The Kamra Tal-Ispizjara Ta’ Malta has issued Guidelines, a Dispensing Flowchart summarizing the Kamra’s Guidelines for the Dispensing of Emergency Contraceptives and an EC Dispensing Record Form in support of pharmacist’s professional practice in this context.

These documents are complementary to the guidelines issued by the Medicines Authority.   Members are reminded that these Kamra documents are for their exclusive use and the result of the work of the Kamra Council in support of the Kamra members,   These documents are absolutely not to be reproduced in any way or published in any media without the sole permission of the Kamra. Members may not provide these documents to third parties and non-members of the Kamra.

Kamra EC Dispensing Flowchart

Kamra EC Dispensing Form

Malta Medicines Authority Guidelines

Emergency Contraception: Scientific Facts, Ethical & Legal Issues15/12/2016The above seminar was held on Tuesday 29th November at the South Auditorium, Mater Dei Hospital at 7.30pm. A truly successful event which was very well attended.The individual presentations may be downloaded by clicking on the title hyperlinks below:8.00Welcome and introduction by the Chair – Ms. Mary Ann Sant Fournier, Chamber President8.10 Medical Aspects of EC – Professor Charles Savona Ventura

M.D.(Melit.),D.Sc.Med.(Warsaw),Accr.C.O.G.(Leuven),F.R.C.O.G.,F.R.C.P.I.; Head of Department, Obstetrics & Gynaecology, Faculty of Medicine & Surgery, University of Malta. Biography: https://www.um.edu.mt/profile/charlessavonaventura8.30 ‘Regulatory aspects regarding Levonelle 1500microgram tablet and ellaOne 30mg tablet.’ – Ms. Helen Vella, Licensing Director, Medicines Authority. CV – EuroPass: http://www.ema.europa.eu/docs/en_GB/document_library/contacts/hvella_CV.pdf8.50 Ethical issues – Rev. Prof. Emmanuel Agius M.A. (Louv.), S.Th.D (Louv.); Dean of the Faculty of Theology, University of Malta. Biography: http://www.um.edu.mt/theology/moral/staff/eagius9.10 Dispensing of EC – Ms. Mary Anne Ciappara (Chamber Exec Council Member, Pharmacy Council Member, Regional Commonwealth Pharmacists Association (CPA) Representative)9.45 Q&A – discussion10:00 Close
EMERGENCY DISPENSING OF PRESCRIPTION ONLY MEDICINES (POM) – GUIDELINES FOR PHARMACISTS – Published by the Malta Chamber of Pharmacists, July 2014 (POSTED 26/07/2014)Joint circular by the Malta Chamber of Pharmacists, Association of Private Family Doctors and Gozo Medical Association and ensorsed by the Malta College of Family Doctors and the Malta College of Pharmacy Practice  re: Prescribing and Dispensing Guidelines issued in the light of LN 389 of 2013 on the legal requirement of Professional Indemnity Insurance Cover – Published , April 2014. (POSTED 26/07/2014)
 
SUSPENSION OF MARKETING AUTHORISATION FOR DIANE 35 AND ITS GENERICS FOR THE TREATMENT OF ACNE(POSTED 01/02/2013)The European Medicines Agency would like to inform you that the French medicines agency announced its plan to suspend the marketing authorisation for Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its generics for acne treatment in France within three months.These medicines are widely used across Europe. In France, they are only authorised for the treatment of acne, but in a number of other Member States they are also authorised for the treatment of acne in women who wish to receive oral contraception, as well as for the treatment of other skin conditions.France has already indicated that it will ask the European Medicines Agency to carry out a European-wide review of Diane 35 and its generics. Pending the outcome of the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) review, women who are currently taking Diane 35 or one of its generics are advised not to stop the medicine. If a woman has concerns, she can discuss this with her doctor.The press release is available for consultation by clicking here.We would be grateful if you could disseminate this email to anyone else who might be interested.With kind regards,Justin Sommerville | Trainee
European Medicines Agency | 7 Westferry Circus | Canary Wharf | London E14 4HB | United Kingdom
Tel. +44 (0)20 7418 8768 | Fax +44 (0)20 7523 7129 | Justin.Sommerville@ema.europa.eu | www.ema.europa.eu

EUROPEAN MEDICINES AGENCY RECOMMENDS THE SUSPENSION OF NICOTINIC ACID/LAROPIPRANT MEDICINAL PRODUCTS – TREDAPTIVE, PELZONT AND TREVACLYN

Issued by Medicines Authority, Malta

16.01.2013/Circular No. P01/2013

Download Full Safety Circular on Tredaptive

IMPORTANT INFORMATION ON TIANEPTINE ISSUED BY THE SUPERINTENDENT OF PUBLIC HEALTH

7th January 2013

SPH Circular No 2/2013.

To Medical Practitioners & Pharmacists

RE: Tianeptine

Tianeptine, a selective serotonin reuptake enhancer (SSRE) having strong antidepressant and anxiolytic properties, may be prescribed in treating major depressive episodes (mild, moderate, or severe).

This medicinal product has been classified as a psychotropic substance and included in the Third Schedule (Part B) to the Medical and Kindred Professions Ordinance (Legal Notice 412 of 2012) and in the First Schedule of the Drugs Control Regulations, 1985 (Legal Notice 413 of 2012).  Hence medical practitioners are now required to prescribe tianeptine on a green prescription (Form DH 129),  whilst being reminded to simultaneously fill in the first half of the control card (form DH 680(i)).

Likewise

pharmacists are being solicited to fill in Part C of the green prescription and the second half of the control card when dispensing tianeptine, and to document all of its sales and purchases.   Any current stock position of tianeptine is to be recorded on the Psychotropic Substances’ Purchases Register.

