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Pharmacy Voice urges MHRA to be tougher on counterfeits

Business The UK is at risk of becoming a soft target for counterfeiters unless the MHRA ensures “robust procedures” are put in place, pharmacy leaders have said.

The UK is at risk of becoming a soft target for counterfeiters unless the MHRA ensures "robust procedures" are put in place, Pharmacy Voice has said.

The contractor body has pressed again for the medicines watchdog to go further in its plans to crack down on counterfeit medicines, by implementing safety features for medicines packaging across all prescription-only drugs, rather than just specific products.  

All prescription-only medicines needed to have safety features, including tamper-evident seals and unique identifiers, otherwise pharmacists would "waste time" confirming which products to authenticate and which not, Pharmacy Voice said, in its response to the MHRA's consultation on how the Falsified Medicines Directive should be applied in the UK. 

All POMs should have safety features, such as unique identifiers and tamper-evident seals, Pharmacy Voice has said, not just specific products

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"This approach will in fact be easier to implement in busy community pharmacies," it said.

"If only a few items, which [the] MHRA considers at high risk of counterfeiting, have to have unique identifiers and authenticated, counterfeiters will simply change the focus of the medicines they produce. The overall cost/benefit ration of this approach will be worse for pharmacy and patients will be put at risk."

The group called for the MHRA to undertake a full impact assessment of the safety feature and authentication element of the directive "as soon as possible".

These safety features would have "the biggest consequences for pharmacists", agreed John Chave, secretary general of the Pharmaceutical Group of the European Union.

However, the British Association of Pharmaceutical Wholesalers (BAPW) warned that the safety measures could cost as much as £50 million a year, some of which would be "passed on to BAPW customers, the NHS and therefore the taxpayer".

And commercial pressure to keep costs down if "distribution costs were to soar dramatically" could "compromise patient health", said BAPW executive director Martin Sawer, in his response to the MHRA consultation.

The BAPW's comments echoed similar concerns by the MHRA earlier this year, when the medicines watchdog argued for the directive to be more flexible and said there would be "very significant challenges" for community pharmacies if scanning at the point of dispensing was mandatory.  

Under the Falsified Medicines Directive, medicine packaging would contain a seal to indicate whether the medicine had been tampered with. It would also display individual barcodes, which could be scanned for verification at the point of dispensing.

Further details of the safety measures would be decided in a separate consultation, the MHRA said.

"The separate consultation on this will be interesting because the MHRA position expressed up to now does not seem to be in line with other EU agencies and indeed the EU commission," Mr Chave told C+D.


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5 Comments

Peter McAuley, Community pharmacist

I am surprised that I am the first to comment on this article.

Why is Pharmacy Voice demanding all these extra cost features?
I source all my prescription medicines from one full-line and two short line wholesalers (plus a specials supplier). I fully believe that it is the responsibility of the wholesaler and their qualified person to provide me with authentic medicines sourced appropriately. This is what I pay them for.
Why should I then do additional time consuming checks? Every pharmacist must resist this, or they will again be complaining about extra work of NO value for NO pay. This is something that must be controlled upstream at the wholesaler level.

Ex Superintendent , Locum pharmacist

You might want to look at the service specifications in your contract for dispensing which states "the pharmacy must have systems in place to guarantee the integrity of
products supplied". I don't believe that saying that it is the wholesalers responsibility would wash it if you ended up giving out a fake which harmed a patient.........It's the risk you take.

Peter McAuley, Community pharmacist

Kevin
I think the answer is that the wholesalers provide us with a written statement(as part of our supply agreement) saying that they will only supply us with bone fide products.
I am not trying to dodge my responsibilities but by having a contract with a particular wholesaler to provide me with a service (ie twice daily delivery etc), they also have a duty of care to ensure that they supply me with the product that I have ordered & not a fake.

Matthew Howard, Community pharmacist

I could not agree more with Peter. This is clearly the responsibility of the wholesaler.

Rajive Patel, Community pharmacist

Absolutely correct, Peter.

Surely, this is another example of how costs will fall onto our shoulders down the supply chain, where we are the "safety net" for not only clinical appropriateness but now for Medicines Authenticity.

The fact is by passing "regulatory burden" down the supply chain onto our door steps, somehow absolves all those up-stream the supply chain. I suggest there needs, as Peter suggests, that wholesalers need to take this responsibility and integrate the checks into their supply logistics by investing in software/hardware that will authenticate medicines before they reach the pharmacies. This way they "certify" authenticity and leave us to assume, quite correctly, that the inventory that we procure is indeed bona-fide.

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