Clinical Governance Working Group

Clinical Governance Working Group

Procedure number: / UKMI-03
Procedure title: / Adverse Incident Reporting

Background:

It is recognised that adverse incidents (errors and near misses) can occur within the speciality of Medicines Information just as they can within any area of clinical practice.

The IRMIS database was launched on January 10th 2005 as a national incident recording system to allow senior medicines information staff to anonymously report adverse incidents that occur within their enquiry answering practice.

Incidents may be identified internally or externally through a number of mechanisms. Examples include:

Self checking prior to providing an answer (near miss)
Peer review
Internal QA
Direct from enquirers themselves/formal complaints
Use of past enquiries
External audit

All incidents should be handled confidentially, sensitively and promptly within a “fair blame” culture. Lessons learnt and solutions to prevent recurrence and improve practice should be shared as appropriate.

Notes:

This procedure only refers to those adverse incidents that are relevant to the practice of medicines information. Any other adverse incidents (e.g. health and safety related issues) will be dealt with by other departmental procedures if appropriate.

The IRMIS database is designed to complement individual Trust’s existing reporting systems and not replace them. Details of the adverse incident should also be submitted via the local Trust’s adverse incident reporting procedures.

Objective/aim of procedure:

To provide guidance on how adverse incidents should be managed by medicines information services.

Risk Management Notes:

1.To ensure that errors and near misses within medicines information services are identified, investigated and reported locally and nationally.

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2.To encourage learning from adverse incidents and devise solutions to prevent recurrence and improve practice.

3.To ensure that any emerging common themes are promptly identified and shared.

4.To allow medicines information services to share the acquired data with other relevant national bodies/groups (e.g. National Patient Safety Agency).

Note: UKMi defines errors and near misses as follows -

Error = any situation where wrong, misleading or incomplete information or advice which may or may not have caused harm to a patient, was given to an enquirer.

Near miss = any situation where wrong, misleading or incomplete information or advice which may or may not have caused harm to a patient, would have been given to the enquirer if an intervention had not been made (NB - this should not include anything picked up whilst processing the enquiry. If the incident is identified once an answer has been formulated, but before the answer was given, this should be classified as a near miss).

Procedure:

As soon as an adverse incident has been identified, it should be brought to the attention of the MI manager (designated deputy or other relevant senior member of pharmacy staff).
Within 3 working days of the incident being identified, the MI manager (designated deputy or other relevant senior member of pharmacy staff) should:

Investigate the incident independently
Discuss the incident with the relevant parties
Agree a course of action to resolve the incident and/or inform future practice to avoid recurrence.

The IRMIS paperwork may help with the above investigation and discussions (see

The incident will require more urgent investigation and action if patient harm has occurred or is likely to occur. If patient harm has occurred or information has been given out that may lead to patient harm in the future, the MI manager (designated deputy or other relevant senior member of pharmacy staff) should:

Acknowledge the incident with the relevant enquirer as soon as possible
Take immediate steps to correct any wrong, incomplete or misleading data
Document the action taken on the MI enquiry record and record any adverse sequelae that may have occurred

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The MI manager (designated deputy or other relevant senior member of pharmacy staff) should input the details of the adverse incident into the IRMIS database within 3working days of the incident being identified. It may be helpful for the member of staff involved in the incident to be involved in the preparation of the information to be submitted to the IRMIS database, however the actual data entry should be undertaken by the MI Manager as above.

The IRMIS database can be found via

Guidance notes on how to input data into the IRMIS database can be found via

The MI manager (designated deputy or other relevant senior member of pharmacy staff) should input the details of the adverse incident into the local Trust incident reporting scheme if appropriate. Relevant local procedures should be followed.

In addition the MI manager (designated deputy or other relevant senior member of pharmacy staff) should consider:

If appropriate, highlighting within local MI meetings, clinical pharmacist meetings, departmental meetings, etc

Including a summary of the adverse incident in any departmental clinical governance report.

Note: If the MI Manager was not involved in the above process, the individual who was involved should bring the incident to their attention at the earliest convenience.

Date of Issue:August 2006

Review Date:August 2007

Version Number:1.0

This version adapted by:(Name)(Signed)

This version approved by:(Name)(Signed)

Date:

Template Approved by: UKMi Clinical Governance Working Group