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Pharmacy Regulations

Dáil Éireann Debate, Thursday - 15 May 2014

Thursday, 15 May 2014

Questions (233, 234, 235, 236)

Paudie Coffey

Question:

233. Deputy Paudie Coffey asked the Minister for Health if Ireland is in compliance with the quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients in view of the European Pharmacopoeia monograph on pharmaceutical preparations (2619) which came into force on 1 April 2013; and if he will make a statement on the matter. [21935/14]

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Paudie Coffey

Question:

234. Deputy Paudie Coffey asked the Minister for Health if community pharmacy premises and processes have to adhere to the standards of European Pharmacopoeia monograph 2619 regarding extemporaneous compounding; if community pharmacists and their staff will have the required facilities to prepare extemporaneous products; the way these preparations are verified and-or certified; and if he will make a statement on the matter. [21936/14]

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Paudie Coffey

Question:

235. Deputy Paudie Coffey asked the Minister for Health in the interest of patient safety, if a community pharmacist outsources manufacture of an extemporaneous product to an IMB GMP approved facility, if these products are reimbursed by the Health Service Executive under the State schemes like other medicinal products; and if he will make a statement on the matter. [21937/14]

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Paudie Coffey

Question:

236. Deputy Paudie Coffey asked the Minister for Health if there was an incident here similar to the Peppermint Water Case in the UK, when the wrong strength of chloroform water was used in an extemporaneous preparation and given to a baby who died; and the repercussions there would be for community pharmacists, the pharmaceutical industry, the Pharmaceutical Society of Ireland or the Irish State, if Ireland is not in compliance with EP 2619. [21938/14]

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Written answers

I propose to take Questions Nos. 233 to 236, inclusive, together.

Ireland is in compliance with the Council of Europe Monograph (2619) on Pharmaceutical Preparations, and also of the Council of Europe Resolution (2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients.

Pharmacists were notified of the coming into force of the Monograph and the Resolution by the Pharmaceutical Society of Ireland (PSI) by means of the PSI Newsletter of March 2013 and PSI guidance to pharmacists is in compliance with the principles of both the Monograph and the Resolution.

The Medicinal Products (Control of Placing on the Market) Regulations 2007 permits the manufacture of extemporaneously prepared medicinal products by pharmacists in certain limited circumstances:

- in response to a bona fide unsolicited order of a practitioner (i.e. on foot of a prescription), where the medicinal product is for an individual patient under the prescribing practitioner’s care; or

- in response to a request from a patient where the extemporaneously produced medicinal product is not subject to prescription-only control and is produced in the pharmacy in accordance with the specifications of the Pharmacopoeia. In Ireland only the European Pharmacopoeia and British Pharmacopoeia are official and as such are the only pharmacopoeias that are relevant for this purpose.

Under the Pharmacy Act 2007, the Regulation of Retail Pharmacy Businesses Regulations 2008 and PSI guidance, pharmacists and pharmacies are required to have comprehensive equipment, policies and procedures in place to facilitate the safe preparation supply of extemporaneous preparations of an appropriate quality and standard. The Act also provides for a robust regulatory system for Pharmacists and registered Retail Pharmacy Businesses. All Retail Pharmacy Businesses in Ireland are registered with and inspected by the PSI. In the event of an incident involving an extemporaneously produced medicinal product there is a comprehensive disciplinary process in place under which a complaint may be made to the PSI in relation to a Pharmacist and/or a Pharmacy.

A pharmacist, who receives a prescription for a medicinal product should only supply an extemporaneously prepared product when an authorised version of the product, or of a suitable authorised alternative, is not available. Pharmacists should also consider the urgency of the situation and endeavour to supply the prescribed product within an appropriate time-frame. The health and safety of the patient is the primary concern of pharmacists and pharmacists must be satisfied that an extemporaneously prepared medicinal product is of appropriate quality and safety and has been prepared under appropriate conditions.

The fee structure relating to extemporaneous preparation and compounding in Schedule 3 of the Health Professionals (Reduction of Payments to Community Pharmacy Contractors) Regulations 2013 makes no provision for outsourcing the manufacture of an extemporaneous product to an IMB GMP approved facility.

My Department is unaware of any public health concern relating to extemporaneous preparation that would require to be addressed outside of the scope of the PSI’s statutory framework as set out above.

Question No. 237 answered with Question No. 231.
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