Morning After Pill – Clarification of Position Statement following Petition

The Kamra Tal-Ispizjara Ta’ Malta notes the petition issued on 30/06/16 by CITIZENGO (http://citizengo.org/en/lf/35479-maltese-mps-reject-bogus-anti-life-advice-morning-after-pill) and the manner in which a part of the Kamra’s position statement issued on 22/06/16 re the morning-after-pill (MAP) was quoted out of context. CITIZENGO quoted part of a paragraph which is quoted in full, as it appeared in the Kamra’s statement, below:

On the one hand one has to view the matter from a purely scientific angle; indeed studies have shown that it is not scientifically possible to exclude that the MAP does not preclude implantation of a fertilised ovum in the endometrium; at the same time women should be informed that there are explanations on the mode of action of the MAP which can be explained by methods that do not interfere with post fertilisation activities. (Trussell et al, 2016)” 

 It is the Kamra’s opinion that the paragraph should be quoted in its entirety to give the publishing authors’ intended balanced approach to the matter. This was also the intention of the Kamra as an association representing science-based healthcare professionals, in choosing to quote verbatim this passage from the Trussel et al (2016) review paper.

Furthermore the Kamra, representing pharmacists as a professional pharmaceutical and pharmacy association, bases its position on science supported by three important criteria; the body of scientific evidence as published in peer-reviewed scientific journals; up to date statements of the Competent Medicines Authorities such as the European Medicines Agency, the Malta Medicines Authority and other such authorities; and information from the Pharmaceutical Industry.

In this regard, the Kamra and pharmacists are guided by the SmPC’s (Summary of Product Characteristics) of medicinal products which are a key part of the marketing authorisation of all medicines authorized in the EU and the basis of information for health care professionals on how to use a medicine safely and effectively. They are kept updated throughout the life cycle of a medicine as new efficacy or safety data emerge (EMA.europa.eu). Such documents are found in the public domain. Patient package inserts (Patient Information Leaflets – PIL’s) are based on the SmPCs.

The Kamra refers to the most recent SmPC’s of MAPs licensed in EU member states containing levonorgestrel (1500mcgms) and ulipristal (30 mg)

These state that with reference to the MAP products containing levonorgestrel, these are “thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. Levonorgestrel is not effective once the process of implantation has begun.”

With reference to the products containing ulipristal acetate, the SmPC states that ‘’Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via high-affinity binding to the human progesterone receptor. When used for emergency contraception the mechanism of action is inhibition or delay of ovulation via suppression of the LH (luteinizing hormone) surge. Pharmacodynamic data show that even when taken immediately before ovulation is scheduled to occur (when LH has already started to rise), ulipristal acetate is able to postpone follicular rupture for at least 5 days in 78.6% of cases (p<0.005 vs. levonorgestrel and vs. placebo) “

Pharmacists, and other independent health care professionals may wish to further refer to published peer reviewed articles to formulate fully their personal position on this matter.

The Kamra also states that at no point did the Kamra express itself in confrontation with the Medicines Authority as reported on the 30/06/16 by newsbook.com.mt.

In the final analysis, and as stated previously by the Kamra, it is the remit of the Licensing Authority after consulting the appropriate bodies, and through the Medicines Authority to decide to legally approve or not the registration of MAPs in Malta.

 

 

 

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