Saturday, June 28, 2008

World Health Organization Statistics on Counterfeiting Worldwide

As reported in our last blog post, most experts agree (including the Chairman of Sanofi-Aventis) that the incidents of drug counterfeiting and adulterations are:

a) completely under reported
b) significantly on the rise

Just to put this into perspective, the following are the statistics from the World Health Organization on the Prevalence of Counterfeit Drugs in the West and the Developing World. These statistics represent WHO's 2006 estimates as to the percentage of counterfeit or adulterated drugs within that country or regions total drug supply chain.

  • United States, less than 1%

  • United Kingdom, less than 1%

  • Europe, less than 1%, some estimate percentages as high as 10%

  • Nigeria, 16%

  • Kenya, 30%

  • Lebanon, 35%

  • Cambodia, 13%

  • China, 8% on OTC medications

  • India, 10-20%

  • Indonesia, 25%

  • Russia, 10%

  • Former Soviet Republics, 20%

  • Colombia, 5%

  • Mexico, 10%

  • Peru, 15-20%

  • Venezuela, 25%

Realize that these numbers are all presumed to be very low and many of the percentages may have nearly doubled since 2006. Consider the tainted Heparin as a good example of the rise of counterfeit, adulterated or otherwise tainted drugs within the United States and other developed countries in 2008. Even the United States figure of less than 1% equals many billions of dollars in undetected counterfeit medications within our drug supply.

Most importantly realize that now, in the era of a Global Pharmaceutical Supply Chain that many drugs that are being imported into the United States and other developed countries now owe their source of raw materials, production and packaging to less developed countries like India, China and other countries whose pharmaceutical supply chain is riddled with counterfeit and adulterated medications.

Encourage your lawmakers and dispensers of medications to demand an authentication technology to double check the pharmaceuticals that your family consumes. Authentication of the pharmaceuticals is the only answer to properly knowing that the drugs you and your family are taking to maintain their health are not in fact harming them instead.

Current initiatives that are being debated in Washington and other regulatory agencies are almost exclusively centered on track and trace technologies that do not authenticate the drug. All the Heparin that has to date caused over 149 deaths in the United States all had a perfect pedigree and would have passed as authentic with track and trace technology.

Friday, June 20, 2008

"Drug counterfeiting underestimated for too long..." states the Chairman of Sanofi-Aventis

As reported by the Dow Jones News Service, "Drug counterfeiting has been underestimated for too long, Sanofi-Aventis Chairman said Thursday, also calling for more action from the European Union."

At the annual meeting of the European Federation of Pharmaceutical Industries and Associations, Jean-Francois Dehecq said that "drug counterfeiting 'used to be marginal, it is now totally industrialized.'" Counterfeit pharmaceuticals "represented approximately EUR45 billion in sales in 2006, making up for almost 10 percent of the world pharmaceutical market the World Health Organization estimates.

Link to the full story at Dow Jones.

Thursday, June 19, 2008

Track and Trace an Expensive Proposition for Retail Drug Stores

The Coalition of Community Pharmacy Action, which is a group formed by the National Community Pharmacists Association and the National Association of Chain Drug Stores, released a study on June 18th that examined the safety of the prescription drug supply chain and the potential effects of the implementation of a federally mandated track and trace system to protect consumers from counterfeit medications.

Of note, the CCPA estimated in its study that it would cost drug store chains $84,000to $110,000 or more per store in the first year to implement a track and trace system. The cost estimate was based on costs of computer hardware, software, infrastructure, labor and other resources.

Not included in the study was the cost to the other members of the pharmaceutical supply chain; manufacturers and distributors to implement this process. All members of the pharmaceutical supply chain must be involved in the process to make the track and trace process a useful tool in protecting medications.

This is why it important to include an authentication technology either in conjunction with or in lieu of track and trace. An authentication technology, EDXRD verifies the content and make up of the contents of the medication and does not rely on tracking the various stops along the supply chain.

Monday, June 16, 2008

What Measures Can Ensure the Integrity of Purchased Pharmaceuticals?

