Etonogestrel-releasing subdermal contraceptive implant: Budget impact analysis based on the Brazilian private healthcare system.

High rates of unplanned pregnancies persist despite pharmacological developments and advancements in contraceptive methods. Here, we demonstrate that the etonogestrel-releasing subdermal contraceptive implant (IMP-ETN) may be an appropriate and cost-effective alternative to levonorgestrel-releasing intrauterine systems (LNG-IUSs) for women in Brazil. For our pharmacoeconomic analysis, we reviewed the literature on IMP-ETN regarding its acceptance, eligibility criteria, choice, relations with age, adverse events and, finally, the unmet need in the fee-for-service private healthcare sector. We considered qualitative observations in combination with quantitative analysis and performed a deterministic sensitivity analysis to investigate whether this technology can be self-sustainable over a period of five years. The target population for this analysis comprised 158,696 women. Compared with the continued use of LNG-IUSs, adopting the IMP-ETN can result in a cost avoidance of $ 7.640.804,02 in the first year and $ 82,455,254.43 in five years. Disseminating information among physicians will promote this change and strengthen the potential cost avoided by private health system payers. These savings can be used to improve other healthcare programs and strategies. Moreover, the principles of care can be promoted by improving and adapting healthcare systems and expanding treatment and follow-up strategies. This would also provide support to women's reproductive rights and improve their quality of life. Our results suggest that the IMP-ETN has a favorable cost-effectiveness profile. Given all its advantages and negative incremental cost impact over a period of five years, the IMP-ETN may be a more favorable alternative to LNG-IUSs. Therefore, it should be offered to beneficiaries with a private healthcare plan. This analysis overcomes previous barriers to the use of cost-benefit models, and our results may help balance decision-making by policymakers, technical consultants, and researchers.

Assessment of the Effects of Abrocitinib on the Pharmacokinetics of Probe Substrates of Cytochrome P450 1A2, 2B6 and 2C19 Enzymes and Hormonal Oral Contraceptives in Healthy Individuals.

BACKGROUND AND OBJECTIVE: Abrocitinib is an oral small-molecule Janus kinase (JAK)-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis. In vitro studies indicated that abrocitinib is a weak time-dependent inhibitor of cytochrome P450 (CYP) 2C19/3A and a weak inducer of CYP1A2/2B6/2C19/3A. To assess the potential effect of abrocitinib on concomitant medications, drug-drug interaction (DDI) studies were conducted for abrocitinib with sensitive probe substrates of these CYP enzymes. The impact of abrocitinib on hormonal oral contraceptives (ethinyl estradiol and levonorgestrel), as substrates of CYP3A and important concomitant medications for female patients, was also evaluated. METHODS: Three Phase 1 DDI studies were performed to assess the impact of abrocitinib 200 mg once daily (QD) on the probe substrates of: (1) 1A2 (caffeine), 2B6 (efavirenz) and 2C19 (omeprazole) in a cocktail study; (2) 3A (midazolam); and (3) 3A (oral contraceptives). RESULTS: After multiple doses of abrocitinib 200 mg QD, there is a lack of effect on the pharmacokinetics of midazolam, efavirenz and contraceptives. Abrocitinib increased the area under the concentration time curve from 0 to infinity (AUCinf) and the maximum concentration (Cmax) of omeprazole by approximately 189 and 134%, respectively. Abrocitinib increased the AUCinf of caffeine by 40% with lack of effect on Cmax. CONCLUSIONS: Based on the study results, abrocitinib is a moderate inhibitor of CYP2C19. Caution should be exercised when using abrocitinib concomitantly with narrow therapeutic index medicines that are primarily metabolized by CYP2C19 enzyme. Abrocitinib is a mild inhibitor of CYP1A2; however, the impact is not clinically relevant, and no general dose adjustment is recommended for CYP1A2 substrates. Abrocitinib does not inhibit CYP3A or induce CYP1A2/2B6/2C19/3A and does not affect the pharmacokinetics of contraceptives. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov registration IDs: NCT03647670, NCT05067439, NCT03662516.

Increases in retail sales of over-the-counter levonorgestrel emergency contraception in the United States, 2016-2022.

