“Ángeles Figuerola, director of SEVeM (the Spanish Medicines Verification System), has announced the development of the verification system in pharmacies.”
Pharmacies are going to play a fundamental role in implementation of the medicines verification system. As Ángeles Figuerola said at Infarma 2017, tests of the system in pharmacies will begin in July.
The managers of the SEVeM have set different targets and dates to comply with all European directives and develop the verification system efficiently before the dead-line set by Europe in February 2019 is reached.
We shall now look at the future functions and requirements to be met by the organisations involved in application of the medicines verification system, and their role in each of the phases which are going to take place in coming months.
1-Choice of a technology supplier
The SEVeM recently chose Arvato to design the system which will enable all pharmacies to be connected to a common database with all the information on medicines.
The name of this platform is Nodofarma, it will store the data and connect the different agents involved and will also include interactive instructions to assist pharmacists on how to use it.
2-Start of pharmacy tests
The last-minute details of NodoFarma are now being decided so that the first tests in pharmacies can begin in July, according to Figuerola.
Furthermore, the role of distributors is also going to be very important in this initial contact, not only because of their direct connection with pharmacies, but also because they will have to adapt packaging and apply the anti-counterfeiting measures required by the European Directive.
3- Unit medicine verification
All folding cartons will have to be identified with a serialised code including information about the medicine, allowing it to be identified and its authenticity checked.
Thus, a unique verification code (unit verification) will be printed on the packaging with the initials ASS, replacing the traditional barcode and tear-off stub.
Each medicine’s information will be included in the printed code on the folding carton by serialisation, using the DATAMatrix two-dimensional code, a process we at Nekicesa Packaging have been carrying out in our facilities for over a year.
The action of pharmacists is going to be essential to ensure the health of the customers and to guarantee the authenticity of what is content on the folding cartons. When they receive the medicine, they will have to validate it and verify its origin and the information on it, and check that it has not been handled by any external agent.
Once the verification process is been completed, the pharmacist will have to deactivate the code included on every product. This will mean no one else will be able to sell the medicine, because it will be registered as “already dispensed”. The pharmacist will also be responsible for the product’s withdrawal if there are signs of manipulation or counterfeit.
Like pharmacists, distributors will also have to verify the authenticity of the unique identifier of all the medicines they process. They will also be required to deactivate the code of medicaments which are to be sent outside the European Union, have expired or need to be destroyed.
As well as verifying, registering or removing codes from the system, they will have to adapt their packaging to the directive’s requirements, either by updating their software or by outsourcing their packaging adaptation to a company specialised in pharmaceutical packaging.
They will have to take into account all the packaging requirements stipulated by the regulation, such as the incorporation of DataMatrix readers (DataMatrix is a two-dimensional code containing the essential information). This is indispensable to manage the packaging handling correctly.
6- The pharmaceutical industry
The phase of introduction of the system in the pharmaceutical labs will be mainly paid for by Farmaindustria, with an outlay of about €200 million, representing 80% of the total investment.
AESEG will then be responsible for the subsequent maintenance stage, assuming 20% of the total cost, an investment amounting to approximately €70 million.
Nekicesa offers the most advanced solutions in pharmaceutical packaging and serialisation, backed up by over 50 years’ experience in this sector. We are aware of the changes the regulation entails, which is why we offer measures in accordance to the industry needs.