Food and Drug Administration v Alliance for Hippocratic Medicine-A Cautious Win for Reproductive Health Care and FDA Authority.

This Viewpoint discusses the recent US Supreme Court ruling allowing mifepristone­a drug used in medication abortion­to be widely available in the US, summarizes the history of challenges to the availability of mifepristone, and highlights reasons for concerns that remain after the Court's current ruling.

Access to mifepristone, misoprostol, and contraceptive medicines in eight countries in the Eastern Mediterranean Region: descriptive analyses of country-level assessments.

BACKGROUND: Despite their importance in reducing maternal mortality, information on access to Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region is limited. METHODS: A standardized assessment tool measuring access to Mifepristone, Misoprostol, and contraceptive medicines included in the WHO essential medicines list (EML) was implemented in eight countries in the Eastern Mediterranean Region (Afghanistan, Iraq, Lebanon, Libya, Morocco, Palestine, Pakistan, and Somalia) between 2020-2021. The assessment focused on five access measures: 1) the inclusion of medicines in national family planning guidelines; 2) inclusion of medicines in comprehensive abortion care guidelines; 3) inclusion of medicines on national essential medicines lists; 4) medicines registration; and 5) procurement and forecasting of Mifepristone, Misoprostol, and contraceptive medicines. A descriptive analysis of findings from these eight national assessments was conducted. RESULTS: Only Lebanon and Pakistan included all 12 contraceptives that are enlisted in the WHO-EML within their national family planning guidelines. Only Afghanistan and Lebanon included mifepristone and mifepristone-misoprostol combination in post-abortion care guidelines, but these medicines were not included in their national EMLs. Libya and Somalia lacked a national regulatory authority for medicines registration. Most contraceptives included on the national EMLs for Lebanon, Morocco and Pakistan were registered. Misoprostol was included on the EMLs-and registered-in six countries (Afghanistan, Iraq, Lebanon, Morocco, Palestine, and Pakistan). However, only three countries procured misoprostol (Iraq, Morocco, and Somalia). CONCLUSION: These findings can guide efforts aimed at improving the availability of Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region. Opportunities include expanding national EMLs to include more options for Mifepristone, Misoprostol, and contraceptive medicines and strengthening the registration and procurement systems to ensure these medicines' availability were permitted under national law and where culturally acceptable.

Ensuring access to Mifepristone, Misoprostol, and contraceptive medicines is critical to improving women's health, and more specifically reducing maternal mortality and improving women's sexual and reproductive health in the Eastern Mediterranean Region.The aim of this study was to analyse findings from national assessments to capture information on the implementation of relevant policies and procedures. Those were the policies that ensure access to Mifepristone, Misoprostol, and contraceptive medicines in the public sector for the eight Eastern Mediterranean Region countries included in the study (Afghanistan, Iraq, Libya, Lebanon, Morocco, Palestine, Pakistan, and Somalia). The assessments were completed between 2020 and 2021.We found that most countries did not include all twelve contraceptives enlisted in the WHO essential medicines list (EML) in their national family planning guidelines. No country had developed a national abortion care guidelines nor included mifepristone (alone or in combination with misoprostol) on national EML. Libya and Somalia lacked a national regulatory authority for medicines registration. Most contraceptives included on the national EMLs for Lebanon, Morocco and Pakistan were registered. Misoprostol was included on the EMLs­and registered­in six countries (Afghanistan, Iraq, Lebanon, Morocco, Palestine, and Pakistan) yet, only three countries procured misoprostol (Iraq, Morocco, and Somalia).Our findings provide evidence on system-level barriers to availability of Mifepristone, Misoprostol, and contraceptive medicines (e.g., lack of guidelines or inclusion on EML, lack of registration and procurement) that can support policy and advocacy efforts to strengthen the pharmaceutical sector to better ensure availability of Mifepristone, Misoprostol, and contraceptive medicines to women in reproductive age at the country-level in accordance with the national law and prevailing culture.

Landscape assessment of the availability of medical abortion medicines in India.

