Clare Daly (Dublin Fingal, Independent)
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218. To ask the Taoiseach and Minister for Defence if he accepts the World Health Organisation malaria unit figures of approximately 130,000 worldwide malaria deaths annually in patients over the age of five. [18601/16]

Clare Daly (Dublin Fingal, Independent)
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219. To ask the Taoiseach and Minister for Defence if he accepts that as per Food and Drug Administration and European Medicines Agency literature, Lariam can cause neurologic side effects that can last for months, years and can become permanent; and if not, if he will produce fully referenced analysis that proves otherwise in each case. [18602/16]

Clare Daly (Dublin Fingal, Independent)
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220. To ask the Taoiseach and Minister for Defence if he accepts that unlike doxycycline and Malarone, Lariam Adverse drug reactions are predominantly neuropsychiatric in nature and that Lariam is the only one of the three drugs that carries a boxed safety warning, the most serious type of warning. [18603/16]

Clare Daly (Dublin Fingal, Independent)
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221. To ask the Taoiseach and Minister for Defence if the Director of the Medical Corps accepts that according to the Health Products Regulatory Authority's Malarone license, the drug can be prescribed for periods of six months. [18604/16]

Clare Daly (Dublin Fingal, Independent)
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222. To ask the Taoiseach and Minister for Defence if the Director of the Medical Corps accepts that as per the World Health Organisation International Travel and Health 2015, mefloquine, doxycycline and Malarone are all effective malaria chemoprophylaxis options for the various countries of Defence Forces deployments in sub-Saharan Africa. [18605/16]

Clare Daly (Dublin Fingal, Independent)
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223. To ask the Taoiseach and Minister for Defence if the Director of the Medical Corps accepts that the absorption of Doxycycline is not notably influenced by simultaneous ingestion of food or milk. [18606/16]

Clare Daly (Dublin Fingal, Independent)
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224. To ask the Taoiseach and Minister for Defence if the official antimalarial policy for sub-Saharan Africa is still Lariam or unfit to travel; and if so, if he will cite as many examples as possible of other armies who have the same Lariam or unfit to travel policy for that region. [18607/16]

Clare Daly (Dublin Fingal, Independent)
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225. To ask the Taoiseach and Minister for Defence if Lariam or unfit to travel is no longer the policy, if he can supply a copy of the new malaria chemoprophylaxis policy for sub-Saharan Africa or individual country policies for that region; and when the changes were first implemented. [18608/16]

Clare Daly (Dublin Fingal, Independent)
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226. To ask the Taoiseach and Minister for Defence if he will request the Director of the Medical Corps to state the year from which prescribing doctors individually screened soldiers for Lariam suitability; and if he will provide all documentation in support of that answer. [18609/16]

Clare Daly (Dublin Fingal, Independent)
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227. To ask the Taoiseach and Minister for Defence the reason some troops, including those who subsequently took their own lives, were prescribed mefloquine despite clear written contraindications already recorded on their medical files. [18610/16]

Clare Daly (Dublin Fingal, Independent)
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228. To ask the Taoiseach and Minister for Defence the percentage of troops the director of the Medical Corps expects to be contraindicated from being prescribed Lariam; and to list the medical studies or other data used in support of this figure. [18611/16]

Clare Daly (Dublin Fingal, Independent)
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229. To ask the Taoiseach and Minister for Defence the percentage of the remaining troops not contraindicated to Lariam, the Director of the Medical Corps expects to then experience adverse drug reactions which mandate discontinuation of the drug as per the Health Products Regulatory Authority safety instructions and to list the medical studies or other data used in support of this figure. [18612/16]

Clare Daly (Dublin Fingal, Independent)
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230. To ask the Taoiseach and Minister for Defence if the director of Medical Corps accepts that Lariam can be associated with suicide. [18613/16]

Clare Daly (Dublin Fingal, Independent)
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231. To ask the Taoiseach and Minister for Defence to release the study or the raw data and methodology if no formal study exists, which shows a decreased risk of suicide in the period when Lariam was being prescribed by the Defence Forces, so that it can be subjected to independent scrutiny. [18614/16]

Clare Daly (Dublin Fingal, Independent)
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232. To ask the Taoiseach and Minister for Defence if he will instigate an independent study to establish if, as per an analysis (details supplied), there was a three to five times increased risk of suicide in Irish soldiers prescribed Lariam in comparison to a similar group who also served overseas but did not take the drug. [18615/16]

Clare Daly (Dublin Fingal, Independent)
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233. To ask the Taoiseach and Minister for Defence if the working group on malaria prophylaxis been reconvened in the original context of current and future litigation, or if it is now instead tasked with examining best practice malaria prophylaxis in a military population with a view to making policy recommendations purely in the context of future overseas missions to sub-Saharan Africa. [18616/16]

Clare Daly (Dublin Fingal, Independent)
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234. To ask the Taoiseach and Minister for Defence if he or any of his officials contacted persons (details supplied) with a view to them contributing to the reconvened working group on malaria prophylaxis after their very generous offer. [18617/16]

Clare Daly (Dublin Fingal, Independent)
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235. To ask the Taoiseach and Minister for Defence if the resources are available to check individual personnel files relating to the prescription and use of Lariam in the Defence Forces, thus releasing crucial information previously requested in a number of different parliamentary questions on the subject. [18618/16]

Enda Kenny (Mayo, Fine Gael)
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I propose to take Questions Nos. 218 to 235, inclusive, together.

