Reasons given by women for discontinuing the use of progestogen implants at Koster Hospital, North West province.

BACKGROUND: In 2014, the South African National Department of Health introduced a new addition to the long-acting reversible contraceptive (LARC) options available in the country. This was a single rod subdermal progestogen implant (Implanon®NXT) which provided 3 years of effective contraception cover. However, the new contraceptive device uptake and general acceptance amongst women quickly diminished, with a slew of requests for its removal. The aim of this study was to explore the reasons given by women for discontinuing the use of their progestogen implants at Koster Hospital, North West province, South Africa. METHODS: A qualitative study was conducted using semistructured interviews. Thirteen women were purposively selected and interviewed at Koster Hospital Family Planning Unit. The transcriptions of the audio-taped interviews were analysed thematically. RESULTS: The following themes emerged from the interviews as reasons the women discontinued their progestogen implants: side effects such as menstrual problems, arm discomfort and weight gain. Other themes were family or social factors and the desire to conceive. CONCLUSION: The reasons for discontinuation of Implanon by women at Koster Hospital were the undesirable side effects they experienced whilst using the contraceptive device. These side effects were mainly menstrual problems, arm discomfort and weight gain. Family and other social dynamics also influenced some of the participants' decision to discontinue their contraceptive implants.

Prevalence of early discontinuation and associated factors among a retrospective cohort of etonogestrel contraceptive implant users.

Purpose: To characterise the frequency of and predictors of contraceptive implant discontinuation within 12 months of insertion in our clinical setting.Materials and methods: This retrospective cohort study included women receiving the etonogestrel contraceptive implant at our hospital between May 2007 and May 2012. We abstracted data from charts including implant removal date, bleeding complaints, reproductive and demographic characteristics, prior contraceptive use, tobacco use and implant insertion timing. Our primary outcome was implant discontinuation within 12 months following insertion. SAS 9.4 (SAS Institute Inc., Cary, NC, USA) was used to generate frequencies, bivariate analyses and multivariate logistic regression models.Results: Implant discontinuation was documented in 16% of implant users prior to 12 months (89/544). Women with documented bleeding complaints in the medical record were more likely to discontinue within 12 months (OR: 4.36, CI: 2.71, 7.00). No other demographic or clinical characteristics were associated with premature discontinuation. Having less than two prior pregnancies and tobacco use were associated with documented bleeding complaints.Conclusions: Discontinuation of the implant is associated with bleeding complaints. Women with lower parity and tobacco users may be more likely to experience bleeding or to find it intolerable.

Real world data on Nexplanon® procedure-related events: final results from the Nexplanon Observational Risk Assessment study (NORA).

OBJECTIVES: We conducted this study to characterize the frequency of insertion-, localization- and removal-related events and their clinically significant consequences among Nexplanon® (etonogestrel radiopaque contraceptive implant) users in the United States during standard clinical practice. STUDY DESIGN: The Nexplanon Observational Risk Assessment (NORA) study was a large, prospective cohort study conducted in the United States. A total of 428 Health Care Professionals (HCPs) who had completed the Nexplanon clinical training program recruited women who were newly prescribed Nexplanon. We collected data on insertion-, localization- and removal-related events experienced during routine clinical practice via questionnaires completed by patients and HCPs. Recruitment began in December 2011 and follow-up ended in October 2017. Data analysis characterized the frequency of procedure-related events. RESULTS: We collected data on 7364 insertion procedures. The incidence of incorrect insertion (i.e., initially unrecognized non-insertion, partial insertion or deep insertion) was 12.6 per 1000 insertions (95% CI, 10.2-15.5). Pins and needles/numbness in the arm/hand/fingers was the most common patient-reported event. We obtained data on 5159 removal procedures, of which all were successful but one (due to the location of the implant in deep muscle tissue). No implants were localized outside the arm. The most common challenge reported by HCPs during implant removal was encasement of the implant within fibrotic tissue. CONCLUSIONS: Events associated with the insertion, localization and removal of the Nexplanon contraceptive implant were rare and their clinical consequences were generally not suggestive of serious injury. IMPLICATIONS: This study is the largest prospective evaluation of events associated with insertion and removal of Nexplanon during routine clinical practice. It demonstrates that complications associated with insertion and removal of Nexplanon are rare when performed by trained clinicians.

Evidence of patients' challenges and barriers related to usage of Implanon®: scoping review protocol.

