The American Society of Health-System Pharmacists (ASHP) expresses its deepest sympathy to those affected by the use of contaminated methylprednisolone acetate injection compounded by New England Compounding Center. ASHP extends its condolences to the families and friends whose loved ones died as a result of this tragedy and expresses its concern for patients who contracted meningitis from the contaminated drug product as well as patients who received the contaminated product.
ASHP is the national professional organization whose nearly 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. ASHP is also the leader in the development of quality assurance guidelines on sterile compounding.
ASHP is working with federal and state officials, our members, media, and other stakeholder groups to help remove contaminated product from the supply chain, and to help identify the root causes of this serious public health event in order to stop the spread of infection and to prevent something of this nature from ever happening again.
Pharmacists who work in hospitals and health systems routinely compound medications in response to a prescription from a physician or other prescriber, and they sometimes may choose to work with an outside compounding pharmacy to prepare some of those sterile products. Hospitals and health systems are accredited by quality improvement organizations such as The Joint Commission, and they often have other types of accreditation and certification to ensure patient safety and quality. Hospitals and health systems also follow United States Pharmacopeia Chapter <797> standards for sterile compounding, which include extensive requirements to help ensure the quality of compounded sterile products.
ASHP believes that any entity that manufactures medications without a prescription should be registered with the United States Food and Drug Administration as a manufacturer and subject to strict federal oversight, including routine inspections.
ASHP strongly encourages pharmacists, physicians, healthcare organizations, and any other entity or provider who receives products from a compounding pharmacy to carefully review ASHP’s longstanding Guidelines on Outsourcing Sterile Compounding Services , complete the ASHP Foundation’s Outsourcing Sterile Products Preparation: Contractor Assessment, and review ASHP’s policies on Accreditation of Compounding Facilities, Compounding by Health Professionals , and Safe and Effective Extemporaneous Compounding.
ASHP will continue to work with and convene key stakeholders to help prevent a tragic and unfortunate event like this from happening again. For more information on ASHP efforts on this subject please visit our website www.ashp.org, or call us at 301-664-8799.
Updated: October 22, 2012