There are areas in health care facilities that require specific environmental controls and operational procedures to ensure safety, such as patient isolation rooms, surgical suites and compounding areas. Environmental or procedural breaches in these “high consequence” spaces may lead to adverse events, causing harm, or even death, for pharmacists, caregivers and patients.
One of the high consequence spaces, usually located in the pharmacy department, is the sterile compounding area. This is where compounded sterile preparations (CSPs) such as injections, IV infusions, ophthalmic medications and irrigations for internal body cavities are made. Maintaining the integrity of the sterile compounding area is essential in order to prevent the contamination of CSPs.
USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations establishes best practice for mitigating the risk of CSP contamination. The guidelines in the USP Chapters set the minimum standards required to prevent patient and worker harm associated with drug compounding.
On June 1, the USP standards for sterile compounding, USP Chapter <797>, were updated to clarify previously ambiguous content, reflect scientific developments, incorporate advancements in clinical practice, and to harmonize with USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. The published changes will become enforceable on Dec. 1, 2019. Conforming to the changes of the revised chapter in a short amount of time will require swift preparation and attention to the following budget considerations.
Enhancements to CSP preparation environment
In the current version of USP Chapter <797>, the beyond-use date (BUD) of a CSP was determined by the likelihood of contaminating the drug during the compounding process, i.e. low, medium, and high risk. Now, the microbial contamination risk levels have been revised into two classifications, Category 1 and Category 2, based on the environment in which the CSPs are prepared. Category 1 CSPs are prepared in an unclassified Segregated Compounding Area (SCA) and have maximum BUDs of 24 hours. Category 2 CSPs are prepared in a cleanroom suite and have longer BUDs.
The type of primary engineering control (hood) in which the CSP is prepared no longer factors into the assigning of BUDs. Therefore entities that currently prepare CSPs in compounding aseptic isolators (CAI) or compounding aseptic containment isolators (CACI) that are not located in a cleanroom suite will no longer be able to assign extended BUDs to those CSPs. Pharmacy leadership will have to assess if a maximum BUD of 24 hours for their CSPs will suffice or if the construction of a cleanroom suite should be considered based on business needs. The cost of changing the current facility design will encompass enlisting cleanroom design and construction services.
Another facility design consideration is the evaluation of the current HVAC system. Can it meet the new specific parameters of sustaining a relative humidity in the compounding cleanroom suite of ≤ 60% and supplying ≥ 20 air changes per hour of HEPA-filtered air in the cleanroom suite’s anteroom? The appropriate HVAC system must be able to maintain the required environmental controls (pressure differential, temperature and relative humidity) specified in the chapter. If not able to meet the standards, a facility’s HVAC system may need to be upgraded or replaced.
Additional monitoring requirements for microbial contamination
USP Chapter <797> requires formal establishment and documentation of a facility’s quality assurance (QA) and quality control (QC) programs. One of the significant changes to mandatory monitoring procedures is the frequency of surface sampling for microbial contamination, which has increased from being collected on a periodic basis determined by the entity to being required to be performed monthly. The increase in surface sampling to monthly will require extra personnel time, the purchase of additional validation consumables such as sampling devices and plates, and an increase in the use of environmental laboratory services for sample identification.
Personnel training and proficiency evaluation requirements
The final budget consideration is the direct and indirect cost of changes to the personnel training and evaluation requirements. USP Chapter <797> requires that all personnel involved in the compounding of CSPs must be initially trained and qualified by demonstrating proficiency in compounding CSPs on an annual basis. Core competencies that must be demonstrated include garbing and hand hygiene and aseptic technique.
The tests to assess competency of these activities are gloved fingertip and thumb sampling and media-fill testing, respectively. The frequency of performing both tests has been revised from a minimum requirement of initially and every 12 months for low- and medium-risk level compounding to initially and every six months for all compounding personnel.
Also included in USP Chapter <797>’s mandate is the designation of one or more individuals to be responsible and accountable for the performance and operation of the facility and personnel in the preparation of CSPs and for performing other functions as detailed in the chapter. Although considerations for who takes on this responsibility is site-specific, the key responsibilities that form the foundation of this position include becoming an expert in this area which may require additional training, developing standard operating procedures, overseeing the facility’s QA and QC programs, and focused attention on staff training and competency, all requiring dedicated labor hours.
Maintaining the sterility of CSPs by ensuring the environmental integrity of work practices in the high consequence pharmacy compounding space is paramount for patient safety. Revisions to the USP Chapter <797> standards, as well as enhanced regulatory oversight and inspection of compounding pharmacies, will require health care facilities to incur additional costs to comply by the enforcement deadline.