BACKGROUND: According to the United Nations Trends in Contraceptive Use 2015 report, at least one in ten married or in-union women in most regions of the world has an unmet need for family planning. Family Planning 2020 reports an estimate of almost 134 million married or in-union women of reproductive age who have an unmet need for modern methods of contraception in 2016 in participating countries. Family planning has therefore been highlighted as a global unmet need. Initiatives such as Family Planning 2020 aim to promote contraceptive use through Implanon® contraceptive implant. Implanon® has been reported to be a highly effective form of contraception. However, poor outcomes from users of the Implanon® have been reported in recent studies. The main objective of this review is to map the literature for the evidence on usage of Implanon® in order to reveal challenges and barriers. METHODS AND ANALYSIS: A scoping review searching evidence on Implanon® use will be conducted. Relevant studies will be identified from 1998 to present. The following databases: PubMed, MEDLINE, EBSCOhost, Google Scholar and Cochrane library will be searched for peer-reviewed literature. We will also search for grey literature in this study area. The eligibility criteria will guide the study selection. A data charting table will be designed to extract information from the literature. The results of this study will be reported by use of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Data will be analysed using thematic analysis and the NVIVO software version 10. The mixed method appraisal tool (MMAT) will be used to assess the quality of included studies. DISCUSSION: We anticipate finding relevant studies on the use of Implanon®. Evidence gathered from included studies will help us identify gaps in research and help guide future research on Implanon® usage. This information can also help guide implementers and users on challenges and barriers related to use of Implanon®. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017072926 .

Re-Evaluating the Possible Increased Risk of HIV Acquisition With Progestin-Only Injectables Versus Maternal Mortality and Life Expectancy in Africa: A Decision Analysis.

OBJECTIVE: The association between increased risk of HIV acquisition and use of progestin-only injectables (POIs) is controversial. We sought to compare the competing risks of maternal mortality and HIV acquisition with use of POIs using updated data on this association and considering an expanded number of African countries. METHODS: We designed a decision-analytic model to compare the benefits and risks of POIs on the competing risks of maternal mortality and HIV acquisition on life expectancy for women in 9 African countries. For the purposes of this analysis, we assumed that POIs were associated with an increased risk of HIV acquisition (hazards ratio of 1.4). Our primary outcome was life-years and the population was women of reproductive age (15-49 years) in these countries, who did not have HIV infection and were not currently planning a pregnancy. Probabilities for each variable included in the model, such as HIV incidence, access to antiretroviral therapy, and contraceptive prevalence, were obtained from the literature. Univariate and multivariate sensitivity analyses were performed to check model assumptions and explore how uncertainty in estimates would affect the model results. RESULTS: In all countries, discontinuation of POIs without replacement with an equally effective contraceptive method would result in decreased life expectancy due to a significant increase in maternal deaths. While the removal of POIs from the market would result in the prevention of some new cases of HIV, the life-years gained from this are mitigated due to the marked increase in neonatal HIV cases and maternal mortality with associated life-years lost. In all countries, except South Africa, typical-use contraceptive failure rates with POIs would need to exceed 39%, and more than half of women currently using POIs would have to switch to another effective method, for the removal of POIs to demonstrate an increase in total life-years. CONCLUSION: Women living in sub-Saharan Africa cope with both high rates of HIV infection and high rates of pregnancy-related maternal death relative to the rest of the world. Based on the most current estimates, our model suggests that removal of POI contraception from the market without effective and acceptable contraception replacement would have a net negative effect on maternal health, life expectancy, and mortality under a variety of scenarios.

LNG-IUS 12: a 19.5 levonorgestrel-releasing intrauterine system for prevention of pregnancy for up to five years.

INTRODUCTION: Globally, intrauterine devices (IUDs) are the second most commonly used form of reversible contraception because of their high efficacy, safety, convenience and cost effectiveness. The levonorgestrel releasing intrauterine system with daily average release of 20 mcg (LNG-IUS 20) is the popular choice because of its favorable bleeding patterns and many noncontraceptive benefits. A three year (LNG-IUS 8) became available three years ago. More recently, the LNG-IUS 12 was added. This new IUD shares a smaller frame, narrow inserter and lower rate of amenorrhea with the LNG-IUS 8, but it offers the five years of contraceptive protection of the LNG-IUS 20. Areas covered: This article provides information on the contraceptive efficacy, safety and tolerability of this new IUS based on approximately 60,000 cycles of use. Where available, the impacts of subject age, parity and body mass index (BMI) on study outcomes are reported. Expert opinion: This new LNG-IUS 12 with mid-dose hormone levels, smaller frame and longer effective life fills a niche that may better meet the needs of women who might appreciate the narrow insertion tube and/or the lower rates of amenorrhea. Cost will ultimately help determine success.

