Early Warning System for Prescription Drug Shortages

Zosia Chustecka

February 08, 2011

February 8, 2011 — A new initiative that will help address and prevent the ongoing prescription drug shortage in the United States has been announced.

The ongoing shortages — the worst in recent years — affect around 150 drugs that are deemed "medically necessary," including many chemotherapy, anesthetic, and analgesic agents. Oncology has been hit hardest, and the shortages are placing cancer patients at risk, as previously reported by Medscape Medical News.

New legislation, introduced by Sens. Amy Klobuchar (D-Minnesota) and Bob Casey (D-Pennsylvania), will require prescription drug manufacturers to give early notification to the US Food and Drug Administration (FDA) of any incident that would likely result in a drug shortage. These factors might include changes in raw material supplies and manufacturing capability, or certain business decisions such as mergers and acquisitions that could affect output.

"This common-sense solution will help set up an early warning system so that pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible," Sen. Klobuchar said in a statement. Currently, they are often the last to know when an essential drug is no longer available, and "that's not right," she said.

"As we move forward, it is important to have better coordination between the pharmaceutical industry, the FDA, and healthcare providers so patients don't lose access to the medications they depend on," she added.

The American Society of Clinical Oncology (ASCO) was quick to praise the move.

The legislation will give both the FDA and healthcare providers "more advanced notice of shortages so we can better anticipate and manage them," ASCO president-elect Michael Link, MD, said in a statement.

The oncology community is continuing to experience "severe and worsening shortages of many critical drug therapies, which disrupt important medication regimens and may threaten patients' health," Dr. Link added.

Among the cancer drugs in short supply are carboplatin, cisplatin, doxorubicin, etoposide, leucovorin, nitrogen mustard, and vincristine.

"In some of these cases, there are no equivalents, there are no work-arounds," Dr. Link, a pediatric oncologist at the Lucile Packard Children's Hospital at Stanford University, California, told Medscape Medical News in a recent interview.

"This is the most difficult problem here — [there are] drugs that are well known and well established as critical components of standards of care, and [we] know from past trials that not having that drug will result in inferior outcomes," Dr. Link pointed out. This could result in shorter survival times, he added.

Also announcing support for the legislation was the American Society of Health System Pharmacists, describing it as a "critical first step toward addressing the serious public health threat posed by drug shortages."

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