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.