For pharmaceutical packages – additional protective equipment



Medication packages must be further protected against forgery: unique identifications of each package will appear and become mandatory protective equipment.

These measures are provided for in EU law and should be introduced in Lithuania for less than half a year – from February 2019 from 9 February.

Gražina Bobelienė, head of the department of pharmaceutical activities at the Ministry of Health (SAM), told BNS that innovation will make patients more vulnerable to the risk of obtaining counterfeit medicines.

At that time, the chairman of the Lithuanian pharmacy association Dangutė Mikutienė points out that the new procedure entails extra costs.

Security is improved by codes and mandatory packaging

According to G. Bobelienė, there were no cases in Lithuania for tracing falsified medicinal products in legal trade, but according to statistics published by the European Commission a few years ago, about one in twenty thousand is falsified in the European Union. pharmaceutical packaging.

"It is known that strengthening drugs are more falsified, oncological drugs", – said G. Bobelienė.

She said that more protection against counterfeit medicines is the unique identification data that appears on the packages – special codes for each package. In addition, the physical protection of packaging, which is damaged by tampering and is now used by manufacturers, is mandatory.

"Now such a stringent requirement does not apply to the manufacturer of the security device, it is voluntary, and from February 9, for medicines that present a risk of counterfeiting mandatory protection measures will be required: a unique identifier and a protective device, that must necessarily be a ribbon or glue aggregate, "Bobelienė explains.

The most stressful are those who give medicines to patients.

"A database is also created, the so-called cache of the European Union If the manufacturer makes a unique identification for the package, he will enter the drug into the database and the pharmacy must scan the two-digit bar code when it delivers the medicine. The database will have an agreement if everything is in order, then the identification in the database will be deactivated If a unique ID is falsified, there will be a warning when it can be falsified because the second such unique identifier can not be. Thereafter, the research begins according to the established procedure, such a drug can not be given to humans, & # 39; she said.

The spokeswoman for the ministry explained that patients should not feel the changes when buying a pharmacy unless the service can be extended within a few seconds.

"The most stressful are those who give medicines to patients," she said.

Pharmacists are afraid of extra costs

The Pharmacy Association claims that unique identification data lead to high medication costs.

"Unique means of identification for pharmaceutical packaging are an extra expense for pharmacies, and scanners who need to scan a package cost hundreds of thousands of euros in all pharmacies in Lithuania, and no one knows exactly how much we will pay for adapting our IT systems. As far as I know, this project is also much more expensive for producers compared to the preliminary calculations: if additional costs are incurred (producers, wholesalers and pharmacies), they have to come and who they carry, and the state does matter nothing ", says D. Mikutienė, chairman of the association.

According to her, the administrative burden is worrying.

"If the system being developed does not work smoothly, it can stay in a row in a row in a pharmacy, because the service will take longer", warns Mikutienė.

Unique identification data are mandatory for prescription medicines.


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