The FDA in the Crosshairs-Science, Politics, and Abortion.

In this Viewpoint, the Supreme Court case FDA v AHM is used to illustrate the tension the FDA faces between science and politics, and state authority over abortion vs federal authority over which drugs may be marketed nationwide.

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.

Understanding the Impacts of the Supreme Court Case FDA v Alliance for Hippocratic Medicine.

This Viewpoint outlines the potential effects of the Supreme Court case regarding mifepristone restrictions: a decision for the FDA would allow current dispensing, while ruling against the FDA would severely curtail access to reproductive health options.

Requests for Self-managed Medication Abortion Provided Using Online Telemedicine in 30 US States Before and After the Dobbs v Jackson Women's Health Organization Decision.

This study assesses changes in online telemedicine requests to self-manage abortions with medications before vs after the Dobbs v Jackson Women's Health Organization Supreme Court decision overturning Roe v Wade.

Abordaje integral de la interrupción voluntaria del embarazo (primera entrega) / Comprehensive approach to the voluntary interruption of pregnancy (first issue)

En enero de 2021 entró en vigencia en Argentina la ley de Interrupción Voluntaria del Embarazo (IVE). Este cambio en la legislación implica una modificación sustancial de la práctica médica. En una serie de artículos, el equipo PROFAM comparte su punto de vista a través de una adaptación de su material educativo sobre la IVE. En esta primera entrega, las autoras abordan la aplicación de las cuestiones legales que determinan la práctica, la consejería general, y algunos lineamientos de cómo actuar ante la situación de un diagnóstico de embarazo inesperado. (AU)

In January 2021, the Voluntary Interruption of Pregnancy (VIP) law came into force in Argentina. This change in legislation implies a substantial modification regarding medical practice. In a series of articles, the PROFAM team shares its point of view through an adaptation of its educational material on the VIP. In this first issue, the authors address the application of the legal aspects that determine the practice, general counselling, and some guidelines on how to act when faced with a diagnosis of an unexpected pregnancy. (AU)

Abordaje integral de la Interrupción Voluntaria del Embarazo: (segunda entrega) / Comprehensive approach to the voluntary interruption of pregnancy: (second issue)

La legalización de la interrupción voluntaria del embarazo ha transformado la práctica médica con respecto a la atención de las pacientes que desean interrumpir la gestación hasta la semana 14 en Argentina. En la primera entrega, el equipo PROFAM compartió su punto de vista a través de una adaptación de su material educativo destinado, sobre todo, a aclarar los aspectos legales que hacen a la práctica cotidiana. En esta entrega se desarrolla en detalle el procedimiento para realizar un aborto farmacológico con misoprostol y mifepristona, así como las generalidades del aspirado manual endouterino. (AU)

The legalization of voluntary termination of pregnancy has transformed medical practice regarding the care of patients who wish to terminate a pregnancy up to 14 weeks in Argentina. In the first issue, the PROFAM team shared its point of view through an adaptation of its educational material aimed, above all, at clarifying the legal aspects of daily practice. In this issue, the procedure to perform a pharmacological abortion with misoprostol and mifepristone is developed in detail, as well as the generalities of manual uterine aspiration technique. (AU)

Resgate histórico do primeiro programa público de interrupção da gestação por estupro no Brasil / Historical rescue of the first public rape pregnancy program in Brazil

Os autores apresentam a evolução histórica dos caminhos percorridos até a criação do primeiro programa público de interrupção legal da gestação no Brasil. Mencionam o atendimento antes desse programa, que era realizado por poucos, de maneira dissimulada e sem publicidade nem publicações para a preservação das equipes. Mencionam como o Hospital Municipal Dr. Arthur Ribeiro de Saboya foi escolhido para esse desafio. Resgatam a luta das mulheres e dos movimentos feministas, e a criação da portaria que determinava a obrigatoriedade do atendimento para a realização do abortamento legal nos casos de antijuricidade, pela Prefeitura Municipal de São Paulo. Mencionam os difíceis caminhos até a constituição das equipes de atendimento e o desenrolar de uma sequência de fatos históricos, passando pelo início do atendimento imediato às vítimas no sentido de realizar as profilaxias pertinentes, a utilização de aspiração manual intrauterina (AMIU) como técnica principal para atendimento ao abortamento em todas as suas situações, os Fóruns Nacionais de Aborto Legal realizados pelo Cemicamp, Ministério da Saúde e Federação Brasileira das Associações de Ginecologia e Obstetrícia (Febrasgo), entre outros, que culminaram com tudo o que temos hoje em termos de atendimento integral à saúde da mulher, mormente no que tange aos direitos sexuais e reprodutivos, à violência sexual e à interrupção legal da gestação.(AU)

