Online Abortion Drug Sales in Indonesia: A Quality of Care Assessment.

This study sought to understand the experience of buying misoprostol online for pregnancy termination in Indonesia. We conducted a mystery client study August through October, 2019. Interactions were analyzed quantitatively and qualitatively, along with the contents of the packages. One hundred ten sellers were contacted, from whom mystery clients made 76 purchases and received 64 drug packages. Almost all sellers sold "packets" containing multiple drugs; 73 percent of packets contained misoprostol, and 47 percent contained at least 800 mcg of misoprostol. Thirty-four packets contained insufficient drugs to complete an abortion. When compared to WHO standards, 87 percent of sellers imparted incomplete information about potential physical effects; no seller provided information about possible complications. Women buying misoprostol from informal online drugs sellers will be underprepared for understanding potential side effects and complications. Educational activities are needed to increase women's access to information about safe use of misoprostol as a harm reduction strategy.

Stocking and over-the-counter sale of misoprostol for medical abortion in Ghana's community pharmacies: comparison of questionnaire and mystery client survey.

OBJECTIVES: In many sub-Saharan African countries with restricted safe abortion services, community pharmacies are important sources of abortifacients. However, data on stocking and over-the-counter sale of abortifacients in community pharmacies are often limited. The main objective of this study was to compare stocking and over-the-counter sale of misoprostol at community pharmacies using questionnaire and mystery client surveys in Ghana. METHODS: A cross-sectional questionnaire-based survey, complemented with a mystery client survey, was conducted at 165 randomly selected community pharmacies in Accra, Ghana. Structured questionnaires were administered to pharmacists/pharmacy workers. A mystery client survey to each of these pharmacies was also undertaken. Descriptive statistical techniques (frequencies and proportions) were used to estimate and compare stocking and over-the-counter sale of misoprostol at community pharmacies from the two data collection methods. KEY FINDINGS: Some 50.3% (83) of community pharmacists/pharmacy workers reported stocking misoprostol and selling it over-the-counter for medical abortion in the questionnaire-based survey. However, in the mystery client survey, 122 (74%) pharmacists/pharmacy workers reported stocking misoprostol and actually selling it over-the-counter to the mystery clients. Thus approximately 39 (24%) more pharmacies stocked misoprostol and sold it over-the-counter even though they originally denied stocking the drug in the questionnaire survey. Also, the drug was often sold without a prescription, and many did so without asking for a confirmatory pregnancy test or gestational age. CONCLUSIONS: In contexts where access to safe abortion services is restricted, mystery client surveys, rather than conventional questionnaire-based survey techniques, may better illuminate stocking and over-the-counter sale of abortifacients at community pharmacies.

Medical versus surgical treatment of first trimester spontaneous abortion: A cost-minimization analysis.

BACKGROUND: Traditionally the gold-standard technique for the treatment of spontaneous abortion has been uterine evacuation by aspiration curettage. However, many studies have proposed medical treatment with misoprostol as an alternative to the conventional surgical treatment. The aim of this study was to apply cost minimization methods to compare the cost and effectiveness of the use of vaginal misoprostol as a medical treatment for first trimester spontaneous abortion with those of evacuation curettage as a surgical treatment. METHODOLOGY/PRINCIPAL FINDINGS: We present a longitudinal, prospective and quasi-experimental research study including a total of 547 patients diagnosed with first-trimester spontaneous abortion, in the period from January 2013 to December 2015. Patients were offered medical treatment with 800 mg vaginal misoprostol or evacuation curettage. Patients treated with misoprostol were followed-up at 7 days and a transvaginal ultrasound was performed to confirm the success of the treatment. If it failed, a second dose of 800 mg of vaginal misoprostol was prescribed and a new control ultrasound was performed. In case of failure of medical treatment after the second dose of misoprostol, evacuation curettage was indicated. The effectiveness of each of the treatment options was calculated using a decision tree. The cost minimization study was carried out by weighting each cost according to the effectiveness of each branch of the treatment. Of the 547 patients who participated in the study, 348 (64%) chose medical treatment and 199 (36%) chose surgical treatment. The overall effectiveness of medical treatment was 81% (283/348) and surgical treatment of 100%. The estimated final cost for medical treatment was € 461.92 compared to € 2038.72 for surgical treatment, which represents an estimated average saving per patient of € 1576.8. CONCLUSIONS/SIGNIFICANCE: Medical treatment with misoprostol is a cheaper alternative to surgery: in the Spanish Public Healthcare System, it is five times more inexpensive than curettage. Given its success rates higher than 80%, mild side effects, controllable with additional medication and the high degree of overall satisfaction, it should be prioritized over the evacuation curettage in patients who meet the treatment criteria.

