Association of pharmacist prescription and 12-month contraceptive continuation rates.

BACKGROUND: States have passed legislation to expand the scope of pharmacists to directly prescribe contraception. It is thought that pharmacist prescription of contraception may promote correct and consistent use of contraception by reducing barriers to access. However, it is not known how this may impact ongoing contraceptive use. OBJECTIVE: This study aimed to determine whether 12-month rates of continuation of an effective form of contraception or perfect use of contraception differ by prescribing provider (pharmacist or clinician). STUDY DESIGN: We conducted a 1-year prospective cohort study of 388 women seeking contraception in 139 pharmacies across 4 states (California, Colorado, Hawaii, and Oregon). Our study was powered to detect a 10% difference in 12-month continuation of an effective form of contraception. We clarified women's pregnancy intention at baseline and subsequent follow-ups. Women received a prescription directly from a pharmacist (n=149) or were filling a prescription from a clinician, our comparison group (n=239). We used multivariable logistic regression to measure the association between pharmacist prescriber and use of any effective contraceptive method or perfect use at 12 months. Model covariates included age, race, education, side effects experienced, payor, and contraceptive supply dispensed at baseline. RESULTS: Of the study cohort, 88% (n=340) completed 12 months of follow-up. Among women not planning to become pregnant, 7 women in the clinic-prescribed group vs 1 woman in the pharmacy-prescribed group (3.4% vs 0.8%; P>.05) reported a positive pregnancy test during the study period. The majority of the cohort was continuing to use an effective method of contraception at 12 months (clinician 89.3% vs pharmacist 90.4%; P=.86). Among women receiving a prescription from a clinician, 53.9% reported perfect use (no missed days) at 12 months, compared with 47% of the pharmacist-prescribed group (P=.69). Pharmacist prescriber type was not associated with continuation of an effective contraceptive method at 12 months (adjusted odds ratio, 0.70; confidence interval, 0.28-1.71) or with perfect use of contraception (adjusted odds ratio, 0.87; confidence interval, 0.51-1.48), controlling for other woman-level characteristics. CONCLUSION: We found no difference in use of any effective contraception, perfect use, or switching at 12 months among those who received their baseline prescription from a pharmacist vs a clinician. This study is limited by not examining information on safety outcomes.

Pharmacists expand access to reproductive heaLthcare: PEARL study protocol.

BACKGROUND: In 2016, Oregon became the first of eight states to allow pharmacists to directly prescribe hormonal contraception (HC), including the pill, patch, or ring, without a clinic visit. In the two years following this policy change, the majority of ZIP codes across the state of Oregon had a pharmacist certified to prescribe HC. METHODS: We will utilize complementary methodologies to evaluate the effect of this policy change on convenient access to contraception (cost, supply dispensed), safety, contraceptive continuation and unintended pregnancy rates. We will conduct a prospective clinical cohort study to directly measure the impact of provider type on contraceptive continuation and to understand who is accessing hormonal contraception directly from pharmacists. We will concurrently conduct a retrospective analysis using medical claims data to evaluate the state-level effect of the policy. We will examine contraceptive continuation rates, incident pregnancy, and safety measures. The combination of these methodologies allows us to examine key woman-level factors, such as pregnancy intention and usual place of care, while also estimating the impact of the pharmacist prescription policy at the state level. DISCUSSION: Pharmacist prescription of HC is emerging nationally as a strategy to reduce unintended pregnancy. This study will provide data on the effect of this practice on convenient access to care, contraceptive safety and continuation rates.

Pharmacists' experience with prescribing hormonal contraception in Oregon.

