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FMD compliance to be included in GPhC pharmacy inspections

GPhC: Pharmacies may face criminal prosecution for the most serious, persistent breaches
GPhC: Pharmacies may face criminal prosecution for the most serious, persistent breaches

The GPhC will be responsible for ensuring community pharmacies are compliant with the EU’s scanning law as part of its inspection process, the regulator has confirmed.

The EU’s medicines scanning law, the Falsified Medicines Directive (FMD), is set to come into force on February 9 and will require all pharmacies to scan barcodes on medicines packaging at the point of dispensing.

In an impact assessment published in July, the Medicines and Healthcare products Regulatory Agency (MHRA) identified a theoretical risk that pharmacists could “fail to decommission products” – scan them to verify their authenticity.

One way to mitigate this risk, the MHRA stated in the impact assessment, would be to use “regulatory inspections” to ensure compliance, as well as “sanctions to enforce” it.

At the time, the General Pharmaceutical Council (GPhC) told C+D it was “too early to say” what its “respective role” would be in monitoring FMD compliance.

However, the regulator confirmed yesterday (January 17) that checking pharmacies were compliant with the scanning law will be part of its pharmacy inspections.

If GPhC inspectors identify breaches of the FMD legislation, “the GPhC will use its regulatory powers, including improvement action plans, to make sure that pharmacies take action”, the regulator said.

The responsibility for decisions regarding “instigating any enforcement action in relation to the safety features legislation” will fall to the MHRA, the GPhC said.

This “may include seeking compliance, enforcement notices or, as a last resort, criminal prosecution for the most serious, persistent breaches”, it added.

Brexit uncertainty

The GPhC stressed that “all health and care providers, including registered pharmacies, are expected to meet the [FMD] requirements under UK law”.

Last month (December 24), the MHRA confirmed that in the case of a no-deal Brexit, UK “stakeholders” – including pharmacies – will not be able to participate in the system after the country is scheduled to leave the EU on March 29.

However, government officials have suggested pharmacies should prepare for the FMD regardless of a no-deal Brexit, as any UK-focused scheme would be based on a similar system.

C+D revealed earlier this month that 64% of UK contractors in the Salary Survey 2018 said they were unprepared for the FMD, and 77% of contractors said they had not yet bought the scanners required to comply with the legislation.

Have you installed a scanner in your pharmacy?

Leon The Apothecary, Student

It's also the death of PI products.

Leon The Apothecary, Student

Decommissioning is going to add so much time to the dispensing process and comes with a loads of caveats such as MDS, split packs, and uncollected medicine that I fear that "waiting" for a prescription is no longer going to be a viable option.

C A, Community pharmacist

I can see a lot of inspections taking place between 9/2/19 and 29/3/19... then it will take the GPhC a while to write up the inspections, and get company agreement on the final version, before publishing the final version, then don't compliance/enforcement notices have a 30 day window to comply? I'll let you ponder on the potential implications of that.

J. Locum, Locum pharmacist

The article talks about pharmacies being liable. Can anyone confirm that a locum finding themselves working in a non compliant pharmacy will not be held responsible for the failure of the company to provide the necessary equipment or if I turn up and find this situation and still sign in as the responsible pharmacist is it me that carries the can ?

Joan Richardson, Locum pharmacist

I've just attempted to raise this issue with the RPS and the GPhC.  RPS have told me to contact the GPhC and also my indemnity insurer!  GPhC have directed me to the appropriate form to "raise a concern" but do not seem prepared to answer the question directly.  I've yet to try my indemnity insurer.  The GPhC have now told me that they set the standards but are unable to tell me how they intend to enforce compliance with FMD.  Guess we just have to keep our fingers crossed then!

I suspect that a pharmacy - one of a group -  that I go to quite regularly is not going to be compliant but will not know for sure until I turn up for a shift after 9th February.

C A, Community pharmacist

Interesting question indeed. Also if you were to turn up and find them to be non-compliant would it not be within your obligation as RP to close the branch?

N O, Pharmaceutical Adviser

How come they did not mention ........ All brexit related topics will also be part of inspection!!! May be can sit with the inspector and go through all the political debates happening around the world and how it might impact patient saftey, oops not patient but PUBLIC, and they be graded incompetant pharmacy?? Eh ???

N patel , Non Pharmacist Branch Manager

what mugs we are... gonna be a no deal brexit so fmd dead and buried(Hurrah!!!!)... hey ho still better go and get the scanners installed

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