I propose to take Questions Nos. 24, 25, 37, 40, 43, 46, 47, 52 and 53 together.
I am advised by the Military authorities that a total of 5,885 deployments to Africa have taken place since 1 January 2000, involving 4,127 personnel. In the period since 1 January 2000 the anti-malarial prophylactic agent for those who have served in Central Africa was and is Lariam.
I am further advised by the Military authorities that since 1 January 1990, a total of 336 Permanent Defence Force personnel have died in service. Of these, 18 personnel had served in overseas missions in continental Africa. The specific cause of death of personnel is not recorded on individual personal files.
The Military authorities have further advised that the main anti-malaria agents available to it are Chloroquine, Malarone, Doxycycline and Lariam. The choice of drug is based on the mission and not on the rank of the individual.
The Defence Forces consider Larium to be the most effective anti-malaria drug for the type of malaria our troops were exposed to in Chad and Central African Republic.
Lariam is authorised for use 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. Lariam was first authorised for use by the IMB in 1989. While certain risks associated with the use of the drug were highlighted in Drug Safety Newsletters in 1996 and 2003, it remained of the view that the benefit / risk factor profile for the product remained acceptable. The Board continues to review the safety of this and all medicines on an ongoing basis and updates the product information as appropriate.
In the case of each of the other three anti-malaria products I referred to earlier, there are specific reasons as to why they are not suitable for use by the Defence Forces in sub-Saharan Africa and I will now set these out:
Chloroquine is no longer of use because of the development of widespread resistance;
Doxycycline has to be taken in the absence of dairy products and it can produce sun-sensitivity skin rashes in some patients. 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;
Malarone is unsuitable for use as it is licensed for no more than 28 days continuous use in a malarious area by the IMB. In this context this prophylactic agent is only suitable for use where the overseas deployment does not exceed 28 days.
All personnel volunteering for service overseas are initially screened for medical suitability and fitness. Fitness to serve overseas is defined by Medical Classification Code. Personnel who do not achieve the specific Code are deemed to be ‘medically unfit' for overseas service. This automatically excludes personnel from overseas service with conditions such as depression, anxiety, pregnancy, neurodegenerative disorders etc which, as indicated by the IMB, are more likely to precipitate serious adverse reactions to Lariam.
In the case of overseas missions to malarious areas, the medical screening involves an assessment of the individual's suitability to be prescribed the selected anti-malarial agent in line with current Irish Medical Board guidelines. This typically involves review of the patient's previous experience, if any, with the medication. The patient'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 those patients 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 buildup of the medication in the bloodstream, it also permits assessment by the patient of their individual reaction to the medication while still in Ireland. During this ‘probationary' period the patient 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 patient will be deemed to have ‘sensitivity' to the medication and will be found not medically suitable for the mission.
All overseas missions provide a medical service for participants. In the case of large Irish units serving with the UN etc. the primary care may be provided by the Medical Corps. Where the Medical Corps provides the primary care service, and where the Medical Officer (MO) forms the opinion that the patient has developed a ‘sensitivity' to Lariam while overseas, the patient will be advised to cease taking the medication, substitute it with a ‘second-line' agent, and the patient will be monitored to ensure symptoms subside. Appropriate ‘anti-symptomatic' medication may be required in the interim and appropriate restrictions will be placed on duties.
Furthermore, all personnel, symptomatic or otherwise, are reviewed at their repatriation medical and advised on the further medical management of any medical problems which may have arisen while overseas.
The Defence Forces have advised me that as of August 2010, three members of the Defence Forces had been treated for serious symptomatology which may have been caused or contributed to by Lariam, although there is nothing conclusive in this regard. I am advised by the military authorities that all these personnel have made a full recovery, and that their cases have been reported to the Irish Medicines Board. In addition, the Defence Forces psychiatrist reports a further cohort of seven personnel with less dramatic symptomatology, and these remain under review. Again there is no conclusive evidence that the use of Lariam was a factor in any of these cases.
The Defence Forces take all necessary precautions in assessing the suitability of personnel before prescribing Larium in accordance with the prescribing instructions and information provided by the Irish Medicines Board. Personnel are screened both before and after deployments and all necessary actions are taken to ensure that those with contraindications to Larium use are deemed unsuitable for overseas service and are not prescribed the medication.
It is my understanding that the US Forces stopped using the Lariam due to concerns about inadvertent prescribing of the drug to soldiers who should not take it. In this regard, I am advised that the US authorities undertook mass administration of mefloquine (the generic name for Lariam) for soldiers serving in areas subject to malaria. The Defence Forces do not mass prescribe but rather follow all the instructions issued by the IMB in order to fully screen out personnel who may potentially have an adverse reaction to the medication.
Finally, I am assured by the military authorities that that they are fully satisfied with the arrangements currently in place in relation to all aspects of the administration of Lariam as an anti-malaria drug to Defence Forces personnel. Consequently, I have no plans to set up a panel of medical experts to inspect all the soldiers who have served in Africa in the last ten years. Equally, I have no plans to meet any individuals in this regard.