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Contraception May 2024In January 2023, the Food & Drug Administration modified the Risk Evaluation and Mitigation Strategy program regulating mifepristone to allow direct dispensation from...
In January 2023, the Food & Drug Administration modified the Risk Evaluation and Mitigation Strategy program regulating mifepristone to allow direct dispensation from retail pharmacies. In June 2023, we conducted a random, distributive survey of pharmacies in California using secret shopper methodology to investigate the feasibility of accessing mifepristone. One pharmacy had mifepristone immediately available (<24 hours), and misoprostol availability was limited. Accessibility to misoprostol varied by type of pharmacy (p < 0.01), but not by region. Even in a reproductive freedom state, access to mifepristone and misoprostol from outpatient retail pharmacies remains limited.
PubMed: 38806139
DOI: 10.1016/j.contraception.2024.110506 -
NEJM Evidence Jun 2024AbstractWith recent severe restrictions to abortion accessibility in the United States and a pending Supreme Court case challenging the Food and Drug Administration's... (Review)
Review
AbstractWith recent severe restrictions to abortion accessibility in the United States and a pending Supreme Court case challenging the Food and Drug Administration's approval of mifepristone, evidence-based strategies to protect and expand access to abortion care are needed. Two safe and effective regimens for medication abortion are widely used globally - misoprostol-only and misoprostol in combination with mifepristone. However, misoprostol-only regimens are rarely used in the United States. In 2023, the National Abortion Federation and the Society of Family Planning updated their recommended protocol for misoprostol-only for medication abortion to 800 μg of misoprostol administered buccally, sublingually, or vaginally every 3 hours for three or more doses. To characterize the data supporting this specific regimen, this article reviews the relevant literature to address the question of how effective misoprostol-only is for medication abortion. The authors conclude that the updated misoprostol regimen is highly effective and a potential strategy for expanding access to abortion.
Topics: Misoprostol; Humans; Female; Abortion, Induced; Pregnancy; Abortifacient Agents, Nonsteroidal; Mifepristone; United States
PubMed: 38804786
DOI: 10.1056/EVIDccon2300129 -
West African Journal of Medicine Mar 2024Post-abortion care (PAC) is a crucial component of emergency obstetric care, and many of the primary health care centres (PHC) in the internally displaced person (IDP)...
Trends in the Management of Miscarriages with the Implementation of the Volunteer Obstetrician Scheme in Selected Primary Health Care Centres in Maiduguri, Northeastern Nigeria.
BACKGROUND
Post-abortion care (PAC) is a crucial component of emergency obstetric care, and many of the primary health care centres (PHC) in the internally displaced person (IDP) camps and host communities in Maiduguri lack it. Improved access to high-quality PACs is essential for meeting the reproductive health needs of the IDPs and reducing the maternal morbidity and mortality that can result from miscarriages. OBJECTIVE: To determine the trend in managing miscarriages in the IDP camps and host communities in Maiduguri and the impact of the volunteer obstetrician scheme (VOS) on PAC.
METHODOLOGY
We conducted a longitudinal study in selected PHCs serving IDP camps and host communities in Maiduguri. The study spanned five (5) years, and we compared the management of miscarriages and PAC services one year before the VOS project, two years during the project and two years after the project. During the two-year VOS project, staff manning the PHCs had supportive supervision with hands-on training on PAC. Chi-square for trend and odd ratio with a 95% confidence interval was used as appropriate to compare the trend in PAC services provided during the study period.
RESULTS
One thousand eight hundred and eight (1808) women presented with miscarriages, and 1562 (86.4%) required uterine evacuation. Medical evacuation with oral misoprostol was offered to 974 (62.4%), and manual vacuum aspiration (MVA) was used in 422 (27.0%) of the women who needed uterine evacuation. There was a statistically significant rise in the use of medical evacuation throughout the study period (52.2% before VOS, and 71.4% by the second year of VOS) with ꭓ2=41.64 and P<0.001. In comparison, the use of MVA fell from 38.6% in 2015 to 27.7% in 2019 (ꭓ2=34.74 and P<0.001). Similar rising trends were also observed in postabortion family planning acceptance (ꭓ2=22.27, P<0.001).
