Open Disclosure

Background

On 12 November 2013, Dr James Reilly, Minister for Health at that time, launched the HSE National Policy and Guidelines on Open Disclosure. Open disclosure is included in the HIQA National Standards for Safer Better Healthcare 2012 and in the National Healthcare Charter 2012. The Open Disclosure Policy and Guidelines are currently being implemented on a phased basis across all health and social care services in Ireland.

What is open disclosure?

Open disclosure is an open, consistent approach to communicating with patients and their relevant person(s) when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the patient informed, providing feedback on investigations and the steps taken to try to prevent a recurrence of the adverse event.

Culture of openness

Health and social care services have a responsibility to ensure that there are effective systems, processes and resources in place to identify, manage and reduce risks to members of the public and staff. This requires a culture that encourages the notification of adverse events when they occur and which also promotes open, honest and timely communication between staff and patients following an adverse event.

When things do go wrong, patients and their families expect to be told honestly and openly about (i) what happened, (ii) how the harm that occurred is being managed, and (iii) what steps are being taken to try to prevent a recurrence to other patients.

Open disclosure should be seen as part of a continuing process of communication with patients about all aspects of their care and treatment, especially when things go wrong.

What patients expect in open disclosure

  • An acknowledgement that an adverse event has occurred
  • An explanation as to why it happened
  • An apology
  • Reassurance regarding their ongoing care
  • Involvement in their ongoing care plan
  • Information and reassurance in relation to the steps being taken, or planned, to try to prevent a recurrence of the event
  • To be involved in and kept informed in any reviews being undertaken and to be provided with a copy of the review report

Establishing a culture of open disclosure in pharmacies

The superintendent pharmacist and pharmacy owner, in partnership with the supervising pharmacist, are responsible for embedding a culture of openness among their staff. The successful implementation of a culture of open disclosure will require;

  • Leadership
  • Training
  • An open disclosure policy (aligned with the national policy)
  • Having adequate support systems in place for staff and patients/families affected by adverse events
  • Approaching open disclosure as a learning opportunity from adverse events
  • Recognition that the principle drivers for open disclosure are the needs, expectations and rights of patients
  • Having good systems of clinical governance in place

Resources and Support

A range of resources including guidelines and checklists are available on the HSE website.

Support and advice in the area of open disclosure is also available from open disclosure leads in your area.

Legislation

Open disclosure legislation within the Civil Liability (Amendment) Act 2017 has been progressed by the Government and commenced on 22 September 2018. This legislation provides protections for healthcare professionals and services in relation to the information provided at an open disclosure meeting and to any apology provided, in that the information provided and the apology cannot be used against them as an admission of fault or liability.

The Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018 take the form of prescribed statements as referred to in Part 4 of the Civil Liability (Amendment) Act 2017. These regulations came into operation on 23 September 2018. The regulations are related to the documentation of open disclosure in the form of written statements to be provided to the patient/relevant person at an open disclosure meeting. These forms have been prepared by the HSE and are available on the HSE website. The legislation sets out how open disclosure must be managed for staff (this includes pharmacists in the context of these provisions) to avail of the legal protections within the Act. The HSE has also prepared guidance for staff on the procedure as set out in the Act.

Further information on this legislation, the details of the protective provisions, and the forms and the procedure are available.

On 5 July, the government approved the general scheme of the Patient Safety Bill. This bill provides for mandatory open disclosure of serious events, mandatory external notification of patient safety incidents, clinical audit guidance and the extension of the remit of HIQA to private hospitals. It is likely that the Minister, in regulations accompanying this legislation, will define a list of the events requiring mandatory open disclosure. The Patient Safety Bill is likely to be commenced in the next 6 to 12 months.

Training

Training is currently being developed and will be made available online through the HSE website in the coming months. Pharmacists interested in becoming a trainer for open disclosure in their organisation should contact angela.tysall@hse.ie for further details.

Code of Conduct

Pharmacists should note that in the course of the review of the Code of Conduct for Pharmacists, the current and pending requirements with regard to the responsibilities of pharmacists from an Open Disclosure perspective have been considered. In particular, Principle 7 (Be open and honest) of the draft revised Code relates to some of the principles of open disclosure. The revised Code will be published in 2019.

The PSI will continue to keep pharmacists updated on developments in this area.

This update was included in Issue 5 of the PSI Newsletter (December) 2018