OBJECTIVES: To describe Oregon pharmacy practices in provision of hormonal contraception (HC) and evaluate if pharmacists' motivation to prescribe changed after 6 and 12 months of experience. METHODS: Pharmacists practicing in Oregon who underwent the mandatory HC training were eligible to take this survey. The survey was launched 6 months after policy implementation; pharmacists who responded to the initial survey were eligible to be queried again at 12 months. Survey responses were anonymous, but pharmacists received a unique identifier so that responses could be linked between the 2 surveys. The survey consisted of pharmacy and pharmacist demographics and questions exploring attitudes toward prescribing HC and prescribing practices (e.g., cost, time needed for visit) and volume estimates. Descriptive statistics were used to analyze responses as well as the differences in key outcomes between 6 and 12 months. RESULTS: A total of 732 pharmacists were eligible to take the survey; 121 pharmacists responded to the 6-month survey (16.5% response rate), and 62 completed the 12-month survey (52% response rate). A large increase in the distribution of pharmacists prescribing HC by zip code occurred between 6 and 12 months: 19% and 63%, respectively. At both 6 and 12 months, almost one-half of all pharmacists were billing insurance for the visit, and the average visit took less than 30 minutes. The top 3 motivators for providing HC did not change over time and included increasing access, reducing unintended pregnancy, and increasing pharmacist scope of practice. CONCLUSION: One year after program implementation, pharmacist prescribing of HC continues to increase and is distributed widely across the state. A geographically diverse sample of Oregon pharmacists began prescribing of hormonal contraception within 12 months of Oregon's implementation of the new pharmacist provision policy. Their experience and the success of the program provide a roadmap for pharmacist participation to increase access to hormonal contraception.

Pharmacist prescription of hormonal contraception in Oregon: Baseline knowledge and interest in provision.

OBJECTIVES: Oregon has implemented legislation expanding the scope of pharmacists to directly prescribe short-acting hormonal contraception (pill and patch) without a medical prescription. Pharmacists are crucial to the success of the new law, but relatively little is known about their intentions to prescribe contraception, or the motivators or barriers in providing this service. METHODS: With the use of a cross-sectional survey of pharmacists practicing in Oregon before the legislative implementation, we analyzed responses to assess contraceptive knowledge, motivation to participate in direct provision, and perception of barriers to pharmacist prescription of contraception. A logistic regression model was used to examine the association between years in pharmacy practice and intention to provide direct access to contraception. RESULTS: A total of 509 pharmacists responded (17%). If training and reimbursement were offered, more than one-half of pharmacists would potentially be interested in prescribing contraception, managing side-effects, or moving women to a different hormonal method (57%, 61%, and 54%, respectively). However, only 39.1% of pharmacists surveyed planned to actually prescribe hormonal contraception when the legislation took effect. Shortage of pharmacy staff to provide services, concerns about liability, and a need for additional training were the three largest barriers to participation. Pharmacists practicing in urban locations (odds ratio 1.73, 95% CI 1.11-2.70) or currently offering emergency contraception (odds ratio 2.23, 95% CI 1.47-3.40) were significantly more likely to be planning to participate. CONCLUSION: Preliminary data indicate a need to support pharmacists with education on contraceptive provision and development of interventions to facilitate counseling in the pharmacy setting.

Prohibiting consent: what are the costs of denying permanent contraception concurrent with abortion care?

OBJECTIVE: Oregon and federal laws prohibit giving informed consent for permanent contraception when presenting for an abortion. The primary objective of this study was to estimate the number of unintended pregnancies associated with this barrier to obtaining concurrent tubal occlusion and abortion, compared with the current policy, which limits women to obtaining interval tubal occlusion after abortion. The secondary objectives were to compare the financial costs, quality-adjusted life years, and the cost-effectiveness of these policies. STUDY DESIGN: We designed a decision-analytic model examining a theoretical population of women who requested tubal occlusion at time of abortion. Model inputs came from the literature. We examined the primary and secondary outcomes stratified by maternal age (>30 and <30 years). A Markov model incorporated the possibility of multiple pregnancies. Sensitivity analyses were performed on all variables and a Monte Carlo simulation was conducted. RESULTS: For every 1000 women age <30 years in Oregon who did not receive requested tubal occlusion at the time of abortion, over 5 years there would be 1274 additional unintended pregnancies and an additional $4,152,373 in direct medical costs. Allowing women to receive tubal occlusion at time of abortion was the dominant strategy. It resulted in both lower costs and greater quality-adjusted life years compared to allowing only interval tubal occlusion after abortion. CONCLUSION: Prohibiting tubal occlusion at time of abortion resulted in an increased incidence of unintended pregnancy and increased public costs.

Contraceptive services in Oregon's state-funded network during the COVID-19 pandemic.

