Niamh Cahill reports on the first National Open Disclosure Framework Stakeholders Annual Report
The National Open Disclosure Framework was launched in October 2023. Since this time its implementation has been progressing across healthcare organisations nationally, including the HSE and the Pharmaceutical Society of Ireland (PSI).
Minister for Health Jennifer Carroll MacNeill recently published the first National Open Disclosure Framework Stakeholders Annual Report, which sheds light on the work of healthcare providers in implementing the framework.
Each stakeholder has specific obligations under the Framework that must be fulfilled within their organisations.
The PSI, as a professional regulator, is one of many healthcare organisation that has obligations under the Framework.
Open disclosure is defined by the HSE as “an open, consistent, compassionate, and timely approach to communicating with patients or, where appropriate, their relevant person (or both of them) following patient safety incidents or notifiable incidents”.
According to the Department of Health, it “includes apologising and expressing regret for what has happened, keeping the patient informed and providing reassurance regarding ongoing care and treatment, learning and the steps being taken by the health or social care service providers to try to prevent a recurrence of a similar incident”.
Despite being launched two years ago, the policy initiative is still very much in its infancy, according to the first National Open Disclosure Framework Stakeholders Annual Report.
The inaugural annual reporting exercise began on March 3, 2025 and concluded on April 4, 2025.
Openness
The framework stems from the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, which became law in September 2024. The legislation requires openness and transparency when patient safety incidents occur and seeks to undo a healthcare culture that has been dogged by a lack of transparency in the past.
On launching the annual report, Minister Carroll MacNeill said: “The development of this Framework marks a significant milestone in fostering a cultural shift within our healthcare service. The collaborative efforts of stakeholders have focused on creating a culture of open disclosure to promote transparency and accountability in patient care.
“By nurturing an environment where healthcare professionals feel confident communicating openly with patients when things go wrong, we can improve patient safety, build trust, and enhance the overall quality of care.
“A culture of open disclosure is crucial for improving the quality and safety of our health and social care services. I strongly believe in the positive impact and difference that open disclosure can make. The patient remains at the centre of everything we do, and we must prioritise openness and transparency in all healthcare interactions.” Some stakeholders, such as the
HSE, have made significant efforts in implementing the Framework, while others have more work to do, the report shows.
The PSI was among a number of organisations that submitted a report to the Department of Health on their efforts on open disclosure, while the Pre-Hospital Emergency Care Council, for example,
did not submit a report, according to the annual report.
Requirements
Professional regulators like the PSI have seven requirements under the Framework. They must first “develop a policy in relation to open disclosure to support registered professional practitioners to embed open disclosure into their individual practice,” according to the Department.
They are required to embed open disclosure in codes of conduct/ethics, guidance, and standards and ensure that open disclosure is incorporated in all undergraduate and postgraduate approved academic health and social care programmes with clinical and practical components.
They are obligated to ensure that all approved clinical training sites involved in the delivery and supervision of student clinical and practice placements have a policy on open disclosure and they must review and approve CPD courses on open disclosure.
An annual report on their efforts under the Framework must be submitted to the Department of Health and they must keep a record of the number of complaints received related to open disclosure and analyse issues raised in any complaints.
According to the recently published annual report, the PSI plans to review the need for a static policy document in 2025.
The report also notes the PSI’s efforts within education and training.
“PSI have been monitoring the implementation of the open disclosure framework requirements in the integrated MPharm programmes through their accreditation processes, which most recently took place in January and February 2025, and feels confident that the schools are taking the initial steps for incorporation. Additionally, a section specifically on open disclosure has been added to the annual reports that the three schools of pharmacy submit each year,” the report outlines. While the PSI has a system in place to receive complaints relating to Open
Disclosure, it had yet to receive any complaints, according to the report.
SOP
In a response to a series of questions posed to the PSI, a spokesperson told Irish Pharmacist (IP) that its requirements involve monitoring and reporting on the implementation of the Open Disclosure Framework, “including that pharmacies have appointed an ‘open disclosure champion’ and have a documented policy or Standard Operating Procedure (SOP) around managing patient safety incidents, including an associated training and support structure for all pharmacy staff”.
