Putting a Stop to Medication Compounding-Related Infections
Apr 06, 2017 | 1217 Views
By Robert Campbell, PharmD
The Joint Commission
Cases of fungal meningitis, bacterial bloodstream infections and other types of infections have been linked to contamination during medication compounding, a process when a pharmacy mixes or “compounds” chemical ingredients into a finished medication.
Medication compounding became a widespread patient safety and quality concern after a multistate meningitis outbreak in 2012. The outbreak resulted in more than 750 cases and 60 deaths, according to the Centers for Disease Control and Prevention (CDC). Since then, great attention has been placed on safe practices for medication compounding.
As any pharmacist knows, it is hard to go to a national or state event without much ado about the United States Pharmacopeial Convention (USP®) General Chapters <797> and/or <795>, the upcoming <800>, and associated regulations and challenges faced by pharmacies across all health care settings. Currently, the national guideline for compounding medications is based on expectations created by USP <795> for non-sterile products and USP <797> for sterile products, both hazardous and non-hazardous. In July 2018, USP <800> will go into effect which will create additional expectations for sterile and non-sterile hazardous medication compounding. The USP guidelines create requirements for:
An appropriate environment: Provides guidance on the design of the compounding complex, including the room where compounding activities occur and the appropriate types of compounding hoods (such as laminar air flow hoods, biological safety cabinets, isolator cabinets, etc.) to allow for the appropriate cleaning and disinfection of these spaces.
Compounding personnel: Requires staff who perform compounding activities are trained in aseptic manipulations and proper workflows to minimize potential contamination of sterile products.
Safe products: Addresses potential transportation and storage of products to ensure they are sterile and chemically stable at the time of administration.
The Compliance Challenge
With calls for greater oversight, state legislatures and boards of pharmacy have implemented new regulations. Yet, despite these efforts, evidence shows compounding facilities continue to struggle with compliance. As a field surveyor, a significant barrier I witness is breaking old habits passed down by years of experience.
In an effort to assist medication compounding pharmacies with compliance, The Joint Commission began developing standards for safe medication compounding for sterile and non-sterile hazardous and non-hazardous medications in 2012. The standards involved strong collaboration between USP, the U.S. Food and Drug Administration (FDA) and a Joint Commission Advisory Council, all of which provided representation across multiple types of pharmacy practices.
The standards require facilities that have a pharmacy that compounds to ensure a sterile environment in an effort to reduce the risk of contamination and possible infection by:
Setting expectations for organizational and pharmacy leadership to create an appropriate compounding environment, ensure adequate and functional equipment, and develop and assess compounding personnel training.
Establishing written policies and procedures on compounding, handling, storing, dispensing and transporting compounded pharmaceuticals.
Ensuring high risk-level compounded sterile preparations are properly sterilized by filtration, steam or dry heat or other USP-allowed methods.
Requiring compounding staff to follow evidence-based cleaning and disinfecting practices in sterile compounding areas.
Following the standards, The Joint Commission launched its Medication Compounding Certification program in 2017. The certification is open to all pharmacies operating or shipping compounded products to states with regulations that require compliance with USP General Chapters <797> and/or <795>. (Note: 503b designated facilities are not eligible for this certification.)
The health care community, including The Joint Commission, recognize that as the need for compounded medications continues to grow, it is more important than ever to ensure safe policies and procedures are being appropriately and effectively implemented to prevent patient harm.