Preventing counterfeits from entering the supply chain

Pharmaceutical Technology Europe speaks to Doug Kahn, Chairman and CEO at Ahura Scientific (MA, USA) about the problem of counterfeit pharmaceuticals and a handheld device called TruScan that is being increasingly used to combat the problem worldwide.

Q1: Why do you think counterfeits have become such a prevalent problem during the last 10 years?
The high cost of medicines, the ease with which they can be counterfeited and the relative low risk this presents to the perpetrator make for a lucrative (and illegal) business model. Furthermore, the fact that the supply chain is globalizing while commensurate measures to ensure its integrity remain unchanged make it easy for counterfeiters to operate, especially those in countries with weak law enforcement incapable of preventing them from distributing their counterfeited products anywhere in the world.

Q2: What actions are agencies such as the World Health Organization (WHO), the EC and the FDA taking against counterfeits?
According to the WHO, sales of counterfeit drugs are expected to reach $75 billion in 2010, which is an increase of more than 90% from 2005. This is a frightening number when you take into account the fact that significant human health issues can be caused by the tampering or accidental contamination of pharmaceuticals from re-labeled drugs in which the active ingredient is fraudulently diluted, substituted, adulterated or misrepresented.

The WHO has created a specific task force called IMPACT (International Medical Products Anti-Countefeiting Task Force), which includes representatives from a number of organizations, including the FDA. IMPACT is dedicated to addressing the problem of counterfeit pharmaceuticals and has contributed to building awareness about the problem, and educating the relevant industry and government agencies. That being said it has also, unfortunately, been handicapped by the challenge of finding common definitions to which all members can agree. Furthermore, while it provides a good forum for discussion, IMPACT lacks the charter to take any meaningful actions. As a result, some individual countries have addressed the problem of counterfeits more aggressively than others. For instance, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has been in the news frequently for its tough stance on counterfeiters and the level of resources deployed to address the problem. In the case of NAFDAC, it has succeeded in making a significant impact on the prevalence of counterfeit drugs in Nigeria.

Q3: What parts of the supply chain are the most vulnerable?
The answer depends on whether one is discussing the developed world or the developing world. In the US, Europe and other countries with well-developed supply chains, the traditional pharmaceutical supply chain, while not being immune, is relatively secure. Occasionally counterfeit products are introduced through unscrupulous wholesalers (a weakness in the US system) or through re-packagers involved in the legal parallel trade system in Europe; however, the greatest weakness in these countries is the introduction of counterfeits through so-called internet 'pharmacies'. For instance, a study conducted last year by the European Alliance for Access to Safe Medicines (EAASM) concluded that 62% of drugs ordered from internet pharmacies not requiring prescriptions were counterfeit.

In the developing world, there are many weak points in the supply chain, each of which leaves patients particularly vulnerable. In these regions, there is often insufficient oversight by regulatory authorities of local manufacturers that while not producing outright counterfeits, may be producing substandard products. For example, inspection at ports of entry is resource — constrained and as a result frequently limited to visual inspection only. Additionally, many countries do not have a well-developed process for filing drug applications, such that the regulatory authorities may have no information about a particular product or brand that is distributed in the country. Finally, products are often sold in single doses outside of their traditional packaging and, to make matter worse, the transaction takes place in unauthorized points of sale such as market stands. All these factors create a market where consumers are very vulnerable to unscrupulous counterfeiters who see an opportunity to make money easily with very little risk.

Q4: Ahura Scientific has developed TruScan — a handheld Raman device that can identify counterfeit drugs. Can you provide an overview of the technology behind the device?
TruScan is a handheld instrument that allows non-technical users to easily and accurately perform laboratory grade analysis in the field. It works by comparing a chemical 'fingerprint' (spectrum) obtained from a sample with a known reference spectrum in its on-board library. In doing so it provides the user with a simple 'Pass' or 'Fail' result. The spectrum is representative of all the ingredients in a product in their relative concentrations (active ingredients, excipients, dyes, coating material, etc.), so a change in any one component will lead to a detectable change in the spectrum.

Q5: How many TruScan units have been sold in Europe and globally? Is uptake better or worse than predicted?
TruScan is deployed across the world in more than 100 facilities where it is used for anti-counterfeiting and/or verification of raw materials for pharmaceutical manufacturing. Most notably, nine of the top ten pharmaceutical companies have adopted TruScan, with seven of those using it specifically for anti-counterfeiting. Furthermore, several national regulatory agencies are using the device and many more, especially in the developing world, are evaluating it for broad deployment in their countries.

Given that the product was not conceived specifically for anti-counterfeiting (its primary target application was to facilitate inspection of incoming raw materials), its uptake has surpassed our expectations. However, we believe we have only scratched the surface, as awareness of the product is growing rapidly now and we expect very strong growth in the year to come.

Q6: What other technologies are being used by the industry to defend against counterfeiting and how does TruScan compare against these?
The pharmaceutical industry's primary defence to counterfeiting is to create more sophisticated packaging that makes imitation more difficult. However, counterfeiters are increasingly sophisticated themselves and this approach only secures the packaging and not the product itself. There are several analytical techniques that can be used to verify the product, but these all require the use of trained chemists in a laboratory, which precludes effective monitoring of products in the supply chain on a meaningful scale. While a few companies have introduced products using techniques such as thin layer chromatography (TLC), near infrared (NIR) or X-ray diffraction, these all have significant limitations when compared with Raman and have not been adopted by the industry as expansively as TruScan.

Q7: To what extent is the global pharmaceutical industry affected by counterfeit medicines (in % or value terms) and do you believe that the impact of counterfeits will increase or decrease over the next 10 years?
There are no reliable numbers available, though the most frequently cited are those from the WHO, which claims that counterfeit drugs represent less than 1% in the developed world but as much as 50% or more in some developing countries, representing a $75 billion market in 2010. A more troubling figure from a recent study conducted by the International Policy Network concluded that counterfeit tuberculosis and malaria drugs alone contribute to 700000 deaths per year. Unfortunately, most experts predict the impact of counterfeit drugs will only increase over time, though Ahura Scientific hopes to have an impact as TruScan becomes more broadly deployed.

Q8: Do you think it will ever be possible to completely eradicate counterfeits from the pharmaceutical supply chain?
No. In fact, it has been said that counterfeiting is 'the oldest profession', with examples dating back to the beginning of commerce. As long as there is money to be made, there will be counterfeiting. However, I hope anti-counterfeiting technologies and greater awareness of pharmaceutical counterfeiting will dramatically reduce the impact counterfeit products have on human lives.

Q9: RFID is a technology that many believe is the future for preventing counterfeits. Do you agree with this or do you think there are more effective solutions?
As with any technology, RFID has its place and will probably have a growing role as its cost comes down. However, at this point in time it is still too expensive and has some technology hurdles to overcome before it can be more broadly applied. Like any packaging technology, one main limitation is that it does not secure the product itself, making it largely irrelevant in markets where the product is sold without its original packaging. The most effective approach will be one that employs several layers of technologies in combination, including Raman for dosage-form analysis as well as other security measures built into packaging.

www.ahurascientific.com