BACKGROUND: Medical abortion with mifepristone and misoprostol can be provided up to 63 days' gestation in India. This accounts for 67.5 percent of all abortions in the country. We conducted an assessment to determine the availability of medical abortion medicines, specifically the combi-pack, in India. METHODS: We applied the World Health Organization landscape assessment protocol at the national level. The assessment protocol included a five-step adaptation of an existing availability framework, including online data collection, desk review, country-level key informant interviews, and an analysis to identify barriers and opportunities to improve medical abortion availability. The assessment was conducted between August and March 2021. RESULTS: Medicines for medical abortion are included in the national essential drug list and available with prescription in India. The assessment identified 42 combi-pack products developed by 35 manufacturers. The quality of medical abortion medicines is regulated by national authorities; but as health is devolved to states, there are significant inter-state variations. This is seen across financing, procurement, manufacturing, and monitoring mechanisms for quality assurance of medical abortion medicines prior to distribution. There is a need to strengthen supply chain systems, ensure consistent availability of trained providers and build community awareness on use of medical abortion medicines for early abortions, at the time of the assessment. CONCLUSION: Opportunities to improve availability and quality of medical abortion medicines exist. For example, uniform implementation of regulatory standards, greater emphasis on quality-assurance during manufacturing, and standardizing of procurement and supply chain systems across states. Regular in-service training of providers on medical abortion is required. Finally, innovations in evidence dissemination and community engagement about the recently amended abortion law are needed.

Medical abortion is popular in India and benefits from a liberal legal context. It is important to understand the availability of quality abortion medicines in the country. Using the World Health Organization country assessment protocol and availability framework for medical abortion medicines we examined the availability of these medicines from supply to demand. We used this information to identify opportunities for increasing availability of quality-assured medical abortion medicines. We found that the context for medical abortion varies across states. Strengthening procurement and supply chain management, with a greater emphasis on quality-assurance and regulation of manufacturing should be instituted at the state-level. Training is also needed to increase provider knowledge of the latest national guidelines and laws to ensure respectful and person-centered services. Finally, the public should be informed about medical abortion as a safe and effective choice, especially for early abortions.

Availability of mifepristone and misoprostol in Oregon pharmacies: A comparison by rural and urban status.

OBJECTIVES: To evaluate the availability of mifepristone and misoprostol at pharmacies in a state with protective abortion legislation and variation in access by rurality. STUDY DESIGN: Using a secret shopper survey, researchers attempted to contact all community pharmacies in Oregon and evaluate their mifepristone and misoprostol provisions. RESULTS: Among the 444 pharmacies surveyed, mifepristone was planned at 19.2%. Misoprostol was available at 77.5%, but stocking issues and medication ordering impact access, without significant differences by rurality. CONCLUSIONS: Pharmacy engagement and support are key to increasing access to these essential medicines, which may be improved through education and referral programs.

Provision of Medications for Self-Managed Abortion Before and After the Dobbs v Jackson Women's Health Organization Decision.

Importance: The Supreme Court decision in Dobbs v Jackson Women's Health Organization overturned the right to choose abortion in the US, with at least 16 states subsequently implementing abortion bans or 6-week gestational limits. Prior research indicates that in the 6 months following Dobbs, approximately 32 360 fewer abortions were provided within the US formal health care setting. However, trends in the provision of medications for self-managed abortion outside the formal health care setting have not been studied. Objective: To determine whether the provision of medications for self-managed abortion outside the formal health care setting increased in the 6 months after Dobbs. Design, Setting, and Participants: Cross-sectional study using data from sources that provided abortion medications outside the formal health care setting to people in the US between March 1 and December 31, 2022, including online telemedicine organizations, community networks, and online vendors. Using a hierarchical bayesian model, we imputed missing values from sources not providing data. We estimated the change in provision of medications for self-managed abortion after the Dobbs decision. We then estimated actual use of these medications by accounting for the possibility that not all provided medications are used by recipients. Exposure: Abortion restrictions following the Dobbs decision. Main Outcomes and Measures: Provision and use of medications for a self-managed abortion. Results: In the 6-month post-Dobbs period (July 1 to December 31, 2022), the total number of provisions of medications for self-managed abortion increased by 27 838 (95% credible interval [CrI], 26 374-29 175) vs what would have been expected based on pre-Dobbs levels. Excluding imputed data changes the results only slightly (27 145; 95% CrI, 25 747-28 246). Accounting for nonuse of medications, actual self-managed medication abortions increased by an estimated 26 055 (95% CrI, 24 739-27 245) vs what would have been expected had the Dobbs decision not occurred. Conclusions and Relevance: Provision of medications for self-managed abortions increased in the 6 months following the Dobbs decision. Results suggest that a substantial number of abortion seekers accessed services despite the implementation of state-level bans and restrictions.

Leadership for success in transforming medical abortion policy in Canada.

