TALLINN – No falsified medicines were detected during checks on the packages of 19.5 million prescription medicines performed by wholesalers, pharmacists and hospital pharmacies in Estonia during 2019.
Over 2.5 million medicinal product packages are checked in Estonia every month as part of the European medicine verification system that launched one year ago on Sunday, REKS, a nonprofit organization established to manage and coordinate the Estonian Medicine Verification System, said.
"The established system is an important prevention tool for the detection of falsified medicines, but also for the elimination of criminal organizations producing or planning to produce them," the CEO of REKS, Raul Mill, said.
He said that verification of the authenticity of medicines has been introduced well among pharmacists and other parties handling medicinal products in Estonia.
"All countries are making joint efforts for ensuring a quality medicines market and the health and wellbeing of patients. The most important thing, however, is that no falsified medicines were detected in Estonia, which means that the system has functioned effectively," Mill said.
All organizations handling medicines -- 495 pharmacies, 23 hospital pharmacies and 19 wholesalers -- have joined the verification system in Estonia, which checks over 700,000 prescription medicines for authenticity every week. Across the EU, some 150 million medicines are subjected to checks during the same period. In about 2,000 cases a week in Estonia the system gives a false alert.
Mill said that false alerts mostly are to do with medicines which either were released for use on the Estonian market before Feb. 9, 2019 and do not have to bear security elements, or which are meant for some other market but bear a similar security code.
He said that producers, users and organizations managing the system across Europe are making efforts for the share of false alerts to be reduced to the recommended level of 0.05 percent.
Where no falsified medicines have been detected in Estonia, in the Netherlands, for instance, a batch of falsified cancer drugs was detected in the course of scanning by a wholesaler in May last year. Since the detection was made before the medicine reached pharmacies, there was no danger to the health of patients. The case in question is still being investigated.
A transition system in the introduction of the medicine verification system in Estonia is in effect until until September 2020. This means that all serialized products must be checked, but if an alert occurs, the subsequent procedure will depend on the content of the alert. During the transition period, in cases where the organization issuing the medicine, such as a pharmacy, is convinced that the medicine is a genuine product, the organization is not obliged to quarantine the product in question. A product has to be quarantined, however, if the unique identifier on the package has been deactivated.
As part of the verification system, pharmaceutical companies provide all medicines subjected to the obligation to be serialized with unique security features, such as a unique identifier and a physical anti-tampering device, meaning a safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with. During the manufacturing process, the manufacturer will load into the database information that such a medicinal product has been manufactured and activated for marketing.
When dispensing a serialized drug to an end user, such as a patient, the medicine is verified through the code on its packaging. In addition for the verification, the pharmacist or wholesale will have to deactivate the code on the packaging, which prevents the same code from being reused.
The medicine verification system has been created as a Europe-wide solution, and it has been joined by Norway, Switzerland, Liechtenstein and the UK, of non-EU member states. A similar system launched in Russia from Jan. 1 this year, while the United States is planning to start checking the authenticity of medicines on a similar scale in 2023.