"That's a tricky one": Access to misoprostol for early pregnancy loss in retail pharmacies across Arizona.

OBJECTIVES: This study aimed to describe the same-day availability of misoprostol for medical management of early pregnancy loss (EPL) at Arizona pharmacies. STUDY DESIGN: We performed a simulated-patient mixed methods study of Arizona pharmacies from October 2022 to February 2023, documenting misoprostol availability and describing pharmacy staff responses. RESULTS: Of 941 pharmacies included, 703 (75%) could fill a misoprostol prescription same day. Ability to fill prescriptions and reasons why the prescription could not be filled varied by pharmacy type. National chain pharmacies most frequently had misoprostol available but also most commonly reported policies restricting dispensing. CONCLUSIONS: Barriers exist to filling misoprostol prescriptions for early pregnancy loss in Arizona that could impact patient care.

Cell-Free DNA as an Addition to Ultrasound for Screening of a Complete Hydatidiform Mole and Coexisting Normal Fetus Pregnancy: A Case Report.

Background Complete hydatidiform mole and coexisting normal fetus pregnancies (CHMCF) are rare and can be life-threatening to the mother. Definitive diagnosis can be made with chorionic villus sampling or amniocentesis. However invasive procedures carry a risk of bleeding. We present the case of a twin molar pregnancy where a cell-free DNA screening test was utilized to evaluate for CHMCF pregnancy. Case A patient presented at 15-week gestational age with suspected CHMCF pregnancy. Ultrasound revealed a normal-appearing pregnancy abutting a multicystic lesion concerning for a complete mole. Cell-free DNA was obtained and was suggestive of complete paternal uniparental disomy. Pathological evaluation of the products of conception confirmed the diagnosis of CHMCF. Conclusion In atypical cases, cell-free DNA may be useful in evaluation of molar pregnancy.

"The Difference between Plan b and ella®? They're Basically the Same Thing": Results from a Mystery Client Study.

Pharmacy staff can serve an important role educating patients about emergency contraceptive pills (ECP), particularly ulipristal acetate (UPA), which requires a prescription. We conducted a secondary analysis of a previously completed mystery client study, assessing accuracy of information provided by pharmacy staffers to patients inquiring by telephone about filling a prescription for UPA. From the period December 2013 to July 2014, researchers used a mystery client methodology, contacting 198 retail pharmacies in Hawai'i. Researchers posed as patients or providers attempting to fill a prescription for UPA. During the course of the call, they asked about differences between UPA and levonorgestrel ECPs. Nearly half of all pharmacy staffers were unfamiliar with UPA. The majority of responses describing differences between the medications were incorrect or misleading, such as responses implying that UPA is an abortifacient. Lack of familiarity and incorrect information provided by pharmacy staffers may act as additional barriers in patient access to UPA. Health practitioners prescribing UPA should ensure patients receive evidence-based counseling at the time of prescription, while efforts should also be made to improve pharmacy staff familiarity with emergency contraceptive options.

Changes in uptake and cost of long-acting reversible contraceptive devices following the introduction of a new low-cost levonorgestrel IUD in Utah's Title X clinics: a retrospective review.

OBJECTIVE: The objective was to assess changes in long-acting reversible contraceptive (LARC) method uptake at Utah's Title X clinics before and after introduction of a new, low-cost levonorgestrel (LNG) 52mg IUD (Liletta®). STUDY DESIGN: We conducted a retrospective medical record review of LARC visits occurring at seven Title-X family planning clinics in Utah before the introduction of the low-cost LNG IUD (preintroduction period: 01/01/2014-04/30/2015) and after (postintroduction period: 05/01/2015-03/31/2016). We ran segmented, interrupted time series ordinary least squares regression models using Newey-West standard errors to assess both the change in numbers of women initiating any LARC method and the average payment amount per LARC method. We evaluated both the low-cost LNG IUD and all LARC methods. RESULTS: At the outset of preintroduction period, there were 29.2 [95% confidence interval (CI): 20.1-38.4] monthly LNG IUD insertions. Immediately postintroduction, there was a significant level of increase of 14.4 LNG IUD insertions the first month (95% CI: 2.0-26.8) followed by a significant trend increase each month of 2.4 additional LNG IUD insertions (95% CI: 0.32-4.47). Postintroduction, there was a significant level of remitted-payment decrease from all sources of -$240.43 per LNG IUD (95% CI: -311.02 to 168.87) followed by a significant monthly trend decrease of -$23.01 per LNG IUD (95% CI: -32.02 to -13.98). There were minimal changes in uptake and payment of other LARC methods following the introduction of the low-cost LNG IUD. CONCLUSIONS: Following introduction of a low-cost LNG IUD at Title X clinics, LNG IUD initiation increased and average payment for the method decreased. IMPLICATIONS: Reducing the cost of LARC methods, both to clinics and to patients, is essential to expanding access. Additional efforts to develop and provide access to low-cost copper IUDs and subdermal implants as well as novel LARC methods should be continued.

