Dáil Éireann Debate, Tuesday - 26 July 2022
1888. Deputy David Cullinane asked the Minister for Health if he will ensure access to gina 10 microgram vaginal tablets for postmenopausal women from their local pharmacies without requiring a prescription in Ireland; if training material and a checklist will be available for pharmacists that will enable them to provide proper advice to women; and if he will make a statement on the matter. [41010/22]
View answerHaving consulted with the Health Products Regulatory Authority (HPRA) and the Pharmaceutical Society of Ireland (PSI) I can confirm that, Gina (estradiol hemihydrate) 10 microgram vaginal tablets, indicated for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above and who have not had a period for at least 1 year, are not currently authorised for sale or supply in Ireland.
However, a similar medicine, Vagifem (estradiol hemihydrate) 10 microgram vaginal tablets, is authorised for sale or supply in Ireland as a prescription medicine for a different indication: the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women.
The process for changing the classification status of a medicine from prescription-only supply to non-prescription supply, is that the company holding the authorisation (marketing authorisation holder, MAH) for the medicine makes an application, including data justifying the change, to the HPRA (or European Medicines Agency for medicines authorised by the European Commission). If the medicine is not authorised, a company may wish to make a new application for a marketing authorisation for a non-prescription medicine. If, following assessment, the benefit/risk of application is considered positive by the HPRA, the method of sale and supply is approved and updated on the HPRA website, and the product can be supplied without prescription.
Unauthorised or exempt medicinal products can only be dispensed from a pharmacy on foot of a prescription in accordance with the specifications of a practitioner for use by their individual patients under their direct personal responsibility, in order to fulfil the special needs of their patients. This exemption is provided for in Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007)(as amended).
With regard to the requirements on pharmacists when supplying medicines on foot of a prescription, Regulation 9 of the Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008) (as amended) provides a legislative basis for the therapeutic and pharmaceutical review that must be undertaken by a registered pharmacist upon receipt of a prescription. In addition, under Regulation 9 a registered pharmacist must ensure that each patient has sufficient information and advice for the proper use and storage of the prescribed medicinal product and must offer to discuss with the patient all such matters as the pharmacist, in the exercise of their professional judgment, deems significant. To facilitate compliance by pharmacists with the requirements of Regulation 9 as they apply to the sale and supply of prescribed medicinal products the PSI has issued Guidelines on the Counselling and Medicine Therapy Review in the Supply of Prescribed Medicinal Products from a Retail Pharmacy Business.
