Patient harm arising from contaminated product supplied by a Texas provider of outsourced sterile products underscores the urgent need for legislation that establishes clear authority and accountability in the oversight of compounding outsourcers, say officials at the American Society of Health-System Pharmacists (ASHP).
Late last week, the Food and Drug Administration (FDA) issued a recall of sterile products supplied by Specialty Compounding in Cedar Park, Texas. The FDA received reports of adverse events experienced by 15 patients in two hospitals. The FDA and the Centers for Disease Control and Prevention (CDC) are working with Texas state officials to investigate the cause of these bacterial infections.
"Our thoughts and prayers go out to the patients affected by this troubling incident,” said ASHP Chief Executive Officer Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. “Patient harm of this sort should never happen. ASHP will continue to push for passage of bipartisan legislation that will close regulatory gaps in the oversight of sterile compounding and ensure that patients are not harmed by the medications that are intended to help them.”
In the Senate, the Pharmaceutical Quality, Security, and Accountability Act (S. 959) creates a new category, "compounding manufacturer," that must register with the FDA. According the legislation, “compounding manufacturers” compound preparations without or in advance of a prescription and offers to sell the drug in interstate commerce.
“We firmly believe that this bipartisan legislation recognizes the shifts in the current environment and provides FDA oversight of a new type of large scale compounder that prepares sterile compounded products as a service to hospitals and other providers who administer them to patients,” said Abramowitz in the Society’s letter
to the bill’s sponsors.
The legislation is designed to prevent another tragedy like the fatal meningitis outbreak last fall caused by tainted sterile products from the New England Compounding Center. Sixty-three deaths and more than 700 cases of meningitis are tied to that incident. “We hope that Congress will quickly pass legislation as we approach the first anniversary of the NECC incident” noted Abramowitz.
ASHP is the national professional organization whose 40,000 members include pharmacists, pharmacy technicians, and pharmacy students who provide patient care services in hospitals, health systems, and ambulatory clinics. For 70 years, the Society has been on the forefront of efforts to improve medication use and enhance patient safety. For more information about the wide array of ASHP activities and the many ways in which pharmacists help people make the best use of medicines, visit ASHP's website, www.ashp.org, or its consumer website, www.safemedication.com.