The nonprofit European Medicines Verification Organisation (EMVO) warns that five months into the operation of the European Medicines Verification System, which is meant to protect against falsified medicines and supply chain disruptions, a significant number of manufacturers and supply chain actors have not yet connected to the tracking system.
“Current available data from EMVO/NMVOs [National Medicines Verification Organisations] estimate that two fifths (40%) of manufacturers as well as one quarter (25%) of other supply chain actors (pharmacies, hospitals, wholesalers, dispensing doctors etc.) have not yet connected to the medicines verification system(s),” EMVO said in a July report.
The nonprofit is now calling on National Competent Authorities (NCAs) to start enforcing the primary requirements of the Falsified Medicines Directive 2011/62/EU and its Delegated Regulation EU 2016/161 and inspect all supply chain actors.
“Both EMVO and NMVOs stand ready to supply all necessary and available information to National Competent Authorities,” EMVO said. “The system can only fully work as intended if all actors are connected to it.”
To help NCAs, NMVOs can provide information on which end users have not yet connected, which end-user IT software providers have not yet upgraded their system to comply with the coding and decoding rules of the new system, which end-users are connecting but are not scanning serialized packs and which manufacturers are releasing serialized medicines in their market without uploading the corresponding data into the respective National Medicines Verification Systems.
A high level of false alerts within the verification system also is raising questions for EMVO, which said the alerts are mostly related to “missing data upload into the European Hub, incorrect data upload, incorrect scanner configuration of end-users, pharmacy/hospital software systems not updated, procedural reasons, system not used properly etc.”
If serialized drugs are released on the market without uploading the corresponding data into the verification system(s), false alerts can be triggered for each drug, EMVO explained.
“EMVO stakeholders consider that they can only credibly create an environment where National Competent Authorities can declare an end of the ‘stabilization periods’ if the number of ‘false’ alerts is significantly decreased (at least 100-fold reduction),” EMVO said. “Until this point is reached, products which are triggering ‘false’ alerts should still be dispensed to the patient and not be returned upstream in the supply chain, since the causes of these ‘false’ alerts are multifactorial. With a ‘false’ alert rate of 3%, this might lead to up to 2,000 products being in short supply. In the interest of continuous supply to patients, EMVO stakeholders suggest allowing end users to dispense products which trigger ‘false’ alerts until the overall alert level has stabilized below 0,05%.”
Supply chain security expert Dirk Rodgers told Focus: “I don’t know why some manufacturers have not complied yet. It could be like the attitude of the local industry in India and Russia when those countries announced aggressive deadlines [for their track and trace systems]. The international manufacturers treated them seriously, even though they had to ‘break their necks’ trying to get ready by those deadlines, but the local guys just laughed it off and ignored them. And, of course, at least in India, they were right. We don’t know yet if Russia will keep their deadlines.”
He also said he thought the “100-fold” improvement “is a good target. “That will require big penalties for non-compliance. It will be interesting to see if they do something like that, especially before they get those management functions.”
Meanwhile, EMVO also said last week that it intends to “propagate all alerts received from the National Systems to OBPs [onboarding partners].”
The FMD is a legal framework that was introduced by the European Union to improve the protection of the public against counterfeit, falsified and tampered medicines.
The directive orders that the more than 2,200 pharmaceutical companies that hold marketing authorisations to supply prescription medication to countries across the European Economic Area, must upload unique identifier codes for each pack of medicine manufactured or repackaged.
However, even back in August 2018, reports suggested that almost half of companies that hold marketing authorisations would miss the deadline, with only 841 companies having completed the first stage of connection to the new system.
The FMD came into effect for pharmaceutical suppliers and healthcare providers, including community and hospital pharmacies, on February 9, 2019. From this date, market authorisation holders were required to place two safety features on all new packs of prescription medication placed on market across Europe.
These safety features include a unique identifier (UI) in the form of a 2D data matrix, or barcode, which can be scanned at the various points across the supply chain to determine the medications authenticity. The UI must contain the product details, including name, pharmaceutical form, strength, pack size and type, a serial number, a national identifying code, a batch number and an expiry date.
Prescription packs must also include an anti-tampering device (ATD), which allows visual checks as to whether the pack may have been tampered with since its manufacture. There are no stringent regulations as to what constitutes an ATD, however typical methods include glued down packaging flaps, seals or labels that must be broken when opening, shrink or film wrap, or foil blister packs.
The aim is for wholesalers and pharmacies to scan the UI and compare the data on the pack with the data stored in the National Medicines Verification System (NMVS), which is a digital system that holds all information and UI for medicinal products that are subject to the FMD in each EU Member State.
In the United Kingdom, SecurMed, the UK Medicines Verification Organisation (UKMVO), was established to implement the UK Medicines Verification System to enable FMD compliance across the nation. Other countries have their own version of the UKMVO. For instance, Germany uses securPharm, France MVO supplies France and Sistema Español de Verificación de Medicamentos (SEVEM) provides the FMD drug verification service for Spain.
Since the FMD was implemented in February 2019, there have been some reports of issues that are affecting its success both in the UK and overseas.
On March 21, 2019, it was reported that a number of UK pharmacies were still not compliant with the new regulations and that there had been a number of delays as a result of a lack of clarity, slow roll out of required technology and external factors such as the uncertainty as a result of Brexit.
A further update was issued on March 25, 2019, which suggested that pharmacies across the UK were struggling to deal with false counterfeit alerts, despite 167,000 packs of medication being dispensed without issue since the launch 44 days prior.
At the time, the National Pharmacy Association reported that nearly 9,000 community pharmacies across the UK, around 62 per cent of the total number operating, had registered with SecurMed and that many had experienced minimal disruption to dispensing services.
Yet, the UK FMD Working Group for Community Pharmacy, which is continuing to manage the rollout of the FMD across the community pharmacy sector, claimed, even before the FMD came in to effect, that ‘false positive’ alerts would be problematic — and they were correct.
Many pharmacy systems displayed ‘false alerts’, including ‘unknown product code’ and ‘failed to find batch’ error codes, which were reportedly caused by manufacturers not uploading the relevant data to the system. The UK FMD Working Group for Community Pharmacy issued guidance on managing false alerts on its website, including a flow chart intended to support compliance.
A roundtable event entitled ‘Improving patient safety with the FMD in the hospital pharmacy, status of implementation’ took place on February 19, 2019 at the EU Parliament, and brought together representatives from hospital pharmacies, patient safety organisations, EU Commission officials, European and national agencies, as well as other industry personnel. The event aimed to help debate solutions that are in support of the implementation of the FMD across the hospital pharmacy setting.
The head of the IT solution, whose responsibilities include all of the bar-coding data, stated that while the system had been built in all 28 Member States, there is a need for a period of stabilisation and inspection to ensure everything is running smoothly.