Feedback for Seeking Feedback on Proposed Implementation Timeline for NAPRA's Sterile Compounding Standards

Cancer Care Ontario  ·  June 30, 2016

The Ontario College of Pharmacist (OCP) is expected to adopt the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations at the September 2016 Council meeting. OCP is requesting feedback on a proposed two-year time frame for facilities to become fully compliant with the standards. The following are considerations requested by OCP: 1. Is two years enough time for pharmacies engaging in compounding hazardous and/or non-hazardous sterile preparations to: o Review the NAPRA standards and identify any gaps in the pharmacy’s current practice o Establish an action plan to become fully compliant o Implement the plan and meet the NAPRA standards 2. If two years is not enough time to complete these tasks, why? How much time would be required? 3. What challenges would pharmacies face in order to meet the proposed implementation timeline of two years?

FEEDBACK

Cancer Care Ontario identified the following key areas where full implementation within a two-year time frame will not be possible for the 78 facilities providing systemic treatment in Ontario. Additionally, the impact on community pharmacies preparing sterile hazardous compounding and non-sterile hazardous compounding remain largely unknown to Cancer Care Ontario but we suspect challenges with full implementation within a two-year time frame and that there may be an impact on access of medications closer to home for cancer patients.

  1. Beyond-Use Date:

The NAPRA guidelines currently indicate that the BUD of hazardous drugs stored in single-dose vials is 6 hours, whereas the BUD of hazardous drugs stored in multi-dose vials is 28 days. This is a problem for single-dose vials because drug must be discarded in a short period of time after initial puncture of the vial. This drug wastage would have a significant financial and utilization impact, as 18 of 19 hazardous drugs funded through the New Drug Funding Program administered by Cancer Care Ontario are packaged into single-dose vials. Cancer Care Ontario is not aware of any facility that currently adopts a BUD of 6 hrs for single-dose vials.

Potential Financial Impact of BUD

A financial impact analysis has been completed to estimate the potential drug wastage implications of adopting BUD according to NAPRA. In considering only the the 18 NDFP funded drugs that are packaged as single-dose vials and the 14 Regional Cancer Centres, the costs in drug wastage exceed $10M. This is without taking into consideration the remaining 68 facilities that deliver systemic treatment in the province, or the many other drugs that would be impacted by this change in practice. This also does not take into consideration existing drug waste considerations, dose rounding, or batching.

Potential Strategies to Extend BUD

A few strategies have been identified to extend BUD, including use of a closed system transfer device, automated robot dispensing units (e.g. RIVA) and other processes currently used to reduce wastage (e.g. dose rounding, batching patients). These strategies will require a thorough assessment by each facility to determine feasibility of financial and space resource. As centres are already into the fiscal year, any plans for an increase in financial resources will need to be requested and approved by the hospital. This will take a minimum of 2 to 3 years. We suggest that this standard be phased in slowly over 5 years. We further recommend that at 2 years, facilities should have performed an assessment of the potential options to determine the best choice for the facility.

  1. Biological Safety Cabinets:

According to the NAPRA standards, biological safety cabinets (BSCs) are required for the preparation of hazardous materials. The standards indicate that Class II or III BSCs are required, without specifically suggesting Class II Type B2. In December 2013, Cancer Care Ontario and the Program in Evidence-Based Care (PEBC) published guidelines on safe handling that recommend use of Class II Type B2 BSCs. The Ministry of Labour is also recommending the use of a Class II Type B2 BSC. However, they have not mandated immediate adoption but rather when major renovations are planned.

Data from April 2014 showed that 51% of facilities that provide systemic treatment did not use a Class II Type B2 BSC. To convert the remaining 49% of facilities will incur significant capital expenditures where physically possible. Some pharmacy departments will need to be physically relocated to an area where external venting to the exterior is possible.

Cancer Care Ontario suggests that provincially there be one recommendation of BSC to be used when compounding sterile hazardous drugs. We further recommend the use of a Class II type B2. Additionally, we recommend that the expectations align with the Ministry of Labour in that a plan should be in place to implement a Class II type B2 BSC when major renovations are planned.

  1. Storage:

The NAPRA standards recommend that hazardous products should be stored in a negative pressure room that is properly ventilated to the exterior. This room has to be separate from the unpacking area. Proper ventilation is required to prevent contamination from hazardous drugs that may be volatile at room temperature. Currently, the NAPRA standards permit facilities to construct a separate storage room for hazardous products or to store hazardous products in clean rooms that are under negative pressure.

Informal data from 2012 suggest that only 1 to 2 facilities have separate negative pressure storage rooms that meet NAPRA standards. In order to meet NAPRA standards, significant capital resource and a possible physical relocation of the pharmacy department may be required. Although storage of hazardous drugs may be in the clean room under negative pressure, this may not be possible for centres with a small clean room or large volumes of inventory that cannot fit into the clean room. Cancer Care Ontario recommends that full adoption of this standard be phased in with major renovation plans.

Summary

We appreciate the opportunity to provide feedback to the two-year time frame for full implementation of the NAPRA standards. We recognize that while many standards may be implemented within this time frame, there are individual standards that will require thoughtful consideration of the financial impact and physical constraints on each facility in order to balance safety with access to care closer to home. As part of this work, we believe that other stakeholders will need to be engaged to find this balance. These stakeholders may include infection control, Ministry of Health, Ministry of Labour, Ontario Hospital Association (OHA) and the Canadian Association of Provincial Cancer Agencies (CAPCA) as well as other relevant stakeholders in community pharmacy impacted by this work.

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