Nations facing drug shortages use registries, other steps

Capsules spilling from bottle
Capsules spilling from bottle

wp paarz / Flickr cc /

Drug supply chain vulnerabilities have achieved greater visibility with the COVID-19 pandemic, but they have increasingly plagued countries in the past few years. A survey published in Health Policy's December issue found that 20 of 24 countries used drug registries to combat them, 20 simplified regulatory procedures during shortages, 18 regularly talked with stakeholders, and 15 had financial sanctions in place for when manufacturers missed notification or supply requirements.

Even with these practices in place, multiple countries expressed an interest in increasing management strategies, and for good reason. Finland, the researchers report, experienced an 18-fold increase in shortages from 2010 to 2018, with instances doubling from 2016 to 2018 alone.

The Netherlands saw a doubling of shortages from 2018 to 2019 as well, going from 769 to 1,492. Germany had 268 shortages in 2018 but 355 shortages in 2019, a jump of 87 new shortages.

The United States, which was not part of the study, has also seen an increase in drug shortages over the years, although the country's two primary shortage databases show just how much the definition of "shortage" matters.

The US Food and Drug Administration (FDA) reported about 75 ongoing drug shortages in 2019, compared with about 65 in 2018, while the American Society for Health-system Pharmacists (ASHP) reported 251 ongoing shortages during the highest quarter in 2018 and 292 for the highest quarter in 2019. As of yesterday, the ASHP reports 204 shortages and the FDA notes 119 shortages.

Recent policies for managing shortages

In March and April 2020, the study's researchers sent out open-ended surveys to countries in the Pharmaceutical Pricing and Reimbursement Network, which consists of all 27 European Union member states, other European countries, Canada, South Korea, Switzerland, and Turkey.

Twenty-four public health officials responded. (The most populous countries to respond were Russia, Germany, and the United Kingdom, with the least populous country being Malta.)

In 20 nations, regulatory authorities—usually the medicines agency or the ministry of health—ran a registry of shortages. In all of those countries but Malta, suppliers were required to report to the registry, most of which were publicly accessible.

The German government made reporting to its shortage registry mandatory in April 2020, a process that began before the COVID-19 pandemic. Throughout that same year, the Netherlands has been working to create requisite stock of defined medicines for marketing authorization holders and wholesalers.

Two countries, Cyprus and Finland, are discussing the possibility of sanctions for drug manufacturers who are not meeting notification or supply requirements. Fifteen countries in the survey already have sanction policies in place, but the study did not state any indication of their parameters or recent usage.

To address drug shortages, 20 countries had simplified regulatory procedures, especially related to the importation, marketing authorization, and dispensing of drugs procured on the world market. Nations also allowed exceptions to package labeling requirements.

Just as indicative of supply concern is the attitude shift toward export bans. Although the researchers note these are less common measures, they also found an increase in ban provisions. At the end of 2019, 5 countries provided for that possibility; whereas, by mid-April, at the height of the pandemic's first wave, 10 countries were considering them.

As for the United States, the nation already uses many of the countermeasures the study looks at through agencies such as the FDA. However, under the prohibited actions defined by section 331 of the Food, Drug, and Cosmetic Act, failing to notify the FDA about a disruption in stock (section 356c) does not result in fines. Currently, the country has no export bans.

A need for a global perspective

While the shortage mitigations listed in the study may help, they are largely reactive and don't address the root issues, say the researchers, Sabine Vogler, PhD, director of the World Health Organization Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, and Stefan Fischer, health expert at the Austrian National Public Health Institute.

The survey questions didn't delve too deeply into future plans to fix this issue, but the findings did mention a possibility of greater collaboration. "For the time being, measures to manage and combat shortages of medicines were predominantly taken at national level, though the need for a multi-country approach to identify global or at least European answers has been repeatedly voiced," the researchers write.

A global approach makes sense, both for each of the countries in this study and for the United States, says Stephen W. Schondelmeyer, PharmD, PhD, co-principal investigator for the Resilient Drug Supply Project at the University of Minnesota's Center for Infectious Disease Research and Policy, which publishes CIDRAP News.

"The end user shortages are critical and make sense to look at from a national perspective, but when you look for root causes in the upstream supply chain like we're trying to do for the United States, you quickly realize the source of most drug shortages is a global issue," he says.

"We need a way to understand the global demand and supply perspective and a process to meet the needs of all countries, not just those who sign exclusive supply contracts and dominate the purchases from the limited number of qualified suppliers in the world market. Otherwise, a shortage may occur in one country because one or a few countries bought all of the available supply, suddenly leaving other countries without needed drugs."

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