David Cullinane (Waterford, Sinn Fein)
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130. To ask the Minister for Health the definition of temporary absence arrived at by an organisation (details supplied) with the permission of his Department in the case of pharmaceutical assistants; and if he will make a statement on the matter. [39153/18]

Simon Harris (Wicklow, Fine Gael)
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Under the Pharmacy Act 2007 the sale and supply of medicinal products must be carried out by or under the personal supervision of a registered pharmacist at all times. Section 30 of the Act allows however for an exceptional circumstance where a registered pharmaceutical assistant may act on behalf of a registered pharmacist during the temporary absence of the registered pharmacist.

In the circumstances provided for in Section 30 of the Act the PSI, subject to the consent of the Minister, may define for how long a pharmacist may be temporarily absent from a pharmacy and what may be done in this absence in circumstances where a registered pharmaceutical assistant acts in the temporary absence.

On Thursday, 20th September 2018, the Council of the PSI, the pharmacy regulator, approved proposed draft rules regarding the length of time that it is permissible for a pharmacy to operate in the absence of a pharmacist.

I understand that the draft statutory rules– Pharmaceutical Society of Ireland (Temporary Absence of a Pharmacist from a pharmacy) Rules 2018– propose that a pharmacist may be absent from a pharmacy for a total one hour per day only, and in these circumstances a registered pharmaceutical assistant may act in the temporary absence of the pharmacist.

Although the draft rules as approved by the Council rules are publically available, under the Act I, as Minister, must await the receipt of the Rules for my consideration from the PSI and until that time I am unfortunately not in a position to discuss the matter raised any further.

David Cullinane (Waterford, Sinn Fein)
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131. To ask 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]

Simon Harris (Wicklow, Fine Gael)
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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.

David Cullinane (Waterford, Sinn Fein)
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132. To ask the Minister for Health the tasks a pharmaceutical assistant may not perform during their temporary absence; and if he will make a statement on the matter. [39155/18]

Simon Harris (Wicklow, Fine Gael)
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A clinical governance framework governing the operation of registered Retail Pharmacy Businesses is created by Sections 26, 27, 28 and 29 of the Pharmacy Act 2007, and Regulations made under Section 18 of the Act further elucidate the specific responsibilities of the pharmacy owner, the superintendent pharmacist, the supervising pharmacist and the registered pharmacist.

Under the Pharmacy Act 2007 the sale and supply of medicinal products must be carried out by or under the personal supervision of a registered pharmacist at all times. Section 30 of the Act allows however for an exceptional circumstance where a registered pharmaceutical assistant may act on behalf of a registered pharmacist during the temporary absence of the registered pharmacist.

Section 30 (2) (a) provides for what may or may not be done by a registered pharmaceutical assistant when acting on behalf of a registered pharmacist in his/her temporary absence.

I understand that the proposed draft Pharmaceutical Society of Ireland (Temporary Absence of Pharmacist from Pharmacy) Rules 2018 rules allow for the Council to approve and publish a professional task list; this task list has not yet been defined by the Council. The draft Pharmaceutical Society of Ireland (Temporary Absence of Pharmacist from Pharmacy) Rules 2018 were approved by the PSI Council on September 20^thand have yet to be submitted for my consent as required by the Act.

The current activity of a pharmaceutical assistant when providing skilled assistance to a pharmacist, is subject to the governance mechanisms instituted by each superintendent pharmacist in the pharmacy practice which determines the parameters of the professional activity undertaken.

Legislation precludes pharmaceutical assistants from providing vaccinations to patients, or from undertaking the governance roles provided for in the Pharmacy Act 2007 (supervising and superintendent pharmacists) when operating in the temporary absence of the pharmacist.

David Cullinane (Waterford, Sinn Fein)
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133. To ask the Minister for Health the conflicts that arise between the definition of temporary absence arrived at by an organisation (details supplied) with the permission of his Department for use with pharmaceutical assistants and public safety issues; and if he will make a statement on the matter. [39156/18]

Simon Harris (Wicklow, Fine Gael)
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The Pharmacy Act 2007 creates a framework whereby patients and members of the public can expect that a pharmacist will be available and practising within a pharmacy when they visit to have medicines dispensed or to obtain advice on a health or medicines matter. The Act provides a robust structure of public safety assurance by requiring that the pharmacist is subject to mandatory CPD, Fitness to Practice, a Code of Conduct and a Core Competency Framework.

A clinical governance framework governing the operation of registered Retail Pharmacy Businesses is created by Sections 26, 27, 28 and 29 of the Pharmacy Act 2007, and Regulations made under Section 18 of the Act elucidates the specific responsibilities of the pharmacy owner, the superintendent pharmacist, the supervising pharmacist and the registered pharmacist.

Under the Pharmacy Act 2007 the sale and supply of medicinal products must be carried out by or under the personal supervision of a registered pharmacist at all times. Section 30(1) of the Act allows however for an exceptional circumstance where a registered pharmaceutical assistant may act on behalf of a registered pharmacist during the temporary absence of the registered pharmacist.

In this context, Section 30 (2) permits the Council of the PSI, subject to the consent of the Minister, to make rules to provide further as to:

1. What may or may not be done by a registered pharmaceutical assistant when acting on behalf of a registered pharmacist; and

2. What constitutes the temporary absence of a registered pharmacist.

It is in the interest of good regulation, using the framework available, that the Council of the PSI has undertaken to propose the draft Pharmaceutical Society of Ireland (Temporary Absence of Pharmacist from Pharmacy) Rules 2018.