Dispensing mifepristone for medical abortion in Canada: Pharmacists' experiences of the first year.

Background: Mifepristone for medical abortion was first dispensed by community pharmacists in Canada directly to patients in January 2017. We asked about pharmacists' experiences over their first year dispensing mifepristone in order to evaluate the frequency of the new practice and assess availability in urban/rural pharmacies. Methods: From August to December 2019, we invited 433 community pharmacists who had completed a baseline survey at least 1 year prior to participate in a follow-up online survey. We summarized categorical data using counts and proportions and conducted a qualitative thematic analysis of open-ended responses. Results: Among 122 participants, 67.2% had dispensed the product, and 48.4% routinely stocked mifepristone. Pharmacists reported a mean of 26 and median of 3 (interquartile range, 1, 8) mifepristone prescriptions filled in their pharmacies in the previous year. Participants perceived that the benefits of making mifepristone available in pharmacies included increased abortion access for patients (n = 115; 94.3%), reduced pressure on the health care system (n = 104; 85.3%), increased rural and remote abortion access (n = 103; 84.4%) and increased interprofessional collaborations (n = 48; 39.3%). Few participants reported challenges to maintaining adequate stock of mifepristone, but these challenges included low demand (n = 24; 19.7%), short expiry dating (n = 12; 9.8%) and drug shortages (n = 8; 6.6%). The overwhelming majority, 96.7%, reported that their communities did not resist the provision of mifepristone by their pharmacy. Interpretation: Participating pharmacists reported many benefits and very few barriers to stocking and dispensing mifepristone. Both urban and rural communities responded positively to enhanced access to mifepristone in their community. Conclusions: Mifepristone is well accepted by pharmacists within the primary care system in Canada.

Pharmacist direct dispensing of mifepristone for medication abortion in Canada: a survey of community pharmacists.

INTRODUCTION: Pharmacists were acknowledged as the most appropriate healthcare professional to dispense mifepristone for medication abortion shortly after the prescription therapy became available in January 2017 in Canada. OBJECTIVE: We aimed to identify the facilitators and barriers for successful initiation and ongoing dispensing of mifepristone among community pharmacists across Canada. STUDY DESIGN: We surveyed community pharmacists from urban/rural practice settings across Canada by recruiting from January 2017 to January 2019 through pharmacist organisations, professional networks, at mifepristone training courses and at professional conferences. The Diffusion of Innovations theory informed the study design, thematic analysis and interpretation of findings. We summarised categorical data using counts and proportions, χ2 tests, Wilcoxon rank-sum and proportional odds logistic regression. RESULTS: Of the 433 responses from dispensing community pharmacists across 10/13 Canadian provinces and territories, 93.1% indicated they were willing and ready to dispense mifepristone. Key facilitators were access to a private consultation setting (91.4%), the motivation to increase accessibility for patients (87.5%) and to reduce pressure on the healthcare system (75.3%). The cost of the mifepristone/misoprostol product was an initial barrier, subsequently resolved by universal government subsidy. A few pharmacists mentioned liability, lack of prescribers or inadequate stock as barriers. CONCLUSIONS: Pharmacist respondents from across Canada reported being able and willing to dispense mifepristone and rarely mentioned barriers to stocking/dispensing the medication in the community pharmacy setting. The removal of initial regulatory obstacles to directly dispense mifepristone to patients facilitated the provision of medication abortion in the primary care setting.

A Virtual Community of Practice to Support Physician Uptake of a Novel Abortion Practice: Mixed Methods Case Study.

