Drug supply chain issues aren't going away, report says

In a new American Society of Health-system Pharmacists (ASHP) report, 92% of its "2021 Pharmacy Forecast" panelists say global issues like trade restrictions, pandemics like COVID-19, or climate change will increase the potential for more drug shortages, and almost 90% say a major technology failure or breach could cause widespread disruptions in the delivery of US healthcare supplies.

To help mitigate these issues, 90% of panelists also predicted that at least 75% of health systems will develop allocation guidelines. In the report, the ASHP notes a 36.6% increase in ongoing drug shortages from 2017 to 2020, with 276 shortages occurring in 2020.

Uncertainty in global supply chains

The first chapter of the ninth edition of ASHP's pharmacy forecast, which was released earlier this month, is called, "The Certainty of Uncertainty for a Global Supply Chain." Written by Erin Fox, PharmD, and Aaron Kesselheim, MD, JD, MPH, the section reflects on responses to an ASHP survey from 272 experts in health-system pharmacy.

Allocation guides, a push for domestic supply chains, manufacturing quality scrutiny, and more were all topics the panelists thought would be highly relevant for the next 5 years, and the authors agree.

"With a global pandemic and continuing uncertainty regarding the stability and quality of the medication supply chain, health-system pharmacists must be prepared for significant disruptions to 'normal' healthcare delivery, including disruption of medication procurement," they write.

To help combat this, Fox and Kesselheim recommend further allocation guidelines, better information sharing, and more contingencies for pandemic-related issues like demand surges or distribution needs (eg, vaccine rollout). They also advocate for drug acquisition contracts that include periodic reports on quality measures as well as for legislative action that facilitates both lower spending and better pharmaceutical product quality.

Desire for a manufacturing quality rating system

Drug supply chain experts have been calling for more mature manufacturing in the industry, but companies have little incentive to invest in better machines or processes. Multiple reports, with one of the latest being Johns Hopkins' "The Pandemic and the Supply Chain," in November 2020, have suggested that the US Food and Drug Administration (FDA) or another entity create a manufacturing quality rating system to help create this incentive.

However, panelists were split (47% agreeing, 53% disagreeing) in their belief that the FDA would rate quality management effectiveness. The survey did not probe further to see if the respondents thought another entity might.

If such a system were created, perhaps it could help give incentives to improve technology infrastructure as well: 87% of panelists said it was at least somewhat likely that a major technology infrastructure failure or breach would have large consequences on the US healthcare delivery system.

COVID-19 spotlight on allocations, domestic production

The COVID-19 pandemic continues to change the healthcare field, but the panelists were optimistic about future pandemic responses. For instance, hydroxychloroquine, azithromycin, and cisatracurium were just three of the drugs that saw unprecedented demand surges this past year, but 90% of panelists predicted that at least 75% of health systems would develop allocation guidelines for future shortages using resources such as ethics committees or crisis standards of care.

Healthcare systems also lost money while dealing with high COVID patient volumes, but 81% of panelists thought that federal resources would increase during similar incidents in the future. Fox and Kesselheim point to wide disparities in assistance.

"Substantial federal funds were provided to wealthy health systems, with 20 large chains receiving $5 billion in federal grants despite holding more than $100 billion in cash," they write. "Smaller hospitals, by contrast, received insufficient federal assistance."

Domestic drug manufacturing also received greater visibility during the pandemic. Fox and Kesselheim note that even though drug shortages largely occurred because of patient demand, not supply chain disruptions, multiple bills emphasizing domestic drug manufacturing appeared in Congress, and the Biomedical Advanced Research and Development Authority (BARDA) created a $345 million contract for generic medicines and raw materials.

Despite this, or perhaps in disregard to it, 68% of panelists believe the United States is likely to import prescription drugs to combat high drug prices. The report notes that the United States spends "by far" the most per capita for brand name drugs in the world, making up the most of the country's $450 billion annual prescription bill.

"While importation of single-source brand-name drugs may not be feasible, FDA may develop pathways for responding to generic drug shortages (or price hikes) by facilitating the regulatory approval of overseas manufacturers of these products," Fox and Kesselheim write.

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