Pelion's activities

It is worth noting that these were the first tests in Poland conducted from the beginning to the end of the process, i.e. from introducing the drug to the market, until its release to the patient.

- The testing process was a large-scale undertaking and required great precision, appropriate technological facilities, a team of IT specialists and knowledge of the process – explains Paweł Mieczkowski, Project Manager and the person responsible for testing the PLMVS medicine authenticity verification system on behalf of Lideo S.A. - In practice, the process was such that MAH, i.e. the drug manufacturer (responsible entity), introduced information into the European medicines database. The PLMVS system managed by the KOWAL Foundation was synchronized with the European database, thanks to which we were able to verify the medicinal products introduced by MAH, i.e. generally speaking we confirmed their authenticity by issuing and returning several medicinal products. We have carried out comprehensive procedures in accordance with the EU guidelines and on the basis of the results of these tests we can state that technologically we are able to properly verify the authenticity of medicines and thus meet the restrictive requirements of the directive – concludes Mieczkowski from Lideo.

The tests were an integral and necessary element in the process of proper implementation of the Falsified Medicines Directive.

The EU directive states that from 9 February 2019, among other actors, hospitals, pharmacies and wholesalers will be obliged to verify the authenticity of the origin of medicines before they are administered or released to the patient. This will apply to all prescription drugs (with few exceptions) and an OTC drug – Omeprazole in two forms. Therefore, in order for such authentication process to be possible in Poland, on 5 July 2017 the Polish Medicines Verification Organisation – KOWAL Foundation was established, its aim is to build and manage an IT system for authenticity verification of medicinal products in Poland, which will be synchronized with the European database and will enable efficient verification of medicines. The system managed by the KOWAL Foundation was positively tested by Lideo on 30 November this year.

- We are very pleased with the results of the tests, as they were of key importance for the verification of Poland's preparedness for changes in the verification of the authenticity of medicines a few months before the date of commencement of the obligation to verify medicinal products in accordance with Delegated Regulation 2016/161. New EU guidelines are necessary to increase the patient’s safety in pharmacotherapy, improve drug control mechanisms and eliminate falsified medicinal products which pose a serious threat to the health systems of the Member States, from the market. In cooperation with pharmaceutical market participants, we do our best to ensure that patients in Poland feel safe and can be sure that the medicines they buy in pharmacies or receive during hospitalization come from legal sources – says Michał Kaczmarski, PhD - President of the Polish Medicines Verification Organisation (KOWAL).

What will the verification of medicines look like in practice?

According to the directive, manufacturers of medicines will have to apply double safety features to allow for correct verification of medicines. These will include: 1) protection against unnoticed opening of the package and 2) identifier embedded in the 2D code unique for each package. Pharmacies will have to scan the 2D code on the drug package before releasing a serialized medicinal product. Then a dedicated system connected to a pan-European database, where serial numbers of drugs will be entered by their manufacturers, will check its authenticity. If the application shows that the medicine is in the database and is authentic, it can be given to the patient.

If the unique identifier read out does not appear in the European medicines database, the manufacturer of the medicine will be automatically informed of this fact and will take appropriate action in accordance with the recommendations of local authorities, which define the rules of conduct in case of an alert.

The Falsified Medicines Directive requires coordinated international action to prevent the presence of counterfeit medicinal products on the market, plays a key role in increasing the safety of patient treatment in the European Union. By allowing the authenticity of medicinal products to be verified before they are administered to the patient, it strengthens the European pharmacovigilance system. The introduction of the directive on combating falsified medicines will significantly improve the quality of healthcare services provided to patients, eliminating medicines from the market which come from illegal sources.

Obtain more info from:

Marta Dec

Senior Brand Manager

Lideo S.A.

+ 48 691 163 305

marta.dec@lideo.tech 

www.lideo.tech 

Lideo S.A. is a nationwide supplier of modern computer and technological solutions on the medical market and the creator of an ecosystem of innovations in the area of digital hospital transformation. It is a part of Pelion S.A., the largest healthcare company in Poland and Urtica Sp. z o.o., the leader on the domestic market of distribution of medicines to hospitals. Lideo is an experienced team of specialists and experts with many years of experience in IT and their own team for commercialization of start-up projects (business analysts, developers, testers, product owner, security specialists, BI analysts). As part of its strategic cooperation with Urtica  Sp. z o.o., the Company has its structures in 5 cities in Poland and 17 regional representatives. Lideo S.A. focuses on technological solutions that will allow to make the functioning of the health service more economically and organizationally friendly, and patients to recover in more comfortable conditions – in three areas: e-health, e-patient, e-organization.