Healthcare Coalition Proposes Ways to Combat Drug Shortages

Ken Terry

December 04, 2018

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 aren't 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.

The coalition's 19 specific recommendations include regulatory measures, new legislation, and market-based initiatives. One regulatory proposal is for the Centers for Medicare & Medicaid Services (CMS) to reevaluate its practice of citing hospitals that use medications after the guaranteed stability period in product labeling. Evidence may exist in the literature that the drug is safe to use after the period on the label, but CMS and the Joint Commission will cite a hospital even if it revises the date based on this evidence, the group notes.

Two of the legislative proposals concern national security. The healthcare coalition recommends that Congress pass a law requiring a risk assessment of foreign-source active pharmaceutical ingredients. "Relying predominantly on other countries for the necessary ingredients to manufacture crucial drugs puts the U.S. at risk," the coalition writes. It also suggests that the government study domestic drug and medical device manufacturing capability for critical products to assess whether a threat to national security exists.

Wasteful Packaging

The coalition also recommends incentivizing manufacturers to work with the FDA to repackage pharmaceuticals according to the amount of medication commonly used to avoid waste. For example, when the most common volume of a drug needed is 5 mL, packaging that drug only in 30 mL vials results in most of the drug being thrown out.

In addition, the group of associations recommends that electronic health record (EHR) vendors make changes in their systems to ease the burden of switching drugs when a shortage occurs. For example, the vendors could allow changes to be made simultaneously to multiple databases, such as EHR and smart pump drug libraries, or automated dispensing cabinets and pharmacy inventory systems.

The coalition's recommendations do not directly address the causes of drug shortages that are described in the Margolis Center paper. Nearly two thirds of drug shortages resulted from problems in maintaining product quality, according to FDA historical data. Other causes include challenges in sourcing raw materials, increased demand stemming from changes in the marketplace, and business decisions to discontinue products. Low profit margins, particularly among generic drugs, make some products less attractive to manufacture, the paper points out.

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