Addressing Drug Shortages: Enhancing Buffer Stock, Transparency to Mitigate Future Crises

Buffer stocks may help mitigate drug shortages, but infrastructure and centralized management are crucial to create a long-term solution to address ongoing and future cancer drug shortages, says Crystal S. Denlinger, MD, FACP, CEO of the National Comprehensive Cancer Network.

Transcript

With 64% of respondents advocating for a broader buffer stock payment and more transparency from suppliers, what steps are being taken to address these needs, and how can they help mitigate future shortages?

We have also seen proposals from federal agencies around the buffer stock, which might be helpful to address future shortages by having backup stock readily available on hand to distribute when needed, if a particular drug shortage reaches a crisis level, as it did with the platinum shortage. But there are some concerns about this. In order to have the buffer stock available and accessible, we need to have infrastructure to communicate the impending shortages, as well as where the needs are. And expecting that 6000 hospitals nationwide can manage and report on the nationwide buffer stock is potentially not a reasonable expectation for the hospitals.

A more streamlined approach might be to centralize the collection and management of this information through an appropriate federal department or agency. Any efforts that we do around the buffer stock will need to be implemented collectively and centrally in order to be effective. There’s also some concern about placing more administrative burden on hospitals to manage the stocks. And this is especially a concern for smaller hospitals that may not have the capacity to manage excess drug stock on hand. And again, if we don't address the root cause of the issue, which is related to market pressures, specifically in the generic drug market, the buffer stock may not be enough to be a long-term solution.

We've also seen some proposals from HHS that focus on quality manufacturing processes and transparency, which is important because any errors or concerns in quality is part of the reason that the generic drug market can grind to a halt. The FDA specifically is establishing a program to promote Quality Management Maturity [QMM] at drug manufacturing establishments, and this aims to really encourage drug manufacturers to implement quality matter management practices that go beyond the current Good Manufacturing Practice, or GMP, requirements. There's also been proposals around a manufacturing resilience assessment program that could help to measure the resilience of the manufacturers and create more transparency in the system. Under this program, a private entity that is administering through the program would assign a resiliency score to manufacturers as an assessment of their practices, their past performance, and their ability to provide [a] drug. But ultimately, again, we need long term solutions because our patients, caregivers, providers, payers and regulatory agencies can't really sustain dealing with the repeated burden of responding to a crisis with a lack of access to optimal effective multi-agent regimens.

The drug crisis that was associated with the shortage of carboplatin first and then cisplatin as a result, really shone a light on a problem that has been ongoing for a while, and really speaks to the importance of ensuring that we have access not only to the best new therapies and the latest and greatest new therapies, but that we also continue to have access to drugs that have proven to be effective time and again. That's really where investment in a resilient and stable generics market is necessary because we recognize that the drugs that have moved into the generic market are still good drugs for a reason. We want to ensure that our patients have access to all of the drugs necessary to obtain the best outcome for their cancer, and that means both the latest and greatest as well as the more tried and true generic agents that have been the focus of so many shortages.