What are falsified medicines?
Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they have not been properly checked for quality, safety and efficacy, as required by strict EU authorisation, they can pose a real risk to your health and your patients.
What is the Falsified Medicines Directive (FMD)?
On 2nd January 2013, to combat the increasing risk that falsified medicines reach patients, the Falsified Medicines Directive (Directive 2011/62/EC) was published. This European Union Directive aims to prevent the entry into the legal supply chain of falsified medicinal products. On 2nd October 2015, the Commission Delegated Regulation (EU) 2016/161 was published, which sets out detailed rules for new safety features to appear on the packaging of medicinal products intended for human use.
From 9th February 2019, market authorisation holders are required to place two safety features on all new packs of prescription medicines placed on the market in Europe:
What is the purpose of the FMD?
The FMD is designed to protect patients my minimising the chances of counterfeit medicines entering into the established medicines supply chain across Europe. It will enable manufacturers, wholesalers, distributors and everyone who supplies to patients to verify the authenticity of a medicinal product, identify individual packs and check whether the outer packaging of medicines has been tampered with.
What does my pharmacy department need to prepare for the new legislation?
In order to comply with the requirements of FMD, pharmacy contractors/departments will be required as part of the dispensing process (from 9th February 2019 and for products that dear safety features) to:
This will involve a number of changes that pharmacy contractors/departments will need to put in place:
Who is our national medicines verification organisation?
SecurMed UK is the biggest UK National Medicines Verification Organisation (NMVO), a not for profit organisation that will deliver the UK Medicines Verification System. SecurMed UK are working with stakeholders from across the medicines supply chain to ensure a fully FMD-compliant service, and an end-to-end Medicines Verification System is implemented for the UK.
SecurMed UK is assisting NHS Digital to develop its implementation plans in England for hospital pharmacies, as well as doctors, GPs and health centres.
Useful websites for further information:
The Hub recently ran a workshop for pharmacists in the East of England; Pharmacy members can access the presentation here and the outputs from this event here.