Safety in Numbers

“There’s safety in numbers,” may be an old saying, but it’s a strategy that Authentix, Inc., the global leader in authentication, has long believed in and it’s gaining momentum in Europe. In May of 2007, The European Federation of Pharmaceutical Industries and Associations (EFPIA) issued a guidance document entitled “Packaging Standard for Counterfeit Resistant Packaging and its Implementation into International Supply Chains in Europe”1. In the May guidance, EFPIA indicated their support for applying unit level, randomized 2D serial barcodes, to pharmaceutical as a component of protecting patient safety and safeguarding the Pan-European drug supply.   

The past few years have illustrated the growing need to develop effective ways to improve the integrity of the drug supply chain in the European Union. Counterfeit medications found in Europe’s legitimate supply chain have been sharply increasing. In 2005, more than 500,000 counterfeit pharmaceutical products were discovered by customs official. In 2006, that number skyrocketed to over 2.7 million counterfeit drug seizures made by European Union customs agents2.   

Some European nations have already started to take steps that require serialization of drug products. Italy was one of the first European Union nations to implement a bar-code based system. In 2005, Italy introduced the “Bollini” which is a label that features the Italian product license number and a sequential number. Belgium also requires each medicine pack to feature sequentially numbered labels. France also requires two bar codes to be applied to each medicine pack3. However there is a need for standardized approach that can be implemented across the entire Pan European supply chain with the potential to be expanded globally as well.

Everyone in the distribution channel, from the pharmaceutical manufacturer to the pharmacist dispensing medicine, shares responsibility for ensuring the safety of medications.  The distribution channel across the EU can be a disjointed and fragmented pathway as drugs can change hands multiple times, often getting repackaged in the process, as they travel throughout the supply chain. Improving transparency into this complex supply chain and improving product surety are key objectives behind EFPIA’s support of unit level 2D serial bar coding as the preferred method for unit level identification.

Mass serialization is a process where unique, individualized codes are assigned to individual dosage units.  It is a process similar to putting a license plate on a car: each individual unit of pharmaceutical product has its own unique identification or “license plate”.

By assigning these unique codes, pharmaceuticals can be monitored as they pass through complicated distribution channels. Unit level serialization makes it possible to identify, track, and even recall individualized product units in the event of a recall. In addition to fighting counterfeiting, this system of identification can also contribute to patient safety by reducing medication errors. The datamatrix 2D barcode is well suited to pharmaceutical products because it is smaller than traditional barcodes, yet capable of holding a large amount of data.

As a first step towards securing the supply chain, a “book-end” strategy can be employed where product is serialized at the point of manufacture and checked at the point of dispensing.  Existing scanning technologies can be used at the point of dispensing (i.e., pharmacies, hospitals) to verify codes of product dispensed, against a database of valid serial numbers. It’s a process that is similar to what happens today when making a credit card transaction: your card is swiped, the information is entered into a database and crosschecked to determine whether the card number is valid, and an authorization or rejection is delivered. With mass serialization, if duplicates of the same serial number are dispensed, a red flag could be raised immediately alerting drug makers to potential counterfeits or diverted product in the supply chain. In addition, mass-serialization can be combined with overt, covert and forensic security features for higher levels of pharmaceutical security and a means to conduct rapid follow-up investigations.

Over time the “pages” between the “book-ends” can be filled in.  Third party
distributors would become involved in the process providing visibility to the movement of product through the supply chain. The incorporation of “parent to child” information into the codes applied to units, cases, and pallets would create linkages to enable single scans of pallets or shipping cases to capture the detail of all units contained within. The data management system developed for handling barcode based information can be forward compatible for use with RFID technology as it matures.

In March 2007, Authentix and AstraZeneca announced the implementation of a Serialized Authentication Program to protect Nexium. This represents one of the first pharmaceutical initiatives to serialize product down to the unit level. The Serialized Authentication Program utilizes unit--level serialized Tamper Evident Security Seals (TESS) that are combined with Unique Carton Numbers (UCN).

The unique serialized codes are assigned to each tablet blister pack via the carton and the associated tamper evident seal. Once this code is assigned, it is activated, validated, and entered into a database where it can be cross-checked against all serialized codes throughout the supply chain.

Each Nexium carton carries a 2D bar code printed at the AstraZeneca facility where the packaging is printed. To further secure the product, the TESS contains authentication technologies that ensure the carton seal, and thus the product inside, is genuine.  The Authentix Serialized Authentication Program is a working example of an approach to mass serialization that can be implemented today using proven technology.

Although AstraZeneca is pioneering this approach to protect its own products, the broader benefit will be realized when an industry-wide initiative is implemented. The challenge to this will be the establishment of an industry wide system for routing and verifying data from the point of dispensing. 

One industry that has pioneered and refined the ability to share data is the banking industry. To prevent fraudulent activity the banking industry keeps an industry-wide watch on loan requests, credit activity, checking account balances, and questionable transactions.  Credit cards are routinely verified at the point of use. This information is used to inform other financial institutions or businesses or consumers if there is an issue that arises. Large banking industries have banded together and utilize the same systems and protocols to prevent theft and fraud.  This information is not only helpful to financial institutions, but important to law enforcement agencies that use this data to catch criminals and support legal action.

This streamlined process offers an existing model for the pharmaceutical industry in Europe to consult and model data sharing efforts upon. Potentially, by building upon the efforts made by financial institutions around the world, and by industry pioneers such as AstraZeneca, the pharmaceutical industry in Europe can make real progress in safeguarding patient safety by tightening up the drug distribution process.