The Preserving Access to Life-Saving Medications Act Would Trigger Alert of Incidents that Could Likely Result in a Drug Shortage
Last Month, Brown Convened Roundtable Discussion with Hospital Officials from Around Ohio to Seek Solutions to Address an Uptick in Drug Shortages, Improve Patient Outcomes, and Combat Counterfeit Drugs
TOLEDO, OH – With cancer patients facing delayed treatment or denied life-saving medications altogether due to drug shortages, U.S. Sen. Sherrod Brown (D-OH) joined Joanne Schwartzberg, a Northwest Ohio lung cancer patient, to outline a bill to address drug shortages at the University of Toledo Medical Center. Schwartzberg is a former Registered Nurse who has had to change chemotherapy drugs twice—she is now on her third treatment—as a result of drug shortages.
“Joanne Schwartzberg’s story should be unimaginable, yet it’s one we see in hospitals and health care systems across Ohio and the country. When a drug is in short supply, a doctor or pharmacist can’t give a patient what he or she needs. It happens to adults and it happens to children—and it’s unacceptable,” Brown said. “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 pharmaceuticals and manufacturers to ramp up production during a drug shortage. That’s why I cosponsored the Preserving Access to Life-Saving Medications Act, which would trigger an alert to the FDA before a possible drug shortage. Joanne and patients around the country should be fighting cancer—and not worried whether there’s enough medicine to help them get better.”
At the news conference, Brown called on the Senate to pass the Preserving Access to Life-Saving Medications Act (S. 296), legislation he has cosponsored which would trigger alert of incidents that could result in a drug shortage. 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. Russ Smith, Director of Pharmacy at UTMC, along with Dr. Roland Skeel, from the UTMC Department of Medicine, Hematology and Oncology, joined Brown to highlight how record drug shortages have forced hospitals and clinics to prescribe medicines that are less effective or may cause side effects.
“Every week I get a report from our chemotherapy infusion nurses about which critical drugs are in short supply or totally unavailable. This not only challenges us as physicians to come up with an acceptable substitute, but also places an unneeded burden on the patient with cancer, who is already faced with the physical and emotional consequences of their disease and the side effects of treatment and the unimaginably high cost of the chemotherapy drugs,” Skeel said. “It is easy to understand how frightening and frustrating it is for our patients to learn in the middle of their treatment course that the medications they were told were the best treatment for their cancer must now be changed because one or more of their drugs could not be obtained. Our patients need their government to act, and we are encouraged to have Senator Brown sponsoring legislation to fix this problem.”
“Drug shortages have affected hospitals and patients nationwide. On a daily basis nationwide physicians, pharmacists, and nurses work together to manage these shortages with the available agents to take care of their patients,” Smith said. “The shortage of medications extends beyond medication to treat cancer; common medications to treat hypertension and other life-threatening cardiac conditions are also in short supply. In many circumstances these alternative medications are more expensive, more complex to administer, or have a different side effect profile. The issue has continued to escalate and it has become evident that government intervention is required to help our patients receive the emergency medications they need.”
According to the Associated Press, at least 15 deaths in the past 18 months can be blamed on 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.
Recently, 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. There are a variety of reasons for drug shortages, including:
- The manufacturer experiences quality control issues or production problems
- Issues in the supply chain for raw materials
- Delays in manufacturing or shipping
- Mergers in the pharmaceutical industry – both branded and generic companies
- The pharmaceutical company decides to stop producing the drug (often due to low profit margins)
In 2009, Brown joined cancer survivors, experts, businesses, and insurance companies at a forum on expanding access to cancer clinical trials at the Ohio State University Comprehensive Cancer Center. Following the forum, Brown introduced the Access to Cancer Clinical Trials Act, which was included in the health reform law signed in March 2010.