The authors present the historical evolution of the paths traveled until the creation of the First Public Program for Legal Interruption of Pregnancy in Brazil. They mention the care before this program that was carried out by a few, in a covert way and without advertisements or publications for the preservation of the team. Mention as the Municipal Hospital Dr. Arthur Ribeiro de Saboya was chosen for this challenge. They rescued the struggle of women and feminist movements, the creation of the ordinance that determined the mandatory care for the performance of legal abortion in cases of anti-juristy, by the city of São Paulo. They mention the difficult paths to the constitution of care teams and the development of a sequence of historical facts, through the beginning of immediate care to victims in order to perform the relevant prophylaxis, in the use of the AMIU as the main technique for abortion care in all its situations, the National Legal Abortion Forums held by Cemicamp, Ministry of Health and Federação Brasileira das Associações de Ginecologia e Obstetrícia (Febrasgo), among others, which culminated in all that we have today in terms of comprehensive care for women's health, especially with regard to sexual and reproductive rights, sexual violence and legal interruption of pregnancy.(AU)

Abortion care pathways and service provision for adolescents in high-income countries: A qualitative synthesis of the evidence.

Limited research in high-income countries (HICs) examines adolescent abortion care-seeking pathways. This review aims to examine the pathways and experiences of adolescents when seeking abortion care, and service delivery processes in provision of such care. We undertook a systematic search of the literature to identify relevant studies in HICs (2000-2020). A directed content analysis of qualitative and quantitative studies was conducted. Findings were organised to one or more of three domains of an a priori conceptual framework: context, components of abortion care and access pathway. Thirty-five studies were included. Themes classified to the Context domain included adolescent-specific and restrictive abortion legislation, mostly focused on the United States. Components of abortion care themes included confidentiality, comprehensive care, and abortion procedure. Access pathway themes included delays to access, abortion procedure information, decision-making, clinic operation and environments, and financial and transportation barriers. This review highlights issues affecting access to abortion that are particularly salient for adolescents, including additional legal barriers and challenges receiving care due to their age. Opportunities to enhance abortion access include removing legal barriers, provision of comprehensive care, enhancing the quality of information, and harnessing innovative delivery approaches offered by medical abortion.

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.

State and federal abortion restrictions increase risk of COVID-19 exposure by mandating unnecessary clinic visits.

OBJECTIVE: To quantify the number of medically unnecessary clinical visits and in-clinic contacts monthly caused by US abortion regulations. STUDY DESIGN: We estimated the number of clinical visits and clinical contacts (any worker a patient may come into physical contact with during their visit) under the current policy landscape, compared to the number of visits and contacts if the following regulations were repealed: (1) State mandatory in-person counseling visit laws that necessitate two visits for abortion, (2) State mandatory-ultrasound laws, (3) State mandates requiring the prescribing clinician be present during mifepristone administration, (4) Federal Food and Drug Administration Risk Evaluation and Mitigation Strategy for mifepristone. If these laws were repealed, "no-test" telemedicine abortion would be possible for some patients. We modeled the number of visits averted if a minimum of 15 percent or a maximum of 70 percent of medication abortion patients had a "no-test" telemedicine abortion. RESULTS: We estimate that 12,742 in-person clinic visits (50,978 clinical contacts) would be averted each month if counseling visit laws alone were repealed, and 31,132 visits (142,910 clinical contacts) would be averted if all four policies were repealed and 70 percent of medication abortion patients received no-test telemedicine abortions. Over 2 million clinical contacts could be averted over the projected 18-month COVID-19 pandemic. CONCLUSION: Medically unnecessary abortion regulations result in a large number of excess clinical visits and contacts. POLICY IMPLICATIONS: Repeal of medically unnecessary state and federal abortion restrictions in the United States would allow for evidence-based telemedicine abortion care, thereby lowering risk of SARS-CoV-2 transmission.

At-home telemedicine for medical abortion in Australia: a qualitative study of patient experiences and recommendations.

INTRODUCTION: This study aimed to explore patient experiences obtaining a medical abortion using an at-home telemedicine service operated by Marie Stopes Australia. METHODS: From July to October 2017, we conducted semistructured in-depth telephone interviews with a convenience sample of medical abortion patients from Marie Stopes Australia. We analysed interview data for themes relating to patient experiences prior to service initiation, during an at-home telemedicine medical abortion visit, and after completing the medical abortion. RESULTS: We interviewed 24 patients who obtained care via the at-home telemedicine medical abortion service. Patients selected at-home telemedicine due to convenience, ability to remain at home and manage personal responsibilities, and desires for privacy. A few telemedicine patients reported that a lack of general practitioner knowledge of abortion services impeded their access to care. Most telemedicine patients felt at-home telemedicine was of equal or superior privacy to in-person care and nearly all felt comfortable during the telemedicine visit. Most were satisfied with the home delivery of the abortion medications and would recommend the service. CONCLUSION: Patient reports suggest that an at-home telemedicine model for medical abortion is a convenient and acceptable mode of service delivery that may reduce patient travel and out-of-pocket costs. Additional provider education about this model may be necessary in order to improve continuity of patient care. Further study of the impacts of this model on patients is needed to inform patient care and determine whether such a model is appropriate for similar geographical and legal contexts.

