Written answers

Tuesday, 25 November 2008

Department of Health and Children

Medicinal Products

10:00 pm

Photo of Brian O'SheaBrian O'Shea (Waterford, Labour)
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Question 110: To ask the Minister for Health and Children if she has plans to address the growing problem of addiction to legal drugs here; and if she will make a statement on the matter. [42444/08]

Photo of Mary HarneyMary Harney (Dublin Mid West, Progressive Democrats)
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The Medical Products (Control of Placing on the Market) Regulations, 2007 (SI No. 540 of 2007) requires that all medicinal products (drugs) must be authorised by the Irish Medicines Board prior to being placed on the market in Ireland. During the assessment of a medicinal product, the IMB determines the appropriate classification and route of sale. Medicinal products that, if used incorrectly, are likely to present a substantial risk of abuse or to lead to addiction are confined to prescription control.

In addition, the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (SI No. 540 of 2003, and amendments) regulate the prescription and dispensing of medicinal products. Under these Regulations, the product information (summary of product characteristics [SPC] and package leaflet [PL]) for medicinal products must contain detailed information, including relevant warnings and precautions relating to the use of the product. For example, the benzodiazepine class of drugs including Valium (diazepam) are subject to prescription and the PL states that prolonged use may lead to tolerance. The PL also states that Valium is intended for short term treatment (2-4 weeks) and that it is not suitable for long term use. Using the drug in this way reduces the risk of dependence.

In relation to medicinal products that are available without a prescription i.e. over the counter, (OTC) medicines, these also include detailed information regarding their use and relevant warnings and precautions in the PL provided with the product. In the case of OTC medicines which can carry a risk of dependence, the PL must include explicit warning statements regarding the risk of physical and psychological dependence (addiction). The IMB has highlighted the importance of doctors and pharmacists discussing the use of all medications, including non-prescribed medicinal products, with patients/consumers, including the need to strictly adhere to the recommended dosage and duration of use and to avoid prolonged use, which is associated with dependence.

The Misuse of Drugs Acts 1977 and 1984 and the Regulations made thereunder regulate the prescription and dispensing of controlled drugs. Following concerns about over prescribing of a category of controlled drugs, the Benzodiazepine Working Group reported in 2002. Good Practice Guidelines for GPs on the prescribing of benzodiazepines were circulated and GPs can now monitor their own prescription of benzodiazepines against prescription by their peers. In addition the Irish College of General Practitioners has a training module on the prescribing of benzodiazepines in place.

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