High quality reporting and management of incidents and harms ensures opportunities for learning and improving medication safety

Role of the Medication Safety Officer

The Medication Safety Officer (MSO) is the named individual within an organisation responsible for managing and promoting medication incident reporting.

The MSO has a responsibility to ensure that reporting of incidents translates into learning.

There is opportunity for MSOs to use their expertise from medication incident management to include the review of medication related harms, adverse effects, complaints and patient engagement in order to promote learning and implementation of safer practice.

Reporting management systems

Using a reporting management system (or equivalent) provides collated information of what led to, or had the potential to, cause harm.

Each organisation will have specific reporting systems for different issues, such as incidents, claims, complaints and mortality. An MSO (or equivalent) will need to know and understand these systems to ensure the responsibilities of the role are met.

Managing medication incident reports

System access

An MSO (or equivalent) 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.

Using the system

To gain a full picture of medication related reports, an MSO (or equivalent) will need to find out how different reporting systems interact. It is useful to understand the full coding structure of the incident reporting system.



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.

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’.


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 description of harm can be found on the NHS Patient Safety Future NHS workspace on the FutureNHS platform 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.

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

The organisation should have a governance structure in place to ensure the MSO is made aware of when a medication related incident issue is reported via routes other than the incident reporting system, for example complaints and through the pharmacy Medicines Advice team.

Data Quality

It is important the data is of high useful quality to ensure that the required learning can be extracted for the investigations. An MSO should ensure that staff reporting incidents/events within the organisation do so in a timely fashion and supply sufficient relevant information.  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.

Managing suspected adverse effects

The yellow card scheme run by the MHRA 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 more further investigation.  As the UK regulatory authority for medicines, the MHRA will take prompt action to ensure safety where required.

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

Managing information from other sources

Information about events which led to patient harm may come from a number of sources. This information can be extracted, managed and translated into learning, which may reduce future potential harms. The MSO (or equivalent) has the expertise and focus on medication safety to recognise these opportunities.

Organisations require a governance structure to ensure that if a medication incident or potential harm is identified via any route that it is reported on the incident management system.  This will ensure the information is included in any escalation for wider learning.

Deaths and complaints

It is recommended that an MSO has involvement in mortality reviews and sight of the complaints reporting system within an organisation to promote learning from deaths and learning from complaints.

Patient and user engagement

A patient or user of a service may make contact to inform the organisation of an incident or harm. There is value in using their perspective of events to inform any investigation or subsequent implementation of safer practice.

Further resources

Guidance on Promoting medication incident reporting is available

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