The Falsified Medicines Directive (FMD) is an international legislation aiming to prevent counterfeit medicines entering the supply chain. As the name suggests, falsified medicines are “fake” or “unauthorised” medicines trying to pass as real. But what does all of this mean for pharmaceutical companies and patients?
These falsified medicines might contain poor quality ingredients or dosages that are either too high or too low. The fact that they have not properly been checked for quality, safety and efficacy could be detrimental to patients’ health. This goes to show how important the FMD is as well as pharmacy training.
The Falsified Medicines Directive Explained
February 2019 marks the deadline for the EU Falsified Medicines Directive (FMD) and it’s essential that pharmaceutical companies and their supply chain partners understand the compliance standards to ensure a smooth implementation.
From the 9th of February 2019, pharma companies must place two safety features on all new prescription medicines in the European market. This includes a unique identifier (UI), a 2D barcode that can be scanned along the supply chain in order to determine its authenticity. Additionally, it also requires an anti-tampering device or ATD.
Community Pharmacies must have the IT capability to accept medication into their pharmacy and book it out of a National Database held in the UK by SecurMed. As previously stated, barcodes are required to book out or decommission medicines to check the authenticity of the product. This involves looking in the global database to verify the medicine so pharmacies can hand it to the patient.
It’s still early days of the implementation as products are only just appearing in the supply chain with the required 2D barcode and SecurMed listing. However, it will become part of the normal working day for pharmacy teams to scan products and check their authenticity.
How Does The FMD Work?
The EMVS (European Medicines Verification System) is essentially a database with the identification data of all medicines in the EU. It acts as a gateway for transferring manufacturer data to the national systems. In turn, the National Medicines Verification Systems (NMVS) serve as verification platforms that pharmacies, doctors, wholesalers or other registered parties use to verify the “authenticity” of medicines. They are responsible for sending data from the manufacturers to all of the (NMVS).
Some manufacturers use pre-wholesalers who then sell the medicine to wholesalers. The wholesaler only scans and verifies medicines that have not come directly from the pre-wholesalers or manufacturers. This process is referred to as “risk-based verification” as a high percentage of medicines don’t need verification or decommissioning. While that may be the case, wholesalers must decommission medicines on behalf of other suppliers like care homes and dentists.
In terms of community pharmacies, they can choose to verify the product when they receive it. However, verifying it at this point won’t change its status in the database. Pharmacy staff must check the anti-theft device and scan the barcode before handing the products to the patient and only then does the item status change. The UI code is essentially veriﬁed against the NMVS data from where the status changes from “active” to “inactive – dispensed”. This ensures that the same UI cannot be veriﬁed multiple times.
Benefits Of FMD
While the system has several benefits, they won’t be quite as clear when it first goes live on February 9th. Looking ahead though, the FMD will prove exceptionally helpful to everyone involved.
- Patient safety could be improved with reduced risk of dispensing errors
- Some systems will allow the pharmacy team to check that they have the right product at the point of dispensing by scanning the barcode
- This may also improve stock control and the re-ordering processes
- The 2D barcode stores the Batch Number and Expiry date of the product
- This means pharmacies can actively manage the expiration dates of products without having to check the shelves
Get Ahead With VirtualOutcomes Training
Most pharmacy teams and owners have trouble understanding exactly how to implement FMD. We know how challenging it is to effectively manage time and resources in a community pharmacy. From assisting patients to checking prescriptions and other day-to-day tasks, there’s barely time left for anything else.
Our 15-minute online pharmacy training course will provide pharmacy teams with a simple, yet detailed, overview of FMD. You will learn everything about becoming compliant and start reaping some benefits. Log onto VirtualOutcomes pharmacy training and enter your F Code to access the course.
If the course is unavailable for your pharmacy, it’s likely that your Local Pharmaceutical Committee (LPC) hasn’t signed up for it yet. Contact us to find out more about our courses and how you can register.