COVID19 Exacerbates U.S. Drug Shortage Issues
If there was any hope for mitigation of drug shortages in the U.S. during 2020, COVID19 pretty much kicked those thoughts to the curb in the first few months of the past year. The usual myriad of impact factors, such as the scarcity of certain chemical precursors, active and inactive pharmaceutical ingredients needed for finished drug product production within the U.S. and worldwide, continued to impair the consistent supply of needed medications within the U.S. As a result, healthcare providers continued to struggle with hundreds of key drug shortages throughout the past year. The pandemic added additional strain to the pharmaceutical supply chain through the repurposing of available manufacturing lines and sites to the slowdown of plant inspections due to the pandemic impact on travel and staffing at pharmaceutical plants both in the US and abroad. In fact, the American Society of Health-System Pharmacists (ASHP) noted that 29 out of the top 40 (72.9%) critical drugs for the treatment of COVID19 patients were unavailable or in short supply during the past year.
From a historical perspective, from 2015–2019, new annual medication shortages increased consistently from five to 31. However, in the first six months of 2020, 27 new shortages were announced in 2020 accounting for 87% that of the total number of shortages reported in 2019 in half of the time. Clearly, the COVID19 pandemic has further exposed to other healthcare providers, patients, policy makers and now even the general public, what those of us in pharmacy practice have known and experienced for at least the last decade. Drug shortages in the U.S. are real, a growing problem with no quick and easy solutions and require significant dedicated resources to manage and result in increased costs for our respective health care organizations in order to assure the continuation of both life-saving and elective patient care treatments and services.
As noted previously, in 2019 the FDA led an inter-agency Drug Shortage Task Force which produced a comprehensive report regarding the root causes and potential solutions for addressing the U.S. drug shortage issue. An updated report was issues in February, 2020, and is available on the FDA website at http://www.fda.gov/media/131130/download.
To recap, the report identified three root causes for drug shortages:
- Lack of incentives for manufacturers to produce less profitable drugs.
- The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues.
- Logistical and regulatory challenges make it difficult for the market to recover from a disruption.
The report also recommends several enduring solutions to address drug shortages, which include:
- Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages,
- Developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities, and
- Promoting sustainable private sector contracts (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs.
Also, the report described legislative proposals in the President’s FY2020 Budget and planned FDA initiatives to prevent and mitigate shortages that look at improved data sharing, risk management, lengthened expiration dates for drugs, and internationally harmonized guidelines for a pharmaceutical quality system. Given the lack of any significant definitive outcomes on these proposals or the recommendations in the FDA report in the past year, the likelihood is that most of not all of these proposals succumbed to the prioritization of the pandemic efforts and 2020 Presidential election, let alone additional political and other influencing factors. It remains to be seen what, if any focus will be undertaken by the Federal government under the new Biden administration in the upcoming 4 years.
Still, there are some bright spots starting to shine on the horizon for 2021 and beyond. As previously announced, consortium-based startup contract pharmaceutical manufacturing companies such as Civca Rx are attempting to address critical drug shortages for their members in particular. The pharmaceutical industry is continuing to explore “fill and finish” plants (particularly related to injectable drug products) as well as the potential transition to automated continuous manufacturing processes versus traditional batch processes to improve pharmaceutical production line utilization with a potential reduction in the occurrence of drug shortages. Additional longer-term considerations in the number and geographic diversity of pharmaceutical manufacturing plants versus the current consolidation of these facilities may hold additional hope for the reduction of drug shortages longer term.
While all of this is certainly a step in the right direction there is still a considerable amount of change that must occur if drug shortages are to be effectively mitigated and controlled. There appears to be a growing recognition and amongst key stakeholders that the U.S. pharmaceutical supply chain is complex, has multiple stakeholders and as further exposed by the COVID19 pandemic, has a number of vulnerable points Further, it depends upon cooperation with multiple foreign countries (most notably China and India) for its most basic ingredients in order to produce readily available, safe and high quality finished drug products. In reality, this fact alone constitutes an urgent national security issue for the well-being of our country’s citizens from natural health causes, let alone acts of terrorism or war. Finally, it will likely take all stakeholders in the U.S. pharmaceutical manufacturing process, from the federal government legislative and policy making agencies to the ingredient suppliers, pharmaceutical manufacturers and healthcare providers effectively redesign the current U.S. drug supply chain.
Unfortunately, it is also widely recognized that this redesign will likely take years to achieve and be the result of innovation on the part of multiple stakeholders with perhaps minimal guidance let alone mandates from the federal government. As such, for 2021 and likely well beyond, health care systems and providers would once again be well advised to continue to formalize and budget appropriate personnel resources and increased acquisition costs for their own shortage risk mitigation strategies and programs.
Accessed Dec 22, 2020