The date for pharmacies to start complying with the EU Falsified Medicines Directive (FMD) has come and gone, but UK implementation is far from complete. Given the latest Brexit delays, pharmacy owners could be forgiven for seeking some certainty before taking the plunge. Now, with the UK staying in the EU for the time being, and FMD-compliant packs arriving in pharmacies in increasing numbers, we asked two suppliers of FMD solutions for an update.
“We’ve noticed that while the large pharmacy companies have in the main taken steps to comply with FMD in time for the 9th February deadline date, many smaller pharmacies delayed taking action. This can only be attributed to the uncertainties created by the Brexit negotiations,” says Optel Group’s vice-president of sales, Barry Long.
“The regulators seem to have a more flexible approach about non-compliance in the short term, and pharmacies everywhere now have some breathing space to implement the relevant technology to comply,” Mr Long adds. “Regardless of what happens with Brexit, FMD was introduced to overcome the problem of counterfeit medicines and that won’t disappear. Whether pharmacies choose to continue delaying taking action or take steps now, they will still need to comply. Whatever the UK’s position with regard to the EU, they still need to protect consumers from the dangers of counterfeit drugs.”
It was always going to be the case that full compliance would take some time. General manager of global digital health at TraceLink, Glenn Kiladis, says that although the implementation deadline passed a couple of months ago, 75-90 per cent of products sitting on shelves are not serialised and do not necessarily carry a 2D barcode and tamper-proof seal, as they were manufactured pre-deadline.
For pharmacies that are FMD-compliant, the scanning and verification process may not yet be fully implemented, Mr Kiladis explained. “A pharmacist currently has to check product packaging prior to scanning it. This creates an extra step and disrupts processes. This situation, however, is expected to improve as more FMD compliant packaging enters the supply chain.”
Even where everything is in place, it’s early days. “The process and infrastructure behind the data exchange required by FMD is entirely new, and this can lead to many “false positive” alerts when pharmacies are scanning and decommissioning medicines,” Mr Kiladis adds. “As with any new major system there is most always an operational stabilisation period and most countries are treating part of 2019 as a ‘use and learn’ period.” Pharmacists are being asked to rely on their expertise while checking tamper-proof seals and continue dispensing medicines to patients. This added step can create workflow disruptions within the pharmacy environment, as pharmacists must question whether or not to dispense a medicine that throws off an alert.”
1. Become familiar with the EU FMD medicines authentication process, how it will be implemented and your role in it. Take a look at pilot studies outlining how software and hardware solutions can be used to support compliance.
2. Research potential software providers and establish a contract and service level agreement with them. Many software solutions are available; the easiest to implement are fully cloud-hosted.
3. Formally register with SecurMed UK, the national medicines verification service for the UK (www.securmed.co.uk) online. The first step for registration is to create an account for your Requestor role. The Requestor should then specify the following:
4. Connect your EU FMD software solution to SecurMed UK using the credentials returned from registration.
5. Install a scanner or barcode reader and ensure it’s working properly with both the software and SecurMed interface.
6. Update pharmacy workflow processes. This is potentially one of the trickier aspects to get right and critical since the EU FMD regulations will inevitably have an impact on workflow. Questions like, “when is the best time to decommission products?” need to be answered. It’s helpful to run a pilot to identify the best point in the pharmacy workflow to scan products to minimise disruption.
7. Update your SOP. Medicines should be scanned during the dispensing process, which requires the SOP for Dispensing to be amended.
8. Start scanning. The regulations are already in force, so our advice is to start scanning products as soon as you have installed a compliance solution.
Optel Group’s online demonstrator of FMD compliance can be viewed on a smartphone at democerta.optelgroup.com/home