I propose to take Questions Nos. 139 and 140 together.
Lariam is a malaria chemo-prophylactic agent first authorised for use in 1989 by the Irish Medicines Board (IMB), which is the statutory regulatory body charged with regulating the use of medicines to ensure the quality, safety and efficacy of medicines available in Ireland. Research has shown that it is one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa. While certain risks associated with the use of the drug were highlighted in Drug Safety Newsletters in 1996 and 2003, the Irish Medicines Board remained of the view that the benefit/risk profile for the product remained acceptable. The IMB continues to review the safety of this and all medicines on an ongoing basis and updates the product information as appropriate. Lariam remains the medication of choice for the Defence Forces for missions to sub-Saharan Africa and continues to be certified by the Irish Medicines Board.
There are two other IMB-licensed anti-malarial medications (chemoprophylaxis) available to the Defence Forces-Doxycycline and Malarone.
The choice of chemoprophylaxis medication depends on the risk 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 finally adherence issues:
a. 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 the anti-malaria chemoprophylaxis of first choice by the Defence Forces in some geographic regions, e.g. Afghanistan;
b. 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. All three 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 contraindication 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.