Assessing hormonal contraceptive dispensing and counseling provided by community pharmacists in the United Arab Emirates: a simulated patient study.
ABSTRACT: Background:Hormonal contraceptive pills have evolved as a common form of contraception worldwide. Pharmacists play a vital role in providing safe and effective access to these medicines. In many developing countries such as the United Arab Emirates (UAE), these medicines are available to the general public without the presentation of a prescription which requires the pharmacist to shoulder responsibility by assessing and educating patients to assure their appropriate use. Objectives:To evaluate community pharmacists' current practice of dispensing and counseling on hormonal contraceptives. Methods:Simulated patient methodology was used in this study. A single simulated patient visited community pharmacies requesting an oral contraceptive as per a preplanned scenario. Information from the visits were recorded on a data collection form including: pharmacist assessing patient eligibility to take hormonal contraceptives, selecting the appropriate oral contraceptive, providing complete counseling on how to use the pill, adherence, missed dose handlings and side effects of the medication. The Pharmacist was prompted by the simulated patient to provide the information if they did not provide spontaneous counseling. The quality of pharmacists' counseling was rated and consequently coded as complete, incomplete or poor. Results:A total of 201 community pharmacies were visited. More than 92% of the pharmacists did not ask the simulated patient any question to assess their eligibility to use contraceptives. Twenty three pharmacists (11.4%) selected the proper product. One hundred seventeen (58.2%) of the pharmacists provided spontaneous counseling on how to use the pill, 17 of them had their counsel rated as complete, but none of the pharmacists provided spontaneous counseling regarding adherence or side effects of the medications. On prompting, 10 pharmacists (12%) provided complete counseling regarding how to use oral contraceptives, 14 pharmacists (7.0%) provided complete counseling on adherence and missing dose handling and five pharmacists (2.5%) provided complete counseling about expected side effects. Conclusions:Pharmacists' practice regarding hormonal contraceptive dispensing and counseling was suboptimal in this study. Areas needing intervention were related to pharmacist assessment of eligibility for oral contraceptive use, choice of optimal oral contraceptive for patient-specific co-morbidities and provision of adequate counseling regarding proper use, adherence and missed dose handlings.
Project description: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.
Project description:Introduction:Oral contraceptives are widely used for both contraceptive and noncontraceptive purposes. Of women ages 15-44 who have ever had sexual intercourse, 88% have used at least one hormonal contraceptive method. Health care providers caring for reproductive-age women need a strong base of knowledge in hormonal contraception. Those who provide contraceptive counseling must apply this knowledge to shared decision making, including effective quantitative communication. Methods:Students and faculty at Florida International University Herbert Wertheim College of Medicine created a prerecorded lecture and in-class interactive case on contraceptive pharmacology and risk communication. The 20-minute lecture focused on mechanisms of action, bioavailability, drug-drug interaction, effectiveness, and major vascular risks of combined hormonal and progestin-only contraceptives. The 55-minute in-class session integrated knowledge of risks and effectiveness of contraception with risk communication surrounding contraceptive decision making and counseling. For the 2018 academic year, 122 first-year medical students participated in the session. Students anonymously answered three questions related to the session on their end-of-course evaluation. Student learning was assessed with five multiple-choice questions on the pharmacology final exam. Results:Students rated the session very positively. They highly rated the lecture's utility and the sesssion's contribution to solidifying their basic science knowledge and understanding of its clinical applications. Class average performance on the relevant final exam questions was 88.4%. Discussion:The lecture and case discussion successfully addressed gaps in the curriculum and provided students the opportunity to integrate multiple domains of learning. Students' perception of the materials was positive, and they demonstrated adequate learning.