CONCLUSION
The Volunteer Obstetrician Scheme project appears to have improved PAC services, especially medical evacuation and family planning uptake in the PHCs in IDP camps and host communities in Maiduguri, Borno State, Nigeria. We recommend task shifting of PAC services and periodic supportive supervision to ensure the quality of care.
Topics: Humans; Female; Nigeria; Primary Health Care; Pregnancy; Volunteers; Abortion, Spontaneous; Longitudinal Studies; Adult; Obstetrics; Abortion, Induced; Young Adult; Obstetricians
PubMed: 38788122
DOI: No ID Found -
Obstetrics and Gynecology Jul 2024To compare 24-hour and 12-hour mifepristone-to-misoprostol intervals for second-trimester medication abortion. (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
OBJECTIVE
To compare 24-hour and 12-hour mifepristone-to-misoprostol intervals for second-trimester medication abortion.
METHODS
We conducted a prospective randomized controlled trial. Participants were allocated to receive mifepristone either 24 hours or 12 hours before misoprostol administration. The primary outcome was the time from the first misoprostol administration to abortion (induction time). Secondary outcomes included the time from mifepristone to abortion (total abortion time); fetal expulsion percentages at 12, 24, and 48 hours after the first misoprostol dose; side effects proportion; and pain and satisfaction scores. A sample size of 40 per group (N=80) was planned to compare the 24- and 12-hour regimens.
RESULTS
Eighty patients were enrolled between July 2020 and June 2023, with 40 patients per group. Baseline characteristics were comparable between groups. Median induction time was 9.5 hours (95% CI, 10.3-17.8 hours) and 12.5 hours (95% CI, 13.5-20.2 hours) in the 24- and 12-hour interval arms, respectively ( P =.028). Median total abortion time was 33.0 hours (95% CI, 34.2-41.9 hours) and 24.5 hours (95% CI, 25.7-32.4 hours) in the 24- and 12-hour interval groups, respectively ( P <.001). At 12 hours from misoprostol administration, 25 patients (62.5%) in the 24-hour arm and 18 patients (45.0%) in the 12-hour arm completed abortion ( P =.178). At 24 hours from misoprostol administration, 36 patients (90.0%) in the 24-hour arm and 30 patients (75.0%) in the 12-hour arm had complete abortion ( P =.139). The need for additional medication or surgical treatment for uterine evacuation, pain scores, side effects, and satisfaction levels were not different between groups.
CONCLUSION
A 24-hour mifepristone-to-misoprostol regimen for medication abortion in the second trimester provides a median 3-hour shorter induction time compared with the 12-hour interval. However, the median total abortion time was 8.5-hours longer in the 24-hour interval regimen. These findings can aid in shared decision making before medication abortion in the second trimester.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT04160221.
Topics: Humans; Female; Misoprostol; Mifepristone; Pregnancy; Pregnancy Trimester, Second; Abortion, Induced; Adult; Drug Administration Schedule; Prospective Studies; Abortifacient Agents, Nonsteroidal; Young Adult; Time Factors; Abortifacient Agents, Steroidal
PubMed: 38781593
DOI: 10.1097/AOG.0000000000005535 -
Issues in Law & Medicine 2024The U.S. FDA has permanently removed the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing...
The U.S. FDA has permanently removed the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing prescribing through telemedicine or on-line ordering and distribution through the mail and pharmacies, without standard pre-abortion testing. This will increase the risk of complications due to failure to adequately determine the gestational age or rule out ectopic pregnancy by ultrasound or physical exam, failure to perform labs to document whether RhoGAM is indicated, and failure to obtain appropriate informed consent to prevent unwanted abortions, among other concerns. The FDA justified this action by referencing flawed studies with significantly undercounted complications. The details of these study deficiencies are examined in this paper.
