Drug Manufacturers Must Increase Transparency During Pandemic

AS MEDICAL PROFESSIONALS BRACE FOR DRUG SHORTAGES because of coronavirus disease 2019 (COVID-19) and interrupted manufacturing, experts say that a lack of transparency from drugmakers contributes to the problem.

The COVID-19 pandemic has interrupted supply chains across the world, leading to a range of shortages, including of personal protective equipment and potential treatments for the virus. Generic drug shortages will occur soon, according Dan Kistner, group senior vice president of pharmacy solutions at Vizient Inc, a health care performance company in Irving, Texas.

Although it is well known that 13% of active pharmaceutical ingredients (APIs) are manufactured in China, the key percentage is the volume of products coming out of China, but that figure is unknown, according to Kistner. The plants’ exact locations also are unclear, which impedes the ability to know which drugs will be in shortage during the pandemic, though generics are likely candidates, he said.

Because they have sole manufacturers, branded drugs have more robust contingency plans, Kistner explained. It is typically assumed that generic drugs have a backup supply with the other manufacturers, but those safeguards can fail during a crisis, he said.

Potential shortages likely will affect not only drugs touted as potential COVID-19 treatments, such as azithromycin and hydroxychloroquine, but also common medications, such as antibiotics, insulin, and intravenous (IV) solutions. “You can’t just think about the shortages of COVID-19 potential therapies,” Kistner said. “There are patients in your hospital [who] are going to be on IV antibiotics, IV opioids—drugs like that are so important.”

Ronald Piervincenzi, chief executive officer of the US Pharmacopeia in Rockville, Maryland, a nonprofit organization that sets medication quality standards, echoes the concern regarding generic drug shortages. “I think that we’ll probably see more acute issues on the generic side than the branded side. I think the risk is higher overall,” he said. “It’s not a risk; it’s gone beyond risk,” he said. “We will have shortages.”

Piervincenzi also reiterated that transparency presents a major issue and compared the situation to Hurricane Maria, which hit Puerto Rico in 2017. Major shortages of sterile products such as IV solutions occurred because they were largely manufactured in Puerto Rico. “[COVID-19] is sort of a hurricane hitting the whole world, not quite at the same time but over the course of a few months,” Piervincenzi said.

Taking certain steps could help prevent similar shortages during future global crises, he said. For example, the language of pending legislation requires manufacturers to disclose where their APIs are made. In addition, The FDA has some power to collect information regarding shortages, but those disclosures are all voluntary, he said.

Countries’ first reaction to global shortages is to begin making their own medications without relying on other countries for manufacturing, but this is not realistic, Piervincenzi said. “It’s ridiculously impossible,” he said. “It would be counterproductive and horribly expensive.”

Implementing global risk-mitigation strategies and working with other governments to build capacity and ensure high quality is the best way to prevent future shortages, according to Piervincenzi.

Meanwhile, as the United States come to grips with COVID-19 and its effects, Vizient has worked with the White House to present several recommendations for dealing with the pandemic, Kistner said. Two core principles involve bringing products to market faster and increasing transparency, which Kistner said is already being implemented by the Drug Enforcement Administration and the FDA.

Other recommendations include prioritizing FDA approval of pending applications for essential medications and API sources, expediting FDA action at manufacturing locations, and temporarily suspending exclusivity for sole sources of essential drugs that are in short supply.¹

Changing how global supply chains and manufacturers operate will be necessary to prevent future shortages, Kistner said: “It’s one thing to have a drug that’s short, but we need to have a call to action.”

REFERENCE

Vizient shares supply strategy recommendations to the administration for personal protective equipment and pharmaceuticals during COVID-19 crisis. News release. Vizient Inc. March 19, 2020. Accessed March 26, 2020. https://www.businesswire.com/news/ home/20200319005068/en/