Apteekkari magazine: Protected by code
Reportage | Medicine verification system
Protected by code
Text by Inkeri Halonen | Pictures by Timo Hartikainen
Published in Apteekkari magazine 2/2016
Production downtime and huge investments await the pharmaceutical industry, as a new system to prevent falsified medicines, will be rolled out in 2019. For Servicepoint, a company that specialises in adapting production lines, this means years of work ahead as an increasing number of companies want to have the security of codes. The next three years will see production lines being revamped as the system to prevent falsifying prescription medicines enters into force in EU countries in 2019.
Servicepoint, based in Kuopio, Finland, is well positioned to face this challenge. The company offers planning and installation services allowing integration of devices and software required by the system into the production line. The company is currently hiring, and existing staff is being trained up. The number of staff is likely to double to almost one hundred over the next couple of years.
The system created to prevent falsified medicines looks simple when looking at the test line assembled in Servicepoint’s premises. At the start of the line, a printer gives each packet of medicine a unique code. Packets are then bundled to groups, and each bundle receives its own code. The machine packs the bundles into a cardboard box, and the box receives its own code. A robot arm lifts the cardboard boxes onto a platform, which receives its own code before being transported away by a forklift. The packet specific code contains the product’s product number, unique serial number code, batch date, batch number and in some cases national reimbursement information. Group, box and platform package codes contain references to the individual codes contained within them. Codes will be mandatory on practically all prescription medicines sold in Europe, with the exception of medicines approved on the so-called white or blacklist. The whitelist contains prescription medicines which until further notice may not receive a code and the blacklist over-the-counter medicines which exceptionally do require a code.
Before giving medicine to the customer, the pharmacy will read its code and check its authenticity. The system shows an alert if the medicine is not deliverable. Reasons for this may be that the product has been withdrawn from the market, is a suspected forgery, has expired or notified as stolen. If the medicine is deliverable, the pharmacy will hand it over to the customer and remove the packaging data from the database.
This is where things get more comlicated. There are 15,000 prescription medicine production lines in Europe. Currently, just under a third of them are equipped to produce a unique identifier for a packet of medicine. This means a lot of work for Servicepoint. “Until now many pharmaceutical manufacturers have waited to see the direction into which legislation will develop. Soon everyone will swing into action at the same time,” says expert Iiro Jantunen, D.Sc. (Tech.), from Servicepoint. Factories that have highly automated functions are in the best position. But even then installing, testing and validating a serialisation system will cause production downtime lasting a couple of months. Costs resulting from this may be many times higher compared to the installation and information system costs.
The situation is especially bad for factories where boxes are still moved manually and that have a low level of readiness to join the European database. “There are still many factories around Europe that focus on ergonomics and not automation. Some of these factories may disappear as the system changes,” says Jantunen. If a factory is one of the only ones manufacturing a rare medicine, a long period of downtime or closure of the factory might affect the availability of the medicine or increase its price significantly for a period of time. Contract manufacturing, common in Europe, presents its own challenges. Each medicinal product must include the marketing authorisation holder’s codes, in other words, the factory must have the ability to constantly switch between the codes of different marketing authorisation holders on the production line.
An exception to the agreed system within Europe complicates matters further. The exceptions must be understood in detail because a unique identifier must not be found on drugs for which it has not been defined. Firstly, three countries – Belgium, Italy and Greece – have been granted an extension period of six years to implement the system because these countries already use their own systems. Some European countries – possibly Germany, France and Spain – want their own national drug reimbursement information to be included in the code. The same drug preparation might be a prescription medicine in certain European countries and an over-the-counter medicine in others. This is why there might be national differences in the so-called black and white list.
In addition, all medicine packets with a code must have anti-tampering measures implemented indicating if the packet has previously been opened. However, a mechanical obstacle, e.g. paper tape, may be used also in other than coded medicines with the permission of the national drugs authority. The pharmaceutical industry needs to take all this into account when planning where to manufacture medicines for sale. “Of course different language versions of packaging and instructions will be needed, but that’s something the pharmaceutical industry is already used to,” says Jantunen.
A unique identifier enables many new things, especially if in the future consumers will be given access to the data behind a code. Reading a code with a smartphone would technically already be possible. However, consumers have not yet been permitted access to the database. The database connection might be useful for example for haemophilia patients who use medicines with varying shelf life. Scanning the code just before taking a medicine would quickly show the patient if exceptions in the shelf life of the product they are using have been found. In this case, the patient could return the medicine to the pharmacy and receive a replacement.
