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UK in ‘minority of one’ in opposing counterfeit medicine checks

The MHRA could argue the case for checking medicines when they arrive at the pharmacy rather than at the point of dispensing, says John Chave of the Pharmaceutical Group of the European Union

EXCLUSIVE

The UK has no choice but to accept EU plans to implement counterfeit medicines checks in pharmacies, a pan-European pharmacist representative chief has warned.


John Chave, secretary general of the Pharmaceutical Group of the European Union, said that the UK medicines regulator MHRA had little chance of success in its long-standing opposition to a European Commission directive for pharmacists to scan the barcodes of all prescription medicines before dispensing.


Mr Chave stressed that the UK was in a "minority of one" in its concerns over whether the directive, due to come into force in 2017, should be applied to every prescription medicine. But there could be scope to relax the requirements, he told C+D exclusively at the annual general meeting of the European Association of Full-line Wholesalers (GIRP) in Vienna on Monday (June 2).

"There is nothing to suggest the European Commission is going to change its mind," says PGEU president John Chave

More on counterfeits

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Wholesalers challenge pharmacies to develop medicine scanners

Pharmacy Voice urges MHRA to be tougher on counterfeits


"The MHRA is going to find it difficult to oppose [the requirements] so they can try to achieve something that's potentially more suitable," said Mr Chave, who represents pharmacist organisations across Europe. "There's probably a deal to be done around flexibility."


The UK could argue the case for checking medicines when they arrived at the pharmacy, rather than at the point of dispensing, Mr Chave suggested. This could avoid the problem of pharmacists being unable to dispense medicines if their scanner stopped working because they lost their internet connection, he said.



The MHRA agreed that the text of the EU directive appeared to allow "some more flexibility" around when medicines were scanned in the pharmacy. It was studying the text with the Department of Health to "fully understand" the consequences for the UK supply chain, an MHRA spokesperson told C+D.



Mr Chave stressed that the European Commission would not move on the principle of pharmacists checking all prescription-only medicines. The MHRA's original argument that only certain medicines should undergo checks was unlikely to gain ground, he argued.



"There's nothing that suggests the European Commission is going to change its mind," Mr Chave revealed. "The commission's own impact assessment suggests [pharmacist checks] are the best outcome from an economic point of view so… at the end of the day, the UK can't actually block this."



Mr Chave urged the UK to start preparing for the directive coming into force in 2017. "I think the UK probably has got time [to implement the requirements] but let's face it – three years isn't a long time to implement something as complex as this," he argued.



Last year, the NPA warned that the ongoing disagreement over the plans could leave pharmacists without enough time to prepare for their introduction.





Do you think the UK should be able to reject the European Commission directive to scan all barcodes?
 
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15 Comments

anil shah, Locum pharmacist

Pharmacist have no time to do all this .it is wholesellers duty to supply authentic medicinal products as when they obtain from manufactures they shoul carry out all the steps necessary before supplying to the registered pharmacy.. Anil Shah

Given that holograms have been counterfeited, I doubt that bar codes are going to present a particular challenge to the counterfeiters

Michael Stewart, Community pharmacist

Surely this is a clear opportunity to introduce an extra level of accuracy checking - scanning barcodes at the point of dispensing will have the enviable side effect of reducing dispensing errors. Forget about the counter-fraud aspect, patient safety is paramount and anything that could improve it should be embraced by the profession.

Nalin Shah, Community pharmacist

HONOURABLE INTENTIONS BUT AS USUAL POORLY EXECUTED.

Peter McAuley, Community pharmacist

Why is there no emphasis on the wholesalers providing certified non counterfeit product.
If I buy all my stock from Alliance, AAH and Phoenix then they must guarantee authenticity.

Paul Skinner,

Peter - How would you then track all the orders pharmacies procure from other suppliers outside of the major wholesalers?

N O, Pharmaceutical Adviser

Hi Paul,

My proposal , considering that any supplier approached by the pharmacies hold a valid licence from MHRA, is that all these suppliers need to have this system of bar-code checking first and be reviewed every 6 months to know the effectiveness. Depending on the outcomes future plans to implement these checks at Pharmacies may be considered.

What I fail to understand here (in the UK) is, why always try to place blame/ put restrictions at the last step (last barrier of defence) than subbing it at the route of origin ? It is always the Pharmacies/ Pharmacists on the receiving end, be it prescribing error, manufacturing fault or now the counterfeit drugs. Feel so sad some times.

David Miller, Hospital pharmacist

Point of dispensing only works with original pack dispensing, also option of simple accuracy check and expiry checks with move to 3D bar codes so are manufacturers going to deliver? Will facilitate automated dispensing and product recalls. However if it is just counterfeiting then easier to manage at wholesaler level

N O, Pharmaceutical Adviser

I do not understand why these agencies making such big fuss. Do they not hire any person with a commonsense any more? We work in a highly regulated market with limited wholesaler options. We cannot buy from any Tom, Dick and Harry. If we do then that itself is breach of law, hence does not make any diference by keeping in place any additional checks. First of all we need to find out what kind of counterfeit problem are we looking at? Is it that counterfeit tablets/capsules/liquid etc. are put in to an outer cartons matching those from a licensed manufacturers ? or the products available themselves are counterfeit in totality? in either case how can scanning the barcodes at the pharmacy stop counterfeiting? for a simple reason we use multiple wholesale suppliers who in tern supply cheapest generics from different manufacturers. It is difficult, for example, to trace back to a supplier if we received 2 different packs of same batch number of sy Teva brand Simvastatin from 2 different suppliers. It will only lead to more work and more confusions at the Pharmacy who are already under a great pressure and limited resources. Unless the DoH provides exclusive budget for such an activity and also holds all the manufaturers and suppliers responsible at the same time, this thing is not going to work !!

N O, Pharmaceutical Adviser

Well said Peter. In fact this is the best cost effective way and actually should have been in place from the beginning as part of their licence.

Dodo pharmacist, Community pharmacist

i hope they are going to pay us for the investment in hardware required and all the extra work involved!

Kevin Western, Community pharmacist

Given that the profits from forging are always going to be more than from legally manufacturing, the money to spend to subvert/ overcome any system will always be there and what man can invent, man can circumvent. It is simply putting another task into our working day, I'm sure someone out there cares but they are keeping very quiet - all nhs/mhra cares about is wether patient get their medicines.

Clive Hodgson, Community pharmacist

Wonder how effective it would actually be? Recently read a fascinating book (Security Engineering. Ross) and examples given of the sophistication and capabilities of forgers, counterfeiters and those wishing to defeat security systems for nefarious purposes were remarkable.

Could just be a box ticking waste of time.

Tariq Atchia, Pharmacy Area manager/ Operations Manager

Moving the verification of received product to the point of receipt in the pharmacy is a good pragmatic solution. If it means an end to manufacturer quotas, I'd welcome received product tracking data being provided to the manufacturers so that they can track exactly where their product ends up. Those that aren't involved in the dirty trade of export have nothing to hide.
The NPA is correct though - the stakeholders need to move this forwards now because otherwise we risk being stuck with being legally required to implement an impractical solution at the final hour.

Rajive Patel, Community pharmacist

The EU Commission is full of narcissistic autocrats. They don't live in the real world. As far as I am concerned, I will never scan a bar-code of a drug, because some pompous autocrat wants me to. The more Pharmacies stand up to the farce the better, and hopefully we can show them we wont be bullied into layered bureaucracy. The quicker we leave the darn EU the better!

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