Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.

BACKGROUND: Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception. METHODS: We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 µg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete). FINDINGS: Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred. INTERPRETATION: Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception. FUNDING: National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).

The use of emergency contraceptive pills in India: A meta-analysis.

BACKGROUND: Unplanned pregnancies are a major public health concern. In India, 33% of an estimated 48.1 million pregnancies end in induced abortions. Emergency contraceptive pills (ECPs) can prevent pregnancy after sexual intercourse, have been part of India's family planning program since 2002-2003 and are available as over-the-counter drugs. While there are concerns about the overuse of ECPs, the pattern of use of ECPs in India is unknown. OBJECTIVES: The objective is to determine the proportion of women who have ever used ECPs and repeatedly used ECPs and also to assess the reasons for use and nonuse of EC pills along with factors associated with the use. METHODS: A systematic review of ECP use in India was conducted by electronically searching three databases-PubMed, Popline, and Google Scholar. All studies were published between 2001 and 2017, and the electronic search was last conducted in July 2018. The proportion of use was calculated using meta-analysis, and the other factors were assessed by narratively synthesizing the findings. Thirty-three articles met the inclusion criteria. RESULTS: The pooled proportion of women who ever used ECPs was 6% (95% confidence interval, 0.03-0.10). The proportion of repeat use ranged from 12% to 69%. Five studies reported reasons for not using ECPs, and the most common reasons were religious/cultural beliefs followed by fear of side effects and inadequate knowledge. Studies to understand sociodemographic and other factors affecting the use of ECPs in India are lacking. There are significant concerns about the quality of the studies. The definition of repeat use of ECPs is inconsistent across papers. Furthermore, judgmental attitudes of health-care providers were apparent in some papers. CONCLUSION: The review highlights important research and program gaps.

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.

What some women want? On-demand oral contraception.

OBJECTIVE: To summarize evidence regarding current demand for on-demand oral contraception. STUDY DESIGN: We used Medline and collegial contacts to find published and unpublished studies conducted or reported in the past 15 years with information assessing women's interest in using any oral drug preparation, including emergency contraceptive pills, in a coitus-dependent manner either repeatedly or as a primary or planned pregnancy prevention method. RESULTS: We found 19 studies with relevant information. The studies were conducted in 16 countries. Eight studies provided data on women's attitudes regarding a coitus-dependent oral contraceptive; all suggested substantial interest in using it. Nine studies assessed actual use of oral tablets on demand for primary contraception. In these studies, 9-97% of women in the analysis populations reported using the pills on demand as main method, although frequency and consistency of use varied. Reported reasons for interest in or use of this contraceptive approach included convenience, ease of remembering, ability to conceal use, lack of coital interruption, and infrequent sexual activity. Three studies were clinical trials of investigational on-demand oral contraceptives which reported Pearl indices ranging from 6.8 to 53 pregnancies per 100 woman-years. CONCLUSION: Data from a variety of settings suggest that demand for an on-demand oral contraceptive may be widespread. The effectiveness of this potential method is not established, however. Considering the seriousness of the unmet need for contraception, further development research into the public health benefits and risks of such a method would be worthwhile. IMPLICATIONS: Demand for an on-demand oral contraceptive may be widespread. Efforts should be made to further explore the possibility of developing such a method.

Over-the-counter access to emergency contraception without age restriction: an opinion of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy.

Family planning remains a high priority area for the United States, with goals to increase the proportion of pregnancies that are intended, reduce pregnancy rates among adolescents, and increase contraceptive use prioritized in the Healthy People 2020 objectives. Contraception intended for use after unprotected intercourse, known as emergency contraception, remains underutilized. Levonorgestrel is one method of oral emergency contraception, which prevents fertilization and does not disrupt an already established pregnancy; thus, timing of administration is critical. Despite data demonstrating safety and efficacy, evidence-based decision making has been overshadowed by politically charged actions involving levonorgestrel emergency contraception for over a decade. The Women's Health Practice and Research Network of the American College of Clinical Pharmacy supports expanded access to levonorgestrel emergency contraception and removal of barriers such as age restrictions on the nonprescription drug product. Pharmacists remain a key provider of emergency contraceptive services and can help ensure timely access. In states where direct pharmacy access to emergency contraception is available, pharmacists are encouraged to participate. Education, research, and advocacy are other important responsibilities for pharmacists in this arena.

