Layer 1

Compliance with EU scanning law could be part of pharmacy inspections

scanner
Pharmacies will have to scan medicines to 'decommission' them from a database of verified products

Ensuring pharmacies have installed a medicines scanner and are checking anti-tampering devices could form part of pharmacy inspections next year, the government has revealed.

Under EU anti-counterfeiting legislation the Falsified Medicines Directive (FMD), every pharmacy in the UK will be required to scan barcodes on medicines and check their anti-tampering device at the point of dispensing from February 9, 2019.

Earlier this month, the government published a consultation document on the legislation, “to identify a solution which results in the lowest burden to UK stakeholders as a whole”.

Ongoing risks

An impact assessment published alongside the document set out the potential risks from implementation, including “that the implementation of safety features will not fully prevent the entry into the legal supply chain of falsified medicinal products”.

One reason for this could be the “failure to decommission products”, which could allow the “unique identifiers” on medicines packaging to be “reused on falsified products”, the government said. It suggested mitigating this risk by using “regulatory inspections” to ensure compliance, as well as introducing “sanctions to enforce” it.

However, when asked by C+D to confirm that monitoring FMD compliance would become part of its pharmacy inspections, the General Pharmaceutical Council (GPhC) said it is “too early to say” what its “respective role” would be.

“We are considering the detail of the consultation document and will respond to any proposals relevant to us as the regulator of registered pharmacy premises,” it said.

Threat of sanctions

In its consultation documents, the government also proposed “legislative changes to provide sanctions to enforce compliance” of the FMD. One approach it suggested was “the sole use of criminal sanctions for failure to comply”, in the form of “an unlimited fine...or imprisonment for a term not exceeding two years, or both”.

However, it also stated it “is minded” to “use a mixture of both criminal and civil sanctions”, which might include “written warnings, stop notices and civil fines”. Under this system, criminal sanctions would only be used for the most serious, “intentionally fraudulent breaches”.

The FMD consultation runs until September 23, and 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

9 Comments
Question: 
Are you preparing to install a scanner in your pharmacy?

C A, Community pharmacist

"The implementation of safety features will not fully prevent the entry into the legal supply chain of falsified medicinal products”.

Well that's a useless waste of time and money then, I'm glad we (pharmacy) have plenty of both!!

Richard MacLeavy, Non Pharmacist Branch Manager

I don't think there is anywhere near enough infomation on how this will work in practice. How does it work with the PMR?, at what point do you decommisssion? Do you need extra terminals? What happens to uncollected meds? What about dossett boxes etc etc. Also who's going to pay for all the hardware and software needed and the extra staff required for the addional workload? My view is as a country we should just be non compliant for a couple of weeks then forget the whole thing after we leave the EU.

 

Leon The Apothecary, Student

Drugs are decommissioned at the point they leave the EU. So, that begs the question, after the UK has left, is FMD relevant?

C A, Community pharmacist

"Drugs are decommissioned at the point they leave the EU. So, that begs the question, after the UK has left, is FMD relevant?"

Why not just have the wholesalers decommission all UK medications, then they can't re-enter the EU. It might even stop some of the damn shortages caused by wholesalers.

Adam Smith, Senior Management

From what I can tell much of the solution end is up to the pharmacy to decide. The only fixed part is the national database provided by Securemed. So PMR providers will provide their intergrated solutions as will stand alone providers. These array of solutions will have both hardware, software and functionality options for you to review and have a variety of costs.

None of the potential providers seem to have ‘gone to market’ so far so we will have to wait and see what the actual end products look like and offer exactly.

My suggestion would be to shop around based on price, functionality and support when the solutions are ready and available. The cost is explicitly stated as being the Pharmacies responsiblity btw, unlike GP’s who seem to have this paid for them. It also looks like vertically intergrated Pharmacies may get away with their Wholesale owners decommissioning the products for them therefore the cost is saved for them, although this isn’t confirmed from what I can tell.

Jack Shanahan, Community pharmacist

I am part of a cohort of pharmacies trialling the FMD scanning in Ireland. It is an exercise in Zen, given the few correct 2D codes on packs and the even fewer codes that are actually uploaded to the verification organisation's database. It is hard to see this running at full tilt next February

SydBashford Sold&Retired&DeRegistered, Community pharmacist

It’s only pharmacists, let’s get them on the “criminal” option again!

Richard MacLeavy, Non Pharmacist Branch Manager

Yeah right after we give them a legal defence for inadvertant errors. Now we can get them for misscanning items instead.

 

David Moore, Locum pharmacist

When was Brexit cancelled? I seem to have missed that.

Job of the week

Pharmacy Manager - Bridlington
Bridlington
Competitive plus benefits (GPhC fees incl)