Dáil Éireann Debate, Tuesday - 18 April 2023
1783. Deputy David Cullinane asked 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]
View answerThe 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.
|
Year |
Registration related inspections (Section 19) |
Section 67 inspections (Systems/ Risk-based focused inspections) |
Advisory Visits [1] (A) /Standards Visits (S)2 |
Total |
|
2007 |
NA |
138 |
138 |
|
|
2008 |
NA |
10 |
10 |
|
|
2009 |
66 |
260 |
326 |
|
|
2010 |
64 |
280 |
344 |
|
|
2011 |
95 |
170 |
265 |
|
|
2012 |
97 |
75 |
172 |
|
|
2013 |
83 |
388 |
471 |
|
|
2014 |
104 |
626 |
730 |
|
|
2015 |
112 |
270 |
382 |
|
|
2016 |
92 |
155 |
247 |
|
|
2017 |
102 |
208 |
1826 (A) |
310 + 1826 (A) |
|
2018 |
109 |
149 |
100 (A) |
258 + 100 (A) |
|
2019 |
114 |
161 |
275 |
|
|
2020 (COVID) |
12 |
24 |
16 (S) |
52 |
|
2021 (COVID) |
4 |
25 |
29 (S) |
58 |
|
2022 |
15 |
97 |
112 |
|
|
Totals |
1069 |
3036 |
1971 |
6076 |
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.
