New focus on safety comes on the heels of numerous USP releases
The Joint Commission announced at the end of July 2018 the on-site survey enhancement process for sterile medication compounding for facilities seeking accreditation.[i]Since implementing their own Medication Certification Program, the Joint Commission has finally seen the opportunity for this to be a focus for patient safety. Although, the safety and efficacy of drugs are regulated at the federal level under the FD&C Act, the Joint Commission and other accreditation bodies with state boards of medicine and pharmacy often survey for compliance. With this announcement for enhanced surveying of sterile compounding practices, the USP has been busy updating existing chapters and introducing new chapters.
The USP recently released two highly anticipated revised chapters: <797>Pharmaceutical Compounding – Sterile Preparations[ii] and <795>Pharmaceutical Compounding – Non- sterile Preparations[iii]; and, two newer chapters <800>Hazardous Drugs- Handling in Healthcare Settings[iv] and <825>Compounding – Radiopharmaceuticals[v].
This newly revised collection of standards sets the stage for the minimum compounding standards for drugs in the United States for hospitals. The expected date of compliance for <797>, <795>, and <800> is December 1, 2019 (no date has been announced from USP for compliance of <825>). Note that some states may have enacted compliance with the newer/revised USP chapters prior to the December 1, 2019 date (e.g. California, Washington, New Jersey).
Pharmacy departments vary greatly in compliance with these standards with reported compliance rates in the 70% range for standards that have been in place in some form for almost 15 years. While pharmacies may comply with most elements of the current USP standards, many require a number of modifications to facilities and practices to be considered in full compliance with current and proposed revised USP standards. The newly revised <795> and <797> put more emphasis on cleaning, dating of products and controlling the compounding environments. Minor facility requirements are emphasized; however, the expectation of facilities is built on the predecessor chapters for facility requirements.
One expectation clearly stated within <797> and <800> is the assignment of a designated expert who can devote the time and sweat equity to develop programs and maintain them for continuous compliance. If sites think that a survey will be based on the limitations of the numbered chapter, they need to understand the USP process. The new and newly revised four USP chapters are supported by numerous USP chapters that are cross referenced and must be in place for full compliance.
Sites should expect a more robust and integrated survey process from the Joint Commission with cross pollination of sterile compounding compliance showing up in other survey interviews within the LifeSafety Code® Surveyor Document Review, Medication Management Systems Tracer, Infection Control Systems Tracer, and, the Competency Assessment System Tracer.
If your site has relied on conducting a paper-based gap assessment for assurance of compliance, it should be noted that this is but a minor assessment of practice. Most sites fall short of compliance based on actual practices for assurance of sterility and product integrity. Achieving 100% compliance to revised <795>, <797> and future <800>, <825> chapter requirements can be difficult. With the proper leadership, designated expert assignment, cleaning programs, facilities, personnel training, work practices enhancement, environmental monitoring, sites can go a long way. Applying the process of ‘continued readiness’ for surveys and properly incorporating all USP standards to the medication management process should put most on the road to successful surveys. Incorporating these important practices into daily, weekly, and monthly routines is critical to achieve these goals.
The ultimate goal of healthcare providers should always be toward protecting patients—and themselves—from significant harm from compounded products versus preparation for surveys.
The expected compliance date of December 1, 2019 applies to USP <795> and USP <797> in their revised forms and the implementation of proposed USP <800>. Developing a roadmap and prioritizing steps to achieving compliance by the expected compliance date for all three chapters can seem daunting. Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.
[i]Campbell R. The Joint Commission: Surveyors Increasing On-Site Focus on Medication Compounding Aug 01, 2018 https://www.jointcommission.org/dateline_tjc/surveyors_increasing_on-site_focus_on_medication_compounding/accessed 2018 August 14.
[ii]USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations
http://www.usp.org/compounding/general-chapter-797accessed 2018 August 14
[iii]USP General Chapter <795> Pharmaceutical Compounding – Non-Sterile Preparations http://www.usp.org/compounding/general-chapter-795accessed 2018 August 14
[iv]USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings
http://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare accessed 2018 August 13.
[v]USP General Chapter <825> Compounding -Radiopharmaceuticals https://www.uspnf.com/notices/825-compounding-radiopharmaceuticalsaccessed 2018 August 14.