On the 9th February 2019 the final phase of the Falsified Medicines Directive will be rolled out across Europe.
Its introduction aims to improve patient safety by reducing the likelihood of counterfeit medicines making it into the established, legal supply chain.
Following on from the introduction of the FMD each prescription-only medicine pack will require a unique identifier in the form of a 2D data matrix code, as well as being fitted with tamper evident devices.
To find out more about what the FMD means for our patients we spoke to Superintendent Pharmacist, Sanjeda Chowdhury.
Why are falsified medicines a problem?
Falsified or fake medication can be extremely problematic and even dangerous. If a medicine is produced by unauthorised manufacturers then the ingredients being used could potentially be poor quality, the incorrect strength or completely different to what they should be.
Regulated manufacturers are subject to strict quality and safety checks that ensure patients receive the intended dosage of the intended medication.
What do the new rules mean for patients?
‘Patient safety has and always will be a top priority for our service.' explains Sanjeda. 'We welcome the introduction of the new FMD measures, they enable our service to further ensure that the medicines we provide are legitimate.'
'From a patient perspective very little should change. Although following on from the implementation of this final step, patients may notice that their medication boxes have a new QR barcode and tamper-proof seals.’
‘All medicine packets intended for a patient will be inspected, to ensure that the anti-tampering device is still intact, and then scanned prior to being distributed.’
The scanning process involves verification of the unique 2D barcode on the UK's National Medicines Verification System (NMVS), and then decommissioning of the medicine pack so that it cannot be reproduced and used on counterfeit products.
Sanjeda goes on to say: ‘This means that there is new hardware and software at our pharmacy headquarters and an update to our dispensing process. The updates are relatively small and will not impact on our patients.
Patients using the Treated.com online pharmacy service can expect to receive their medicine as they would have prior to the introduction of FMD.’
Medicine packs that have not been registered by the manufacturer, or are shown as decommissioned, will trigger a safety warning advising staff that it should not be issued.
Anti-tamper packaging also bolsters the safety precautions in place to keep patients protected from counterfeit treatments.
These measures hope to further prevent the introduction of counterfeit medicines into the supply chain and thus improve patient safety throughout Europe.
What steps can patients take to protect themselves when buying medications online?
Patients looking to purchase prescription medication online can take certain steps to make sure they are using a legitimate website.
In the first instance patients should look to use a reputable service that clearly displays its credentials. All online pharmacies based in the UK must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and online sellers must display the EU common logo on every page. You should also be able to locate the seller’s registration number with the General Pharmaceutical Council (GPhC).
Sanjeda tells us: ‘Online pharmacies displaying the GPhC logo must adhere to the FMD rules. If you are unable to locate the GPhC registration details for an online pharmacy then the pharmacy could be working outside the law and may even be selling counterfeit products.’
In the UK, health services are regulated and inspected by the Care Quality Commission (CQC). Online pharmacies providing prescriptions through remote consultations with UK doctors should display the CQC logo on the site. Patients can also search the CQC website to locate up to date inspection reports.
Prescription medications cannot be purchased without a prescription being issued to the patient making the purchase. If you wish to purchase your prescription medication online you should expect to complete a thorough medical questionnaire.
If you come across a website that is offering to sell prescription medications without the need for a valid prescription, you should steer well clear. It is likely that they are involved in illegal practices.
Will Brexit impact on FMD?
Many medications are moved in and out of the UK via Europe. Therefore in order to continue to do so following the conclusion of Brexit, the UK is still likely to be required to adhere to the rules of FMD.
Sanjeda explains. 'Brexit adds some uncertainty around the new regulation, as UK pharmacies might not have access to the EU database if we leave the EU without a deal. In any case, we've prepared and ensured we have the necessary EU requirements implemented.'
A ‘no-deal’ Brexit could alter the way that the Directive is applied in the UK. But the government has said that it wants to maintain a close working relationship with the EU to maintain the current supply chain.