U.S. Rep. John Carney announced HR 3839—The Drug Shortage Prevention Act—designed to address prescription drug shortages, on Jan. 31 at Christiana Care’s Helen F. Graham Cancer Center.
Nicholas Petrelli, M.D., Bank of America endowed medical director of the Helen F. Graham Cancer Center, Stephen Grubbs, M.D., a practicing oncologist and the managing partner of Medical Oncology Hematology Consultants, P.A., located at the Graham Cancer Center, as well as Terri Corbo, vice president of Christiana Care Pharmacy Services, joined Carney at the press conference.
“Since 2005, the number of drug shortages in the United States has quadrupled, and cancer patients have been disproportionately impacted by this troubling trend,” Carney said. “We must ensure that Americans have access to the critical drugs they need to stay healthy and fight back against deadly diseases. The Drug Shortage Prevention Act brings more efficiency to the manufacturing and distribution processes and requires the FDA to take action to prevent drug shortage problems before they begin impacting patients.”
Carney addressed a packed auditorium of oncologists, pharmacists, nurses and social workers at the Helen F. Graham Cancer Center. State dignitaries such as Rita Landgraf, secretary of the Delaware Department of Health and Social Services, and Bettina Riveros, chair of the Delaware Health Care Commission, also were on hand.
Carney’s legislation mandates an expedited review of drugs vulnerable to shortage in order to prevent shortages in the first place. The bill, which is co-sponsored by Rep. Larry Bucshon (R-IN), also requires the FDA to use a more refined regulatory process that addresses manufacturing problems without instigating drug shortages. The bill streamlines communications between the FDA, manufacturers, distributors, providers and patients to ensure that all parties have the information they need to act proactively to prevent shortages from occurring. The Drug Shortage Prevention Act is endorsed by The American Society of Clinical Oncology, the American Society for Parenteral and Enteral Nutrition, AstraZeneca, and the Hematology/Oncology Pharmacy Association.
“My colleagues and their patients face major issues with prescription drug shortages, not only here in the state of Delaware, but across the United States,” said Dr. Petrelli. “My major concern is for the drug shortages that my colleagues have for their patients. In my experience, John Carney has made health care one of his top priorities and has helped us move forward with some major results.”
Six years ago, there were 61 different drug shortages. Last year, there were more than 230. Cancer, anesthesia and nutrition medicines, which are delivered intravenously rather than in pill form and have a complex, time-consuming, and highly precise manufacturing process, are overwhelmingly affected by these shortages.
“With one drug we even have had to figure out a rationing system,” added Dr. Grubbs. “We’ve been finding ways to get through this challenge, but it has been a struggle.”
Many of these drugs have only one or two manufacturers in the market, so when a manufacturing problem occurs, it can quickly cause a shortage.
“Inadequate medication supplies force the use of alternate medication that can increase the risk of side effects and sometimes is not as effective,” said Terri Corbo, vice president of Christiana Care Pharmacy Services. “The potential risk to patients, whether direct or indirect, is significant.”
Photo gallery: Drug Shortage Prevention Act press conference
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