BACKGROUND: Virtual communities of practice (VCoPs) have been used to support innovation and quality in clinical care. The drug mifepristone was introduced in Canada in 2017 for medical abortion. We created a VCoP to support implementation of mifepristone abortion practice across Canada. OBJECTIVE: The aim of this study was to describe the development and use of the Canadian Abortion Providers Support-Communauté de pratique canadienne sur l'avortement (CAPS-CPCA) VCoP and explore physicians' experience with CAPS-CPCA and their views on its value in supporting implementation. METHODS: This was a mixed methods intrinsic case study of Canadian health care providers' use and physicians' perceptions of the CAPS-CPCA VCoP during the first 2 years of a novel practice. We sampled both physicians who joined the CAPS-CPCA VCoP and those who were interested in providing the novel practice but did not join the VCoP. We designed the VCoP features to address known and discovered barriers to implementation of medication abortion in primary care. Our secure web-based platform allowed asynchronous access to information, practice resources, clinical support, discussion forums, and email notices. We collected data from the platform and through surveys of physician members as well as interviews with physician members and nonmembers. We analyzed descriptive statistics for website metrics, physicians' characteristics and practices, and their use of the VCoP. We used qualitative methods to explore the physicians' experiences and perceptions of the VCoP. RESULTS: From January 1, 2017, to June 30, 2019, a total of 430 physicians representing all provinces and territories in Canada joined the VCoP and 222 (51.6%) completed a baseline survey. Of these 222 respondents, 156 (70.3%) were family physicians, 170 (80.2%) were women, and 78 (35.1%) had no prior abortion experience. In a survey conducted 12 months after baseline, 77.9% (120/154) of the respondents stated that they had provided mifepristone abortion and 33.9% (43/127) said the VCoP had been important or very important. Logging in to the site was burdensome for some, but members valued downloadable resources such as patient information sheets, consent forms, and clinical checklists. They found email announcements helpful for keeping up to date with changing regulations. Few asked clinical questions to the VCoP experts, but physicians felt that this feature was important for isolated or rural providers. Information collected through member polls about health system barriers to implementation was used in the project's knowledge translation activities with policy makers to mitigate these barriers. CONCLUSIONS: A VCoP developed to address known and discovered barriers to uptake of a novel medication abortion method engaged physicians from across Canada and supported some, including those with no prior abortion experience, to implement this practice. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-028443.

Dispensing and practice use patterns, facilitators and barriers for uptake of ulipristal acetate emergency contraception in British Columbia: a mixed-methods study.

BACKGROUND: Ulipristal acetate 30 mg became available as prescription-only emergency contraception in British Columbia, Canada, in September 2015, as an addition to over-the-counter levonorgestrel emergency contraception. In this study, we determined dispensing and practice use patterns for ulipristal acetate, as well as facilitators of and barriers to emergency contraception for physicians, pharmacists and patients in BC. METHODS: In the quantitative component of this mixed-methods study, we examined ulipristal acetate use from September 2015 to December 2018 using a database that captures all outpatient prescription dispensations in BC (PharmaNet) and another capturing market sales numbers for all oral emergency contraception in BC (IQVIA). We analyzed the quantitative data descriptively. We conducted semistructured interviews from August to November 2019, exploring barriers and facilitators affecting the use of ulipristal acetate. We performed iterative qualitative data collection and thematic analysis guided by Michie's Theoretical Domains Framework. RESULTS: Over the 3-year study period, 318 patients filled 368 prescriptions for ulipristal acetate. Use of this agent increased between 2015 and 2018. However, levonorgestrel use by sales (range 118 897-129 478 units/yr) was substantially higher than use of ulipristal acetate (range 128-389 units/yr). In the 39 interviews we conducted, from the perspectives of 12 patients, 12 community pharmacists, and 15 prescribers, we identified the following themes and respective theoretical domains as barriers to access: low awareness of ulipristal acetate (knowledge), beliefs and experiences related to shame and stigma (beliefs about consequences), and multiple health system barriers (reinforcement). INTERPRETATION: Use of ulipristal acetate in BC was low compared with use of levonorgestrel emergency contraception; lack of knowledge, beliefs about consequences and health system barriers may be important impediments to expanding use of ulipristal acetate. These findings illuminate potential factors to explain low use of this agent and point to the need for additional strategies to support implementation.

Pharmacist dispensing of the abortion pill in Canada: Diffusion of Innovation meets integrated knowledge translation.

