RPh, BScPhm, ACPR
Owner – Designated Manager,
Elora Apothecary Pharmasave
Please note that on March 23, 2020, Council approved an extension to the deadlines for implementation of the non-sterile compounding standards. This change is in recognition of the evolving COVID-19 pandemic situation and the need for pharmacy professional to focus on continuity of care and minimizing public risk. The updated deadline dates are:
- Phase 2: July 1, 2021 - Personnel Training and Quality Assurance
- Phase 3; January 1, 2022 - Facilities and Equipment
As owner and designated manager of a community pharmacy and a practicing hospital pharmacist, Bronwyn Tolmie was recently involved in the implementation of the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations in both community and hospital settings.
The Ontario College of Pharmacists requires all pharmacies engaging in non-sterile compounding activities to comply with the standards, using the following phased approach:
Phase 1: Assessing Risks and Gaps - January 1, 2020
Phase 2: Personnel Training and Quality Assurance - July 1, 2020
Phase 3: Facilities and Equipment - January 1, 2021
In fulfilling Phase 1 of the standards, Bronwyn did a full review of compounding practices at her existing community pharmacy location, applying the knowledge she acquired from her involvement in the hospital experience. She also applied lessons learned to ensure appropriate facilities were set in place to accommodate non-sterile compounding facilities and procedures at a future pharmacy location.
In this article, Bronwyn describes the steps she took to assess risks and gaps in order to meet the initial January 1, 2020 timeline.
DESIGNATE A NON-STERILE COMPOUNDING SUPERVISOR
When preparing for the implementation of the new NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations an important first step is to designate a regulated pharmacy practitioner to be the non-sterile compounding (NSC) supervisor. With hospital experience and training in sterile compounding and an interest in expanding my knowledge of non-sterile compounding, it was determined that I would assume this role. The NSC supervisor is responsible for developing, organizing and overseeing all activities related to non-sterile compounding; therefore, it is imperative that individuals in this role review and understand the standards and accompanying guidance document.1,2 The standards are based on General Chapter USP <795> (2016) and refer to hazardous drugs classified by National Institute for Occupational Safety and Health (NIOSH) as Table/Group 1 and hazardous materials classified by Workplace Hazardous Materials Information System (WHMIS). 3,4 As NSC supervisor, I wanted to ensure I had a strong understanding of these resources – including the ability to interpret the content and apply the standards to my practice site. Reviewing the standards is a critical first step in performing a gap analysis when one evaluates their current pharmacy compounding procedures and plans the changes required to successfully implement the new standards.
DETERMINE RISK OF COMPOUNDS AND LEVEL OF REQUIREMENTS
The facility requirements for non-sterile compounding are based on the complexity and risks associated with preparing each compound. After reviewing the standards, the NSC supervisor should understand how to assess and determine the level of risk and complexity of the compounds one is making or planning to make at their pharmacy. I found this exercise to be an excellent opportunity to evaluate the compounding services my pharmacy currently provides and to facilitate decision making in terms of the level of compounding I was equipped to offer moving forward.
The NSC supervisor should identify all compounding ingredients currently being used at the pharmacy and determine for each the risk to the compounding personnel handling these chemicals. Identification of ingredients classified as hazardous drugs can be determined by reviewing the NIOSH List of Hazardous Drugs.3 One should also identify any ingredients that WHMIS deems as a potential health hazard by reviewing the safety data sheets provided by the supplier or manufacturer of the ingredient.5 With knowledge as to the ingredient’s classification as hazardous or not, the NSC supervisor is able to evaluate a compound being prepared and determine if it is classified as simple, moderate, or complex as defined by USP General Chapter <795> (2016), and summarized in Section 8 of the guidance document.2,4
Once the risk and complexity of the compounds being prepared have been established, the Decision Algorithm for Risk Assessment in the guidance document can be used to determine if your pharmacy compounding space will be required to meet Level A, B, or C requirements.2 Both the standards and guidance document outline what is required for a Level A, B, or C compounding space and can be used to decide if any facility modifications are needed within one’s current place of practice.1,2
TRAINING AND SKILLS ASSESSMENT
After determining what level of compounding you will be performing at your pharmacy, it is important to decide if there is a need for additional training. As the NSC supervisor is responsible for training and performing skills assessments for all compounding personnel practicing at the pharmacy, I determined that attending a non-sterile compounding training course would enhance my skills and ability to oversee the assessment program. The course provided training on foundational compounding techniques, as well as education on developing master formulations and implementing standard operating procedures. The training was key to instilling confidence in my ability to properly ensure all compounding personnel at my pharmacy have the required knowledge, skills, and resources to competently perform non-sterile compounding procedures within the scope of our facility.
DEVELOP MASTER FORMULATIONS
Each non-sterile compound requires a master formulation, which includes all necessary information to compound the preparation, as well as safety data sheets for each chemical used. The guidance document (Section 6), provides an outline of the information to be included in each master formulation, as well as a template.2 The master formulation should be developed by pharmacy personnel with adequate experience and broad knowledge of non-sterile compounding – for example, the pharmacy’s NSC supervisor. Any references used in the development of the master formulation should be clearly documented and easily retrievable.
MY FINAL THOUGHTS
There are many steps to take when implementing the new standards at one’s practice site, as well as decisions to make regarding the level of compounding you feel confident in continuing to provide. Acknowledging some initial intimidation, my experience in this process taught me that a strong understanding of the standards, coupled with additional training, provided me with the confidence to enhance our compounding practices at our current and future pharmacy locations.
- National Association of Pharmacy Regulatory Authorities (NAPRA). Model standards for pharmacy compounding of non-sterile preparations: Companion to the Model standards for pharmacy compounding of non-sterile preparations. Ottawa, ON: NAPRA; 2018 Mar.
- National Association of Pharmacy Regulatory Authorities (NAPRA). Guidance document for pharmacy compounding of non-sterile preparations. Ottawa, ON: NAPRA; 2018 Mar.
- NIOSH . NIOSH list of antineoplastic and other hazardous drugs in healthcare settings. Cincinatti, OH: U.S. Department of Health and Human Services, Centres for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161.
- United States Pharmacopeial Convention (USP). General chapter <795>: pharmaceutical compounding – nonsterile preparations. In: USP compounding compendium. Rockville, MD: USP; 2016.
- Health Canada. Workplace Hazardous Materials Information System (WHMIS). Ottawa, ON: Health Canada; 2016.