OBJECTIVES: To understand patterns in demand for emergency contraception (EC), we characterize the sales of over-the-counter (OTC) levonorgestrel (LNG) EC in the United States from traditional retail outlets. STUDY DESIGN: We describe sales of OTC LNG EC using retail sales data aggregated from traditional retail channels, including grocery stores, drug stores, mass merchandisers, club stores, dollar stores, and military outlets. RESULTS: Sales of OTC LNG EC doubled between 2016 and 2022 (approximately 7.2-14.8 million). CONCLUSIONS: Increasing sales of EC are consistent with increased use and use frequency of EC by those at risk of pregnancy in the United States. IMPLICATIONS: OTC LNG EC sales since 2016 exceed what national survey usage estimates would suggest, indicating that national surveys underreport EC use, those using EC purchase it somewhat frequently, and/or individuals stockpile EC for later use. The role of EC in individual contraceptive strategies, particularly as access to reproductive healthcare is restricted, warrants further study.

Midostaurin drug interaction profile: a comprehensive assessment of CYP3A, CYP2B6, and CYP2C8 drug substrates, and oral contraceptives in healthy participants.

PURPOSE: Midostaurin, approved for treating FLT-3-mutated acute myeloid leukemia and advanced systemic mastocytosis, is metabolized by cytochrome P450 (CYP) 3A4 to two major metabolites, and may inhibit and/or induce CYP3A, CYP2B6, and CYP2C8. Two studies investigated the impact of midostaurin on CYP substrate drugs and oral contraceptives in healthy participants. METHODS: Using sentinel dosing for participants' safety, the effects of midostaurin at steady state following 25-day (Study 1) or 24-day (Study 2) dosing with 50 mg twice daily were evaluated on CYP substrates, midazolam (CYP3A4), bupropion (CYP2B6), and pioglitazone (CYP2C8) in Study 1; and monophasic oral contraceptives (containing ethinylestradiol [EES] and levonorgestrel [LVG]) in Study 2. RESULTS: In Study 1, midostaurin resulted in a 10% increase in midazolam peak plasma concentrations (Cmax), and 3-4% decrease in total exposures (AUC). Bupropion showed a 55% decrease in Cmax and 48-49% decrease in AUCs. Pioglitazone showed a 10% decrease in Cmax and 6% decrease in AUC. In Study 2, midostaurin resulted in a 26% increase in Cmax and 7-10% increase in AUC of EES; and a 19% increase in Cmax and 29-42% increase in AUC of LVG. Midostaurin 50 mg twice daily for 28 days ensured that steady-state concentrations of midostaurin and the active metabolites were achieved by the time of CYP substrate drugs or oral contraceptive dosing. No safety concerns were reported. CONCLUSION: Midostaurin neither inhibits nor induces CYP3A4 and CYP2C8, and weakly induces CYP2B6. Midostaurin at steady state has no clinically relevant PK interaction on hormonal contraceptives. All treatments were well tolerated.

Uptake, discontinuation, and continuation rate of long-acting contraceptive methods when offered at no cost in Campinas, Brazil.

OBJECTIVES: This study aimed to compare the uptake, reasons for discontinuation, continuation, and satisfaction of long-acting contraceptive methods (LARC) when offered at no cost in Campinas, Brazil. STUDY DESIGN: This was a prospective cohort study conducted at University of Campinas, Campinas, São Paulo, Brazil, including women aged 18 to 48 years, who adopted one of three methods. Participants underwent telephone follow-up every 3 months for up to 24 months after insertion. Satisfaction was assessed at the end of 2 years of use through the Likert scale. RESULTS: We invited 1222 women, and among the 971 women who volunteered to participate in follow-up, 414 (42.6%) chose the levonorgestrel 52-mg intrauterine device (IUD), 358 (36.9%) chose the etonogestrel (ENG) implant, and 199 (20.5%) chose the TCu380A IUD. Discontinuation due to bothersome bleeding was higher among users of the ENG implant (10/358; 2.4%) and the TCu380A IUD (32/199; 8.9%), and expulsion was higher for the TCu380A IUD (30/199; 15.1%). Women continued at 24 months were 340/414 (82.1%), 270/358 (75.4%), and 119/199 (59.8%) among users of the levonorgestrel 52-mg IUD, ENG implant, and TCu380A IUD, respectively. The users of the levonorgestrel 52-mg IUD (301/339, 88.8%), the ENG-implant (222/270, 82.2%), and the TCu380A IUD (105/119, 88.2%) were satisfied or very satisfied by 24 months of follow-up. CONCLUSIONS: The three LARC methods had great uptake, high continuation, and discontinuation due to bothersome bleeding was higher among users of the ENG implant and the TCu380A IUD, and expulsion was higher for the TCu380A IUD compared to the 52-mg levonorgestrel IUD. Most of the participants reported being very satisfied. IMPLICATIONS: When the LARC methods were offered at no cost in a Brazilian public clinic the uptake, satisfaction and continuation were high by 24 months after device placement, and high level of satisfaction was reported by most of the participants.

