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.

Factors Associated With Use of an Online Telemedicine Service to Access Self-managed Medical Abortion in the US.

Importance: People in the US have been seeking self-managed abortions outside the formal health care system using medications obtained through online telemedicine. However, little is known about this practice, including potential motivating factors. Objective: To examine individual reasons for accessing medication abortion through an online telemedicine service as well as associations between state- and county-level factors and the rate of requests. Design, Setting, and Participants: This population-based cross-sectional study examined all requests for self-managed medication abortion through an online consultation form available from Aid Access, a telemedicine service in the US, between March 20, 2018, and March 20, 2020. Main Outcomes and Measures: Individual-level reasons for accessing the telemedicine service were examined as well as the rate of requests per 100 000 women of reproductive age by state. Zip code data provided by individuals making requests were used to examine county-level factors hypothesized to be associated with increased demand for self-managed abortion: distance to a clinic (calculated using location data for US abortion clinics) and the population proportion identifying as a member of a racial/ethnic minority group, living below the federal poverty level, and having broadband internet access (calculated using census data). Results: During the 2-year study period, 57 506 individuals in 2458 counties in 50 states requested self-managed medication abortion; 52.1% were aged 20 to 29 years (mean [SD] age, 25.9 [6.7] years), 50.0% had children, and 99.9% were 10 weeks' pregnant or less. The most common reasons cited by individuals making requests were the inability to afford in-clinic care (73.5%), privacy (49.3%), and clinic distance (40.4%). States with the highest rate of requests were Louisiana (202.7 per 100 000 women) and Mississippi (199.9 per 100 000 women). At the county level, an increase of 1 SD (47 miles) in distance to the nearest clinic was significantly associated with a 41% increase in requests (incidence rate ratio, 1.41; 95% CI, 1.31-1.51; P < .001), and a 10% increase in the population living below the federal poverty level was significantly associated with a 20% increase in requests (incidence rate ratio, 1.20; 95% CI, 1.13-1.28; P < .001). Conclusions and Relevance: In this cross-sectional study, clinic access barriers were the most commonly cited reason for requesting self-managed medication abortion using an online telemedicine service. At the county level, distance to an abortion clinic and living below the federal poverty level were associated with a higher rate of requests. State and federal legislation could address these access barriers.

Abortion exceptionalism and the mifepristone REMS.

Since its initial approval, mifepristone has been regulated with a strictness out of proportion to its risks. This paper explores how the regulation of mifepristone, specifically the Risk Evaluation and Mitigation Strategies (REMS) requirements, are a manifestation of abortion exceptionalism-the phenomenon of abortion being treated differently under the law than other comparable health care. The weight of medical and public health evidence demonstrates that mifepristone is extremely safe and the REMS are unnecessary. In fact, the mifepristone REMS is neither justified by the absolute risk of the medication itself, nor comprehensible as a logical response to the risks actually posed by mifepristone. Nevertheless, the REMS remain in place. From July 2020 through January 2021, enforcement of the REMS elements requiring in-person distribution of mifepristone were enjoined by court order due the COVID-19 pandemic. In other words, COVID-19 created a context so exceptional as to temporarily outweigh abortion exceptionalism. However, the reprieve did not last-in January 2021, the Supreme Court ruled to dissolve the injunction, allowing FDA to resume enforcement of the in-person requirements. In response, advocates called on the incoming Biden administration to direct FDA to suspend enforcement once more. This regulatory whiplash is itself further evidence that the REMS flow from political, rather than scientific, concerns. Abortion exceptionalism is apparent in the specific requirements of the REMS, and it is also apparent in the precarity of the regulatory scheme itself.