“In support of our obligations, a comprehensive training programme focused on Open Disclosure in pharmacies was procured through the Irish Institute of Pharmacy (IIOP) earlier this year and will be available to pharmacists this October on the IIOP’s e-learning platform. It aims to raise awareness amongst all pharmacists — particularly those in community pharmacy settings — about their responsibilities under the Framework.
“The PSI is the statutory body responsible for receiving complaints about pharmacists and pharmacies. In our report to the Minister for Health on our requirements, we must also include data on any complaints received that relate to open disclosure and, where appropriate, an analysis of these matters. Any relevant inspection and complaint data for the period will be shared as part of our next annual report to the Department in Q1/Q2 2026.”
In the annual report, the PSI outlined that in order to review its obligations of pharmacies as health service providers, the PSI would begin inspecting in 2025 “to ensure all retail pharmacy businesses have open disclosure policies in place” (even if they do not accept pharmacy students).
When asked how the inspections would be conducted, the spokesperson advised that: “We have already incorporated updates into the inspections undertaken for new pharmacy openings since mid- September 2025. Further integration into other inspection formats will commence from January 2026.
“This will include reviewing how pharmacists and pharmacies are meeting their obligations under the Framework. We will include all relevant activities in our next report to the Minister for Health.”
Lack of information
It appears, however, that a lack of information and awareness among the pharmacy profession regarding their requirements on open disclosure exists, with many pharmacists still unaware exactly how the framework will impact them.
Information on inspections and around open disclosure more generally appears to be lacking among community pharmacists.
Duleek-based pharmacy owner and pharmacist Kathy Maher said that it was her understanding “that pharmacists should have an open disclosure policy in place, ensure all staff have had open disclosure training and demonstrate a culture of open disclosure in practice”.
“I would hope that more detail is forthcoming soon,” she added.
A policy document on Open Disclosure has not been developed by the PSI, however.
A spokesperson for the regulator told IP that relevant policies and documents developed by the PSI since 2024 have included the term ‘open disclosure’ where it has been appropriate. “The PSI believes that the core elements of open disclosure are appropriately addressed within the PSI Code of Conduct for pharmacists and our Core Competency Framework, where open and honest communication, legal and ethical practice, and person-centered care are incorporated throughout. Future reviews of these will consider whether they continue to be sufficient, given best practice, feedback, and learnings on application of the Framework at that point,” the spokesperson added.
Kerry-based pharmacist Jack Shanahan said that in community pharmacy, if a first person contacted would be the pharmacist’s insurer.
“Open disclosure is a great idea but unless it’s implemented properly as a learning platform and as a way
to improve services as distinct from something to be used as a human resources tool, which is what it is being seen as being used as, then it’s very hard to see how it’s going to progress,” Mr Shanahan said.
He added that he did not feel he was receiving adequate information and support from the PSI in implementing open disclosure, while stressing that the regulator has “an awful lot of things on its plate”.
“A regulator has a difficult job to do… it [PSI] is more fit for purpose than it was, but it is still finding itself to a certain extent. I think most pharmacists would feel that the PSI could be more helpful
in improving the standards of life for pharmacists and I think that would have a better impact on public safety than being overly restrictive on certain things.”
Mr Shanahan said it was not surprising that the PSI had not received any complaints related to open disclosure, according to the report.
“It doesn’t feature highly on anybody’s agenda to be honest. Within hospitals it has a higher profile but within the community, you have to bear in mind community pharmacy is a series of islands in its own way, every pharmacy works in its own right while quite a few are parts of groups.
“One of the things we have to do is we track errors and try to learn from mistakes made, as there are always things that can be done better, and there are always issues arising, and you have to make sure you have a system in place to learn from it, and we do it (error tracking and error reporting). But I think the open disclosure conversation broadly hasn’t happened yet in community pharmacy.”
With regard to inspections on open disclosure, he queried what that would entail exactly and said further information would be helpful.