The role of pharmacists and emergency contraception: Are pharmacists' perceptions of emergency contraception predictive of their dispensing practices?

BACKGROUND: Pharmacists can play a critical role in the access to emergency contraception (EC). We assessed if knowledge and attitudes were predictive of EC dispensing among a statewide sample of Florida pharmacists, who have legal authority to refuse to dispense medications. STUDY DESIGN: In 2008, surveys were mailed to a random sample of 1264 pharmacists registered with the Florida Board of Pharmacy. Data from 272 pharmacists (22% response rate) were analyzed using bivariate and multivariate logistic regression. RESULTS: Fifty-six percent of respondents incorrectly answered that EC causes birth defects, and 46% replied that it causes abortion. Only 22% said that EC can be purchased in advance of need. Many felt uncomfortable dispensing to adolescents (61%) and men (58%). Knowledge about EC was the most important predictor of dispensing [odds ratio (OR)=1.57, 95% confidence interval (CI) 1.22-2.03]. In particular, pharmacists who reported that EC does not act as an abortifacient were more likely to dispense it (OR=4.64, 95% CI 2.15-10.00). CONCLUSIONS: Correct information about EC was the most important predictor of pharmacists' dispensing EC. To expand availability of EC, pharmacists will have to become better informed.

Ulipristal acetate: review of the efficacy and safety of a newly approved agent for emergency contraception.

BACKGROUND: Emergency contraception (EC) is used to prevent unintended pregnancies. The current gold standard for oral EC is levonorgestrel (LNG) administered as a single 1.5-mg dose or in 2 doses of 0.75 mg separated by 12 hours. LNG has shown to be effective up to 72 hours after coitus. Ulipristal acetate (UPA) is a selective progesterone receptor modulator approved for EC use in the United States in August 2010. UPA is administered as a one-time, 30-mg dose within 120 hours of intercourse. OBJECTIVE: The goal of this review was to provide a summary of the available literature on the use of UPA for EC. METHODS: PubMed, Cochrane Library, ClinicalTrials.gov, International Pharmaceutical Abstracts, EBSCO, and Iowa Drug Information Service were searched from February 2011 through September 2011 to identify relevant articles. Search terms included ulipristal acetate, CDB-2914, VA 2914, and emergency contraception. RESULTS: In an open-label study, UPA was effective in preventing pregnancy in 1241 women who presented for EC up to 120 hours (5 days) after unprotected intercourse, with an observed pregnancy rate of 2.1% (95% CI, 1.4%-3.1%) versus 5.5% (ie, the expected pregnancy rate without EC). The efficacy of UPA did not decrease significantly (P = 0.44) over time, with pregnancy rates at intervals between >48 and 72 hours at 2.3% (95% CI, 1.4%-3.8%), >72 and 96 hours at 2.1% (95% CI, 1.0%-4.1%), and >96 and 120 hours at 1.3% (95% CI, 0.1%-4.8%). In a single-blind, comparative noninferiority study of 1696 women, UPA was at least as effective as LNG when used within 72 hours for EC, with 15 pregnancies in the UPA group and 22 pregnancies in the LNG group (odds ratio = 0.68 [95% CI, 0.35-1.31]). In addition, UPA prevented significantly (P = 0.037) more pregnancies than LNG when used between 72 and 120 hours after unprotected intercourse, with 0 pregnancies in the UPA group and 3 pregnancies in the LNG group. In a meta-analysis, UPA prevented a greater percentage of pregnancies than LNG at intervals up to 24 hours (0.9% UPA vs 2.5% LNG; P = 0.035), up to 72 hours (1.4% UPA vs 2.2% LNG; P = 0.046), and up to 120 hours (1.3% UPA vs 2.2% LNG; P = 0.025). The most commonly (>10%) reported adverse events included headache, nausea, and abdominal pain. In addition, UPA delayed onset of menstruation by a mean of 2.1 to 2.8 days. CONCLUSIONS: Based on clinical trials, UPA seems to be a reasonably tolerable and effective method of EC when used within 120 hours of intercourse. UPA is at least as effective as LNG when used within the first 72 hours after unprotected intercourse. However, UPA may be more effective than LNG when used between 72 to 120 hours after unprotected intercourse, extending the window of opportunity for EC. UPA may provide a new option for women who require EC up to 5 days after unprotected intercourse.