Beyond usual care: the economic consequences of expanding treatment options in early pregnancy loss.

OBJECTIVE: The objective of this study was to estimate the economic consequences of expanding options for early pregnancy loss (EPL) treatment beyond expectant management and operating room surgical evacuation (usual care). STUDY DESIGN: We constructed a decision model using a hypothetical cohort of women undergoing EPL management within a 30 day horizon. Treatment options under the usual care arm include expectant management and surgical uterine evacuation in an operating room (OR). Treatment options under the expanded care arm included all evidence-based safe and effective treatment options for EPL: expectant management, misoprostol treatment, surgical uterine evacuation in an office setting, and surgical uterine evacuation in an OR. Probabilities of entering various treatment pathways were based on previously published observational studies. RESULTS: The cost per case was US $241.29 lower for women undergoing treatment in the expanded care model as compared with the usual care model (US $1033.29 per case vs US $1274.58 per case, expanded care and usual care, respectively). The model was the most sensitive to the failure rate of the expectant management arm, the cost of the OR surgical procedure, the proportion of women undergoing an OR surgical procedure under usual care, and the additional cost per patient associated with implementing and using the expanded care model. CONCLUSION: This study demonstrates that expanding women's treatment options for EPL beyond what is typically available can result in lower direct medical expenditures.

[Cost of medical treatment with methotrexate for ectopic pregnancy. Study comparing medical treatment versus laparoscopy. Experience of Aziza Othmana Hospital]. / Coût du traitement médical par méthotrexate de la grossesse extra utérine. Etude comparative traitement médical versus traitement coeliochirurgical. Expérience de l'Hôpital Aziza Othmana.

BACKGROUND: The ectopic pregnancy can be treated surgically (conservative or radical) or medically. Currently, the choice between medical and surgical treatment is a critical issue. One of the parameters of this choice is the total cost of management. AIM: To compare the cost of the management of ectopic pregnancy by medical treatment (methotrexate, MTX) and coeliochirurgicaux. METHODS: This is a prospective, comparative, nonrandomized,unicentric study, on 39 patients who have ectopic pregnancies treated with MTX versus 16 patients treated by laparoscopic surgery with conservative treatment. This study was collected at the service of Obstetrics and Gynecology Reproductive Medicine Aziza Othmana Hospital (Tunis) for a period of two years. RESULTS: The average cost of hospital stay per patient was 549.38 dt for the MTX group against 268.39 dt for laparoscopic surgery group (p <0.001). There was no statistically significant difference between the two groups. In terms of overall absenteeism, there is no statistically significant difference (16.43 vs 17.5 days). CONCLUSION: The initial treatment with MTX costs more cost than the conservative laparoscopic treatment and this is mainly due to the long period of hospitalization.

New hope: community-based misoprostol use to prevent postpartum haemorrhage.

The wide gap in maternal mortality ratios worldwide indicates major inequities in the levels of risk women face during pregnancy. Two priority strategies have emerged among safe motherhood advocates: increasing the quality of emergency obstetric care facilities and deploying skilled birth attendants. The training of traditional birth attendants, a strategy employed in the 1970s and 1980s, is no longer considered a best practice. However, inadequate access to emergency obstetric care and skilled birth attendants means women living in remote areas continue to die in large numbers from preventable maternal causes. This paper outlines an intervention to address the leading direct cause of maternal mortality, postpartum haemorrhage. The potential for saving maternal lives might increase if community-based birth attendants, women themselves, or other community members could be trained to use misoprostol to prevent postpartum haemorrhage. The growing body of evidence regarding the safety and efficacy of misoprostol for this indication raises the question: if achievement of the fifth Millennium Development Goal is truly a priority, why can policy makers and women's health advocates not see that misoprostol distribution at the community level might have life-saving benefits that outweigh risks?

