Non-Sterile Compounding

Non-Sterile Compounding Q&A with a Community Pharmacist

Threse Guirguis group shot at pharmacy
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Pictured above is Threse Guirguis (centre) and her pharmacy team.

The implementation and adherence of NAPRA’s non-sterile compounding standards is an important way pharmacy professionals can increase patient safety and protect pharmacy personnel.

With support from resources available on the College’s website, pharmacies and pharmacy professionals are to continue to work towards full implementation.

The implementation of these standards requires an investment in time and effort to understand the gaps in current practice, where the priority should be placed and to reflect on how available resources can support successful implementation.

Threse Guirguis, Designated Manager at Leeds Pharmacy in Brockville, chats with Pharmacy Connection about her implementation approach and shares advice with her pharmacy peers.

Pharmacy Connection: Describe the impact non-sterile compounding standards have had on your practice and on patient care

Threse Guirguis: Many pharmacists have been doing compounding for years, however I think the new standards have increased our awareness on two main aspects of compounding, specifically the need for standardized processes and the development of polices that govern compounding to improve safety.

PC: Describe your approach and process while implementing the non-sterile compounding standards

TG: Our approach was to study in detail the new NAPRA standards, read the guidance and information on the OCP website as well as information from other Canadian pharmacy regulators to better understand the standards.

Also since NAPRA standards reference USP Chapters <795> and <800>, it was important to review these chapters to understand the context and how they have been incorporated into the NAPRA standards. This allowed us to interpret and apply the NAPRA standards to our practice.

PC: Your pharmacy did a lot of research on best practices for non-sterile compounding. Why did you feel this was important and what were the benefits of this?

TG: There are a few reasons that compelled us to do more research:

    • The need to create and implement standardized detailed policies and procedures specific to our practice. For example, the calibration intervals of various devices, cleaning processes for non-sterile space, specific deactivation and cleaning materials being used.
    • The need to research the sources of some of these materials and calibration services as they are not all supplied by the traditional compounding services subscription providers.

PC: You have a Level C compounding area. Please share the challenges you experienced in meeting Level C requirements and how you overcame them.

TG: Our team was debating whether to apply Level B or Level C requirements to our compounding area as we were doing hazardous compounding initially only occasionally. After doing the research and gap analysis, it became clear that the safety and ease of process streamlining that a Level C area provides while costing a minor additional investment made it an obvious choice going forward. We’re very glad that we opted for Level C as when our hazardous compounding increased, we did not have to modify our policies and procedures already in place.

The safety of myself as a pharmacist providing compounding services, and the safety of my staff was a paramount factor in my decision to invest in a Level C compounding area.

In fact, I find that working in a Level B compounding area is much more challenging as the NAPRA standards require you to conduct an initial risk assessment and to review annually or more frequently if there are practice changes. Additionally, risk mitigation strategies must be specified for each compounding formula and a review of additional mitigation strategies must be done annually to ensure that the environment is safe for compounding hazardous preparations without a C-PEC (containment-primary engineering control or hood) inside a negative pressure room.

Even if one could determine that Level B is sufficient for compounding occasional small quantities of hazardous preparations, this doesn’t take into account the risk of an accidental exposure during possible powder spills. The exposure to the compounder and other staff during an accident would not qualify as a small quantity and the contamination that may be caused could easily extend outside of the Level B compounding area.

PC: What is some key advice you’d share with other Designated Managers as they continue to meet the non-sterile compounding standards?

TG: Do your own research even if you are taking a compounding course or subscribed to compounding services. You will find that you’ll become more confident in your own safety and the safety of your team, and more confident that you can meet the standards and provide guidance to your staff. You will also find it a very rewarding and thrilling learning experience.

Key Advice Takeaways

  • Review key resources, including information on the College’s website
  • The safety of a pharmacy’s staff should be a paramount factor in deciding whether to invest in a Level C compounding area
  • Do your own research even if you are taking a compounding course or subscribed to compounding services

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