OBJECTIVES: Mifepristone was approved for use in medical abortion by Health Canada in 2015. Approval was accompanied by regulations that prohibited pharmacist dispensing of the medication. Reproductive health advocates in Canada recognized this regulation would limit access to medical abortion and successfully worked to have this regulation removed in 2017. The purpose of this study was to assess the leadership involved in changing these regulations so that the success may be replicated by other groups advocating for health policy change. METHODS: This study involved a mixed methods instrumental design in the context of British Columbia, Canada. Our data collection included: a) interviews with seven key individuals, representing the organizations that worked in concert for change to Canadian mifepristone regulations, and b) document analysis of press articles, correspondence, briefing notes, and meeting minutes. We conducted a thematic analysis of transcripts of audio-recorded interviews. We identified strengths and weaknesses of the team dynamic using the Develop Coalitions, Achieve Results and Systems Transformation domains of the LEADS Framework. RESULTS: Our analysis of participant interviews indicates that autonomy, shared values, and clarity in communication were integral to the success of the group's work. Analysis using the LEADS Framework showed that individuals possessed many of the capabilities identified as being necessary for successful health policy leadership. A lack of post-project assessment was identified as a possible limitation and could be incorporated in future work to strengthen dynamics especially when a desired outcome is not achieved. Document analysis provided a clear time-line of the work completed and suggested that strong communication between team members was another key to success. CONCLUSIONS: The results of our analysis of the interviews and documents provide valuable insight into the workings of a successful group committed to a common goal. The existing collegial and trusting relationships between key stakeholders allowed for interdisciplinary collaboration, rapid mobilization, and identification of issues that facilitated successful Canadian global-first deregulation of mifepristone dispensing.

Online access to abortion medications: a review of utilization and clinical outcomes.

We performed a search in PubMed and Web of Science on the self-use of abortion medication after online access. Studies published between January 1, 1995, and March 31, 2019, were considered. We included studies of online services that were (i) led by healthcare staff (n = 14), (ii) led by non-healthcare staff (n = 4), and (iii) providing noninteractive access (n = 17). Our outcomes were utilization (frequency and demand for services), acceptability for women, safety, and success rate. Key findings: Women are increasingly using the Internet to access abortion medication. Available services are of varying quality. Women accessing noninteractive services report feelings of distress related to the lack of medical guidance, and the demand for interactive guidance through the abortion process is high. Women using services led by healthcare staff report high rates of satisfaction and similar rates of clinical outcomes as those of in-person abortion care.

Exploring the feasibility of obtaining mifepristone and misoprostol from the internet.

OBJECTIVES: We aimed to document the experience of buying abortion pills from online vendors that do not require a prescription and to evaluate the active ingredient content of the pills received. STUDY DESIGN: We searched the internet to identify a convenience sample of websites that sold mifepristone and misoprostol to purchasers in the United States and attempted to order these products. We documented price, shipping time and other aspects of ordering. We sent the samples received to a testing laboratory that measured the amount of active ingredient in individual tablets. RESULTS: We identified 18 websites and ordered 22 products: 20 mifepristone-misoprostol combination products and 2 that contained only misoprostol. We received 18 combination products and the 2 misoprostol products from 16 different sites. No site required a prescription or any relevant medical information. The time between order and receipt of the 20 products ranged from 3 to 21 business days (median 9.5 days). The price for the 18 combination products ranged from $110 to $360, including shipping and fees; the products without mifepristone cost less. Chemical assays found that the 18 tablets labeled 200 mg mifepristone contained between 184.3 mg and 204.1 mg mifepristone, while the 20 tablets labeled 200 mcg misoprostol contained between 34.1 mcg and 201.4 mcg of the active ingredient. CONCLUSIONS: Obtaining abortion medications from online pharmaceutical websites is feasible in the United States. The mifepristone tablets received contained within 8% of the labeled amount of active agent. The misoprostol tablets all contained that compound but usually less than labeled. IMPLICATIONS STATEMENT: Given our findings, we expect that some people for whom clinic-based abortion is not easily available or acceptable may consider self-sourcing pills from the internet to be a rational option.

Abortion choices among women in Cambodia after introduction of a socially marketed medicated abortion product.

OBJECTIVE: To assess whether a social marketing initiative focusing on medicated abortion via a mifepristone/misoprostol "combipack" has contributed to reducing unsafe abortion in Cambodia. METHODS: In a questionnaire-based cross-sectional study, annual household surveys were conducted across 13 Cambodian provinces in 2010, 2011, and 2012. One married woman of reproductive age who was not pregnant and did not wish to be within the next 2 years in each randomly selected household was approached for inclusion. Participants were interviewed using a structured questionnaire. RESULTS: The questionnaire was completed by 1843 women in 2010, 2068 in 2011, and 2059 in 2012. Manual vacuum aspiration was reported by 61 (72.6%) of 84 women surveyed in 2010 who reported an abortion in the previous 12 months, compared with only 28 (52.8%) of 53 in 2012 (P=0.001). The numbers of women undergoing medicated abortion increased from 22 (26.2%) of 84 in 2010 to 27 (49.1%) of 53 in 2012 (P=0.003), whereas the numbers undergoing unsafe abortion decreased from 4 (4.8%) in 2010 to 0 in 2012 (P=0.051). CONCLUSION: Social marketing of medication abortion coupled with provider training in clinical and behavioral change could have contributed to a reduction in the prevalence of unsafe abortion and shifted the types of abortion performed in Cambodia, while not increasing the overall number of abortions.

