Kamra Presents its Position to Conjoint Parliamentary Standing Committee re Emergency Contraception (EC)

The Kamra was invited to present its position re Emergency Contraception (EC) to the conjoint Parliamentary Standing Committee for Family, Health and Social Affairs on Monday 25/07/16 . As a professional body the Kamra clarified its approach, did not take a political position, whilst making it clear that it was firmly going to safeguard the interests of pharmacists and the patients they ultimately serve. Full position may be downloaded by clicking the link  ParlSubCommECP250716

Pharmacy Council Elections 2016

Kamra tal-Ispizjara ta’ Malta is pleased to note that following a call for nominations to fill five (5) vacancies of Pharmacists as members of the Pharmacy Council in accordance with the provisions of Section 15 of the Health Care Professions Act, 2003 (Cap. 464), seven nominations from Pharmacists namely those of Ms. Alison Anastasi, Mr. Jurgen Azzopardi, Ms. Mary Ann Ciappara, Mr. Mark Mallia, Mr. Alfie Palmier, Dr. Claire Shoemake and Mr. John Vella were received.

An election by postal ballot was held and the aforesaid vacancies were filled up accordingly for a period of 3 (three) years from the 12th July 2016 by Pharmacists: –
Dr. Claire Shoemake
Mr. Jurgen Azzopardi
Ms. Maryanne Ciappara
Mr. John Vella
Mr. Mark Mallia.

Whilst we thank all candidates and congratulate the elected, the Kamra looks forward to working and collaborating further with the new Pharmacy Council.

Executive Council.

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.

 

 

 

Pharmacists are Free, Independent HCPs

The Malta Chamber of Pharmacists refers to the report carried in Times (June 22)  entitled “Leading Medicine Importer Willing to Apply for Morning After Pill” (click here for article) and  would like to correct the point made by our anonymous colleague who stated that

” If the prescription is coming from a doctor, then as a pharmacist, I cannot refuse to sell it to the customer,” ,

The Chamber wishes to state that pharmacists are independent healthcare professionals(HCPs)  have every right and responsibility to question a doctor’s prescription, not only in this  context, but in any other situation, and use his or her discretion on whether a prescription is to be dispensed or not. This is enabled by the Medicines Act and the Code of Ethics of the Pharmacy profession issued by the Pharmacy Council.

Response to the Press – Chamber’s Position re the Morning After Pill

Below is the Chamber’s response to questions sent by the Malta Independent.

The Malta Chamber of Pharmacists notes the present debate on Emergency Contraception (EC) or Morning After Pill (MAP) on which several statements have been made in public in the various media.

The Chamber bases its views on evidence based, peer reviewed literature together with reference to the Ethical Code of the Pharmacy Profession issued by the Pharmacy Council.

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, http://ec.princeton.edu/questions/ec-review.pdf.2016).

Levonorgestrel (LNG) is already available in Malta in oral contraceptive preparations (OCP), but at much lower doses (than as in the preparation for EC). It is also to be noted that LNG is replaced by safer OCP combinations in preparations containing for example, drospirenone and ethinyl oestradiol.

Ulipristal is also available in Malta in a 5 mg dose.  It is a relatively new medicinal product belonging to the class of second generation antiprogestins, a selective progesterone receptor modulator with anti-progesterone activity used for its therapeutic indication. Its structural relationship with mifepristone, an abortifacient, causes it to be treated with caution as EC (at a much higher dose) as it cannot be scientifically excluded that it is not also so.

Pharmacists as independent healthcare professionals are guided by the ethical code of the Pharmacy Council which is based on the principle of beneficence and abhors maleficence.  Pharmacists may refuse to dispense prescriptions which would mimic the action of the MAP on the basis of conscientious objection. They may do this without being judgemental and indicating another pharmacy where the client may receive the service.

With reference to the question of supply on the Maltese market, that is a matter for suppliers to decide.  In the final analysis, it is the remit of the Licensing Authority after consulting the appropriate bodies, to legally approve or not a Marketing Authorisation for MAPs.

 

Annual General Meeting Outcome

The Annual General Meeting of the Kamra tal-Ispizjara ta’ Malta (Malta Chamber of Pharmacists) was held yesterday, Thursday 5th May 2016 and elections for a new Executive Council were held.

President Mary Ann Sant Fournier was re-elected and the following are the elected Members of the incoming 2016-2019 Executive Council:

President – Mary Ann Sant Fournier

Max Borg Millo
Claire Calleja
Maryanne Ciappara
Duncan Decelis
Jojo Grima
Margaret Parascandalo
Claire Shoemake
John Vella

The Council would like to thank all those colleagues, including previous Council Members, members of subcommittees and all members for their ongoing support and commits to further it’s thrusts in the best interest of the Pharmacy Profession, Patients and Society.

Annual General Meeting

The Annual General Meeting of the Malta Chamber of Pharmacists will be held on Thursday 5th May 2016 at 7.30pm at the Main Conference Hall, Malta Federation of Professional Bodies, Sliema Road, Gzira.

AGENDA

7.30 Minutes of the last General Meeting

Matters arising

Presentation of Administrative Report

Presentation of Financial Report

Presidential Address

Statute – Amendments and Approval

Motions

Elections

Other Matters

End of Meeting

The Draft Statute as amended and proposed by the Council to be approved by this AGM may be viewed by online by logging in to spizjara.org with the password STATUT2016.  Any motions that members would like to present for discussion are to be duly signed by a proposer and seconder, both paid up members of the Chamber.  Below please find a nomination form for contestation of the Council, all of which must reach the undersigned by Tuesday 3rd May 2016.

Members’ presence is kindly requested in order that a fully representative vote may be taken on matters under discussion and in the election of the Executive Council for the forthcoming administrative year.  Please note that only fully paid up 2016 members are eligible to attend and vote.  New members will only be accepted by Tuesday 3rd May 2016.

Full circular with nomiation form may be downloaded by clicking AGM 2015 Circular