Introduction
Part 1 of the Hospital Practice Direction (HPD) Project, which explored the evidence around patient safety hazards associated with hospital pharmacy practice in Manitoba has concluded. A summary of the purpose, methods, results, analysis, and recommendations of the Needs Assessment Report is provided below.
Purpose
A comprehensive needs assessment was completed to better understand significant patient safety issues (the What) and support the development of quality regulatory guidance for pharmacy professionals in addressing these issues (the How). The HPD Needs Assessment describes patient safety hazards in Manitoba along with Canadian and international evidence pertaining to hospital pharmacy safety issues and regulatory solutions. The central research questions of the Needs Assessment included:
A: What aspects of hospital pharmacy practice significantly impact on safety of patient care?
i. Which hazards present the greatest risk to patients?
ii. Can the hazard be effectively targeted through regulatory guidance?
B: What are the local key partners’ needs and vision for HPD?
C: Are there perceived or actual negative attitudes toward the HPD that may require attention?
Process
The Needs Assessment followed accepted policy research methods. Using an evidence-based approach to develop regulatory guidance directs the HPD’s content focus while also conveying credibility and buy in from hospital pharmacy professionals. Research used a qualitative mixed methods approach. Evidence sources included grey and peer-reviewed literature and survey of local hospital and non-hospital Manitoba pharmacy professionals.
Methods
Data Collection: Grey literature was identified through a search of individual organisations’ websites as well as through conversations with CPhM. All CPhM’s regulatory guidances with potential to impact the HPD were scanned and cataloged. Peer reviewed literature was identified through a literature search of EMBASE. Local data from pharmacy professionals and CPhM staff was collected through interviews, e-questionnaire, focus groups, and meetings using virtual communications.
Data Analysis: Data from interviews with CPhM staff was the first dataset analysed for hazard evidence. This data set formed the early backbone for organising other hospital practice hazards gathered from other evidence sources. Grey literature review was initiated next and occurred throughout the needs assessment phase. The grey literature synthesis expanded on themes emerging from CPhM interviews and allowed an early skeleton for the evidence-based ‘Hazard Framework’ that other sources’ evidence could refine, reinforce, refute, or add to. Electronic questionnaire items were developed out of interim findings from the ‘Hazard Framework’. The questionnaire was used to collect data from Manitoba pharmacy professionals about their perceptions of particular hazards. Data was analysed as the grey literature review was concluding. A targeted peer-reviewed literature review was also undertaken near the conclusion of the grey literature review. Data from post-electronic questionnaire focus groups rounded out the collection and analysis of local data. Analysis employed constant comparison method where data collection, review and analysis are concurrent.
The hazards derived from the integrated analysis of these sources are combined within the ‘Hazard Framework’.
Results Highlights
A. Grey Literature:
Quantitative: Sixty-four relevant electronic print documents were analysed for hazards in hospital pharmacy practice. Most were Canadian in origin. Four of Canada’s five Pharmacy Regulatory Authorities (PRAs) (1) that regulate hospital pharmacies (out of total of 10 provincial PRAs) publish dedicated hospital practice guidance. Five PRA organisations’ websites in the United States of America (US) were arbitrarily reviewed for their hospital practice guidances.
Qualitative: Canadian PRA’s use mixed approaches to these guidances, however, most focus on operational aspects of hospital pharmacy and include only limited content relating to requirements around clinical role of pharmacists. US regulatory organisations overtly focused on medication security and in some cases, safe compounding practices.
Grey literature originating within governments and safety-focused organisations provided some interprofessional perspective on hospital practice hazards related to medication and med-related information.
B. Peer-Reviewed Literature:
Quantitative: Of the 93 articles returned on search, 15 were determined to be of interest to the research questions and were reviewed in detail for hazards related to hospital pharmacy practice. These15 were combined with two others: the Hospital Pharmacy in Canada Survey (HPCS) (2024/25) and an article outlining clinical pharmacy key performance indicators (cpKPI) in Canada.
Qualitative: Peer-reviewed articles did not add hazards beyond those identified from other evidence sources but did corroborate the results. The HPCS aggregated responses from Manitoba (MB) with Saskatchewan (SK) which made it impossible to know which jurisdiction drove the results. The MB-SK results were concerning in that this jurisdiction ranked last or second from last on many quality (direct or surrogate) research dimensions.
