by Lyn McCarthy February-03-2022 in Healthcare Law, Regulatory & Administrative Law, COVID-19
The Pharmaceutical Society of Ireland (the “PSI”) has recently published statistics relating to the volume and nature of complaints for 2020.
The report relates to the activities of the Preliminary Proceedings Committee (the “PPC”) during that period and contains very useful information regarding the nature of complaints during that period, together with some particular insights on the impact of the COVID-19 pandemic on the complaints received by the pharmacy regulator.
Function of the PPC
The PPC is the screening committee for complaints within the PSI and forms part of the disciplinary structure of the PSI. Under the Pharmacy Act 2007 (the “Act”), the PPC is the initial committee to receive complaints regarding registered pharmacists and retail pharmacy businesses.
The PPC considers each complaint and advises the Council of the PSI on whether there is sufficient cause to warrant further action being taken in respect of each complaint. 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 Act, as appropriate.
In addition to the processing of complaints, the PPC provides an overview report on an annual basis of the complaints it has received throughout the year, together with its observations on the matters that have arisen.
Complaints
According to the most recent PPC report, there were six meetings of the PPC during 2020, representing a reduction in meetings from previous years, owing to the COVID-19 pandemic.
Over this period, 37 complaints were considered by the PPC, compared to 74 complaints in 2019. This represents an overall reduction by half in the number of complaints to the regulator compared to the previous year. It would appear from the report that this is owed in part to the suspension of the PSI complaints procedure for a number of months. In this regard, the PSI suspended many of its regulatory activities, to include the processing of complaints, between March 2020 and May 2020. Accordingly, the PPC did not sit to consider complaints during this period.
Complaints Requiring Further Action
Of the 37 complaints received in 2020, the PPC sent 15 complaints forward for further action.
The breakdown of the complaints referred forward was as follows:
- 13 complaints were referred to the Professional Conduct Committee for Inquiry;
- 2 complaints were referred for resolution by mediation;
- There were no complaints referred to the Health Committee for Inquiry in 2020.
It is particularly noteworthy that, in respect of the two complaints referred to mediation, one complainant withdrew consent to mediation and the other complaint could not be resolved by mediation. Accordingly, both complaints were referred to the Professional Conduct Committee for Inquiry, notwithstanding the initial referral to mediation.
Separately, it is significant that there were no referrals to the Health Committee for Inquiry in 2020, representing a departure compared to previous years.
Key Trends
The report provides helpful insights in relation to the breakdown of complaints both received and referred forward by the PPC. From the available information, the PPC has identified the following key issues which have emerged as trends in the context of complaints considered by the PPC for the relevant period:
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Pharmacy practice issues
Over one quarter of complaints considered by the PPC in 2020 related to pharmacy practice issues. In this regard, examples cited in the report include the supply of a non-prescription medicine to a minor; the supply of methadone otherwise than in accordance with PSI guidance; the supply of a pharmacy-only medicine without a pharmacist on duty in the pharmacy and the supply of halved tablets to achieve the correct dosage, in circumstances where the original strength was in short supply/unavailable and not providing any or adequate information or advice to the patient on the change to their dispensed medicines.
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Behaviour (Manner/Attitude) of Pharmacists
This category represented the next highest category of complaints. The report notes that in the context of this category of complaint, patients had concerns with regard to the manner in which they were dealt with and spoken to by the pharmacist and/or where a breakdown in communication appears to have occurred between the complainant and pharmacist.
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Dispensing Errors
Dispensing errors as an overall category saw a reduction in complaints with the percentage of complaints considered as a result of dispensing errors reducing from 23% in 2019 to 13% in 2020. Notwithstanding this reduction in volume however the types of errors complained of were consistent with those noted in previous years
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Complaints arising specifically in a COVID-19 context
Interestingly, the report outlines that a number of complaints received during the specified period related to refusals by pharmacists to provide an early supply or further medication in the absence of a prescription in emergency circumstances during the COVID-19 pandemic.
In response to the outbreak of COVID-19, changes were made to relevant legislation to facilitate how prescription only medicines were to be supplied to patients so as to ensure continued care and treatment for patients in the particular circumstances. Such legislative changes included the extension of the validity period of prescriptions in particular circumstances.
According to the report, a number of the complaints considered by the PPC in 2020 related to circumstances where pharmacists refused to supply the requested medication in emergency circumstances. In other cases, the issue related to whether the validity of the prescription for the particular medicine could be extended.
Comment
Whilst the report reflects an overall reduction in the number of complaints, the impact of the COVID-19 pandemic as a whole and the suspension of the PSI complaints procedure for a number of months will have been significant. Accordingly, the impact which this may have on the complaints volume in subsequent periods will be particularly illuminating. In addition, the significant changes in the breakdown in complaint types and the emergence of new heads of complaint is particularly interesting and reflects the ever-changing regulatory landscape and the constantly evolving needs and trends in the context of professional regulation.
The information contained in the report also provides useful comparisons and contrasts as against the volumes and nature of complaints received and processed by other healthcare regulators over similar periods and particularly in the context of the COVID-19 pandemic. The report will be of interest to pharmacists and owners of retail pharmacy businesses alike, in addition to professional regulation practitioners.
The report can be accessed here. Previous articles on Pharmacy Regulation can be accessed below:
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The Pharmaceutical Society of Ireland – The Process For Dealing With Complaints Against Registered Pharmacists - link
- Pharmacy Regulation Update: Codes, Complaints and Legislative Change - link
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Major Regulatory Reform on the way for Health and Social Care Professions - link
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Getting Personal: The Regulation of Professionals’ Private Lives - link
For further information or to discuss, please contact Lyn McCarthy lmccarthy@hayes-solicitors.ie or any member of our Healthcare Law team.
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About the Author
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.