This is the first of two articles from the law firm DAC Beachcroft, which will discuss the PSI complaints process and what pharmacists should do if a complaint is made against them or against a retail pharmacy business. This article will examine the process from when a complaint is received by the PSI, up to the decision of the Preliminary Proceedings Committee.
Taking expert legal advice may lead to a complaint not being sent forward to inquiry.
The complaints process is governed by Part 6 of the Pharmacy Act 2007 as amended (the 2007 Act). Significant amendments to the 2007 Act were introduced by the Regulated Professions (Health and Social Care) (Amendment) Act 2020 (the 2020 Act), including in relation to fitness to practise and sanctions. The key changes will be highlighted in this article, and a follow-up article, which will be published in the coming months.
Similar to most statutory professional regulators in Ireland, the PSI’s disciplinary processes incorporate an investigatory stage, inquiry stage, a decision on sanction and a confirmatory/appeal stage. As a result, if a complaint is made against you or your retail pharmacy business, the process can be quite costly, stressful and time-consuming. All of these can be minimised if the Preliminary Proceedings Committee (PPC), decides not to send the complaint to inquiry.
The overarching purpose of the fitness to practise regime is to assure the quality of professional services in the public interest. There should be three key outcomes from the fitness to practise process:
In this regard, any sanction imposed on a pharmacist should be transparent, consistent and proportionate.
A complaint may be made against a pharmacist under section 35 of the 2007 Act, or against a retail pharmacy business under section 36.
A complaint may be made by or on behalf of any person, or by the Registrar of the PSI, on any of the grounds specified in the 2007 Act. For example, the Registrar may decide to make a complaint on foot of an investigation and report by an Authorised Officer of the PSI following an inspection(s) of the retail pharmacy business.
The grounds of complaint against a registered pharmacist include professional misconduct and poor professional performance. Professional misconduct includes conduct that is in breach of the PSI’s Code of Conduct, is infamous or disgraceful in a professional respect, or involves moral turpitude, fraud or dishonesty. Poor professional performance “means any failure of the registered pharmacist to meet the standards of competence that may be reasonably expected of a registered pharmacist”. The grounds of complaint have also been broadened under the 2020 Act to include:
The 2020 Act also allows the PSI to make requests of any health or social care regulator with whom a pharmacist was previously registered (whether in Ireland or another jurisdiction) for information relating to a material matter regarding a pharmacist’s registration. A material matter would include, amongst other categories, the imposition of conditions on any registration or licence, the suspension, withdrawal or removal of any registration or licence, the refusal to grant registration or licence, or a conviction in the State or outside the State for an offence triable on indictment, or a conviction of an equivalent nature.
The grounds of complaint against a registered retail pharmacy business include where the pharmacy owner or an employee, or a partner of the pharmacy owner, has been convicted of certain offences, or, in a ground inserted by the 2020 Act, where the pharmacy owner has failed to comply with the provisions of specified legislation, including the 2007 Act.
If you are notified that a complaint has been made to the PSI against you, you should immediately consult the IPU Professional Services Team and contact your insurers. In most cases it would also be important to retain a solicitor with expertise in pharmacy fitness to practice cases. You should also gather any relevant documentation which may be of assistance to you in responding to the complaint.
The complaint will initially be dealt with by a Case Officer at the PSI, who will generally write to all parties relevant to the complaint. You will be given an opportunity to respond and/or make submissions in relation to the complaint before it is considered by the PPC.
This can be one of the most important stages in the fitness to practise process. Amongst the most common issues we see are pharmacists providing too much information at PPC stage, or not enough!
You should not reply to a request for observations and comments on a complaint without the input of the IPU Professional Services Team and/or a solicitor who is experienced in pharmacy fitness to practise cases. Depending on the nature of the complaint, it may be appropriate either to submit a robust, detailed response, or a more nuanced approach may be advisable to avoid making any unnecessary admissions, or taking a position which is disadvantageous at an inquiry stage — ultimately it is a matter for the PSI to prove matters beyond reasonable doubt at inquiry. In other cases, it may be in a pharmacist’s best interests to hold their hands up and make admissions at an early stage.
The IPU Professional Services Team and your solicitor can assist you in deciding whether it is in your best interests to respond to the complaint thoroughly, in a more limited way, or not at all.
If you submit observations and comments in relation to the complaint, a copy will be sent to the complainant who may respond to your observations. You will be given a copy of any further comments made by the complainant and will be given the opportunity to respond. Again, any response should be carefully considered.
Once all comments and observations have been received, the complaint will be referred to the PPC for consideration.
The PPC reviews the complaint and advises the Council on “whether there is sufficient cause to warrant further action being taken”. Before arriving at its advice, the PPC is required to consider whether the complaint is trivial, vexatious, or made in bad faith.
The PPC must also consider any information given to it under the process outlined above, and this highlights the importance of taking appropriate legal advice before replying to a request for observations and comments.
On receiving the PPC’s advice, the Council may decide to take no further action in relation to the complaint. This is of course the preferable outcome for the pharmacist involved. You will be notified if the Council decides to take no further action.
Alternatively, the Council may decide that further action should be taken. In this case, the complaint will be referred for mediation or an inquiry. Our second article will address these processes.
Unfortunately, many pharmacists don’t receive appropriate legal or professional advice at PPC stage as to the kind of response (if any), they should submit. They then produce documents or other evidence after the matter has been referred to an inquiry, which may well have led to the PPC deciding to take no further action if they had provided it earlier in the process. We cannot stress enough the importance of taking appropriate advice at PPC stage — doing so may lead to a complaint not being sent forward by the PPC or ensure the pharmacist or retail pharmacy business is in the best position to put up a robust defence at inquiry.
About the authors: Ruth Cormican is a solicitor and Aidan Healy is Legal Director in DAC Beachcroft Dublin’s Professional, Public and Regulatory Law team, which is led by Gary Rice, Partner. DAC Beachcroft has advised the IPU and its members for many years and specialises in the legal aspects of pharmacy practice. For more information, please contact Ruth Cormican on rcormican@dacbeachcroft.com. For more information on any legal aspect of pharmacy practice, please contact Aidan Healy (ahealy@dacbeachcroft.com) or Gary Rice (grice@dacbeachcroft.com).
IPU Professional Services Team
The IPU Professional Services Team can be reached via email on pharmacists@ipu.ie or via 01 493 6401.
Danielle Barron
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