Interim guidance on FMD alerts published

The final phase of FMD implementation begins on 9th February 2019. FMD is a huge project and it is important that during the initial period, medicines are not unreasonably withheld from patients, unless there is a high degree of suspicion that the pack might be falsified.

At present, there are not many FMD-compliant packs in pharmacies. We also know that some generic medicine packs that have a 2D data matrix are not actually FMD-compliant packs (one indication of this is that they do not have an anti-tampering device). If you scan them the system will generate an alert.

In the initial phase of implementing FMD, many “false positive” alerts are expected; this does not necessarily indicate a falsified medicine, and in most cases it will be appropriate to dispense the medicine, subject to the normal checks. The alerts will reduce in number as more of the packs reaching pharmacy are FMD-compliant.

The UK FMD Working Group for Community Pharmacy has today (7/2/19) published interim guidance for pharmacy teams on dealing with FMD alerts generated when products are scanned.


New MHRA guidance

The MHRA issued the following guidance on 7th February 2019:

Guidance on safety features: 7 February 2019

The United Kingdom is committed to meeting the 9 Feb 2019 deadline for the launch of EU FMD safety features Delegated Regulation, and we expect all stakeholders in the UK supply chain to be aiming to comply with these new requirements, indeed we know much of the UK supply chain is already prepared.

Despite the significant work undertaken to date in the UK and given the complexities associated with setting up the medicines verification system across the EU it is anticipated issues will arise especially during the initial operational/implementation phase. It is important that these issues do not compromise confidence in the medicines supply chain. The Government’s priority is the continued supply of safe medicines to patients.

For example, several Member States have formally advised those who may receive ‘unknown’ error messages to dispense anyway. Therefore, the MHRA will also be taking a pragmatic, flexible approach to how we enforce the new legal requirements, as long as the normal checks are carried out, and there is no reason to think that the medicine is falsified. This position will be kept under review.

We are also aware of issues around non-FMD compliant packs released to market before 9 February 2019, and wholesalers’ designated status, We will continue to work with UK stakeholders to help bring them into full compliance with the safety features regulation as soon as possible.

https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features#history

Statement from UK FMD Working Group for Community Pharmacy

Community pharmacies must work towards compliance with the Falsified Medicines Directive (FMD) in time for February 9th deadline irrespective of any Brexit scenario, pharmacy bodies have said.

The guidance, from the UK FMD Working Group for Community Pharmacy, follows recent meetings between the regulators, the government and the Working Group itself.

In particular, it concerns the safety features Regulation under FMD that requires medicines packaging to have a unique 2D-barcode and an anti-tampering device, both of which must be checked at various points in the supply chain.

Chair of the Working Group, Raj Patel, said:

“All parties recognise the challenges around FMD and we are confident that the regulators will take a pragmatic and even-handed approach to enforcement.

“Nevertheless, pharmacies must make efforts to be compliant with the new FMD safety features, by the deadline.

“Pharmacies must act promptly, but they must also act properly to ensure they are prepared for the new FMD safety features.

“They must carefully consider the terms of any contract for FMD solutions and make sure they are futureproof in any post-Brexit scenario.

“Other practical adjustments might be required, such as modifying dispensing workflows and all pharmacies will need to update their standard operating procedures.

“However, there will be very few packs of medicines in pharmacies with the FMD safety features, on February 9th, as they will take time to come through the medicines supply system, so inevitably the sector is on a journey towards full implementation.”

From February 9th, pharmacies must check the integrity of the anti-tampering device and scan the 2D barcode to mark each pack as decommissioned (or dispensed) in the FMD database.

It is understood there will be significant quantities of medicines in the supply chain that do not carry the new safety features, after February 9th, but it can still be wholesaled and dispensed.

Pharmacies are expected to have clear standard operating procedures in place to empower individuals to make judgement calls they could later justify, rather than disrupt supply to patients.

General Pharmaceutical Council inspectors will not focus unduly on any single issue and will assess the pharmacy in the round considering the health, safety and wellbeing of patients and the public.