A coalition of healthcare groups issued a series of recommendations last week to address the ongoing shortages of critical medications across the country. Among the groups that formulated the recommendations are the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), the American Society of Health-System Pharmacists (ASHP), and the Institute for Safe Medication Practices (ISMP).

The 19 proposals, which resulted from a summit meeting of healthcare leaders in September, were issued the day before a public meeting held by the US Food and Drug Administration (FDA) and the Duke-Margolis Center for Health Policy. This conference was designed to get stakeholder input on the root causes of drug shortages and what to do about them.

In 2017, the FDA reported 39 new drug and biologic shortages, plus 41 ongoing shortages at the end of the year, according to a background paper from the Margolis Center, part of Duke University. Many important products remain in shortage, including such common agents as injectable saline and sodium bicarbonate, according to the report.

The FDA, which formed an Inter-Agency Drug Shortages Task Force in July, regards this situation as a threat to public health, the paper states. Patients may experience treatment delays, receive alternatives that are not as effective or well tolerated, or may not receive treatment as a result of drug shortages. In addition, the shortages cost healthcare providers more than $400 million a year in labor costs and the sourcing of alternative medications.

In an ISMP survey of nearly 300 pharmacy directors, managers, and purchasing agents, 71% of respondents said they were unable to provide some patients with recommended drugs due to shortages, and nearly half said this resulted in patients receiving a less-effective medication. Three-quarters of the respondents said patient treatments had been delayed because of drug shortages.

Preparing for Emergencies

The healthcare coalition recommends strategies that would allow healthcare providers to prepare for an imminent shortage of certain drugs. The group urges the industry to ask the FDA to share information on the type of products that may be impacted during a public health emergency and the expected duration of the impact on the drug supply chain.

These communications, the coalition says, would "allow healthcare organizations to assess their inventories and would give manufacturers the time needed to manage their supplies to ensure equitable distribution and guard against potential hoarding of drugs," according to a news release.

The coalition also recommends that the Government Accountability Office (GAO) be commissioned to report on the new and emerging factors that contribute to shortages.

It advocates for the creation of "a list of critical drugs deemed essential for emergency response and saving and preserving life." And it suggests offering incentives to manufacturers to create contingency production plans for medications on the critical drug list.