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Pharmacy Regulations

Dáil Éireann Debate, Thursday - 27 September 2018

Thursday, 27 September 2018

Questions (131)

David Cullinane

Question:

131. Deputy David Cullinane asked the Minister for Health the evidential research that was used to substantiate the definition of temporary absence for pharmaceutical assistants arrived at by an organisation (details supplied) with the permission of his Department; and if he will make a statement on the matter. [39154/18]

View answer

Written answers

In October 2013 the Council of the Pharmaceutical Society of Ireland (PSI) considered a memorandum from the Registration and Qualification Recognition Committee and the Inspection and Enforcement Committee (Both advisory committees to the Council). It was outlined that during inspections it has been found that some Pharmaceutical Assistants had been working outside the 1994 Code of Practice regarding covering temporary absences. Council of the PSI requested that a policy position be developed to enable and facilitate the drafting of rules in line with the requirements of Section 30(2) of the Act.

In March 2017, the PSI Council considered the matter of temporary absence and a proposed draft set of rules under section 30 of the Act. At this meeting the Council heard a presentation from the Chair of the Pharmaceutical Assistants’ Association, following an invitation. The Council decided to reject the proposal presented at that time and requested further examination of the issue of temporary absence, and what would be covered within the scope of the rules.

A Working Group was established to produce a report, which was submitted to Council on the 17 May 2018. The membership of the Working group was based on competency requirements, and the Group would provide expertise, advice and input to assist in developing policy options, and drafting rules.

The working group comprised of persons combining expertise across the areas of operation of, management of, and supervision of an Retail Pharmacy Business (RPB) including where there is practical use of “temporary absence cover” as currently understood and operated; professional registration and continued competence; regulation; inspection of RPB; risk and quality expertise; public and patient interest/advocacy and policy development.

The Pharmaceutical Assistants Association were invited to nominate a member to the Working Group and nominated its Chairperson.

The terms of reference of the Group (Remit and Terms of Reference of the Group considered and agreed at its first meeting on 21 June 2017) and the competencies of its members are contained in Appendix 2 of the Working Group Report, which is available on the PSI website.

The Working Group Report details the considerations of the group, which were informed by an independent report from UK NARIC benchmarking the Pharmaceutical Assistant qualification, and centred on patient safety, public protection, and risk in proposing how long a pharmacist may be absent from a pharmacy. The Group considered the current legislative provisions pertaining to pharmacists and pharmacies in Ireland under the Pharmacy Act 2007; the governance and accountability requirements provided, and the regulatory framework which provides patients with the expectation of appropriate regulatory protections. Pharmaceutical assistants fall outside the current regulatory disciplinary mechanism with no disciplinary recourse available against the actions taken by any individual pharmaceutical assistant, and outside the mandatory competence assurance schemes notwithstanding that individual registered pharmaceutical assistants would undertake CPD and CE.

The draft Pharmaceutical Society of Ireland (Temporary Absence of Pharmacist from Pharmacy) Rules 2018, were produced on foot of the Working Group Report and were subject to a public consultation process. These draft Rules were approved by the PSI Council on September 20th and have yet to be submitted for my consent as required by the Act.

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