The dangers in developed countries
Although supply chains in developed regions, such as the EU and the US, are tighter than those in less developed countries,
they are still not 100% secure against counterfeiters, which is why it is still necessary for manufacturers in these areas
to implement anti-counterfeiting strategies. Counterfeit identification rates will be lower in these regions compared with
less developed countries, but every case counts. The biggest risk in these countries lies in medicine purchases made via the internet. As such, it is very important to educate consumers to allow them to better tell whether the medicine they are
buying is legitimate. There are little things consumers can do to check the medicine they are taking is authentic, such as
checking the seal to confirm it's not broken, reviewing the expiration date and buying medicines only from legal pharmacies.
Another significant risk facing developed countries stems from globalisation. Many businesses outsource the manufacture of
drugs or raw materials to foreign countries, which creates the potential for substandard or counterfeit products and ingredients
to enter the supply chain. One example of this is the 2008 Heparin incident when it was discovered that Heparin, which is
used daily in many hospitals worldwide, was contaminated with a toxic substance. The contamination occurred in China and resulted
in hundreds of patient injuries and more than 80 deaths.
The FDA and the European Medicines Agency rely on manufacturers to meet certain standards, but many medicines now have foreign
sources beyond the reach of these agencies. This situation will not be resolved unless new policies and regulations are put
in place.
Counterfeiters will inevitably focus on products that are easiest to counterfeit, as well as the countries with the least
amount of enforcement. The challenge for manufacturers is to keep pace with counterfeiters by making it as difficult as possible
for drugs to be copied. This will be achieved by deploying serialisation technologies, such as RFID, as well as chemical identification
instruments that can provide a quick "pass" or "fail" analysis of a medicine on the spot.
Duane Sword is Vice President Marketing & International Sales at Thermo Fisher Scientific.
References
1. RFID Journal, "Pfizer's RFID Pilot Is the Start of Something Big" (2006).
http://www.rfidjournal.com/
2. Federal Communications Commission, "Radio Frequency Safety" (2009).
http://www.fcc.gov/
3. Thermo Fisher Scientific, "Thermo Fisher Scientific Helps Nigerian FDA Fight Counterfeit and Substandard Pharmaceuticals
Using State-of-the-Art Portable Raman Instrument" (2010).
http://www.ahurascientific.com/
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