By Marla M. Ekola, Pharm.D., BCPS, M.B.A., director of pharmacy, Memorial Healthcare, Pharmacy Systems Inc.
Since 2004, USP <797> has been the guiding principle for sterile product production. The Joint Commission began enforcement of these standards in 2008, yet still more than half of the pharmacies self-reported being out of compliance with this standards.1 All the while, several high profile issues occurred to remind the pharmacy world of the high risks of sterile product production. The New England Compounding Center caused a disastrous outbreak of fungal meningitis in 2012. In 2014, Governor Rick Snyder signed into law the amendment to the pharmacy licensure and drug control provisions of the Michigan Public Health Code.2 This amendment defined a compounding pharmacy and established limits on compounding activities and recordkeeping requirements.
There was much discussion regarding the intent of this amendment. Initially, it was believed this did not apply to hospital pharmacies but rather to compounding pharmacies exclusively. Ultimately, it was determined that all pharmacies that compound sterile products were impacted by these changes. This meant all hospital pharmacies in Michigan would need to seek accreditation from one of the accepted accreditation bodies of Pharmacy Compounding Accreditation Board/Accreditation Commission for Health Care (PCAB/ACHC) or National Association of Boards of Pharmacy's Verified Pharmacy Program (VPP). The Board was successfully petitioned to accept The Joint Commission (TJC) accreditation in addition to the other previously mentioned organizations. The initial set of requirements were set to be enforceable on Sept. 30, 2015. Michigan Health and Hospital Association (MHA)/Michigan Pharmacists Association (MPA)/Michigan Society of Health-System Pharmacists (MSHP) worked collaboratively to secure a legislative fix that delayed the deadline until Sept. 30, 2016. At that time, all Michigan pharmacies that compound sterile products should be in process of accreditation and should have completed the accreditation by June 30, 20173.
The purpose of the accrediting bodies is to ensure that our patients have access to safe sterile compounds. Their standards follow the basic guidelines set by USP <797> for each of the following areas:
- Design of the Facility
- Environmental and Engineering Controls
- Environmental Testing
- Personnel Training and Competency Testing
- Standard Operating Procedures and Documentation
- Quality Assurance
- Patient Monitoring and Adverse Events Reporting
- Storage and Dating4
As with all quality initiatives, the bar is constantly moving, and as we gather more data and draw more comprehensive conclusions, we often see areas that could compromise safety and cause patients harm. While this article is being published, the latest update of USP <797> is being republished for a second round of comments; however, there is not an anticipated date for the chapter’s republication.
This constantly moving target can come with a very hefty price tag. Updating IV rooms to meet the environmental and engineering standards required by <USP 797> can cost millions for some facilities. Ever increasing requirements for environmental testing and training come with reoccurring fees. This does not include the daily nonpatient charges of sterile gloves, sterile alcohol and other items required by the standards. All of this at a time when payment models are shifting and reimbursement is becoming more unreliable. It can be difficult to get the full backing from the C-Suite when the standards will continue to evolve. Even now, the next standard <USP 800> looms at our doors.
Hospital pharmacies have been compounding sterile products for decades. It can be difficult for our profession to accept that our previous practices created an environment fraught with potential patient safety issues. It was not so very long ago that washing your hands was enough, now we scrub, use hand sanitizer and don sterile gloves, then sanitize again prior to compounding a sterile product. As with many things in our profession, practice standards continue to evolve to improve patient outcomes. Patient safety and quality assurance are what make these changes a positive step in the right direction.
- Douglass K, Kastango ES, Cantor P. The 2012 USP <797> compliance survey: measuring progress. Pharm Purchasing Products. 2012;8(10):S4–24
- Legislative Service Bureau. Senate Bill 0704 (2013). Michigan Legislature website. http://www.legislature.mi.gov/(S(jzkp350cpjgobvcdjch4hnmr))/mileg.aspx?page=GetObject&objectname=2013-SB-0704. Accessed February 2017.
- State of Michigan. Michigan Department of Licensing and Regulatory Affairs Bureau of Professional Licensing, Board of Pharmacy. Michigan.gov website. http://www.michigan.gov/documents/lara/Pharmacy_license-full_052014_456621_7.pdf. Accessed February 2017.
- U.S. Pharmacopeial Convention. USP Compounding Standards. USP.org. http://www.usp.org/usp-healthcare-professionals/compounding. Accessed February 2017.