A cost-effectiveness analysis of surgical versus medical management of early pregnancy loss.

OBJECTIVE: To determine the cost-effectiveness of medical and surgical management of early pregnancy loss. DESIGN: Analyses of cost, effectiveness, and incremental cost-effectiveness ratios and utilities of a multicenter trial with 652 women with first-trimester pregnancy failure randomized to medical or surgical management. SETTING: Analysis of data from a multicenter trial. PATIENT(S): Secondary analysis of a multicenter trial. INTERVENTION(S): Cost-effectiveness analysis. MAIN OUTCOME MEASURE(S): Cost and effectiveness of competing treatment strategies. RESULT(S): Cost analysis of treatment demonstrates an increased cost of US$336 for 13% increased efficacy of surgical management. This analysis was sensitive to the probability of an extra office visit, the cost of the visit, and the probability of success. When the surgical arm is divided into outpatient manual vacuum aspiration (MVA) versus inpatient electric vacuum aspiration (EVA), there is an increased cost of $745 for EVA but a decreased cost of $202 for MVA compared with medical management. In general, MVA was found to be more cost-effective than medical management. For treatment of incomplete or inevitable abortion, medical management was found to be less costly and more efficacious. Utilities studies demonstrated that a patient would need to prefer surgery 14% less than medication for its treatment efficacy to be outweighed by the desire to avoid surgery. CONCLUSION(S): Surgical or medical management of early pregnancy failure can be cost effective, depending on the circumstances. Surgery is cost effective and more efficacious when performed in an outpatient setting. For incomplete or inevitable abortion, medical management is cost effective and more efficacious.

Cost-effectiveness analysis of unsafe abortion and alternative first-trimester pregnancy termination strategies in Nigeria and Ghana.

To explore the policy implications of increasing access to safe abortion in Nigeria and Ghana, we developed a computer-based decision analytic model which simulates induced abortion and its potential complications in a cohort of women, and comparatively assessed the cost-effectiveness of unsafe abortion and three first-trimester abortion modalities: hospital-based dilatation and curettage, hospital- and clinic-based manual vacuum aspiration (MVA), and medical abortion using misoprostol (MA). Assuming all modalities are equally available, clinic-based MVA is the most cost-effective option in Nigeria. If clinic-based MVA is not available, MA is the next best strategy. Conversely, in Ghana, MA is the most cost-effective strategy, followed by clinic-based MVA if MA is not available. From a real world policy perspective, increasing access to safe abortion in favor over unsafe abortion is the single most important factor in saving lives and societal costs, and is more influential than the actual choice of safe abortion modality.

Cost-effectiveness analysis of alternative first-trimester pregnancy termination strategies in Mexico City.

OBJECTIVE: To assess the comparative health and economic outcomes associated with three alternative first-trimester abortion techniques in Mexico City and to examine the policy implications of increasing access to safe abortion modalities within a restrictive setting. DESIGN: Cost-effectiveness analysis. SETTING: Mexico City. POPULATION: Reproductive-aged women with unintended pregnancy seeking first-trimester abortion. METHODS: Synthesising the best available data, a computer-based model simulates induced abortion and its potential complications and is used to assess the cost-effectiveness of alternative safe modalities for first-trimester pregnancy termination: (1) hospital-based dilatation and curettage (D&C), (2) hospital-based manual vacuum aspiration (MVA), (3) clinic-based MVA and (4) medical abortion using vaginal misoprostol. MAIN OUTCOME MEASURES: Number of complications, lifetime costs, life expectancy, quality-adjusted life expectancy. RESULTS: In comparison to the magnitude of health gains associated with all safe abortion modalities, the relative differences between strategies were more pronounced in terms of their economic costs. Assuming all options were equally available, clinic-based MVA was the least costly and most effective. Medical abortion with misoprostol provided comparable benefits to D&C, but cost substantially less. Enhanced access to safe abortion was always more influential than shifting between safe abortion modalities. CONCLUSIONS: This study demonstrates that the provision of safe abortion is cost-effective and will result in reduced complications, decreased mortality and substantial cost savings compared with unsafe abortion. In Mexico City, shifting from a practice of hospital-based D&C to clinic-based MVA and enhancing access to medical abortion will have the best chance to minimise abortion-related morbidity and mortality.

