Published On April 28, 2020Healthcare supply chain management has been severely impacted during COVID-19. Here’s a look at the FDA’s response.
Personal protective equipment and ventilator shortages have dominated headlines, but COVID-19 has also caused shortages across a range of drugs — many of which are critical for maintenance of unrelated conditions. At the same time, actions taken by the Food and Drug Administration (FDA) have had a significant impact on healthcare supply chain management in intercepting challenges and mitigating disruptions in access to drugs.
At Risk of Falling Short
In addition to a shortfall in drugs vital to the maintenance of chronic illnesses, anesthetics and medications to reduce pain are in danger of running low, as well.
Chloroquine and Hydroxychloroquine
Lupus and arthritis patients have been vocal about their challenges obtaining hydroxychloroquine ever since rumors began to spread that the drugs could be effective in treating COVID-19. Prescriptions of hydroxychloroquine (brand name Plaquenil) have spiked, putting the drug in short supply since March 9, according to the American Society of Health System Pharmacists. Currently, manufacturers are working to increase production to respond to demand.
To minimize the spread of COVID-19 within hospitals, doctors in many facilities began avoiding nebulizers for patients with respiratory issues, instead shifting to albuterol asthma inhalers. The result has been an inhaler shortage in both hospitals and retail pharmacies, largely caused by dependence on bulk ingredients and medicines produced offshore.
To mitigate the issue, the FDA recently approved the first generic albuterol inhaler to support the public’s needs, reports U.S. News.
While efforts to ramp up ventilator production are helpful, they only resolve part of the shortage issue — patients on ventilators require sedatives, anesthetics and paralytic agents to address respiratory failure.
For example, New York has seen a spike in demand for fentanyl, used as a sedative, and the FDA placed midazolam on the official drug shortage list in March, according to the Regulatory Affairs Professionals Society. These increases in use run headlong into challenges produced by the opioid epidemic; in response, the Drug Enforcement Administration proposed reducing quotas of fentanyl and midazolam back in September.
Supply Chain Dependence on China
As far back as January, experts expected interruptions to the supply of active pharmaceutical ingredients (APIs). A report by API wholesaler Kemiex found that 85% of supply professionals expected low to high impacts, which, at the time, was largely based on the spread of COVID-19 through China, the effects of an extended Chinese New Year and delayed start of production. As the disease continues to spread across the country, more professionals are questioning reliance on China for production of critical drugs.
Today, it’s unclear just how much we depend on China. So far, the FDA has reported that the number of Chinese facilities licensed to produce APIs is 13% (compared to 28% domestically), but that number provides no insight into whether they’re producing the drugs, how much they’re producing or where the drugs are being distributed, notes FiercePharma.
The agency has suggested advanced manufacturing technologies (such as continuous manufacturing and 3D printing) as an approach to improve U.S.-based production, but they can’t force drug manufacturers to move away from the century-old method of batch production toward more modern methods.
FDA Taking Action
Since the end of January, the FDA has been in contact with over 180 drug manufacturers to remind them of their legal obligation to notify the agency of anticipated disruptions, but also to urge them to evaluate their entire supply chain, including main ingredients that are manufactured in China. The agency also has identified about 20 drugs whose active ingredients or finished drug products are sourced directly from China, and has been in contact with those firms to assess COVID-related shortage risks.
In addition, the president of the United States’ budget includes three, drug-related proposals to support the agency in addressing product shortages:
lengthening expiration dates on critical drugs to the longest possible date that is scientifically justifiable
improving critical infrastructure through risk management plans that would identify supply chain vulnerabilities and enable the agency to strengthen the supply chain by creating contingencies for emergency situations
improving critical infrastructure by empowering the FDA to require access to information needed to assess infrastructure, and manufacturing quality and capacity
The FDA is keeping updated information about actions being taken around drug shortages, healthcare supply chain management and more on the U.S. FDA COVID-19 information page.