Solution for SEVeM compliance in the reception and dispensing of medicines
The Spanish Medicines Verification System (SEVeM) was created five years ago to comply with the European Union's anti-counterfeiting regulations and guarantees the authenticity of all prescription medicines circulating in the European Union, preventing counterfeit medicines from entering the authorized sales channel. Compliance with SEVeM is crucial to guarantee patient safety, as not purchasing medicines from community or hospital pharmacies can have negative consequences for patients.
Hospital pharmacy services must adapt their management systems to incorporate the necessary communication interfaces to integrate with SEVeM, complying with data exchange standards. At an operational level, this means adapting their processes to the new regulations when the medicine is received in the warehouse, as it must be checked by consulting the national repository to ensure that the identifier of a container is unique, is authentic, and does not meet any of the circumstances described in the regulations (expiration, theft, withdrawal, already dispensed) that prevent its dispensing. Likewise, it must also be reported when it enters the dispensing circuit, as it must be reported to the national repository to prevent this container from being dispensed again.
Costaisa has a SEVeM compliance solution that meets the data exchange standards required by the Administration, and covers the entire verification process both in the reception of the medicine and its dispensing, with all the casuistics that hospitals will encounter in their day-to-day work: drug withdrawal, non-dispensing or withdrawal of containers, among others. It is an integral and modular solution that can be implemented in both SAP R3 and S/4 HANA environments and can be integrated via API.
The Spanish Agency for Medicines and Medical Devices (AEMPS) and the Spanish health authorities are responsible for adapting European regulations to the Spanish context and supervising their implementation. Non-compliance with the regulations may entail various sanctions, both economic and operational, such as temporary suspension of professional practice or even professional disqualification in the pharmaceutical field.