The already-fragile U.S. supply chain for medicines used in hospitals got another jolt last week when a category EF-3 tornado ripped through a Pfizer facility in North Carolina. Although the impact on the health care system is still unclear, it should be (yet another) wake-up call that the U.S. needs to fix its long-standing problem of drug shortages.
A Pfizer pharmaceutical factory after a tornado damaged the facility. Travis Long/The News & Observer via AP
Many ideas have been thrown around to address shortages, which this year hit their highest level in nearly a decade. One that should stick: creating a government-funded reserve of vital medicines that can be equitably distributed if supplies of a drug are weakened by an unexpected event – like a generic company shutting down or a natural disaster striking a vital plant like Pfizer’s.
Unlike sites that make the ingredients in our medicines or press them into tablets, Pfizer’s Rocky Mount site puts drugs into the vials and syringes typically used at hospitals. The Food and Drug Administration’s rules governing this “fill and finish” work are among the agency’s most stringent.
According to Pfizer, the Rocky Mount manufacturing site makes about 25% of the sterile injectables used at U.S. hospitals. Although the company has not provided details about specific drugs affected, a report from The New York Times suggested the drugs produced at the site include the sedative propofol, the painkillers fentanyl and morphine and the antibiotic vancomycin.
Local news reports suggested some 50,000 pallets of medicine were strewn about in the aftermath of the twister. Pfizer hasn’t confirmed that claim, but on Friday offered an initial assessment of the storm’s impact, saying most of the damage was to its warehouse and medicine production lines appear secure.
Depending on what was in that building, the volume of lost product could represent something like three to four months’ worth of work, says James Bruno, who consults for pharmaceutical manufacturers.
The tornado struck the Pfizer site at a particularly bad moment in the pharmaceutical supply chain for hospital drugs. Shortages for older but vital chemotherapies and injectable forms of antibiotics are already forcing doctors to prioritize some patients over others. Unsurprisingly, “we don’t have a whole lot of capacity for an emergency,” says Bruno.
And while the lost medicine is the biggest problem, Bruno notes that the loss of more mundane items – the boxes and cartons the drugs are packaged in – could also end up hurting patients.
Nevertheless, a behemoth like Pfizer is in the best possible position to shift production around to other sites. It has the resources to rebuild as quickly as possible. A smaller generic drug manufacturer operating at razor-thin margins might not be able to recover from such a disaster, which could make healing the supply chain more difficult – particularly if it was one of the only or the only company to make a certain drug.
The next natural disaster – whether that’s a tornado, a wildfire or a hurricane – might be different. And with climate change intensifying the severity and frequency of storms, we know there will be a next time.
Even in the best-case scenario for the Pfizer plant – where the warehouse is damaged but the manufacturing lines are intact – the damage to the facility could still cause problems if it spurs hospitals to start hoarding drugs. That could cause existing shortages to linger or worsen, and even create other tightness in the market, says Erin Fox, associate chief pharmacy officer at the University of Utah Health.
Hospital systems that are anxiously watching the Pfizer news and have the resources “are right now probably buying and hoarding whatever they can because they can,” Fox says. But that will make things harder for patients at smaller or poorer hospitals. “Not every hospital has people that can stay on the phone all day long and try to buy as much as they can of whatever they can get their hands on.”
Some players in the supply chain are working on solutions – to both the shortages themselves and to the behaviors that can exacerbate them. Several hospital systems banded together to fund the nonprofit CivicaRx, which provides them with a secure stream of drugs from quality suppliers. But that approach, while welcome, doesn’t cover every drug or every patient.
A more equitable strategy was recently put forth by the Brookings Institution: a government-backed inventory for certain vulnerable products. Those could include medicines like older cancer drugs, for which there are “no substitutes, those whose unavailability leads to immediate and significant adverse health outcomes, and those for which supply chains are vulnerable.”
That’s an approach worth pursuing. As the authors note, the social costs of shortages can be so high that government investment in a buffer “is likely socially efficient.”
How many more painful reminders of the fragility of the drug supply chain do we need to make the changes to fix it?
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