The US Pharmacopeial Convention (USP) is proposing a set of best practices to help ensure that drugs can be traced back to their manufacturer, are not adulterated or counterfeited and arrive at their intended destination with their quality intact.
While individual pharmaceutical companies have their own approaches to addressing the problems of supply chain integrity, the size and sophistication of drugmakers and their suppliers vary widely, as do their quality systems and risk management approaches. Broad consensus around issues such as track-and-trace technology does not exist, and smaller companies that may be relied upon for sourcing pharmaceutical ingredients may or may not have security approaches comparable to their larger counterparts, says USP.
The proposed new standard is intended to serve as a central guidance document outlining the essential elements of an effective strategy, and covers four main areas:
– importation: it details the three primary incentives which importers should undertake to help prevent and detect potential risks – supply chain risk management, development of effective supplier partnerships and building a supply chain quality system;
– counterfeit drugs and medical devices: it documents the types of counterfeit drugs, their medical consequences and the distribution and extent of counterfeit drugs and devices;
– best practices to combat counterfeit drugs and medical devices, covering topics including: packaging technologies (tamper-evident designs, authentication technologies and serialisation); drug pedigrees; machine-readable data carriers (2D bar codes and radio frequency identification [RFID] tags); repackaging guidance, information retention and security; international standards; and best anti-counterfeiting practices; and
– diversion and theft, addressing the factors that raise the risk of theft of drug products, drug components and medical devices, plus the security systems, devices and procedures that should be implemented to reduce risk, and the critical information to be gathered following discovery of a theft.
“There is incentive for all players in the pharmaceutical industry – large and small companies, regulators and standards-setting bodies – to come to some agreement on hot-button issues such as track-and-trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply chain integrity,” said Praveen Tyle, USP’s chief science officer.
“USP has developed an initial proposal that we expect to evolve as industry, the Food and Drug Administration [FDA] and others weigh in. Our role as an independent body provides an opportunity to convene all these parties and advance this critical issue. While some pockets of information are available via FDA guidances, trade organisations and other sources, an overall approach is lacking. USP can move forward something more concrete than a technical report, as part of a mechanism that can be regularly updated to best meeting the needs of all,” added Dr Tyle.
The proposal is available on the USP website at: www.usp.org/USPNF/notices/generalChapter1083.htm.
It will be published formally in Pharmacopeial Forum 38(2), March-April 2012, the vehicle (freely and publicly available online) through which USP accepts public comment on its standards. USP will also be holding a workshop on supply chain integrity on May 22-23 in Rockville, Maryland.
