News Release

Inside the Drug Shortages


American patients are currently being affected by shortages of various medicines, including Adderall, pediatric antibiotics and painkillers, as well as critical chemotherapy drugs. 

    Qato is the director of the pharmaceutical health services research graduate program and an associate professor of practice, sciences, and health outcomes research at the School of Pharmacy at the University of Maryland, Baltimore. 

Shortages of critical medications, as well as of sterile products used in hospitals (such as saline bags), are due to a confluence of factors, Qato said. Oftentimes, “the profit margin [of these products] is so minimal” for manufacturers that they have “consolidated,” and “that results in a problem if one manufacturer ends up having a quality problem.” Though much attention has already been paid to the country’s reliance on manufacturers overseas, “this is not just an overseas manufacturing issue. We still have problems with good-quality manufacturing at plants here.”

Earlier this month, U.S. lawmakers introduced legislation to identify the country’s pharmaceutical supply chain weaknesses. The Pharmaceutical Supply Chain Risk Assessment Act “gets at some of the opaqueness of supply chain issues,” Qato said, and could mitigate “inability to actually track the pharmaceutical supply chain from A to Z. There’s zero transparency when it comes to the longitudinal process of a drug going from manufacturer to the market, which makes it difficult to predict and mitigate harm from shortages. Current regulations aren’t strong enough to compel manufacturers to be transparent about the causes of active pharmaceutical ingredient shortages or to give potential timelines to resolve them.”

Less than 15 percent of active pharmaceutical ingredients are produced in the United States. As such, “this legislation refocuses manufacturing to national sites. But the framing is problematic,” Qato added: it posits the U.S.’s reliance on international partners primarily as a national security risk. (Sen. Gary Peters (D-MI), the bill’s co-author, stated that “our over-reliance on foreign nations for critical drugs threatens our military readiness.”)

That being said, “the issue remains,” Qato said. “We are reliant on international partners and manufacturing sites, which we de facto have little oversight over compared to national manufacturing sites.” 

But Qato is also an advocate for several interventions that can be introduced at stages earlier in the manufacturing and distribution process—before shortages occur. “Drug shortages are one part of the conversation, but there are other aspects to it.” Access to medicines is also dictated by the role that the FDA plays in setting targets for production, the discretion that individual pharmacies have around decisions to stock particular medicines, and challenges pharmacies and pharmacists face in communicating with one another about drug supply. Pharmacies lack a consolidated electronic system to communicate about prescriptions, for instance. To transfer prescriptions or help a patient find a drug that they don’t have in stock, pharmacists work on a “1-to-1 basis. That’s taxing in terms of time. There are lots of barriers to answering what might seem like a simple question. Pharmacists are overwhelmed by these responsibilities.” 

Mainstream media may frame the issue as pharmacist burnout, while corporations frame it as a pharmacist shortage. “That’s the greatest lie ever told,” Qato said. “It’s not about burnout, because burnout assumes the workload was okay to begin with. We’re talking about inordinate responsibilities for one pharmacist.” In recent years, pharmacists work with less overlap in shift schedules. “Corporations are not allowing their pharmacists and pharmaceutical technicians to do their work in a safe way. There has been an abdication of responsibility by the corporations to adequately staff and support pharmacists.”

“Access isn’t just about [drug] cost or supply,” Qato said. “It’s also structural.”