Thursday, 20 September 2012
Defence Forces Medicinal Products
To ask the Minister for Defence the number of legal proceedings that have been initiated against his Department concerning the prescription of Lariam to members or former members of the Defence Forces. [39496/12]
I propose to take Questions Nos. 8 and 26 together.
Malaria is a serious disease which can cause serious complications and death. It is estimated by the World Health Organization that approximately 1 million people die every year from malaria in sub-Saharan Africa alone. It has long been recognised as being a serious threat to any military force operating in a malarious area.
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 indicated that it is one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa. Whereas certain risks associated with the use of the drug were highlighted in drug safety newsletters in 1996 and 2003, the IMB 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 IMB. In accordance with best international practice in prescribing Lariam 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, such as depression, anxiety and other disorders 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 a 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 the liver is healthy, as liver disease is an accepted contra-indication to the use of Lariam.
It is the policy of the Defence Forces medical corps that personnel found suitable for Lariam should commence their medication three to four weeks in advance of their travel. This precaution allows a slow build up of the medication in the bloodstream and it also permits assessment by the person of the individual reaction to the medication while still in Ireland. Personnel are screened both before and after deployments and all necessary actions are taken to ensure those with contra-indications to Lariam use are not prescribed the medication.
To date, legal proceedings have been served against the Minister for Defence in five cases concerning the prescription of Lariam. These claims are being managed by the State Claims Agency in conjunction with the Chief State Solicitor's office. Given that legal proceedings have been served, the Deputy will appreciate that it would not be appropriate to comment further on individual cases.
I thank the Minister of State for the response. There is ongoing international controversy, not least in the United States, about the impact of this particular drug. I welcome the Minister of State's assurances that the position within the Defence Forces is being carefully monitored. One cannot but be a little amused at the idea that anxiety is one of the symptoms doctors check in soldiers going overseas on peacekeeping missions. It would be unlikely to find many who would not be a bit anxious at the prospect of going to Chad, Syria or Lebanon.
I took Lariam in the mid-1990s before a trip to Africa and suffered no ill-effects. The Minister of State has indicated there are five legal cases concerning the administration of the drug. My understanding is that three personnel presented with some serious side-effects and they received treatment and were improving. Whatever about the five indicated cases, is the Minister of State or others in the Department aware of other pending cases? Has there been a significant number of inquiries to the Department about possible claims in this regard?
If it is the case that some Defence Forces personnel are determined to be unsuited to the use of this particular drugs, with possible substitute drugs that have no concerns surrounding them, why is it that the Defence Forces do not administer the alternative product to all personnel rather than continuing to use Lariam? As I noted, use of the drug seems to be causing concern internationally.
I have explained that, to date, legal proceedings have been served against the Minister for Defence in five cases concerning prescription of Lariam. These claims are being managed by the State Claims Agency in conjunction with the Chief State Solicitor. Given the legal proceedings served, I will not comment further on any individual cases. I am personally unaware of any other potential cases.
The Deputy asked why the US forces have stopped using Lariam.
My understanding is that the US forces have stopped using the medication due to concerns about inadvertent prescription of the drug to soldiers who should not take it. In this regard, I am advised that the US authorities undertook mass administration of Lariam to soldiers serving in areas subject to malaria without individual screening of personnel. The Defence Forces do not mass prescribe the drug but rather follow the instructions issued by the IMB, fully screening personnel who may potentially have an adverse reaction to the medication.
We are advised by the IMB and the World Health Organization that Lariam is the most effective drug to be prescribed to any member serving in malaria-stricken areas. We are following the medical advice received. The drug's use was first authorised in 1989 by the IMB and it continues to be authorised as a very effective drug.
I knew one had been issued but was unaware it had been served. Does the Minister of State know of any other proceedings that may follow and has an assessment been done of the potential outlay to be borne by the State if the cases are successful?
I am unaware of any other cases. I have been told five cases have been referred to the Chief State Solicitor, who will deal with the issue. If I become aware of any other cases I will pass the information to the Deputy. There is a Lariam action group which was set up to deal specifically with this issue, and the Minister has met its representatives twice, in May 2011 and February 2012.
He expects to meet them again after he receives the final report from the working group on malaria. I have no doubt this will happen shortly. If I become aware of information, I can pass it on to the Deputies.
My question is on the risk-benefit profile. From my reading of this, there is great disparity in the suggested risks from one in 10,000 to other experts stating it could be as high as one in 140. Were this latter figure to be the case, the potential risk to our Defence Force members is enormous. Has the Irish Medicines Board, in consultation with the Department of Defence, investigated alternative preparations that might be provided to deal with the risk of malaria?
The claims are being managed by the State Claims Agency in conjunction with the Office of the Chief State Solicitor and these are the five cases involving the Defence Forces. I hope the Deputy appreciates I cannot comment on any individual case. The Minister has met the support group on two occasions. As soon as the final report is published, he will meet them again.
Deputy Ó Fearghaíl asked whether other antimalarial drugs have been approved for use. Three other antimalarial medications are available. However, there are specific reasons for each of these products not being suitable for use by the Defence Forces in sub-Saharan Africa. Chloroquine is no longer in use because of the development of widespread resistance. Doxycycline must be taken in the absence of dairy products. It also produces some sensitivity to sun and sun rashes in some individuals. This is particularly significant when used in very sunny climates and 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 by the Irish Medicines Board to be used for no more than 28 continuous days. In this context, the prophylactic agent is suitable only for use where overseas deployment does not exceed 28 days. These are some of the reasons lariam remains the antimalarial agent of choice where malaria is virulent. Advice has been sought from the Medicines Board and the World Health Organization.