Should an issue develop, or the safety of a Pharmacy Fluid comes into question, a recall may be initiated and the fluid may then be removed from the market because it is found to be either defective or potentially harmful. Sometimes, the makers of the drug will discover a problem with their drug and voluntarily recall it. Other times, the MHRA will request that the medicine be recalled after receiving reports of problems from the public.
So how long should it take to locate and action all the defect fluids and associated batches?
The MHRA guidelines advise that Class 1: The defect presents a life-threatening or serious risk to health should be actioned immediately. Class 2: The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious should be recalled within 48 hours and Class 3: The defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification, .actions should be taken within 5 days.
Whilst these guidelines are very clear, how long, in reality, does it take?
Well, who really knows, but it is certainly not within the guidelines that is for sure! and this is not because our NHS teams don’t care, it’s just a very difficult and manual process.
How do you know what pharmacy fluid bags and batches are in your storeroom? or have previously been in your hospital storeroom? How would you know without system technology? How is it possible to know if the fluids are not scanned?
If the truth be known, very few hospitals can tell you and therefore it is often down to the clinical teams to go and physically hunt down any affected batches in their storerooms, their ward areas and corridors.
This whole process requires departments within the hospital(s) and their associated porters/clinical teams to waste their valuable time carrying out this physical search, and even with this concentrated effort, nobody can really be sure it is 100% fail-safe, ensure full patient safety, have confidence in the collective reporting back to Pharmacy and the MHRA and indeed the recovery of all the effected fluids back to a central quarantined area.
Technology can change all of this; Just 2 weeks ago, Eleanor was notified that a pharmacy fluid product and specific batch may need to be recalled, In just 2 minutes the Eleanor customer service team ran just one consolidated report for the last 18 months across all 14 hospitals and 527 departments we manage, identified who had or was currently using this fluid and sent this report across to all our staff working at each hospital. Within 5-6 minutes all affected batches were identified and the fluids physically removed, quarantined and suspended on the system.
Embrace digitalisation, Embrace Patient Safety, Embrace Change, the results are in every way ‘Life Changing’.