by David Phelan , Lyn McCarthy December-07-2019 in Healthcare Law, Litigation & Dispute Resolution, Regulatory & Administrative Law
2019 has seen significant change in the area of pharmacy regulation, with even greater change anticipated in 2020.
Most significantly, the latter part of this year has seen the launch of a revised Code of Conduct by the Pharmaceutical Society of Ireland (the “PSI”); the passage of the Regulated Professions (Health and Social Care)(Amendment) Bill 2019 through Dáil Éireann and the publication of a report by the Preliminary Proceedings Committee of the PSI which provides significant insights in relation to the nature and volume of complaints in respect of pharmacists and retail pharmacy businesses.
1. Code of Conduct
The revised Code of Conduct for registered pharmacists, which was launched on 25 September 2019 to coincide with World Pharmacists Day, came into effect on 21 October 2019. The Code is a public declaration of the principles and ethical standards which govern pharmacists in the practice of their profession and which the public, patients, other healthcare professionals and society require and expect from pharmacists.
Key Changes
The updated Code, entitled Professional Principles, Standards and Ethics for Pharmacists (2019) was revised and updated in 2019, following a public consultation process in 2018. This review involved a process of research and engagement with pharmacists, stakeholders and the public. The revised Code acknowledges the changes that have taken place in the delivery of healthcare in recent years and particularly the evolving role of pharmacists in that context.
The updated Code applies to all registered pharmacists and seeks to take into account changes both in Irish healthcare legislation and in society generally since the publication of the previous Code of Conduct in 2009.
Compliance with Code of Conduct
Compliance with the Code of Conduct is taken particularly seriously by the PSI in circumstances where, somewhat unusually amongst the regulated healthcare professions, a breach of the Code of Conduct constitutes professional misconduct for the purposes of the governing legislation, the Pharmacy Act 2007.
In the event of a finding of serious misconduct for a breach of the Code of Conduct following Fitness to Practise Inquiry, the Council of the PSI can impose sanctions, up to and including the suspension or cancellation of a pharmacist’s registration. This differs from the equivalent provisions in the governing legislation for certain other healthcare professions e.g. the Medical Practitioners Act 2007 where no such express correlation as between the ethical guide and professional misconduct is provided for, although breaches of the ethical guidance may be taken into account in the context of any such allegations.
2. Complaints
In terms of complaints to the regulator, the PSI has recently published statistics relating to the volume and nature of complaints for 2018, being the last complete year for statistical purposes.
Preliminary Proceedings Committee
The Preliminary Proceedings Committee (“PPC”) which is the screening committee of the PSI for complaints considers whether further action is warranted when complaints are received concerning registered pharmacists and registered retail pharmacy businesses.
The PPC considers each complaint and advises the Council on whether there is sufficient cause to warrant further action being taken. Where appropriate, these complaints are referred forward for mediation or for inquiry before either the Health Committee or the Professional Conduct Committee, being the two Committees of Inquiry under the Pharmacy Act 2007.
Number of Complaints
According to the most recent PPC report, there were eight meetings of the PPC during 2018. Over this period, 42 complaints were considered by the PPC compared to 57 complaints in 2017. This indicates an overall reduction in the number of complaints to the regulator from the previous year however it still represents a significant increase compared to previous years- 2015 & 2016.
Key Trends
The report provides helpful insights in relation to the breakdown of complaints referred forward by the PPC and identifies the following key issues which have emerged as trends in the context of complaints considered by the PPC:
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Dispensing Errors
The PPC report recites that complaints under this category related to incorrect strength of the correct medication being provided to patients; incorrect medication being provided on foot of a valid prescription and incorrect labelling, to include errors in dosage instructions. -
Checking Procedures
The reference to checking procedures in the report highlights the significance of ensuring thorough and robust checking procedures for all prescriptions. This particular reference would appear to also to encompass the significance of appropriate and thorough Standard Operating Procedures and the periodic review of these within pharmacy businesses. -
Non Prescription Medicines
The PPC report outlines that a number of complaints considered in 2018 related to the refusal to supply pharmacy only medicines such as Solpadine, Nurofen Plus or cough bottles. In this regard, complaints were made by patients who were dissatisfied with the manner in which the supply of such medications was refused.
Whilst pharmacists are expected to use their professional judgement when deciding whether a supply of a non-prescription medicinal product is in the best interests of the patient, the report is a helpful reminder to consider the manner in which a decision not to supply may be made. In this regard, the PPC Report outlines that the communication should include the reasons for the pharmacist’s decision not to supply the medicines and this should be accompanied by relevant advice, to include referring the patient to another healthcare professional or service, as appropriate.
3. Regulated Professions (Health and Social Care)(Amendment) Bill 2019
The Regulated Professions (Health and Social Care) (Amendment) Bill 2019 (“the Bill”) has recently passed through Dáil Éireann and is expected to be signed into law by the end of 2019, following consideration by Seanad Éireann. The draft legislation, once enacted, will mean significant change for pharmacy regulation, particularly in the areas of registration and fitness to practise.
Annual declarations
The Bill proposes to introduce a requirement that healthcare professionals, including pharmacists, make an annual declaration providing details of any disciplinary or judicial proceedings and of any sanctions imposed on them in the State or another jurisdiction affecting their ability to provide care.
Admissibility of evidence relating to disciplinary/ judicial proceedings/ inquiries in another jurisdiction
In addition to the foregoing, the Bill allows for the admissibility of documents relating to any such disciplinary or judicial proceedings in other jurisdictions for the purposes of disciplinary proceedings in the State.
Right of Appeal for ‘Minor’ Sanctions/ Confirmation applications for all sanctions to the High Court
Significantly, under the Bill, pharmacists and other healthcare professionals on whom the less serious sanctions of advice, admonishment or censure (reprimands of varying levels of seriousness) have been imposed will have the right to appeal to the High Court. This is a significant departure from the previous position whereby only the more ‘serious’ sanctions such as conditions, suspension and erasure could be appealed.
Under the new regime, all sanctions imposed will require confirmation and, as such, will be amenable to oversight by the High Court. This is also a significant change from the current position which provides that lesser sanctions do not require confirmation by the High Court.
Full Publication of Sanctions
The Bill provides that all sanctions imposed on health care professionals must be published.
4. Comment
2020 is likely to see the first complaints considered both by the PPC and Committees of inquiry involving the new Code of Conduct. The impact this may have on the number and nature of complaints will make for interesting comparison with the statistics discussed above.
Separately, the 2019 Bill is likely to become law by early 2020. The Bill as currently drafted heralds significant change in the areas of fitness to practise and registration for pharmacists. The proposed changes will also have significant impact for retail pharmacy businesses and those who employ pharmacists. Developments in relation to the Bill will be monitored with interest.
For further information on these issues, please contact David Phelan dphelan@hayes-solicitors.ie or Lyn McCarthy lmccarthy@hayes-solicitors.ie
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About the Authors
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David Phelan
David is Head of the Commercial & Business team at Hayes solicitors and advises a number of the firm’s major corporate clients. He advises on a wide range of corporate and commercial law issues. He has expertise in advising on general corporate and commercial matters, particularly in the manufacturing, retail, aviation, sports and motor sectors, and also frequently advises clients who operate in regulated areas.
Lyn McCarthy
Lyn is a partner in the Healthcare team at Hayes solicitors. Lyn advises clinical practitioners and indemnity bodies in respect of the defence of medical negligence claims and also in respect of the defence of professional disciplinary matters before Committees of inquiry.