Patients and health care providers who rely on medicines to treat everything from asthma to ADHD to cancer may have had a harder time finding medicines last year than in years past, it was announced Wednesday. A new Senate report reveals
By the end of 2022, 295 drug shortages have been recorded over the five-year period. But while the COVID-19 pandemic may have heightened the challenge of drug access, the problem is not new, the report said.
Erin Fox, a pharmacist and professor of pharmacy at the University of Utah, has been tracking drug shortages since 2001.
Her team found a wealth of drugs in short supply, most notably generic injectables used in hospitals, including anesthetics, some steroids and old chemotherapy drugs. The Senate report highlights various shortfalls, notably vincristine, an important adult and pediatric chemotherapy drug used to treat many types of cancer without alternative treatments, and immunotherapy. A shortage of Bacillus Calmette Guerin (BCG), a biologic, is noted.It is used to treat bladder cancer.
“Due to shortages, patients and hospitals are unable to access the most basic and essential prescription medications on a daily basis,” Fox will tell the Senate Homeland Committee.
She will tell ABC News the challenges of providing care in an environment where shortages are the norm, citing research showing that when providers face shortages, they have adverse outcomes for patients. He said there is
“Shortages are detrimental to patients, health professionals, and the healthcare system. Entire generations of clinicians have never practiced when there were no shortages,” Fox tells the committee.
Peters, chairman of the committee, began investigating drug shortages in 2019 before COVID-19 increased scrutiny of the issue. Since his 2019 report, shortages have increased as the United States relies on overseas providers for some active pharmaceutical ingredients needed to give medicines the desired effect. That dependency became a significant weakness for the United States during the pandemic, when some foreign countries placed restrictions on pharmaceutical exports.
Michigan Democrats said, “Continued over-reliance on foreign suppliers for key ingredients needed to make critical pharmaceuticals, primarily those from China, poses an unacceptable national security risk. continue to be,’ he would argue.
According to a new report, nearly 80% of the manufacturing facilities that make active pharmaceutical ingredients (the key ingredients that give a drug its intended effect) are located outside the United States, and many China-based manufacturers are registered with the FDA. I’m here. That’s more than double the number from 2010 to 2015.
Outsourcing production to India and China means the US is vulnerable to global catastrophes and the whims of market forces. If the U.S. faces another pandemic or global crisis, major pharmaceuticals could face even more serious supply chain problems.
The report also points to blind spots in the ability of the Food and Drug Administration and other US regulators to monitor or address shortages.
Under current law, manufacturers are not required to report increased demand or export restrictions on drugs to the FDA, making it difficult for regulators to predict sharp increases in shortages. In the report, the Senate Homeland Committee recommends that Congress implement changes to these rules.
FDA also does not have a list of life-support drugs and life-support drugs, so it cannot assess the number of drugs that have a limited number of manufacturers or rely on only one supplier for manufacturing. you can’t.
“The federal government’s inability to comprehensively assess the vulnerabilities of the U.S. pharmaceutical supply chain and address known causes of critical drug shortages is critical to predicting drug shortages and effectively assessing their impact on patient care. It continues to frustrate efforts to mitigate the effects of the virus,” the report said.
It is not yet clear what actions Congress can take to strengthen supply chains for critical medicines.
The commission’s report recommends that the federal government make new investments in domestic manufacturing of key drugs that are regularly in short supply. After Congress ruled last year that reliance on foreign-made microchips used to power automobiles, computers, and other technology poses a national security risk, similar measures have been taken in other areas. A tip that took action.
It’s not clear if a similar effort targeting pharmaceuticals will gain momentum in Congress.