OBJECTIVES: To understand how changes to in-person health care during the COVID pandemic impacted contraceptive use in Oregon's state-funded network. STUDY DESIGN: A retrospective cohort of 245,600 visits (virtual and in-person) among 70,295 women presenting to publicly funded family planning clinics in Oregon between January 2019 and June 2021. Data were abstracted from clinic records and restricted to visits of patients identifying as female, 12-51 years old, not using sterilization as a method. Contraception was grouped by effectiveness Tier (Tier 1: intrauterine device, implants; Tier 2: progestin injectable, pill/patch/ring). Multivariable logistic regression predicted the use of contraception by stage of the COVID pandemic which corresponded to service availability (prepandemic, acute: nonemergency services halted, subacute: restricted services), patient demographics, including insurance type, and clinic and geospatial characteristics. RESULTS: Overall during the acute stage, people with visits were more likely to leave with a method of contraception odds ratios (OR) 1.39 (95% confidence interval [CI] 1.24-1.57); however, it was significantly less likely to be a Tier 1 method (OR 0.82, 95% CI 0.74-0.91) as compared to prepandemic. This finding was particularly marked in rural areas (OR 0.69 [96% CI 0.58-0.83]) and among the publicly insured (OR 0.87 [95% CI 0.80-0.94]). CONCLUSIONS: Demand for contraception increased during the acute phase of the COVID pandemic, and shifts in method mix from Tier 1 to Tier 2 methods occurred. Disparities in contraceptive access persisted for those in rural locations or with public insurance. IMPLICATIONS: Lessons learned from the COVID-19 pandemic are critical to informing our future emergency response. The need for family planning services increased during the public health emergency.

Double Dosing Levonorgestrel-Based Emergency Contraception for Individuals With Obesity: A Randomized Controlled Trial.

OBJECTIVE: To assess whether dose escalation (ie, doubling the dose) of emergency contraception that contains levonorgestrel (LNG) improves pharmacodynamic outcomes in individuals with obesity. METHODS: We enrolled healthy, reproductive-age individuals with regular menstrual cycles, body mass index (BMI) higher than 30, and weight at least 176 lbs in a randomized pharmacodynamic study. After confirming ovulation (luteal progesterone level greater than 3 ng/mL), we monitored participants with transvaginal ultrasonography and blood sampling for progesterone, luteinizing hormone, and estradiol every other day until a dominant follicle measuring 15 mm or greater was visualized. At that point, participants received either oral emergency contraception with LNG 1.5 mg or 3 mg (double dose) and returned for daily monitoring for up to 7 days. Our primary outcome was the difference in the proportion of participants with no follicle rupture 5 days postdosing (yes or no) between groups. The study had 80% power to detect a 30% difference in the proportion of cycles with at least a 5-day delay in follicle rupture (50% decrease). RESULTS: A total of 70 enrolled and completed study procedures. The two groups had similar baseline demographics (mean age 28 years, BMI 38). We found no difference between groups in the proportion of participants without follicle rupture more than 5 days post-LNG dosing (LNG 1.5 mg: 18/35 [51.4%]; LNG 3.0 mg: 24/35 [68.6%], P=.14). Among participants with follicle rupture before 5 days, the time to rupture did not differ between groups (day at 75% probability of no rupture is day 2 for both groups). CONCLUSION: Individuals with higher BMIs and weights experience a higher risk of failure of emergency contraception with LNG and exhibit an altered pharmacokinetic profile. However, the simple strategy of doubling the dose does not appear to be an effective intervention to improve outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, 02859337.

Safety and efficacy of contraception--Why should the obese woman be any different?

The public health impact of obesity and unintended pregnancy is profound with far reaching consequences. Obese women are less likely to use contraception due to a variety of self-induced and systems-based barriers but their risk of becoming pregnant is similar to their normal weight counterparts. However, pregnancy-associated risks for obese women are higher than that of normal weight women and thus, pregnancy generally outweighs the risks of contraceptive use. Adequate counselling to prevent and/or plan for pregnancy is imperative for these women. Research that investigates the relationship between obesity and contraceptive use is urgently needed.

Medical abortion offered in pharmacy versus clinic-based settings: A systematic review.