The integrity of our pharmaceutical supply chain is being questioned! Diversion, counterfeited products and adulterated ingredients have left consumers, regulators, and dispensers clamoring for more stringent anti-counterfeiting methods. Furthermore, the recent heparin recalls have emphasized the need for protection not only of the finished product, but also of the raw materials used in the production of medications.

James C. McAllisterIn the May issue of Pharmacy Times, James C. McAllister, a health-systems consultant, addresses the security responsibilities of all players within the supply chain to combat these threats.

Mr. McAllister states, “Solving this dilemma will be challenging. Collaboration of pharmacists, manufacturers, wholesalers, and distributors, as well as regulatory agencies at the state and national level, should begin expeditiously.”

He moves forward to suggest that manufacturers bear all recall costs and financial responsibility for the quality of their drugs. For distributors and manufacturers, he asks that the FDA levy heavy economic sanctions on those selling substandard drugs. His proposal is a wake up call to the risks that are present – Those who risk our health – Risk their wealth.

Which begs the question - How do your anti-counterfeiting methods measure up?

Friday, June 6, 2008

What the True Pharmaceutical Security Focus Should Be: Authentication

As many of those who have spent many years within the Pharmaceutical Supply Chain, I watch the major players within the pharmaceutical industry jockey and debate the current initiatives that are intended to secure the safety and efficacy of the medications that we in the United States take daily.

In this era of globalization we in the United States find ourselves increasingly consuming medications that use foreign produced raw materials, outsourced manufacturing and are packaged overseas. Although most of these efforts are managed and regulated according to tight corporate and FDA scrutiny, serious issues have arisen recently which demonstrate nefarious intent to circumvent the safety and security of these globally produced products.

Additionally we find international and domestic criminal organizations, realizing the potential of high profits and low risk, using sophisticated operations to adulteration, dilute or counterfeit medications that make their way into our drug stores and healthcare providers.

The threats to our safety as a nation are real. The danger that contaminated, adulterated, diluted or counterfeit medications that our population currently faces is increasing every day.

Unfortunately we find that there are few deterrents or regulatory processes in place to adequately protect our population from these sophisticated threats to our collective health.

Currently the Congress, Federal and State regulatory agencies are grappling with the most effective way to deal with this clear and present danger. To date most if not all of their efforts have been focused on track and trace technologies and protocols. Track and trace encompass RFID, advance bar codes; hologram labels technology and pedigree protocols.

Although these efforts are part of the solution, they fall short of truly and efficiently solving the problem. The obstacles to quickly adapting them as an effective solution are many. They are costly, time consuming to adopt, have numerous technical challenges, are not standardized and most importantly require each member of the supply chain to be synchronized and monitored for them to be an effective deterrent.

However the biggest drawback is that the only thing that track and trace technologies and protocols adequately track and trace is the packaging that the medication is packaged. Despite all of the cost, technical challenges and time consuming efforts that they entail, these efforts do not authenticate or verify the actual contents which may have been adulterated, counterfeited, diluted or contaminated at one of various points within the supply chain.

Currently XStream Systems, XT250 technology has the ability to quickly, efficiently and effectively authenticate and verify the contents of the medication within the sealed container. This process can happen in a very cost effective manner anywhere within the Pharmaceutical Supply Chain with little or no change in processes or protocols. It can complement existing Track and Trace initiatives by actually providing authentication documentation or operate as a standalone system.

The cost of implementing and operating authentication technology such as the XT250 is a fraction of the initial start up costs of an RFID system and it could be operational in a fraction of the time that it would take for one segment of the Pharmaceutical Supply Chain to implement universally.

Maybe it is just too obvious but I hope that those in a position to make a difference take time to look at filling in the gaps in the current mindset and direction of protecting our Pharmaceutical Supply Chain. Hopefully they discover that the ultimate solution is to authenticate and verify what is in the bottle.

Alan Clock, Senior Vice President, Sales and Marketing, XStream Systems, Inc