scholarly journals Use of Model-Informed Drug Development to Streamline Development of Long-Acting Products: Can These Successes Be Translated to Long-Acting Hormonal Contraceptives?

2021 ◽  
Vol 61 (1) ◽  
pp. 745-756 ◽  
Author(s):  
Li Li ◽  
Doanh Tran ◽  
Hao Zhu ◽  
Praveen Balimane ◽  
Gerald Willett ◽  
...  
Keyword(s):  
Hormonal Contraceptives ◽  
Development Programs ◽  
Contraceptive Methods ◽  
Case Examples ◽  
Unintended Pregnancies ◽  
Exposure Response ◽  
The Us ◽  
Long Acting ◽  
Long Acting Contraceptives ◽  
Conceptual Translation

Long-acting contraceptives are the most effective reversible contraceptive methods. Increasing patients’ access to these contraceptives may translate into fewer unintended pregnancies and lead to substantial individual and public health benefits. However, development of long-acting products can be complex and challenging. This review provides ( a) an overview of representative development programs for long-acting antipsychotics as cases for conceptual translation to long-acting contraceptives, ( b) several case examples on how modeling and simulation have been used to streamline the development of long-acting products, and ( c) examples of challenges andopportunities in developing long-acting contraceptives and information on how exposure-response relationships of commonly used progestins may enable regulators and developers to rely on prior findings of effectiveness and safety from an approved contraceptive to streamline the development of long-acting contraceptives. The US Food and Drug Administration is seeking assistance from stakeholders to provide data from studies in which pharmacokinetic and pharmacodynamic or clinical outcomes of hormonal contraceptives were evaluated and not previously submitted.

scholarly journals Improving Access to Long-Acting Contraceptive Methods and Reducing Unplanned Pregnancy among Women with Substance Use Disorders

2016 ◽  
Vol 10s1 ◽  
pp. SART.S34555 ◽  
Author(s):  
Kirsten I. Black ◽  
Carolyn A. Day
Keyword(s):  
Substance Use ◽  
Substance Use Disorders ◽  
Unplanned Pregnancy ◽  
Economic Benefits ◽  
Treatment Programs ◽  
Contraceptive Methods ◽  
Unintended Pregnancies ◽  
Long Acting ◽  
Long Acting Reversible Contraceptive ◽  
Access To Contraception

Much has been written about the consequences of substance use in pregnancy, but there has been far less focus on the prevention of unintended pregnancies in women with substance use disorders (SUDs). We examine the literature on pregnancy incidence for women with SUDs, the clinical and economic benefits of increasing access to long-acting reversible contraceptive (LARC) methods in this population, and the current hurdles to increased access and uptake. High rates of unintended pregnancies and poor physical and psychosocial outcomes among women with SUDs underscore the need for increased access to, and uptake of, LARC methods among these women. A small number of studies that focused on improving access to contraception, especially LARC, via integrated contraception services predominantly provided in drug treatment programs were identified. However, a number of barriers remain, highlighting that much more research is needed in this area.

scholarly journals Geospatial Distribution of Family Planning Services in Kira Municipality, Wakiso District, Uganda

2021 ◽  
Vol 1 ◽  
Author(s):  
Moses Tetui ◽  
Tonny Ssekamatte ◽  
Pierre Akilimali ◽  
Judith Sirike ◽  
Osvaldo Fonseca-Rodríguez ◽  
...  
Keyword(s):  
Family Planning ◽  
Local Governments ◽  
Unmet Need ◽  
Quality Data ◽  
Modern Contraceptive ◽  
Contraceptive Methods ◽  
Cross Sectional ◽  
Unintended Pregnancies ◽  
Long Acting ◽  
Privately Owned

Introduction: Access to family planning (FP) services remains a challenge, particularly in informal urban settlements. The unmet need for FP in these settings is high, with a correspondingly high prevalence of unintended pregnancies that may lead to unsafe abortions. However, there is a paucity of quality data on the distribution of FP services in such settings in Uganda. This paper described the geospatial distribution of FP services in Kira Municipality, Wakiso District, Uganda.Methods: This was a cross-sectional study in which we determined the availability and distribution of FP services in Kira Municipality. Community mapping and analysis were conducted using ArcGIS (version 10.1) and ArcGIS Online. Stata version 13.1 was used for data analysis. Chi-square test was used to compare the contraceptive provision and availability among facilities from informal and formal settlements.Results: Of the 176 healthcare facilities surveyed, only 42% (n = 74) offered contraceptives in informal settlements. The majority of the facilities were privately owned small clinics (95%). At least 80% of the facilities provided three or more modern contraceptive methods, with no difference (p = 0.107) between facilities in informal and formal settlements. Only 30.7% (p = 0.001) of the facilities provided at least one long-acting contraceptive. Similarly, 20 and 12% (p = 0.001) of the facilities had implants and intrauterine devices (IUDs) on the day of the survey. Almost 25% of the facilities did not offer contraceptive services (counseling and commodities) to unmarried adolescents.Conclusions: Most facilities were small privately-owned clinics, offering at least three modern contraceptive methods. The unavailability of long-acting reversible methods in the informal settings may affect the quality of FP services due to limited choice. The inequity in service provision that disfavors the unmarried adolescent may increase unwanted/unintended pregnancies. We recommend that local governments and partners work toward filling the existing commodities gap and addressing the discrimination against unmarried adolescents in such settings.