Project description:To assess the effect of oral and injectable contraceptive use compared to nonhormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial.This is a prospective cohort study using data from women enrolled in HIV Prevention Trials Network protocol 035. At each quarterly visit, participants were interviewed about self-reported contraceptive use and sexual behaviors and underwent HIV testing. Cox proportional hazards regression was used to assess the effect of injectable and oral hormonal contraceptive use on HIV acquisition.The analysis included 2830 participants, of whom 106 became HIV infected (4.07 per 100 person-years). At baseline, 1546 (51%) participants reported using injectable contraceptives and 595 (21%) reported using oral contraceptives. HIV incidence among injectable, oral and nonhormonal contraceptive method users was 4.72, 2.68 and 3.83 per 100 person-years, respectively. Injectable contraceptive use was associated with a nonstatistically significant increased risk of HIV acquisition [adjusted hazard ratio (aHR)=1.17; 95% confidence interval (CI) 0.70, 1.96], while oral contraceptive use was associated with a nonstatistically significant decreased risk of HIV acquisition (aHR=0.76; 95% CI 0.37,1.55).In this secondary analysis of randomized trial data, a marginal, but nonstatistically significant, increase in HIV risk among women using injectable hormonal contraceptives was observed. No increased HIV risk was observed among women using oral contraceptives. Our findings support the World Health Organization's recommendation that women at high risk for acquiring HIV, including those using progestogen-only injectable contraception, should be strongly advised to always use condoms and other HIV prevention measures.Among Southern African women participating in an HIV prevention trial, women using injectable hormonal contraceptives had a modest increased risk of HIV acquisition; however, this association was not statistically significant. Continued research on the relationship between widely used hormonal contraceptive methods and HIV acquisition is essential.
Project description:OBJECTIVE:To evaluate the association between pregravid use of a variety of contraceptive methods and subsequent fecundability. DESIGN:Prospective cohort study. SETTING:Denmark and North America, 2007-19. PARTICIPANTS:17?954 women who had tried to conceive for up to six menstrual cycles at study entry. At baseline, participants reported their contraceptive histories, and personal, medical, and lifestyle characteristics. MAIN OUTCOME MEASURES:Pregnancy, determined by bimonthly follow-up questionnaires for up to 12 months. RESULTS:Approximately 38% (n=6735) of participants had recently used oral contraceptives, 13% (n=2398) had used long acting reversible contraceptive methods, and 31% (n=5497) had used barrier methods. Women who had recently stopped using oral contraceptives, the contraceptive ring, and some long acting reversible contraceptive methods experienced short term delays in return of fertility compared with users of barrier methods. Use of injectable contraceptives was associated with decreased fecundability compared with use of barrier methods (fecundability ratio 0.65; 95% confidence interval 0.47 to 0.89). Users of injectable contraceptives had the longest delay in return of normal fertility (five to eight menstrual cycles), followed by users of patch contraceptives (four cycles), users of oral and ring contraceptives (three cycles), and users of hormonal and copper intrauterine devices and implant contraceptives (two cycles). Lifetime length of use of hormonal contraceptive methods was not associated with fecundability. CONCLUSIONS:Use of some hormonal contraceptive methods was associated with delays in return of fertility, with injectable contraceptives showing the longest delay. The findings indicated little or no lasting effect of long term use of these methods on fecundability.
Project description:The contraceptive effectiveness of intrauterine devices has been attributed in part to effects of a foreign body reaction on the endometrium. We performed this study to identify compare the effects on the endometrial transcriptome of intrauterine devices and combined oral contraceptives, to better understand their mechanisms of action. We collected endometrial and cervical biopsies from women using the levonorgestrel-intrauterine device, copper intrauterine device or levonorgestrel-containing combined oral contraceptives, and from women not using contraceptives (control group). Transcriptional profiling was performed with Affymetrix arrays, Principal Component Analysis and the bioconductor package limma. Pathway analysis was performed using EnrichR and Reactome 2016. In endometrial samples from copper intrauterine device users (n=13), there were no genes with statistically significant differential expression compared to controls (n=11), whereas in levonorgestrel-intrauterine device users (n=11), 2509 genes were significantly dysregulated and mapped onto several immune and inflammatory pathways. In combined oral contraceptive users (n=12), 133 genes were significantly dysregulated and mapped predominantly onto pathways involving regulation of