This is a companion article to our December 1 complimentary webinar on sterile compounding issues and updates and featuring Visante experts Fred Massoomi and Jim Jorgenson. Use this link to register now.
USP 797 and 800 guidelines are on everyone’s radar in hopes of promoting safe compounding of sterile products that will have a significant impact on patient care and safety. Unfortunately, we have all seen the reports of how failing to follow these important standards and regulations has led to negative patient outcomes and can result in significant patient, employee and environmental harm.
Consider the following incidents over the last decade:
• Epidemic meningitis and deadly strokes attributed to the mold Exserohilum rostrtum from contaminated pharmaceuticals;
• Some 17,000 doses of steroid injections sold to pain centers, clinics and hospitals around the country that resulted in 45 deaths and 651 illnesses from an outbreak of fungal meningitis linked to contaminated materials produced by the New England Compounding Center (NECC);
• A fungal meningitis outbreak associated with Exophiala dermatitidis from another compounding facility.
The U.S. Food and Drug Administration has been called upon to provide clarity and guidance to the compounding industry as well as respond to the gaps between state pharmacy boards and nationally recognized best practices. The government and professional societies have taken action, but errors still abide due to confusion over proper production protocols to meet these mandates.
The Drug Quality and Security Act (DQSA) was signed into law in November of 2013. This legislation contains important provisions relating to the oversight of compounding of human drugs. For example, Title I of this new law, the Compounding Quality Act, removes certain provisions from section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) that were found to be unconstitutional by the U.S. Supreme Court in 2002. By removing the unconstitutional provisions, the new law removes uncertainty regarding the validity of section 503A, which will be applicable to compounders nationwide.
Now the major discussion among hospitals that maintain their own sterile compounding operations as well as commercial compounding pharmacies is focused on USP chapter 797 and the anticipated updates in chapter 800.
Visante has been a part of this discussion from the start. Our consultants include a veritable list of “Who’s Who” in the world of compounding, clean room design, safe handling of hazardous drugs and safe disposal of pharmaceuticals. Among these are:
• James Jorgenson (MS, RPh, FASHP) is an internationally sought after speaker on the issues and options for safe handling of hazardous pharmaceuticals including the use of closed system transfer devices for added safety and economy when dealing with highly toxic specialty medications.
• Kenneth Latta (RPh, FIACP, FACA) conducts “how to” courses around the world for compliant clean room design, procedures, and the precise manufacturing processes of compounded pharmaceuticals. He serves on the ASHP Standards Committee for the Pharmacy Compounding Accreditation Board. Since 2006 he has focused his attention on establishing national standards and accreditation processes for the compounding profession.
• Fred Massoomi (PharmD, FASHP) is an international expert on aseptic medicines management and speaks often on USP 797 and 800 compliance, hazardous drug management, and the proper disposal of pharmaceutical drug waste.
• Clive Richards (B Pharm, MR Pharm, MR PharmS) is one of Europe’s leading experts in the design, build, and operation of aseptic compounding units. He is a member of Baxter’s global compounding group, achieving the rank of Pharmacist Superintendent and Qualified Person.
Visante experts have also been actively engaged in sterile compounding research and publication of their findings in the professional literature. Below is a sampling of their journal articles concerning issues in the sterile compounding and safe handling of pharmaceuticals.
“Assessing the Efficiency of CSTDs for Compounding” Fred Massoomi (et al.). PP&P July 2015, Volume 12, No. 7
“Improving Compounding Safety: New Regulations and Options for Institutional Insourcing” Kenneth Latta, Gregory Burger, James Jorgenson. AJPB July/August 2013
“Compounding vs. Manufacturing: New Interest in and Old Question” James Jorgenson. AJPB Nov/Dec 2012
“A Second Look at Utilization of a Closed System Transfer Device” James Jorgenson (et al.). AJPB 3(6) 2011
Attend Visante’s Webinar on Sterile Compounding Update:
If the issues surrounding sterile compounding of medicines and the safe handling and disposal of toxic elements are important to you, register here to learn more during Visante’s webinar on these topics.
– Review of major incidents involving sterile compounded products in the U.S.
– Summary of the historical, current and proposed sterile compounding standards
– Pictorial description of some of the complexities with compounding pharmaceutically elegant sterile products
– List of available resources for further information