OBJECTIVE: Expanding access to medical abortion through pharmacies is a potential strategy to promote safe abortion care. To compare the effectiveness and safety of medical abortion offered in pharmacy settings with clinic-based medical abortion. STUDY DESIGN: We searched multiple databases and the gray literature through November 2020. No language restrictions were applied. We included randomized and nonrandomized comparative studies. We applied standard risk of bias tools to each included study and used GRADE methodology to assess certainty of evidence. The primary outcomes were completion of abortion without additional intervention, need for blood transfusion, and presence of uterine or systemic infection within 30 days of medical abortion. RESULTS: Our search yielded 2030 studies. One prospective cohort study from Nepal met inclusion criteria. This study collected data on 605 women obtaining medical abortion rom either a clinic or pharmacy, and was judged to have low risk of bias for our primary outcome. For women who received medical abortion in a pharmacy compared to a clinic there was probably little or no difference in complete abortion rates (adjusted risk difference 1.5%; 95% confidence interval [CI] -0.8 to 3.8, 1 study, 600 participants; low certainty of evidence). No cases of blood transfusion were reported in the study and a composite outcome comprised mainly of infection complications showed little or no difference between settings (adjusted risk difference 0.8; 95% CI -1.0 to 2.8, 1 study, 600 participants; very low certainty of evidence). CONCLUSION: Evidence from just one nonrandomized study provides low certainty evidence that the effectiveness of medical abortion is probably not different between the pharmacy or clinic setting. IMPLICATIONS: Provision of medical abortions through pharmacy-based models of care may improve access to safe abortion. Comparative studies examining each model of care and outcomes on safety, effectiveness, and patient experience are needed.

Heavy menstrual bleeding in women on oral anticoagulants.

BACKGROUND: Although heavy menstrual bleeding (HMB) is a known complication of anticoagulant therapy, rates of HMB in users of the direct oral anticoagulants (OACs) apixaban and rivaroxaban are largely unknown. METHODS: We performed a retrospective cohort study of menstruating women prescribed rivaroxaban, apixaban and warfarin over a six-year period (2012-2018). The primary outcome was HMB requiring medical or surgical intervention. We used descriptive statistics and logistic regression to evaluate associations between OAC type, age, history of HMB, and the primary outcome. RESULTS: We identified 195 women of reproductive-age with a new therapeutic OAC prescription (62 on rivaroxaban, 54 on apixaban, 79 on warfarin). A minority (26/195, 13.3%) had a documented history of HMB, including 9 rivaroxaban users, 7 apixaban users and 10 warfarin users but most women (117/195, 60%) had no menstrual history documented. One third of subjects (64/195) required treatment for HMB within 6 months of starting OAC therapy. After controlling for a history of HMB, rivaroxaban users were 1.4 times more likely to require treatment as compared to users of other OACs. DISCUSSION: We found an association between rates of HMB necessitating medical or surgical intervention and rivaroxaban use. We also found that the majority of women did not have a documented menstrual history, suggesting that many providers do not inquire about menstrual bleeding when starting OAC therapy. Menstruating women, particularly those with a history of HMB, may be at increased risk for HMB necessitating medical treatment depending on the type of OAC used.

Association of Pharmacist Prescription With Dispensed Duration of Hormonal Contraception.

