Dáil Questions: Defence – Lariam

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Dáil Issues, Defence, Oral Questions

To ask the Minister for Defence if his attention has been drawn to the Freedom of Information request, released by the British Ministry of Defence in April 2015 which revealed almost 1000 former servicemen and women required psychiatric treatment and are suffering serious mental health problems after being prescribed Lariam; and his plans to review the Irish Defence Forces use of the controversial drug. 
– DEPUTY CLARE DALY.

For ORAL answer on Tuesday, 9th June, 2015.

Ref No: 21352/15 Lottery: 24

REPLY

As the Deputy will be aware, Malaria is a very serious disease. It kills approximately 1 million people per year in sub-Saharan Africa alone. It is a grave threat to any military force operating in that area.
My Department is aware of recent media articles in relation to the Freedom of Information request, released by the British Ministry of Defence to which the Deputy refers. While I appreciate the Deputy raising this matter, the issues relating to the use of Lariam are well documented. With regard to the issue in the U.K. Defence Forces to which you refer, the Irish Military Authorities advise me that it is a matter for individual Defence Forces to determine whichever malaria chemoprophylaxis it deems most suitable for use. Individual Defence Forces may have regard to the operational commitments and the medical and ancillary support available to its personnel on the ground whilst also taking account of the particular licensing regulations in respect of the drug, pertaining to their jurisdiction. It would be inappropriate for the Irish Defence Forces to comment on other Nations policy in this regard.

As you will be aware, the Health Product Regulatory Authority (HPRA) formerly the Irish Medicines Board is the statutory authority with responsibility for quality, safety and efficacy of medicines in Ireland. The Defence Forces policy in regard to the prescribing of Lariam is in line with current HPRA guidelines.

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.

The Defence Forces are fully aware of the range of reported side effects attaching to all anti-malarial medications. Significant precautions are taken by the Medical Corps in assessing the medical suitability of members of the Defence Forces to take any of the anti-malarial medications. The choice of chemoprophylaxis is dependent on a number of factors. These include 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 having regard to the specific circumstances of the mission and the individual member of the Defence Forces.

Former Ministers for Defence have 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.

Lariam must remain in the formulary of medications 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 the most effective protection from the very serious risks posed by this highly dangerous disease.

SIMON COVENEY T.D.
MINISTER FOR DEFENCE

PQ21352/15

QUESTION NO : 137

To ask the Minister for Defence his views in relation to whether he is aware of any under reporting of suspected adverse effects of Lariam by the Defence Forces to the Health Product Regulatory Authority; and if he will make a statement on the matter.
– DEPUTY CLARE DALY.

For ORAL answer on Tuesday, 9th June, 2015.

Ref No: 21354/15 Lottery: 26

REPLY

As the Deputy will be aware, the Health Product Regulatory Authority (HPRA) formerly the Irish Medicines Board is the statutory authority with responsibility for the quality, safety and efficacy of medicines in Ireland. The Defence Forces policy in regard to the prescribing of Lariam is in line with current HPRA guidelines.

While there is no mandatory legal requirement on an individual or medical practitioner to report adverse reactions to any medication, it is open to anyone to report issues relating to safety and quality of healthcare products to the HPRA. This includes patients, carers, other members of the public and healthcare professionals. I can confirm that individual Defence Forces Medical Officers have reported adverse reactions to the HPRA in accordance with standard practice. I understand, based on the latest information that there were three members of the Defence Forces with 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 three of them have made a full recovery and that their cases were reported to the HPRA. Again there is no conclusive evidence that the use of Lariam was a factor in any of these cases.

The HPRA has informed me that to date it has received a total of one hundred and thirteen adverse drug reaction reports relating to the use of Lariam. Of those, I am advised that thirty six reports appear to be associated with current or ex-members of the Defence Forces. However the HPRA advises that these figures are open to an element of duplication due to incomplete material and the manner in which reports are made.

Given that reports can be made directly to the HPRA by individual members of the Defence Forces or health care professionals, I am not aware as to whether any under reporting of suspected adverse effects of Lariam by the Defence Forces members occurs. It should also be noted that the occurrence of an adverse reaction may not always be attributable to a particular medication and may be attributable to other causes.

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.
Former Ministers for Defence have 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.

Lariam must remain in the formulary of medications 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 the most effective protection from the very serious risks posed by this highly dangerous disease.

SIMON COVENEY T.D.
MINISTER FOR DEFENCE

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