Falsified Medicine’s Directive: Stamping out the fakes
John Finey, head of regulatory of BF Mulholland and Dental Directory explores the recently implemented Falsified Medicine’s Directive Delegated Regulations (FMD DR) by talking with the British Dental Industry Association (BDIA) and Septodont and reveals how they’ve has been working hard to make sure they’ve got it covered for dental customers.
In February of this year the Falsified Medicine’s Directive Delegated Regulations (FMD DR) came into force across most parts of Europe to help prevent counterfeit prescription medicines, as well as those featuring false information about a medicine’s source, from entering the pharmaceutical supply chain.
The FMD DR introduces new safety features to ensure full traceability of any prescription item and make identification of fake medicines easier.
It also improves controls at EU external borders through which false medications could enter and ensures the active pharmaceutical ingredients in the medicine are high-quality and not falsified.
And the regulations are much needed to keep the supply chain clean and patients safe according to the BDIA’s chief executive, Edmund Proffitt.
Last year more than £2m of fake drugs and medical devices, accounting for more than a million doses, were intercepted in the UK. The confiscations were part of a wider initiative by Interpol involving 116 countries, which collectively led to 859 arrests and a haul of £10.9m of unlicensed and falsified medicines. They included anti-inflammatory medication, painkillers, dermal fillers and sedatives which were stopped before they presented a risk to patients.
Commenting on the Interpol campaign, Alistair Jeffrey, the head of enforcement at the Medicines and Healthcare products Regulatory Agency (MHRA) said: “Our intelligence-led enforcement operations have seized millions of counterfeit and unlicensed medicines and devices in the UK. This is just the tip of the iceberg, and we will continue to take action against known criminals – working with our international partners to stop illegal medicines from entering the UK.”
Proffitt says: “The success of this latest initiative, named Operation Pangea, shows the scale to which the fake medicines and devices market has grown with a dramatic rise in unscrupulous sellers trading potentially life endangering medicines and devices online. In the same operation more than 123 websites on the open and dark web where shut down and a further 535 online adverts removed. This activity complements the BDIA’s joint ongoing CSIDI counterfeits awareness campaign run in partnership with the MHRA.
“Despite this, little has been said about the FMD DR coming into play, especially with regards to what it means for dentists and dentistry.”
So what changes will the FMD bring?
Under the new regulations all prescription medicine packs will be tamper-proof and feature a 2D barcode containing a unique serial number, product code, batch number and expiry date.
A central database of all Prescription Only Medicines has also been established so operators can check a pack is genuine.
Who will be impacted by the FMD?
· 66m patients
· 1,200 dispensing doctors
· 1,500 authorised wholesalers and distributors
· 790 market authorisation holders
· 190 private hospitals
· 260 acute NHS hospitals
Most people or organisations supplying to the public, like pharmacies or healthcare institutions including hospitals, have computer systems in place that allow them to communicate with the central database.
This allows these organisations to check the product is genuine and tell the database it has been used, or decommission it, as it is supplied. This gives a real-time view of legitimate product within the market.
But it is recognised for certain groups, like dentists, that this is impractical as dentists do not supply patient packs of pharmaceuticals to their patients. The supplier or wholesaler of these products is therefore responsible for decommissioning the product before it is supplied to the practitioner.
Article 23 of the regulations lists the categories, including dentists, where it is likely the wholesaler will be responsible for decommissioning.
For example, for Dental Directory customers that fall within one of those categories and do not have to decommission stock before it is supplied to the public, they, as the supplier, do that for them. However, for those who do have the ability to decommission it is a legal requirement that they do so.
How will it work?
1. Manufacturing – pharmaceutical manufacturers will apply a unique identifier (UI) code and anti-tampering device (ATD) to the medicine’s packaging, uploading the UI to a central database called the European Medicines Verification System, via SecurMed UK, the not-for-profit company set up to establish the UK Medicines Verification System as required under the Delegated Regulation of the EU Falsified Medicines Directive.
2. Pre-wholesaler – medicines are moved to the pre-wholesaler warehouse before being sold to the wholesaler. Medicines can be checked on the European Medicines Verification System.
3. Wholesaler – the wholesaler performs a risk-based verification of the medicines by scanning their UIs which interrogates the system to confirm its status as either ‘active’, meaning it’s ready to dispense or ‘inactive’, which indicates it’s been stolen or already dispensed.
4. Pharmacies – pharmacists will check ATDs and scan UIs to verify on receipt of the medicines. When supplied to a patient the system’s status will change to ‘inactive’ (de-commissioned) to prevent duplication or re-use.
5. Patients – patients receive genuine, traceable medicines.
As a leading supplier of dental anaesthetics, Mike Cann, managing director of Septodont UK adds, “The phrase we’re only as strong as our weakest link is key to maintaining a clean pharmaceutical supply chain and it’s great to see that despite all the uncertainty around Brexit we’re working together with our European neighbours to stamp out fakes and keep our patients safe.
“The FMD DR brings one of the biggest changes to the medicines supply chain we’ve seen in a number of years, perhaps even in decades. Because of this, it’s odd that it’s not been more widely discussed in our industry, especially as it will affect every healthcare sector.”
And here at Dental Directory we agree with the BDIA and Septodont. We should be talking about this issue more.
We’ve been talking to our customers about the FMD DR and, in the run up to the regulations coming into effect on 9th February, we reminded them of their obligations and reassured those who need do nothing that we’ve got it covered.
We welcome the changes the FMD DR brings to our industry and the protection it offers our dental customers and their patients.