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MHRA investigates medicines that left supply chain as FMD alert issued

The Medicines and Healthcare products Regulatory Agency (MHRA) is investigating circumstances under which multiple medicines left the supply chain before entering it again.

The medicines watchdog is “investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via [the wholesaler] Kingsley Specials”, it said as a falsified medicines directive (FMD) alert was issued last week (September 1).

The products were reintroduced into the supply chain by Kingsley Specials after it purchased them from a company that does not “hold a wholesale dealers authorisation”, the MHRA said in the alert. The company subsequently “sold [them] on to a number of other wholesalers”, it added.

Kingsley Specials has had its license to trade suspended while the watchdog investigates the incident, an MHRA spokesperson told C+D last week (September 3). C+D has contacted Kingsley Specials, but the company declined to comment while the investigation is ongoing.

The products involved “appear to be genuine, with legitimate batch numbers and safety features”, the MHRA said. However, they “are thought to have left the legitimate supply chain and been reintroduced between March and August,” it added.

“This means that the correct transport and storage conditions cannot be guaranteed and, while unlikely, could impact their effectiveness,” the MHRA explained.

The affected products are listed in appendix two of the MHRA's alert. Some of the products included in the alert are Eliquis, Stelara and Zebinix.

Affected medicines should be quarantined and reported

Wholesalers and healthcare professionals have been told to check their stocks and all the listed products – available in full on the alert – for the relevant batches supplied from wholesalers Smartway Pharmaceuticals, Drugsrus and Optimal Pharma.

The three companies – who did not purchase directly from Kingsley Specials but via intermediate companies – are "not implicated in any wrongdoing and are co-operating with the MHRA to resolve the matter,” the MHRA stressed.

Smartway Pharmaceuticals, Drugsrus and Optimal Pharma have also “implemented safety measures by decommissioning the impacted packs [and] changing the status to stolen/inactive in the National Medicines Verification System”, the MHRA said.

If any affected products are identified by healthcare providers, they are asked to quarantine these packs, and notify the Defective Medicines Report Centre, the MHRA said.

Healthcare professionals dispensing the affected products should “ensure that appropriate scanning takes place at the point of dispensing” and not dispense goods that flag as “stolen” or “inactive”, the MHRA said.

“Where there is no ability for scanning, healthcare professionals and wholesalers should consider using the unique serial number or product code or global trade item number information available on the outer packaging of the product,” it added.

Smartway: Customers have been alerted

Smartway has “effective traceability for the affected stock", which has allowed it "to identify affected customers”, a spokesperson for the company told C+D yesterday (September 8).

It has “contacted this small group [of customers] with specific instructions” and if any customers “did not receive information” from Smartway on August 21, they can “assume that any products from [it] are unaffected”, the spokesperson added. 

However, pharmacy teams should “check to see whether they have purchased products from other wholesalers named on the alert and follow the instructions,” the spokesperson added.

Drugrus told C+D today (September 9) that it can “confirm that Drugsrus had no part in any wrongdoing and is co-operating fully with the MHRA to help resolve the matter”.

C+D also contacted Optimal Pharma, who declined to comment as the matter is still under MHRA investigation.

What do you make of the FMD alert?

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