Counterfeit protection: each pack is unique

SecurPharm: In the future, prescription drugs must be provided with an individual identifier and tamper-evident protection. However, packs without these security features remain marketable until their expiry date

The countdown is on: As of February 9, 2019, the EU directive on counterfeit protection will be implemented across the EU. All prescription drugs that manufacturers place on the market after this deadline must have additional security features and be checked for authenticity prior to dispensing in the pharmacy. In the future, a 2-D code will make every pack unique: in addition to an individual serial number, it contains the product code, the batch and the expiry date.

Tamper-evident protection is also intended to ensure that the pack has not been tampered with in the distribution channel. The only exception: In the pharmacy, the tamper-evident protection can be opened for testing purposes and closed again with a special adhesive label. Because the pharmacy operating regulations stipulate random checks of finished medicinal products: Every year the local pharmacies check more than six million industrially manufactured medicinal products.

To ensure that the pack has not been forged or stolen, the 2-D code is scanned in the pharmacy before it is given to the customer and the serial number is compared with a central database. "If the number has already been recorded there or if it is not recognized by the system, a warning appears and the pack must not be dispensed," explains Dr. Hans-Peter Hubmann, Vice-Chairman of the German Pharmacists Association.

Increasing problem

But why all the effort? After all, counterfeit drugs have only rarely appeared in the legal distribution channel so far. "Counterfeit drugs are a growing problem worldwide and criminal gangs are becoming more and more resourceful," says Hubmann. The actors involved in the supply chain have made enormous efforts to ensure that the path from the manufacturer to the wholesalers to the pharmacy remains safe.

With SecurPharm they have developed a joint system that makes it almost impossible to smuggle counterfeit packs into the legal supply chain. "Patients' trust in safe drugs from the pharmacy must not be gambled away," emphasizes Hubmann. For four years, the system for authenticating prescription drugs was tested in around 400 test pharmacies for suitability for everyday use. But is it really ready for widespread use?

Fear of false positives

Even before the official starting shot, critical voices are loud: false alarms occurred far too often during the test phase. For example, due to technical errors at the manufacturer who did not correctly book the package into the system. Or through handling errors in the pharmacy such as accidentally double booking. Such error messages could lead to major problems in real operation.

Because every warning involves a time-consuming procedure: the pharmacy employees have to withhold the relevant pack and provide the patient with a replacement product as quickly as possible. If the individual serial number cannot be found in the database, the manufacturer receives a message.

If he cannot clarify the reasons for the false alarm within seven days, the pharmacy must inform the responsible supervisory authority. Should there be a large number of false alarms in the course of the changeover, this would significantly affect the processes in the pharmacy.

The Federal Ministry of Health admits: "At the start of the drug verification
systems within the framework of the European guideline for the protection against counterfeiting of pharmaceuticals, technical start-up difficulties cannot be ruled out in principle. "

However, the responsible organization in Germany, SecurPharm, has prepared suitable measures to investigate the cases marked in the system as quickly as possible and thereby differentiate handling errors or technical errors from cases in which a suspicion of falsification cannot be dispelled. Good communication between all actors involved should help to solve any problems that arise quickly and efficiently.

Longer conversion process

SecurPharm is also confident: "As required by law, the system will be launched on February 9th," emphasizes SecurPharm spokeswoman Nathalie Steinhauser. Pharmaceutical companies, pharmacies, wholesalers and clinics are now almost completely connected to the system and are therefore able to carry out the data exchange necessary for the authenticity check.

After the start, the protection system will be continuously developed and adapted according to the findings from ongoing pan-European operations. Steinhauser: "This is the beginning of a longer process of conversion in the entire legal pharmaceutical distribution, which improves the protection against counterfeit medicines every day."

Fluid transition

At least in the beginning, it is highly unlikely that a false alarm can actually be traced back to a forgery: On the reporting date, there will probably not be any packages requiring inspection in circulation. These are only gradually coming onto the market and will gradually replace the older packs. The latter may still be handed in without being checked until their expiry date has expired.

This means that packs with and without safety features will be available in pharmacies and clinics for several years. If this is missing, it says nothing about the quality of the drug in question. But only that it was placed on the market before February 9, 2019.