Safety and Acceptability of Community-Based Distribution of Injectable Contraceptives: A Pilot Project in Mozambique.

Mozambique has witnessed a climbing total fertility rate in the last 20 years. Nearly one-third of married women have an unmet need for family planning, but the supply of family planning services is not meeting the demand. This study aimed to explore the safety and effectiveness of training 2 cadres of community health workers-traditional birth attendants (TBAs) and agentes polivalentes elementares (APEs) (polyvalent elementary health workers)-to administer the injectable contraceptive depot-medroxyprogesterone acetate (DMPA), and to provide evidence to policy makers on the feasibility of expanding community-based distribution of DMPA in areas where TBAs and APEs are present. A total of 1,432 women enrolled in the study between February 2014 and April 2015. The majority (63% to 66%) of women in the study started using contraception for the first time during the study period, and most women (over 66%) did not report side effects at the 3-month and 6-month follow-up visits. Very few (less than 0.5%) experienced morbidities at the injection site on the arm. Satisfaction with the performance of TBAs and APEs was high and improved over the study period. Overall, the project showed a high continuation rate (81.1%) after 3 injections, with TBA clients having significantly higher continuation rates than APE clients after 3 months and after 6 months. Clients' reported willingness to pay for DMPA (64%) highlights the latent demand for modern contraceptives. Given Mozambique's largely rural population and critical health care workforce shortage, community-based provision of family planning in general and of injectable contraceptives in particular, which has been shown to be safe, effective, and acceptable, is of crucial importance. This study demonstrates that community-based distribution of injectable contraceptives can provide access to family planning to a large group of women that previously had little or no access.

New Zealand women's experience during their first year of Jadelle® contraceptive implant.

INTRODUCTION Subsidisation of the levonorgestrel-releasing Jadelle® contraceptive implant in 2010 resulted in a rapid uptake. Clinicians had little prior experience of client satisfaction, side effect profile, and removal rate of this contraceptive method. AIM To obtain information on satisfaction, bleeding patterns, continuation rates and reasons for removal for New Zealand women during their first year of use of a subsidised contraceptive implant, Jadelle®. METHODS Women having a Jadelle® implant inserted in New Zealand Family Planning clinics were recruited to be followed up by phone, text or email at 1, 3, 6, 9 and 12 months. They were asked about their bleeding pattern, satisfaction and their views on benefits of, or problems with, implant use. RESULTS 252 women were recruited. The three common bleeding patterns in the cohort were regular periods, amenorrhoea and irregular bleeding. Eighteen percent had their implant removed within the first year with more than half of those being unhappy with their bleeding pattern. This was usually prolonged bleeding. Otherwise satisfaction rates were high throughout the year. DISCUSSION The majority of New Zealand women using Jadelle® were satisfied with this method of contraception during their first year of use. Implant removals were most likely to be related to prolonged bleeding. However the commonest bleeding pattern was regular periods. KEYWORDS Contraceptive implant; progestin; bleeding; satisfaction; continuation rate; reducing reproductive health inequalities.

Emergency Contraception.

Emergency contraception (EC) may help prevent pregnancy in various circumstances, such as contraceptive method failure, unprotected sexual intercourse, or sexual assault, yet it remains underused. There are 4 approved EC options in the United States. Although ulipristal acetate requires a provider's prescription, oral levonorgestrel (LNG) is available over the counter for women of all ages. The most effective method of EC is the copper intrauterine device, which can be left in place for up to 10 years for efficacious, cost-effective, hormone-free, and convenient long-term primary contraception. Ulipristal acetate tends to be more efficacious in pregnancy prevention than is LNG, especially when taken later than 72 hours postcoitus. The mechanism of action of oral EC is delay of ovulation, and current evidence reveals that it is ineffective postovulation. Women who weigh more than 75 kg or have a body mass index greater than 25 kg/m(2) may have a higher risk of unintended pregnancy when using oral LNG EC; therefore, ulipristal acetate or copper intrauterine devices are preferable in this setting. Providers are often unaware of the range of EC options or are unsure of how to counsel patients regarding the access and use of EC. This article critically reviews current EC literature, summarizes recommendations, and provides guidance for counseling women about EC. Useful tips for health care providers are provided, with a focus on special populations, including breast-feeding women and those transitioning to long-term contraception after EC use. When treating women of reproductive age, clinicians should be prepared to counsel them about EC options, provide EC appropriately, and, if needed, refer for EC in a timely manner.