Importance: Since 2016, 11 states have expanded the scope of pharmacists to include direct prescription of hormonal contraception. Dispensing greater than 1 month's supply is associated with improved contraceptive continuation rates and fewer breaks in coverage. Scant data exist on the practice of pharmacist prescription of contraception and its outcomes compared with traditional, clinic-based prescriptions. Objective: To compare the amount of hormonal contraceptive supply dispensed between pharmacists and clinic-based prescriptions. Prescribing patterns were assessed by describing prescribing practices for women with contraindications to combined hormonal contraception. Characteristics of women seeking hormonal contraception directly from pharmacists were also described. Design, Setting, and Participants: This cohort study surveyed women aged 18 to 50 years who presented to pharmacies in California, Colorado, Hawaii, and Oregon for hormonal contraception prescribed by a clinician or a pharmacist between January 30 and November 1, 2019. Exposures: Pharmacist or clinic-based prescription of contraception. Main Outcomes and Measures: Months of contraceptive supply dispensed. Results: Four hundred ten women (mean [SD] age, 27.1 [7.7] years) were recruited who obtained contraception directly from a pharmacist (n = 144) or by traditional clinician prescription (n = 266). Women obtaining contraception from a pharmacist were significantly younger (82 [56.9%] vs 115 [43.2%] participants aged 18-24 years; P = .03), had less education (38 [26.4%] vs 100 [37.6%] with a bachelor degree; P = .002), and were more likely to be uninsured (16 [11.1%] vs 8 [3.0%] participants; P = .001) compared with women with a prescription from a clinician. Pharmacists were significantly more likely to prescribe a 6-month or greater supply of contraceptives than clinicians (6.9% vs 1.5%, P < .001) and significantly less likely to only prescribe a 1-month supply (42 [29.2%] vs 118 [44.4%] prescriptions; P < .001). Controlling for all covariates, women seen by pharmacists had higher odds of receipt of a 6-month or greater supply of contraceptives compared with those seen by clinicians (odds ratio = 3.55; 95% CI, 1.88-6.70). Pharmacists were as likely as clinicians to prescribe a progestin-only method to women with a potential contraindication to estrogen (n = 60 women; 8 [20.0%] vs 6 [30.0%], P = .52). Conclusions and Relevance: These findings suggest that pharmacist prescription of contraception may be associated with improved contraceptive continuation by preventing breaks in coverage through the provision of a greater supply of medication. Efforts are needed to educate prescribing providers on the importance of dispensing 6 months or greater contraceptive supply.

Reasons for and experience in obtaining pharmacist prescribed contraception.

OBJECTIVE: To describe reasons for and experiences with obtaining contraception from pharmacists. STUDY DESIGN: Cross-sectional survey. RESULTS: Our sample included 426 women presenting for hormonal contraception (n = 150 pharmacist prescribers). The most common reasons women chose to obtain their contraception from a pharmacist were because no appointment was required (25%) or their prescription had lapsed (24%). Women receiving contraception from pharmacists were highly satisfied (95.3% vs 100.0%; p = 0.007). Women recalled similar side-effects counseling points regardless of prescriber type (p = 0.30). CONCLUSION: Women chose to obtain contraceptive care at the pharmacy because it was timely and convenient.

Simultaneous assay of segesterone acetate (Nestorone®), estradiol, progesterone, and estrone in human serum by LC-MS/MS.

OBJECTIVE: To develop a method to simultaneously quantify the synthetic contraceptive progestin segesterone acetate (Nestorone®, NES) and the endogenous steroid hormones estradiol (E2), progesterone (P4), and estrone (E1) in human serum samples by liquid chromatography-tandem mass spectrometry (LC-MS/MS). STUDY DESIGN: We analyzed 615 serum samples collected from 67 reproductive-age women actively using a contraceptive vaginal ring (CVR) designed to release NES (200 mcg/d) and E2 (75-200 mcg/d). Samples were taken prior to and up to 30 days after CVR insertion and analyzed for concentrations of NES, E2, P4, and E1 in human serum using a Shimadzu Nexera-LCMS-8050 LC-MS/MS platform. Precision, accuracy, and sensitivity for all analytes were determined across multiple assays. RESULTS: The assay ranges for NES, E2, P4, and E1 in this analytical method were 10 pg/mL to 10 ng/mL with a lower limit of quantification of 10 pg/mL for all targets. Assay precisions were less than or equal to 14.5% and accuracies ranged from 87.0% to 110.8%. When applied to the 615 clinical samples, 550 samples had quantifiable concentrations of NES (value range 0.014-1471 ng/mL). Similarly, 595 samples had quantifiable concentrations of E2 (0.010-0.312 ng/mL), 596 samples had quantifiable concentrations of P4 (0.010-5.791 ng/mL), and 609 samples had quantifiable concentrations of E1 (0.010-0.416 ng/mL). CONCLUSIONS: The LC-MS/MS platform results in a robust, accurate, and sensitive method for the simultaneous quantification of NES and endogenous steroid hormones in human serum. IMPLICATIONS: The analytical method described allows for the simultaneous quantification of NES and endogenous steroids and can be used to monitor NES concentrations during clinical trials and subject adherence to treatment with NES.

