Responding to medication safety alerts and notifications

Medication safety alerts and notifications

Organisations receive multiple types of medication safety communications. Each notification should be acknowledged and assessed for local relevance. A risk assessment should be undertaken and appropriate actions implemented where required. Organisations may choose to record all safety notifications and their organisational response through their local governance meetings.

National Patient Safety Alerts

National Patient Safety Alerts are issued by a range of accredited national bodies where there is a risk of serious harm to patients. These alerts set out actions that healthcare organisations must take to reduce an identified risk.

Once an organisation has completed all the actions required of a National Patient Safety Alert, the organisation must respond via the Central Alerting System (CAS).

A useful flow chart is available on the CAS website describing the provider process for managing National Patient Safety Alerts.

Failure to take the actions required under any National Patient Safety Alert may lead to the Care Quality Commission (CQC) taking regulatory action.

For more information on CAS see below.

MHRA safety communications

The Medicines and Healthcare products Regulatory Agency (MHRA) issue a number of safety communications to notify healthcare organisations and healthcare professionals of risks with medicines and medical devices. More information on the different communications can be found on the MHRA website.

Drug Safety Updates

Drug Safety Updates communicate necessary actions that healthcare professionals should take to reduce a specific medication safety risk. They may also be used to raise general awareness around risks with medicines.

Device Safety Information

Device Safety Information alerts communicate safety messages to support the safer use of medical devices.

Medicines Recalls or Notifications

Recalls and defect notifications are used to alert healthcare professionals of defective medicinal products. They are issued by the Defective Medicines Report Centre (DMRC) and notify healthcare professionals of actions required to mitigate the risk.

Health Services Safety Investigation Body

The Health Services Safety Investigations Body (HSSIB) is an independent arm’s length body of the Department of Health and Social Care. It investigates patient safety concerns across the NHS in England where lessons learned could help improve the safety of NHS care. Medication safety is one of the themes covered by its investigations. Following each investigation, HSSIB publishes reports that include safety recommendations for the healthcare system, or local level learning prompts for organisations.

Receiving alerts

Medication safety alerts enter organisations via a variety of mechanisms.

Central Alerting System (CAS)

The Central Alerting System (CAS) is a web-based cascading system for issuing National Patient Safety Alerts, important public health messages and other safety critical information and guidance to the NHS. Organisations should have a dedicated point of contact, often via a generic or shared email box, to ensure timely acknowledgement and cascade of safety critical alerts.

Notification of other alerts

Organisations and individual healthcare professional can register directly with the organisations for notification of other safety notifications.

• Register directly with the MHRA.
• Register directly with HSSIB.

Acting on safety alerts and notifications

Organisations should have a governance structure in place to provide assurance that all medication related alerts and notifications are acknowledged and led by a nominated person.

Nominating a lead

An operational lead is needed to ensure delivery of any required actions from an alert. Executive oversight is also required for complex National Patient Safety Alerts to provide assurance to the board and to aid the embedding of actions across the organisation.

Where the alert is medication related consideration should be given to whether the Medication Safety Officer (MSO) should be part of the multidisciplinary team co-ordinating the organisational response.

Scoping

There are a number of methods to gain intelligence on the extent of the medication safety issue within the organisation. Examples include:

• dispensing and prescribing reports to identify product usage
• reviewing area stock lists
• physical review of stock-holding areas to find out what is stored in each area and how
• finding out what’s available on all ordering systems
• discussion with lead clinical experts
• liaising with professional leads
• discussion with front line staff

Actioning an alert

Some alerts will require a formal response from your organisation but others will not. Regardless, your organisation should assess your local position in relation to each alert, considering whether it affects the organisation and whether there is potential for harm.

Stakeholder engagement

Engagement with all key stakeholders ensures an organisational wide response, incorporating all systems and users.

Engagement will:

• ensure effective communication of both the risk, local issues and any change required
• provide a variety of views and opinions, leading to effective actions
• encourage the development of local champions which is essential for any sustained change, and
• support the timely delivery of the action plan.

Identification of stakeholders

Stakeholders should be multidisciplinary and include:

• strategic leaders (decision makers)
• clinical experts (related to the issue)
• pharmacy representation
• Medication Safety Officer (MSO) or deputy
• frontline users from across the organisation
• system representation (where issues span across care interfaces)
• patients and carers (where appropriate)

Deadline for actions

National Patient Safety Alerts are published with a target deadline for actions. Where immediate actions are required, the alert will have a shorter deadline.

It is important that the review and implementation process starts immediately.  Actions should be given a realistic timeframe to ensure delivery before the deadline.

Organisations may find it useful to set their own deadlines for other safety notification action plans.

NHS Trusts and Foundation Trusts with National Patient Safety Alerts remaining open past their deadline will be published on the CAS website.

Documenting alert actions

Recording the organisational actions taken in response to a safety alert is essential for demonstrating accountability and showing that risks are being actively managed. Using electronic systems to document these actions makes the process more consistent, reliable and fully auditable.

Escalation

Concerns or identified barriers to delivering the action plan within the required time frame should be escalated in a timely fashion through the agreed organisational mechanism. In some organisations this will be the Patient Safety Group, or it could be directly to the named executive lead.  Escalation can prompt support with engagement, identification of solutions and may release capacity.

Compliance

The organisation should consider how it will demonstrate that it meets the requirements of the alert and implement methods to ensure these are sustained.

Sustained compliance

The organisation should consider how it will sustain compliance with the safety recommendations of an alert. The alert action plan should promote embedding change and the continual review of practice and systems

Methods to give confidence of sustained compliance include assurance reports, audit and spot checks. Planning automation of assurance feedback will make this easier to sustain.

Historical alerts

MSOs should be familiar with historical alerts and ensure that previous actions developed to address the issues are sustained and monitored within their organisation.

NHS England’s enduring standards have been published to highlight actions from previous patient safety alerts that remain valid and are unlikely to change in the immediate future. NHS England has also set out aspects from previous alerts that have been identified as continuing to apply to broader safety initiatives.

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