Achieving cost-neutrality with long-acting reversible contraceptive methods.

OBJECTIVES: This analysis aimed to estimate the average annual cost of available reversible contraceptive methods in the United States. In line with literature suggesting long-acting reversible contraceptive (LARC) methods become increasingly cost-saving with extended duration of use, it aimed to also quantify minimum duration of use required for LARC methods to achieve cost-neutrality relative to other reversible contraceptive methods while taking into consideration discontinuation. STUDY DESIGN: A three-state economic model was developed to estimate relative costs of no method (chance), four short-acting reversible (SARC) methods (oral contraceptive, ring, patch and injection) and three LARC methods [implant, copper intrauterine device (IUD) and levonorgestrel intrauterine system (LNG-IUS) 20 mcg/24 h (total content 52 mg)]. The analysis was conducted over a 5-year time horizon in 1000 women aged 20-29 years. Method-specific failure and discontinuation rates were based on published literature. Costs associated with drug acquisition, administration and failure (defined as an unintended pregnancy) were considered. Key model outputs were annual average cost per method and minimum duration of LARC method usage to achieve cost-savings compared to SARC methods. RESULTS: The two least expensive methods were copper IUD ($304 per women, per year) and LNG-IUS 20 mcg/24 h ($308). Cost of SARC methods ranged between $432 (injection) and $730 (patch), per women, per year. A minimum of 2.1 years of LARC usage would result in cost-savings compared to SARC usage. CONCLUSIONS: This analysis finds that even if LARC methods are not used for their full durations of efficacy, they become cost-saving relative to SARC methods within 3 years of use. IMPLICATIONS: Previous economic arguments in support of using LARC methods have been criticized for not considering that LARC methods are not always used for their full duration of efficacy. This study calculated that cost-savings from LARC methods relative to SARC methods, with discontinuation rates considered, can be realized within 3 years.

Preferences for a potential longer-acting injectable contraceptive: perspectives from women, providers, and policy makers in Kenya and Rwanda.

BACKGROUND: Between 1995 and 2005, injectable use doubled worldwide. However, discontinuation rates remain high, partly because of side effects but also because of missed appointments for reinjection. A longer-acting injectable (LAI) may improve compliance by reducing the required number of reinjection visits, thereby reducing unintentional discontinuation. This study examined acceptability of LAI characteristics comprising the target product profile (TPP). METHODS: In 2012, we conducted qualitative case studies in Kenya and Rwanda, consisting of 19 focus group discussions (FGDs) with 177 current, previous, or never users of injectables and 46 in-depth interviews (IDIs) with providers, program implementers, and policy makers. FGDs and IDIs assessed current injectable experiences; attitudes toward potential LAI products; and perceptions of TPP attributes, including ranking preferences for the most and least important characteristics. In addition, we obtained completed electronic surveys from 28 international family planning opinion leaders about the perceived need for an LAI, important product characteristics, and challenges to LAI development or introduction. RESULTS: Many FGD participants and interviewees spontaneously expressed strong interest in an LAI, but there was some variation in TPP preferences. The majority of participants ranked effectiveness as the most important TPP attribute. Providers were generally more concerned about side effects than potential users; some potential users suggested that side effects were related less to the product than to their own body chemistry and that side effects were acceptable as long as they did not last a long time or disrupt daily activities. Women and providers, especially in Kenya, preferred a method with a predictable return to fertility. Some participants associated amenorrhea with delayed or reduced fertility. Most women and providers preferred delivery of the LAI in a single, prepackaged, disposable injection system to facilitate injections by providers and to reduce the risk of pain or discomfort for women. While providers and policy makers ranked cost as one of the most important issues, it was among the least important issues for most potential users. Many Kenyan, but few Rwandan, participants appeared willing to pay for an LAI, with some presuming cost savings from reduced menstruation and fewer clinic visits. CONCLUSIONS: Some TPP preferences for an LAI have implications for product development decisions about formulation, delivery mechanism, or presentation, while others point to the need for tailored communication and counseling approaches to ensure acceptability and adherence within clinical trials and beyond.

Roles of the pharmacist in the use of safe and highly effective long-acting reversible contraception: an opinion of the women's health practice and research network of the American College of Clinical Pharmacy.