As I have made clear, the health and welfare of the Defence Forces are a priority for me and this informs my approach to the issue of Lariam.

I have noted from the World Health Organisation (WHO) publication regarding the number of deaths from malaria that there has been a 60 % reduction in Malaria mortality since 2000. The WHO reports that in 2015 the number of deaths was 438,000 of which deaths in children under 5 years was 306,000. However, the key issue remains the fact that malaria is a significant killer on the world stage.

It is acknowledged that Lariam can cause, inter alia, neuropsychiatric side effects. However, it is more difficult to comment on the duration. Conventional thinking is that side-effects are directly related to blood levels of the product, and as Lariam has a relatively long half-life, the side effects, even by conventional wisdom, could be expected to remain to some degree until the product is ‘washed out’ of the system, and this could take several weeks.

With regard to overseas military service, there are numerous confounding factors that may contribute to the patient’s symptoms, and it is difficult if not impossible to determine which symptoms are due to any specific entity. Stress can present in many guises and can result from overseas deployment through absence of usual support mechanisms, operational tempo, fears, worries and concerns related to the family back home, exposure to different climate and culture etc. Consequently, it is objectively very difficult to attribute symptomatology to any specific cause.

Lariam can have, inter alia, neuropsychiatric side-effects in certain individuals. Malarone, as listed on the Summaries of Product Characteristics (SPC) (June 2015 edition), can cause certain patients to suffer from similar neuropsychiatric side-effects such as nightmares, depression, (both listed as ‘common’) and anxiety in addition to dizziness and insomnia. The SPC (June 2015 edition) warnings on Lariam are more emphatic than those contained on the Malarone SPC, although neuropsychiatric side-effects are listed. Doxycycline is not associated with neuropsychiatric side effects. It is important, however, to place all warnings in context. The fact that a medication can exhibit adverse reactions in certain individuals does not, nor should it, prevent its use where the overall benefit to hazard ratio remains positive. It is vital to follow all the manufacturer’s advice and guidance with regard to its use.

The Director Medical Branch ( DMB) is fully aware of the Health Products Regulatory Authority (HPRA) recommendations with regard to Malarone. The DMB has commented in various fora, including with the HPRA, on the changes which have occurred in recent times with regard to Malarone’s SPC. On the one hand, the ‘embargo’ on its prescription for periods in excess of 28 days was removed, but it was replaced with the information that “ in non-immune subjects, the average duration of exposure in clinical studies was 27 days” (SPC June 2015 edition). This raises questions related to its efficacy, side effect and adverse reaction profile when used for longer periods.

The DMB accepts that the three medications mentioned above have malaria chemoprophylactic effects. The precise efficacy of one over the other depends on many factors, including local sensitivity of the particular species to the individual drug (this can vary over time and over location), proposed exposure of the patient, as well as patient compliance, to name a few relevant factors. Patient compliance in turn is related to the dosing regimen, the availability of the medication, and the individual’s tolerance of any side effects etc.

The manufacturers report that absorption of Doxycycline is impaired by calcium, zinc, magnesium or iron salts irrespective of whether the calcium is contained in an antacid or in a dairy product.

The DMB’s current advice, guidance, and policy in relation to malaria chemoprophylaxis is that, in the case of Sub Saharan Africa, Lariam is the agent of first choice. In special circumstances the other agents may be used. For example, if for operational reasons it was imperative that an individual deploy immediately without the normal ‘lead-in’ time which is required for Lariam, then one of the other alternative medications should be used. Equally, if an individual who had a specific skill set which was fundamental to mission success and either had previously demonstrated sensitivity to Lariam, or had a contraindication to its use in the first place, then that individual would receive derogation from the ‘normal’ policy and be placed on another medication. If during the course of deployment, an individual developed sensitivity to Lariam, he/she would desist from Lariam and be placed on an alternative. In all the examples above, the basic principle remain the same – it revolves around the balance struck between mission success and patient safety. In the case of immediate deployment, mission success dictates that an alternative is used. In the case of the individual who cannot take the first choice medication, mission success dictates that he/she deploys on an alternative. In the case of the late manifestation of sensitivity, an alternative medication is substituted for Lariam, the individual remains under medical supervision and continues to contribute to mission success.