Improving access to safe abortion in a rural primary care setting in India: experience of a service delivery intervention.

BACKGROUND: Abortion services were legalized in India in 1972, however, the access to safe abortion services is restricted, especially in rural areas. In 2002, medical abortion using mifepristone- misoprostol was approved for termination of pregnancy, however, its use has been limited in primary care settings. METHODS: This paper describes a service delivery intervention for women attending with unwanted pregnancies over 14 years in four primary care clinics of Rajasthan, India. Prospective data was collected to document the profile of women, method of abortion provided, contraceptive use and follow-up rates after abortion. This analysis includes data collected during August 2001-March 2015. RESULTS: A total of 9076 women with unwanted pregnancies sought care from these clinics, and abortion services were provided to 70 % of these. Most abortion seekers were married, had one or more children. After 2003, the use of medical abortion increased over the years and ultimately accounted for 99 % of all abortions in 2014. About half the women returned for a follow-up visit, while the proportion using contraceptives declined from 74 % to 52 % from 2001 to 2014. CONCLUSIONS: The results of our intervention indicate that integrating medical abortion into primary care settings is feasible and has a potential to improve access to safe abortion services in rural areas. Our experience can be used to guide program managers and service providers about reducing barriers and making abortion services more accessible to women.

Attitudes and preferences toward the provision of medication abortion in an urban academic internal medicine practice.

BACKGROUND: Mifepristone offers internal medicine doctors the opportunity to greatly expand access to abortion for their patients. Almost 70% of pregnancy terminations, however, still occur in specialized clinics. No studies have examined the preferences of Internal Medicine patients specifically. OBJECTIVE: Determine whether patient preference is a reason for the limited uptake of medication abortion among internal medicine physicians. PARTICIPANTS: Women aged 18-45 recruited from the waiting room in an urban academic internal medicine clinic. MEASURES: A semi-structured questionnaire was used to determine risk of unintended pregnancy and attitudes toward abortion. Support for provision of medication abortion in the internal medicine clinic was assessed with a yes/no question, followed by the open-ended question, "Why do you think this clinic should or should not offer medication abortion?" Subjects were asked whether it was very important, somewhat important, or not important for the internal medicine clinic to provide medication abortion. KEY RESULTS: Of 102 women who met inclusion criteria, 90 completed the survey, yielding a response rate of 88%. Twenty-two percent were at risk of unintended pregnancy. 46.7% had had at least one lifetime abortion. Among those who would consider having an abortion, 67.7% responded yes to the question, "Do you think this clinic should offer medication abortions?" and 83.9% stated that it was "very important" or "somewhat important" to offer this service. Of women open to having an abortion, 87.1% stated that they would be interested in receiving a medication abortion from their primary care doctor. CONCLUSIONS: A clinically significant proportion of women in this urban internal medicine clinic were at risk of unintended pregnancy. Among those open to having an abortion, a wide majority would consider receiving it from their internal medicine doctor. The provision of medication abortion by internal medicine physicians has the potential to greatly expand abortion access for women.

Has mifepristone medical abortion expanded abortion access in New Mexico? A survey of OB-GYN and Family Medicine physicians.

BACKGROUND: The FDA approval of mifepristone in 2000 broadened the available options for abortion. The aim of this study was to evaluate whether physicians in New Mexico have integrated the use of mifepristone into their practice. STUDY DESIGN: We performed a mail-out survey of New Mexico Obstetrician Gynecologists (Ob-Gyn) and Family Medicine (FM) physicians in 2001 and 2008. Questions addressed integration of abortion services, attitudes towards providing abortion in different scenarios and barriers to offering abortion services. RESULTS: The response rates were 59% for the 2001 survey and 54% in 2008. In 2001 and 2008, 11% and 15% (p=.26) of physicians, respectively, provided any abortion - medical or surgical. Similarly, in 2001 and 2008, 5% and 10% (p=.07) provided medical abortion. Commonly cited barriers to provision of abortion in both years were beliefs against abortion and lack of training. CONCLUSIONS: The number of physicians offering any abortion or medical abortion in New Mexico has not changed since the FDA approval of mifepristone. Residency training programs in FM and in Ob-gyn should include training in medical abortion.