Anglo-Swedish drug giant AstraZeneca says it is introducing new security seals onto packs of its blockbuster antiulcerant Nexium in a bid to beat “counterfeiting and tampering and illegal diversion.”
The firm is adopting the serialised authentication programme (SAP), which is “the result of several years of collaborative work” with partner Authentix and makes AstraZeneca one of the first drugmakers ”to implement a comprehensive system to serialize and authenticate its pharmaceutical products down to the unit-level.”
The SAP, which will be launched to protect supplies of Nexium (esomeprazole) in the next quarter, uses a tamper evident security seal (TESS), and a unique carton number (UCN). The TESS makes sure that any attempt to open a pack will be obvious, while the UCN allows any pack to be authenticated at any point through the whole supply chain. If the Nexium scheme proves a success, other drugs will be incorporated into the programme.
David Teale, director of product security at AstraZeneca, said that as well as giving the firm the potential to monitor its supply chain, by working with other drugmakers, 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.” He added that it can also be combined with "other brand protection mechanism for field authentication and tamper evidence.”
A number of other firms have adopted the radio frequency identification (RFID) system to help protect against counterfeiting. GlaxoSmithKline distributes its HIV drug Trizivir (abacavir/zidovudine/lamivudine) with RFID, and Pfizer added the tags to its erectile dysfunction product Viagra (sildenafil) at the beginning of 2006. However Authentix noted that in November last year, the European Federation of Pharmaceutical Industries and Associations “endorsed serialisation as the most promising solution to fight counterfeiting and illegal diversion threats in Europe and globally” and will work easily with “radio frequency identification technologies when RFID matures.”
The World Health Organisation and the US Food and Drug Administration estimate that 5%-10% of medicines worldwide are counterfeit with recent reports indicating that up to 30% of drugs in Southeast Asia and China may be illegal. “The problem is expected to accelerate at an enormous rate,” AstraZeneca concluded.