Pharmacy access to Ulipristal acetate in major cities throughout the United States.

OBJECTIVE: Ulipristal acetate (UPA) is a prescription emergency contraceptive pill (ECP). Despite the potential for UPA to reduce the risk of unintended pregnancies, a recent study in Hawaii demonstrated less than 3% of pharmacies stocked UPA and less than 23% reported the ability to order it. The primary outcome of our study was to assess the availability of UPA in a sample of large cities nationwide. STUDY DESIGN: We conducted a telephone-based secret shopper study of 533 retail pharmacies sampled proportionally from 10 large cities in five geographic regions across the US. Callers represented themselves as uninsured 18-year-old women attempting to fill prescriptions for UPA between February and May 2016. Using a semi-structured questionnaire, callers inquired regarding availability and use of UPA. RESULTS: Less than 10% (33/344; 95% CI: 6.5-12.7%) of pharmacies indicated the ability to immediately fill a UPA prescription, while 72% (224/311; 95% CI: 65.0-77.0%) of pharmacies without immediate availability reported the ability to order UPA, with the median predicted wait time of 24 h (IQR: 21.5 to 26.0 h). CONCLUSION: Despite evidence for increased efficacy of UPA over levonorgestrel (LNG) ECPs, the availability of UPA in a sample of US major cities is extremely limited. Given that ECPs should be taken as soon as possible after unprotected sex, the long wait times when ordering UPA present an access barrier. Efforts to improve the availability of UPA are important to optimize the potential of ECPs to decrease unintended pregnancy following unprotected sex. IMPLICATIONS: Interventions are needed to address barriers to obtaining UPA from retail pharmacies nationwide.

Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial.

BACKGROUND: Immediate postpartum levonorgestrel intrauterine device insertion is increasing in frequency in the United States, but few studies have investigated the effect of early placement on breast-feeding outcomes. OBJECTIVE: This study examined the effect of immediate vs delayed postpartum levonorgestrel intrauterine device insertion on breast-feeding outcomes. STUDY DESIGN: We conducted this noninferiority randomized controlled trial at the University of Utah and the University of New Mexico Health Sciences Centers from February 2014 through March 2016. Eligible women were pregnant and planned to breast-feed, spoke English or Spanish, were aged 18-40 years, and desired a levonorgestrel intrauterine device. Enrolled women were randomized 1:1 to immediate postpartum insertion or delayed insertion at 4-12 weeks' postpartum. Prespecified exclusion criteria included delivery <37.0 weeks' gestational age, chorioamnionitis, postpartum hemorrhage, contraindications to levonorgestrel intrauterine device insertion, and medical complications of pregnancy that could affect breast-feeding. We conducted per-protocol analysis as the primary approach, as it is considered the standard for noninferiority studies; we also report the alternative intent-to-treat analysis. We powered the study for the primary outcome, breast-feeding continuation at 8 weeks, to detect a 15% noninferiority margin between groups, requiring 132 participants in each arm. The secondary study outcome, time to lactogenesis, used a validated measure, and was analyzed by survival analysis and log rank test. We followed up participants for ongoing data collection for 6 months. Only the data analysis team was blinded to the intervention. RESULTS: We met the enrollment target with 319 participants, but lost 34 prior to randomization and excluded an additional 26 for medical complications prior to delivery. The final analytic sample included 132 in the immediate group and 127 in the delayed group. Report of any breast-feeding at 8 weeks in the immediate group (79%; 95% confidence interval, 70-86%) was noninferior to that of the delayed group (84%; 95% confidence interval, 76-91%). The 5% difference in breast-feeding continuation at 8 weeks between the groups fell within the noninferiority margin (95% confidence interval, -5.6 to 15%). Time to lactogenesis (mean ± SD) in the immediate group, 65.3 ± 25.7 hours, was noninferior to that of the delayed group, 63.6 ± 21.6 hours. The mean difference between groups was 1.7 hours (95% confidence interval, -4.8 to 8.2 hours), noninferior by log-rank test. A total of 24 intrauterine device expulsions occurred in the immediate group compared to 2 in the delayed group (19% vs 2%, P < .001), consistent with the known higher expulsion rate with immediate vs delayed postpartum intrauterine device insertion. No intrauterine device perforations occurred in either group. CONCLUSION: Our results of noninferior breast-feeding outcomes between women with immediate and delayed postpartum levonorgestrel intrauterine device insertion suggest that immediate postpartum intrauterine device insertion is an acceptable option for women planning to breast-feed and use the levonorgestrel intrauterine device. Expulsion rates are higher with immediate postpartum levonorgestrel intrauterine device insertion compared to delayed insertion, but this disadvantage may be outweighed by the advantages of immediate initiation of contraception. Providers should offer immediate postpartum intrauterine device insertion to breast-feeding women planning to use the levonorgestrel intrauterine device.

