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Medicinal Products Licensing

Dáil Éireann Debate, Thursday - 3 July 2014

Thursday, 3 July 2014

Ceisteanna (155)

Clare Daly

Ceist:

155. Deputy Clare Daly asked the Minister for Defence further to Parliamentary Question No. 23 of 18 June 2014, the fact that while Lariam is licensed by the Irish Medicines Board, it also licenses Malarone and Doxycycline, and does not make recommendation regarding which should be used; and if Ireland is following international best practice in this area, the reason we are the only country which uses only Lariam. [28887/14]

Amharc ar fhreagra

Freagraí scríofa

The Irish Medicines Board (IMB) is the statutory authority with responsibility for the quality, safety and efficacy of medicines in Ireland.

The Defence Forces Medical Corps is advised that the three anti-malarial medications licensed by the IMB – Lariam (mefloquine), Malarone and Doxycycline – can all have significant side effects and protocols are in place to control the risk of side effects in individuals.

Each of the three drugs has been used by the Defence Forces, depending on individual circumstances including the type of malaria in the destination, the duration of travel, etc. Where malaria has been identified as a risk in a particular mission area, the choice of chemoprophylaxis is dependent on a number of factors including the type of malaria in the destination, resistance to particular drugs, the profile of the traveller (contra-indications, underlying health conditions, purpose of travel), the duration of travel and adherence issues. The choice of medication is a medical decision made by Medical Officers in the Defence Forces on the basis of best international practice having regard to the specific circumstances of the mission and the individual member of the Defence Forces.

Doxycycline has to be taken in the absence of dairy products. It has a daily dosage regime. While it can cause minor but troublesome, mainly gastrointestinal side effects, it can also produce sun-sensitivity skin rashes (akin to severe sun burn) in some individuals. This is particularly significant when used in very sunny climes. For this reason it is not recommended for first line use by the Defence Forces in sub-Saharan Africa. It is, however, the anti-malaria chemoprophylaxis of first choice by the Defence Forces in some geographic regions, e.g. Afghanistan where the predominant malaria species is the Plasmodium Vivax.

Malarone has a daily dosage regime and up to September 2012, Malarone was only licensed for up to 28 days continuous use and was not an option as the usual duration of deployment for the Defence Forces is 6 months. The 28-day limit was removed in September 2012. However, there is limited evidence as to the safety and effectiveness of Malarone usage for longer periods. On this basis the Defence Forces Policy to use Malarone up to the 27 day limit remains unchanged.

Lariam is one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa and remains the anti-malaria chemoprophylactic agent of choice where the predominant species of malaria is the virulent Plasmodium Falciparum.

I am advised that the Defence Forces follow best international practice in prescribing Lariam. It is the policy of the Defence Forces that personnel are individually screened for fitness for service overseas and medical suitability, i.e. a medical risk assessment for Lariam is carried out on an individual basis. This is intended to rule out personnel from overseas service with certain conditions, e.g. depression, anxiety, pregnancy, neurodegenerative disorders etc. which, as has been indicated by the IMB, are more likely to precipitate serious adverse reactions to Lariam.

The former Minister for Defence had the various concerns surrounding the use of Lariam investigated thoroughly and obtained the advice of leading medical experts, who concur with the prescribing practices followed by the Defence Forces.

As I stated previously on 18 June last, Lariam remains licensed by the IMB and must remain in the formulary of medication prescribed by the Medical Corps for Defence Forces personnel on appropriate overseas missions, particularly those in sub-Saharan Africa, to ensure that our military personnel can have effective protection from the very serious risks posed by this highly dangerous disease.

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