Ulipristal - a new emergency contraceptive pill.

Until recently, women in the UK who wanted emergency contraception had two options: an oral hormonal method (levonorgestrel), which is licensed for use up to 3 days after unprotected sexual intercourse; or a copper-bearing intrauterine device (IUD), which can be inserted up to 5 days after unprotected intercourse or up to 5 days after the earliest likely calculated ovulation. Now ulipristal acetate (ellaOne - HRA Pharma), a new oral hormonal emergency contraceptive, has been licensed in the European Union for use within 120 hours (5 days) of unprotected intercourse. Here we assess whether it is an advance for emergency contraception.

Emergency contraception.

Emergency contraception is used to prevent pregnancy after a coital act not adequately protected by a regular method of contraception. In contrast to early medical abortion, emergency contraception prevents a pregnancy from starting and does not disrupt an established pregnancy. The most commonly used approaches consist of two oral doses of contraceptive steroids. The levonorgestrel-only regimen (levonorgestrel, 0.75 mg, repeated in 12 hours) appears to be more effective and better tolerated than the Yuzpe regimen (ethinyl estradiol, 100 microg, and levonorgestrel, 0.5 mg, repeated in 12 hours). In the largest randomized, controlled trial to date, levonorgestrel prevented about 85% of pregnancies that would have occurred without its use. Hormonal emergency contraception has no known medical contraindications, although it is not indicated for suspected or confirmed pregnancy. However, if hormonal emergency contraception is inadvertently taken in early pregnancy, neither the woman nor the fetus will be harmed. Nausea and vomiting associated with the Yuzpe regimen can be reduced by prophylactic use of meclizine. A strong medical and legal case exists for making hormonal emergency contraception available over the counter, as has happened in countries other than the United States. Easier access to and wider use of emergency contraception could dramatically lower the high rates of unintended pregnancy and induced abortion in the United States.

Emergency contraception.

Emergency contraceptives are methods that prevent pregnancy when used shortly after unprotected sex. Three different emergency contraceptive methods are safe, simple, and widely available in the United States. These are: (1) ordinary combined oral contraceptives containing ethinyl estradiol and levonorgestrel taken in a higher dose for a short period of time and started within a few days after unprotected intercourse; (2) levonorgestrel-only tablets used similarly; and (3) copper-bearing intrauterine devices inserted within approximately 1 week after unprotected intercourse. Emergency contraceptive use is best known for women who have been raped, but the methods are also appropriate for women who have experienced condom breaks, women who did not use any method because they were not planning on having sex, or women who had unprotected intercourse for any other reason. Unfortunately, few women know about emergency contraceptives, and few clinicians think to inform their patients routinely about the option. A nationwide toll-free hotline (1-888-NOT-2-LATE) and a website (http://not-2-late.com) can help women learn about these options. Sharing "family planning's best-kept secret" widely with women could prevent as many as a million unwanted pregnancies annually in the United States.

The next step for emergency contraception: over-the-counter availability.

Emergency contraception to prevent pregnancy after episodes of unprotected sexual intercourse has existed since ancient times. Modern medicine began to use hormonal methods in the 1960s, and today emergency contraception is used regularly in many countries. In the United States, providers do not routinely prescribe it, nor do they adequately inform their patients that it is available. This occurs even though sufficient information exists on the safety and efficacy of this method. Because the effectiveness of emergency contraceptive pills relies heavily on prompt administration, better access for patients is essential. Recently, proponents of emergency contraception have attempted to better inform the public of this resource. In addition, two oral contraceptive products are now available and marketed specifically for emergency contraception. The purpose of this article is to discuss the safety and efficacy of emergency contraceptive pills and the potential for them to become available without a prescription.

