Open Disclosure is an open, honest, empathic, and timely approach to communicating with patients and their families when things go wrong in healthcare.

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 was enacted in September 2024. The legalisation aims to embed openness and transparency in healthcare settings in Ireland, including in private healthcare. The Act sets out the legal framework for the reporting and the management of incidents for mandatory open disclosure and includes a list of specific patient safety incidents that must be reported. Noticeable incident must be reported to the Health Information and Quality Authority, Chief Inspector of Social Services and the Mental Health Commission.

The Department of Health has also developed a Patient Safety Act guidance document to assist stakeholders in understanding the provisions of the Act.

 

What are the legislative provisions around ‘Open Disclosure’? 

There are 13 specific notifiable incidents which are explicitly bound by legislation in how they are responded to and are subject to mandatory reporting. These include incidents involving surgery, use of blood products, or an unexpected death in hospital.

 

Notifiable Incident 8

Notifiable Incident number 8 is described as a “Patient death associated with a medication error and the death was unintended and unanticipated as it did not arise from or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.”

 

What is a ‘Designated Person’ under the Act?

A ‘Designated Person’ is someone who has been assigned to act as a liaison between the health services provider and the patient or relevant person (or both of them) in relation to the open disclosure of the notifiable incident and in respect of a request for clarification under section 23.

A ‘designated person’ is not a permanent role. This person is only required when open disclosure of a particular notifiable incident is necessary. In the case of an independent pharmacy, it is likely that this will be the Superintendent Pharmacist. Again, it is important to note that this requirement is in respect to open disclosure of ‘notifiable incidents’.

 

National Open Disclosure Framework

The National Patient Safety Office (NPSO) of the Department of Health developed the National Open Disclosure Framework. This policy document is to aid in the implementation of the new patient safety and open disclosure legislation.

The National Open Disclosure Framework aims to promote a clear and consistent approach to open communication, by health and social care service providers and other organisations where appropriate, with patients/service users and any relevant support person, following a patient safety incident or an adverse event. It aims to provide a unified and consistent approach to open disclosure across the entire health sector:

• Public and private health and social care service providers (this includes community pharmacies);
• Service regulators;
• Health and social care professional regulators such as the PSI; and
• Health and social care educators.

The Framework is designed to be used in the development, or upgrading, of an organisation’s internal policies, processes, education and training, and practices regarding patient safety incidents and adverse events.

The Framework ensures that the rights of all patients/service users and health and social care staff involved in and affected by patient safety incidents and adverse events are met and respected.

The Framework provides six overarching principles that are expected to be used to underpin open disclosure in practice, including in pharmacy practice (see Table 1).

 

Table 1: Principles of the National Open Disclosure Framework

Principle 1: Open, Honest, Compassionate, and Timely Communication

Principle 2: Patient/Service User and Support Person’s Entitlement in Open Disclosure

Principle 3: Supporting Health and Social Care Staff

Principle 4: Promoting a Culture of Open Disclosure

Principle 5: Open Disclosure for Improving Policy and Practise in Health and Social Care

Principle 6: Clinical and Corporate Governance for Open Disclosure

 

Definitions observed within the Framework

Patient safety Incident

A patient safety incident, in relation to the provision of a health service to a patient by a health services provider, means “an incident which occurs during the course of the provision of a health service”, which:

1. Has caused an unintended or unanticipated injury, or harm, to the patient;
2. Did not result in actual injury or harm to the patient but was one which the health services provider has reasonable grounds to believe placed the patient at risk of unintended or unanticipated injury or harm; or
3. Unanticipated or unintended injury or harm to the patient was prevented, either by “timely intervention or by chance”, but the incident was one which the health services provider has reasonable grounds for believing could have resulted in injury or harm, if not prevented (Civil Liability (Amendment) Act 2017).

Therefore, a patient safety incident includes harm events, no harm events, and near miss events.

 

Adverse event

An adverse event is an incident which resulted in harm that may or may not be the result of an error.

 

Open disclosure champion

Open disclosure champions must be identified and appointed by health and social care service providers to lead and promote open disclosure policy, education, and training, and monitor practice.

Any pharmacy staff member can be nominated as a champion, for example a pharmacist/owner, pharmacy technician, manager or other staff.

