Reporting and management of medication safety events

Reporting management systems

Organisations use incident reporting and management systems to record incidents, claims, complaints and safety alerts. An MSO will need to know and understand their local system to ensure the responsibilities of the role are met.

These systems support efficient and effective incident management including categorisation of incidents for thematic review and data analysis to support improvement work.

Managing medication incident reports

System access

An MSO will require access to the organisational incident reporting system and have a level of privilege within the system to review, revise and approve incidents where appropriate. The ability to interrogate and create reports within the system supports the monitoring of trends and thematic analysis. The organisation’s incident reporting system manager or lead should be contacted to arrange access and appropriate system privileges.

Classification

Type

Most systems classify incidents by ‘type’, This allows for filtering of incidents and focused interrogation of the data.  ‘Medication incident’ is often an option and is useful for an MSO when reviewing reports. Further subcategories for each part of the medicines use process can be useful for thematic review but may cause confusion when the incident involves multiple parts of the process.

Categories available within the system should support the organisation in their considered and proportionate response to medication incidents. For example, incidents within a theme that is currently the focus of improvement work need not be individually investigated. Correct categorisation at the point of reporting can support this.

There may be elements of medicines use and safety in incidents reported which are not classified as ‘medication’.  Medication omissions or delays attributed to lack of staff for example, may be reported as ‘infrastructure’ or ‘inadequate staffing’.

Harm

Classification of harm may inform the level of action required following the incident.

Harm caused by medication incidents can be physical as well as psychological. Current descriptions of harm can be found on the NHS Patient Safety workspace on the Future NHS platform (login required) in the ‘Learning from Patient Safety Events (LFPSE)’ section.

MSO notification

Where possible an automatic notification should be sent to the generic MSO email when an incident classified as ‘medication’ is reported. This facilitates oversight of all medication incidents and may assist with trend analysis and recognising emerging trends.

Strong relationships between central governance teams and clinical divisions should ensure the MSO is notified of incidents where a medication use related issue is present, but the incident has not been classified as ‘medication’.

Data quality

An MSO should ensure that staff reporting incidents and events within the organisation do so in a timely fashion and supply sufficient relevant information. Staff may benefit from training on how and what to report. Data within the system may need to be cleansed at a local level to ensure that incidents are reported under the correct classification, which will facilitate thematic analysis.

Promoting event reporting

Increased medication safety event reporting provides greater opportunities for learning and improving medication safety.

Ability to report

All healthcare professionals within the organisation require access to the organisational reporting system. An MSO should have assurance that anyone involved in or informed of a medication safety event is aware of how and what to report.

Some systems are set up to report incidents separately from excellence reports.

Barriers

Barriers to reporting should be addressed. These may include limited access and poor usability of the system, fear of perceived repercussions to reporting and failure to feedback outcomes from the report to the reporter.

Access

Making access simple may support reporting. Linking any electronic reporting systems with other systems routinely used may simplify access, for example links from electronic prescribing systems.

Usability

Consideration should be given as to whether individuals within the organisation require training on when and how to use the reporting system.

Reducing fear

Staff need reassurance that organisations will endeavour to implement systems solutions rather than focus improvement at an individual staff level.

Feedback

Providing feedback to reporters on how the event has been managed and any outcomes from the report gives positive reinforcement and may encourage further reporting.

Supporting staff

Healthcare professionals who are involved in patient safety incidents need to be supported in the period following the incident. The emotional impact of being involved in an incident should not be underestimated. Local occupational health and wellbeing teams should be contacted where necessary.

Being fair

Patient safety incidents are rarely due to a single individual but signs of underlying systemic issues. It is important to foster an open culture and ensure consistent, constructive and fair evaluation of actions of staff involved in patient safety incidents.

The NHS England being fair tool can help staff decide what next steps to take in the rare circumstance a learning response raises concerns about an individual’s conduct or fitness to practise.

Managing suspected adverse effects

The MHRA yellow card scheme collects and monitors information on suspected safety concerns involving healthcare products, including side effects of medicines, adverse medical device incidents and potential defective or falsified medicines. The scheme is used to identify issues which might not have been previously known about and the purpose is to provide an early warning that the safety of a product may require further investigation. As the UK regulatory authority for medicines, the MHRA will take action to ensure safety where required.

It is expected that MSOs will be advocates of and encourage yellow card reporting within their organisation.

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