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Dáil Éireann debate -
Tuesday, 13 Feb 2001

Vol. 530 No. 3

Adjournment Debate. - Sale of Medicines.

I thank the Ceann Comhairle for selecting this matter. The sale of paracetamol products must be restricted to pharmacies and the Minister should immediately introduce regulations to provide for this. In 1999, 439 people, 349 males and 90 females, died by suicide. Pharmacists have called on the Government to control the sale of paracetamol because of possible links to suicide. In the US, paracetamol products can only be bought from pharmacists. Ireland and the UK are the only EU countries where the drug can be bought in the corner shop, supermarket or petrol station. Paracetamol poisoning is not a problem in other EU countries where restrictions are in place. In 1999, 1,452 people were discharged from Irish hospitals with a diagnosis of paracetamol poisoning. Of that number, 43 were diagnosed with a liver condition. This is almost double the number of the previous year when 25 were diagnosed with a liver condition.

Paracetamol is a potential killer which can be found in almost every home. It is freely available. I am extremely concerned that there is an epidemic of potentially lethal paracetamol overdoses among young people, especially young women. One study found that the female ratio was 2:1. This has been of concern to doctors and psychiatrists and costs the country a fortune. Yet the public seems blissfully unaware that a drug, which is contained in the bathroom cabinets of most homes, can have such lethal effects.

There are currently 129 medicinal products on the market which contain paracetamol The sale of these products should be confined to pharmacy outlets. At point of sale, advice should be given on the dangers of the drug in terms of overdose. Due to concerns over the serious effects arising from overdoses in paracetamol, the Irish Medicines Board drew up a series of recommendations in 1997 in relation to the sale of paracetamol, including a recommendation that non-pharmacy retail outlets should only carry packs containing not more than 12 500 mg tablets or equivalent. It is a disgrace that three years after this recommendation was made, the Minister for Health and Children has failed to give statutory effect to the recommendations made by the board.

In reply to a parliamentary question I tabled last October, the Minister stated that "regulations to restrict the availability of paracetamol, which would give statutory effect to the recommendations by the Irish Medicines Board, are currently under consideration in my Department". These recommendations have been under consideration for more than three and a half years and it is time the Minister made up his mind to save lives and prevent huge levels of suffering.

In 1999, 3,406 cases of self-inflicted poisonings were recorded, of which 1,003 were diagnosed as paracetamol poisoning. Of these, 315 were male and 688 were female. A reduction in the number of poisonings through the control of paracetamol products would have a significant effect on the number of poisonings.

A total of 25 liver transplants was carried out in Ireland in 1999. It is estimated that half of all liver transplants result from paracetamol poisoning. People have a perception that this is a harmless drug but it can cause severe damage. Taken in small doses, paracetamol is an excellent drug which is broken down in the liver to harmless by-products to be eliminated by the kidneys. However, of the 1,758 cases of hospitalisation in 1999 due to kidney failure, it is estimated that 10% were due to misuse of painkillers. Opponents of restriction suggest that people of suicidal tendencies will obtain drugs elsewhere or use other methods. I do not accept this. Suicidal ideation may be transient. It may be a crisis moment. It is internationally accepted that if one restricts availability of means, one can limit suicide.

A striking reduction in suicide rates occurred in Britain in the mid-1960s. This reduction is thought to have been largely due to the detoxification of the domestic gas supply. Following the discovery of North Sea gas, domestic supplies in Britain were gradually changed from highly toxic coal gas to relatively non-lethal natural gas. In the 1960s, domestic gas poisoning was the most commonly used means of suicide in Britain and its reduced lethality led to a marked reduction in overall suicide rates. Similar changes occurred in Australia with restrictions on barbiturate prescribing, in the USA with the introduction of catalytic converters and in Canada with the introduction of gun control laws.

In his address to the 1998 annual conference of the Irish Association of Suicidology in Castlebar, Dr. David J. Gunnell, senior lecturer in epidemiology and public health medicine at Bristol University, had at the top of his list of six proposals for suicide prevention by the reduction of access to means: "Reduce the quantity of paracetamol and aspirin that may be purchased over the counter."

I thank Deputy Neville for raising this matter and appreciate his concerns about the need to restrict paracetamol products to pharmacies. I am sadly aware that paracetamol overdose still represents one of the most common types of overdose in Ireland.

The current position in regard to the sale of medicinal products containing paracetamol both in pharmacy and non-pharmacy outlets is based on the recommendations of the Irish Medicines Board. As the Deputy is aware, the board is the competent authority for the granting and renewal of product authorisations under the Medicinal Products (Licensing and Sale) Regulations, 1998. These authorisations set out the conditions subject to which medicinal products may be placed on the market. The primary aim is to promote public health by ensuring that medicinal products available to members of the Irish public meet the required standards of safety, quality and efficacy in accordance with the obligation arising from current EU and national legislative requirements.

Due to concerns about the serious effects arising from overdoses of paracetamol, the Irish Medicines Board drew up a series of recommendations in 1997 on the sale of paracetamol, including a recommendation to restrict its sale in non-pharmacy retail outlets to packs containing not more that 12 500 mg tablets or equivalent. Following extensive consultation, almost all of the manufacturers concerned have supported the recommendations and have agreed to conform with them with a view to implementing them in order enhance public safety. However, I am aware of a recent report which indicates that not all non-pharmacy outlets are complying with the board's recommendations and this is a matter of concern to me.

Regulations to restrict the availability of paracetamol, which would give statutory effect to the recommendations of the Irish Medicines Board, are currently under consideration in the Department. These recommendations relate to pack size and availability in both pharmacy and non-pharmacy outlets and will, as outlined, subject packs of paracetamol above a particular size to pharmacy only or prescription only control, as appropriate. I understand the majority of manufacturers already operate within these guidelines in anticipation of the introduction of the new regulations.

The draft regulations are at an advanced stage and I will take the steps necessary to ensure their completion at an early date. I will also take on board the other points made by the Deputy in regard to the broader issue of suicide.

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