metal ions. Both levonorgestrel-intrauterine device and combined oral contraceptive use were associated with significant downregulation of members of the metallothionein gene family. In cervical samples, none of the groups showed statistically significant differential gene expression compared to controls. In conclusion, hormonal and copper intrauterine devices differ significantly in their effects on the endometrial transcriptome, with endometrium from copper intrauterine device users being indistinguishable from luteal phase endometrium. These results suggest that the contraceptive mechanisms of intrauterine devices are unlikely to rely on a common pathway involving a foreign body reaction in the endometrium. Overall design: Cross-sectional study using cervical and endometrial samples from 4 groups of women: controls not on hormonal or intrauterine contraceptives (n=12), copper intrauterine device users (cuIUD, n=14), combined oral contraceptive users (COC, n=14), and levonorgestrel-intrauterine device users (LNG-IUD, n=12),
Project description:Oral contraceptives are known to influence the risk of cancers of the female reproductive system. Evidence regarding the relationship between injectable contraceptives and these cancers is limited, especially in black South Africans, among whom injectable contraceptives are used more commonly than oral contraceptives.We analysed data from a South African hospital-based case-control study of black females aged 18-79 y, comparing self-reported contraceptive use in patients with breast (n?=?1,664), cervical (n?=?2,182), ovarian (n?=?182), and endometrial (n?=?182) cancer, with self-reported contraceptive use in 1,492 control patients diagnosed with cancers with no known relationship to hormonal contraceptive use. We adjusted for potential confounding factors, including age, calendar year of diagnosis, education, smoking, alcohol, parity/age at first birth, and number of sexual partners. Among controls, 26% had used injectable and 20% had used oral contraceptives. For current and more recent users versus never users of oral or injectable contraceptives, the odds ratios (ORs) for breast cancer were significantly increased in users of oral and/or injectable contraceptives (OR 1.66, 95% CI 1.28-2.16, p<0.001) and separately among those exclusively using oral (1.57, 1.03-2.40, p?=?0.04) and exclusively using injectable (OR 1.83, 1.31-2.55, p<0.001) contraceptives; corresponding ORs for cervical cancer were 1.38 (1.08-1.77, p?=?0.01), 1.01 (0.66-1.56, p?=?0.96), and 1.58 (1.16-2.15, p?=?0.004). There was no significant increase in breast or cervical cancer risk among women ceasing hormonal contraceptive use ?10 y previously (p?=?0.3 and p?=?0.9, respectively). For durations of use ?5 y versus never use, the ORs of ovarian cancer were 0.60 (0.36-0.99, p?=?0.04) for oral and/or injectable contraceptive use and 0.07 (0.01-0.49, p?=?0.008) for injectable use exclusively; corresponding ORs for endometrial cancer were 0.44 (0.22-0.86, p?=?0.02) and 0.36 (0.11-1.26, p?=?0.1).In this study, use of oral and of injectable hormonal contraceptives was associated with a transiently increased risk of breast and cervical cancer and, for long durations of use, with a reduced risk of ovarian and endometrial cancer. The observed effects of injectable and of oral contraceptives on cancer risk in this study did not appear to differ substantially.
Project description:OBJECTIVE:To evaluate the potential for a clinically relevant drug-drug interaction with concomitant use of a dapivirine vaginal ring, a novel antiretroviral-based HIV-1 prevention strategy, and hormonal contraception by examining contraceptive efficacies with and without dapivirine ring use. DESIGN:A secondary analysis of women participating in MTN-020/ASPIRE, a randomized, double-blind, placebo-controlled trial of the dapivirine vaginal ring for HIV-1 prevention. METHODS:Use of a highly effective method of contraception was an eligibility criterion for study participation. Urine pregnancy tests were performed monthly. Pregnancy incidence by arm was calculated separately for each hormonal contraceptive method and compared using an Andersen-Gill proportional hazards model stratified by site and censored at HIV-1 infection. RESULTS:Of 2629 women enrolled, 2310 women returned for follow-up and reported using a hormonal contraceptive method at any point during study participation (1139 in the dapivirine arm and 1171 in the placebo arm). Pregnancy incidence in the dapivirine arm versus placebo among women using injectable depot medroxyprogesterone acetate was 0.43% vs. 0.54%, among women using injectable norethisterone enanthate was 1.15% vs. 0%, among women using hormonal implants was 0.22% vs. 0.69%, and among women using oral contraceptive pills was 32.26% vs. 28.01%. Pregnancy incidence did not differ by study arm for any of the hormonal contraceptive methods. CONCLUSIONS:Use of the dapivirine ring does not reduce the effectiveness of hormonal contraceptives for pregnancy prevention. Oral contraceptive pill use was associated with high pregnancy incidence, potentially because of poor pill adherence. Injectable and implantable methods were highly effective in preventing pregnancy.
