by Matthew Austin October-26-2021 in Commercial & Business, Mediation, Regulatory & Administrative Law

The Pharmaceutical Society of Ireland is the regulator in respect of many of the professional obligations of pharmacists in Ireland.  The Pharmacy Act, 2007 (the Act) sets out the complaints and disciplinary process administered by the PSI.  It is open to anyone to make complaint to the PSI in relation to the professional conduct of a registered pharmacist.  The Act prescribes the procedures and committees that must address those complaints and which are designed to secure fair procedures for the registered pharmacist in dealing with any such complaint.

This article summarizes the process that a pharmacist may go through when dealing with a complaint in relation to his or her professional conduct.

 

Initial Steps

The process most often begins when a complainant sends a written complaint to the PSI. The PSI will then send the complaint to the pharmacy/pharmacist about whom the complaint was made for their response. The response is then sent to the complainant for further comment and, if they have any, these comments are sent back to the pharmacy/pharmacist for final comment.

 

Preliminary Proceedings Committee (PPC)

The PPC is the complaints screening committee, and they can request further information from both the complainant and the pharmacy/pharmacist. The PPC’s function is to ensure complaints made have merit and are not frivolous or vexatious.  The PPC ultimately decides whether a complaint requires further action to be taken.

 

Complaints the PPC can consider:

The PPC can consider complaints that deal with one or more of the following:

  1. professional misconduct;
  2. poor professional performance;
  3. impairment of the registered pharmacist’s ability to practice because of a physical or mental ailment, an emotional disturbance or an addiction to alcohol or drugs;
  4. failure to obey the conditions attached to the pharmacist’s registration;
  5. failure to comply with an undertaking or to take agreed action following a request from a Committee of Inquiry under Section 46 of the Pharmacy Act 2007;
  6. failure to comply with certain provisions of the Health (Pricing and Supply of Medical Goods) Act 2013;
  7. failure to comply with any duties imposed by section 18(1)(A) of the Pharmacy Act which relate to the Health (Pricing and Supply of Medical Goods) Act 2013;
  8. breaching a provision of the Pharmacy Act 2007 or rules made by the PSI under the Act;
  9. conviction in the State or outside the State for indictable offences

It is important to note that the PSI cannot consider complaints that relate to commercial matters such as pricing or non-payment of rent on commercial premises, nor can they deal with employment issues such as hours of work or contracts of employment.

Similar to most complaints committees for professional bodies, most of the members of the PPC are not pharmacists.

Once the PPC has reached a decision, it advises the Council of the PSI on what steps to take. The PPC can advise either of the following:

  1. That the complaint requires further action, and the PPC will refer it either for mediation or to a Committee of Inquiry.
  2. That there is insufficient cause to take the complaint any further. If the Council agrees, the complaint process ends. If the Council disagrees, the complaint is referred back to the PPC who will in turn refer it for mediation or to a Committee of Inquiry.

 

Mediation

Mediation is a confidential alternative dispute resolution process whereby an impartial third party (the mediator) meets with both parties in an attempt to find a solution to the problem in a manner that is agreeable to all involved. Mediation can only take place if both sides to the complaint agree to it. If either side does not consent to mediate, the complaint is referred to a Committee of Inquiry. Equally, if mediation takes place and is unsuccessful, the complaint will be referred by the PPC to a Committee of Inquiry.

No statement made by the complainant or by the pharmacy owner/pharmacist in the course of mediation may be communicated to any person other than those participating in the mediation, nor may the statements be used in any disciplinary, civil or criminal proceedings. However, the details of a successful mediation process may be published on the PSI website and/or the PSI Newsletter.

 

Committees of Inquiry

There are two committees who are engaged depending on the complaint made.