 

What does the new Open Disclosure legislation and Framework mean for community pharmacy practice?

 

For pharmacists working in patient facing roles, they must:

• Familiarise themselves with the new legislation, the framework, and the definition of incidents within these; and
• Review policies and SOPs that have been updated due to the new legislation and framework. Undertake training on open disclosure

 

For pharmacists undertaking governance roles and pharmacy owners, they must ensure robust policies and SOPs are in place which underpin open disclosure practices and support a culture of open disclosure in the pharmacy. This may include:

• Development and implementation an Open Disclosure Policy. The content of this policy will be informed by:
  • The new Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023;
  • The National Open Disclosure Framework; and
  • HIQA reporting requirements.
• Update existing SOPs on incident management to reflect the Open Disclosure Policy. Some SOPs that may need to be reviewed include:
  • Incident reporting;
  • Incident management;
  • CAPA processes; and
  • Management of customer complaints.
• Development of new SOPs for management of an open disclosure meeting;
• Provide training for all staff on open disclosure. This may include the following:
  • Completion by all staff of the HSELanD training module on open disclosure;
  • Training on the open disclosure framework; and
  • Reviewing the content of the IPU open disclosure section of the IPU website.
• Maintain records of staff who have completed open disclosure training;
• Maintain a record of open disclosure events initiated and closed;
• Appoint an open disclosure champion to monitor the implementation of all open disclosure policies, training and SOPs in the pharmacy;
• Develop a support structure for all staff, should there be an incident that required open disclosure. This may include signposting staff to the VHI EAP and other employee supports provided by the IPU; and
• Implement policies/systems for monitoring and continuous learning and improvement around open disclosure.

 

There may be additional annual reporting requirements on open disclosure to the Department of Health for community pharmacies, dependant on the number of employees in the community pharmacy, or chain of community pharmacies. The IPU are awaiting further information on this from the Department of Health.

 

What happens if a medication safety incident occurs in my practice?

The incident should be reported as per incident management policy and SOPs implemented at the pharmacy. Identify the category level the incident falls into. For example, the Framework notes that different approaches may be taken to open disclosure, depending on whether a ‘low’ or ‘high’ level response is required. The level of response required will be defined by the degree of harm the patient has experienced, the level of additional interventions or treatments required because of this harm, and the expectations of the patient and their support person. Responses may vary from one open disclosure meeting to a number of meetings.

Examples of where ‘lower’ level responses might be required include:

• Near misses and no-harm incidents;
• No increased level of care required; or
• No, or minor psychological, or emotional distress.

 

What happens if a Serious Notifiable incident occurs in my practice?

Firstly, it is imperative to appropriately manage the situation in the immediate aftermath of the patient safety incident or adverse event to avoid any possible or further potential harm to the patient.

The incident should be reported as per incident management SOPs implemented at the pharmacy which reflects the requirements of the Patient Safety Act. As outlined policy and SOPs should include:

• Support offered to staff involved in the patient safety incident or adverse event as appropriate to their needs;
• Effective internal communication processes between staff involved to avoid mixed messaging which could cause confusion and further distress to the patient/service user; and
• Communication with patients/service users and their support persons must be compassionate, truthful, timely, and clear. If things go wrong, the patients/service users and their support persons must be provided with information about what happened in a timely, open, compassionate, and honest manner.

A notifiable incident must ALSO be reported via the National Incident Management System (NIMS) to HIQA. For community pharmacists there is a specific NIMS portal to be used for reporting. There is further information on the NIMS on the HIQA website including specific guidance for health service providers on how to notify HIQA of a notifiable incident under the Patient Safety Act.

An open disclosure meeting must be held with the patient and/or their representatives. A designated person should lead on this meeting.  The Framework provides a useful checklist of issues to consider prior to this meeting.

When a patient safety incident or adverse event occurs, patients/service user and their support person want:

• An acknowledgment of what happened;
• An explanation of what happened and why;
• An apology and reassurance as to their ongoing treatment and care; and
• The steps being taken to prevent a recurrence of the incident.

 

Image 1: Open Disclosure Process 

 

Further information

The PSI has published information on open disclosure which can be accessed via psi.ie > Information and Resources > Open Disclosure. For further information please visit ipu.ie > Professional or contact the IPU professional services team on pharmacists@ipu.ie.