The Partnership for Safe Medicines
Weekly Update January 25, 2010
In This Issue
Top News
World News
Quick Links
More About Us
Join Our Mailing List
Follow us on Twitter
European Coding System Looks to Combat Counterfeits: Part Two

This is the conclusion of our interview with Anthony Barron, the European Federation of Pharmaceutical Industries and Associations' (EFPIA) coding and identification project coordinator, who spoke with us about a tracking pilot project currently underway in Sweden aimed at reducing the risk of counterfeit drugs dispensed to patients. Read part one of the interview.

PSM: PSM has written at length about a batch of Levemir, which was stolen in North Carolina in February and surfaced in a Texas medical facility four months later. Could the EFPIA's coding system have prevented these stolen medicines from entering the supply chain? How so?

AB: Currently, the ability to identify and trace medicines in the supply chain is done only at batch level, meaning that it's impossible to uniquely identify medication once it's split up into individual packs. This makes it difficult to ensure a complete recall of products.

Identification could be much improved if medications were uniquely identified at the pack level in combination with online verification to provide real-time information on the status of the product, which is what is currently under trial by EFPIA in Sweden.

The use of a unique product identifier would allow pharmacists and wholesalers to verify the status of each pack in the pilot before dispensing, alerting them to the potential existence of a counterfeit product before it reaches the patient.

PSM: Can you talk about the challenges you're working to overcome in regard to parallel trade?

AB: While parallel trade is legal in the EU, the practice of repackaging medications can cause serious weaknesses in the integrity of the supply chain. That's because original packaging contains safety measures to ensure that the pack has not been opened or tampered with. Removing these features makes it easier for counterfeits to enter the supply chain undetected.

The simplest solution to this problem would be to ban repackaging. However, to date, the Commission does not support such measures. Thus, EFPIA maintains that repackagers should be subject to the same obligations as the original manufacturers.

In addition, repackaged medicines should also carry unique codes to be created in accordance with the national coding requirements of the receiving country. Ideally, these unique codes would be linked to the original code from the manufacturer-allowing us to trace the product from the patient back to the manufacturer.

PSM: Do you have any words of wisdom for U.S. policymakers who might be considering drug importation in healthcare reform measures?

AB: U.S. policymakers should proceed cautiously in opening importation of medicines from other countries.

So far, most warnings of counterfeit issues in the U.S. were related to drugs purchased on the Internet as opposed to supply chain failures-a stark contrast to the cases of counterfeit drugs found in the UK's legitimate supply chain mentioned earlier.

But as the number of commercial parties involved in the sourcing, brokering and distribution of medicines increases, so too does the risk of counterfeits entering the system. The U.S. should gauge the effectiveness of their current systems against the risks associated with making the pharmaceutical supply chain more vulnerable.

Learn more about the EFPIA's coding project and visit our Consumer Resources section for tips on protecting yourself from substandard and counterfeit drugs.
Top News


FDA Warns Consumers about Counterfeit Weight-Loss Drug


The Food and Drug Administration on Monday warned consumers about a counterfeit version of the over-the-counter weight-loss drug Alli. The counterfeit version of Alli was purchased by consumers on the Internet from online auction sites like eBay. Counterfeit Alli did not contain the active ingredient and instead contained sibutramine, which is the active ingredient in the prescription weight-loss drug Meridia. The FDA has asked consumers who think they have received the counterfeit product to contact the FDA's Office of Criminal Investigations at 800-551-3989 or to visit the agency's Web site at ("Warning on Fake Alli," The Wall Street Journal, January 19, 2010; Story here)

World News


Pakistan: Legal Action Needed Combat Spread of Counterfeit Drugs


Pakistani Interior Minister Rehman Malik told the National Assembly on Tuesday that according to estimates, 50 percent of the medicines available in the country were substandard or counterfeit. The House passed two resolutions urging the government to take action against those selling counterfeit drugs and to provide support to needy children and women. Pakistan Muslim League-Nawaz parliamentarian, Barjees Tahir, pointed out that there are already several laws in the country to combat counterfeit drugs, but lack of enforcement has given a free hand to the culprits. "The drug inspectors do not perform their duty honestly," he stated. ("50% Medicines in Country Substandard, Spurious: Malik," The Daily Times, January 20, 2010; Story here)



Singapore: Counterfeit Lifestyle Drugs are a Major Risk to Consumers


The International Journal of Clinical Practice just published a report warning that counterfeit lifestyle drugs could pose serious risks to consumers. "The presence of unknown pharmaceutically active ingredients and/or impurities may lead to undesirable and serious adverse events, even death" warns cardiologist Graham Jackson. "We discovered that 150 patients had been admitted to hospitals in Singapore after taking counterfeit tadalfil and other medications that claimed to cure [dysfunction]. Seven patients were comatose, as the drugs contained a powerful drug used to treat diabetes, and four subsequently died." ("Men Who Buy Fake Internet Drugs for [Lifestyle] Problems Face Significant Health Risks," The Medical News, January 21, 2010; Story here)

About the Partnership for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit