Travel health update

THE FALSIFIED MEDICINES DIRECTIVE

The FMD was published in 2011, aiming at guaranteeing the safety and quality of medicines sold in the European Union. The final stage of this initiative was adopted on 9 February 2019 when new rules on safety features for prescription medicines sold in the EU were applied. These rules mean that the industry has to affix a 2-D barcode and an anti-tampering device on the box of prescription medicines. The pharmacies – including on-line pharmacies – and hospitals have to check the authenticity of medicines before dispensing to patients. Information about this development was published in the April edition of Vaccine Update https://www.gov.uk/government/publications/vaccine-update-issue-293-april-2019. Vaccines used in the National immunisation programme would come under this new regulation and it said ‘in practice this means that at the end of the supply chain before a vaccine is administered to a patient, the integrity of the product seal should be checked and the barcode on the packaging should be scanned to verify authenticity and register the removal of the product from the supply chain on a central database – this is the process of decommissioning.’ The database for the UK is called the National Medicines Verification System (NMVS), which is supplied by SecurMed UK, which comprises bodies representing manufacturers, importers, wholesalers and pharmacies.

Article 23 of the Directive provides Member States with legal flexibility regarding where, in their respective supply chains, the decommissioning process should take place. The UK has classed General Practitioners (GPs) as health centres and therefore healthcare institutions – that includes both dispensing and non-dispensing GPs. Therefore GP surgeries must decommission medicines.

Having searched the online forums for ‘chatter’ on this subject there was little information so a couple of days ago I asked the question myself. It was clear from a number of responses that GP surgeries have nothing implemented as yet and no information has been forthcoming from their CCGs either. Private travel clinics also seem in flux as to what should happen, but some community pharmacies have scanners already in place. There are so many resources in the public domain on the topic, none of which I have to say I found easy to follow but I’ve written a blog that will at least take you to a number of the available resources - found at http://janechiodini.blogspot.com/2019/09/falsified-medicines-directive.html What happens though with Brexit* looming is another big question since this is a European Directive. The concept of ensuring our patients are not exposed to fake drugs though is essential, so I’m guessing for now the next thing is to continue to increase your knowledge of this important initiative and eventually we will hear what exactly is to happen!

NATIONAL IMMUNISATION PROGRAMMES

It is always essential that a traveller is up to date for their general immunisations prior to travelling abroad and this would be part of your travel risk assessment, including ensuring the individual is brought up to date if need be. The flowchart, Vaccination of individuals with uncertain or incomplete immunisation status has just been published by PHE and is effective from September 2019 https://www.gov.uk/government/publications/vaccination-of-individuals-with-uncertain-or-incomplete-immunisation-status. In June PHE also published a tool, the UK and International Immunisation Schedules Comparison Tool, which provides the National immunisation programmes from 20 different countries and compares them to the UK schedule. This downloadable document (in Excel format) is a welcome addition to the resources we use in primary care and can be found at https://www.gov.uk/government/publications/uk-and-international-immunisation-schedules-comparison-tool

TravelHealthPro

We’ve been through a quiet period of activity for travel health in respect to our day-to-day practice, but NaTHNaC has been prolific in the publication of a number of factsheets over the past 6 months. Were you aware of their new ones on: Asplenia and Hyposplenia, Diseases Transmitted by Insects and Ticks in Europe and Summer Travel, and updated factsheets on: Food and Water Hygiene, Travellers' Diarrhoea, Hajj and Umrah, Immunosuppression and Rabies? See https://travelhealthpro.org.uk/"‹"‹"‹"‹"‹"‹"‹factsheets

*Official guidance on FMD can be found at https://digital.nhs.uk/services/falsified-medicines-directive-fmd (last updated 3 July 2019)