Seán Crowe (Dublin South West, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

849. To ask the Minister for Health if his Department entered into discussions with the Department of Defence, before the mass issuing of Mefloquine-Lariam by the Defence Forces in 2001; and if his Department provided the Department of Defence with any guidelines regarding possible side effects in relation to Mefloquine-Lariam. [38338/15]

Seán Crowe (Dublin South West, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

850. To ask the Minister for Health if the Health Service Executive and-or the Health Products Regulatory Authority entered into discussions with the Department of Defence, before the mass issuing of Mefloquine-Lariam by the Defence Forces in 2001; and if the executive and-or the authority provided the Department of Defence with any guidelines regarding possible side effects in relation to Mefloquine-Lariam. [38339/15]

Kathleen Lynch (Cork North Central, Labour)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 849 and 850 together.

I am advised that there is no record of discussions between my Department or the Health Service Executive (HSE) with the Department of Defence prior to the decision to use Mefloquine/Lariam. The Health Products Regulatory Authority (HPRA), the statutory authority with responsibility for the quality, safety and efficacy of medicines in Ireland, has advised that they are not aware of any specific discussions with the Department of Defence in this regard but cannot provide a definitive reply at short notice as there may be correspondence in archived files.

In addition, no guidelines for clinical use were provided by my Department, the HSE or the HPRA to the Department of Defence.

When any medicine is authorised it is issued with specific approved product information. This consists of the summary of product characteristics (SmPC), which is the legal licence for that medicine, a package leaflet (PL) and the labelling (outer carton). An SmPC is a document for healthcare professionals which contains all the known information available about a particular medicine at a given time, including information on how to use that medicine safely. It is updated on an ongoing basis and at any stage of the life cycle of a medicine whenever new information becomes available about it. The corresponding document for patients is the package leaflet (PL). The PL is required to be presented in patient-friendly language and is subject to user testing. The SmPC and PL for Mefloquine/Lariam are available on the HPRA website.

My Department is advised that a medical risk assessment is carried out on an individual basis and there has been no mass issuing of Mefloquine/Lariam by the Defence Forces. The question of the prescribing procedures followed in the Defence Forces is a matter which should be addressed to the Minister for Defence and I understand that the Minster for Defence addressed this question from the Deputy in responding to parliamentary questions on the 8 October, 2015.