scholarly journals Economic Burden of Contraception Management in Spain

10.36469/9785 ◽  
2018 ◽  
Vol 6 (1) ◽  
pp. 63-74
Author(s):  
Inmaculada Parra Ribes ◽  
Juan José Rascón Poza ◽  
Ezequiel Pérez Campos ◽  
Ignacio Bugella Yudice ◽  
Maria Jesús Rodríguez Domingo
Keyword(s):  
Economic Burden ◽  
Contraceptive Use ◽  
National Health System ◽  
Cost Savings ◽  
Vaginal Ring ◽  
Contraceptive Methods ◽  
Younger Women ◽  
Unintended Pregnancies ◽  
Spanish National Health System ◽  
Long Acting

Background: A wide variety of contraceptive methods are available, some of them reimbursed by the Spanish National Health System (SNHS). However, the number of unintended pregnancies (UP) is still significant, leading to a high economic burden, mainly derived from non-adherence to and the incorrect use of contraceptive methods. Objectives: This study aims to estimate the economic burden associated with reversible contraception management in Spain, from the perspectives of both the SNHS and women, over a 5-year period. Methods: A survey was performed to identify contraception management in Spain based on the experience of a panel of six expert gynecologists. An economic model was conducted to quantify the current burden of contraception according to healthcare resources use over 5 years. The costs included in the analysis were diagnostic tests, initial and follow-up consultations, methods acquisition costs, and UP derived from therapy failure. Results: Reversible contraception costs in Spain amount to €12.5 billion over a 5–year period. Condoms and combined oral contraceptives (COC) account for 86.8% of the total cost and the other methods only 13.2%. There are differences in contraceptive use according to women’s age. Short-acting reversible contraceptives (SARC) such as COC, condom and vaginal ring, are most commonly used by younger women. However, SARC are correlated with the highest failure rate, resulting in over €7.2 billion cost, explained by the high number of UP. Long-acting reversible contraceptives (LARC), such as the levonorgestrel-releasing intrauterine system (LNG-IUS20), implant and copper intrauterine devices (IUD), are selected by women over 35 years of age due to user-independent compliance. SARC methods result in a higher cost per woman over 5 years: vaginal ring €2427.8, patch €2402.6, condom €2060.1 and COC €1895.1; while LARC methods are the most economic option per women: LNG-IUS20 €630.4, copper IUD €658.2, LNG-IUS12 €703.8, intramuscular injectable €907.8 and implant €940.5. Conclusions: LARC methods result in lower costs compared with SARC options from the perspectives of the SNHS and women, explained by user-independent compliance, preventing a significant number of UP and its elevated economic burden. An increased LARC methods use could avoid UP events, leading to significant cost-savings for the SNHS.

DEMAND FOR LONG-ACTING AND PERMANENT CONTRACEPTIVE METHODS AMONG KURDISH WOMEN IN MAHABAD, IRAN

2014 ◽  
Vol 46 (6) ◽  
pp. 772-785 ◽  
Author(s):  
HATAM HOSSEINI ◽  
FATEMEH TORABI ◽  
BALAL BAGI
Keyword(s):  
Reproductive Age ◽  
Fertility Survey ◽  
Reproductive Health Services ◽  
Contraceptive Methods ◽  
Number Of Children ◽  
Unintended Pregnancies ◽  
Kurdish Women ◽  
Children Ever Born ◽  
Long Acting ◽  
Near Future

SummaryIt is anticipated that the demand for contraceptives in Iran will increase in the near future as the number of women of reproductive age increases and with women wanting smaller families. The aim of this paper was to study the demand for long-acting and permanent contraceptive methods (LAPCMs), and its determinants, among Kurdish women in Mahabad city, Iran. Data were taken from the Mahabad Fertility Survey (MFS) conducted on a sample of over 700 households in April 2012. The results show that the demand for LAPCMs was 71.35% at the time of survey, although only 27.7% of women were using these methods. Thus, the number of unintended pregnancies is likely to increase in the future if this gap is not reduced. The multivariate analysis showed significant impacts on the dependent variables of the number of children ever born, perceived contraceptive costs and childbearing intentions. Moreover, women at the end of their reproductive lives and those with higher education were more likely to desire LAPCMs. It is concluded that despite a growing use of contraceptive methods in Iran in recent decades, the development of reproductive health services and promotion of the quality of family planning services remains a necessity.

scholarly journals Prevalence of Long-acting Reversible Contraceptive Methods and Factors Affecting their Use among Married Women in Akasta Town, North-East Ethiopia

