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Medicinal Products Licensing

Dáil Éireann Debate, Wednesday - 11 March 2015

Wednesday, 11 March 2015

Questions (105)

Ruth Coppinger

Question:

105. Deputy Ruth Coppinger asked the Minister for Health if he will change the status of NorLevo (details supplied), currently licensed by the Health Regulatory Association, as being available only from behind the counter in pharmacies to allow women to avail of the product without the required consultation and approval of a pharmacist; and his views on the matter [10686/15]

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Written answers

Since 2011, a number of levonorgestrel products, including Norlevo, have been reclassified from ‘prescription only’ to ‘pharmacy only’ supply for use as emergency contraception. This reclassification which increases public access to these medicines has been considered appropriate in light of the role of the pharmacist in ensuring the safe supply and correct use of these products. Without this essential input these medicines would continue to be available by prescription only and would not be readily accessible to patients through pharmacies.

The pharmacist is in a position in this context to provide advice and support with regard to this and related matters including advice on long-term contraceptive methods and information on sexually transmitted infections. This provides an opportunity for patients, should they require it, to access the advice and support of a trained healthcare professional, in a private and confidential setting, and further referral to a medical practitioner if necessary. Pharmacists provide a robust clinical service in assessing each patient’s suitability for the supply of levonorgestrel, screening for any potential drug interactions, side effects and co-morbidities. This is done to ensure that the health, well-being, care and safety of the patient is supported and maintained.

The Pharmaceutical Society of Ireland (PSI), the statutory body, to regulate the practice and profession of pharmacy in Ireland has issued a guidance document ‘PSI Guidance for Pharmacists on the Safe Supply of Non-Prescription Medicinal Products Containing Levonorgestrel 1500mcg for Emergency Hormonal Contraception’, which provides guidance for pharmacists in fulfilling their professional responsibilities in the supply of these medicines. The guidance document was reviewed, updated and circulated to the profession in February 2015 and is available on the PSI website.

Due to the nature of this medicinal product, its therapeutic indication and its potential for drug interactions and side effects, the supply of levonorgestrel by a pharmacist is deemed an appropriate and robust mechanism to ensure the safety of patients is assured, whilst facilitating patient access to these medicines in a timely manner.

The sale and supply of levenorgestrel for the indication of emergency contraception is also confined to pharmacies in other EU Member States.

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