Dáil Éireann Debate, Tuesday - 18 April 2023
1784. Deputy David Cullinane asked 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]
View answerEnforcement - 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:
|
Year |
Total No. of enforcement actions (Section 71 of the Act) |
Complaints against Pharmacies |
Complaints against Pharmacists |
Prosecutions initiated/ taken [Section 71(1)(d)] |
Other Actions [Section 71(1)(d)] |
No further action [Section 71(1)(a) |
|
2022 |
21 |
4 |
4 |
4 |
9 |
6 |
|
2021 |
14 |
3 |
4 |
0 |
7 |
1 |
|
2020 |
30 |
6 |
11 |
1 |
12 |
8 |
|
2019 |
75 |
1 |
9 |
0 |
65 |
29 |
|
2018 |
43 |
4 |
5 |
3 |
31 |
10 |
|
2017 |
29 |
0 |
5 |
2 |
22 |
8 |
|
2016 |
30 |
1 |
6 |
3 |
20 |
28 |
|
2015 |
33 |
0 |
1 |
1 |
31 |
26 |
|
2014 |
29 |
0 |
5 |
0 |
24 |
29 |
|
2013 |
11 |
0 |
3 |
4 |
4 |
19 |
|
2012 |
44 |
0 |
5 |
12 |
27 |
2 |
|
2011 |
9 |
0 |
1 |
5 |
3 |
0 |
|
2010 |
10 |
0 |
1 |
8 |
1 |
5 |
|
2009 |
0 |
0 |
0 |
0 |
0 |
11 |
|
TOTAL |
378 |
19 |
60 |
43 |
256 |
182 |
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:
correspondence/communications with pharmacists
conducting meetings with pharmacists
conducting focused risk-based inspections and/or
initiating investigations, i.e., where there is reason to believe there are serious patient safety issues and/or serious non-compliance issues.
This escalating range of measures allows PSI to effectively respond to expressions of concern in a reasonable and proportionate manner. A combination of measures may also be required to mitigate the risks / close out the concern.
The PSI has set out the number of concerns referred for follow up/management within the them since 2015 in Table 2, below:
|
Year |
Total No. of Concerns referred to I&E |
|
2022 |
50 |
|
2021 |
63 |
|
2020 |
72 |
|
2019 |
55 |
|
2018 |
65 |
|
2017 |
55 |
|
2016 |
32 |
|
2015 |
57 |
