18th August 2016

PRESS RELEASE

The Malta Chamber of Pharmacists, whilst welcoming the move toward electronic prescriptions as announced in the media yesterday, regrets the lack of consultation with the representatives of Pharmacists who truly are on the frontline (definitely not ‘the front office of POYC Unit’) of health care day in day out in the community pharmacies providing a pharmaceutical care service to all patients visiting their pharmacies, including registered POYC patients.

Whilst the Kamra was invited to participate in the Ministry for Health working party on e-prescriptions in 2013, wherein Kamra’s submissions were made and went beyond the generation of a doctor’s prescription via computer, the Kamra would have expected to continue to be consulted on the developments in this respect; not least, on the content of the prescription per se, and the modus operandi in the POYC system where the Kamra understands will see the introduction of the electronic prescription.

The forum for such presentation and discussion is the existent POYC Standing Advisory Committee (SAC) which has not had the computer generated prescription subject on its agenda prior to launching.

This so that the professionals at the receiving end would be well versed in this new application and so that any glitches could be avoided at inception.

It is a moot point that a prescription is a comunique between the prescriber and the pharmacist about a patient. While all good will has been shown by pharmacists since time immemorial, pharmacists have long been submitting to their medical colleagues and the authorities concerned their dilemmas when trying to decipher most handwritten doctor’s prescription which can be the reason for loss of precious time which could be better spent in giving a patient pharmaceutical care.

It is also regretted that to date and as stated in the media, data is held by the POYC ‘back office’ and albeit the Kamra has made strong representations on this matter, pharmacists still have no access to linking the medicines their patients are taking to their patients’ bio data.

The Pharmacy of the Patient’s Choice is not just a medicines delivery point in the community, but the patients first and /or last point of call in his or her access to healthcare; pharmacists are healthcare professionals well deserving to be heard and have their needs addressed in this context. In the final analysis, Pharmacists have their patients’ well-being as their priority.

Executive Council

Kamra tal-Ispizjara ta Malta

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Expression of Interest for Screening and Monitoring Point of Care Device

Expression of interest for the identification of point of care testing devices capable of simultaneously delivering a full lipid profile (Total cholesterol, HDL, LDL and TGc) and HbA1c measurement from a capillary blood sample.

The sample must be drawn by the operating pharmacist through a single finger prick and > 25uL of blood must be sufficient to perform both tests. The device must support an internal quality control system and must have inbuilt automatic calibration capabilities as well as the ability to connect to an IT interface for data management, storage and retrieval.

The selected device provider must  be demonstrably capable of installation of the device and of training the device operators. Training should not be limited to device operation but must be designed in order to equip participating pharmacists with the skills necessary to interpret results and to positively intervene with patients in a community pharmacy scenario.

Interested parties are invited to reply to this expression of interest via email toinfo@spizjara.org by not later than noon of August 30th.

The Kamra is committed to meet all interested parties.

The Kamra will select a provider from among interested parties based upon the information provided.

The Kamra reserves the right of selection, and its decision is final.

Date published 16th August 2016

Deadline of submission 30th August 2016

General Info about the Project

Targeting Obesity as a National Disability through a Community Pharmacist Driven Approach

The Executive Council has been successful in securing funds from the Malta Community Chest Fund (90% Funding, 10% Benficiary Funds) to run a project within community pharmacies that aims to screen ‘at risk ‘ patients for dyslipidaemia and diabetes mellitus. The ultimate aim of this project is to secure epidemiological data to submit to government in support of the concept of placing point of care testing services in  community pharmacies, for which the community pharmacist would then be reimbursed.

The project as designed is 2 tiered. On the one hand is a school based educational campaign run by pharmacists, and on the other is the community pharmacy based point of care screening project

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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

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.

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.

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.

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.