Refusal to prescribe EC in Italy met with legal action

In contrast to the stories of EC refusal we’ve been hearing about in Poland, recent stories of EC refusal in Italy have been met with legal action and consequences. In the province of Pavia, a nurse has resigned following an investigation by the hospital she worked at into why she denied EC access to two women who requested it. The nurse, who refused access to two women in their twenties who requested EC in the middle of the night, claimed that she did it in an effort to help them save lives and that her motives were based solely on her conscious and religion. Read the full article in Italian here. Additionally, in Vicenza, denial of EC access has led to prosecution. A doctor who refused to provide EC has been found to be in breach of her duties as a doctor of public health and will receive a disciplinary measure. The case now goes to the courts for final judgement. For more information, see the full article in Italian here.

ICEC shares new evidence on safety of EC pills in ongoing pregnancies

The International Consortium for Emergency Contraception shared an updated summary of studies on the theme of safety of EC pills in ongoing pregnancies. We hope you find it useful for your work.

“Evidence continues to accrue confirming that emergency contraceptive pills (ECPs) do not harm a developing fetus if they are mistakenly taken early in an ongoing pregnancy. In ICEC’s 2010 “Fact Sheet on the safety of levonorgestrel-alone emergency contraceptive pills (LNG ECPs)” (published jointly by the World Health Organization, UNFPA and IPPF and available in English, French and Spanish), we cited two studies that found that LNG ECPs have no effect on the developing fetus if the contraceptive fails and pregnancy occurs. Studies by De Santis et al. in 20051 and Zhang et al. in 20092, which compared pregnancy outcomes in women who used LNG ECPs during their conception cycle with women who had not used LNG ECPs, found no difference in rates of miscarriage, birth weight, malformations, or in the sex ratio at birth between the two groups.

The longitudinal study designed by Zhang et al has now produced further results. The children born in the original study have now been followed for two years after birth, and results show that that children who were exposed in utero to LNG ECPs exhibit normal development.  Over a two-year period the authors found no statistically significant differences between the 195 children who were exposed to LNG ECPs and the 214 children who were not with respect to children’s weight, height, head circumference, and intelligence scores.3

In addition, growing evidence shows that ulipristal acetate (UPA) ECPs also will not harm an ongoing pregnancy. HRA Pharma, the manufacturer of UPA (sold under brand names such as ella and ellaOne), recently published its post-marketing surveillance data combined with data from its clinical trials.  Although few pregnancies and fewer live births occurred, the 28 live births that did occur have been followed, and results reported in an article by Levy, et al. Rates of miscarriage and pregnancy and delivery complications were normal, and one fetal anomaly was identified that was determined not to be related to UPA exposure in utero. 4

All available evidence to date supports the safety of LNG and UPA EC, and indicates that prenatal exposure to these medications does not produce birth defects or developmental delays.”

Citations

1 De Santis M, et al. Failure of the emergency contraceptive levonorgestrel and the risk of adverse effects in pregnancy and on fetal development: an observational cohort study. Fertility & Sterility, 2005, 84:296-299.

2 Zhang L, et al. Pregnancy outcome after levonorgestrel-only emergency contraception failure: a prospective cohort study. Human Reproduction, 2009, 24:1605-1611.

3 Zhang L, et al. Physical and mental development of children after levonorgestrel emergency contraception exposure: a follow-up prospective cohort study. Biology of Reproduction, 2014, 91:1-7.

4 Levy D, et al. Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women. Contraception, 2014, 89:431-433.

Study: Pharmacy-based interventions for initiating effective contraception following the use of emergency contraception: a pilot study

A pilot study by L. Michie, et al. entitled “Pharmacy-based interventions for initiating effective contraception following the use of emergency contraception: a pilot study” was recently published in Contraception. This study, conducted in Scotland, aimed to determine the feasibility of a larger study designed to ascertain if pharmacy-based interventions can increase the uptake of effective contraception after EC. See abstract below:

Objectives In Scotland most women get emergency contraception (EC) from pharmacies. Pharmacists currently cannot provide effective ongoing contraception after EC. In this pilot study, we aimed to determine the feasibility of a larger study designed to ascertain if pharmacy-based interventions can increase the uptake of effective contraception after EC.

