Non-Sterile Compounding

Exploring the Foundations of Pharmacy Renovations

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When considering a pharmacy renovation—whether to meet growing needs of evolving practices, new activities such as COVID-19 vaccinations and testing, or to meet standards such as NAPRA’s Model Standards for Pharmacy Compounding of Non-Sterile Preparations—a well thought out renovation plan will help create a space that encourages and supports safe and appropriate workflow and optimizes the delivery of patient care.

The case study below provides an example of a real-world renovation consideration and guides Designated Managers (DM) through some key questions to help inform decision making. When it comes to pharmacy renovations, it’s important to think strategically about the layout of your pharmacy to ensure it meets standards and supports any services you provide now or may provide in the future

Case Study – Using the Consultation Room for Compounding Activities

To implement NAPRA’s non-sterile compounding standards, a community pharmacy is considering using the consultation room, which is separate from the dispensary, for compounding purposes. Under the standards, pharmacies are required to have the proper facilities and equipment for the preparation of hazardous and non-hazardous non-sterile compounds, including access to a sink with hot and cold running water. The pharmacy’s DM is also wondering whether installing a sink in the consultation room to support compounding is a good idea considering the pharmacy is engaged in professional services that requires the use of this room.

Below are some key considerations and questions the DM should ask before submitting a renovation plan to the College.

Some Considerations and Questions to Ask

Physical Space
QUESTIONS ABOUT PHYSICAL SPACE
  • Is there a risk to making the room multipurpose? What is the safest outcome for pharmacy staff and the patients?
    • Using the consultation room for compounding purposes may not make sense for workflow if your pharmacy is administering vaccinations or providing counselling/ medication reviews, for example.
    • A multipurpose room increases the risk of being interrupted (which is not appropriate for complex compounds), and could introduce a greater risk of cross-contamination and a compounding incident occurring.
Activities
QUESTIONS ABOUT ACTIVITIES
  • Does the consultation room have the appropriate space, layout, facilities and access to ingredients to support compounding activities?
  • What is the frequency and complexity of your pharmacy’s compounding activities?
  • Are the characteristics of the raw ingredients (e.g., APIs) being used in compounding taken into account?
    • Do any of the ingredients pose a potential health hazard according to WHMIS? Have the safety data sheets (SDS) been reviewed?
  • What additional precautions are needed if compounding with these ingredients?
    • Is there equipment in the room to allow for manipulation of the APIs in a manner that ensures safety of staff? (i.e., if crushing tablets or manipulating an API, are there safeguards in place)
  • Can ingredients in the consultation room be safely secured when the room is being used for non-compounding purposes? Or, if stored elsewhere, can ingredients be safely transported to the room for compounding purposes? Is there increased risk involved as a result of these decisions?
Health and Safety
QUESTIONS ABOUT HEALTH AND SAFETY
  • Will there be health and safety measures in place, including regular and thorough cleaning and other infection prevention and control measures in between activities?
    • If the pharmacy will be compounding hazardous materials, it could increase risk to patients by exposing them to the particles. It’s important to ensure proper safeguards are in place.
  • How many sinks will be available throughout the pharmacy?
    • Having a sink in the compounding/consultation room only could create challenges when other staff need to perform tasks that requires running water, such as cleaning equipment or handwashing. This would be especially challenging if the compounding practice is busy and the room is frequently in use.
    • The Checklist for Opening a New Pharmacy requires a pharmacy to have two sinks (or one double sink) within the dispensary. It would not be appropriate if the only sink is located in the consultation room.

Making the Call

After asking the appropriate questions and taking all factors into consideration, including workflow and potential risk to staff and patients, the DM and owner determined it was too risky to renovate the consultation room for the purpose of accommodating compounding activities. The DM and owner decided to rethink their renovation plans prior to submitting their proposal to the College for review.

<strong>KEY TAKEAWAY</strong>
It’s important to think about how renovations could impact workflow, employee and patient safety, patient care and any services you are planning or might provide in the future. Safe, quality patient care should always outweigh any potential cost savings.

Submitting Renovation Plans for College Approval

All pharmacies must notify the College of their proposed renovations – any material change to the size or physical layout of an existing accredited pharmacy. A completed Notice of Pharmacy Renovation form along with a pharmacy floor plan (for community pharmacies only) must be submitted for the College’s approval at least 15 days prior to beginning any renovations to a pharmacy.

A College Community Operations Advisor will review the proposed changes and provide any necessary guidance and support. Once a Community Operations Advisor is satisfied that the proposed changes comply with the Drug and Pharmacies Regulation Act and its regulations, an email will be sent confirming the renovation has been approved by the College.

Additional Resources
Pharmacy Renovations – Submission and Approval Process
Notice of Pharmacy Renovation Form
Non-Sterile Compounding Standards and Implementation

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