Every wholesaler should be actively subscribed to the medicine recall and drug alerts and be aware of their responsibilities for carrying out recalls within the time limits required.
If no recall happens during the year the licence holder must carry out a dummy recall. This has historically been a big part of non-compliance with GDP, however view our excellent FREE and informative post on carrying out dummy recalls from our Senior Associate Bernard Lawlor.
If you receive the drug alert, you should check as soon as is possible, and within the prescribed times.
But… what are those times? How should you carry out your recall? How can you check that you have “done it right”?
Read our post on dummy recalls, and this gives you a solid idea of how and what to do. But for real.
In relation to times and classes of drug recall, please see as follows;
|Recall Classification||Class 1 – Critical Defect||Class 2 – Major Defect||Class 3 – Minor Defect||Caution in Use Notification (Class 4)|
|Notification Period**||Immediate – inc out of hours||Within 48hrs||Within 5 days||Within 5 days|
|Method of Notification||Phone & fax, Radio/TV (if necessary), press announcements followed by letter||Letter/Fax if necessary, followed by phone (if necessary)||Letter/Fax if necessary,||Letter|
|Extent of Notification||Wholesalers, pharmacies, other retailers, medical practitioners and patients,||Wholesalers, pharmacies, other retailers possibly medical practitioners||Wholesalers, possibly pharmacies and other retailers||Pharmacies, possibly medical practitioners possibly wholesalers.|
|Method of Retrieval of recalled stock||Direct uplift of stock||Via wholesaler||Via wholesaler||Not applicable|
So… why are products recalled? There are varying reasons, however they are typically one of the following;
A risk to human health; some products are recalled and withdrawn from market after a review of risk vs benefit. For example, Diclofenac Sodium which had been reclassified from POM (Prescription Only Medicine) to P (Pharmacy) has now been ordered withdrawn and quarantined,
“All unexpired stock of the above products marketed by Novartis Consumer Health UK and Actavis Group PTC EHF is being recalled and should immediately be quarantined. This follows a review of the safety of oral diclofenac products which has resulted in the conclusion by the UK Commission on Human Medicines (CHM) that oral products containing diclofenac no longer meet the requirements for supply with legal status ‘P’ (ie available in a pharmacy without prescription but under the supervision of a pharmacist.)”
Potentially contaminated; products can potentially be contaminated during production or distribution, or storage.
A sad recent case was was in 2014 when more than 20 premature babies were given an ITH Pharma product, and two died.
Poorly manufactured; when a manufacturing deficiency (or series of deficiencies) are noted, then large recalls of stock can occur. One such example was Wockhardt, when their sites were closed and multiple products were found to have not been manufactured in line with GMP (Good Manufacturing Practice).
Badly packaged/incorrect labeling; in many cases this can be serious, however in some cases it can merely be a slight typo on the PIL (Patient Information Leaflet).
Not what it says on the tin; In some cases the wrong product is packed in the “right” box.
This can however be mistaken, as some leading branded generics are made by various companies. For example opening a pack of Alliance Healthcare’s Almus brand could turn up different contents. Correct drug, form and strength but a different manufacturer.
So, what about CIUNs? (Caution in Use Notices)
CIUNs are generally issued when there is a lower associated risk, such as PIL typo, however they are also issued when there are no other products of a similar type available, and it could cause more harm to recall than to merely warn people of the issue.
So when you receive your recall notice, and check that no stock has been sold (by checking invoices, shelves (don’t forget quarantine, returns and destruction areas) etc) what should you do?
One acceptable method is to sign the recall notice, add the date checked and scan/file it. This shows you carried out the recall and when it was done (we hope within the time limit?).
If the drug was never stocked or sold, then this could be classed as a “negative recall”… but you still need to print, sign and store the record.
Retain these records for at least five years.
Where you are a pharmacy and already carry out a recall for the dispensary, then a shared folder is acceptable, however the RP should ensure that the recalls are carried out and signed by whomsoever is responsible. Duties can be delegated, but responsibility remains with you!
Are you up to date with your drug recalls?
Can you evidence GDP compliance?
Call us for a free five minute consultation if you need further help, it may be that we can assist without charging!
Welcome to a new Paradigm!
17 Oct 2018
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