Counterfeiting or distribution of medicines whose manufacture does not comply with regulations – in some countries it represents 20% of the pharmaceutical market – has serious consequences, both for the safety of the citizens and for the economy of the sector.
Although it certainly lashes harder against developing countries, Europe is also not free from this problem that has raised the alarm bells of national and international administrations. But what exactly is the situation?
European Directive on Counterfeit Medicines
To protect people from this public health risk, the European Union launched the European Directive 2011/62 / EU on Falsified Medicines Directive (FMD).
The verification of medicines (known as the European Medicines Verification System or EMVS) entered into force all EU member states (with the exception of Belgium, Italy and Greece, which have until 2025 for implementation).
Therefore, pharmacies are now required to verify medications prior to dispensing. In case of not doing so, the competent authorities could impose sanctions during an inspection or audit.
Advantages of serialization
Some advantages of Pharmaceutical serialisation solutions. The implementation of this verification system will be beneficial for citizens, but also for authorities, manufacturers and distributors.
With it, you will have more thorough control of the batches produced. For example, when making a recall in the market, it will no longer be necessary to withdraw a complete batch of medicines (since authorities and manufacturers will be able to identify each product in a unitary way, through the codes ).
Thanks to the traceability, the user, for his part, ensures the authenticity of the product he buys, the pharmaceutical laboratory endorses the quality of his drug and the pharmacy reaffirms itself as a guarantor of the dispensation of safe and effective medications.
For the pharmacist, the verification will allow a streamlining of the product withdrawal processes, an improvement in the logistics processes of the pharmacy (such as stock, batch and expiration management ) and will be an opportunity for the removal of the seal coupon ( one that is cut when dispensing a prescription drug). Regarding the latter, the will of the Ministry of Health is to suppress it, although it has not yet specified when it will be eliminated.
Pharmaceutical serialization solutions
How will the regulations affect the daily life of pharmacies?
The pharmacist, as the dispersing agent, must be ready to verify medications – through a visual inspection of the container to certify that the anti-tamper device (DCM) is intact – and deactivate their unique codes or identifiers (this is, unsubscribe from the database).
To do this, pharmacies must have camera-based scanners that can read both two-dimensional codes and barcodes, since serialized medications will coexist with those that incorporate the usual barcode
Along with the scanner (one is recommended for each dispensing station and at least one for the reception station), pharmacies must adapt their software and need to have their own access credentials to Nodofarma Verification – the platform that will perform the authentication.
Investment and possible incidents
In recent years, pharmaceutical laboratories have been forced to adapt their structures and make a huge investment to comply with EU regulations against counterfeit drugs. This investment has materialized in the acquisition of new machinery and new code printing technologies.
The adaptation to the new Directive has also entailed costs for pharmacy offices. Added to the unit authentication of the containers is the task of informing users about this novelty and training personnel on the operation of the new system, as well as the resolution of possible incidents.
For example, it could be the case that, after deactivating a code, the patient decides not to take the medicine.
In these cases, the pharmacist can and should request reactivation. It will do so by contacting the national repository through the software. The repository will verify if the conditions are met to proceed and, if so – that is, if the pharmacy is the same one that dispensed the medication and if no more than 10 days have elapsed since the deactivation – this will be carried out. reversal and the medication will be dispensed again.
At Inno4life.com we have been providing unit code printing solutions for more than six years and providing pre-serialization services to our clients.