Medicines Authority recommends OTC sale of EC in Malta

On October 17th, 2016, the head of the Malta Medicines Authority, Serracino Inglott, announced that the sale of EC pills will be allowed without a prescription. According to an article from Times of Malta:

“The authority has always based its decisions on three things; quality, safety of patients and efficacy. By asking patients to go to doctors to get their hands on the contraceptive, you are compromising efficacy,” [Inglott] said. The authority head also insisted that the parliamentary committee failed to take into consideration that Malta’s pharmacists not only have the necessary skills to be able to give the MAP [morning after pill] but they also rank among Europe’s best pharmacists in patient-centered care.

This decision comes shortly after a Parliament Committee recommended to permit the sale of EC pills only with a prescription and to allow doctors to refuse prescribing EC on the basis of conscious objection.

 

New study on EC users in Italy

A study published in September 2016 in the European Journal of Contraception & Reproductive Health Care looks at the characteristics and profiles of 1773 women who presented at an emergency service (ES) for a prescription of EC (mandatory until May 2015) in Italy.

The study found that the mean age of the women was 26.0 years; 78.5% of the women were Italian; 91.5% were unmarried; 55.2% were still studying and 51.9% had high school education; 61.2% reached the ES within 12 hours of unprotected sexual intercourse (USI); and 42.4% had USI during days 9–16 of their menstrual cycle. LNG was prescribed in 81.4% of women and UPA in 17.7%. When looking at why women were requesting EC, the majority (57.9%) requested EC for condom rupture; 49.5% reported previous use of EC; and 41.6% received information on the subject through friends. The vast majority (83.8%) reported prior use of contraception; in 25.4% the reason for not using it was the absence of a relationship. This study highlights the importance of understanding the profile of women requesting EC so that they can better choose the right long-term contraception for them.

To read the full article in English, please click here

 

New 3-D video about EC mechanism of action

 (October  5, 2016) Gideon Richter released a new video that provides a very clear and easy-to-understand explanation of the mechanism of action of EC. This video, which incorporates 3-D animation, can be found here and is available for use in educational programas and trainings.

Malta Medical Journal editorial on emergency contraception

(October 5, 2016)  The fall issue of the Journal of the University of Malta Medical School (Vol.28 Issue 3, 2016) focuses its editorial on emergency contraception. The article states that the most recent scientific evidence shows that LNG ECP delays ovulation and does not prevent implantation nor does ECP cause the loss of implanted embryos, and calls for a rigorous and evidence-based approach when debating this issue. Read the editorial here and related news published on Malta Today here.

 

 

EMA recommends double dose of LNG EC when used with enzyme-inducers

On May 2016, the European Medicines Agency (EMA) recommended the use of a non-hormonal emergency contraceptive (EC) when a woman in need of EC is using other interacting medicines (such as the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy, and herbal medicines containing St John’s wort). If using a cooper IUD is not an option, the EMA recommends doubling the dose of levonorgestrel (1500 microgram tablets).

The Agency’s Committee for Medicinal Products for Human Use (CHMP) issued this recommendation upon a review for Levonelle and associated names. The effectiveness of 3mg LNG-EC in women taking enzyme-inducing medications has not been studied, but no concerns are identified in relation to safety or side effects associated with the use of this dose.

On 1 August 2016 the European Commission issued a EU-wide legally binding decision to implement the EMA´s recommendation. The EMA has requested that changes be made on LNG EC product packages and leaflets, in order to ensure the correct use.

Read the EMA´s assessment and the statement issued by the Clinical Effectiveness Unit of the United Kingdom´s Faculty of Sexual and Reproductive Healthcare on this matter.

Sources:

European Medicines Agency. Levonelle 1500 microgram tablets and associated namesgoo.gl/v0JttY (accessed 27 September 2016)

FSRH Clinical Effectiveness Unit. Statement from the Clinical Effectiveness Unit. Use of double dose (3mg) levonorgestrel emergency contraception by women taking enzyme-inducing medications. 2 July 2016. https://www.fsrh.org/standards-and-guidance/documents/ceu-statement-double-dose-lng-ec-2-july-2016/ (accessed 27 September 2016)

New study looks into EC status in Europe one year after the UPA switch

A study published in March 2016 by researchers from the Department of International Health of Maastricht University, assesses the status of EC pills in European Union and associated countries a year after UPA was allowed for sale without prescription, and also looks into the impact of this switch on EC pills sales.