BACKGROUND: Since Canadian drug regulatory approval of mifepristone for medical abortion in 2015 and its market availability in January 2017, the role of pharmacists in abortion provision has changed rapidly. We sought to identify the factors that influenced the initiation and provision of medical abortion from the perspectives of Canadian pharmacists, bridging two frameworks - Diffusion of Innovation in Health Service Organizations and integrated knowledge translation. METHODS: We conducted one-on-one semi-structured interviews with pharmacists residing in Canada who intended to stock and dispense mifepristone within the first year of availability. Our data collection, analysis, and interpretation were guided by reflexive thematic analysis and supported by an integrated knowledge translation partnership with pharmacy stakeholders. RESULTS: We completed interviews with 24 participants from across Canada: 33% had stocked and 21% had dispensed mifepristone. We found that pharmacists were willing and able to integrate medical abortion care into their practice and that those who had initiated practice were satisfied with their dispensing experience. Our analysis indicated that several key Diffusion of Innovation constructs impacted the uptake of mifepristone, including: innovation (relative advantage, complexity and compatibility, technical support), system readiness (innovation-system fit, dedicated time, resources), diffusion and dissemination (expert opinion, boundary spanners, champions, social networks, peer opinions), implementation (external collaboration), and linkage. Participants' experiences suggest that integrated knowledge translation facilitated evidence-based changes to mifepristone dispensing restrictions, and communication of those changes to front line pharmacists. CONCLUSIONS: We illustrate how Diffusion of Innovation and integrated knowledge translation may work together as complimentary frameworks for implementation science research. Unlike in the USA, UK, and other highly regulated settings globally, pharmacists in Canada are permitted to dispense mifepristone for medical abortion. We contribute to literature that shows that mifepristone dispensed outside of hospitals, clinics, and medical offices is safe and acceptable to both patients and prescribers. This finding is of particular importance to the current COVID-19 pandemic response and calls for continued and equitable access to abortion care in primary practice.

Perspectives Among Canadian Physicians on Factors Influencing Implementation of Mifepristone Medical Abortion: A National Qualitative Study.

PURPOSE: Access to family planning health services in Canada has been historically inadequate and inequitable. A potential solution appeared when Health Canada approved mifepristone, the gold standard for medical abortion, in July 2015. We sought to investigate the factors that influence successful initiation and ongoing provision of medical abortion services among Canadian health professionals and how these factors relate to abortion policies, systems, and service access throughout Canada. METHODS: We conducted 1-on-1 semistructured interviews with a national sample of abortion-providing and nonproviding physicians and health system stakeholders in Canadian health care settings. Our data collection, thematic analysis, and interpretation were guided by Diffusion of Innovation theory. RESULTS: We conducted interviews with 90 participants including rural practitioners and those with no previous abortion experience. In the course of our study, Health Canada removed mifepristone restrictions. Our results suggest that Health Canada's initial restrictions discouraged physicians from providing mifepristone and were inconsistent with provincial licensing standards, thereby limiting patient access. Once deregulated, remaining factors were primarily related to local and regional implementation processes. Participants held strong perceptions that mifepristone was the new standard of care for medical abortion in Canada and within the scope of primary care practice. CONCLUSION: Health Canada's removal of mifepristone restrictions facilitated the implementation of abortion care in the primary care setting. Our results are unique because Canada is the first country to facilitate provision of medical abortion in primary care via evidence-based deregulation of mifepristone.

Slow implementation of mifepristone medical termination of pregnancy in Quebec, Canada: a qualitative investigation.

Objectives: Mifepristone for first-trimester medical termination of pregnancy (MTOP) became available in Quebec in 2018, one year after the rest of Canada. Using the theory of the Diffusion of Innovation (DOI) and the transtheoretical model of change (TTM), we investigated factors influencing the implementation of mifepristone MTOP in Quebec.Material and Methods: Semi-structured interviews were conducted with 37 Quebec physicians in early 2018. Deductive thematic analysis guided by the theory of DOI explored facilitators and barriers to physicians' adoption of mifepristone MTOP. We then classified participants into five stages of mifepristone adoption based on the TTM. Follow-up data collection one year later assessed further adoption.Results: At baseline, three physicians provided mifepristone MTOP (Maintenance) and two were about to start (Action). Thirteen physicians at Preparation and Advanced Contemplation stages intended to start while, within the Slow Contemplation, two intended to start and ten were unsure. Seven had no intention to provide mifepristone MTOP (Pre-Contemplation). Major reported barriers were: complexity of local health care organisations, medical policy restrictions, lack of support, and general uncertainty. One year later, ten physicians provided mifepristone MTOP (including three at baseline) and nine still intended to, while seventeen did not intend to start provision. Seven of sixteen participants (44%) who worked in TOP clinics at baseline were still not providing MTOP with mifepristone one year later.Conclusion: Despite ideological support, mifepristone MTOP uptake in Quebec is slow and laborious, mainly due to restrictive medical policies, vested interests in surgical provision and administrative inertia.

