I propose to take Questions Nos. 183 to 188, inclusive, together.
Malaria is a serious disease which can cause serious complications and death. It is estimated by the World Health Organization that approximately 1 million people die every year from malaria. It has long been recognized as being a serious threat to any military force operating in a malarious area.
For the individual, prevention of malaria depends largely on minimizing skin exposure to mosquito attack. This involves the wearing of long sleeved shirts and long trousers, avoidance of outdoor activities at times when mosquitoes are most active, use of various insect repellents, etc. A second line of defence involves the use of a chemoprophylactic agent. This is taken orally and designed to ‘mop' up any parasites which may have entered the blood stream through the bite of an infected mosquito.
The Defence Forces may only prescribe drugs, including anti-malarial drugs, which are licensed by the Irish Medicines Board (IMB). The IMB is the national competent authority for the regulation of medicines and medical devices in Ireland. The objective of the IMB is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy of medicines available in Ireland and to participate in systems designed to do that throughout the European Union. There are three IMB-licensed anti-malarial medications (chemoprophylaxis) available to the Defence Forces — Doxycycline, Lariam and Malarone.
Cost has never been a deciding factor in choosing which of the three medications is prescribed for an individual. The choice of chemoprophylaxis medication is based solely on which product gives the individual the best protection having regard to their medical profile, their destination and the duration of the deployment.
a. Doxycycline has to be taken in the absence of dairy products. It has a daily dosage regime. It is cheaper than both Lariam and Malarone. 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 the anti-malaria chemoprophylaxis of first choice by the Defence Forces in some geographic regions, e.g. Afghanistan;
b. Lariam (mefloquine) was first authorised for use by the IMB in 1989. The authorised product information provides details to ensure its safe and effective use given its side-effects profile including potential neuropsychiatric effects. The IMB is of the view that the benefit/risk profile for the product remains acceptable. From a compliance point of view, its weekly dosing regimen scores over the other available chemoprophylaxis. Very simply stated, it is easier to remember a weekly medication than a daily medication, particularly where the entire unit uses the same ‘medication day'. Lariam is the chemoprophylaxis agent of first choice in sub-Saharan missions undertaken by the Defence Forces;
c. Malarone is unsuitable for use as it is licensed for no more than 28 days continuous use in a malarious area by the Irish Medicines Board (IMB). In this context this prophylactic agent is only suitable for use where the overseas deployment does not exceed 28 days. It has a daily dosage regime. It is more expensive than both Doxycycline and Lariam.
All of these drugs are recommended by the World Health Organisation and other travel advisory bodies such as the United States Centre for Disease Control.
In accordance with best international practice in prescribing any of these medications, and taking account of the contra-indications, warnings and side effects highlighted by the IMB, the Defence Forces screen all personnel for medical suitability. The screening system rules out personnel from overseas service with certain conditions for example depression, anxiety, neurodegenerative disorders etc., which, as has been indicated by the IMB and other regulatory bodies worldwide, are more likely to precipitate serious adverse reactions to Lariam.
In the case of overseas missions to malarious areas, the medical screening involves a one-on-one assessment of the individual's suitability to be prescribed the selected anti-malarial agent in line with current IMB guidelines. This typically involves review of the individual's previous experience, if any, with the medication. The individual's medical history is also screened for those conditions which have been identified as precipitating serious side effects in association with the medication. In addition, blood tests are carried out to ensure that the liver is healthy, as liver disease is an accepted contra indication to the use of Lariam.
It is the policy of the Defence Forces Medical Corps that personnel who are found suitable for Lariam should commence their medication three — four weeks in advance of their travel. The purpose of this precaution is two-fold — while it allows a slow build-up of the medication in the bloodstream, it also permits assessment by the person of their individual reaction to the medication while still in Ireland. During this ‘probationary' period the individual can consult with a Medical Officer (MO) over any adverse reaction, minor or major. Some minor reactions may be transient but if persistent, or troublesome, the individual will be deemed to have ‘sensitivity' to the medication and will be found not medically suitable for the mission.
Personnel are screened both before and after deployments and all necessary actions are taken to ensure that those with contraindications to Lariam use are deemed unsuitable for overseas service and are not prescribed the medication.
I am informed by the Director of the Defence Forces' Medical Corps (DMC) that the US Centre for Disease Control's Health Information for International Travel 2012 (the "Yellow Book") advises that a risk assessment be carried out before deciding on the use of a malaria chemoprophylactic agent. Chapter 3 of the "Yellow Book" lists recommended malaria chemoprophylaxis, including Mefloquine (Lariam).
Chapter 8 of this book contains a section relating to special considerations for US military deployments. Reference is made to a policy memorandum issued by the US Assistant Secretary of Defence (Health Affairs) that recommended that Doxycycline or Malarone should be used instead of Lariam if they were equally efficacious for the areas being deployed to. This, however, was in the context of very large-scale deployments where it is not possible to have the one-on-one assessment of an individual's suitability for Lariam that is carried out prior to deployments by members of the Irish Defence Forces. I am informed by the DMC that he is aware of this memorandum.
It should be noted that the primary area of operations for US Forces is Afghanistan currently. Neither the US Army nor Irish Defence Forces recommend Lariam as a first-line malaria chemoprophylaxis for Afghanistan. A breakdown of costs in relation to malaria chemoprophylaxis dispensed by the Defence Forces (e.g. Lariam and Doxycycline) over the last 3 years is not readily available. I will write separately to the Deputy about this matter.
The Defence Forces Medical Corps do not perform post mortems when a member of the Defence Forces dies in service. It is a matter for the Coroner's Office to determine whether a Post Mortem should be carried out which would then be carried out by an appointed pathologist. It is therefore a matter for that pathologist to determine what procedures are used in post mortems.
I am not aware of the specific views of the State Pathologist but I have confirmed that following the death of an Irish man in Vietnam in 2000 that the Dublin City Coroner notified the Irish Medicines Board that "concerns were expressed at the inquest in relation to possible psychotic reactions to Lariam". I understand that the coroner made no conclusion whether Lariam was a contributing factor in the death.