From Kaua'i to Hawai'i Island: Interisland Differences in Emergency Contraceptive Pill Availability.

Emergency contraceptive pills (ECPs) are medications used after unprotected intercourse, underprotected intercourse, or sexual assault to decrease the risk of pregnancy. Availability of ECPs in Hawai'i's retail pharmacies was last assessed in 2007, following over-the-counter access to levonorgestrel ECPs (LNG-ECP) for women age 18 years or older and prior to U.S. Food and Drug Administration (FDA) approval of prescription-only ulipristal acetate (UPA). We conducted a county-by-county subanalysis from a larger observational population-based study on statewide availability of ECPs in Hawai'i's pharmacies. In the original study, researchers called all 198 unique retail pharmacies in Hawai'i between December 2013 and June 2014. Only 3% of pharmacies had UPA immediately available on-site in the state, with UPA available on Kaua'i and O'ahu only. At least one form of LNG-ECPs was available in 82% of pharmacies in 2013-2014, roughly the same as 2007 (81%) (P=0.9) when Lana'i and Moloka'i lacked access. Currently, only Moloka'i lacks retail pharmacy access to ECPs. When controlling for general inflation, the 2013-2014 mean price for name brand LNG-ECP fell within the reported range of 2007 prices. Generic LNG-ECPs were substantially lower in price than name brand LNG-ECPs in 2007 and 2013-2014. Availability of UPA is limited and significantly lower compared to LNG-ECPs. Availability of LNG-ECPs statewide has remained stable and the arrival of generics has decreased prices.

Pharmacy access to ulipristal acetate in Hawaii: is a prescription enough?

OBJECTIVE: To determine pharmacy availability of ulipristal acetate (UPA) and compare to availability of levonorgestrel-containing emergency contraceptive pills (LNG-ECPs). METHODS: We conducted an observational population-based study utilizing a telephone-based secret shopper methodology. Researchers called all 198 unique retail pharmacies in Hawaii on December 2013-June 2014, representing themselves as patients and physicians. RESULTS: Only 2.6% of pharmacies had UPA immediately available, though 22.8% reported ability to order UPA. In contrast, 82.4% reported immediate availability of LNG-ECPs. No significant difference in availability was reported to patients and physicians. CONCLUSIONS: Availability of UPA is limited and significantly lower compared to LNG-ECPs. The study period did overlap with a change in distributor for UPA, likely capturing some disruption of the supply chain. IMPLICATIONS: Systems-based interventions are needed to address barriers to obtaining UPA.

Emergency Contraception: Do Your Patients Have a Plan B?

Emergency contraception is used after unprotected sex, inadequately protected sex, or sexual assault to reduce the risk of pregnancy. Of emergency contraceptive methods available in the United States, the copper intrauterine device has the highest efficacy, followed by ulipristal acetate, levonorgestrel-containing emergency contraceptive pills, and the Yuzpe method. However, access to the most effective methods is limited. Although advanced prescription of emergency contraceptive pills and counseling on emergency contraception to all reproductive-aged women is recommended, women should be advised to contact their health care providers after taking emergency contraceptive pills to discuss possible copper intrauterine device placement and other follow-up.

Domain analyses reveal that Chlamydia trachomatis CT694 protein belongs to the membrane-localized family of type III effector proteins.

