Written answers

Tuesday, 7 November 2017

Department of Health

Pharmacy Regulations

Photo of Bríd SmithBríd Smith (Dublin South Central, People Before Profit Alliance)
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798. To ask the Minister for Health to ensure there will be no changes to the definition of temporary absence of a pharmacist in view of the fact that some proposed changes could have dramatic effects on the working arrangements of pharmaceutical assistants who have experience and skill at their jobs; and if he will make a statement on the matter. [46756/17]

Photo of Catherine ByrneCatherine Byrne (Dublin South Central, Fine Gael)
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Pharmaceutical Assistants (PAs) are registered with the pharmacy regulator, the Pharmaceutical Society of Ireland (PSI). Under section 30(1) of the Pharmacy Act 2007 (the Act) PAs may perform the same functions as a pharmacist, in the temporary absence of a pharmacist, with the exception of functions that are restricted to pharmacists under specific medicines legislation, such as vaccination services. Since 1994, the provisions of "temporary absence" have been understood with reference to a Code of Practice agreed that year between the PSI and the Pharmaceutical Assistants' Association (PAA).

Section 30(2) of the Pharmacy Act 2007 provides that the PSI Council may make Rules, with the consent of the Minister, to provide further as to what constitutes the temporary absence of a registered pharmacist and what may or may not be done by a PA when acting on behalf of a pharmacist. In 2013, the PSI Council directed that a policy position be developed to enable and facilitate the drafting of rules relating to the circumstances in which a registered PA may act in the temporary absence of a registered pharmacist in line with the requirements of Section 30(2) of the Act. The PSI Registration and Qualification Recognition Committee (RQR) was assigned responsibility to progress this work. A Pharmaceutical Assistant was sought to join this Committee and was appointed by the PSI Council in March 2014.

The PSI developed the draft Pharmaceutical Society of Ireland (Regulation of Temporary Absence Cover by Pharmaceutical Assistants) Rules 2016 following debate and engagement with interested parties including the Pharmaceutical Assistants Association (PAA). The draft Rules were issued for public consultation on 8 February 2016. Following discussion at the PSI Council meeting of 23 March 2017, and taking account of the responses received through the consultation process, the Council decided not to submit the draft Rules to me for approval. The Council instead directed that the matter be re-examined by the PSI Executive with further consideration to be given to what could be covered within the scope of the Rules. In making its decision at this meeting the Council confirmed that the current approach to regulating temporary absence by PSI inspection staff under the 1994 Code of Practice would continue to apply pending the future adoption of statutory Rules.

A working group consisting of 6 persons (two Council members, two PSI staff members, and two external participants - a Pharmaceutical Assistant and a person with regulatory and risk expertise) was then established to provide expertise, advice and input to assist in developing policy options and drafting rules. To date this group has met three times, and I understand the group will recommend a position to the Councilin the coming months.

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