Study Design This is a pilot study of women presenting for levonorgestrel EC to community pharmacies in Edinburgh, UK, in 2012. Pharmacies were cluster randomized to provide either standard care or one of two interventions: (a) one packet of progestogen-only pills (POPs), giving women 1 month to arrange ongoing contraception; (b) invitation to present the empty EC packet to a family planning clinic (FPC) for contraceptive advice (rapid access).

Results One hundred sixty-eight women were recruited from 11 pharmacies to POP (n=56), rapid access (n=58) and standard care (N=54) groups, respectively. Telephone follow-up was conducted successfully in 102 women (61%) 6–8 weeks later to determine current contraceptive use. In the POP arm, 35/39 (90%) women used the pills provided, and 9/28 women (32%) in the rapid access arm attended the FPC. The proportion of women using effective contraception at follow-up was significantly greater in both POP [56% (22/39), p=<0.001] and rapid access [52% (13/25), p=0.006] groups compared to standard care [16% (5/31)]. The relative probability of a woman using an effective method of contraception versus barrier/no method, after use of EC, was 3.13 [95% confidence interval (CI), 1.90–5.13] in the POP group and 2.57 (95% CI, 1.55–4.27) in the rapid access group.

Conclusions This promising pilot study suggests that simple pharmacy-based interventions may increase the uptake of effective contraception after EC. A larger study is required to provide further validation of these findings.

Implications Statement For women obtaining EC from a pharmacy, simple interventions such as supplying 1 month of a POP, or offering rapid access to a FPC, hold promise as strategies to increase the uptake of effective contraception after EC.

Refusal to prescribe EC in Poland

According to Polish law, EC can be prescribed by any primary care doctor to any woman who needs it. A journalist in Poland, Agata Diduszko-Zyglewska, undertook an experiment to try and obtain EC in public health care centers with the aim of exposing how many doctors prefer to break the law and professional ethics’ rules instead of prescribing EC to women who need it. Diduszko-Zyglewska visited three health care centers and was told at each one that she could not be prescribed EC without a full exam by a gynecologist to rule out pregnancy, for which she would have to wait between two and four hours (or longer), and even then it was not assured that the doctor would prescribe it. She finally was able to obtain EC from friends who had procured it on holiday in those European countries where it is available without a prescription. Diduszko-Zyglewska encourages women to speak out against this mistreatment so that the Polish Minister of Health will be forced to react to this unethical behavior. Read the full article here.

ECEC supports UPA OTC access

Upon request by the manufacturer of ulipristal acetate emergency contraception (UPA EC) pills, the Committee for Medicinal Products for Human Use of the European Medicines Agency will consider a proposed change in the classification for supply of UPA EC pills from “medicinal product subject to medical prescription” to “medicinal product not subject to medical prescription” in the European Union[i].

As a Consortium striving to increase access to EC, we envision a European region where all women receive evidence-based information about all EC methods available to them and are free to chose the EC method they prefer to use to reduce the risk of pregnancy after unprotected sex.

We believe that an additional and more effective oral EC method available without prescription would be an important public health benefit to the women of Europe. Keeping in mind the data available from post-marketing surveillance of UPA EC and the fact that in most European countries women prefer to obtain their EC methods directly from the pharmacy, we believe that the benefits of increased access to the newest EC method exceed any potential risks.

Europe has a renewed opportunity to show its commitment and global leadership in protecting and promoting the reproductive rights of its population. Making all oral EC methods equally accessible will contribute to strengthening European women’s capacity to exercise their reproductive and human rights.

For information on over-the-counter access to LNG EC pills, please read our factsheet on this topic, available in English, German and Italian.


[i] European Medicines Agency: EMA/CHMP/59462/2014 – Committee for Medicinal Products for Human Use (CHMP). Minutes of the 20-23 January 2014 meeting. http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2014/02/WC500162067.pdf, October 2014

 

New host agency for ECEC

As many of you know, the European Consortium for Emergency Contraception (ECEC) brings together a group of individuals and organizations committed to increasing access to and knowledge of emergency contraception in Europe. ECEC works with the support of an organization that hosts the Consortium, making it possible for us to operate.

Since its inception in November 2011, ECEC has been hosted by the International Consortium for Emergency Contraception (ICEC) at Family Care International (FCI). We thank the ICEC and FCI teams for all their work and help during this period.

