Five steps U.S. federal, state regulators can take to ensure drug access during COVID-19 pandemic
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Federal and state regulators, as well as distributors and pharmacies, must act now to establish anti-stockpiling measures and expand mail-order programs, as well as other policies, to ensure access to needed medications in the United States during the COVID-19 pandemic, according to an editorial published in JAMA.
“The pharmaceutical supply chain is complex and vast, and the COVID-19 pandemic is a stress test that reveals its shortcomings,” G. Caleb Alexander, MD, MS, of the Johns Hopkins Bloomberg School of Public Health Center for Drug Safety and Effectiveness and Department of Epidemiology, told Healio Rheumatology.
“There are many ways that shortages may occur, not just from lack of overseas ingredients,” he added. “Types of shortages or access barriers may include disruptions in domestic supply chain due to worker outages, access barriers due to difficulty accessing open pharmacies or using mail-order or home delivery and demand surges for specific medicines driven by media reports or emerging evidence.”
Alexander and coauthor Dima M. Qato, PharmD, MPH, PhD, of the University of Illinois at Chicago College of Pharmacy, penned the editorial against the backdrop of widely reported shortages of several drugs due to the spread of COVID-19. According to the authors, these include acetaminophen and hydroxychloroquine shortages fueled in part by “media coverage, emerging evidence of benefit, or other factors.”
Hydroxychloroquine in particular has been listed on the FDA’s drug shortages website since March 31, preventing many patients with rheumatoid arthritis and lupus from receiving needed treatments. This followed comments from President Donald Trump touting hydroxychloroquine’s supposed benefits for COVID-19, despite the current lack of data. Several clinical trials studying the drug’s efficacy and safety in COVID-19 are ongoing.
According to Alexander and Qato, there are five steps state and federal officials, as well as distributors and pharmacies, can take to ensure access to necessary medications throughout the pandemic. These include:
- Developing an essential medicines strategy, which would first require the FDA to develop a list of essential drugs, including antibiotics, antivirals, antidiabetic agents, cardiovascular drugs, respiratory agents, contraceptives, mental health products and analgesics.
- Preventing stockpiling and drug shortages by requiring all wholesalers to adopt allocation strategies to protect their inventories and identify and mitigate risk, as well as restricting the retail dispensing of all essential drugs to a 30-day emergency supply.
- Financing an emergency supply of essential drugs by asking providers to consider waiving copayments, especially for low-income patients.
- Expanding mail-order pharmacies and home delivery services, which currently account for less than 10% of all retail prescriptions dispensed in the United States, by providing incentives for pharmacies in underserved areas.
- Implementing a long-term strategy to protect drug access, stressing the need federal and state agencies to establish and maintain central inventories of essential medicines that can be distributed at state or local levels based on need.
“This isn’t first time we’ve faced a national disaster threatening our supply chain, and won’t be the last,” Alexander said. “But it’s also important to note that for many in the United States, barriers accessing medicines isn’t anything new — many people go without medicines every day due to economic, clinical, social and structural factors.”
“For example, many simply can’t afford the costs of their prescriptions, and others don’t have access to a stable source of comprehensive primary care to get them in the first place,” he added. “But the pandemic has shined a bright light on our supply system, and what we can do to safeguard it. These are major challenges, but people all along the supply chain are rising to the challenge.” – by Jason Laday
Disclosures: Alexander reports that he is past chair of FDA’s Peripheral and Central Nervous System Advisory Committee, that he has served as a paid advisor to IQVIA, is a cofounding principal and equity holder in Monument Analytics, and is a member of OptumRx’s National P&T Committee. Qato reports consulting fees from Public Citizen’s Health Research Group.
Perspective
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Teri Puhalsky, RN, CRNI
This pandemic has taught us that it is vital that we understand the medication supply chain and how unexpected and potentially dangerous disruptions will impact our patients and health care in the U.S. In 2019, the General Accounting Office reported that more than 60% of the drug manufacturers for the U.S. markets are overseas, so inspecting and assuring the safe and adequate supply of critical drugs is essential. We must have transparency in our supply chain, resources to actively monitor it and a central strategy to ensure we are prepared.
Patients should not have to hoard medications, pharmacies should not have to ration quantities and providers should not have to be creative with dosing regimens because we did not have a disaster plan. Thinking outside of the box to determine ways to protect our patients will take the cooperation of all involved from the government, manufacturers, pharmacies, prescribers and the public but it is absolutely necessary for us to be prepared for any future disaster.
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