Treating miscarriages: a randomised study of cost-effectiveness in medical or surgical choice.

OBJECTIVE: The aim was to carry out a cost effectiveness analysis (CEA) of medical and surgical treatment of miscarriage using quantitative and qualitative indicators. DESIGN: A prospective study where the data of the clinical course of the treatment and the patients; experiences (pain and satisfaction) were collected from a previous randomised study. SETTING: Department of Obstetrics and Gynecology, Oulu University Hospital, Oulu, Finland. POPULATION: Ninety-eight eligible women with a diagnosed miscarriage. METHODS: The incremental cost-effectiveness ratio (ICER) was calculated by using institutional prices (provider's aspect) of the medical care and the number of patients who experienced pain, dissatisfaction or unsuccessful treatment while treated for the miscarriage. MAIN OUTCOME MEASURES: Primary (uncomplicated treatment) and secondary (complications and other unplanned events) costs of the treatments. RESULTS: Primary costs of the surgical treatment were higher, but the more frequent unplanned events and complications in the medical group brought the costs to the same level. In the medical group, based on the ICER, 12 patients more experienced pain, 7 patients more were dissatisfied with the treatment and 5 patients more had unsuccessful treatment compared with surgically treated patients. In theory, these negative outcomes could have been avoided by investing euro1688 more in the surgical treatment. CONCLUSIONS: Medical treatment of miscarriage was not more cost-effective, when the adverse events were considered. As neither of these two methods was economically superior, the treatment choice should be made on an individual basis by respecting the patient's choice.

Assessing the global availability of misoprostol.

OBJECTIVE: To assess the worldwide availability of misoprostol. Documenting the extent of misoprostol use in obstetrics-gynecology is difficult because the drug typically is unregistered for such indications. METHODS: Data for 2002-2007 on annual sales (measured in weight) to hospitals and retail pharmacies, plus manufacturer prices per 200-microg misoprostol, were analyzed for medications containing misoprostol alone or combined with a nonsteroidal anti-inflammatory drug (NSAID); regional and country-specific trends were identified. Consumer prices per pill are documented for all formulations of registered medications. RESULTS: Of the misoprostol sold worldwide, 70% was misoprostol-NSAID-combination drugs; of this, 91% was sold in North America and Western Europe. Asia sold the most misoprostol-only drugs; sales increased dramatically in Bangladesh (by 128%) and India (646%), where various low-price brands are sold. Misoprostol sales decreased in Latin America but increased in the Middle East-North Africa and Sub-Saharan Africa; these regions generally had low amounts sold per population. CONCLUSION: Availability is improving in some low-income regions where misoprostol could significantly reduce maternal deaths due to postpartum hemorrhage and unsafe abortion.

Current evidence on surgery, systemic methotrexate and expectant management in the treatment of tubal ectopic pregnancy: a systematic review and meta-analysis.

BACKGROUND: To evaluate the effectiveness of surgery, medical treatment and expectant management of tubal ectopic pregnancy (EP) in terms of treatment success (i.e. complete elimination of trophoblast tissue), financial costs and future fertility. METHODS: We searched for randomized controlled trials which described treatment interventions that have been widely adopted in clinical practice. A systemic literature search identified 15 trials. RESULTS: Laparoscopic salpingostomy was significantly less successful than the open surgical approach (relative risk, RR 0.9, 95% CI 0.82-0.99) due to a higher persistent trophoblast rate, but was significantly less costly. A prophylactic single shot methotrexate (MTX), given intramuscularly (i.m.) immediately post-operatively, significantly reduced persistent trophoblast after laparoscopic salpingostomy (RR 0.89, 95% CI 0.82-0.98, number needed to treat of 10). With systemic MTX in a fixed multiple dose i.m. regimen the likelihood of treatment success was higher than with laparoscopic salpingostomy (RR 1.15, 95% CI 0.93-1.43), but the difference was not significant. Systemic MTX in a fixed multiple dose i.m. regimen was only cost-effective if serum human chorionic gonadotrophin (hCG) concentrations were <3000 IU/l. If serum hCG concentrations were <1500 IU/l, then the single-dose MTX i.m. regimen-if necessary with additional MTX injections-was also cost-effective. Expectant management could not be evaluated yet. Subsequent fertility did not differ between the interventions studied. CONCLUSIONS: This meta-analysis shows that laparoscopic surgery is the most cost-effective treatment for tubal EP. Systemic MTX is a good alternative in selected patients with low serum hCG concentrations.