The Professional Conduct Committee (PCC) deals with complaints about professional misconduct or poor professional performance on the part of a pharmacy/pharmacist. At least three people will sit on the PCC and there will always be a non-pharmacist majority. The PCC consults a legal assessor to advise it about law and procedure however the legal assessor will not take part in decisions. PCC hearings are normally held in public. This means that the media and other members of the public may be present for the inquiry. The date, time and location of the inquiry will be published on the PSI’s website in advance of the inquiry, however the pharmacy/pharmacist’s name will not appear on the website. Names may be published following the inquiry and this point is dealt with further below.

The Health Committee (HC) deals with complaints about impairment of a pharmacist’s ability to practice due to a physical or mental ailment, emotional disturbance or an addiction to alcohol or drugs. At least three people will sit on the HC and there will always be a non-pharmacist majority. The HC also consults a legal assessor to advise it on legal matters and procedures, but the legal assessor does not partake in decision-making. The HC consults a registered medical doctor with relevant expertise to advise the HC on any medical issue. The doctor will not take part in decisions. HC hearings are normally heard in private. This means that no media or other members of the public will be present during the hearing. The PSI will not publish information on its website in advance of the inquiry.

 

Findings and Decisions

At the end of an inquiry the Committee will decide if the allegations against the pharmacy/pharmacist are proven beyond a reasonable doubt. The matter is then referred to Council of the PSI. The Council will consider what sanctions, if any, should be imposed.

 

Possible Disciplinary Sanctions

If the Committee of Inquiry decides a complaint is substantiated, the Council can impose one or more of the following disciplinary sanctions:

  1. an admonishment or a censure.
  2. the attachment of conditions to the registration of the pharmacy/pharmacist which may include restrictions on practice or carrying on a business.
  3. the suspension of the registration for a specified period.
  4. the cancellation of the registration.
  5. a prohibition for a specified period on applying for restoration to the register.

 

Notification of Disciplinary Sanctions

If the Council decides to impose a disciplinary sanction on a pharmacy/pharmacist, the Council must notify the pharmacy/pharmacist and the complainant of the following:

  1. the disciplinary sanction(s) imposed;
  2. the reasons for the imposition of the sanction(s);
  3. the date of the decision.

If the Council imposes a disciplinary sanction (other than an admonishment or a censure) the pharmacy/pharmacist must also be notified of

  1. the time within which the registered pharmacist or pharmacy owner may apply to the High Court for cancellation of the decision, and
  2. the time within which the Council may apply to the High Court for confirmation of the decision.

It is important to note that where a pharmacist is an employee and where the Council know the identity of the pharmacist’s employer, it must notify the employer of the imposition, removal or expiry of a sanction.

 

Applying to have a Disciplinary Sanction Cancelled

A pharmacy/pharmacist may apply to the High Court to have a disciplinary sanction imposed by the Council cancelled. The application by the pharmacy/pharmacist must be made within 30 days following receipt of the notification of the decision from the Council.  The High Court may consider any evidence adduced or argument made to it, whether or not adduced or made to a Committee of Inquiry. The High Court has the power to make any order it considers just, including an order confirming or modifying the decision, and it may give the Council direction.

It is important to note that a decision to impose a disciplinary sanction (being an admonishment or a censure) does not take effect unless and until it is confirmed by the High Court.

If no application is made to the High Court by the pharmacy/pharmacist within 30 days, the Council will apply to the High Court for confirmation of the decision to admonish/censure. This application must be made within 60 days of the Council notifying the pharmacy/pharmacist of the sanction.  

 

Public Notice of Sanctions

Pursuant to S.57 of the Pharmacy Act 2007, if the Council is satisfied that it is in the public interest to do so, it may give public notice of any of the abovementioned disciplinary sanctions. Examples of this occurring can be seen on the PSI website.

 

Conclusion

For any pharmacist or pharmacy dealing with a complaint, the process is undoubtedly stressful.  Akin to the experience of many regulated professionals in equivalent circumstances, the process itself can often be as stressful as the threat of sanction, particularly having regard to the potential publicity around a fitness to practise inquiry.  Whilst the procedures can initially seem daunting and complex, in fact they offer the pharmacist or pharmacy involved significant protections and opportunity to defend the allegations advanced against them.

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