Open Disclosure

New patient safety legislation has been commenced that requires mandatory open disclosure processes in specific, rare, but very serious, circumstances. Additionally, a new national open disclosure framework has been produced that sets out requirements and expectations across all health and social care settings and seeks to ensure a clear and consistent approach to open disclosure in practice.  

What is open disclosure

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

Sometimes, and in other jurisdictions, you might see open disclosure referred to as ‘open communication’, ‘duty of candour’, or ‘being open’.   

The HSE Open Disclosure Policy defines open disclosure as “an open, consistent, compassionate, and timely approach to communicating with patients and, where appropriate, their relevant person(s) following patient safety incidents. This includes expressing regret for what has happened, keeping the patient informed, and providing reassurance in relation to on-going care and treatment, learning, and the steps being taken by the provider to  prevent a recurrence of the incident.”   

The principles of open disclosure are captured in the PSI’s Core Competency Framework and in the Code of Conduct, where open and honest communication, legal and ethical practice, and person-centred care are incorporated throughout.    

What are the legislative provisions around ‘Open Disclosure’? 

On 26 September 2024, the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 commenced. This Act provides a legislative framework for mandatory open disclosure and aims to embed openness and transparency in healthcare settings in Ireland, including in private healthcare. The Act contains a list of very rare, very serious incidents. These specific notifiable incidents are explicitly bound by legislation in how they are responded to and are subject to mandatory reporting through the National Incident Management System (NIMS). You can find more information on 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. 

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

In addition to the legislative requirements for defined notifiable incidents, the National Patient Safety Office (NPSO) of the Department of Health developed The National Open Disclosure Framework.

The Framework seeks to further embed structures for transparency and open communication from all health and social care professionals with patients following a patient safety incident or an adverse event.   

The Framework provides six overarching principles that are expected to be used to underpin open disclosure in practice, including in pharmacy practice. You can read more about these in the Framework. 

Patient Safety Incident or Adverse Event 

A patient safety incident is an incident that occurs during the course of the provision of a health service that: 

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 to believe could have resulted in injury or harm, if not prevented.  (Civil Liability (Amendment) Act 2017)

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

What does the Framework mean for a pharmacist or a pharmacy owner?  

A patient-facing Pharmacist  

All patient-facing pharmacists must ensure they are aware of the new legislation, the framework, and the overall expectations should a patient safety incident or adverse event arise.  

A Pharmacy Owner and Superintendent and/or Supervising Pharmacist  

Pharmacists in governance roles and pharmacy owners are required to ensure robust policies are in place which underpin open disclosure practices and support a culture of open disclosure in the pharmacy. Pharmacists and relevant members of the pharmacy team must receive training on the open disclosure policies that are in place and on how to appropriately respond to patient safety incidents, such as medication errors, in the pharmacy.  

Policies and Procedures in your Pharmacy  

The Framework provides guidance on open disclosure policy requirements for pharmacies as health and social care providers.   

At a summary level, the Framework requires that open disclosure policies in the pharmacy should ensure that the pharmacy team, as relevant to their roles, understand: 

• what open disclosure means,  
• what types of incidents require open disclosure,  
• the information that must be provided to patients,  
• how open disclosure processes should be managed,  
• what is disclosed and how it works 

The policies should:   

• empower the pharmacy team to report patient safety incidents and adverse events 
• set out how to communicate with patients and their support persons openly in relation to any such incidents.
• ensure that open disclosure is managed in a manner that is compassionate, caring and empathetic toward all those involved in and/or affected by patient safety incidents or adverse events.

Levels of Response 

The Framework includes an open disclosure process diagram (see below) which outlines all possible considerations when designing an open disclosure process and pharmacies should update or design their policies with this in mind.

Guidance is provided on each of the steps in the Framework. 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, for example.

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

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

The Framework notes that it is likely that ‘low-level’ responses will not require all the steps described in the diagram.

For those incidents requiring a high-level response, pharmacists must first determine whether the incident is a ‘notifiable incident’, as listed under Schedule 1 of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2003. Notifiable incidents must be responded to as set out under the Act. 

Additional considerations for policy development, as set out in the Framework, include but are not limited to: 

• Provision of appropriate medical care, treatment, and support services to patients following patient safety incidents.
• Requirements revolve around timely communication with the patient and their support person. 
• Communicating with younger people under the age required for medical consent and/or other vulnerable persons.
• The role of a designated person for dealing with clarification requests received from the patient and to maintain a seamless line of communication between the patient, the support person, and the pharmacy.  
• Preparation for and provision of information at open disclosure meetings.
• Expectations around apologies and expressions of regret.
• Record-keeping and confidentiality requirements.
• Processes for the provision of additional information, on-going communication and follow-up care.
• How to close out an open disclosure process, including consideration of whether a summary of the process should be provided to the patient and their support persons, asking if there are any outstanding concerns or complaints about the process, and consideration of any further action arising from this.
• Support requirements for the pharmacy team following patient safety incidents. 

A culture of open disclosure 

The superintendent pharmacist and pharmacy owner, in partnership with the supervising pharmacist, are tasked with establishing and embedding a culture of openness in the pharmacy. The Framework notes that successful implementation of a culture of open disclosure will require: 

• Policies/systems for monitoring and continuous learning and improvement around open disclosure. 
• Leadership and designation of an ‘open disclosure champion’ who can lead and promote open disclosure policy, education/training, and monitor practice. 
• Opportunities for open communication, engagement, and feedback from all pharmacy team members as well as patients/support persons, including mechanisms to assess how well the culture and practice of open disclosure are working. 
• Training and development for all pharmacy team members.