Barriers and Facilitators to the Implementation of First Trimester Medical Abortion With Mifepristone in the Province of Québec: A Qualitative Investigation.

OBJECTIVE: Mifepristone became available in Canada in January 2017, but provincial medical policy delayed its use for medical abortion (MA) in Québec for 1 year. The objective of this study was to identify barriers and facilitators experienced by physicians who could potentially provide this newer abortion practice in Québec. METHODS: This study was part of the Canadian Contraception and Abortion Research Team-Mifepristone Implementation Study, an observational, prospective, mixed-methods study. Interviews were conducted with physicians representing all health regions of Québec. Using thematic analysis guided by diffusion of innovation theory, the study identified key barriers and facilitators to implementation. RESULTS: From January 2017 to March 2018, study investigators interviewed 25 family physicians and 12 obstetrician-gynaecologists. Most were women (81%), over 40 years old (65%), with >20 years in practice since residency (49%). Less than half of the sample provided abortion services (41%), and only 8% provided MA with mifepristone. Key barriers to implementation were: (1) uncertainty or confusion about policies regarding MA, (2) lack of human resources or support from colleagues, (3) uncertainty about product distribution, (4) confusion about professional collaboration, and (5) lack of local infrastructure. Key facilitators were: (1) perception of support and influence from colleagues, (2) previous experience with provision of first trimester MA, (3) requests for first trimester MA by patients or other physicians, and (4) knowledge of research on mifepristone MA. CONCLUSION: Despite Health Canada's approval of mifepristone in Canada and supportive federal policies for provision of MA in primary care, physicians in the province of Québec face onerous barriers to the practice of mifepristone MA.

Could implementation of mifepristone address Canada's urban-rural abortion access disparity: a mixed-methods implementation study protocol.

INTRODUCTION: In January 2017, mifepristone-induced medical abortion was made available in Canada. In this study, we will seek to (1) understand facilitators and barriers to the implementation of mifepristone across Canada, (2) assess the impact of a 'community of practice' clinical and health service support platform and (3) engage in and assess the impact of integrated knowledge translation (iKT) activities aimed to improve health policy, systems and service delivery issues to enhance patient access to mifepristone. METHODS AND ANALYSIS: This prospective mixed-methods implementation study will involve a national sample of physicians and pharmacists recruited via an online training programme, professional networks and a purpose-built community of practice website. Surveys that explore constructs related to diffusion of innovation and Godin's behaviour change frameworks will be conducted at baseline and at 6 months, and qualitative data will be collected from electronic interactions on the website. Survey participants and a purposeful sample of decision-makers will be invited to participate in in-depth interviews. Descriptive analyses will be conducted for quantitative data. Thematic analysis guided by the theoretical frameworks will guide interpretation of qualitative data. We will conduct and assess iKT activities involving Canada's leading health system and health professional leaders, including evidence briefs, Geographical Information System (GIS)maps, face-to-face meetings and regular electronic exchanges. Findings will contribute to understanding the mechanisms of iKT relationships and activities that have a meaningful effect on uptake of evidence into policy and practice. ETHICS AND DISSEMINATION: Ethical approval was received from the University of British Columbia Children's and Women's Hospital Ethics Review Board (H16-01006). Full publication of the work will be sought in an international peer-reviewed journal. Findings will be disseminated to research participants through newsletters and media interviews, and to policy-makers through invited evidence briefs and face-to-face presentations.

Regulatory approval time for hormonal contraception in Canada, the United States and the United Kingdom, 2000-2015: a retrospective data analysis.

