CHA News Article

FDA Announces Action to Relieve Opioid and Other IV Drug Shortages
Commissioner issues statement

As hospitals and health systems continue to experience critical shortages of a number of injectable opioid medications, the Food and Drug Administration (FDA) has announced that health care providers may use certain opioid and other intravenous drug products. The drugs, made by Hospira, were previously on hold due to a potential manufacturing defect. According to the agency, providers should ensure that products used are neither visibly damaged nor contain particulate matter. Though the probability of defect is low, providers should maintain vigilance and share this information with staff responsible for administering these drugs. To report adverse reactions or quality issues, contact Hospira at (800) 438-1985. Detailed instructions are included in the FDA announcement.

Earlier this week, FDA Commissioner Scott Gottlieb, MD, released a statement reiterating the agency’s commitment to resolving the shortage. However, Gottlieb also noted that manufacturers often do not notify the FDA about potential supply disruption, which presents challenges when trying to mitigate short product supply. Gottlieb also said that the administration will continue to do all it can to address the shortages, but that “mitigating drug shortages requires a sustained effort by industry, the FDA, and other partners to return to production levels that adequately meet the needs of patients.”