Status of Emergency Contraceptives in Europe One Year after the European Medicines Agency’s Recommendation to Switch Ulipristal Acetate to Non-Prescription Status  can be accessed here.

In Malta: women´s groups demand access to EC

In June 2016, the Maltese NGO Women’s Rights Foundation (WRF) filed a judicial protest on behalf of 102 women, requesting that emergency contraception is licensed, available, and accessible locally. The Minister of Health announced that the issue will be discussed at the Parliament Social Affairs committee in the coming months. Despite being a member of the European Union, Malta does not have a dedicated EC product registered nor available in the local market.

If you want to follow this process or get in touch with the WRF you can do so through their Facebook page

UPA ECPs mandatory dispensing protocol in Croatia cancelled

As of June 2016, the mandatory dispensing protocol for UPA EC pills in Croatia has been cancelled.

The dispensing protocol was developed by the Croatian Pharmacy Chamber, and its mandatory status was imposed by the Minister of Health in April 2015 following the European Medicine Agency’s (EMA) recommendation to sell UPA EC without a prescription. The mandatory dispensing protocol was introduced without any legal grounds and in major contradiction to the product documentation approved by the EMA. Ever since, the Croatian Society of Gynecological Endocrinology and Human Reproduction has been executing evidence-based professional education activities and workshops for gynecologists and pharmacists to educate them on EC, and they, along with other professional societies of gynecologists, the Croatian Pharmacists Association, public ombudsman for women’s and children’s rights, NGOs, and many prominent politicians (even of conservative provenience) raised their voices against the dispensing protocol. Local press attention to this matter helped those voices to be heard and gained the attention of the evidence-based, medicine-oriented Minister of Health, who helped to get the mandatory dispensing protocol removed.

For more information on EC in Croatia, please visit ECEC’s Croatia country profile page.

US FDA announcement on LNG EC efficacy and weight

On May 24, 2016, the United States Food and Drug Administration (FDA) announced completion of a review of the existing data related to the efficacy of EC and body weight, concluding that the data do not warrant a change to product labels:

“The FDA has completed a review of available scientific data concerning the effectiveness of levonorgestrel (LNG) emergency contraceptives (ECs) in women who weigh more than 165 pounds or have a body mass index (BMI) above 25 kg/m2. The data are conflicting and too limited to reach a definitive conclusion as to whether effectiveness is reduced in this group. The FDA does not believe that a change in the labeling for LNG EC products is warranted at this time. There are no safety concerns that preclude use of LNG ECs in women generally, and the FDA continues to believe that all women, regardless of how much they weigh, can use these products to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure. The most important factor affecting how well emergency contraception works is how quickly it is taken after unprotected sex.”

The announcement recommends that further research by manufacturers of LNG EC on the potential impact of body weight on effectiveness of the product should be a priority.

ECEC’s 2015 statement on this issue reached a similar conclusion, and can be accessed here: Efficacy of emergency contraception and body weight: Current understanding and recommendations. In this statement, ECEC acknowledges that while there may be an association between the effectiveness of EC pills and the weight or BMI of the user, the available data are not sufficient to support a change to product labels. We note that the copper IUD followed by UPA EC are the most effective forms of EC for all women, regardless of weight, but that women should be not be denied LNG EC because of their weight.

For more information from the FDA, please read:

Main page

Consumer Q & A

Health Care Provider Q & A

The EC wheel: now available on-line and in French

 “Emergency contraception methods” (the EC wheel), a counselling tool for pharmacists and health providers published in May 2016 by ECEC, is now available in French,  and can be used from tablets, cellphones and computers (on and off line).

This tool is inspired in the WHO Medical eligibility criteria for contraceptive use (MEC) wheel, and based on the WHO MEC 2015 and the UK Faculty of Sexual and Reproductive Healthcare recommendations for EC use. The methods included are the Cooper IUD, Levonorgestrel EC pills and Ulirpristal Acetate EC pills. Read more in our Resources page or contact us for further information on how to use this tool in your country. Visit this pages to access the on-line wheel in  English and French here.