Implementing NAPRA Standards into a Sterile Practice
In recent years, Canada’s National Association of Pharmacy Regulatory Authorities (NAPRA) published Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations. Navigating through these new requirements and strategizing their practical implementation can be challenging.
To overcome these challenges, an initial home study program will provide the participant with a needed foundational knowledge. It addresses:
- Basic scientific principles underlying parameters of air quality control
- Primary and secondary engineering control dynamics
- Airflow dynamics related to positive and negative pressure controlled environments
- Environmental monitoring and sampling; non-viable particulate
- Environmental monitoring and sampling; viable particulate
- Principles of sterility and microbiological proliferation
- Viable particulate testing, interpretation, and trending
- Compounded sterile preparation testing for non-viable and viable particles
During the 8-hour live event, participants will be guided through the 2016 NAPRA standards of practice with an emphasis on how to practically implement and apply these standards today. The framework of this program mirrors NAPRA’s model standards’ unique infrastructure:
- Regulatory framework
- Quality assurance program
- Risk management
- Verification program (emphasis on compounded sterile preparations)
- Personnel competency and compliance
- Facility and technology management (emphasis on engineering controls)
- Procedures in support of maintaining an ISO classified controlled environment
- Aseptic process development leading to approved master formulation records
- Master formulation record database management
- Compounding record and patient management
This program aims to take NAPRA’s standards of practice to the next level by teasing apart ambiguities and providing recommendations and justifications for the adoption of best practices, where applicable. The overarching goal of this program is to provide its audience with clear and concise practical tools that will enable them to achieve compliance with NAPRA’s standards of practice. Through interactive group discussion, participants will establish goals, place tasks on timelines, determine work task allocations, resource requirements, and master task schedules that address competency and compliance requirements. In doing so, participants will be guided through a smooth transition to a new standard of practice, while continuing to manage and oversee current compounding operations.
FOR PHARMACISTS & PHARMACY TECHNICIANS
Learning objectives for this program will be based on a combination of three types of objectives as outlined in the Canadian Council on Continuing Education in Pharmacy:
Knowledge Measurement Objectives
- Demonstrate an understanding of the current regulatory framework for compounding in Canada as it applies to Federal, Provincial/Territorial jurisdictional law, and standards of practice.
- Describe quality assurance, risk management, and verification program requirements outlined in the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.
- Identify policy and procedure requirements that reflect the current NAPRA model standards.
- Review current requirements of master formulation and compounding records.
- Discuss approaches to ensure personnel safety, and the quality and safety of compounded sterile preparations.
Reflective Assessment Objectives (integration of concepts and ideas)
- Apply and adapt standards of practice to best suit your sterile compounding practice.
- Demonstrate the application and integration of a learned policy and procedure infrastructure into your practice.
- Differentiate competency assessments from compliance indicators.
- Integrate a best practice’s approach commensurate with the size, complexity, and risks associated specifically to your sterile compounding practice.
Authentic Assessment Objectives (compounding practice performance-based)
- Develop a strategic action plan to manage the implementation of the 2016 NAPRA standards of practice for non-hazardous and hazardous sterile compounding.
This learning activity has received financial support from MEDISCA Inc. in the form of an educational grant.
The live activity workbook is copyright © 2018 LP3 Network.
QUINTON DIDYK, BSc, BS Pharm, RPEBC
Mr. Didyk graduated from the University of Manitoba Faculty of Pharmacy in 2002 and immediately went to work as a Pharmacy Services Specialist for the Western Canada division of a national pharmacy provider. Mr. Didyk gained early experience in community pharmacy practice, and in 2005 his career evolved into the ownership and management of community health services. He developed health centres in the Winnipeg area that provided primary and ancillary healthcare services all under one roof. These clinics were pioneers in establishing solid patient outcomes through the use of electronic medical records. His efforts were noted in 2006 when he received the Young Leader in Pharmacy award from the Manitoba Society of Pharmacists.
Mr. Didyk has been a facilitator for sterile and non-sterile compounding programs since 2008. His skills and expertise in compounding have made him nationally recognized as an expert in his field. He owns and operates the largest compounding-only facility in Manitoba that delivers specialized patient specific healthcare on a daily basis. In 2015, Mr. Didyk expanded his scope by becoming a surveyor for the Accreditation Commission for Health Care (ACHC).
|NEIL COHEN, BSc|
CE Program Developer
Disclosure: Consultant, MEDISCA
QUINTON DIDYK, BSc, BS Pharm, RPEBC
Please see the final activity description for details.