At OSU Breast Center, Sen. Brown Joins Doctors To Announce New Effort That Will Allow Hospitals To Tackle Drug Shortages, Treat More Patients, And Save Lives

Under Current FDA Regulations, Hospitals Prevented From “Repackaging” Larger Doses of Life-Saving Medications to Treat Multiple Patients Within a Hospital System; Brown’s Legislation, Passed 96-1 Gives Hospital Systems Like the James Cancer Center Flexibility to Best Treat Patients

Idea for Legislation Came From “Drug Shortages Roundtable” Brown Hosted With Pharmacy Directors, Healthcare Workers, and Hospitals at OSU in January


Brown, OSU Internal Medicine Chair Joined by Sharon Brown, Hilliard Breast Cancer Patient Who Experienced Severe Side Effects After Switching Drugs Due to Shortage of Preferred Treatment

COLUMBUS, OH — U.S. Sen. Sherrod Brown (D-OH) and Dr. Michael Grever, chair of the department of internal medicine at the Ohio State University Comprehensive Cancer Center, today announced new legislation passed through the Senate that would allow hospital systems to tackle drug shortages, treat more patients, and save more lives. Brown’s bill, which was conceived at a roundtable Brown held at OSU in January and which passed the Senate last week by a vote of 96-1, is aimed at addressing shortages of critical cancer drugs and other lifesaving medications. Nationwide, a record 267 reported drug shortages occurred last year, with at least 15 deaths attributed to drug shortages.

“When a drug is in short supply, doctors and other healthcare providers are often forced to make tough decisions about how to best treat multiple patients—all in need of a single, hard-to-find drug. In January, right here at the Ohio State University, I met with doctors and pharmacists from all across Ohio, and they all told me the same thing—that they needed better flexibility to tackle drug shortages and treat more patients,” Brown said. “After that roundtable, I came back to Washington and pushed for provisions that would allow our hospitals to do just that. Last week, the Senate passed a provision that would allow hospitals like the James Cancer Center to better adjust to drug shortages by dividing a larger dose for distribution to patients within a hospital system—even if they aren’t in the same building.

“The Senate also passed a provision that would help combat drug shortages in the first place. Right now, pharmaceutical companies are under no obligation to report production problems or decisions that would create shortages, and the U.S. Food and Drug Administration (FDA) lacks the authority to compel pharmaceuticals and manufacturers to ramp up production during a drug shortage. That’s why I pushed the Senate to pass the Preserving Access to Life-Saving Medications Act, which would trigger an alert to the FDA before a possible drug shortage. Patients, doctors, and healthcare staff around the country should be able to focus on fighting and treating cancer—instead of having to worry about whether enough drugs are available for them to do so.”

While hospital systems like the James Cancer Center often have enough medications to treat their patients, federal law often prevents them from easily dividing and distributing them among their affiliated hospitals. Brown and Dr. Grever were joined by Sharon Brown, a Hilliard breast cancer patient who, because of a shortage of medication in her treatment plan, had to take a different drug and experienced severe side-effects that delayed her chemotherapy treatment. Ms. Brown depended on the drug Taxol for her breast cancer treatment, but had to switch to an alternative treatment, called Taxotere, due to a drug shortage. She experienced severe side-effects from Taxotere and was rushed to the emergency room with hand-foot syndrome and throat sores. Treating these side effects delayed her chemotherapy treatments by four weeks.

“Drug shortages of life-saving medications have become a national crisis, one whose resolution has been a top priority for the University. In January, I joined a roundtable with Senator Brown here at the OSU Wexner Center where we examined ways to address drug shortages. As healthcare professionals, my colleagues and I have been too often stymied by FDA guidance that prevented us from being able to effectively treat multiple patients all in need of the same drug. It has become clear that we cannot resolve the issues creating these shortages without the necessary element of government intervention,” Grever said. “I’m pleased that Sen. Brown heard from us at the roundtable and went back to Washington and passed legislation that would give hospital systems and doctors ability the to tackle drug shortages. Outcomes can be fatal for patients with cancer if they can’t get the drug most effective in treating their specific type of disease at the time when they need it. We are thankful to Sen. Brown for his leadership on this issue and for working so effectively to address a problem facing our hospital system and patients.”

Brown’s legislation would allow for the “repackaging” of larger doses of life-saving medications into multiple doses that can be used throughout the hospital system. Currently, the U.S. Food and Drug Administration (FDA) prevents hospital systems from dividing a larger vial of medication for redistribution among its hospitals—only within a single building—which is a significant obstacle at a time of record-high drug shortages for many life-saving medications. The legislation passed by the Senate—the Prescription Drug User Fee Act—also includes legislation cosponsored by Brown, the Preserving Access to Life-Saving Medications Act. This bill would trigger alert of incidents that could result in a drug shortage, and the FDA would be required to provide updates to the public about potential shortages—allowing doctors, pharmacists, and patients to work together to avoid an interruption in care.

According to the Associated Press, as of September 2011, at least 15 deaths in the prior 15 months could be attributed to drug shortages. These deaths were caused either due to the preferred drug being unavailable, problems with the preparation or administration of the alternative medication, or because of dosing errors with the alternative medication. In 2009, 166 drug shortages were reported to the University of Utah’s Drug Information Service—the clearing house for drug shortage reports.  In 2010, a record 211 shortages were reported, and that record was broken again in 2011 with 267 reported shortages.

In January, Brown convened a roundtable discussion in Columbus at the James Cancer Center with hospital CEOs, Directors of Pharmacy, and other hospital staffers who confront this problem from around Ohio—to discuss possible solutions to improve patient outcomes. During the roundtable, more than 40 participants discussed issues their hospitals were facing due to shortages and ideas to fix the problems. The concept for Brown’s legislation was borne out of that roundtable.           


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