Congress Passes Brown Provisions 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 Provision Gives Hospital Systems Flexibility to Best Treat Patients

WASHINGTON, D.C. — U.S. Sen. Sherrod Brown (D-OH) released the following statement after Congress passed his legislation that would allow hospital systems to tackle drug shortages, treat more patients, and save more lives. Brown’s provision, which was conceived at a roundtable Brown held at OSU in January, is aimed at addressing shortages of critical cancer drugs and other lifesaving medications. It was included in a larger bill passed by Congress, the Prescription Drug User Fee Act (PDUFA). The PDUFA legislation also includes major provisions from a second Brown-sponsored bill, 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. The House passed PDUFA last week, and the Senate approved the bill yesterday.

“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. Earlier this year, 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. Soon, hospital systems in Ohio will be able 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.

“Congress 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 Food and Drug Administration (FDA) lacks the authority to compel pharmaceutical manufacturers to ramp up production during a drug shortage. That’s why the Preserving Access to Life-Saving Medications Act, which was included in the law passed by Congress, is so important. It would trigger an alert to the FDA before a potential drug shortage occurs, so that the FDA can work with the industry to prevent it. That way, doctors and healthcare staff around the country can focus on treating life-threatening illnesses,” Brown continued.

While larger hospital systems often have enough medications to treat their patients, federal law often prevents them from easily dividing and distributing them among their affiliated hospitals. The lack of guidance from the FDA prevented hospital systems from dividing a larger vial of medication for redistribution among its hospitals—only allowing it within a single building—which is a significant obstacle at a time of record-high drug shortages for many life-saving medications. Brown’s legislation allows hospitals to “repackage” larger doses of life-saving medications into multiple doses that can be used throughout the hospital system.

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 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.         

   

###

Press Contact

202 - 224 - 3978