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 2^nd 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 2^nd 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:

• a unique identifier (UI) in the form of a 2D data matrix (barcode) which can be scanned at various points along the supply chain to determine its authenticity; and
• an anti-tamper device (ATD). 

 

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 9^th February 2019 and for products that dear safety features) to: 

1. check the anti-tampering device (ATD) to ensure it is intact prior to dispensing; and 
2. change the status of the pack in the UK's National Medicines Verification System from 'active' to 'inactive - supplied'. This involves scanning the 2D barcode on each pack and communicating with the National Medicine Verification System (NMVS). 

 

This will involve a number of changes that pharmacy contractors/departments will need to put in place: 

• Pharmacy Departments and all staff will need to have an awareness of the new legislation, as with any changes in the law. 
• New software will be required to connect with the NMVS. Trusts can either enquire with their current pharmacy system provider as to compliance (for EMIS contact helen.mcknight@emishealth.com) or look in to some of the end-to-end solutions on the markets that are able to integrate with pharmacy systems. 
• New hardware will be required for verification of medicines
• Standard Operating Procedures (SOPs) will need to be revised to accommodate the new processes, including those for 
  • Dispensing
  • Managing returns
  • Decommissioning of medicines/raw materials
  • Verification of medicines
  • Reporting exceptional events
  • Business continuity plans
  • Staff training

 

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: 

• SecurMed The UK National Medicines Verification System (NMVO)
• Questions about IT solutions for FMD can be directed to SecurMed: info@securmed.org.uk
• There is a secondary care FAQ hosted by the Specialist Pharmacy Service. They also have a mailbox: psc.su@nhs.net.
• The UK FMD Working Group for Community Pharmacy have a website that provides guidance. 
• There has been a pilot carried out at Oxford University Hospitals that may be of interest, more information can be found here and here. 
• The MHRA website has more information, as well as a newsletter. 
• The European Commission also have further information on the legal framework. 
• The Royal Pharmaceutical Society has also provided guidance on FMD. 
• The MHRA Inspectorate has launched a blog on FMD expanding on their recent statement, expanding to the CP Interim Guidance on Alerts, both directly and via the RPS site. 

 

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.