9 Out of 10 Physicians Report Drug Supply Chain Issues
Nine out of ten United States physicians reportedly are concerned that the drug supply chain may not be reliable in a time of crisis, according to results shared by the United States Pharmacopeial Convention (USP).
The survey was conducted in Sept. 2021 and sampled 500 healthcare professionals from all 50 states, all of whom are board-certified and affiliated with a hospital system.
The COVID-19 pandemic may have a lot to do with the results. 95% of those surveyed agreed that the pandemic showed the vulnerabilities of the medicine supply chain, while 73% said that their trust in the supply chain to deliver safe, quality medicines is lower today than it has been in the past.
Their beliefs are not unfounded. In 2020, the Johns Hopkins Bloomberg School of Public Health published a 20-page report that highlighted drug policy issues, actions taken and policy recommendations. The report illustrates how the pandemic exacerbated already existing drug supply chain issues that began a decade earlier, with low-cost, generic drugs being the most at risk. This includes life-supporting drugs such as vasopressors, sedatives, injectable solutions and others that experienced an unexpected increase in demand when COVID-19 patients began filling hospitals.
The report also highlights other major problems in the U.S. drug supply chain due to the pandemic. These included the disruption of the production of critical medication due to depletion of resources and reliance on the resources of other countries for manufacturing; delayed regulatory oversight of medication production from postponed inspections; interruption of global trade in therapeutics; limited understanding of local and demand-driven shortages; and inadequate supply chain planning and management. Many of these issues existed before the pandemic began, as 83% of survey respondents indicated that drug shortages have become a bigger problem in recent years.
Of course, patients in need of critical care are the most at risk when examining drug supply chain vulnerabilities. Nearly 80% of physicians responded that there were shortages of medication needed by all patients, regardless of whether their illness was related to COVID-19. When these medications were unavailable, physicians were most likely to prescribe a second choice of medication, not prescribe certain medications, cancel elective procedures or ration treatments to the most severely ill.
An example of a drug that has been particularly impacted by the COVID-19 pandemic is the anti-inflammatory tocilizumab, needed for both chemotherapy and the treatment of COVID-19. With drug supply chain shortages, there often wasn’t enough of the drug to go around, forcing hospitals and health care providers to decide which patients are the best candidates for the drug, putting patients in a more vulnerable position.
In the light of these results, USP announced that it is organizing with health care groups such as the American Medical Association, the American Society of Anesthesiologists, the American Society of Health-System Pharmacists and the Association for Clinical Oncology.
The groups have released a series of policy and marketplace recommendations to address the significant challenges faced by the drug supply chain. The group asked policymakers to implement a range of legislative and regulatory actions, such as incentivizing the development and use of advanced manufacturing technology for critical drugs, improving the function, composition and accessibility of the U.S. Strategic National Stockpile (SPS) during public health emergencies and improving international cooperation and collaboration with foreign supply chain partners.
The Johns Hopkins report also recommended policy changes and amendments mainly directed towards the U.S. Food and Drug Administration. The report recommended that the FDA should disclose and mitigate demand-driven and local-level shortages by expanding their drug shortage surveillance system in times of public health emergencies. They also called for Congress to authorize the FDA to create and publish quality metrics for the manufacturing process and strengthen the global supply chain by having the FDA establish a database of approved manufacturers.
The U.S. has made several policy changes in light of the pandemic, including introducing reporting requirements for manufacturers about actual and expected medication shortages and requiring manufacturers to develop a risk management plan to address shortage risk. The FDA currently identifies drugs that are experiencing a shortage and provides guidance on their production.