As a result of its extended half-life in the blood, Lariam is taken on a weekly basis rather than on a daily basis. This has two direct and significant consequences. Firstly, a weekly medication facilitates compliance. Secondly, even if a dose is missed by 24 hours, there is still a residual quantity of the active ingredient in the blood which gives a certain degree of protection. If, however, one of the daily medications is missed by 24 hours, the patient is immediately susceptible to malaria. Prevention of disease for military personnel serving overseas is of the utmost importance. In addition, a peace keeping or peace enforcing military force has to prepare for all eventualities. The military activity of a force is dictated, not so much by a clock or calendar, but by the operational tempo at any given time. Such a reality creates difficulty in abiding by a daily dosing regimen. With the best will in the world, unforeseen circumstances can arise. A daily medication may be overlooked, misplaced, forgotten, left in another location etc., as a result of a change in operational demand and tempo. This is a fact of life which differentiates the civilian office worker or tourist from the deployed soldier. Thus the weekly medication provides some mitigation against the unforeseen and unpredictable aspect of overseas service. This is one of the reasons why Lariam remains the medication of choice in malaria chemoprophylaxis for Defence Forces personnel deployed to Sub Saharan Africa. While there are other agents available, their use is associated with an increased risk of contracting malaria as indicated above. Therefore, subject to the special circumstances listed above, an individual who can take Lariam is selected in preference to one who cannot take Lariam because of the lesser risk to the individual and, by extension, to the mission. There are, however, circumstances when the demands of the mission justify this increased risk.

It is the policy of the Irish Defence Forces that personnel are individually screened for fitness for service overseas and medical suitability. I am advised by the Director Medical Branch that this has been the policy since the Defence Forces first embarked on overseas service.

It is not appropriate for the DMB to comment on any individual case raised in the Deputy’s question both for reasons of medical confidentiality and professional ethics, especially without in-depth knowledge of the particular case and the consent of all concerned. It should however be noted that it is totally contrary to DMB policy to knowingly prescribe medication to a patient who has a contraindication to that medication.

In relation to side effects, the literature varies on the overall percentage of side effects as a result of each of the three malaria chemoprophylactic agents, and each has its own relatively specific spectrum of side effects with Lariam and Malarone sharing certain groups of symptoms and Doxycycline having largely different (mainly gastro-intestinal related) symptoms. The numbers of Defence Forces personnel who have actual contraindications to the use of Lariam can be anticipated to be smaller than that in the civilian population because certain cohorts of individuals are precluded from joining the Defence Forces because of a past medical history which would also preclude the use of Lariam. Of course, there are individuals who, despite having no apparent contraindication contained within their past medical history, can develop sensitivity to Lariam. There is no way to predict in advance who will develop such sensitivity, once those with an already known contraindication have been excluded. In the same way it is impossible to predict who will be sensitive to penicillin before administering the drug.

There are individuals who are unsuited to Lariam either because they have a contraindication to its use, or have developed sensitivity to it. If the former group are prescribed Lariam, they are at an increased risk of suffering a severe adverse reaction, but the latter group also could, unpredictably, also suffer an adverse reaction. The spectrum of serious adverse reactions to Lariam includes neuropsychiatric disorders such as anxiety, depression and psychosis.

In a small study within the Defence Forces, the incidence of death by self-harm was greater during a period where overseas deployment was to non-Lariam type missions than during a period where deployment was on missions where Lariam was prescribed. The study involved an examination of individual files and therefore, it would be inappropriate to disclose the raw data for reasons of medical confidentiality. The death rate in the Defence Forces from self-inflicted injuries in the period 2000 to 2010, when Lariam was being prescribed, was 0.24%. The death rate from self-inflicted injuries in the period 1989 to 1999, when Lariam was not being prescribed, was 0.32%.

As I have indicated to the Dáil, I am currently awaiting the second report of the Malaria Chemoprophylaxis Working Group and until I have had the opportunity to review it, I have no plans to commission any separate studies. The purpose of the re-convened Malaria Chemoprophylaxis Working Group is to review issues arising in relation to the use of Lariam, particularly in the context of the current and potential litigation. The Working Group has invited the doctors referred to the Deputy’s question, Dr. Nevin and Dr. Croft, to provide information to the group and information from those doctors has been received and is being reviewed by the Group.

As the original report of the Working Group was produced in the context of current and potential litigation it is, therefore, legally privileged. Any further report prepared by the re-convened Group will also be produced in the context of current and potential litigation and will, therefore, be legally privileged also.

The information requested in relation to individual files is contained on confidential medical files and would require review by medical personnel. There are currently approximately 9,137 personnel serving in the Defence Forces, a significant proportion of whom may have served on a Lariam mission. In addition, there are probably many hundreds of other personnel who served on Lariam mission but who have now retired, and whose files have been archived. In that context, it is therefore not considered feasible to carry out such a review of all individual files.