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.
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