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

Ontario Pharmacists Association  ·  June 30, 2016

The Ontario Pharmacists Association (‘OPA’ or the ‘Association’) welcomes the opportunity to comment on the Ontario College of Pharmacists’ (‘OCP’ or the ‘College’) proposed timeline as it relates to the implementation and adoption of the standards for the compounding of non-hazardous and hazardous sterile preparations as set by the National Association of Pharmacy Regulatory Authorities (‘NAPRA’). The Ontario Pharmacists Association represents the interests of Ontario’s pharmacists, pharmacists-in-training and pharmacy technicians. Our more than 9,500 members work in a wide variety of settings, including but not limited to community pharmacies, hospitals, long-term care, family health teams, and industry. The Association maintains as a key element of its mandate the support for pharmacists in the delivery of the highest quality of care for all Ontarians. We recognize the importance of practice standards (and the establishment of competencies to meet those standards) as they pertain to the safety of both the patient, who requires a compounded preparation, and the pharmacy professional who is tasked with preparing it and delivering continuity of care. Notwithstanding the essential development of these robust standards that protect the patient and the practitioner, implementation of these new standards must be done in a way that is both rational and pragmatic, allowing for a reasonable rate of adoption and the full acknowledgement of the challenges toward that adoption. The Association appreciates the urgency that seems to drive NAPRA’s two-year implementation period, we suggest that this is a highly ambitious timeline that could contribute to unintended consequences, such as interruption in continuity of care due to an inability to be in full compliance by September 2018. For this reason we ask for in-depth needs and gap analysis and risk assessment to more appropriately inform the determination of a timeline that works for the majority of providers, in both the hospital and community pharmacy sector.

Based on discussions with interested stakeholders in both the community and hospital sectors, OPA is concerned that while the new standards are robust and necessary, implementation of them will pose significant challenges to pharmacy providers, including financial that should be considered. The comprehensiveness of the compounding standards for both non-hazardous and hazardous sterile preparations will require substantial changes to the physical layout and operational workflow of involved pharmacies, and the costs associated with such changes can be quite large, if not prohibitive. This is further magnified with the simultaneous rollout of both sets of standards for non-hazardous and hazardous preparations, which might make it difficult for many pharmacy providers to comprehend the magnitude of all of the changes, possibly leading to an underestimation of costs. Hospitals and community-based pharmacies are similar in the fact that both are businesses that rely on strategic business plans and a strict adherence to budgets. While some plans and budgets are perhaps more flexible than others, changes of the magnitude suggested by the new standards will require a significant reinvestment. With a particular focus on hospitals who continue to see little to no growth in their annual budgets, this will pose a serious fiscal strain on the institutions. Unless there is additional funding from the LHINs or the Ministry of Health and Long-Term Care, the Ontario Pharmacists Association sees this as a substantial and possibly insurmountable challenge. Insofar as this consultation is about the ability to meet the proposed two-year timeline, acquiring the financial capital to effect the needed changes will take considerable time, possibly four or even five years for some providers.

Time itself will also be a barrier to many pharmacies attempting to become compliant with the new standards. To make the changes, budgets will need to be revisited, and this will certainly require time to ascertain the size and scope of the budgetary request, and such a request would need to be put into the organization’s budget process. For many, this may be months away. In addition, hospital and community pharmacies may need to pursue a formal and lengthy RFP process to secure the most appropriate service provider (e.g. contractors, architects, other vendors) who will ultimately be tasked to make the physical changes. These time constraints will be exacerbated with the degree of sophistication in ventilation requirements pursuant to the standards for preparation of hazardous sterile products. Further, while changes are being made, there will be the need for a significant time commitment and dedicated resources allocated to train staff and to establish new operating protocols and procedures once the physical changes have been completed. Finally, even when no physical changes are necessary, workflow and quality control will be impacted with new tasks and processes introduced with the new standards, and these must be taken into account with any consideration of timelines to effect change.

Just as patients are unique, so too are pharmacy providers. Each pharmacy, whether it is a community-based practice or one within a hospital, will have unique capabilities and challenges. Many of these capabilities and challenges will be related to the physical layout of the practice site and may or may not be readily changeable within the two-year timeline proposed for standards implementation and adoption. It appears that the proposed two-year NAPRA timeline was not well-informed, and in addition, seems to be a uniform approach for all affected providers. In other words, some providers may be better prepared for the new standards than others, and as such, their timetable to adoption may be shorter. Pursuant to an in-depth needs assessment and gap analysis commissioned by the Ontario College of Pharmacists and/or NAPRA, OPA recommends that each pharmacy provider develop and submit to OCP their own site-specific workplan for implementation and adoption. We believe that this would be the most fair and reasonable approach by OCP as it assists pharmacies in implementing the many changes as expediently as possible. However, as this might likely require additional visits from a College Practice Advisor to the practice sites, and therefore a new strain on the College, an alternative approach would be to extend the timeline to one that better addresses the needs of most providers – to a four or possibly five-year timeline (2020 or 2021), and perhaps coupled with an incentive for more rapid adoption (i.e. a one-time reduction in the site’s accreditation fee for adoption ahead of plan).

Summary The Ontario Pharmacists Association fully understands the importance of the standards and a process to drive implementation and adoption as quickly as possible. That said, the costs will be substantial to implement and may, in fact, be prohibitive, potentially forcing some providers out of the practice of compounding non-hazardous and hazardous sterile preparations. Should the latter occur, there will definitely be a tangible impact on continuity of patient care. It is imperative that NAPRA and OCP gain a full understanding the significant logistical barriers and the costs and time required to get by them given the depth of the changes. Second, too rapid an implementation plan may impact a smooth adoption plan, and accordingly, this could lead to unintended negative consequences for the patient. Lastly, it is worth recognizing the unique nature of each pharmacy operation and to have OCP help providers identify the gaps and needs via a thorough, site-specific assessment that could, in turn, lead to a unique implementation plan tailored specifically to the needs of the site. This site-specific assessment would be informed by an externally created needs assessment and gap analysis report commissioned by the College and/or NAPRA. Alternatively, OPA would recommend a more reasonable and achievable timeline that meets the needs of all providers – perhaps a four or even five-year plan instead of two.

The Ontario Pharmacists Association appreciates the opportunity to submit comments to the NAPRA proposed timelines. Should you have any questions or comments with respect to this submission, please do not hesitate to contact me at your earliest convenience.

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