NAS panel says better approach needed for COVID-related supply chain problems

Drug delivery system
Drug delivery system

UBC Media Relations / Flickr cc

Essential medicines and better, diverse solutions to disruptions in the US drug supply caused by the COVID-19 pandemic were the main topics of the National Academies of Science, Engineering, and Medicine's (NAS) public workshop held by its Security of America's Medical Product Supply Chain committee this week.

This was the second meeting by the committee, which was created as part of the COVID-focused CARES Act to provide recommendations regarding the US medical supply chain.

The panelists included representatives from Civica Rx, Vizient, government and public health agencies, the American Hospital Association, the American Society of Health-system Pharmacists (ASHP), and the Resilient Drug Supply Project (RDSP), which is a part of the University of Minnesota's Center for Infectious Disease Research and Policy, which publishes CIDRAP News.

Multiple solutions needed for agility

In her presentation, Lisa Hedman, MHM, the World Health Organization's (WHO's) group lead on supply and access to medicines, details the WHO's inter-agency emergency health kits, which, in a way, can be compared to an optimal response to shortages in the drug supply chain.

The kits are designed to provide affordable drugs and supplies quickly in public health emergencies. The kits consist of modules that can be adapted to fit different needs, but the packaging of the modules is identical, so every recipient can look at the kit's instructions and identify everything rapidly, says Hedman.

Similarly, the drug supply chain faces many threats, and responses to those threats may contain certain core elements but cannot all be the same, says Craig Kennedy, senior vice president of global supply chain management at Merck. (The latest CIDRAP "Viewpoint" report points out nine root causes of drug shortages.)

Heather Wall, chief commercial officer of Civica Rx, immediately agreed. "We need redundancy and strategic stockpiles and also a look at the supply chain diversity," she said. "Some of them might not make sense for redundancy, and many of them completely make sense. But that can't be the only solution."

Just as important, once the solution is settled upon, it has to be followed through with the same methodical precision that the WHO kit shows in its packaging. Stephen Schondelmeyer, PharmD, PhD, RDSP co-principal investigator, relayed examples of hospitals that received the antiviral drug remdesivir in unmarked boxes in their labs and monoclonal antibodies arriving at long-term care facilities that weren't equipped to administer them.

"You can run a marathon, but if you don't finish the last 200 yards, you don't finish the marathon," he says.

Substandard products, shortages among COVID-19 problems

As Michael Schiller, CISM, senior director of the Association for Health Care Resource & Materials Management, said, "COVID-19 was the perfect storm," as it led to export bans, factory shutdowns, delayed transportation, and demand surges, allocation issues, and substandard and falsified (SF) products.

For instance, Pernette Bourdillon Esteve, team lead of incidents and SF medical products at the WHO, presented a timeline of COVID-19 treatments correlating with reports of SF products, with some of the latest being COVID-19 vaccinations and dexamethasone in November. Because emerging treatments and vaccines often go to high-income countries first, she predicts a shift of SF problems to these countries, which may have historically considered the problem a lower priority.

Hoarding and supply shortages have also made their presence known. Without widely adopted guidelines, drug cascade shortages are more likely, said Michael Ganio, PharmD, director of pharmacy practice and quality at ASHP. Additionally, standard operational items such as isopropyl alcohol, which are used for sterilizing rooms, were in short supply.

On the patient end, Suzanne Schrandt, JD, founder and CEO of patient-engagement company ExPPect, added that not only was there a lack of antimalarials for those suffering from rheumatic diseases, but the disappearance of common items like alcohol pads caused difficulties for people who self-inject treatments. (The antimalarial drug hydroxychloroquine was touted early in the pandemic as an effective COVID-19 treatment.)

Pre-positioning and preparing the process

Stakeholders across the supply chain dealt with disruptions due to COVID-19, but some areas had larger breakdowns because pre-positioning available products to meet upcoming demand surges can last only so long, said Hedman. When surge stock runs out, the industry relies on processes already established.

Calling up another regulator to share dossier information is much easier to achieve when the relationship and the reliance already exists before an emergency, she explains. Creating rosters of emergency staff is another example, and other workshop presenters talked about areas that needed improvement such as the slow process to change transportation channels, decentralized reporting and resource pooling, and a lack of personal protective equipment research and education, such as classifications, decontamination, and reuse of respirators.

The panelists also said that manufacturers that discontinue products should have transitional regulations so market demand can be appropriately transferred, especially in the case of generics. Some suggested that agencies should even address economic issues and create more incentives for companies to stay in critical markets.

Transparency needs to increase in more than one area, as well. Pharmacists need to have easier access to drug quality information at the buying stage, the experts said, and drug companies should be more transparent about what  manufacturing sites they use throughout the supply chain. However, the latter is not as cut-and-dry as it may seem: Kennedy reminded the committee that transparency must be balanced with security, as some counterfeiters target facilities to steal discarded parts meant for disposal.

Different medicine lists reflect different purposes

At least five lists of important drugs were mentioned during the workshops, which is OK, says Schondelmeyer. For example, he says, the list for stockpiling for active military would differ from the list that the Federal Emergency Management Agency or the Biomedical Advanced Research and Development Authority would develop for natural disasters, which would likewise vary from the list needed for the American public if factories around the world were to shut down.

While some of these lists are still in development, such as the Food and Drug Administration's Executive Order 13944 list, others have already changed policy in their respective spheres of influence. Dan Kistner, PharmD, Vizient group senior vice president of pharmacy services, says that by working off the company's list of 200-plus drugs (created in January and already updated multiple times), Vizient's private-label Novaplus program has a 6-month supply for 151 of the products.

At the WHO, the essentials medicine list (updated biannually since 1977) helps dictate what is in the inter-agency emergency health kits.

At this time, there is no published timeline for the committee's study and recommendations. The full recording of the public workshops will be available at the NAS site in the coming week.

This week's top reads

Our underwriters