ROCKVILLE, Md. — The U.S. Pharmacopeial Convention (USP) has proposed best practices aimed at preserving the integrity of the pharmaceutical supply chain — namely to reduce the risk of counterfeit drugs and mishandled medications.
USP said this week that the set of best practices will help ensure that medicines can be traced back to their original manufacturer, aren’t adulterated or counterfeited, and are transported to their intended destination with their quality intact.
The recommended practices are contained in the proposed USP General Chapter Good Distribution Practices — Supply Chain Integrity, which the standards organization said is intended to as a guidance document outlining key elements of an effective strategy. USP is currently seeking comments and feeback on the proposal.
"USP is in a unique position to provide added value in this area," USP chief executive officer Roger Williams wrote in an article for Chain Drug Review‘s Pharmacy Outlook 2012 report (see Jan. 2, 2012, print issue of CDR).
"Many parties are looking for information on hot topics such as track-and-trace technology that we address in the chapter," Williams said. "Though supply chain integrity is a daunting topic, given its many dimensions, it is also too important to ignore. We expect interest from a host of parties."
USP explained that pharmaceutical firms have their own approaches to addressing supply chain integrity, yet the size and sophistication of companies and their suppliers, their quality systems and their risk management approaches vary widely. The organization also noted that there’s a lack of wide consensus on such issues as track-and-trace technology, and smaller firms relied on for sourcing pharmaceutical ingredients may or may not have security approaches comparable to those of their larger counterparts.
"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," Praveen Tyle, chief science officer for USP, said in a statement.
"USP has developed an initial proposal that we expect to evolve as industry, FDA and others weigh in. Our role as an independent body provides an opportunity to convene all these parties and advance this critical issue," Tyle stated. "While some pockets of information are available via FDA guidances, trade organizations 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 meet the needs of all."
Supply chain integrity involves minimizing risks that arise anywhere along the supply chain, from sourcing pharmaceutical raw materials to their manufacture and distribution. USP’s proposed standard covers the following areas:
• Importation — Details three primary initiatives 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 — Documents types of counterfeit drugs, medical consequences, and the distribution and extent of counterfeit drugs and devices.
• Best practices to combat counterfeit drug and medical devices — Covers topics such as packaging technologies (tamper-evident designs, authentication technologies and serialization); drug pedigrees; machine-readable data carriers (2D bar codes and RFID tags); repackaging guidance, information retention and security; international standards; and best anti-counterfeiting practices.
• Diversion and theft — Addresses factors that raise the risk of theft of drug products, drug components and medical devices; security systems, devices and procedures that should be implemented to reduce risk; and critical information to be gathered following discovery of a theft.
Plans call for the formal proposal to be published in Pharmacopeial Forum 38(2) in March/April 2012, according to USP. The draft general chapter and comments submitted to USP will be a key topic of the USP Workshop on Supply Chain Integrity, scheduled for May 22 and 23 at the organization’s Rockville, Md., headquarters. USP said the deadline for submitting comments and feedback on the proposal is May 31.
