Tim Kearns, Strategic Account Manager US - Pharmaceutical Market, Videojet Technologies
Pharmaceutical products travel through a very complex distribution network and are nearly impossible for the user to authenticate so they have become an attractive target for counterfeiting, theft and diversion around the world. The World Health Organization estimates that counterfeit drugs make up approximately 1% of the supply chain in developed countries and between 10% to 30% in developing countries1. Governments around the world have implemented or are planning to implement legislation requiring serialization and reporting to prevent counterfeiting and falsification of life-saving drugs. These regulations are forcing pharmaceutical manufacturers to take a closer look at labeling and coding technology which is very important in meeting the new regulations. The latest generation of coding printers can ensure the generation of high quality human and machine readable codes that will ensure the traceability of the product from the point of manufacture to the point of use.
Need to address drug counterfeiting and theft
Many of today’s life-saving drugs are small, high-value items whose appearance can be relatively easily duplicated by a counterfeiter. The complexity of the drug supply chain in which products change hands as many as ten times between the manufacturer and the consumer makes it relatively easy for counterfeiters to insert drugs into the supply chain. The complexity of the supply chain also leaves the door open to theft and diversion – taking a product that was intended to be sold in a particular market at a given price and instead selling it in a different market at a higher price. Theft and diversion are estimated to cost the pharmaceutical industry about $40 billion per year in lost sales2.
Governments around the world are addressing these problems through regulations that call on pharmaceutical manufacturers to improve supply chain track-and-trace capabilities by printing serialized information on primary, secondary and outer case packaging. For example, in November 2013, the US signed into law the Drug Quality and Security Act (HR 3204). Title II of this law, the Drug Supply Chain Security Act (DSCSA), addresses the security of the pharmaceutical supply chain by setting a series of milestones over several years mandating a unique product ID on prescription drug packaging, tracing of drugs through each step of the supply chain, and the ability to detect and quarantine suspect drugs. The DSCSA sets a deadline of 2017 for drug manufacturers to upgrade their production lines to enable them to print unique serial numbers on their product packaging, and 2023 to introduce electronic coding capable of tracking medicines from the factory to the pharmacy shelf.
New regulations create coding challenges
These new regulations will require significant efforts on the coding application for all pharmaceutical manufacturers. Historically, coding was used to hold key data on lot/batch number, timestamps, expiration dates and packaging types. Coding was primarily regarded as a crisis management tool that was used primarily to identify drugs that had been recalled and needed to be pulled off pharmacy shelves. But compliance with current and upcoming serialization regulations requires that more information than ever before fit inside each product’s code in order to effectively track products throughout the supply chain. Companies need to develop the capability to print unique serial numbers on prescription drug primary, secondary and tertiary packaging, greatly increasing the volume of information required to be captured in the product coding and labeling process.
The new regulations typically require that packaging be encoded with either a 2D GS1 DataMatrix code or a stacked, linear bar code called GS1 DataBar. These codes generally must contain the Global Trade Identification Number, expiration date, batch or lot number, and serial number. Most of these regulations specify that coding be applied to product packaging at the packaging lines and also to their aggregations including bundles, cases and pallets. While specifics of these regulations and implementation deadlines vary around the world, what is absolutely clear is that traceability is now a critical requirement for pharmaceutical manufacturers.
Importance of serialization-ready printers
Serialization-ready printers are needed to help ensure the necessary variable data, like serial number, lot and expiry date, is transmitted smoothly in order to deliver high quality coding that meets regulatory and supply chain requirements. There are a number of coding technologies that manufacturers can utilize, from thermal inkjet and continuous inkjet printing, to thermal transfer overprinting and laser marking. The latest generation of coding printers has a track record of successful integration into even the most challenging pharmaceutical production lines and OEM equipment, allowing code assurance without compromising productivity. These technologies are ideally suited for printing codes accurately on pharmaceutical products’ primary, secondary and tertiary packaging for clear identification as they move through the supply chain. They offer precise, quality codes at high speeds on a wide variety of substrates.
It is important for manufacturers to find the right solution rather than simply picking the right printer. All inks, ribbons and other supplies will not deliver equal performance with any coding technology. Specific application needs, such as smudge resistance or high-resolution bar codes or even packaging film type, can affect ink or ribbon selection. Environmental conditions can also dictate which ink or ribbon is best for the application. Experienced suppliers that understand these factors offer an advanced portfolio of supplies for each technology and their expertise can help manufacturers get the most from their printer.
Ensuring coding accuracy
Pharmaceutical applications demand the highest quality variable coding. Even in instances where final labeling is completed post-autoclave, on-vial traceability codes ensure the integrity of the data through the packaging process. Errors caused by entering the wrong code can lead to product rework or regulatory noncompliance. Ensuring the right code is printed on the right product time after time is becoming increasingly difficult as variations in product and packaging type leave pharmaceutical manufacturers with more codes to keep track of than ever. In collaboration with a solution provider, manufacturers can create and implement a coding procedure with built-in code assurance elements that limit the potential for user error. As an example of one approach, multiple coders can be networked together so that a single person can load specific codes from a saved database. Centralized code management helps ensure that all coders on a given line are printing the right message time after time.