The U.S. population continues to experience an alarmingly high rate of unintended pregnancies that have an impact on individual families and society alike. Lack of effective contraception accounts for most unintended pregnancies, along with incorrect use of contraceptives. The most common reversible contraceptive method used in the United States is the oral contraceptive pill, which has significant failure and discontinuation rates. Use of long-acting reversible contraceptive (LARC) methods has been increasing in recent years after efforts to educate providers and patients. Women are more likely to use LARC methods when barriers such as access and cost are removed. An uptake in the use of LARC methods would allow for markedly reduced contraception failure rates and higher user satisfaction and thus higher continuation rates than those seen with current contraception use. Promoting the use of LARC methods is an important strategy in improving both individual and public health outcomes by reducing unintended pregnancies. The pharmacist's role in family planning is expanding and can contribute to these efforts. Although knowledge regarding LARC has not been studied among pharmacists, a knowledge deficit exists among health care professionals in general. Thus pharmacist education and training should include LARC methods along with other contraceptives. The American College of Clinical Pharmacy Women's Health Practice and Research Network advocates for the pharmacist's role in the use of safe and highly effective LARC methods. These roles include educating patients, informing providers, facilitating access by providing referrals, and modifying institutional procedures to encourage provision of LARC methods.

Does switching contraceptive from oral to a patch or vaginal ring change the likelihood of timely prescription refill?

OBJECTIVE: This study evaluated contraceptive refill patterns of women insured commercially in the US who switched from oral contraceptives (OCs) to the patch or vaginal ring and assessed if switching contraceptive methods changes refill patterns. STUDY DESIGN: Women aged 15-44 with ≥2 patch or ring prescriptions and ≥2 OC prescriptions before the first patch/ring prescription were identified from the MarketScan® Commercial database (1/1/2002-6/30/2011). Refill patterns 1-year pre- and postindex date (first patch/ring prescription) were evaluated, and women were categorized as timely or delayed refillers on OCs and patch/ring. Regression modeling was used to investigate the association between refill patterns and contraceptive methods and switching effects on refill patterns. RESULTS: Of 17,814 women identified, 7901 switched to the patch, and 9913 switched to the ring. Among timely OC refillers, the percentage of timely refills decreased (patch: 95.6% to 79.4%, p<.001; ring: 96.5% to 74.3%, p<.001). However, among delayed OC refillers, the percentage of timely refills improved (patch: 47.9% to 72.2%, p<.001; ring: 50.4% to 64.0%, p<.001) during patch/ring use. Nonetheless, compared to timely OC refillers, women who were delayed OC refillers had 1.68-fold [95% confidence interval (CI): 1.52-1.84, p<.001] and 1.85-fold greater odds (CI: 1.69-2.02, p<.001) of being a delayed refiller while on the patch and ring, respectively. CONCLUSION: Switching to the patch or ring may improve refill behavior for women who have problems refilling OCs timely; however, the magnitude of the improvement may fail to improve ultimate contraceptive efficacy by simply switching to the patch or ring. IMPLICATIONS: The impact on timely refills of switching from OCs to either the patch or ring is complex and varies depending on the pattern of timely refills on OCs.

Obstetrician-gynecologists and contraception: long-acting reversible contraception practices and education.

OBJECTIVES: Long-acting reversible contraception (LARC) - the copper and levonorgestrel intrauterine devices (IUDs) and the single-rod implant - are safe and effective but account for a small proportion of contraceptive use by US women. This study examined obstetrician-gynecologists' knowledge, training, practice and beliefs regarding LARC methods. DESIGN: A survey questionnaire was mailed to 3000 Fellows of the American College of Obstetricians and Gynecologists. After exclusions, 1221 eligible questionnaires were analyzed (45.8% response rate, accounting for exclusions). RESULTS: Almost all obstetrician-gynecologists reported providing IUDs (95.8%). Most obstetrician-gynecologists reported requiring two or more visits for IUD insertion (86.9%). Respondents that reported IUD insertion in a single visit reported inserting a greater number of IUDs in the last year. About half reported offering the single-rod implant (51.3%). A total of 92.0% reported residency training on IUDs, and 50.8% reported residency training on implants. Residency training and physician age correlated with the number of IUDs inserted in the past year. A total of 59.6% indicated receiving continuing education on at least one LARC method in the past 2years. Recent continuing education was most strongly associated with implant insertion, and 31.7% of respondents cited lack of insertion training as a barrier. CONCLUSIONS: Barriers to LARC provision could be reduced if more obstetrician-gynecologists received implant training and provided same-day IUD insertion. Continuing education will likely increase implant provision. IMPLICATIONS: This study shows that obstetrician-gynecologists generally offer IUDs, but fewer offer the single-rod contraceptive implant. Recent continuing education strongly predicted whether obstetrician-gynecologists inserted implants and was also associated with other practices that encourage LARC use.