Topics: United States; United States Food and Drug Administration; Humans; Pregnancy; Abortion, Induced; Female; Misoprostol; Mifepristone
PubMed: 38771713
DOI: No ID Found -
PloS One 2024[This corrects the article DOI: 10.1371/journal.pone.0227245.].
[This corrects the article DOI: 10.1371/journal.pone.0227245.].
PubMed: 38768081
DOI: 10.1371/journal.pone.0304233 -
Contraception May 2024To evaluate the availability of mifepristone and misoprostol at pharmacies in a state with protective abortion legislation and variation in access by rurality.
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.
PubMed: 38763275
DOI: 10.1016/j.contraception.2024.110491 -
Reproductive Health May 2024In 2019, the World Health Organization identified improving access to safe abortion as an important priority toward improving sexual and reproductive health and rights...
BACKGROUND
In 2019, the World Health Organization identified improving access to safe abortion as an important priority toward improving sexual and reproductive health and rights and achieving Sustainable Development Goals. One strategy for addressing this priority is strengthening access to medicines for medical abortion. All 11 countries in the South-East Asia Region have some indications for legal abortion and permit post-abortion care. Therefore, strengthening access to medical abortion medicines is a reasonable strategy for improving access to safe abortion for the Region.
METHODOLOGY
We applied an adapted version of an existing World Health Organization landscape assessment protocol for the availability of medical abortion medicines at the country-level in the South-East Asia Region. We collected publicly available data on the existence of national health laws, policies, and standard treatment guidelines; inclusion of medical abortion medicines in the national essential medicines list; and marketing authorization status for medical abortion medicines for each country and verified by Ministries of health. The findings were once more presented, discussed and recommendations were formulated during regional technical consultation workshop. Each country teams participated in the process, and subsequently, the suggestions were validated by representatives from Ministries of Health..
RESULTS
Few countries in the Region currently have national policies and guidelines for comprehensive safe abortion. However, either mifepristone-misoprostol in combination or misoprostol alone (for other indications) is included in national essential medicines lists in all countries except Indonesia and Sri Lanka. Few countries earmark specific public funds for procuring and distributing medical abortion commodities. In countries where abortion is legal, the private sector and NGOs support access to medical abortion information and medicines. Several countries only allow registered medical practitioners or specialists to administer medical abortion.
CONCLUSION
Following this rapid participatory assessment and technical consultation workshop, the World Health Organization South-East Asia Regional Technical Advisory and Sexual and Reproductive Health and Rights technical committee recommended priority actions for policy and advocacy, service delivery, and monitoring and evaluation, and indicated areas for support.
Topics: Humans; Asia, Southeastern; World Health Organization; Health Services Accessibility; Female; Pregnancy; Abortion, Induced; Abortifacient Agents; Drugs, Essential
PubMed: 38760864
DOI: 10.1186/s12978-024-01791-4 -
Journal of Minimally Invasive Gynecology May 2024To investigate the feasibility of operative hysteroscopy by a hysteroscopic tissue removal system (HTRS) without anesthesia in women with endometrial polyps (EP) or...
STUDY OBJECTIVE
To investigate the feasibility of operative hysteroscopy by a hysteroscopic tissue removal system (HTRS) without anesthesia in women with endometrial polyps (EP) or retained products of conception (RPOC).
DESIGN
Prospective observational cohort study.
SETTING
University-affiliated Department of Obstetrics and Gynecology.
PATIENTS
Consenting women aged >18 years diagnosed with EP or RPOC from 9/2022 to 8/2023 confirmed by a prior office hysteroscopy.
INTERVENTIONS
Office-based vaginoscopic operative hysteroscopy without anesthesia using the Mini-Elite Truclear HTRS. Oral misoprostol was prescribed for cervical ripening. The patients rated intraoperative and 5-minute postoperative pain levels on a visual analog scale, with mild pain defined as a score of 0 to 4, moderate as 5 to 7, and severe as 8 to 10. A successful procedure was defined as complete removal of the pathology.