Giving consumers access to the data would also support drug effectiveness studies. “It’s quite easy to arrange access to the data, and it’s likely that this will be allowed at some point,” speculates Jantunen. Jantunen believes that the code will prevent medicine falsifications or at least make them a lot harder. “Forgers are able to make a packet and product look very authentic, we’ve already seen that. But now they’d need to get the product into the database, which is difficult. Or then sell the product to a buyer who doesn’t care.” However, the risk is that the forgery business will simply change the target. “As forging prescription medicines becomes more difficult, forgers will move to over-the-counter medicines. Already now the most copied products of a certain large pharmaceutical company are paracetamol and toothpaste.”
Jantunen thinks that the black list will quickly become longer. The list now includes only Omeprazole, a suppressor of gastric acid secretion. Serialisation may also reduce the black market, or parallel, imports and exports as packaging costs rise. “If you buy a batch say from Romania and want to re-package it for the Finnish market, the packets and their codes need to be undone, in other words, marked as used. Then the product needs to be re-packaged and registered with new identifiers,” explains Jantunen.
In addition, a re-packager must inform the central administrator from which removed packages the new packages have been created so that the packages can be linked. For Servicepoint, an increasing black list would mean even more work. Not that there’s a shortage of work, as it’s not just the pharmaceutical industry that is adopting the use of unique codes. Next, anti-plagiarism codes will be likely adopted in the aviation and car spare parts industry, pesticides, infant formulas, brand products and health technology. In other words, wherever a forged, poor-quality product might pose a serious danger. “There’s a lot of potential in the serialisation business; even a small slice of it will mean growth for us,” says Jantunen.
The pharmacy as the verification system gatekeeper
The role of pharmacies in the new drugs verification system is crucial: primarily a product’s authenticity will be verified systematically only in the pharmacy before handing It to the consumer. The pharmacy can carry out the verification also in connection with unloading product deliveries into its stock or stock robot. In connection with a delivery, the pharmacy must decommission the unique identifier from use from the verification system. To implement the system, pharmacies will need to adapt their stock management and supply processes and renew their IT systems and hardware. For example, current barcode readers will need to be replaced by readers that allow reading a two-dimensional barcode. Until now the Nordic or national product number code VNR has been used for reliable verification of medicine packages for medicines sold in Finland. With the introduction of the drugs verification system, VNR will be used less and manufacturers will start using so-called GTIN barcodes, which run as part of a two-dimensional security code.
Data included in the code
– Product number
– Unique serial number code
– Use by date
– Batch number
– National reimbursement information (not mandatory)
Will the system prevent forgeries?
Pasi Virta, Responsible Pharmacistat Pfizer; Sami Paaskoski, Senior Pharmaceutical Inspector at Fimea; and Ulla Närhi, Ministerial Advisor at the Ministry of Social Affairs and Health, discuss the new system.
Will the new system reduce the number of falsified drugs in legal distribution channels?
PV: Yes. Sneaking medicines into the legal distribution channel will become harder than before.
SP: Yes. The safety feature in the packaging coupled with the data in the database will make it more difficult to get forgeries into the legal distribution channel.
UN: Yes. Increasing the safety features of medicines is being done exactly to prevent falsified medicines entering legal distribution channels.
Will implementation and verifications in the new system cause problems in terms of the availability of medicines?
PV: This is possible because of the tight schedule. However, I think it’s more likely that significant availability issues will continue to be caused by availability problems in raw ingredients.
SP: Possibly. Even though the transition period is three years, practical measures might build up towards the end of this period. Availability problems are however likely to be caused mostly by other reasons.
UN: It’s possible, but I don’t think that the implementation of the new system and verification alone would cause availability problems.
Will we see an increased interest in falsifying over-the-counter medicines as falsifying prescription medicines becomes more difficult?
PV: No. All medicines that have a demand will be falsified.
SP: No. In practice, everything is falsified, and demand increases falsifications.
UN: I don’t think so. A security feature will be added to over-the-counter medicines that are at risk of falsification.
Will the system have an impact on falsified medicines purchased on the internet?
PV: No. As long as there is demand, falsified medicines will be sold on the internet.
SP: No. The system will protect the legal distribution channel.
UN: It won’t have an impact on falsified medicines bought through illegal distribution channels.
In the future, will consumers have the right to check the authenticity of a medicine using their smartphone?
PV: No, because the code will be read already in the pharmacy.
SP: At present this is not in the pipeline. Verification requires the use of special databases, access to which will be limited to distribution channel players and the authorities.
UN: I don’t think so. A system like this would be very expensive and would not necessarily be very cost effective.
CTO, Chief Technology Officer
Servicepoint Kuopio Oy