Clinical Assessment of 3 Intrauterine Devices in Adolescent Girls: A Randomized Clinical Trial.

STUDY OBJECTIVE: To assess clinical performance, bleeding pattern, dysmenorrhea, and satisfaction up to 1 year after placement of 3 types of intrauterine devices (IUDs) (TCu380A, levonorgestrel 52 mg, and levonorgestrel 19.5 mg) in adolescents METHODS: The study was a randomized trial with 318 adolescents allocated to the 3 IUDs. We assessed reasons for removal, continuation, menstrual patterns, dysmenorrhea, and satisfaction. RESULTS: Participants aged (mean ± SD) 17.9 ± 1.4 years, with 80.8% being nulligravidae. After 1 year, 265 (83.3%) continued using the IUD; however, the continuation rate of TCu380A (75.4 ± 4.2) was lower than that of both the levonorgestrel 52-mg (88.6 ± 3.1) and 19.5-mg IUDs (86.8 ± 3.3), and bleeding/pain and expulsion were the main reasons for removal of the TCu380A IUD. The duration of menstruation was longer among the TCu380A IUD users (6.0 ± 2.0 days) than those using the levonorgestrel 52 mg (2.5 ± 3.9) and 19.5 mg (3.2 ± 3.2) devices, P < .001. Amenorrhea was reported by 49.5% and 37.8% users of the levonorgestrel 52-mg and 19.5-mg devices, respectively, P < .001. Dysmenorrhea was reported in 68.5% of all participants at the baseline; this was 67.9% of the TCu380A group and 33.3% and 36.0% of the levonorgestrel 52-mg and 19.5-mg IUD groups, respectively, P < .001. Satisfaction ranged from 80.7% in the TCu380A group to 97.8% in the levonorgestrel 52-mg group (P = .03). CONCLUSION: The 3 IUDs are suitable for adolescents, with high contraceptive efficacies and rates of continuation within 1 year of use and high degrees of satisfaction. Users of the hormonal IUDs reported lower expulsion rates, more favorable menstrual patterns, and less dysmenorrhea compared with the TCu380A IUD.

Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study.

Background: Heavy menstrual bleeding is a common problem that can significantly affect women's lives until menopause. There is a lack of evidence on longer-term outcomes after seeking health care and treatment for heavy menstrual bleeding. Objectives: To assess the continuation rates of medical treatments and the rates of ablative and surgical interventions among women who had participated in the ECLIPSE trial (ISRCTN86566246) 10 years after initial management for heavy menstrual bleeding in primary care. To explore experiences of heavy menstrual bleeding and influences on treatment for women. Design: This was a prospective observational cohort study, with a parallel qualitative study. Setting: Primary care. Participants: A total of 206 women with heavy menstrual bleeding who had participated in the ECLIPSE trial consented to providing outcome data via a questionnaire approximately 10 years after original randomisation. Their mean age at follow-up was 54 years (standard deviation 5 years). A purposeful sample of 36 women also participated in semistructured qualitative interviews. Interventions: The ECLIPSE trial randomised participants to either the levonorgestrel-releasing intrauterine system (52 mg) or the usual medical treatment (oral tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone, chosen as clinically appropriate by general practitioners and women). Women could subsequently swap or cease their allocated treatment. Main outcome measures: The main outcome measures were rates of ablative and surgical treatments; the rate of continuation of medical treatments; and quality of life using the Short Form questionnaire-36 items and EuroQol-5 Dimensions; women's experiences of heavy menstrual bleeding; and the influences on their decisions around treatment. Results: Over the 10-year follow-up period, 60 out of 206 (29%) women had received a surgical intervention [hysterectomy, n = 34 (17%); endometrial ablation, n = 26 (13%)]. Between 5 and 10 years post trial intervention, 89 women (43%) had ceased all medical treatments and 88 (43%) were using the levonorgestrel-releasing intrauterine system alone or in combination with other oral treatments. More women in the usual medical treatment group had also used the levonorgestrel-releasing intrauterine system than women in the levonorgestrel-releasing intrauterine system group. Fifty-six women (28%) used the levonorgestrel-releasing intrauterine system at 10 years. There was no statistically significant difference in generic quality-of-life scores between the two original trial groups, although small improvements in the majority of domains were seen in both groups across time. Women reported wide-ranging impacts on their quality of life and normalisation of their heavy menstrual bleeding experience as a result of the taboo around menstruation. Women's treatment decisions and experiences were influenced by the perceived quality of health-care interactions with clinicians and their climacteric status. Limitations: Fewer than half of the original 571 participants participated; however, the cohort was clinically and demographically representative of the original trial population. Conclusions: Medical treatments for women with heavy menstrual bleeding can be initiated in primary care, with low rates of surgical intervention and improvement in quality of life observed 10 years later. Clinicians should be aware of the considerable challenges that women with heavy menstrual bleeding experience at presentation and subsequently over time, and the importance and value to women of patient-centred communication in this context. Future work: Any further evaluation of treatments for heavy menstrual bleeding should include long-term evaluation of outcomes and adherence. Trial registration: The original ECLIPSE trial was registered as ISRCTN86566246. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 17. See the NIHR Journals Library website for further project information.

