October 13, 2015
ASA Pushes for Appropriate Vial Sizes at Pew Roundtable
On October 8 and 9, ASA leaders presented at a Pew Charitable Trusts roundtable on the need for appropriately sized vials and pre-filled syringes as mechanisms to address shortages of anesthesia drugs. The “2015 Pharmaceutical Compounding Roundtable: How Can Outsourcing Facilities Meet Provider Needs taking place at The Pew Charitable Trusts?”, hosted by the Pew Charitable Trusts and the American Society of Health-System Pharmacists (ASHP), brought together practitioners that routinely need sterile compounded or repackaged drugs to treat patients with outsourcing facilities – a new category of FDA-regulated drug compounders created by Congress in 2013 that are subject to good manufacturing practices. The roundtable focused on three therapeutic areas: anesthesiology, pain management, and ophthalmology.
ASA Vice President of Scientific Affairs Beverly Philip, M.D., presented on compounded drugs needed in anesthesiology, highlighting the need for appropriately sized vials and pre-filled syringes to address waste in anesthesia drugs. Other ASA members that contributed to the Roundtable included Steven Gayer, M.D., M.B.A., Chair of the Committee on Ambulatory Surgical Care; Ed Michna, M.D., a member of the Committees on Professional Liability and Expert Witness Testimony Review; and Usman Latif, M.D., M.B.A.
The goals of the roundtable were to:
• Advance provider awareness of products and services available from FDA-regulated outsourcing facilities, as well as outsourcing facility awareness of compounded or repackaged drug supplies needed by practitioners.
• Identify and understand barriers to outsourcing facilities producing compounded or repackaged products for use by practitioners, and facilitate discussion on ways to overcome these barriers.
• Identify actions that stakeholders can take to help ensure reliable supplies of needed sterile compounded preparations, such as reducing variation in drug formulations.
ASA looks forward to working with these and other partner organizations and outsourcing facilities to improve access to anesthesia drugs and ensure the best possible care for patients.
Read about the Drug Quality and Security Act
Learn more about FDA actions to Implement the Compounding Quality Act and view available guidance documents