AstraZeneca protects Nexium supply chain

The global player will be one of the first pharmas to implement a comprehensive security system serialising and authenticating its products down to the unit level, when the programme is implemented next quarter at a cost of tens of millions of dollars. While the benefits of supply chain protection through radio frequency identification (RFID) have been much talked about but slow to materialise in a practical and applicable form, counterfeiters have not slowed down their attacks on the pharmaceutical industry. It's noteworthy that AstraZeneca have opted for an alternative product protection measure, right down to the unit level, rather than adopting RFID in its current form as some other pharmas have done. AstraZeneca has gone for US firm Authentix's serialisation authentication programme to protect supplies of Nexium (esomeprazole), the company's gastrointestinal drug, which generated sales of $5.2bn (€4bn) in 2006. The drug supply chain will be protected by unit-level, serialised, tamper evident security seals (TESS), along with unique carton numbers (UCN). Unique serialised codes will be allocated to each blister pack via the carton, and will then be activated, validated and entered into a database where they can be checked against all serialised codes in the company's supply chain. "The tamper evident security seal and unique carton number is being rolled out on Nexium initially, and other products will follow. A brand risk assessment has been carried out to decide in which order,"​ David Teale, director of product security at the company, told In-PharmaTechnologist.com. Only last week the International Narcotics Control Board warned of the dangers of counterfeit medicines currently flooding the market and the threat posed to consumers, not to mention the impact on pharma company coffers. By 2010 the World Health Organization has estimated that the counterfeit drugs market with be worth a hefty $75bn worldwide. Other pharma heavyweight Pfizer recently announced that it would be tagging bottles of its blockbuster erectile dysfunction drug Viagra (sildenafil) with RFID chips in a bid to protect the supply chain, with hordes of Viagra fakes being seized around the world almost daily. "The Serialised Authentication Programme gives AstraZeneca the potential to monitor our supply chain,"​ said Teale. "Furthermore, working with other pharma companies, industry bodies and government agencies, the system will eventually help facilitate the identification or verification of products across the entire supply chain, from the point of manufacture to the point of dispensing."​ AstraZeneca are following the advice of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which last November released a paper on the identification and coding of pharmaceutical products in Europe, and recommended the use of a 2D bar code system for product authentication. The mechanism recommended included the use of unique serialisation numbers for each secondary packaging unit distributed and sold across Europe, and the EFPIA highlighted the fact that the system could be adopted progressively - first at batch level, then at product level - without requiring a radical change of European coding systems. In addition, the use of a 2D unit serialisation system would not preclude the adoption of RFID at a later stage when the technology has matured, nor would it result in a double cost, according to the EFPIA. While the organisation backed unit-level serialisation, it also endorsed RFID as "one of the options that could better respond to the needs identified by the industry, while offering also some flexibility to adapt to future developments and needs."​ However, this came with the caveat that, according to experts, RFID may not be fully available for at least another 10 years, meaning that effective interim measures are required to protect supply chains in the mean time. AstraZeneca already has security tactics in place to protect its supply chain, but has decided to implement further measures in the face of the severe impact of counterfeit activities on patients and the healthcare industry, as well as the company itself, Teale explained. "AstraZeneca has a wide range of activities focused on combating the counterfeiters,"​ he said. "These include robust internal procedures and dedicated staff for identifying, responding to, and investigating suspect counterfeit products. The application of the TESS/UCN is AstraZeneca's response to the growing threat from counterfeit medicines." ​ Authentix, who will be working with AstraZeneca to safeguard Nexium, supply a range of product authentication products and services to industry and government. Over the past four years the company's authentication solutions have resulted in the recovery of $4bn (€3bn) in lost revenues across a range of industries.