Drug shortages remain an ongoing public health concern in the U.S. With increases in new shortages, patient care and pharmacy operations are severely impacted. Prior to COVID-19, hospitals were already experiencing shortages of key injectable drugs. However, unprecedented demand due to large numbers of critically ill patients with COVID-19 has worsened drug shortages, says an AMA Council on Science and Public Health report adopted at the November 2020 AMA Special Meeting.
“As the COVID-19 pandemic has illustrated, shortages of critical drugs can have a major impact on patient health. That’s why it’s essential for physicians to have access to the right drugs in order to provide high-quality care for our patients,” said AMA Immediate-Past Board Chair Jesse M. Ehrenfeld, MD, MPH.
“While this pandemic has exposed vulnerabilities in the global medicine supply chain, the AMA remains committed to working with stakeholders to act quickly on solutions that alleviate supply shortages now and in the future,” Dr. Ehrenfeld said.
In 2019, the American Society of Health-System Pharmacists (ASHP) reported 166 new drug shortages. A spike in shortages occurred again in the first quarter of 2020, which developed with the emergence of the COVID-19 pandemic. These shortages were seen in analgesics, sedatives and paralytics because of the need to put many patients with COVID-19 on ventilators.
While advocacy efforts continue to successfully create changes to improve the current situation, more work needs to be done. In response to shortages of some chronic disease medications, the AMA, ASHP and the American Pharmacists Association created a joint statement on ordering, prescribing or dispensing COVID-19 medications.
Additionally, says the council’s report, the AMA signed on to a letter to the U.S. Drug Enforcement Administration (DEA) about shortages of injectable Schedule II controlled substances needed for ventilation of patients. The DEA immediately responded, increasing annual production quotas. They also issued two exceptions to regulations for DEA-registered hospitals and clinics to facilitate continuous patient care during changing scenarios, says the council’s report.
The AMA House of Delegates modified existing policy on drug shortages to:
- Urge continued analysis of the root causes of drug shortages that includes consideration of federal actions, evaluation of manufacturer, group purchasing organization (GPO) and distributor practices, contracting practices by market participants on competition, access to drugs, pricing and analysis of economic drivers.
- Urge the FDA to require manufacturers to provide greater transparency regarding the pharmaceutical product supply chain, including production locations of drugs, and provide more detailed information regarding the cause and anticipated duration of drug shortages.
- Support the collection and standardization of pharmaceutical supply chain data in order to determine the data indicators to identify potential supply chain issues, such as drug shortages.
- Encourage global implementation of guidelines related to pharmaceutical product supply chains, quality systems, and management of product lifecycles, as well as expansion of global reporting requirements for indicators of drug shortages.
- Urge drug manufacturers to accelerate the adoption of advanced manufacturing technologies such as continuous pharmaceutical manufacturing.
- Support the concept of creating a rating system to provide information about the quality management maturity, resiliency and redundancy, and shortage mitigation plans, of pharmaceutical manufacturing facilities to increase visibility and transparency and provide incentive to manufacturers.
- Encourage GPOs and purchasers to contractually require manufacturers to disclose their quality rating, when available, on product labeling.