Tianeptine is locally available as Stablon®.

Dr.

R. Busuttil
Superintendent of Public Health

RECOMMENDATION FOR THE UPDATE OF PATIENT AND PRESCRIBER INFORMATION FOR PRADAXA by the Malta Medicines Authority

Circular  P11/2012 |14.06.2012

Pradaxa
Pradaxa contains the active ingredient dabigatran and is an anticoagulant medicine which prevents blood from clotting. It is prescribed to adults who have had hip or knee replacement surgery to prevent venous thromboembolic events (thrombosis) and also to patients with non-valvular atrial fibrillation (irregular

heart beat

) to prevent stroke and other obstructions to blood vessels. Pradaxa was first authorised in the EU in March 2008 and is marketed in all EU states, including Malta…..

Download full circular here.

SALE OF ELECTRONIC CIGARETTES FROM COMMUNITY PHARMACIES by the  Superindendence of Public Health

DH1632/2012; SPH Circular No 1/2012

Issued on the 1st of June hereunder is the legal position regarding sale of electronic cigarettes from Community Pharmacies.  Please take note.

Download Circular – Sale of Electronic Cigarettes

GUIDELINES FOR THE MANAGEMENT OF MOSQUITO BITES by The National Antibiotics Committee

Over the past two years, we have been witnessing severe reactions to mosquito bites, especially in children, adolescents and young adults after the discovery of the Asian tiger mosquito on our island. These are largely due to a local chemical cellulitis rather than hypersensitivity. The clinical manifestations are mainly characterised by a zone of erythema around the bite, pruritus and moderate to extensive swelling of the part.

In severe cases, especially when multiple bites occur with gross swelling and severe pruritus of the part, a topical and/or oral corticosteroid might be indicated, following specialist advice.

Initial management

It is recommended that a cold compress

be

initially applied to the affected area, followed by the application of an antiseptic cream such as chlorhexidine or hydrogen peroxide cream. A suitable, oral anti-histamine preparation should be given, followed by frequent application of an anti-histamine cream. There is absolutely no reason to prescribe an antibiotic cream for such situations since the vast majority of bites will not be infected.

Secondary infections

Evidence of secondary bacterial infection includes the development of pain, tenderness and an extension of the erythema beyond the bite. Only in such cases is an oral antibiotic indicated and it should have a spectrum of activity directed primarily against Staph. aureus and Str.

pyogenes

, such as cefalexin or flucloxacillin. As in most skin infections, there is no need for Gram-negative cover; therefore antibiotics such as co-amoxiclav, cefuroxime and ciprofloxacin are not treatments of choice. Topical antibiotics should also be avoided because of the likelihood of poor penetration to the site of infection in the deep dermis and high levels of resistance in local strains of Staph. aureus to some topical preparations. If a vesicle or bulla forms, which is not uncommon, its contents may be aspirated using an insulin syringe, after decontamination of the skin with 70% isopropyl alcohol. If the fluid is turbid, a direct Gram stain and culture should be performed on such specimens, which should be submitted to the testing laboratory in a plain, sterile (urine-type) container.

Public Health measures to avoid mosquito bites and control mosquitoes

· This particular mosquito bites mainly during the daylight hours; where possible
minimize areas of exposed skin during outdoor activities

· Insect repellants like Permethrin can be applied to clothing.

· Aerosol insecticides, vaporizing mats and mosquito coils can help to clear rooms of mosquitoes.

· Optimum protection can be obtained by using repellents on exposed skin. (Products containing DEET.)

· Have secure screens on windows and doors.

· Get rid of mosquito sources in your yard, garden by emptying empty standing
water from flower pot, buckets and barrels. Change water in pet dishes every three days and replace water in bird containers every week.

· Keep children’s wading pools empty and on their sides when not in use.

· Do not leave fish ponds without fish. Keep suitable fish such as goldfish,

gambuzja (guppy), muzaq (jelly fish) in bore holes and fish ponds.

· Empty swimming pools when these aren’t being used, especially if the water is not chlorinated.

· Locate puddles that last more than three days, inlets to sewers and drainage systems holding stagnant water and drain them.

· Roof gutters should be kept clean of fallen leaves and other debris so that water
does not collect in them.

· Flower pots, standing flower vases, knotholes and other crevices that can collect
water should be filled with sand or fine gravel to prevent mosquitoes from laying
eggs in them.

· Neighbourhood residents should work together to eliminate breeding sites like
abandoned cars, old machinery and other junk in vacant areas. Litter can also hold

rain water and should be removed.

· Any standing water in pools, catchment basins, etc, that cannot be drained or
dumped can be periodically treated with properly labelled insecticides.

· Businesses should cover tyres, store them indoors or treat them with an insecticide for control of mosquito larvae.

SCHEDULE V REFORM AND DIABETES MELLITUS MANAGEMENT

The Directorate for Pharmaceutical Affairs has issued a very important Memo with respect to the above reform.  Please click on the link below to see full details.

Schedule V reform and Diabetes mellitus management

(POSTED 26/04/2012)

RECENT CHANGES ON THE GOVERNMENT FORMULARY LIST (GFL)

Please find attached the latest Circular from the POYC Department. There are four (4) documents attached including:

1. POYC Circular PP048/12 dated 23rd April 2012

2. DH 104/2012 Diabetes Managment & Schedule V Applications

3. DH 106/2012 Updated GFL (March 2012)

4. Frequently Asked Questions (FAQs) re changes in medicines entitlement..how to handle them.

It is advisable to go through these documents in this order.

(POSTED 26/04/2012)