Childbirth, Puerperium and Abortion Care Protocol during the COVID-19 Pandemic.

The new coronavirus (severe acute respiratory syndrome-related coronavirus 2, SARS-CoV-2) is a virus that causes a potentially serious respiratory disease that has spread in several countries, reaching humans in all age groups, including pregnant women. The purpose of this protocol is to provide technical and scientific support to Brazilian obstetricians regarding childbirth, postpartum and abortion care during the pandemic.

O novo coronavírus (severe acute respiratory syndrome-related coronavirus 2, SARS-CoV-2) é um vírus que causa uma doença respiratória potencialmente grave que se espalhou por vários países, acometendo seres humanos de todas as faixas etárias, incluindo gestantes. O propósito deste protocolo é fornecer apoio técnico e científico aos obstetras brasileiros com relação aos cuidados no parto, pós-parto e aborto durante a pandemia.

COVID-19 and abortion: The importance of guaranteeing a fundamental right.

Because of the COVID-19 Pandemic many problems have emerged in the organization of the National Health Systems. In Italy, a very serious problem is emerging which needs a rapid solution. Italian women are finding increasingly difficult to access abortion. These difficulties are related to the organizational changes that have occurred in many hospitals due to the emergency COVID-19. A possible solution would be to resort to the procedure of pharmacological abortion which, however, in Italy, is characterized by many limitations imposed by law. To protect the right to health of all women will need a reorganization of abortion procedures in Italy with implementation of telehealth services.

Childbirth, puerperium and abortion care protocol during the Covid-19 pandemic / Protocolo de cuidados no parto, no puerpério e no abortamento durante a pandemia de Covid-19

Abstract The new coronavirus (severe acute respiratory syndrome-related coronavirus 2, SARSCoV- 2) is a virus that causes a potentially serious respiratory disease that has spread in several countries, reaching humans in all age groups, including pregnant women. The purpose of this protocol is to provide technical and scientific support to Brazilian obstetricians regarding childbirth, postpartum and abortion care during the pandemic.

Resumo O novo coronavírus (severe acute respiratory syndrome-related coronavirus 2, SARS-CoV- 2) é umvírus que causa uma doença respiratória potencialmente grave que se espalhou por vários países, acometendo seres humanos de todas as faixas etárias, incluindo gestantes. O propósito deste protocolo é fornecer apoio técnico e científico aos obstetras brasileiros com relação aos cuidados no parto, pós-parto e aborto durante a pandemia.

Comparison of Medical Abortion with Manual Vacuum Aspiration in Termination of Pregnancy up to Nine Weeks.

BACKGROUND: Nepal government has legalized abortion and approved both medical abortion and manual vacuum aspiration for first trimester pregnancy. However, there is inadequate evidence in our setup to comment on the acceptability and complications of medical abortion and manual vacuum aspiration for termination of pregnancy up to nine weeks of gestation. The objective of this study is to compare the reasons for termination of pregnancy, effectiveness and complications between medical abortion and manual vacuum aspiration in termination of pregnancy up to nine weeks. METHODS: A comparative study was conducted among women requesting termination of pregnancy up to nine weeks of gestation in Comprehensive Abortion Care unit of Paropakar Maternity and Women's Hospital. Women were kept in medical abortion and manual vacuum aspiration groups after they chose the method. They were advised for follow up in two weeks. Reasons for termination, effectiveness and complications of medical abortion and manual vacuum aspiration were compared using Chi square test. RESULTS: In a total of 160 women, the most common reason for termination of pregnancy was completion of the family. In manual vacuum aspiration group 43 (58.9%) women had minimal per vaginal bleeding while 30 (40.54%) women in medical abortion group had per vaginal bleeding for 6-10 days(p less than 0.001). Rate of complete abortion in medical abortion group was 85.14% (n=63) and in manual vacuum aspiration group was 93.15% (n=68). CONCLUSIONS: The complications following medical abortion were higher than manual vacuum aspiration in termination of pregnancy up to nine weeks. Rate of completeness of abortion following manual vacuum aspiration is superior over medical abortion.