David Cullinane (Waterford, Sinn Fein)
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1782. To ask the Minister for Health the number of staff employed by the Pharmaceutical Society, by grade, in tabular form; the number of staff employed for inspections of retail pharmacy businesses and the wider number involved in assessing compliance of retail pharmacy businesses; and the number of staff involved in enforcement actions or actions otherwise taken to address poor practice, behaviour, or performance taken against retail pharmacy businesses. [18270/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Department of Health has confirmed the following information with the PSI:

PSI sanctioned post headcount by business area

Community Pharmacy Assurance (made up of Registrant and Customer Relations, Community Pharmacy Quality and Safety, and Investigations teams)

Practitioner Assurance (made up of Professional Standards and Fitness to Practise and Legal Affairs teams)

Strategic Policy and Communication

Corporate Services

Governance and Programme Delivery

Office of the Registrar

David Cullinane (Waterford, Sinn Fein)
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1783. To ask the Minister for Health the number of inspections of retail pharmacy businesses conducted by the Pharmaceutical Society in each year since establishment, by purpose, in tabular form. [18271/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Pharmaceutical Society of Ireland (PSI), the pharmacy regulator, is a public body established under the Pharmacy Act 2007 (‘the Act’) to protect the health, safety and well-being of patients and the public by regulating pharmacists and pharmacies in Ireland.

Under the Pharmacy Act 2007, the PSI’s responsibilities include:

- Regulating the profession of pharmacy in the State, having regard to the need to protect, maintain and promote the health and safety of the public

- Supervising compliance with the Act and the instruments made under it.

Amongst the regulatory actions the PSI takes, it inspects pharmacies to assess compliance with the Pharmacy Act 2007, guidelines, and good pharmacy practice. The inspection function aims to promote good and safe pharmacy practice within pharmacies and promote and ensure high standards of compliance with legislative requirements, guidelines, best practice requirements and the Statutory Code of Conduct for Pharmacists. Pharmacy inspections may be carried out on a notified or unnotified basis.

The Department of Health has confirmed the following information with the PSI:

There are currently 1,987 pharmacies on the Register of Retail Pharmacy Businesses (Statistics and Data - PSI (thepsi.ie)). The number of pharmacies registered with the PSI in 2007 was 1,628 (PSI Annual Report 2007). This includes community pharmacies and pharmacies within hospitals.

The PSI Inspection & Enforcement Policy is available here.

Table 1 shows the number and types of inspection visits conducted by PSI.

Table 1

[1] Between February and June 2017, PSI inspectors visited 1,826 registered pharmacies to conduct advisory visits and to answer questions in support of the introduction of the Pharmacy Assessment System, as a self-audit tool in pharmacies

PSI introduced COVID-19 Operational Standards for the retail pharmacy sector in 2020. During the ‘use and learn’ phase, pharmacies volunteered to participate in a standards assessment visit with PSI authorised officers.

David Cullinane (Waterford, Sinn Fein)
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1784. To ask the Minister for Health the number of enforcement actions, or actions otherwise taken to correct or address poor practice, behaviour, or performance by pharmacists or by pharmacies, taken by the Pharmaceutical Society against retail pharmacy businesses in each year since establishment, by action type and grounds, in tabular form. [18272/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Enforcement - Consideration by the Registrar of inspection/investigation reports under Section 71 of the Pharmacy Act

The PSI protects the health and safety of the public by carrying out inspections and investigations of pharmacies. Occasionally, significant matters are identified during an inspection or investigation. The Registrar considers any significant issues identified during an inspection or an investigation under Section 71 of the Pharmacy Act 2007. This is a function designated to the Registrar by the Council of the PSI. Following the consideration of an authorised officer’s inspection/investigation report, and any responses received from registrants/parties involved, the Registrar can decide to take the following actions under the authority of Section 71 of the Pharmacy Act 2007:

- No further action [Section 71(1)(a)

- Make a complaint about a pharmacist(s) and/or a pharmacy [Section 71(1)(b)]

- Take any other action deemed appropriate [Section 71(1)(d)], for example, initiating a prosecution in the District Court, directing a re-inspection of a pharmacy, requiring a registrant to attend a meeting, seeking undertakings, referral to other agencies, issuing enforcement letters etc.

The PSI has submitted the following information to the Department of Health.

Table 1 outlines the numbers and categories of enforcement actions taken by the Registrar of the PSI under Section 71 of the Pharmacy Act following the consideration of an authorised officer’s inspection/investigation report:

Table 1

Concerns

The PSI also takes regulatory action to ensure any expressions of concern reported to PSI are reviewed and acted on where it is necessary. Expressions of concern arise when a person does not wish to make a formal complaint to the PSI but to bring some information to the attention of the PSI. The PSI regularly receives a significant amount of unsolicited information in relation to pharmacies and pharmacists from members of the public and others (for example, 2021: 120 concerns; 2020: 184; 2019: 144).

Any unsolicited information received by PSI is risk-assessed by a multidisciplinary team to inform decision-making and regulatory actions, where necessary. Regulatory actions taken by PSI in response to expressions of concern include the following range of measures:

1. correspondence/communications with pharmacists
2. conducting meetings with pharmacists
3. conducting focused risk-based inspections and/or
4. initiating investigations, i.e., where there is reason to believe there are serious patient safety issues and/or serious non-compliance issues.

The PSI has set out the number of concerns referred for follow up/management within the them since 2015 in Table 2, below: