Self-defence in the pharmacy

When faced with a situation where something has gone wrong, having good processes in place is vital, especially with the advent of the CCS. Niamh Cahill reports

Pharmacy negligence is not a topic openly or indeed often discussed by pharmacists.

But it is one that is perhaps more prominent in minds of late with the introduction of the Common Conditions Service (CCS) and greater changes in pharmacy.

According to the Pharmaceutical Society of Ireland (PSI), the pharmacy regulator, it received 78 complaints in 2024, while the number of complaints fell to 48 in 2025.

Considering the fact that there are around 6,000 actively practicing pharmacists in Ireland currently, these numbers are low and align with research that shows pharmacists are among the most trusted professions globally.

But the advent of the common conditions service, which for the first time enables pharmacists to prescribe and give advice on eight specific conditions, has potentially created more scope for negligence to occur.

And as the service brings new grounds for prescribing negligence and expands pharmacists’ liability, it places a greater burden on pharmacists to work to ensure errors are avoided.

Kerry-based pharmacist Jack Shanahan told Irish Pharmacist (IP) that cases of negligence within pharmacy are rarely discussed by pharmacists.

“It is not a subject that is talked about much and there have been no specific cases in recent times that I am aware of. You tend not to hear about these cases unless they make the headlines,” he related.

“If a pharmacist feels they may have been exposed to a potential case of negligence, the first requirement placed on them by their insurers is they must notify their insurer,” Mr Shanahan said.

“I have never been in the unfortunate situation of having to face something like this, but every pharmacist has been faced with a situation where something has gone wrong. You protect yourself by having good processes in place and you ensure that everyone follows the same process.”

SOPs

“Standard operating procedures have their uses and are important for ensuring a consistent approach, so generally speaking if you follow your SOPs, nothing will ever go wrong,” he continued.

“But the reality is there is always a possibility that something will go wrong at some stage. You may
be exceptionally busy, you may be understaffed, or you might be sick. There could be all sorts of reasons why something doesn’t happen the way it should happen. Then it’s a case of how you handle that. You ensure no harm has been done and if there is a potential for harm, you ensure that it is removed as quickly as possible.”

Mr Shanahan suggested that claims against pharmacists are relatively low in number, based on current indemnity trends.

“Insurance premiums are relatively low for professional indemnity in community pharmacy compared
to other medical professions. They have increased in recent years, like everything else, but they have not hugely increased, suggesting that there might not be too many claims,” he indicated.

According to information supplied by the PSI, in 2024 a total of 20 fitness to practise inquiries were heard. Of these, 15 inquiries were held by the Professional Conduct Committee (PCC) and five inquiries were heard by the PSI’s Health Committee.

In 2025, a total of 23 fitness to practise inquiries were heard. Of these, 20 inquiries were before the PCC and three inquiries were before the Health Committee.

The majority of complaints received by the PSI are not referred to committees of inquiry, however.

Claims

A spokesperson for the PSI said that all complaints received by the PSI are considered by an independent complaints screening committee called the Preliminary Proceedings Committee (PPC).

“The role of the PPC is to decide whether further action is necessary in relation to complaints received. The PPC may decide there is insufficient cause to take further action. In such situations, the PSI Council considers the advice of the PPC and will either agree that no further action can be taken or may request that it be referred for further action for an inquiry or for mediation in suitable circumstances.

“By way of illustration, in 2025, out of 90 complaints considered by the PPC, 24 were referred for further action, five of which were referred to mediation.”

The spokesperson pointed out that the number of complaints considered in any given year by the PPC may relate to complaints received in the current year and from the year prior and will depend on the complexity of matters presenting and information available to be considered.

According to the PSI 2024 Annual Report, in 2024, of the 20 hearings held that year, findings were made in five inquiries. They included professional misconduct, poor professional performance or impairment.

“A total of 10 undertaking applications were accepted by the Committees under Section 46 of
the Pharmacy Act 2007. When an undertaking is accepted, no findings are made against the respondent. Undertakings allow complaints, where appropriate, to be resolved without the need for a prolonged inquiry process,” the report states.

“In 2024, the Council considered 25 reports from the Committees of Inquiry, some of which pertained to inquiries heard in 2023. The Council imposed 15 sanctions, with some respondents receiving multiple sanctions. Sanctions included cancellation of registration (two), suspension from the register for defined periods (two), the imposition of conditions (four), censure (five), and admonishment (two).”