BACKGROUND: Access to a wide range of contraceptive methods improves prevention of unintended pregnancy by ensuring the best method fit for each individual. We compared approval times of new hormonal contraceptives by Health Canada, the US Food and Drug Administration (FDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA). METHODS: We obtained dates of applications to Health Canada, the FDA and the MHRA for contraceptive methods approved from January 2000 to January 2015. We used public data sources and direct correspondence, and excluded generic versions of previously approved drugs. The primary outcome of interest was median time to approval for novel hormonal contraceptives. Secondary outcomes included the median time to approval for all hormonal contraceptives and the number of approved hormonal contraceptives comparing countries studied, as well as the median time for approval of novel compared with nonnovel hormonal contraceptives within each country. RESULTS: During this period 16 contraceptives were approved in Canada, 26 in the US and 14 in the UK. Applications for novel contraceptives were initiated later in Canada, and time to approval was longer in Canada than in the US (p = 0.03). The median time to approval for all contraceptives in Canada was 529.5 (interquartile range [IQR] 420.8 to 784.0) days, compared with 396.0 (IQR 308.0 to 594.5) days in the US and 341.0 (IQR 244.8 to 512.2) days in the UK. No subdermal implant contraceptives are approved in Canada. INTERPRETATION: Canadian women wait longer for novel contraceptive methods and have fewer options. Canada could improve population health by addressing the regulatory barriers associated with the unmet need for contraception. Facilitation for approval of a contraceptive implant, and improvement to prolonged novel drug approval times, could support Canadians to plan and space their pregnancies.

Measuring interprofessional competencies and attitudes among health professional students creating family planning virtual patient cases.

BACKGROUND: The Virtual Interprofessional Patients-Computer-Assisted Reproductive Health Education for Students (VIP-CARES) Project took place during the summers of 2010-2012 for eight weeks each year at the University of British Columbia (UBC). Undergraduate health care students worked collaboratively to develop virtual patient case-based learning modules on the topic of family planning. The purpose of this study was to evaluate the changes in perception towards interprofessional collaboration (IPC) among the participants, before and after the project. METHODS: This study utilized a mixed methods evaluation using self-assessment survey instruments, semi-structured interviews, and reflective essays. Pre- and post- project surveys were adapted from the Canadian Medical Education Determinants (CanMEDS) and Canadian Interprofessional Health Collaborative (CIHC) frameworks, as well as the Memorial University Interprofessional Attitudes (IPA) questionnaire. The survey results were analyzed as mean (M) and standard deviation (SD) on Likert scales. The non-parametric Wilcoxon signed-rank test was used to determine if any significant changes were measured between each participant's differences in score (p ≤ 0.05). Post-project interview transcripts and essays were analyzed using recursive abstraction to elicit any themes. RESULTS: Altogether, 26 students in medicine, pharmacy, nursing, midwifery, dentistry, counselling psychology, and computer science participated in VIP-CARES, during the three years. Student attitudes toward IPC were positive before and after the project. At the project's conclusion, there was a statistically significant increase in the participants' self-assessment competency scores in the CanMEDS roles of health advocate (p = 0.05), manager (p = 0.02), and medical expert (p = 0.03), as well as the CIHC domains of interprofessional communication (p = 0.04), role clarification (p = 0.01), team functioning (p = 0.05), and collaborative leadership (p = 0.01). Qualitative evaluations yielded three major themes: communication and respect as key to team functioning, importance of role clarification within the team, and existence of inherent challenges to IPC. From the reflections, students generally felt more comfortable with their improvements in the CIHC domains of interprofessional communication, team functioning, and role clarification. CONCLUSION: After working within an interdisciplinary team developing virtual patient learning modules on family planning, the student participants of the VIP-CARES Project indicated general improvement in the skills necessary for effective interprofessional collaboration. Triangulation of the overall data suggests this was especially observed within the areas of interprofessional communication, team functioning, and role clarification.

Medications Used in Evidence-Based Regimens for Medical Abortion: An Overview.

OBJECTIVE: Abortion is one of the most common medical procedures a woman experiences in her lifetime. Even though overall rates of abortion are decreasing slightly, medical abortion rates are expected to increase in Canada following approval by Health Canada of a combination of mifepristone and misoprostol for use in medical abortion. METHODS: We conducted a literature review as part of the development of the 2016 Society of Obstetricians and Gynaecologists of Canada's Clinical Practice Guidelines on medical abortion. We searched the PubMed, MEDLINE, and Cochrane databases for articles published between 1986 and 2015 using the MeSH terms "induced abortion," "medical abortion," "mifepristone," "misoprostol," "methotrexate," and "prostaglandin." Additionally, we reviewed existing international medical abortion guidelines and searched reference lists. RESULTS: The most commonly studied medical abortion regimens are combinations of mifepristone and misoprostol, methotrexate and misoprostol, mifepristone and prostaglandin, and misoprostol only. Each of these regimens is a potential therapeutic choice; the advantages and disadvantages of each regimen are discussed. CONCLUSION: Drugs used for medical abortion are safe; however, clinicians who provide medical abortion and those who provide care to women who have undergone medical abortion should have an understanding of the pharmacokinetics and clinical effects of the medications used to improve outcomes and mitigate risk.

