Who issues medication safety alerts?
The Medicines Healthcare Products and Regulatory Agency (MHRA) is responsible for issuing medication and medical device safety alerts.
How are these communicated?
This autumn, the way the MHRA communicates safety alerts is changing. All medication safety and critical alerts that need to be actioned by healthcare organisations will be issued by The National Patient Safety Alerting Committee (NaPSAC) and meet the criteria set below:
- National Patient Safety Alerts are only issued for safety-critical issues (those that have a risk of death or disability) that need organisations to act
- Alerts explain risks clearly and effectively
- Have required actions that have been assessed for feasibility, safety, efficacy and cost-effectiveness
- Can be quickly recognised and actioned by senior personnel
- Have actions that are SMART (specific, measurable, achievable, realistic and timely)
The introduction of these new alerts is expected to result in a lower number of national alerts being issued.
Drug alerts and medicine safety communications that do not meet these criteria will continue to be made in the current format. Alerts for medical devices will change in due course and this will be communicated later.
All healthcare providers that currently receive medical device alerts and drug alerts should now ensure that they subscribe to receive National Patient Safety Alerts.
How to register for the new system
Independent health and social care providers registered with the Care Quality Commission (CQC) can sign up to receive safety alerts via email by contacting the CAS Helpdesk on firstname.lastname@example.org
- Full name of the organisation
- Business of organisation
- First and last name
- Job title
- Full postal address
- Email address for CAS alerts
- Telephone number
- Mobile number
The CAS helpdesk can be accessed here.
All national patient safety alerts need executive level oversight (or equivalent in organisations without executive boards) of governance systems that provide evidence that the required actions have been fully completed before any National Patient Safety Alert is recorded as action completed on the Central Alerting System (CAS).
A CAS officer at a healthcare provider will typically be the person receiving the alert when issued and who (after confirmation from the executive team) has the responsibility of updating the CAS system to say that all actions have been completed. Please see figure 1. above – Drug Device Recall Pathway.
National Patient Safety Alerts are designated as being either complex, or straightforward.
Complex alerts require actions that cannot be delivered by any single division or professional group within an organisation and will require the organisations executive leader to nominate a senior clinical leader relevant to the alert to co-ordinate delivery.
Straightforward alerts may be actioned on behalf of the whole organisation by agreed senior leaders. For example, they can ensure that all stocks of a drug with that specific batch number are removed.
Each healthcare organisation is responsible for responding to patient safety alerts and declared compliance with those alerts is a key safety indicator. This is a hot topic for all CQC inspections.
Each healthcare organisation is responsible for responding to patient safety alerts and declared compliance with those alerts is a key safety indicator. This is a hot topic for all CQC inspections. This new process should be incorporated into all relevant standard operating procedures. The CQC will expect to see these updates being monitored and acted upon in a timely manner.
How do I contribute to patient safety?
In addition to being able to report adverse clinical events involving medication, all staff should know how to report a medicine or medical device quality issue.
There are currently two national reporting systems for incidents involving medical devices. The MHRA oversee one and NHS England oversees the other – the National Reporting and Learning System (NRLS).
The NRLS defines a patient safety incident as any unintended or unexpected incident which could have or did lead to harm for one or more patients receiving NHS care. NRLS reports include a wide variety of incidents such as falls, diagnosis, surgery, medication and medical devices.
The MHRA defines a reportable ‘adverse event’ as any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or instructions for use.
Any event that meets these three basic reporting criteria should be reported to the MHRA:
a. an event has occurred
b. a medical device is suspected, or cannot be ruled out, as a contributory cause of the adverse incident
c. the event led, or might have led, to one of the following outcomes:
- death of a patient, user or other person
- serious deterioration in state of health of a patient, user or other person
Medicine/medical device quality issues are reported through the Yellow Card Portal by selecting the button applicable to the complaint (e.g. side effects, devices, defective, fake, e-cigarette).
The reporter must simply register with the site to create an online login and then report the defect through the submission of the electronic form.
In order to report a faulty medicine/ device it is important to gather the following information:
- The brand or the non-proprietary name
- The name of the manufacturer, supplier or parallel importer
- The strength and dosage form of the product
- The product licence number
- The batch number or numbers of the product
- The expiry date or dates of the product
- The nature of the defect
- The account of any action taken in consequence.
How do I identify a product included in the safety alert?
Every safety alert will have the following information:
- An alert number
- Company name
- Product description
- Brief description of the problem.
It is important to download the recall information fully and this can be done by clicking on the live Alert Number live link embedded in the recall. To help you comply with CQC requirements Ashtons have created access to this link in Live View. This can be found as an MHRA CAS button on the Live View dashboard.
Once on the portal, select the recall, scroll to the bottom and download the document(s).
Medical Device alerts will be available to view on the MHRA portal.
Where do I find the information needed on the product?
Please refer to figure 2 to the right.
How do we demonstrate compliance to the CQC during inspections?
Although executive teams now confirm that action has been taken, it is expected that this pathway can fully be demonstrated to CQC inspectors. It is essential that at ward level staff acknowledge that they have received and actioned the safety alerts to show that this alert has progressed through the hospital.
Remember to complete and update the Safety Warnings Checklist (AF8) located in the Ashtons Clinic Room folder (see right). Completion of this form will ensure that each numbered alert is not missed. This simple form will demonstrate the safety cascade within the hospital. Hospital Directors or Clinical Service Managers should archive copies of their alert responses to the executive team.