2019 ◽  
pp. 1-11
Author(s):  
Kibir Temesgen ◽  
Amare Workie ◽  
Yared Mulu
Keyword(s):  
Educational Status ◽  
Reproductive Age ◽  
Sub Saharan Africa ◽  
Contraceptive Methods ◽  
Factors Affecting ◽  
North East ◽  
Long Acting ◽  
Long Acting Contraceptives ◽  
Long Acting Reversible Contraceptive ◽  
Long Acting Reversible Contraceptives

Background: Long acting contraception is a human right and is essential to women’s empowerment. It is essential to reduce poverty, promote economic growth, raise female productivity, lower fertility and improve child survival and maternal health. Even though some long acting reversible contraceptive methods are the world’s most prevalent form of reversible contraception, the utilization is very low in sub-Saharan Africa. Study Aim: To assess the prevalence and factors affecting use of long acting contraceptive methods in Akasta Town, North East Ethiopia. Methods: A community based cross-sectional study was conducted on 422 women of reproductive age between March and May 2016 to achieve study aim. The actual respondents were selected by systematic sampling method at household level. Pretested and structured questionnaires were used to collect data. Result: The prevalence of use of long acting contraceptives in the study area was found to be 33.6% and implants were the most commonly used methods. One hundred thirty one (46.8%) of respondents did not use these methods because of inadequate information provided for them. Two hundred eighty one (66.6%) of respondents said that they knew at least one type of long acting methods and implants were widely known which accounts 139 (49.5%) of respondents. Age, husband’s educational status, knowledge of long acting reversible contraceptives and attitude towards these methods were significantly associated with use of these contraceptives. Conclusions: The study showed that the prevalence of long acting reversible contraceptives in the study area was low. Only 33.6% of respondents ever used any type of these methods in their life time and implants were the most commonly used method. In this study, age of women, husband’s educational status, knowledge of long acting reversible contraceptives and attitude were found to be independent determinants for long acting reversible family planning use. As knowledge and practice of long acting contraceptives was low, extensive health information should be provided.

scholarly journals Knowledge and Perception on Long Acting and Permanent Contraceptive Methods in Adigrat Town, Tigray, Northern Ethiopia: A Qualitative Study

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Alem Gebremariam ◽  
Adamu Addissie
Keyword(s):  
Family Planning ◽  
Qualitative Method ◽  
Married Women ◽  
Northern Ethiopia ◽  
Contraceptive Methods ◽  
Group Discussions ◽  
Unintended Pregnancies ◽  
Contraceptive Choice ◽  
Long Acting ◽  
Depth Interviews

Background. Long acting and permanent contraceptive methods have the potential to reduce unintended pregnancies but the contraceptive choice and utilization in Ethiopia are highly dominated by short term contraceptives. Objective. To assess the knowledge and perception on long acting and permanent contraceptives of married women and men in Northern Ethiopia. Method. A qualitative method was conducted in Adigrat on January, 2012. Four focus group discussions with married women and men and six in-depth interviews with family planning providers were conducted. Content analysis was used to synthesize the data. Result. Participants’ knowledge on long acting and permanent contraceptives is limited to recognizing the name of the methods. Most of the participants are not able to identify permanent methods as a method of contraception. They lack basic information on how these methods work and how they can use it. Women had fears and rumors about each of these methods. They prefer methods which do not require any procedure. Family planning providers stated as they have weakness on counseling of all contraceptive choices. Conclusion. There are personal barriers and knowledge gaps on these contraceptive methods. Improving the counseling service program can help women to increase knowledge and avoid misconceptions of each contraceptive choice.

Contraception and thrombophilia

2009 ◽  
Vol 29 (02) ◽  
pp. 193-196 ◽  
Author(s):  
H. Rott ◽  
A. Kruempel ◽  
G. Kappert ◽  
U. Nowak-Göttl ◽  
S. Halimeh
Keyword(s):  
Chronic Illness ◽  
High Risk ◽  
Children And Adolescents ◽  
Hormonal Contraception ◽  
Hormonal Contraceptives ◽  
Thromboembolic Events ◽  
Contraceptive Methods ◽  
Secondary Complications ◽  
Increased Risk ◽  
Coagulation Proteins

SummaryThe risk of thromboembolic events (TE) is increased by acquired or inherited thrombo -philias (IT). We know that some hormonal contraceptives also increase the risk of thrombosis, thus, the use of such contraceptives are discussed as contraindications in women with IT. TEs are infrequent events in children and adolescents and in the majority of cases are associated with secondary complications from underlying chronic illness. Although adolescents are not typically considered to be at high-risk for TE, this cohort is frequently using hormonal contraception, leading to an increased risk in cases with unknown IT. The risk of TE with pregnancy alone is higher than associated with combined hormonal contra -ception. Progestin-only methods have not been found to increase the risk of TE with only moderate changes of coagulation proteins compared to normal reference values. Conclusion: Thrombophilic women are good candidates for progestin-only contraceptive methods.

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