Management of Postpartum Hemorrhage With a Mini-Sponge Tamponade Device.

BACKGROUND: Postpartum hemorrhage is a leading cause of maternal mortality globally. A tamponade agent that can be quickly and easily placed in a range of settings could advance the treatment of atonic hemorrhage. METHOD: We adapted a highly effective trauma dressing for use in postpartum hemorrhage. This mini-sponge tamponade device is comprised of two components: compressed mini-sponges contained within a strong mesh pouch and a tubular applicator. Compressed mini-sponges rapidly absorb blood, expand within seconds, and exert sustained pressure uniformly to bleeding sites. The sponges are deployed within a mesh pouch to facilitate simple vaginal removal. EXPERIENCE: We successfully placed the mini-sponge device in nine patients experiencing postpartum hemorrhage after vaginal birth, with resolution of bleeding within 1 minute. The mean time to place the device was 62 seconds. Uterine fill was documented in all cases by ultrasound scan, and device placement was rated as "easy" to "very easy." Mini-sponges were left in place on average for 1 hour (0.5 hours-14 hours). Bleeding did not recur. There were no adverse events; all patients remained afebrile and did not require subsequent surgical intervention. CONCLUSION: This study supports further evaluation of the mini-sponge device for the management of postpartum hemorrhage. FUNDING: This study was funded by OBSTETRX, Inc.

Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether a short course of tamoxifen decreases bothersome bleeding in etonogestrel contraceptive implant users. METHODS: In a 90-day, double-blind randomized control trial, we enrolled etonogestrel implant users with frequent or prolonged bleeding or spotting. A sample size of 40 per group (N=80) was planned to compare 10 mg tamoxifen or placebo twice daily for 7 days after 3 consecutive days of bleeding or spotting no more than once per 30 days (maximum three treatments). Participants then entered a 90-day open-label study where all received tamoxifen if needed every 30 days (maximum three treatments). Participants used text messages to record daily bleeding patterns. Our primary outcome was the total number of consecutive amenorrhea days after the first treatment. Secondary outcomes included time to bleeding or spotting cessation and restart after first treatment, overall bleeding patterns, and satisfaction. RESULTS: From January 2017 to November 2018, 112 women enrolled in the study; 88 (79%) completed 90 days, and 79 (71%) completed 180 days. Participant characteristics did not differ between groups; mean age 24, majority identified as white not Hispanic with at least some college education. After the first treatment, the tamoxifen group reported an average of 9.8 (95% CI 4.6-15.0) more consecutive days of amenorrhea and more total days of no bleeding (amenorrhea or spotting) in the first 90 days (median 73.5 [range 24-89] vs 68 [range 11-81], P=.001). The placebo group showed a similar treatment benefit after first active use of tamoxifen in the open-label phase. At the end of the randomized study (first 90 days), women who received tamoxifen reported higher satisfaction (median 62 mm [range 16-100]) than those treated with placebo (46 mm [range 0-100]; P=.023). CONCLUSION: A short course of tamoxifen reduces problematic bleeding and improves satisfaction in users of etonogestrel implants. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02903121.

Ulipristal acetate compared to levonorgestrel emergency contraception among current oral contraceptive users: a cost-effectiveness analysis.

OBJECTIVE: To estimate the cost-effectiveness of ulipristal acetate (UPA) and levonorgestrel (LNG) emergency contraception (EC) on pregnancy prevention among combined oral contraceptive (COC) pill users with an extended pill-free interval. We accounted for the potential interaction of COCs and obesity on EC efficacy. METHODS: We built a decision-analytic model using TreeAge software to evaluate the optimal oral EC strategy in a hypothetical cohort of 100,000 twenty-five-year-old women midcycle with a prolonged "missed" pill episode (8-14 days). We used a 5-year time horizon and 3% discount rate. From a healthcare perspective, we obtained probabilities, utilities and costs inflated to 2018 dollars from the literature. We set the threshold for cost-effectiveness at a standard $100,000 per quality-adjusted life-year. We included the following clinical outcomes: number of protected cycles, unintended pregnancies, abortions, deliveries and costs. RESULTS: We found that UPA was the optimal method of oral EC, as it resulted in 720 fewer unintended pregnancies, 736 fewer abortions and 80 fewer deliveries at a total cost savings of $50,323 and 79 additional adjusted life-years. UPA continued to be the optimal strategy even in the case of obesity or COCs impacting UPA efficacy, in which a COC interaction would have to change efficacy of UPA by 160% before LNG was the dominant strategy. CONCLUSION: Our models found that UPA was the dominant choice of oral EC among COC users with a prolonged "missed" pill episode, regardless of body mass index or an adverse interaction of COCs on UPA. IMPLICATIONS: Ulipristal acetate is the dominant choice of oral emergency contraception among combined oral contraceptive users.