The Chlamydia trachomatis type three-secreted effector protein CT694 is expressed during late-cycle development yet is secreted by infectious particles during the invasion process. We have previously described the presence of at least two functional domains within CT694. CT694 was found to interact with the human protein Ahnak through a C-terminal domain and affect formation of host-cell actin stress fibers. Immunolocalization analyses of ectopically expressed pEGFP-CT694 also revealed plasma membrane localization for CT694 that was independent of Ahnak binding. Here we provide evidence that CT694 contains multiple functional domains. Plasma membrane localization and CT694-induced alterations in host cell morphology are dependent on an N-terminal domain. We demonstrate that membrane association of CT694 is dependent on a domain resembling a membrane localization domain (MLD) found in anti-host proteins from Yersinia, Pseudomonas, and Salmonella spp. This domain is necessary and sufficient for localization and morphology changes but is not required for Ahnak binding. Further, the CT694 MLD is able to complement ExoS ΔMLD when ectopically expressed. Taken together, our data indicate that CT694 is a multidomain protein with the potential to modulate multiple host cell processes.

Six-month follow-up of a brief intervention on self-reported safety belt use among emergency department patients.

OBJECTIVES: Safety belt use (SBU) reduces motor vehicle deaths by 45%. We previously reported that a brief intervention improved self-reported SBU among emergency department (ED) patients at 3 months. We sought to determine if these effects were sustained at 6 months postenrollment. METHODS: This was a prospective, randomized controlled trial of adult patients (age > or = 21 years) at an academic medical center ED from February 2006 to May 2006. Patients were systematically sampled for self-reported SBU. Those with self-reported SBU less than "always" were asked to participate. Subjects were surveyed at baseline with a nine-item series of situational SBU questions scored on a five-point Likert scale (e.g., 5 = always, 1 = never). This nine-item average comprised the mean SBU score. Subjects were randomized to a control group (CG) and an intervention group (IG). The CG received an injury prevention brochure; the IG received a brief motivation interview by a trained interventionist and the brochure. Subjects were phoned at 3 and 6 months to determine interval change in SBU scores via a standard script. Repeated-measures analysis of covariance and t-tests were used to analyze trends in mean SBU scores between groups, as well as to test mean changes in SBU scores from the 3- to 6-month intervals. RESULTS: Of 432 eligible patients, 292 enrolled (mean age = 35 years, SD +/- 11.2 years; 61% male). At baseline, there were no significant demographic differences; the IG (n = 147) and CG (n = 145) had similar mean SBU scores (2.8 vs. 2.6, p = 0.31), and 66% (n = 96 in each) completed both 3- and 6-month follow-up. The mean SBU score at 6 months in the IG was greater than in the CG group (3.6 vs. 2.9, p < 0.001), as were the mean SBU score differences from baseline (IG = 0.84 vs. CG = 0.29, p < 0.001). These differences were sustained from the 3-month interval (IG = -0.02 vs. CG = -0.06, p > 0.05). CONCLUSIONS: The previously reported finding that ED patients who received a brief motivation interview reported higher SBU scores at 3 months compared to a CG was sustained at 6-month follow-up. Although limited by self-report, a brief intervention may enhance lasting SBU behavior among high-risk ED patients.

Brief motivational intervention to increase self-reported safety belt use among emergency department patients.

OBJECTIVES: Brief motivational interventions have shown promise in reducing harmful behaviors. The authors tested an intervention to increase safety belt use (SBU) among emergency department (ED) patients. METHODS: From February 2006 to May 2006, the authors conducted a randomized trial of adult ED patients at a teaching hospital in Boston. ED patients were systematically sampled for self-reported SBU. Those with SBU other than "always" were asked to participate. At baseline, participants answered a 9-item series of situational SBU questions, each scored on a 5-point Likert scale. SBU was defined as a continuous variable (9-item average) and as a dichotomous variable (response of "always" across all items). Participants were randomized to an intervention or a control group. The intervention group received a 5- to 7-minute intervention, adapted from classic motivational interviewing techniques, by a trained interventionist. Participants completed a 3-month follow-up phone survey to determine changes from baseline SBU. Continuous and dichotomous SBU were analyzed via analysis of covariance and chi-square testing. RESULTS: Of 432 eligible patients, 292 enrolled (mean age 35 years, standard deviation [SD] +/-11 years; 61% male). At baseline, the intervention and control groups had similar mean (+/-SD) SBU scores (2.8 [+/-1.1] vs. 2.6 [+/-1.1], p = 0.31) and SBU prevalence (each 0%). At 3 months, 81% completed follow-up. The intervention group had significantly greater improvement in mean (+/-SD) SBU scores than controls (0.76 [+/-0.91] vs. 0.34 [+/-0.88], p < 0.001). Also, SBU prevalence of "always" was higher for the intervention group than controls (14.4% vs. 5.9%, p = 0.03). CONCLUSIONS: Participants receiving a brief motivational intervention reported higher SBU at follow-up compared to controls. An ED-based intervention may be useful to increase SBU.