Twenty provider organizations are throwing their weight toward the proposed Food and Drug Administration Safety and Innovation Act to help combat what experts are saying is the worst drug shortage in American history.
The groups representing hospitals, clinicians and patient advocacy groups, including the American Hospital Association and the Children's Hospital Association, submitted their recommendations to the House and Senate Friday regarding the bill (S. 3187/H.R. 5651), which the Senate passed last month.
Sponsored by Sen. Michael Enzi (R-Wy.), the proposed legislation expands the Food and Drug Administration's oversight of drugs, as well as medical devices and biologicals.
Hospitals are deeply concerned about more and persistent drug shortages, particularly drugs used in surgery and emergency medicine and cancer and blood treatment.
Almost 100 percent of hospitals reported a shortage in the past six months, according to an AHA survey last spring. More than 90 percent of hospitals reported shortages in surgery or anesthesia drugs and emergency care drugs, and two-thirds reported shortages of chemotherapy drugs.
"[The drug shortages] have serious consequences for patient safety, quality of care and access to therapies," Roslyne Schulman, AHA director of policy development, told FierceHealthcare in an emailed statement.
Eighty-two percent of hospitals have had to delay treatment, and 69 percent of hospitals said patients got a less effective drug as a result of shortages.
"Drug shortages lead to delays in treatment and force the use of alternative drugs with which the provider may not be as familiar," Schulman said. In addition, using unfamiliar drugs can mean unexpected side effects for patients.
The AHA, therefore, supports hospitals and nonhospital providers repackaging non-controlled drugs in short supply within the same health system. For example, hospitals might conserve and extend existing supplies of drugs by transferring a drug from a larger container into a smaller ready-to-use container, such as a syringe. Current FDA regulations only allow hospitals to repackage drugs for use within the same building, but under the House drug user fee reauthorization legislation, other hospitals in the system could share the short-supply drugs, Schulman explained. "This would provide an immediate solution for hospitals and health systems struggling to manage drug shortages in the near term," she said.
The repackaging work-around solution, however, draws questions about contamination and infection. Nevertheless, Schulman noted that it must be done in compliance with state pharmacy regulation and consistent with national standards, such as USP 797--the far-reaching regulation that requires sterile compounding procedures to avoid contamination and infection.
For more information:
- see the bill text and its status
- here's the letter (.pdf) to the House and the letter (.pdf) to the Senate
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