Drug company Pfizer this week issued a nationwide recall of two batches of naloxone, a drug used to treat opioid overdoses. The manufacturer cited “embedded and loose particulate matter” on the syringe plungers that could cause harmful side effects, according to the Food and Drug Administration.
Pfizer, a drug giant with more than $52 billion in revenues, is number 57 on this year’s Fortune 500 list and the largest of America’s pharmaceutical companies.
The company controls the vast majority of the market for sterile injectable drugs in the U.S., a category that includes naloxone and injectable opioids, of which Pfizer commands a 75% national share. But as Fortune’s Erika Fry reported in a recent feature, Pfizer’s production, for a host of reasons, is not keeping up with demand.
Those reasons have included problems with quality control in the production process. Last year and into 2018, Pfizer’s plant in McPherson, Kan., experienced delays due to manufacturing issues with its Carpuject products, a type of sterile syringe. Those issues followed a 2,500-word FDA warning letter, issued by the agency in February 2017 following an inspection of the McPherson facility. The letter more broadly condemned Pfizer’s “repeated failures at multiple sites” and said that those breakdowns demonstrated that Pfizer’s “oversight and control over the manufacture of drugs is inadequate.”
According to Pfizer customer documents, the company’s supply of naloxone pre-filled syringes were depleted prior to this week’s recall. In early May, the company estimated supply would be fully replenished in June 2019. (Pfizer has two other preparations of naloxone that were available.)
Shortages caused by these sorts of supply chain issues affect products like naloxone — a drug so integral to saving people from overdosing amid the opioid crisis that U.S. Surgeon General Jerome Adams has recommended more Americans carry it with them. They also have an impact on drugs like bupivacaine, an anesthetic administered to mothers in labor, and medical staples like epinephrine, morphine, and sterile water.
These sterile injectable drugs are the bread and butter of modern medical care, and health workers across the country are facing shortages more and more frequently.
“Our primary responsibility is taking care of patients,” Debbie Simonson, VP of pharmacy services at Ochsner Health System in Louisiana, told Fortune. “That becomes a challenge when we’re making sure we can get a drug to take care of them.”
Pfizer alone had 370 products that were depleted or in limited supply as of May 11, 102 of which it estimated would not be available until 2019, according to the company.
But drug shortages are a problem for other manufacturers as well. At the end of last year, 202 medicines faced shortages, and experts point out that many of the drugs currently in short supply do not have good alternatives. This leaves healthcare providers in a difficult position.
“We need to ask, ‘What does this look like when we’re taking care of patients? How are all these hospitals dealing with it?’” Chris Snyder, a Cleveland Clinic drug shortage specialist, told Fry. “Nobody wants to look behind that curtain.”