We are now very pleased to announce that as of September 2014, ECEC is hosted by the East European Institute for Reproductive Health (EEIRH), an international NGO based in Tirgu-Mures (Romania), working to promote the right of women and men to sexual and reproductive health, to a life without gender-based violence, and to a healthy and dignified ageing.  EEIRH is a regional implementing partner for UNFPA, active in countries in Eastern Europe and Central Asia.

EEIRH will provide legal status and perform legal obligations on behalf of ECEC and will ensure financial management and administrative and logistical support.  EEIRH will also provide advice and guidance to ECEC in the process of getting formally established as an operative network and of acquiring legal acting capacity.  The EEIRH team working with ECEC will be led by Dr. Mihai Horga.

We are confident that being based in the region will open new opportunities for collaboration with regional partners, and will hopefully make us more effective in advancing our mission.

Study: Effect of changes to cost and availability of EC on users’ profiles in an emergency department in Catalunya

A study by Cristina Trilla, Raquel Senosiain, Joaquim Calaf, and Juan José Espinós entitled “Effect of changes to cost and availability of emergency contraception on users’ profiles in an emergency department in Catalunya” was recently published in The European Journal of Contraception and Reproductive Health Care. The study examined whether free-of-charge EC access within the Public Health System, which was authorized in 2004, and over-the-counter access of EC, which was implemented in 2009, impacted demand and users’ profiles at a health institution in Catalunya. See abstract below.

Objective Emergency contraception (EC) accessibility has evolved differently in Catalunya as compared with other autonomous communities in Spain. Free-of-charge access within the Public Health System was authorised in 2004, and over-the-counter (OTC) access was implemented in 2009. The aim of the study is to assess the impact of these measures on demand and users’ profiles at our institution.
Methods A retrospective study, in our Emergency Department, was conducted to evaluate EC requests in relationship to accessibility modifications. The age of women and which days of the week they attended were analysed.
Results The number of EC requests, the distribution by age and the demand over the
week remained stable after access to EC became free of charge. However, requests sharply decreased following OTC access implementation. Distribution by age also changed, with a significant increase in requests from women under 25 years (72% vs 56%, p 0.001). Demand was greatest on Sunday and Monday, and this distribution persisted over the study period.
Conclusion EC requests remained unchanged following free-of-charge access to EC, but decreased after OTC implementation. Women currently seeking EC at no cost at our institution are more likely to be younger and to request it on a Monday.

Study: Intention to use ECPs and the role of knowledge in a Dutch national sample

A study by Charles Picavet, Ineke van der Vlugt, and Ciel Wijsen entitled “Intention to use emergency contraceptive pills and the role of knowledge in a Dutch national sample” was recently published in the The European Journal of Contraception and Reproductive Health Care. The study examined whether increased knowledge of ECPs among Dutch women increased their intention to use them. See abstract below.

Objectives Emergency contraceptive pills (ECPs) are underused for preventing unintended pregnancy. Not all women are willing to use them even when at risk of conceiving. This paper examines whether increased knowledge about ECPs may increase the intention to use these products.
Methods Factors associated with intention to use emergency contraception (EC) were
assessed among 1310 women who participated in the nationally representative Sexual Health in the Netherlands 2009 Survey. Logistic regression models included demographics, prior use of ECPs, and ECP knowledge.
Results Seventeen percent of the women did not intend to use EC after unprotected
sexual intercourse and a further 27% were unsure whether they would use it. Intention
is most strongly related to prior use and not having children. Only two of six knowledge
items were related to intention in the multivariate analyses. Being aware that ECPs can be obtained without prescription upgrades intention, whereas knowing that a woman can still get pregnant after having taken the ECP has a negative impact on intention.
Conclusions Improving knowledge may contribute to intention to use EC, but its
role will be modest. To understand the reasons behind ECP use it is essential to study the contribution of other factors, like attitudes and social norms.

New EC resource from SEXUAL HEALTH Switzerland

SEXUAL HEALTH Switzerland has recently published information on its website detailing all the methods of emergency contraception that are available in Switzerland. This resource, entitled “Emergency contraception in 4 steps: How to avoid an unwanted pregnancy in an emergency,” is available in French, German, and Italian and integrates the recent conclusions of the EMA regarding EC.

LNG and UPA remain suitable EC options for all, EMA concludes

The European Medicines Agency (EMA) released the following statement today:

“The European Medicines Agency has concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure. The Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends that these emergency contraceptives can continue to be used in women of all weights as the benefits are considered to outweigh the risks.”

To read the full statement, click here.