Written answers

Thursday, 25 October 2012

Department of Health

Medicinal Products

Photo of Aengus Ó SnodaighAengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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To ask the Minister for Health if consideration has been given to making it compulsory for ID to be produced for everyone purchasing medical products containing pseudo ephedrine, that all such products are stored out of customers' reach and that a doctor prescription will be required for all products containing more than 800mg of pseudo ephedrine per pack as is the case in Australia [46922/12]

Photo of Aengus Ó SnodaighAengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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To ask the Minister for Health the plans, if any, he has of rolling out a drug awareness programme aimed at pharmacists in particular to increase vigilance about pseudo ephedrine and the production of methamphetamine crystal meth [46924/12]

Photo of Alex WhiteAlex White (Dublin South, Labour)
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I propose to take Questions Nos. 235 and 236 together.

Pseudoephedrine is a nasal decongestant contained in many cough and cold medicines. Under the Medicinal Products (Prescription and Control of Supply) Regulations, pseudoephedrine is listed as a prescription medicine which may, in limited circumstances, be supplied without a prescription. It may only be supplied without a prescription from a pharmacy, by or under the personal supervision of a pharmacist. In addition, it may only be supplied if the maximum daily dose that a patient would consume is less than 240mg per day in the case of pseudoephedrine hydrochloride products and 180mg per day in the case of pseudoephedrine sulfate products. The maximum dose of pseudoephedrine products which may be supplied without a prescription is 60 mg.

Irish medicines legislation does not currently limit the pack size of pseudoephedrine which may be supplied to a person without prescription. There is a range of pack sizes available covering solid dosage forms and liquid formulations. The maximum size authorised on the Irish market for over the counter sale is 32 tablets of 30mg pseudoephedrine/tablet (or 960mg total quantity per pack). Regarding the liquid preparations the maximum authorised pack size in Ireland is 200mls which contains a total quantity of 450mg pseudoephedrine per pack.

Pseudoephedrine products are useful and effective medicines for the treatment of symptoms of cold and flu or sinusitis. Restriction of pseudoephedrine to prescription control would require patients to visit a doctor for management of self-treatable conditions, placing additional financial burdens on patients and increased demand for GP services.

In recognition of the concern that pseudoephedrine can be used in the illicit manufacture of methylamphetamine (commonly known as “methamphetamine”, “crystal meth” or “ice”), professional guidance was issued by the Pharmaceutical Society of Ireland (PSI) to pharmacists in relation to sales of pseudoephedrine-containing products in September 2012. PSI guidelines to pharmacists recommend that the pharmacist should identify an appropriate and secure location in the pharmacy to store pseudoephedrine products, that requests for these products should be referred to the pharmacist personally and that pharmacists should use their professional judgment and discretion in deciding whether a genuine clinical need exists for the medicine and that the medicine is appropriate for the patient. Community pharmacists exercise professional judgment and can refuse to supply pseudoephedrine-containing products if deemed necessary.

The benefits and risks of all medicines are assessed by the Irish Medicines Board (IMB) on an ongoing basis, with changes to the product information and new recommendations/restrictions applied as appropriate, on the basis of new and emerging safety information. The situation regarding pseudoephedrine is being monitored closely by the Department, IMB, PSI and the other relevant agencies.

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