Emergency contraception.

The time has come for emergency contraception. It is highly underused worldwide, and especially in the United States, where patient and physician awareness remain low. There are several highly effective, well-tolerated methods that can be used to prevent undesired pregnancy after unprotected intercourse. This article discusses these methods, their method of action, effectiveness, safety, and tolerability.

Women's experience and satisfaction with emergency contraception.

CONTEXT: If any new contraceptive technology is to become a viable option for decreasing unintended pregnancies, women must be willing to use the method and find it acceptable. However, because emergency contraceptive pills have not been widely used, very little is known about this method's acceptability. METHODS: Telephone interviews were conducted with 235 women who had received emergency contraceptive pills through a demonstration project at 13 Kaiser Permanente medical offices in San Diego to assess women's experience and satisfaction with the pills. RESULTS: More than two-thirds of the women (70%) were using a contraceptive method prior to their need for emergency contraception, and 73% of these users were relying on condoms. When asked about the situation that led to unprotected intercourse, 45% reported that their condom broke or slipped, while 23% said they had had unplanned sex. More than three-quarters of the sample (81%) experienced at least one side effect. The overwhelming majority were satisfied with emergency contraceptive pills (91%) and would recommend them to friends and family members (97%). Just one-quarter of the sample (28%) believed that emergency contraceptive pills should be dispensed over the counter, and an even lower proportion agreed that they should be available from vending machines (6%). CONCLUSIONS: Because women were overwhelmingly accepting of emergency contraceptive pills, found them easy to use and did not intend to substitute them for regular contraceptive use, this new method is an important addition to the contraceptive options available to women, providing a way to prevent pregnancy after unprotected intercourse or method failure.

PIP: This study examines the experiences and satisfaction of using emergency contraceptive pills in preventing unintended pregnancy among women in the US. The data used were collected through telephone interviews with 235 women aged 18-48 years receiving emergency contraceptive pills through a demonstration project at 13 Kaiser Permanente medical offices in San Diego. The results of the study revealed that 70% of the women were using contraceptive method prior to their use of emergency contraceptive pills. Moreover, the situation that led them to use emergency contraceptive pills was due to contraceptive failure particularly condom failure. Despite an 81% statistics of women experiencing side effects, 91% were satisfied with emergency contraceptive pills and would recommend them to friends and family members. Only 28% agreed that emergency contraceptive pills should be made available over the counter, and 6% from vending machines. Therefore, this method is an important addition to the contraceptive options among women during unprotected sexual intercourse or method failure.

Safety of emergency contraception.

Emergency contraception (EC) prevents pregnancy. Four regimens are available in different parts of the world, a combination of ethinyl estradiol and levonorgestrel, levonorgestrel alone, mifepristone, and emergency insertion of an intrauterine device. All the regimens are also used either as long-term contraception or, in the case of mifepristone, as an abortifacient, and considerable data indicate their safety when used in these ways. Data on safety when the regimens are used as EC are lacking, but theoretically, and from practical experience, all appear to be extremely safe, particularly when compared to the risks of pregnancy. There has been a tendency to over-"medicalize" EC. Prescribing EC is simple. Consideration should be given to making EC available off prescription because it is so safe.

Feasibility of a telephone follow-up on use of emergency contraceptive pills in a college health center.

The authors examined the feasibility and effectiveness of a telephone follow-up procedure on use of emergency contraceptive pills (ECP) at a college health center. They made 264 telephone calls to the 97 women who had received ECPs during one 16-week academic semester and were successful in reaching 65 (67%) of the women, who responded with information about their experiences with ECPs. The women demonstrated a high rate of adherence to the medical regimen and reported very few side effects from ECPs; a majority said that ECPs did not affect their ability to carry out daily activities. On weighing the relative absence of problems following ECP distribution against the time, effort, and cost required to reach just over two thirds of the women, the researchers concluded that an ECP telephone follow-up procedure was neither cost-effective nor particularly useful.

