The medicines verification system roots out falsified medications

Even one falsified medical product is one too many, says Maija Gohlke-Kokkonen, the General Director of the Finnish Medicines Verification Organisation, FiMVO. An EU-wide medicines verification system is a way to fight against organised crime which is increasingly often involved even in the legal medicine distribution system.

In Europe, falsified medications appear in approximately one per cent of all medicine packages within the legal medicine distribution system every year. There have been such cases in Finland, as well. In developing countries, up to a third of the medications received from a pharmacy or health care centre is falsified. Falsified medications are a worldwide problem, which is why other markets, such as the USA and Russia, are also developing their own verification systems.

“However, a medicines verification system can’t stop the falsified medication business operating outside the legal distribution chain. I truly hope and believe that this reform will wake people up and get them to avoid purchasing medications from sources other than pharmacies and legal online pharmacies. A falsified drug is a serious health hazard,” says Gohlke-Kokkonen.

Verifying the functionality of the system

FiMVO is responsible for building and managing the medicines verification system in Finland. The medicines verification system consists of a central European database where medicine manufacturers enter the identification information for each medicine package they bring to the market.

The information entered into this central database flows to the national databases used by the local actors in the medicine distribution chain: wholesale distributors, pharmacies and hospital medical services.

“The systems used by EU countries are very similar and can communicate with each other. However, their preparedness levels vary. The systems in the Nordic countries and Central Europe are very advanced, but there are countries whose systems won’t be ready by the deadline of 9 February 2019,” says Gohlke-Kokkonen.

In Finland, both the medicine manufacturers and the pharmacies’ system providers have already tested the system. Wholesalers and hospital medical services will also participate in the testing phase to ensure the functionality of the system in all parts of the medicine distribution chain. The medicine distribution chain in Finland alone processes 7,000 different products and 70 million packages every year.

“We’ll start increasing the number of users in a controlled manner during the summer, and our goal is to have 95 per cent of wholesalers, pharmacies and hospital medical services linked to the medicines verification system by November. We want to ensure the system’s functionality well before the deadline set in legislation,” Gohlke-Kokkonen states.

Instructions for problematic situations

Connecting pharmacies to the medicines verification system requires collaboration with the pharmacies’ system and automation providers. For example, NewIcon sees to the software and hardware updates of their automation devices to ensure the connection between the pharmacy system and the medicines verification system.

“Our common goal is to keep delivering medicine packages to patients and pharmacies’ customers without delays or interferences,” says Gohlke-Kokkonen.

FiMVO and the actors of the medicine distribution chain are working on instructions that will provide pharmacies and other actors with practical solutions for possible problems. Medicines verification will be a new stage in the pharmacy workflow, which requires some learning.

“We will go over the process of medicines verification in advance. We’ll create clear instructions for situations where the system alerts the user about a falsified medication or when there’s a technical issue, for example. The practical work and customer service will be easier and faster when all parties are already familiar with the process,” Gohlke-Kokkonen says, explaining the purpose of the instructions.

According to Gohlke-Kokkonen, automated dispensing systems will make the new work stages easier for pharmacies. The information on the identification code of a medicine package, such as the product’s expiry date and batch number, will be recorded on the automated dispensing system, which will make it easier to manage the storage and recall products in case of a problem.

100% safe

Connecting to the medicines verification system requires great effort from pharmaceutical companies, who will need to deliver medicine packages labelled with an identification code that verifies the product’s authenticity. The reform will require investments on production line devices that add the codes on the packages and transfer the information on the code to the medicines verification system. At the same time, an anti-tampering mechanism, such as an adhesive seal, needs to be added on the packages.

“The costs per company will be significant. I feel that some companies will completely stop manufacturing some of their products. Even we don’t know how many companies will hold sales permits next year.

However, the investments are small compared to the benefits that can be gained from them. Medication safety will improve, meaning that the legal medicine distribution chain will provide people with medications that are 100% safe.

“The medicines verification system will also impact the reputation of pharmaceutical companies and strengthen people’s trust in the entire distribution chain. In the future, you can be sure that your medication is safe,” Gohlke-Kokkonen states.