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Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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fake-drugsOctober 22 2014

The organisation representing pharmacy owners has queried costs and responsibilities for pharmacy in its response to a consultation on the Falsified Medicines Directive.

The FMD introduces “obligatory ‘safety features’ to verify the authenticity of medicinal products,” says the medicines regulator, the MHRA. It means that medicines will have to be categorised into whether or not they need to comply with having the safety feature - most likely to be a 2D data matrix barcode with a unique number identifier.

The MHRA has proposed that “all prescription medicines will bear the safety features unless they are listed by the European Commission and all non-prescription medicines will not bear the safety features unless they are listed.”

Ordinarily prescription medicines would need to be scanned at some point prior to being dispensed to patients so that the unique identifier code can be checked and recorded to verify that the product is genuine and not a counterfeit or falsified medicine.

The MHRA has been consulting on how the FMD will be implemented in the UK with regards to which products should be listed and required to be checked. Prescription medicines that will not need to bear the safety features would be included on the ‘white’ list, while the ‘black’ list would list non-prescription medicines that need to be scanned.

In its response to MLX 387, Pharmacy Voice says it supports initiatives to reduce counterfeit medicines entering the supply chain. However, it argues that “any new requirements from the FMD need to be incorporated into processes in a way which makes them routine.

“In our view the complexities introduced with positive and negative lists, which may change from time to time, fails this test by creating operational inefficiencies. To scan all items will be much more efficient than having to decide if a product has to be scanned.”

It is concerned that any unnecessary complexity will add unnecessary time to the dispensing process, reducing the time to be spent on patient-centred care. “As well as adding to the bureaucratic burden on pharmacies, it may increase the potential for errors.” There will also be costs to pharmacy including software and hardware as well as training.

Pharmacy Voice is also is concerned about the criteria for determining which products should be in which list, and says that the chemical entity alone is insufficient as medicines classification varies widely across the EU. Instead it says the safety feature should also be based on brand and marketing authorisation.

It argues that no prescription only medicines should be included in the ‘white’ list (ie POMs which would not need to be scanned), except for specials and extemporaneously dispensed medicines. “The inclusion of any items on a white list, particularly one that changes from time to time, will add unnecessary challenges to pharmacy staff who will inevitably end up operating two systems by having to consider which items need to be scanned.”

Adopting an approach to scan all prescription medicines would have upsides for pharmacies and patients, it adds. “In addition to product authentication, scanning could be used for safety checking, stock ordering and reimbursement. It could also be linked to the provision of patient information.”

With regards non-prescription medicines which would have to be scanned if listed in the ‘black’ list, Pharmacy Voice points out that General Sales List medicines are sold in retail outlets “for which there are currently no plans for connection to the European Medicines Verification Service.”

It adds that the UK also allows non-prescription medicines to be supplied on the NHS. “Requiring safety features on a few non-prescription medicines (likely to be supplied or prescription or otherwise etc), which may be defined from time to time, adds a level of complexity to the system, which is not justified by the aims of the Directive,” it says.

Links:

MLX 387 Safety Feature (falsified Medicines Directive - ‘black’ and ‘White’ lists

Pharmacy Voice response via NPA

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