PIP: Researchers at the University of Maryland at College Park analyzed data collected by a trained pregnancy counselor at the student health center of a large, public, East Coast university through follow-up telephone calls to 97 women who had received emergency contraceptive pills (ECPs). They aimed to examine the feasibility and usefulness of a telephone follow-up procedure for women who had received ECPs at a university health center as well as the women's experiences after ECP use. 27.8%, 52.6%, 18.6%, 1% of the students asked for ECPs within 12, 13-24, 25-48, and 49-72 hours of unprotected intercourse, respectively. The main circumstances necessitating the need for ECPs were condom breakage (43.8%) and failure to use contraception (33%). 53.7% used a condom during intercourse, either alone or with another contraceptive method. Despite many efforts, the counselor could only reach 67% of the women. The leading source of information about ECPs was a friend (49.2%). 93.4% took the first dose of ECPs within six hours after their clinic visit. All 65 women took Tigan to prevent nausea, but 18.5% did not take it as prescribed. Nausea was the most common side effect (40% after 1st dose and 29% after 2nd dose). Other side effects were rare. All four women (6.2%) who did not bleed after taking ECPs were tested for pregnancy and found to be pregnant. The entire follow-up procedure took 4-6 hours/week (total of 264 calls), which would cost $45-200/week depending on who is doing the follow-up. Many students viewed the telephone call with suspicion and did not want to talk about their ECP experience. These findings suggest that an ECP follow-up telephone call is neither useful nor cost-effective because user compliance was high, there were minimal ECP side effects, and ECPs are effective in preventing pregnancy.

Emergency contraception--why women don't use it.

AIM: The aim of the study was to examine knowledge of and perceived availability of the emergency contraceptive pill as well as reasons for its non use. METHODS: One hundred women each attending Epsom day unit or the Auckland medical aid clinic in Auckland seeking termination of pregnancy, and 100 women seeking contraceptive advice from the Alice Bush centre in Auckland, were asked to take part in the study. RESULTS: At Alice Bush centre 57% of women had previously used the emergency contraceptive pill compared with 43% women at Epsom day unit and 32% women at Auckland medical aid clinic. Only 7% of women attending Epsom day unit or Auckland medical aid clinic had used the emergency contraceptive pill in the month they conceived. When asked why they had not used the emergency contraceptive pill 38% of respondents said they had not heard of it and 41% did not know where to obtain it. Pacific Island women were least likely to have heard of it. Approximately 50% knew the correct time interval for using the emergency contraceptive pill. Sixty two percent attending the abortion clinics would have used the emergency contraceptive pill if they had a supply at home and 57% stated they would have used it if it was available over the counter through pharmacies. CONCLUSIONS: The discrepancy between the numbers of women who knew of the emergency contraceptive pill (72%) and the numbers who used it to try to prevent pregnancy (7%) indicates that there are barriers to obtaining and using the emergency contraceptive pill. This study demonstrated a lack of knowledge of the emergency contraceptive pill in women attending the abortion clinics. The majority of women seeking termination of pregnancy would have used the emergency contraceptive pill if they had it available at home or over the counter through a pharmacy. Doctors prescribing the pill and barrier methods of contraception should consider providing a supply of emergency contraceptive pill at the same time and consideration should be given to over the counter prescribing of the emergency contraceptive pill in New Zealand.

[Basic considerations in the choice of contraceptive methods for male and female]. / Grundsätzliche Betrachtungen zur Wahl der Methode bei Mann und Frau.

PIP: Causes for the widespread divergence in choice of contraceptive methods are outlined in this article. The reasons for this lack of uniformity can be found in differences in historical and cultural development of groups, religious preferences, and socioeconomic phenomena, especially the influence of mass media. It is found that there is little uniformity within countries of the East and West, as well as within ethnic groups of similar social strata and economic development. It is also noted that the choice of individual contraceptive methods depends on considerations related to use, risk factors, acceptability, and such other variables as age, health condition, sexual behavior, educational level, and religious or ideological judgments.^ieng