MEASUREMENTS AND MAIN RESULTS
Fifty patients were included in this pilot study, and 47 (94.0%) procedures were completed successfully, including 21/24 (87.5%) cases of EP and all cases of RPOC (26/26, p = .06). No intra- or postoperative complications occurred. The intraoperative pain levels were rated as mild, moderate, and severe by 26 (52.0%), 16 (32.0%) and 8 (16.0%) patients, respectively. Severe intraoperative pain was more common in nulliparous women and those >10 years from their last vaginal delivery and was not associated with patient age, menopausal status, presence of abnormal uterine bleeding, or pathology size. Severe postoperative pain, reported by 5 (10.0%) patients, was significantly associated with removal of EP compared with RPOC, longer operative time, and nulliparity or >10 years from the last vaginal delivery. The procedure was considered acceptable by 46 (92.0%) patients, and 45 (90.0%) would recommend it to a friend/relative.
CONCLUSIONS
Office-based operative hysteroscopy by the HTRS is successful and well tolerated by most women, especially for RPOC removal.
PubMed: 38740128
DOI: 10.1016/j.jmig.2024.05.005 -
JAMA Internal Medicine May 2024Before 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion.
IMPORTANCE
Before 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion.
OBJECTIVE
To estimate the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy.
DESIGN, SETTING, AND PARTICIPANTS
This prospective cohort study was conducted from January 2020 to May 2022 and included 11 clinics in 7 states (5 abortion clinics and 6 primary care sites, 4 of which were new to abortion provision). Eligible participants were seeking medication abortion at 63 or fewer days' gestation, spoke English or Spanish, were age 15 years or older, and were willing to take misoprostol buccally. After assessing eligibility for medication abortion through an in-person screening, mifepristone and misoprostol were prescribed using a mail-order pharmacy. Patients had standard follow-up care with the clinic. Clinical information was collected from medical records. Consenting participants completed online surveys about their experiences 3 and 14 days after enrolling. A total of 540 participants were enrolled; 10 withdrew or did not take medication. Data were analyzed from August 2022 to December 2023.
INTERVENTION
Mifepristone, 200 mg, and misoprostol, 800 µg, prescribed to a mail-order pharmacy and mailed to participants instead of dispensed in person.
MAIN OUTCOMES AND MEASURES
Proportion of patients with a complete abortion with medications only, reporting satisfaction with the medication abortion, and reporting timely delivery of medications.
RESULTS
Clinical outcome information was obtained and analyzed for 510 abortions (96.2%) among 506 participants (median [IQR] age, 27 [23-31] years; 506 [100%] female; 194 [38.3%] Black, 88 [17.4%] Hispanic, 141 [27.9%] White, and 45 [8.9%] multiracial/other individuals). Of these, 436 participants (85.5%; 95% CI, 82.2%-88.4%) received medications within 3 days. Complete abortion occurred after medication use in 499 cases (97.8%; 95% CI, 96.2%-98.9%). There were 24 adverse events (4.7%) for which care was sought for medication abortion symptoms; 3 patients (0.6%; 95% CI, 0.1%-1.7%) experienced serious adverse events requiring hospitalization (1 with blood transfusion); however, no adverse events were associated with mail-order dispensing. Of 477 participants, 431 (90.4%; 95% CI, 87.3%-92.9%) indicated that they would use mail-order dispensing again for abortion care, and 435 participants (91.2%; 95% CI, 88.3%-93.6%) reported satisfaction with the medication abortion. Findings were similar to those of other published studies of medication abortion with in-person dispensing.
CONCLUSIONS AND RELEVANCE
The findings of this cohort study indicate that mail-order pharmacy dispensing of mifepristone for medication abortion was effective, acceptable to patients, and feasible, with a low prevalence of serious adverse events. This care model should be expanded to improve access to medication abortion services.
PubMed: 38739404
DOI: 10.1001/jamainternmed.2024.1476