Project description:<h4>Objective</h4>To summarize published evidence on drug interactions between hormonal contraceptives and antiretrovirals.<h4>Design</h4>Systematic review of the published literature.<h4>Methods</h4>We searched PubMed, POPLINE, and EMBASE for peer-reviewed publications of studies (in any language) from inception to 21 September 2015. We included studies of women using hormonal contraceptives and antiretrovirals concurrently. Outcomes of interest were effectiveness of either therapy, toxicity, or pharmacokinetics. We used standard abstraction forms to summarize and assess strengths and weaknesses.<h4>Results</h4>Fifty reports from 46 studies were included. Most antiretrovirals whether used for therapy or prevention, have limited interactions with hormonal contraceptive methods, with the exception of efavirenz. Although depot medroxyprogesterone acetate is not affected, limited data on implants and combined oral contraceptive pills suggest that efavirenz-containing combination antiretroviral therapy may compromise contraceptive effectiveness of these methods. However, implants remain very effective despite such drug interactions. Antiretroviral plasma concentrations and effectiveness are generally not affected by hormonal contraceptives.<h4>Conclusion</h4>Women taking antiretrovirals, for treatment or prevention, should not be denied access to the full range of hormonal contraceptive options, but should be counseled on the expected rates of unplanned pregnancy associated with all contraceptive methods, in order to make their own informed choices.
Project description:To investigate if continuation rates in first-time users of oral hormonal contraceptives differed between different formulations and to measure if the rates were related to the prescribing categories, that is, physicians and midwives.A longitudinal national population-based registry study.The Swedish prescribed drug register.All women born between 1977 and 1994 defined as first-time users of hormonal contraceptives from 2007 to 2009 (n=226 211).A tendency to switch the type of hormonal contraceptive within 6 months use and repeated dispensation identical to the first were estimated as percentages and relative risks (RRs). Physicians' and midwives' prescription patterns concerning the women's continuation rates of oral hormonal contraceptive type.In Sweden, there were 782 375 women born between 1977 and 1994 at the time of the study. Of these, 226 211 women were identified as first-time users of hormonal contraceptives. Ethinylestradiol+levonorgestrel, desogestrel-only and ethinylestradiol+drospirenone were the hormonal contraceptives most commonly dispensed to first-time users at rates of 43.3%, 24.4% and 11.1%, respectively. The overall rate of switching contraceptive types in the first 6 months was 11.3%, which was highest for desogestrel-only (14.3%) and lowest for ethinylestradiol+drospirenone (6.6%). The switching rate for all three products was highest in the 16-year to 19-year age group. Having a repeated dispensation identical to the initial dispensation was highest for users of ethinylestradiol either combined with levonorgestrel or drospirenone, 81.4% and 81.2%, respectively, whereas this rate for the initial desogestrel-only users was 71.5%. The RR of switching of contraceptive type within the first 6 months was 1.35 (95% CI 1.32 to 1.39) for desogestrel-only and 0.63 (0.59 to 0.66) for ethinylestradiol+drospirenone compared with ethinylestradiol+levonorgestrel as the reference category. There were no differences in the women's continuation rates depending on the prescriber categories.Desogestrel-only users conferred the highest switcher rate to another hormonal contraceptive within a 6-month period. Users of ethinylestradiol+levonorgestrel were more prone to switch to another product within 6 months than women using ethinylestradiol+drospirenone. These findings may be of clinical importance when tailoring hormonal contraceptives on an individual basis.
Project description:HIV vaccine trials generally require that pregnant women are excluded from participation, and contraceptive methods must be used to prevent pregnancy during the trial. However, access to quality services and misconceptions associated with contraceptive methods may impact on their effective use in developing countries. We describe the pattern of contraceptive use in a multi-site phase I/IIa HIV Vaccine trial in East Africa (Uganda, Kenya and Tanzania) and factors that may have influenced their use during the trial.Pregnancy prevention counseling was provided to female participants during informed consent process and at each study visit. Participants' methods of contraception used were documented. Methods of contraceptives were provided on site. Pregnancy testing was done at designated visits during the trial. Obstacles to contraceptive use were identified and addressed at each visit.Overall, 103 (31.8%) of a total of 324 enrolled volunteers were females. Female participants were generally young with a mean age of 29(+/-7.2), married (49.5%) and had less than high school education (62.1%). Hormonal contraceptives were the most common method of contraception (58.3%) followed by condom use (22.3%). The distribution of methods of contraception among the three sites was similar except for more condom use and less abstinence in Uganda. The majority of women (85.4%) reported to contraceptive use prior to screening. The reasons for not using contraception included access to quality services, insufficient knowledge of certain methods, and misconceptions.Although hormonal contraceptives were frequently used by females participating in the vaccine trial, misconceptions and their incorrect use might have led to inconsistent use resulting in undesired pregnancies. The study underscores the need for an integrated approach to pregnancy prevention counseling during HIV vaccine trials.ClinicalTrials.gov NCT00123968.