Association of Pharmacist Prescription of Hormonal Contraception With Unintended Pregnancies and Medicaid Costs.

OBJECTIVE: To estimate unintended pregnancies averted and the cost effectiveness of pharmacist prescription of hormonal contraception. METHODS: A decision-analytic model was developed to determine the cost effectiveness of expanding the scope of pharmacists to prescribe hormonal contraception compared with the standard of care and contraceptive access in clinics. Our perspective was that of the payor, Oregon Medicaid. Our primary outcome was unintended pregnancies averted. Secondary outcomes included: costs and quality-adjusted life years (QALYs). Model inputs were obtained from an analysis of Medicaid claims for the first 24 months after policy implementation in Oregon, and the literature. Univariate and bivariate sensitivity analyses, as well as a Monte Carlo simulation, were performed. RESULTS: Among Oregon's Medicaid population at risk for unintended pregnancy, the policy expanding the scope of pharmacists to prescribe hormonal contraception averted an estimated 51 unintended pregnancies and saved $1.6 million dollars. Quality of life was also improved, with 158 QALYs gained per 198,000 women. Sensitivity analysis demonstrated that the model was most sensitive to the effect on contraceptive continuation rates. If contraceptive continuation rates among women receiving care from a pharmacist are 10% less than among clinicians, than pharmacist prescription of hormonal contraception will not avert unintended pregnancies. CONCLUSION: Pharmacist prescription of hormonal contraception averts unintended pregnancies and is cost effective. Full implementation of the policy is needed for maximum benefits. Prospective data on the effect of the policy on contraceptive continuation rates are needed.

Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial.

OBJECTIVE: To determine if a course of oral tamoxifen initiated following placement of a levonorgestrel 52-mg intrauterine system (IUS) reduces bleeding/spotting days over 30 days. STUDY DESIGN: In this single-center, double-blind, placebo-controlled trial, we recruited women ages 15-45 years initiating the levonorgestrel 52-mg IUS. We randomized eligible women to tamoxifen 10 mg or placebo twice daily for 7 days starting 21 days after levonorgestrel 52-mg IUS insertion. Participants tracked bleeding/spotting days via daily electronic diaries for 30 days after starting drug treatment. We assessed participant satisfaction with their bleeding pattern and the IUS using a visual analog scale (0-100 mm). A sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t test, accounting for an expected 20% dropout rate. RESULTS: From September 2016 to January 2018, 42 women enrolled. A total of 34 women provided complete bleeding/spotting data, and 30 women provided satisfaction data. Mean bleeding/spotting days over 30 days did not differ between tamoxifen (12.0±5.8 days) and placebo users (16.8±9.0 days), p=.08. We found no significant differences in mean satisfaction with bleeding profiles (51 mm tamoxifen vs. 59 mm placebo, p=.48) or with the IUS (83 mm vs. 75 mm, p=.36) between groups. Both groups reported similar rates of adverse events, with no serious adverse events reported. CONCLUSION: A course of oral tamoxifen did not improve early breakthrough bleeding or satisfaction in new users of the levonorgestrel 52-mg IUS. IMPLICATIONS: Although tamoxifen treatment caused a trend toward modest bleeding/spotting day reduction in new levonorgestrel 52-mg IUS users, bleeding satisfaction did not improve. Future studies of tamoxifen treatment for IUS-related bleeding issues may be best targeted toward users with ongoing bleeding irregularities or lower-dose IUS products which cause more bleeding irregularities.