Misoprostol for the treatment of early pregnancy failure.

Nearly 20% of all pregnancies end in early pregnancy failure, and surgical evacuation of retained products of conception is often used to manage this failure. Misoprostol is an inexpensive, stable analog of prostaglandin E(1), and is powerful at contracting the uterus. With intravaginal misoprostol, the peak plasma levels are lower, but the levels after 4 hours are higher, than after oral or sublingual administration. With oral misoprostol, the evacuation rates in early pregnancy varied from about 50% up to 96%. Similar variation in evacuation rates were obtained from small trials with intravaginal misoprostol. To date, only small studies have used sublingual misoprostol, and there has been no direct comparison to oral or intravaginal misoprostol. A recent large clinical trial has shown, that with intravaginal misoprostol 800 microg, an expulsion rate of 84% can be achieved by 8 days. This large trial also established that women prefer misoprostol to surgical evacuation. Two economic evaluations have shown that misoprostol treatment is less costly than surgical intervention. On the basis of recent findings, it seems likely that misoprostol treatment will become a standard or preferred treatment for early pregnancy failure.

Cost-effectiveness of dilation and evacuation versus the induction of labor for second-trimester pregnancy termination.

OBJECTIVE: The purpose of this study was to compare the cost-effectiveness of dilation and evacuation versus misoprostol induction of labor for second-trimester termination. STUDY DESIGN: Using decision analysis, we compared the cost-effectiveness of dilation and evacuation and misoprostol induction of labor for second-trimester termination. Complications for dilation and evacuation and induction of labor included repeat dilation and curettage, cervical laceration repair, hospital admission, laparotomy, hysterectomy, and maternal death. Induction of labor complications also included failed induction of labor. The primary outcome was cost per quality-adjusted life year. Sensitivity analyses were performed for all relevant variables. RESULTS: Dilation and evacuation was less costly and more effective than misoprostol induction of labor for second-trimester termination with baseline estimates. In 1-way sensitivity analysis, the model was robust to all variation in probabilities and costs. In Monte Carlo simulation with 1000 trials and a cost-effectiveness threshold of $50,000/quality-adjusted life year, dilation and evacuation was the preferred approach in 97.9% of trials. CONCLUSION: Dilation and evacuation is less expensive and more effective than misoprostol induction of labor for second-trimester termination.

Misoprostol and declining abortion-related morbidity in Santo Domingo, Dominican Republic: a temporal association.

OBJECTIVE: To validate anecdotal reports that abortion-related complications decreased in the Dominican Republic after the introduction of misoprostol into the country. DESIGN: Retrospective records reviews and cross-sectional surveys, interviews and focus groups. SETTING: Family planning clinics, pharmacies, door-to-door canvassing and a tertiary care maternity hospital in Santo Domingo, Dominican Republic. POPULATION: Women of reproductive age in Santo Domingo, Dominican Republic. METHODS: Qualitative and quantitative methods were used. Individual interviews and focus groups of reproductive health professionals, non-governmental organisation leaders and women's group leaders (n= 50) were conducted to discover the role of misoprostol in the Dominican Republic. Local women (n= 157) were surveyed to determine their knowledge of misoprostol as an abortifacient and mystery client visits were made to 80 pharmacies in order to purchase misoprostol without a prescription. Sales data were obtained that documented when misoprostol was introduced to the Dominican Republic pharmacies. Hospital admissions for abortions from the prior eight years were reviewed and hospital emergency room consultation ledgers of 31,190 visits for the period 1994-2001 were reviewed for abortion complications. MAIN OUTCOME MEASURES: Frequencies of maternal morbidities and knowledge of misoprostol. RESULTS: Mystery clients purchased misoprostol without a prescription in nearly 64% of pharmacies; staff provided little additional information or counselling. Reliable sales data documented the introduction of misoprostol in 1986. Abortion complications decreased from 11.7% of abortions in 1986 to 1.7% in 2001. The majority of professionals interviewed felt that knowledge of these findings should be made public. CONCLUSIONS: The data were of too poor quality to validate the verbal reports reliably, but misoprostol appears to have been widely used over a period when abortion-related morbidity fell. It remains plausible that the use of misoprostol contributed to the reduction.

