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The shortages highlight heavy US dependence on bulk drug ingredients.
Esther Choo, MD, MPH
The original article, “Calls for Action on Dwindling Medication Supplies for COVID-19,” was published on ContagionLive.
Coronavirus disease 2019 (COVID-19) has led to a shortage of medical supplies, from personal protective equipment to medication—including the agents needed by patients on mechanical ventilation. The lack of necessities is spurring calls to address inadequacies in the medication manufacturing supply chain.
There is a range of shortages and frustrated efforts by providers to secure adequate supplies, according to a report in the Washington Post. The report also examines problematic aspects of sourcing medication ingredients from regions which are affected by the global pandemic.
"The shortages highlight heavy US dependence on bulk drug ingredients and finished medicines manufactured in China, India and Europe, medical experts say, as well as the FDA's [US Food and Drug Administration’s] limited ability to monitor global supply chains, creating vulnerabilities for the health system in a time of crisis," the report states.
The conditions underlying these medication shortages must be immediately addressed with several specific measures, declares Esther Choo, MD, MPH, Department of Emergency Medicine, Oregon Health and Science University, Portland OR, and Vincent Rajkumar, MD, Division of Hematology, Mayo Clinic, Rochester, MN, in the Mayo Clinic Proceedings.
"We are exceeding capacity in terms of our vital medication supply," Choo and Rajkumar state. "The usual supply chains, mechanisms, and administrative processes are inadequate for this crisis."
Choo and Rajkumar call on the FDA to revamp regulatory procedures and accelerate approval processes. They recommend that the FDA institutes a 24-hour turnaround for approving the importation of generic drugs from established manufacturers that are now in short supply. Alternatively, the agency could also grant immediate reciprocal approval for selected generic drugs manufactured in other countries, they suggest.
"Not having access to a drug must be considered far worse for the public the agency is charged to protect than any safety concerns that arise with the use of a generic drug that is made by an established manufacturer hitherto not authorized to sell in the United States," Choo and Rajkumar insist.
In addition, they recommend that the federal government work with major brand name and generic pharmaceutical companies to increase the output of the approved drugs which are now in short supply, as it has prompted General Motors to repurpose factories to make ventilators.
Choo and Rajkumar also call for direct funding to non-profit generic drug manufacturers, such as Civica Rx.
"Although it will take time to set up, government manufacturing of essential drugs is something we have to consider long term because generic drugs with small profit margins are unattractive to for-profit companies despite critical need," they explain.
They offer an additional recommendation, which corresponds with one voiced by Peter Navarro, the principal adviser on trade in the White House: to increase domestic manufacturing of the active chemical ingredients that are now principally manufactured in China.
"This pandemic reminds us of the importance of having back-up manufacturing within the United States, supported by taxpayer funds if needed," Choo and Rajkumar indicate.
Choo and Rajkumar also call for the federal government to mobilize distribution of critical medications from stockpiled supplies. For hospital-use medications, it is particularly important for the government to establish a centralized system to track need based on patient caseload, they point out.
Their final recommendations relate to controlling costs. Choo and Rajkumar note the dramatic increases in prices that have accompanied shortages of basic supplies such as hand sanitizers and personal protective equipment. An alternative to allowing an open market when there is broken supply and overwhelming demand of critical medicine is to institute a "Netflix" option, they propose.
"We must pursue contracts with manufacturers, especially for new antiviral drugs and vaccines, for a 'Netflix' option, in which they receive a fixed reimbursement for an unlimited supply."
Additional cost containment measures they offer include: broadening of Medicare eligibility, with its great capacity for cost negotiation; eliminating the deductibles and rebates that can fuel pharmacy benefit manager selection of more expensive treatment options and disproportionately affect the uninsured; and, as a possible last resort, issue compulsory licensing to alternative manufacturers when a company fails to provide critical medication at reasonable price.
"The fragility of the complex medication supply chain was not created overnight, and yet we must overcome its limitations rapidly and decisively," Choo and Rajkumar urge. "And we must act before it is too late."