
Five years ago, many in the industry were convinced that wireless technologies would ultimately deliver the lion share of supply chain security improvements in the life sciences, leading to the eventual elimination of most counterfeit drugs from US-based distribution channels. However, RFID and related wireless technologies have been slow to reach critical mass due to a mixture of lacking standards, cost issues, and reliability concerns. At the beginning 2009, 43% of companies were assessing RFID (doubling from 21% a year earlier) and 20% had actually implemented RFID in some fashion within their organization. Use cases ranged widely from the track & trace of drugs, to areas like biospecimen tracking and sample management. The greatest traction had come in areas where companies had full control over the technology's application without 3rd party adoption dependence (such as in supply chain situations).
While the technology experienced steady growth from 2005 through early 2009, adoption then reached a plateau, and adoption levels have since reduced by two percentage points (18% now using RFID), and evaluations have dropped significantly with just 15% of companies currently evaluating the technology. The economy, combined with delayed pedigree legislation and ancillary serialization technologies such as 2D bard codes capturing increased mindshare, are largely responsible for the decline in momentum. While wireless technology is not contributing to the improvement of supply chain security as quickly as many in the industry had hoped, other steps are being taken to reduce the presence of counterfeits. For example, last month Google announced that it would stop allowing non-NABP accredited pharmacies to purchase online advertising. Online drug channels are responsible for a significant portion of counterfeit drug distribution in the USA. Many consumers turn to online pharmacies to gain access to the drugs they need at severely discounted prices, but oversight of these channels is lacking. Although many online pharmacies have professional looking websites, it is difficult to verify their authenticity, and even legitimate online pharmacies have had their share of violations. A survey conducted by NABP in 2008 found that 96% of online pharmacies were violating at least one professional standard for pharmacy practice, such as licensed pharmacists failing to review and authorize the fulfillment of each prescription. Google's decision to now only accept advertising purchases from VIPPS (Verified Internet Pharmacy Practice Sites, as established by the National Association of Boards of Pharmacy), is a major step in the right direction for improving the security of drug distribution. The policy change is long overdue, though understandably given its likely effect on advertising revenue (fewer than 20 pharmacies have been certified). Hopefully most large online advertising engines will follow in Google's footsteps.
Although RFID adoption has slowed, interesting new areas of application continue to emerge. For example, wireless technology evaluations designed to support clinical trial regimen compliance are receiving increased attention, as evident by Novartis' recent acquisition of "smart pill" technology from Proteus Biomedical for $24M. The technology bakes a wireless transmission into edible pills, and sends a signal to a chip which then uploads the data via the Internet so that a doctor or caregiver can monitor patient compliance and track any warning signs of an adverse event. The chip is designed to be unnoticeable and implanted under a patient's skin. The adoption of technologies like this seem inevitable, given the costs that these technologies could remove from our current healthcare system (both time and actual dollar savings), but concerns around safety, security, and privacy will need to be addressed before these areas of wireless application become more widespread.
The figures around counterfeit activity remain daunting. Global estimates range from $75B in counterfeit drug trade(CMPI) , to nearly 10% of the global drug supply (WHO). Regardless of how quickly or slowly wireless technologies help close security gaps in the channel, the larger solution will clearly encompass a mixture operational/process improvements (ie. drug pedigrees, item-level serialization) and technology improvements (ie. RFID), but policy improvements (ie. Google ads) are likely the most important pieces of the puzzle to achieve near-term improvement.