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MMI Scenario 2
You are working in general practice as a pre-registration pharmacist and your practice manager has left you an MHRA product recall to action within 24 hours. The alert is for a patient level recall for a batch of Emerade Pens as detailed within the MHRA report. How would you action this? What resources would support you in achieving this activity in a timely manner?
Timescale: Firstly, it is important to consider the deadline of this activity. A 24-hour timeline indicates significance to patient safety and will require co-ordination and administrative support from other team members. Consideration to potential fault with an Emerade pen could be a life-threatening outcome.
Stakeholders: Who else could support you in actioning the alert in this timely manner, e.g. admin teams, prescription clerks, technicians.
Audit: Initially it is important to discover the time frame the ‘defective’ batch started so that a population search can be defined within the clinical system. A population search can be conducted by identifying any patients issued with Emerade within the time frame and establishing a list of patients with their NHS/practice numbers.
Contact identified population: The list of patients can then be informed by way of text messaging/email/letters to home address to send them the link to the MHRA ‘for patient info’ or copy of this in the post. It would be crucial if working in community pharmacy to identify any existing stock with the affected batch numbers and quarantine stock to ensure they are not issued to patients.
Patient queries: It would also be important to ensure any concerns or queries patients may have are directed towards the relevant health care professional and that they can be directed to their GP for resupply if they have discovered they are in receipt of the affected batch.
Communicate outcomes: It would be important to liaise with prescribing teams and dissipate this alert amongst the practice team and communicate this during weekly clinical meetings to ensure any patient queries/concerns that may arise have been reflected on and answers prepared in advance.
Document outputs: Actions taken and final sign off should be stored on the practice shared net, pharmacy alerts folder for future audit and demonstration of compliance in case of future inspections.