturers that produce critical drug products in exchange for guarantee of continued production
• Requiring pharmaceutical manufacturers to confidentially notify the FDA when there is a single active pharmaceutical ingredient or manufacturing source
• Establishing a modified or reduced user fee program for FDA approval of generic drugs that would support expedited review of applications
• Establishing an expedited approval pathway for those unapproved drugs that are deemed critical therapies
• Requiring manufacturing redundancies to minimize the impact of quality issues,
• Enhancing communication among health care providers and stakeholders in the pharmaceutical supply chain about the nature and expected duration of shortages
• Improving adherence to the FDA’s Good Manufacturing Practices
• Evaluating and addressing the impact of just-in-time and sole-source inventory practices
• Considering distribution options for products in short supply

The drafted recommendations are a crucial first step in confronting a vast and complex system of policies and procedures that contribute to drug shortages, according to the authors of the report.

“The recommendations will be further evaluated and implemented, if appropriate, based on an assessment of feasibility, impact, and resources required for implementation,” ASHP said in a statement.

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