On July 9th, marks five months since the Directive 2011/62/UE concerning medicinal products for human use came into force.
Aiming to avoid counterfeit and guarantee the traceability of sanitary products, packaging already has security systems that pharmacist has to verify before dispensing a prescription medicine. It is not enough to read the Data Matrix Code on the folding carton, the pharmacist must also ensure that the product has not been handled.
The recent implementation of this system is affecting different agents within the pharmaceutical sector. But how? Let us make a recap.
Public hospitals: waiting to connect
According to data provided by the Spanish Medicines Verification System (Sevem), a total of 22.061 pharmacies, 42 military pharmacies and 141 hospitals are already connected. On top of that, 277 warehouses and 384 laboratories have uploaded codes.
In Spain, in pharmacy offices all was appropriately adapted in the established period. However, hospitals lack the technological systems suitable for the verification. Public hospitals: waiting to connect
Public hospitals are having difficulties to connect since the initiative to create Nodo SNSFarma by the Health Department, and by which all the information of verified medicines could be tracked, has not been officially approved.
Several private hospitals were able to begin with the verification, connecting through Nodofarma, the node created by the General Board of the Official Colleges of Pharmacists of Spain and co-signed by Sevem and by which the industry, distribution and pharmacies are making verifications with no further major incidents.
Manufacturers and Pharmacies: new equipment, a bigger investment
Many medicine manufacturing labs have chosen to make the needed investment on serialization codes equipment and its software solutions to include them on their affected packaging lines. The investment has also been necessary to comply with the application of Tamper Evidence solutions.
Some of the laboratories have decided to externalize the code printing process and leave the serialization process to a third party, some through CMO’s and others through pre-serialized folding cartons suppliers. The laboratories who have installed the equipment on their packaging lines have determined that some special formats have presented difficulties to print certain codes.
According to Sevem information, pharmacist offices have deactivated 22 million single unique identification codes. Professional sources declare that 92% of their activity is not generating alerts in the system, although a minimum number of unresolved issues are registered. Losing and forgetting passwords, opened sessions, scanning errors, deactivation of a medicine more than once and system loops are some of the most common problems.
As a consequence of having to purchase three code reading devices per establishment, the pharmacies have also had to face an important investment. Luckily for them, some autonomous regions such as Catalonia are subsidizing the supply of these equipments.
The guarding role of the wholesalers
Distributors are not getting away from the first issues either. For example, they are receiving products with codes that are already deactivated and the causes are unknown. It seems to indicate that some pharmacists may be confusing the action of reading, to verify the identification code of the product, with the deactivating action.
Pilar Fernández del Pozo, pharmaceutical inspector for the Spanish Agency of Medicines and Medical Devices, has spoken concerning the distribution work in the verification. According to her, “each time there are less wholesalers who are not connected to Sevem”. These professionals have, ‘an essential guarding role in the supplying chain”. It has been proved in several cases of counterfeit detected in Europe. As it so happens, the inspector has thanked several warehouses in Spain who are making “voluntary verifications” that are being problematic.
Tamper evident, a key part of packaging manufacturing
The pharmacists, on top of reading the Data Matrix Code, have to verify that each medicine pack has not been opened or tampered. To this end, the folding carton contains an anti-tampering device provided by security labels or by integrated systems in the packaging. In any case, these systems have to remain intact.
Since it is one of the requirements of the European Directive 2011/62, the pharmaceutical laboratories have already incorporated the opening evidence system in their prescription medicines packaging.
Spain, the most complying country
Despite the errors, according to recent information, Spain is the European country who complies the most with the new system. Let us not forget that last February 9th, United Kingdom had 6,500 registered pharmacies looking toward the Brexit, France had none, in Belgium they could only operate, and Greece and Italy had an extension data since they already had verification models previously installed. According to Sevem, only Portugal and Nordic countries are close to Spanish figures.
And you, do you need counseling to comply with the new normative requirements? If so, do not hesitate to contact us!