Heavy menstrual bleeding is a common problem that can significantly affect women's lives, yet many women do not seek medical help. Medical treatments, such as tablets and a hormonal coil inserted in the womb, were shown to help women with heavy menstrual bleeding in a previous clinical trial that we conducted, called ECLIPSE. In the ECLIPSE trial, women provided information for 5 years after their treatment started. We planned to continue to ask these women about their periods, their symptoms and quality of life, and the treatments that they chose about 10 years after they first joined the trial. We did this using questionnaires and by interviewing women. We received questionnaires from 206 out of the 490 women (42%) who had participated in the ECLIPSE trial 10 years earlier. Responders were, on average, 54 years old, and half reported that they had reached the menopause. About 3 in 10 women overall had either received a hysterectomy or undergone destruction of the womb lining. Just over one-quarter of women were using the hormonal coil. Quality of life remained improved and was generally higher than that before treatment. There was no big difference in quality of life or in the numbers of women having surgery between those who first used tablets and those who received the coil. Women described the wide-ranging impact of heavy bleeding on their lives and the taboo around periods. Women's experience of good or poor communication with their doctors, and thoughts about fertility and menopause, influenced the treatment choices that they made. Women's quality of life was improved by medical treatments for heavy menstrual bleeding, even as menopause approached, and this shows the importance of these treatments. This research can help doctors and women to make more informed decisions about medical and surgical treatments.

Facile Ball Milling Preparation of Flame-Retardant Polymer Materials: An Overview.

To meet the growing needs of public safety and sustainable development, it is highly desirable to develop flame-retardant polymer materials using a facile and low-cost method. Although conventional solution chemical synthesis has proven to be an efficient way of developing flame retardants, it often requires organic solvents and a complicated separation process. In this review, we summarize the progress made in utilizing simple ball milling (an important type of mechanochemical approach) to fabricate flame retardants and flame-retardant polymer composites. To elaborate, we first present a basic introduction to ball milling, and its crushing, exfoliating, modifying, and reacting actions, as used in the development of high-performance flame retardants. Then, we report the mixing action of ball milling, as used in the preparation of flame-retardant polymer composites, especially in the formation of multifunctional segregated structures. Hopefully, this review will provide a reference for the study of developing flame-retardant polymer materials in a facile and feasible way.

Assessment of pain and ease of intrauterine device placement according to type of device, parity, and mode of delivery.

OBJECTIVE: We compared pain and the ease of insertion of two different types of intrauterine devices (IUDs; the levonorgestrel intrauterine systems 52 mg (LNG-IUS 52 mg) and the copper-bearing IUD [TCu380A]) among nulligravidas and parous women with and without caesarean delivery. METHODS: A cross-sectional study assessed pain referred by women and ease of insertion of the two IUDs models. We applied a visual analogue scale (VAS) to assess pain, while the ease of insertion was defined by healthcare professionals. RESULTS: We assessed 1076 women, including 334 nulligravidas and 566 parous women who had had at least one caesarean delivery and 176 women with history of only vaginal delivery. Regarding pain at IUD placement, 26 (2.5%) women reported no pain, 167 (16.4%) light pain, 319 (31.3%) moderate and 506 (49.7%) intense pain. The highest scores for pain were reported by nulligravidas (67.2%, p = 0.001), while the mean pain score was higher in the LNG-IUS 52 mg group. Difficulties reported by healthcare providers were more frequent in the nulligravidas (21.2%) and women with previous caesarean delivery (16.9%). CONCLUSIONS: Our findings suggested differences between the two IUDs tested, with higher pain associated with the LNG-IUS 52 mg, and highlights the need for pain management, mainly among nulligravida and women with history of caesarean delivery.SHORT CONDENSATIONIntense pain at insertion was more related to nulligravida than parous women and more pain with placement of LNG-IUS 52 mg IUDs than TCu380A IUDs. Nevertheless, our results confirmed that ease of IUD placement was between 80% to 90% of all insertions, being more common in parous women without previous caesarean delivery.

