Supply Chain Crunch is Creating Drug Shortages – Healthline

Being diagnosed with a life threatening disease is traumatic.
But imagine being diagnosed with a severe illness, and then your doctor tells you that the only treatment is unavailable.
That’s what’s happening right now in the United States for many people who rely on crucial medications.
The disruption in the nation’s supply chain is reportedly creating shortages for several drugs, including those used to treat cancer and COVID-19.
In all, the Food and Drug Administration (FDA) now lists more than 100 medications that are in short supply.
The American Medical Association told CBS News the drug shortage is an “urgent public health crisis” that “threatens patient care and safety.”
The American Society of Health-System Pharmacists noted that three of the top five shortages are drugs used for chemotherapy and heart conditions as well as antibiotics.
One of the medications is tocilizumab, a drug used to treat both COVID-19 and cancer.
A University of Virginia pharmacy manager told CBS News that the college’s medical center has been faced with the prospect of deciding whether their limited supply of tocilizumab should be given to people with cancer or people with COVID-19.
Drug shortages happen more often than you might think, especially when it comes to drugs for cancer treatment.
Two years ago, there was a widespread shortage of vincristine, a chemotherapy treatment for pediatric acute lymphoblastic leukemia, adult non-Hodgkin’s lymphoma, and other cancers.
The shortage was primarily the result of Teva Pharmaceutical’s decision to discontinue its generic version of vincristine in summer 2019.
When Teva opted out, Pfizer became the only company to supply the drug and scaled up production.
But the drug supply issue did not go away overnight.
“The shortage of vincristine was dramatic for our patient population,” Dr. Gwen Nichols, the chief medical officer for the Leukemia & Lymphoma Society, told Healthline.
The shortage was especially hard on pediatric cancer patients.
The drug is part of virtually every childhood cancer therapy regimen, and there are no viable substitutes.
“An earlier shortage of Asparaginase, for which there were no suitable substitutes, also impacted childhood leukemia patients,” Nichols said.
“We were involved in advocating to manufacturers and governmental agencies in that instance – as children’s lives were at stake,” she noted.
The COVID-19 pandemic has made drug shortages an even more pressing issue.
The FDA monitors the medical product supply chain with the expectation that it may be impacted by the pandemic, potentially leading to supply disruptions or shortages.
One of the reasons for this is that more than 80 percent of active pharmaceutical ingredients are produced overseas.
Shortages can occur for multiple reasons, including compliance with good manufacturing practices, regulatory delay, shortage of an active ingredient or inactive ingredient component, delay in shipping, and demand increase for the drug.
Some hospitals are struggling to keep up with demand, while others remain well-stocked.
A study from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting looked at the significant prevalence of oncology drug shortages and how they can hinder care for people with cancer.
The study noted that the top five oncology drugs on shortage are epirubicin, flutamide, decitabine, mechlorethamine, and dactinomycin.
Dr. Melissa S. Dillmon, FASCO, an oncologist and past chair of the government relations committee at ASCO, said one of the most recent and most alarming drug shortages is Abraxane.
“It’s a chemotherapy that is used to treat breast cancer, pancreatic cancer, and lung cancer,” Dillmon told Healthline. “It is well tolerated, with fewer side effects. Without warning, there was a nationwide shortage.”
Over the past few weeks, a manufacturer’s shortage of Abraxene forced some Alaska chemotherapy patients to postpone lifesaving treatment.
Jeremy Kahn, a press officer with the FDA, told Healthline that the agency is “committed to working with our public health partners, manufacturers, and distributors to help mitigate shortages.”
But according to Nichols, solving this problem will require a multi-pronged approach.
“The government needs to not only keep a list of drugs that are in shortage or at risk of shortage, but come up with planning for encouraging manufacturing, which is really important for drugs which are no longer on patent,” she said.
It is also essential to understand which critical drugs are made by only one manufacturer, Nichols said.
“We also need to be clear about which drugs are critical — the ones with no alternatives, lifesaving regimens, etc.,” she said. “Hopefully, some of what we’ve learned about the fragility of the supply chain during COVID will help us think creatively about assuring that people don’t lose the chance at access to the agents they need.”
Nichols said this could be with incentives or keeping a national supply.
“It needs to be proactive,” she said, “rather than the current reactive situation we often find ourselves in.”
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