Expectant, medical or surgical treatment for spontaneous abortion in first trimester of pregnancy: a cost analysis.

BACKGROUND: Misoprostol and expectant care have been shown to be acceptable alternatives to routine surgical evacuation for treatment of spontaneous abortion in the first trimester of pregnancy. The objective of this study was to analyse the cost of expectant care, misoprostol therapy and surgical evacuation. METHODS: A decision tree was designed to simulate the clinical outcome and health care resource utilization of surgical evacuation, misoprostol and expectant care for patients presenting with uncomplicated spontaneous abortion in the first trimester of pregnancy. Clinical inputs were estimated from literature and the cost analysis was conducted from the perspective of a public health care provider in Hong Kong. RESULTS: The base-case analysis showed that the misoprostol group (1000 US dollars per patient) was the least costly alternative, followed by the expectant care (1172 US dollars per patient) and surgical evacuation (2007 US dollars per patient). Rates of complete abortion using misoprostol and expectant care were identified as influential factors. Monte Carlo simulation (10000 cohorts) showed that the misoprostol and the expectant care groups were less costly than the surgical evacuation group 100 and 88% of the time. The misoprostol group was less costly than the expectant group 100% of the time. CONCLUSIONS: Misoprostol therapy appears to be the least costly approach for treatment of uncomplicated spontaneous abortion.

Cost-effectiveness of presumptively medically treating women at risk for ectopic pregnancy compared with first performing a dilatation and curettage.

OBJECTIVE: To compare the cost and complication rate of two alternative strategies for the diagnosis and medical management of ectopic pregnancy when ultrasound is nondiagnostic. DESIGN: A decision tree was constructed to compare [1] dilatation and curettage (D&C) followed by treatment of all ectopic pregnancies with methotrexate versus [2] empiric treatment of all patients with possible ectopic pregnancies with methotrexate without D&C. SETTING: University setting. PATIENT(S): Ten thousand hypothetical women with nonviable pregnancies and a known incidence of ectopic pregnancy were entered into a computer model. MAIN OUTCOME MEASURE(S): The two approaches were compared with respect to the number of missed ectopic pregnancies, complications, procedures performed, admissions to the hospital, and cost. RESULT(S): The D&C group had 1% more failed managements of ectopic pregnancies and 13.4% fewer patients with a miscarriage undergo a second treatment for resolution. The D&C group had 13.7% fewer complications including 6.3% fewer hospitalizations. D&C costs $173 to $223 more than empiric use of methotrexate per patient. CONCLUSION(S): Empirically treating women at risk for ectopic pregnancy with methotrexate does not reduce complications or save money. In the absence of such savings, the desire to make an accurate and definitive diagnosis, allowing objective prognosis on future fertility and risk of repeat ectopic pregnancy, supports the need to distinguish a miscarriage from ectopic pregnancy before treatment with methotrexate.

The true cost differential between mifepristone and misoprostol and misoprostol-alone regimens for medical abortion.

Our objective was to evaluate relative differences in direct and total (direct and indirect) costs for medical abortion regimens using mifepristone and misoprostol or misoprostol alone. We created formulas to evaluate relative differences in costs in the United States, Chennai (Madras), India, and a hypothetical developing country based on published protocols and efficacy data. Follow-up visits and suction aspiration procedures in the United States were evaluated over a range of costs. American indirect costs were estimated using earning data. Indirect costs in India and the hypothetical developing country were based on mifepristone cost differences between the United States and India. Although mifepristone costs US dollar 83.33 for every 200-mg tablet in the United States, the actual excess cost of using a mifepristone regimen, as compared with a misoprostol-alone regimen, is only US dollar 22 to US dollar 32. The actual cost of a mifepristone regimen is lower than that of a misoprostol-alone regimen in India. In a hypothetical developing country, a mifepristone regimen is likely to be less expensive than regimens using misoprostol alone. Because of the higher efficacy of medical abortion regimens using mifepristone and misoprostol and the need for fewer follow-up evaluations, such regimens are less expensive or only minimally more expensive than those using misoprostol alone.