A PSI spokesperson said that in 2024, 72 per cent of Fitness to Practise inquiries concluded with disciplinary action, whether by the acceptance of undertakings or by the imposition of a sanction other than cancellation of registration. Eight per cent concluded with cancellation of registration, where two registrants had their registration cancelled.

In 2025, the spokesperson said that 65.6 per cent of Fitness to Practise inquiries concluded with disciplinary action, while 12.5 per cent concluded with cancellation of registration, with four registrants having their registration cancelled.

In 2024, of the 78 complaints made, 23 related to dispensing errors and 21 concerned behaviour (manner/attitude).

But data from other sources would suggest that the number of medication errors more generally is perhaps much higher than the number of complaints.

According to data from the State Claims Agency, between 2019 and 2022, 69,889 medication incidents were reported on the National Incident Management Systems (NIMS) used by the HSE and HSE funded facilities.

Most of these incidents, almost 94 per cent in fact, were reported as negligible or causing no harm.

As well as making a complaint to the PSI, patients can pursue financial damages through civil claims, where awards for harm suffered can range from €500 to €500,000 and over. According to the Statute of Limitations Act 1991, patients generally have two years to file a claim.

Supports

The good news is there are many ways in which pharmacists can protect themselves from complaints. Supports and advice are available from the Irish Pharmacy Union (IPU) and the PSI.

A spokesperson for the IPU said that all of its pharmacists are registered professionals who work to the PSI Code of Conduct and “endeavour to provide high quality, safe services to their patients”.

“Despite their best efforts, incidents such as medication errors do sometimes occur. At the IPU, we provide advice and support to members to help minimise the risk of errors occurring and to effectively manage an error should it occur. We also support our members in the promotion of a safe working environment where an open disclosure culture is fostered.

“Ensuring a robust governance culture, underpinned by standard operating procedures, is in place
in the pharmacy is the best way to minimise the risk of errors. We support pharmacies to put in place documented systems for the management, continuous review and recording of medication errors and near-misses. Learning from mistakes and near- misses also ensures that the risk of future mistakes is minimised.”
A spokesperson for the PSI said that it expects pharmacies to have written procedures for processes within the pharmacy and for these to be followed.

“It is expected that all staff should have clarity of roles and responsibilities and receive necessary training aligned to their role,” the spokesperson said.

“There are governance roles within a pharmacy, and these have both leadership and clinical responsibilities. In relation to initial issue/complaint handling, where suitable, the PSI suggests that the supervising or superintendent pharmacist within the pharmacy should be contacted about a patient’s issue or query, so that these may be dealt with in a timely fashion.”

Information on the PSI website on medication error management, adhering to the National Open Disclosure Framework and on the PSI’s Code of Conduct and Core Competency Framework, along with other helpful data, is available, the spokesperson added.

This information emphasises that effective communication, transparency, and professional accountability can help pharmacists prevent complaints, even when an error occurs, the spokesperson advised.

“When mistakes happen, including no-harm events or near-misses, pharmacists can demonstrate accountability and reduce the likelihood of escalation by being proactive: Communicating openly and honestly with the patient about what happened, offering a genuine apology, and explaining the steps being taken to

prevent the issue from recurring.”

Mr Shanahan said that the introduction of the Common Conditions Service in pharmacy is “definitely an area where it is possible liability issues could rise over the next few years,” as the service constitutes a broadening of pharmacists’ remit.

A spokesperson for the IPU said that pharmacists prescribing under the Common Conditions Service protect their patients by “operating in accordance with the legislation, clinical protocols and training underpinning the service”.

“Whilst pharmacists will make every effort to minimise the risk of errors occurring with this service, it is possible that errors may occur and indeed be reported to the Pharmaceutical Society of Ireland.”

Highest standard

A spokesperson for the PSI highlighted the body of work undertaken by it and other stakeholders to ensure the new service is of the highest standard.

“We developed the necessary statutory rules under the Pharmacy Act 2007 to underpin the education
and training infrastructure. We worked closely with the School of Pharmacy and Biomolecular Science in RCSI and the Irish Institute of Pharmacy to ensure that the mandatory pharmacist training for this service is clinically robust and proportionate. Regulation anchors all elements of the service — the training, clinical protocols, governance structures, and quality assurance — so that patients can be confident they are receiving safe and appropriate care.

“Regulatory oversight will continue to ensure that the service operates and grows safely, with each stage supported by the safeguards, clarity, and accountability required for effective implementation. A strong regulatory framework also supports continuous improvement by enabling learning from service data, evaluation of outcomes, and the development of future policy and legislation based on evidence.”