This week, USP officially launched a public database of information collected on the quality of drugs from 8,700 records of tested samples from Ghana, Laos, Vietnam, Cambodia, the Philippines, Thailand, Peru, Guyana, and Columbia. The database is part of the USAID-supported Promoting the Quality of Medicines (PQM) program

Data collected through 2010 shows, for example, that 4.6 % of all drugs tested in Africa, Southeast Asia and Latin America failed PQM’s quality tests, with antimalarials the primary target.

The fight against drug counterfeiting is one of endless challenges and, increasingly, proven victories. One recent triumph has been that, with help from the Promoting the Quality of Medicines (PQM) program, Cambodia has reduced the number of its illegal pharmacies by 65% and has taken great strides in managing its internal counterfeiting problem. We emailed USP's Dr.

The press release has not gone out yet, but USP has posted on its web site (and Tweeted, which is how we found out) that its revised standards for elemental impurities are available for public comment. The standards will be open for industry feedback through next spring.

At the USP science meeting in Toronto, I met Janeen Skutnik of Pfizer, currently chair of IPEC Americas, and former IPEC chair, Colorcon's David Schonecker. (Also met incoming chair,  William Dale Carter of JM Huber, who will start his new role next year).

I spent the first part of this week in Toronto, Canada (light years away from the staid, dull town I remember visiting as a kid----with rush hours that easily rival New York’s.  I almost missed my flight home!) to attend USP’s annual science meeting.

A key theme was protecting the pharmaceutical supply chain.  A number of scientists discussed the analytical tools that are being developed to help law enforcement specialists identify fakes.  Quite a few of these presentations focused on handheld Raman, but more on that, and the conference, later.

Any crime covered by the press inspires a wave of copycats.  So, it seems, the global heparin supply chain will have to be closely monitored for some time.  Both 2-D NMR and capillary electrophoresis have been recognized as the best ways to assess the purity of heparin. Both are beautiful techniques, and yield a lot of information, but they also require highly experienced analysts and expensive equipment. 

Ever see the old Abbott and Costello "who's on first" baseball routine?  "I don't know" was on third base.

Pharma is not the only industry that suffers from less-than-perfect supply chain risk management, as Juran Institute CEO Joe De Feo pointed out in a recent audio interview. 

As the heparin tragedy has pointed out, many companies may not be aware of who their second- and third-tier suppliers are, especially when there are shortages of raw materials and a first-tier supplier opts to buy material on a spot basis or to work, temporarily,  with a new source. 

How well does your company know its business partners---all of them?  Drug industry professionals, please take a few minutes to respond to a new survey we've developed with experts from Marsh Consulting Group, to benchmark drug company supply chain risk management.  Results will be kept strictly confidential---and, besides, you can also use an alias and your hotmail address for an additional layer of security.

Marsh will interpret results in September's issue.

Established compendial tests are inadequate (topic for an upcoming article) for assessing intentionally adulterated material ---just as we never factored in the potential for suicide bombers in national security plans, we may never have suspected that so many people would intentionally profit from counterfeit drugs.  USP and FDA have been meeting for the past few months to change that, and to specify the use of advanced analytical techniques---USP is also developing standards for  process analytical technologies (PAT) and incorporating PAT into its framework.

(Recent news reports find that drug counterfeiting is dramatically on the rise, and Nigeria's brave Dr. Dora Akunyili , head of FDA-equivalent NAFDAC has reportedly asked for life prison terms for offenders (read on for more).  Stiff penalties are allegedly on the books in India.  Even Peru has reportedly instituted 10-year prison sentences for offenders---more here.) .

AMS