Population-based evaluation of the effectiveness of two regimens for emergency contraception.

OBJECTIVE: To estimate and compare the effectiveness of the levonorgestrel and Yuzpe regimens for hormonal emergency contraception in routine clinical practice. METHODS: A retrospective population-based study included women who accessed emergency contraceptives for immediate use prescribed by community pharmacists in British Columbia, Canada, between December 2000 and December 2002. Linked administrative healthcare data were used to discern the timings of menses, unprotected intercourse, and any pregnancy-related health services. A panel of experts evaluated the compatibility of observed pregnancies with the timing of events. The two regimens were compared with statistical adjustments for potential confounding. RESULTS: Among 7493 women in the cohort, 4470 (59.7%) received levonorgestrel and 3023 (40.3%) the Yuzpe regimen. There were 99 (2.2%) compatible pregnancies in the levonorgestrel group and 94 (3.1%) in the Yuzpe group (P=0.017). The estimated odds ratio for levonorgestrel compared with the Yuzpe regimen after adjusting for potential confounders was 0.64 (95% confidence interval 0.47-0.87). Against an expected pregnancy rate of approximately 5%, the relative and absolute risk reductions were 56.0% and 2.8%, respectively, for levonorgestrel and 36.7% and 1.8% for the Yuzpe regimen. CONCLUSION: The levonorgestrel regimen is more effective than the Yuzpe regimen in routine use. The data suggest that both regimens are less effective than has been observed in randomized trials.

The acceptability of contraception task-sharing among pharmacists in Canada--the ACT-Pharm study.

BACKGROUND: Access to prescription contraception is often limited by the availability of physicians, particularly in rural areas. Pharmacists are available but are not authorized in Canada to prescribe contraceptives, an innovation proved successful in the United States. It is unknown whether Canadian pharmacists, particularly those in rural areas, are willing to adopt this innovation and what barriers and facilitators they predict. We explored the acceptability and feasibility for independent provision of contraception at pharmacies throughout British Columbia (BC). METHODS: This mixed-methods study used validated questionnaires followed by optional structured interviews among all rural, and a sample of urban, community pharmacies in BC. Analyses use descriptive, logistic regression and qualitative thematic evaluation. RESULTS: Responding community pharmacies represent all geographic health regions of BC and the range of pharmacy business models. Respondents reported a mean of 17 years in practice. Seventy percent of pharmacies reported a private counseling area. Over 80%, including pharmacies in all regions, indicated willingness to prescribe hormonal contraceptives. Factors associated with willingness to prescribe were comfort using a protocol to assess sexual history, confidence about staff availability and public acceptability, and fewer years in practice. Pharmacists requested training in assessment protocols and liability issues prior to implementation. INTERPRETATION: Pharmacies from all areas throughout BC, responded and report a high degree of acceptability and feasibility for independent prescription of hormonal contraceptives. As pharmacists are often the most accessible health professional in rural areas, pharmacist provision of hormonal contraceptives has potential to improve access to contraception.

Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

BACKGROUND: Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. OBJECTIVES: The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. METHODS: A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. RESULTS: Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. CONCLUSIONS: As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

Canadian demand for highly qualified personnel for therapeutic evaluation: an opportunity for academic institutions.

Achievement of optimal therapeutics requires individuals with analytic skills appropriate to the balancing of enterprise, innovation and the need for rigorous scientific validation. A synergistic convergence of discovery research, clinical investigation, evaluative, regulatory and implementation sciences will be essential. None of the needed research capacities are likely to prove obtainable on demand. On the contrary, they require accurate projection of future needs and careful planning of post-secondary training programs. A survey conducted for Health Canada in 2010 revealed significant shortfalls in research skills available outside government and industry. This commentary argues that such an environment represents an outstanding opportunity for the academic community to demonstrate that it is eager to meet the needs of the Canadian public. University leaders should be assertive about their commitment to the ideals of patient oriented research and all governments should be clear about deliverables anticipated in return for consistent post-secondary funding.