Low-income women and use of prescribed contraceptives in the context of full health insurance coverage in France, 2019.

OBJECTIVE: Major socioeconomic differences in contraceptive use are observed in high-income countries. Cost is often cited as a main factor to explain these differences but other barriers may also exist. Our aim was to compare prescribed contraceptive use among low-income and non-low-income women in a national context of full health insurance coverage. STUDY DESIGN: In the French national health insurance database, we selected all women (14.8 million) aged 15-49 years living in France in 2019. We compared the prevalence of use of each prescribed contraceptive between low-income and non-low-income women: oral contraceptives, copper intrauterine devices (IUDs), the levonorgestrel intrauterine system (LNG-IUS), and implants. RESULTS: In the study population, 11% had a low income. Fewer low-income women used prescribed contraceptives than non-low-income women (36% vs. 46%, p < 0.001). When using a contraceptive, low-income women used a different method: at 20-24 years old, they used less oral contraceptives (60% vs. 77%, p < 0.001) and more implants (22% vs. 9%, p < 0.001), while at 40-44 years, they used less levonorgestrel intrauterine systems (18% vs. 30%, p < 0.001). CONCLUSIONS: Even in a national context of free access to medical care for low-income women, they use less and different prescribed contraceptives than non-low-income women. These results could reflect barriers other than financial cost to the use of prescribed contraceptives by low-income women. IMPLICATIONS: Financial barriers need to be removed in order to increase contraceptive use. However, this may not be sufficient and further research should explore barriers that low-income women may encounter in accessing and choosing their contraception.

Emergency Contraception: Access and Challenges at Times of Uncertainty.

BACKGROUND: The UN Commission on Life-Saving Commodities for Women and Children identified emergency contraceptive pills as 1 of the 13 essential underused, low-cost, and high-impact commodities that could save the lives of millions of women and children worldwide. In the US, 2 emergency contraceptive regimens are currently approved, and their most plausible mechanism of action involves delaying and/or inhibiting ovulation. AREAS OF UNCERTAINTY: Abortion and contraception are recognized as essential components of reproductive health care. In the US, in the wake of the Dobbs v. Jackson Women's Health Organization Supreme Court decision on June 24, 2022, 26 states began to or are expected to severely restrict abortion. It is anticipated that these restrictions will increase the demand for emergency contraception (EC). Several obstacles to EC access have been described, and these include cost, hurdles to over-the-counter purchase, low awareness, myths about their mechanisms of action, widespread misinformation, and barriers that special populations face in accessing them. The politicization of EC is a major factor limiting access. Improving sex education and health literacy, along with eHealth literacy, are important initiatives to improve EC uptake and access. DATA SOURCES: PubMed, The Guttmacher Institute, Society of Family Planning, American College of Obstetricians and Gynecologists, the World Health Organization, The United Nations. THERAPEUTIC ADVANCES: A randomized noninferiority trial showed that the 52 mg levonorgestrel intrauterine device was noninferior to the copper intrauterine device when used as an EC method in the first 5 days after unprotected intercourse. This is a promising and highly effective emergency contraceptive option, particularly for overweight and obese patients, and a contraceptive option with a different bleeding profile than the copper intrauterine device. CONCLUSIONS: EC represents an important facet of medicine and public health. The 2 medical regimens currently approved in the US are very effective, have virtually no medical contraindications, and novel formulations are actively being investigated to make them more convenient and effective for all patient populations. Barriers to accessing EC, including the widespread presence of contraception deserts , threaten to broaden and accentuate the already existing inequities and disparities in society, at a time when they have reached the dimensions of a public health crisis.

Cost of providing family planning services & management of pregnancy outcomes at public health facilities in India.

