Noel Rock (Dublin North West, Fine Gael)
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366. To ask the Minister for Health his views on the regulation issued by the Health Products Regulatory Authority, HPRA, that medicine packs containing more than 720mg of pseudoephedrine will not be available without a prescription and that all pharmacy sales of all medicines containing pseudoephedrine will be limited to one pack per transaction; and if he will make a statement on the matter. [29292/16]

Simon Harris (Wicklow, Fine Gael)
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Pseudoephedrine is an active ingredient in non-prescription cough and cold medicines and acts as a decongestant. These medicines are intended for short-term use.

Pseudoephedrine is also a precursor material in the production of methamphetamine. Methamphetamine is a dangerous, highly addictive controlled drug which is associated with fatalities and a high risk of causing harm.

The diversion of pseudoephedrine containing medicines for use in the illicit manufacture of methamphetamine is a significant problem in countries such as the USA and Australia and this has led to the implementation of measures to limit the access to non- prescription pseudoephedrine.

The Health Products Regulatory Authority (HPRA) has implemented two risk minimisation measures in relation to the sale and supply of pseudoephedrine containing medicines in Ireland:

- A maximum quantity of 720mg pseudoephedrine per pack is now permitted to be included in packs intended for sale in pharmacies without a prescription. Packs containing more than 720mg would only available subject to a prescription; and

- Pharmacy sales of all pseudoephedrine containing medicines are limited to one pack per transaction.

These conditions have been added to the licences of all relevant pseudoephedrine containing medicinal products.

A number of other EU Member States have also taken action, with the UK and Germany implementing similar restrictions, whilst the Czech Republic has limited sales to one pack of pseudoephedrine containing medicine, per person, per week. In certain other Member States, including Sweden, Finland and Norway, pseudoephedrine is a prescription only medicine and not available over the counter.

Noel Rock (Dublin North West, Fine Gael)
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367. To ask the Minister for Health if he will consider making more medications available over the counter rather than prescription based in an effort to lower medical costs; and if he will make a statement on the matter. [29293/16]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland and is responsible for determining their method of sale and supply. EU and Irish law lays out the circumstances under which a medicine must be subject to a prescription, including consideration of the risk of side effects if a medicine is used without medical supervision or the risk of incorrect or misuse of a medicine.

Medicines may be classified on the basis of their availability i.e. subject to a prescription or available without a prescription (over-the-counter). In Ireland, over-the-counter medicines are further classified as being: available only from a pharmacy and are sold by, or under the personal supervision of, a pharmacist; or on general sale where the product is more widely available in general retail outlets such as supermarkets.

In 2014 the HPRA introduced a revised approach in the area of medicines reclassification. The HPRA proactively identified medicines which could be safely made available without prescription in pharmacies, or made more widely available in general retail outlets, and directly invited the industry to make applications to have these medicines reclassified.

A reclassification from prescription-only to pharmacy-only supply will always require an application to be made by the marketing authorisation holder of the medicine due to the legal requirement to provide product information that is suitable for non-prescription supply. A reclassification from pharmacy-only to general sale may be acceptable if the current product information is suitable for use without the supervision of a pharmacist.

Over the past two years, 19 reclassifications from prescription-only to pharmacy-only status have been approved. This has extended the range of medicines available without prescription through pharmacies. Furthermore, 34 medicines have been reclassified from pharmacy-only to general sales status.

In addition to the proactive approach outlined above, a marketing authorisation holder can at any stage directly make an application to the HPRA for reclassification of a medicine without an invitation to do so. Applications of this nature continue to be received by the HPRA as part of routine business.

The HPRA also continues to review other substances that may be considered suitable for reclassification in order to maintain its proactive approach and has actively encouraged the industry to consider the submission of applications for innovative reclassifications.