Q&A with the Minnesota Board of Pharmacy
Pharmacy Purchasing & Products: What was the impetus to attend an onsite compounding training program?
Fleming, Ferguson, and Carlson: As inspectors for the Minnesota Board of Pharmacy (BoP), a thorough understanding of USP requirements is needed to evaluate our licensees and to ensure compliance with the standards. All of our inspectors are pharmacists with different backgrounds and pharmacy experiences. We wanted to increase our understanding of <797> to improve our knowledge and ensure that sterile products are compounded safely. In addition to verifying compliance with state and federal regulations, we consider educating our licensees to be an integral function of our job. Attending onsite training and receiving hands-on compounding instruction was an effective way to ensure we were up-to-date with all requirements. The training enabled us to be consistent in our education on proper compounding practices with our licensees.
Encouraging licensee compliance with USP <797> sterile compounding regulations became an area of focus in 2004 when the Chapter became the official standard for sterile compounding in the US. In 2005, Minnesota had a sterile compounding incident involving two patients who were blinded after receiving contaminated compounded trypan blue ophthalmic injections. At that time, the Minnesota BoP began working with a <797> consultant, who provided extensive expertise on how to ensure that compounded sterile products are prepared safely and in compliance with the Chapter. In an effort to prevent future patient harm, Minnesota made rules changes in 2007 including requiring compliance with USP <797>.
Given our firsthand experience with the consultant’s compounding knowledge and passion for patient safety, the board’s executive director made the decision to appropriate funds in 2012 for every state BoP inspector to attend the consultant’s onsite compounding personnel training.
PP&P: How can a pharmacy director justify the expense of attending an onsite compounding training course to administrators?
Fleming, Ferguson, and Carlson: Ensuring medication safety is a primary concern for every health care professional, including administrators. Experience shows that interpreting USP <797> requirements and implementing changes to improve compliance are challenging for many facilities. The training we attended provided a best practice approach and a rationale for standardizing compounding processes to decrease variability in practice and ensure compliance with standards. The quality standards that must be met for preparation of compounded sterile injectable products are very strict because of the risk of infection involved. Comprehensive training is required for all staff to ensure an understanding of the USP requirements for compliance with the standards.
PP&P: Describe your experience at the training facility.
Fleming, Ferguson, and Carlson: The training was an ACPE-accredited, two-and-a-half day, onsite compounding training program. Completion of 10 e-learning modules was required as a prerequisite to arriving at the facility. The program consisted of both didactic classroom lectures and hands-on learning, which included realistic workplace simulations. Being fully immersed in an educational setting and mentored by teachers who are experts in USP <797> compliance was integral to the experience. Each participant received electronic templates for example P&Ps, reference materials, and the presentations.
The training was comprehensive and covered all of the diverse USP <797> requirements that work together to protect patients, as well as all factors affecting sterile compounding practices, including sterile compounding facility design, primary and secondary engineering controls, personnel media-fill testing and process validation, workflow considerations, cleanroom cleaning, environmental sampling, staff training and competency assessments, quality assurance compliance, and documentation. We found the information detailing the requirements for extension of beyond-use dates, as well as the hands-on training inside the cleanroom, particularly helpful. Prior to attending the training, our inspectors were already cognizant of ensuring that licensees had appropriate P&Ps and a robust documentation process in place. The hands-on training reinforced appropriate garbing and gowning practices in sterile compounding areas, and included the use of smoke tests to view first air, which are crucial to ensuring proper sterile compounding techniques.
PP&P: How should pharmacies evaluate the adequacy of their training?
Fleming, Ferguson, and Carlson: Pharmacy directors must be vigilant and responsive with monitoring to ensure personnel are continuously complying with sterile compounding training and standards. Compounding personnel must demonstrate adequate skills to correctly perform activities in their sterile compounding duties. They must complete all initial training and competency assessments as required in USP; in addition, an ongoing training program must be established for revalidation of skills and competencies, as well as routine evaluation of each individual’s performance to the standards.
Documentation of cleaning and disinfection of the primary and secondary engineering controls must be reviewed frequently to ensure compliance, and a comprehensive quality assurance plan must be developed and maintained. Review and evaluate environmental monitoring of primary and secondary engineering controls frequently. Include a sampling plan for viable and non-viable air and surface sampling with documented investigation and actions that will be taken when results are not within acceptable limits. Finally, be sure to review the results with compounding personnel to educate and reinforce training.
PP&P: How should a pharmacy director impart to staff the importance of continuous <797> adherence?
Fleming, Ferguson, and Carlson: The pharmacy director should remind staff during training that the medications they are compounding could be administered to individuals such as their own family members, and that following best practices is never optional. Moreover, directors should conduct a preliminary and annual gap analysis to validate sterile compounding practices. Completion of the gap analysis should identify any areas in which current pharmacy operations differ from those outlined in USP <797>. If areas of noncompliance are identified, a detailed action plan, including staff retraining, should be developed. Implementing robust monitoring practices allows for efficient identification of trends and implementation of correction action.
By Candice Fleming, Associate Director for Compliance; Beth Ferguson, Deputy Director; and Ame Carlson, Pharmacy Surveyor
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