Background & objectives: Lack of costing data is a critical gap that exists in the field of family planning (FP) in India. The aim of this study was to estimate health system costs of FP in India for existing modern methods, and potential newer methods (etonorgestrel implant and levonorgestrel intrauterine device) and pregnancy-related services in India. Methods: A bottom-up micro-costing study was conducted in five public health facilities of an Indian State. Data of last one year were collected from existing hospital records and hospital staff was interviewed. Collected data were analyzed using standard costing methods. Results: Package costs of delivering FP services ranged from ₹ 807 (95% CI 685, 931) for condoms and ₹ 10,539 (8796, 12269) for tubal ligation. Estimates of etonorgestrel implant and levonorgestrel intrauterine system were ₹ 3,200 (2800, 3625) and 3,426 (3232, 3623). Cost of antenatal care along with vaginal delivery, caesarean and abortion were ₹ 10,916 (8744, 13078), 22,136 (17570, 26910) and 8,574 (6791, 10379), respectively. One way sensitivity analysis showed that the three most influential factors on the costs of FP services were prices of drugs and consumables, number of beneficiaries and health personnel cost. Interpretation & conclusions: The present study has generated package costs for FP and pregnancy-related services in India which could be used by publicly-funded insurance schemes, for budgeting, economic evaluations and improve resource allocation of services. The cost estimates from this study add to the limited literature in India on costs of FP.

Surveying the persistence of age- and gender-based restrictions on over-the-counter emergency contraception across pharmacies in Los Angeles County, CA.

BACKGROUND: Over-the-counter levonorgestrel emergency contraception (OTC EC) is safe and effective but underutilized for postcoital pregnancy prevention. Unnecessary restrictions imposed by pharmacies and pharmacy workers may impede EC uptake. OBJECTIVE: To assess the persistence of age- and gender-based barriers to OTC EC access among pharmacists and pharmacy staff across Los Angeles, CA. METHODS: We conducted a cross-sectional survey of registered community pharmacies randomly chosen from regions with the highest unintended pregnancy rates in Los Angeles County. Using an adaptation of the 2017 American Society for Emergency Contraception EC Access and Price Survey, we interviewed pharmacy staff about their attitudes and practices related to OTC EC, with attention to age- and gender-based barriers. RESULTS: We surveyed 139 staff members (45% pharmacists, 20% technicians, 26% retail) from 93 publicly accessible pharmacies. Thirteen pharmacies did not stock EC. Half of respondents cited age-based restrictions; only 4% noted gender-based restrictions. More than 75% reported being asked for EC by a man; 7% reported refusing to sell to a man. Nearly 40% reported that men never or rarely purchased EC. Pharmacists were more likely than technicians or retail staff to believe men rarely purchased EC (P = 0.01). The most frequently cited concern about selling to men was inability to confirm the female partner's age. CONCLUSION: Although gender-based restrictions to EC are rare, more than half of pharmacy staff continue to report age-based restrictions. Inability to verify the female partner's age may underlie cases where men are unable to purchase OTC EC.

Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation.

BACKGROUND: Tubal ligation remains common in the USA, especially among low-income patients. OBJECTIVE: To compare the effectiveness and safety of intrauterine contraceptives (IUC) to laparoscopic tubal ligation for Medicaid clients. DESIGN: We partnered with patient and clinician stakeholders to conduct a retrospective cohort study using California Medicaid claims for patients who had an IUC placed or laparoscopic tubal ligation performed in 2008-2014, excluding procedures performed within 42 days of a birth. We applied log-linear (Poisson) event-history regression models for clustered person-period data to adjust for sociodemographic variables and pre-procedure health status when examining associations between these contraceptive procedures and claims related to contraceptive failure, complications, and pain in the first year post-procedure. KEY RESULTS: We identified 35,705 patients who had a levonorgestrel IUC placed, 23,628 patients who had a copper IUC placed, and 23,965 patients who underwent laparoscopic tubal ligation. In unadjusted analyses, rates of pregnancy within 1 year were similar following levonorgestrel IUC (2.40%) or copper IUC placement (2.99%) or tubal ligation (2.64%). In adjusted analyses, compared to tubal ligation, pregnancy was less common following placement of a levonorgestrel IUC (adj IRR 0.72, 95% CI 0.64-0.82) and similar with placement of a copper IUC (adj IRR 0.92, 95% CI 0.82-1.05). Procedural complications such as infection (0.35% vs. 2.91%) were significantly less common with IUC placement than tubal ligation. Claims for pelvic and abdominal pain decreased in frequency with time since all procedures; 6 to 12 months post-procedure, pelvic pain claims were less common after levonorgestrel IUC (adj IRR 0.69, 95% CI 0.65-0.73) or copper IUC placement (adj IRR 0.70, 95% CI 0.66-0.75) than tubal ligation. CONCLUSIONS: IUC appears at least as effective as laparoscopic tubal ligation at 1-year post-procedure with lower rates of infection and pelvic pain 6 to 12 months post-procedure. CLINICAL TRIAL REGISTRATION: NCT03438682.