C. Local Interests Survey:
Quantitative: Five interviews were held with eight CPhM staff who had knowledge and experience about issues arising within hospital pharmacy in the course of their work with CPhM. Four conversations (individual or small groups) with eight hospital leaders were completed. Seventy-seven pharmacy professionals completed the electronic questionnaire and nine hospital pharmacy professionals participated in focus groups.
Qualitative: There is little hard data residing within CPhM that constitutes evidence of hazard or harm to patients arising from actions or omissions on the part of pharmacy professionals providing services within Manitoba hospitals. Anecdotally, staff have knowledge of safety issues associated with transfers of patient care (including temporary leave of absence), diversion of narcotics and controlled medications, and administration of medication from wardstock supply that delays or precludes pharmacy safety processes. Pharmacy leadership consistently identified workforce shortages as impacting on safety/quality care and challenges to safe transfers of patient care. Top organisational/system level concerns for pharmacists and pharmacy technicians included issues around safe transfers of patient care, maintaining essential service during times of crisis, and human processes for accurate provision of patient medications. Top team/individual level concerns included communication at hospital-to-hospital transfer, at hospital to community transfer and responsibility and accountability for the team achieving essential minimum requirements.
Aggregate Analysis
Question A: The ‘Hazard Framework’ contained 48 hospital practice patient safety hazards. Analysis of these 48 determined that the HPD would not be effective at addressing all hazards due to their heterogeneity. Each hazard was reviewed individually and assigned an appropriate regulatory solution.
Question B: Local key partners perceive a need for the HPD to be the basis for inspections (CPhM requirement), that the HPD may be more valuable to rural practitioners and communities (rural pharmacists and CPhM). The guidance should be simple, succinct and link to high-quality published guidance.
Question C: Users of the HPD were concerned about the HPD placing barriers to progressive models of medication provision, believe the HPD may not be relevant to pharmacists’ practice and that it should not duplicate Accreditation Canada/Health Standards Organisation (HSO) standards.
Recommendations
Approximately half of the hazards were determined to be best addressed by the HPD using three interlinked conceptual regulatory guidances:
- Hospital Pharmacy Direction (HPD): Standards of Practice or Practice Directive: Central stand-alone regulatory solution.
- Hospital Inspection Framework
- Hospital Site Visit Preparation Guide
The hazards for focus of the HPD will be detailed in an upcoming Phase 2 communication.
Recommended solutions for the remaining hazards encompass eight different regulatory strategies. Some would be new from the CPhM:
- Hospital Safety and Security of Controlled Substances: Interprofessional Joint Solution
- Transitions of Care: Interprofessional Joint Solution
- Workplace Wellness Initiative
And some would involve revisions to existing CPhM regulatory publications such as:
- Medication Incidents and Near-Miss Events: 6a) Standards of Practice #9
- Safety IQ Program (parallel hospital version)
- Code of Ethics Explanatory Document: Applying the Code of Ethics in Pharmacy Practice: Statement III Obligations
- Pharmacy Professionals’ Duty During and Emergency, Disaster or Pandemic Ethical Framework
- Interprofessional Collaborative Care Practice Direction
Conclusion
Phase 1: Needs Assessment identified evidence-based safety hazards to patients associated with hospital pharmacy practice and identified recommendations for effectively mitigating each hazard. Pharmacy professionals in hospital and other practice settings in Manitoba have been consulted on this project through electronic questionnaire, focus groups, interviews, and presentations. Hospital pharmacy leadership and risk management have been apprised and offered interviews to ensure their perspectives are included.
Phase 2: Design begins summer of 2026. In autumn, Manitoba hospital pharmacists and pharmacy technicians, pharmacy managers, and leaders will have opportunities to contribute expertise as sections of the HPD are drafted. Please monitor CPhM’s regular communications and consider contributing to the HPD Project’s mandate of supporting professionals in their provision of safe hospital pharmacy services across the province.
Phase 2’s completion target is Q1-2 of 2027.
Questions, requests for information, or comments related to the HPD project are welcome via the convenient feedback form at the bottom of the HPD webpage.
References
- Statistics of Pharmacists, Pharmacy Technicians & Pharmacies in Canada [Internet]. 2022 [cited 2026 Jun 1]. Available from: https://www.napra.ca/resources/national-statistics/