The tornado that ripped through a major Pfizer pharmaceutical plant in North Carolina on Wednesday “almost completely destroyed” the plant’s warehouse, which stored raw materials, packaging supplies and finished medications awaiting release to hospitals across the United States, Pfizer CEO Albert Bourla said during a press conference on Friday.
The company is working with the Food and Drug Administration, which on Friday said it was still trying to gauge the impact the natural disaster could have on the nation’s drug supply. The plant, based in Rocky Mount, North Carolina, made about 150 medicines, many of which are used by hospitals, including fentanyl and morphine for pain management, and anesthetics for surgery. Half of the drugs made at the facility are on the FDA’s essential medicines list, according to the United States Pharmacopeia, a group that tracks drug supply chains.
A review from USP released Friday found many of the medications were already at risk of a shortage before the tornado occurred.
The Pfizer plant is “obviously an important contributor to the U.S. supply chain,” said Vimala Raghavendran, vice president of informatics product development at the organization.
Assessing the damage will be difficult, according to Pfizer, as only a small number of people have limited access to the facility due to hazards still present from the tornado.
“We are watching the situation closely as it evolves,” Chanapa Tantibanchachai, an FDA spokesperson, said in an email.
Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said that damage to warehouses storing supplies and finished products would be likely easier to recover from, by ramping up production again.
Repairing or replacing equipment to make the drugs would be a more challenging and slower process, he added.
Bourla said that the production facility didn’t suffer any damage. Still, he said, the company is exploring alternative manufacturing locations.
Pfizer said in a statement that it is moving what it can to nearby sites for storage. The facility will remain closed while the damage continues to be assessed.
The Pfizer Rocky Mount facility produces nearly 25% of the drugmaker’s sterile injectables drugs used in hospitals in the U.S. and is one of the largest facilities for these drugs in the world, according to the drugmaker’s website. Sterile injectable drugs refer to any medications that are injected, either intravenously or as a shot, and are free from contamination.
Among the drugs made at the facility are anesthetics used to sedate patients during surgery and intubation, including propofol and etomidate, said Mittal Sutaria, senior vice president for pharmacy contract and program services for Vizient, a group dedicated to preventing drug shortages.
The facility also makes analgesics for pain management; powerful antibiotics such as vancomycin; and neuromuscular blockers such as cisatracurium and succinylcholine, which are used during surgical procedures, Sutaria said.
The natural disaster comes as the nation’s supply of drugs is already strained. As of the end of June, there were 309 active drug shortages in the U.S., the most in nearly a decade, according to the ASHP.
Problems at Pfizer’s plant have the potential to tip the U.S. past 320 active drug shortages, the highest ever reported, Ganio said. “I am absolutely concerned,” he said.
It would mean more patients are unable to get access to the medications they need.
“We are working with distributors to request they immediately implement proactive management of any product anticipated to be affected to help minimize additional strain to the supply chain,” Sutaria, of Vizient, said.
The last time a natural disaster caused a critical shortage of drugs in the U.S. was in 2017, after Hurricane Maria battered a Baxter manufacturing plant in Puerto Rico, which cut into the supply of amino acids used to feed sick patients, and saline solution, which is used to administer IV drugs.
It took close to a year before the shortages from Hurricane Maria were alleviated, Ganio said.
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Nicole Duarte contributed.
Source: | This article originally belongs to Nbcnews.com