Contraceptive utilization at publicly funded clinics before and after introduction of low-cost levonorgestrel intrauterine system: a retrospective case study analysis.

Cost can be a barrier to accessing safe and affordable contraception. Therefore, we sought to understand how the availability and utilization of a low-cost levonorgestrel intrauterine system (hormonal IUD) impacts uptake relative to other contraceptive methods. Another objective was to determine if the percentage of self-pay women who obtained a hormonal IUD changed over time. Electronic health record (EHR) data was collected from five public health organizations enrolled in the 340B drug-pricing program (30 individual health centers) from April 15, 2014, through December 31, 2017, with most sites receiving Title X funding. The study captured data before and after low-cost hormonal IUD introduction. Interview data from 28 key informants provided a deeper understanding of how trends in hormonal IUD use changed after low-cost hormonal IUD introduction. Encounters from 101,075 women were analyzed. Locally weighted scatterplot smoothing (LOWESS) trends revealed an increasing utilization for all long-acting reversible contraception (LARC) and a decreasing trend for short-acting methods. Among self-pay women, hormonal IUD uptake increased 3 percentage points (p < .001) after the introduction of low-cost hormonal IUD. Privately insured women saw a 7-percentage point increase in hormonal IUD uptake while women whose family income was greater than 200% of the federal poverty level (FPL) saw a 13.9 percentage point increase in hormonal IUD uptake. The introduction of a low-cost hormonal IUD was associated with more self-pay and low-income women accessing this method. Access to and utilization of low-cost hormonal IUDs are complicated by many factors including product availability and provider training.

A Cost Effectiveness Model of Long-Acting Reversible Contraceptive Methods in the Brazilian National Health System.

INTRODUCTION: The use of long-acting reversible contraceptives is low among adolescents owing to the high up-front cost. In this study, a 5-year cost-effectiveness model and budget impact analysis were used to compare the use of long-acting reversible contraceptives with the use of combined oral contraceptives among Brazilian adolescents. METHODS: A Markov model was developed to mirror the clinical and economic effects of long-acting reversible contraceptives among sexually active Brazilian adolescents in the public health system for a 5-year duration, starting from 2018. The costs were expressed in U.S.$, and a 5% discount rate was applied for both costs and benefits. Model inputs included costs of the contraceptive methods, contraceptive discontinuation and adherence rates, abortion, and birth costs associated with unintended pregnancies. The model outcomes were avoided pregnancies, abortions, and births. Univariate and probabilistic sensitivity analyses were conducted. RESULTS: Copper intrauterine device use was dominant 100% of the time for all outcomes, and a budget impact analysis revealed a cost savings of $422,431,269.10 in the 5-year period. Levonorgestrel intrauterine system and subdermal implant use were cost effective for all outcomes. The budget impact analyses revealed costs of $65,645,417.54 for levonorgestrel intrauterine system and $302,852,972.12 for subdermal implant use during the 5-year study period. CONCLUSIONS: According to this Brazilian model, copper intrauterine device use is dominant, and levonorgestrel intrauterine systems and subdermal implants are more cost effective than combined oral contraceptives.

[Preparation, Confidence, and Attitude to Sell Emergency Contraceptive Pills at Pharmacies: A Web Survey of Japanese Community Pharmacists].

