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Installing medicine scanners could cost each pharmacy nearly £4k

Every UK pharmacy is required to scan medicines when EU legislation comes into force in February
Every UK pharmacy is required to scan medicines when EU legislation comes into force in February

Every pharmacy faces paying up to £4,000 every five years to buy scanners to comply with EU legislation, the government's medicines watchdog has suggested.

From February 9, 2019, every pharmacy in the UK will be required to scan barcodes to 'decommision' medicines and verify they are genuine under EU anti-counterfeiting legislation the Falsified Medicines Directive (FMD).

The Medicines and Healthcare products Regulatory Agency (MHRA) has not published specific calculations of the cost of the legislation to community pharmacies, but its impact assessment estimates that “healthcare institutions” that will have to decommission medicines themselves – rather than have the process done for them by a wholesaler – “will require two to three scanners…[at] a cost of £1,300 per scanner, which includes software”.

“We assume [scanners] will be replaced every five years,” it added.

NPA: “Hard to justify this investment”

Responding to the MHRA's consultation documents, Raj Patel, chair of the National Pharmacy Association’s FMD working group, said: “With a lack of certainty as to just how long the FMD system will be needed for, combined with the financial squeeze on community pharmacy, and the lack of any announcement on government funding for this regulation, it is hard to justify the investment.”

“However, we are mandated to comply, so we must proceed, albeit with caution.”

The FMD consultation runs until September 23. Pharmacists and their staff can respond by completing the online response form and emailing it to [email protected].

What is the Falsified Medicines Directive?

The directive introduces EU measures to prevent counterfeit medicines entering the supply chain. The measures include:

  • New, compulsory safety features – including a unique identifier that can be scanned at fixed points along the supply chain, and an anti-tampering device – on the outer packaging of medicines
  • A common, EU-wide logo to identify legal online pharmacies
  • Tougher rules on importing active pharmaceutical ingredients
  • Strengthened record-keeping requirements for wholesale distributors.

Source: European Commission

21 Comments
Question: 
Are you prepared to install scanners in your pharmacy by Feburary?

George Romanes, Community pharmacist

I hear dispensing doctors ARE being funded for their FMD IT equipment while we get "nowt"

There is inequality !!

donald macarthur, Senior Management

PSNC should bill the ABPI for all pharmacy costs associated with scanners. The FMD resulted mainly from lobbying of the European Commission by the pan-European grouping of national R&D pharma company associations, EFPIA. While this aim was said to counteract market acsess by counterfeit medicines, the actual risk of this in Europe was very low. The real intention was to stop parallel trade by preventing traders opening packs to replace the patient inserts. In the event,,traders were allowed to reseal packs themselves..

Peter Sainsburys, Community pharmacist

When will pharmacists realise that nobody wants us? The government wants us gone ASAP so they can use online medicines suppliers. The industry, or "profession" is a dead duck and it's only going to get worse. Once the government sees savings then they will push harder.

Get out of pharmacy now or make plans about what you can do in a few years time when it really hits the fan.
 

You can do a lot with a Master's degree, so don't waste it on this joke of a career.

Leon The Apothecary, Student

I'm curious as to the time increases for such a process and are pharmacies capable of handling the additional pressure this will cause?

Richard MacLeavy, Non Pharmacist Branch Manager

Yeah and also if additional terminals will be needed to decommission and wheather pharmacies will have enough space for this. 

Chris Locum, Locum pharmacist

How many previous edicts included some subsequent statement (in hindsight from 'informed' decision-makers) along the lines of "We did not consider the impact on staff resources," or, words to such effect?

Peter Sainsburys, Community pharmacist

This is outrageous. Far better to tell the GPhC to do one, refit your store as a kebab shop, a newsagent or even a beauty salon. Watch the money roll in, hassle free.

Pharmacy contractors who refuse to chuck in the towel are flogging a dead horse. The government wants you gone, and with people like Rudkin, the profession hasn't got a chance. Good luck if you want to hold onto a sinking hull.

It's gonna be one corrupt person born out of wedlock from here on in, and they don't give a rodents posterior about you or your family.

Steve Mosley, Community pharmacist

This isn't an accurate representation of the MHRA document.  The table and accompanying text that has been used refers to the total economic cost of eg a dentist installing the infrastructure, connectivity, staff training etc to decommission on site.

The cost, in the same document, for pharmacies and wholesalers who already have the majority of that infrastructure, is put at £200-£750 per scanner.

T Jenns, Community pharmacist

Please, please could someone start a survey that the 10 day decommissioning period is not long enough. It needs to be 28 days. We cannot keep assembling prescriptions that are sent by eps and then dismantling them 7 days later if they are not collected. 28 days is workable.

Richard MacLeavy, Non Pharmacist Branch Manager

Even 28 days is too short. You would have to be super hot on your processes to decommission within 28 days. If you missed the 28 days deadline the medicine would need to be wasted so it needs to be much longer. This is especially required in areas with longer prescribing cycles as the gap bettween ordering and collecting medicines tends to also increase

Dave Downham, Manager

Anyone would think that this is an opportunity for PMR providers to line their pockets...

Leon The Apothecary, Student

I'm certain they will profit from such a venture.

Garry Tyson,

For those of you usnure - there will be a number of education sessions at this years Pharmacy Show on the 7th and 8th of October at The NEC - come and learn firsthand and get the "right" advice on how to be FMD compliant.

Register for Free in the link below.

https://closerstill.circdata-solutions.co.uk/Microsites/RFG/publish/PS18/?source=homepage

 

 

Richard MacLeavy, Non Pharmacist Branch Manager

Do we want to be compliant though? If everyone complies bar one or two pharmacies that cannot afford it, those one or two will get the rap, but they can't punish all of us if as an industry we don't comply. It's time to re-raise the funding argument as for sure we will need extra funding for both the short term set up costs and ongoing additional workload costs associated with this. We can't afford to be in a position in which we need to fund this from current reimbursement arrangments

Dave Downham, Manager

If you're suggesting that community phamacy should take organised concerted action, ha, ha,ha!

Nigel Barrington,

@ David 

If the EU are putting provisions in place to counteract falsified medicines, and we don't, where do you think those medicines are going to end up?
 

Brexit is irrelevant in this instance. 

Richard MacLeavy, Non Pharmacist Branch Manager

What false medicines? The number of suspected false medicines cases is exceptionally low right accross Europe, and thats now without any of this rubbish in place. These measures are totally disproportiante to the level of threat. For a start the number of medicines worth counterfeiting is in the minority. I doubt many people are making a living contereiting bendroflumethiazide. 

SIMON MEDLEY, Community pharmacist

seem to remember govt said it was staying regardless of brexit vote  ( so glad i wasnt selfish enough to vote leave just to try and get out of it !! )

David Moore, Locum pharmacist

It's an EU directive. We'll be out of the EU next March. Don't waste your money. It's short enough as it is.

Lilian Anekwe, Editorial

The MHRA has suggested FMD will apply post-Brexit. Its document states:

"The European Union (Withdrawal) Bill will ensure that, so far as possible, the same rules and laws will apply in the UK after exit as the day before. The Bill will convert existing direct EU law such as EU regulations into UK law as it applies in the UK at the date of exit. It will also preserve the laws we have made in the UK to implement our EU obligations, such as laws already made to implement the Falsified Medicines Directive, which will apply in UK law from 9 February 2019."

Lilian Anekwe

Deputy editor, C+D.

David Fyfe, Senior Management

FMDirective comes into force before Brexit is in effect. Plus, overtures from Eu and UK is they both want full regulatory alignment post brexit to ensure trials and approvals are not impacted in any way. Its here to stay!

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