We return with a new perspective on the implementation of the serialization project, this time from Ms. Florina Bonifate, representative of the Romanian Pharmacists’ College.
- What has been the biggest challenge that serialisation brought to the industry you are representing?
The pharmacists represented by the Romanian Pharmacists’ College, who work in community and hospital pharmacies – End Users, have an important role in the functioning of the serialization system. The implementation of the serialization process meant providing the working points with scanners necessary for the decommissioning transaction and updating the internal software applications for the connection to the National Medicines Verification System (NMVS).
Thus, the first challenge was represented by the IT infrastructure (hardware and especially software), this being an essential part in fulfilling the obligations set out in the European legislation
The provision of the IT infrastructure was followed by the registration of the pharmacy in the NMVS, a complex process that involved collaboration with the software providers and the OSMR representatives, to ensure compliance with the necessary steps for the authentication and legitimacy confirmation of the respective organization. At the same time, the scanner configuration and the possibility of using the graphical version – WEB GUI in case the NMVS platform cannot be accessed must be checked periodically.
All these actions had to be performed in a relatively short time, often with limited resources and for every single case with a lot of work.
The greatest challenge was the involvement of the human factor, meaning the training, adapting the procedures to medicines’ supply, which actually implies a few extra steps, additional resources of effort and time from pharmacists so as to have a successful implementation of the serialization project.
- What is in your opinion the biggest advantage that the Falsified Medicines Directive (FMD) has to offer?
The Falsified Medicines Directive has been implemented because a growing number of falsified medicines – medicines which are falsified in relation to their identity, name or composition, source or history – was present on the market at the European Union level.
Therefore, the biggest advantage of implementing the Directive is patients’ safety and their increased trust in the legal supply chain.
- What have been the major concerns expressed by members within the industry you represent?
First of all, the successful implementation of the serialization involved a process of informing pharmacists about the need and obligation of implementing the Falsified Medicines Directive.
The Romanian legislation related to the falsified medicines came with a segment contested by us regarding the exaggerated amount of the fines for non-compliance with the legal obligations related to decommissioning.
In addition to this, some of the smaller or rural pharmacies, with limited resources and staff, had difficulty connecting, but the main concern has been the additional activities that pharmaceutical staff have to do. Pharmacy procedures have been adapted to the rules of good pharmaceutical practice, training has been provided and compliance has been regularly verified.
Even if the implementation process was a more difficult one, requiring time and understanding from our colleagues, they have understood the importance of the serialization project by placing patients’ safety first.
- What are some of the dangers associated with medicines falsification?
The highest risk for the patient is the consumption of falsified medicines, as they often cannot be distinguished from the authentic ones.
These may contain sub-standards ingredients or even toxic substances, or the dosage of the active substances may be incorrect, all of which pose a danger to patients’ health.
When the pharmacist provides a decommissioned medicine that has been verified on the supply chain, the patient has the certainty that he is receiving an authentic medicine.
- What are the most valuable lessons learned that can be taken by the industry from the serialisation experience so far?
An important lesson for pharmacies is the perception change related to this serialisation project.
While at the beginning the impression might have been that the process of implementing the Falsified Medicines Directive will be one that will significantly disrupt the pharmacist’s daily activity, it has been shown that the medicines’ decommissioning activity has been slowly integrated into the daily tasks, both in community pharmacies and in hospitals.
In the end, the safety that the pharmacist has, namely that he provides an authentic medicine to the patient is all that matters.