Emergency contraceptive (EC) pills are used to prevent pregnancy after unprotected sexual intercourse. Levonorgestrel is an EC pill, which has been only approved in Japan; it is more effective the sooner it is used after intercourse and safe without serious side effects. EC pills are already available at accessible community pharmacies in more than 90 countries around the world. In Japan, citizens have signed a petition calling for the sale of emergency contraceptives at community pharmacies. However, little is known about the thoughts of pharmacists who engage with patients and sell medicines at pharmacies. Therefore, we conducted a web-based cross-sectional survey to determine the level of preparation in community pharmacies and the awareness of pharmacists regarding the sale of EC pills. A total of 1338 pharmacists responded to the survey from November 7, 2020, to December 16, 2020. In terms of the level of preparation for selling EC pills at pharmacies, 1067 (83.9%) respondents cited "lack of preparation of medical questionnaires and explanatory materials", and 975 (76.7%) respondents cited "lack of knowledge of pharmacists" as the most common reasons that were "barriers to EC pill sales at pharmacies". In terms of confidence level, only 289 (22.7%) respondents were confident about conducting the necessary checks while administering medicine. On the other hand, 944 (74.3%) respondents agreed to be able to sell EC pills at their pharmacies. The survey revealed that most of the pharmacists who participated in the survey believe that it is possible to sell EC pills in pharmacies.

Use of Immediate Postpartum Long-Acting Reversible Contraception Before and After a State Policy Mandated Inpatient Access.

OBJECTIVE: To assess the rate of immediate postpartum long-acting reversible contraceptive (LARC) use in a multihospital health care system 2 years before and after the policy was implemented, and to assess factors associated with LARC use and repeat pregnancy rates within 12 months after delivery. METHODS: We conducted a retrospective chart review of all patients giving birth at three Cleveland Clinic Ohio hospitals from July 1, 2015, to June 30, 2019. We reviewed the inpatient medication reconciliation to identify the LARC initiation rate. We compared all patients who received inpatient postpartum LARC to a 1:3 matched sample of patients who did not receive LARC, matched by delivery date and location, to identify patient characteristics associated with LARC use. The electronic medical record (Epic) was reviewed to identify new pregnancies occurring within 12 months postdelivery. RESULTS: We identified 17,848 deliveries prepolicy and 18,555 deliveries postpolicy. Immediate postpartum LARC was used by 0.5% (monthly range 0-2.1%) of patients prepolicy and 11.6% (monthly range 8.3-15.4%) of patients postpolicy. Levonorgestrel intrauterine devices (IUDs) were used by 56.5%, implants by 29.1%, and copper IUDs by 14.5% of LARC users. Characteristics associated with LARC use included younger age, public insurance, non-White race, Hispanic or Latina ethnicity, higher body mass index, sexually transmitted infection in pregnancy, and tobacco use. Long-acting reversible contraceptive users had a lower rate of repeat pregnancy at 12 months postpartum compared with the non-LARC group (1.9% vs 3.6%, P<.001). CONCLUSION: Immediate postpartum LARC use increased after a state policy change mandated universal access and was associated with decreased pregnancy rates in the first year postdelivery.

Comparison of Levonorgestrel-releasing Intrauterine System (LNG-IUS) against Laparoscopic Assisted Supracervical Hysterectomy (LASH) for menorrhagia treatment: An economic evaluation.

BACKGROUND: This economic evaluation and literature review was conducted with the primary aim to compare the cost-effectiveness of laparoscopic assisted supracervical hysterectomy (LASH) with NICE's gold-standard treatment of Levonorgestrel-releasing intrauterine system (LNG-IUS) for menorrhagia. MATERIALS AND METHODS: A cost-utility analysis was conducted from an NHS perspective, using data from two European studies to compare the treatments. Individual costs and benefits were assessed within one year of having the intervention. An Incremental Cost-Effectiveness Ratio (ICER) was calculated, followed by sensitivity analysis. Expected Quality Adjusted Life Years (QALYS) and costs to the NHS were calculated alongside health net benefits (HNB) and monetary net benefits (MNB). RESULTS: A QALY gain of 0.069 was seen in use of LNG-IUS compared to LASH. This yielded a MNB between -£44.99 and -£734.99, alongside a HNB between -0.0705 QALYs and -0.106 QALYS. Using a £20,000-£30,000/QALY limit outlined by NICE,this showed the LNG-IUS to be more cost-effective than LASH, with LASH exceeding the upper bound of the £30,000/QALY limit. Sensitivity analysis lowered the ICER below the given threshold. CONCLUSIONS: The ICER demonstrates it would not be cost-effective to replace the current gold-standard LNG-IUS with LASH, when treating menorrhagia in the UK. The ICER's proximity to the threshold and its high sensitivity alludes to the necessity for further research to generate a more reliable cost-effectiveness estimate. However, LASH could be considered as a first line treatment option in women with no desire to have children.