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.

In October 2009, the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced its pilot project—a coding system aimed at reducing the risk of counterfeit drugs dispensed to patients.

The project entails the use of a small barcode to verify individual packs of medicine, aiming for an end-to-end tracking, which allows the pack to be checked at all points of distribution, including pharmaceutical retailers and wholesalers.

In November, we got in touch with Anthony Barron, the EFPIA coding and identification project coordinator, to learn more about the project currently under trial in Sweden. This is part one of our interview.

PSM: PSM covers counterfeit drug incidents, which we map out for folks online. It's hard not to notice that a fair amount of counterfeit incidents occur in Europe. How dire is the counterfeit drug situation in the European Union (EU)?

Anthony Barron: Counterfeit medicines have become an increasing threat around the world, especially where regulatory and enforcement systems are the weakest. Figures show that this trend is no longer restricted to developing countries, with Europe seeing a growing number of cases of counterfeit medicines. Within the EU, we've seen an increase in the numbers of counterfeit incidents from 202 in 2006 to 347 in 2008.

The UK Medicines Health products Regulatory Agency (MHRA) has also reported that incidents affecting the regular distribution chain have steadily increased since 2004, with counterfeit medicine reaching patients on nine occasions.

PSM: The EFPIA is partnering with pharmaceutical retailers and local wholesalers on the coding system—how is this teamwork instrumental in the success of the project?

AB: Our objective was to collaborate on a coding solution that was effective, technically robust, cost-effective for manufacturers, wholesalers and pharmacists alike and could work for the long-term.

An end-to-end product verification system at the point of dispense (i.e. a pharmacy or hospital) seemed like the best way meet this criteria while providing a good scope for improving supply chain security and patient safety. A more efficient identification of products may also lead to more effective product recalls in case of an alert.

Coming up, the conclusion of our interview with Anthony Barron. In the meantime, learn more about the EFPIA's coding project and visit our Consumer Resources section for tips on protecting yourself from substandard and counterfeit drugs.

Partnership for Safe Medicines (PSM) Board Member Dr. Bryan Liang was recently criticized in the American Journal of Law & Medicine for the "many inaccuracies and notable omissions," in his article "Searching for Safety: Addressing Search Engine, Website and Provider Accountability for Illicit Online Drug Sales," which he co-authored with Tim Mackey.

The critique came from Dr. Tod Cooperman and Gabriel Levitt, the president and vice president of PharmacyChecker.com, a verification service of online drug sellers that Liang and Mackey identified for its limited enforcement of and "stringent requirements" for online pharmacies.

Cooperman and Levitt claimed that "the online pharmacies that are verified by PharmacyChecker.com are rigorously monitored for compliance with strict standards," and that "leading search engines use these verifications to qualify pharmacy advertisers and help protect consumers."

In a published response, Dr. Liang and Mr. Mackey refuted Cooperman and Leavitt’s assertions regarding the article’s "inaccuracies and omissions," as well as their claims regarding PharmacyChercker.com verification and search engine monitoring, noting that:

• PharmacyChecker.com has provided verification for online drug sellers engaged in actions directly in violation of its own purported requirements.
• PharmacyChecker.com-verified sites are linked to additional, related unlawful activities, including selling narcotics without a prescription.
• One PharmacyChecker.com-verified online drug seller, Pharmnet.com, was investigated by CNN, which found the site was simply selling controlled substances without a prescription, and was shipping drugs to all 50 states despite having only a Texas pharmacy license in violation of virtually all state drug dispensing laws.
• Recent investigations of Yahoo and Microsoft's online drug advertising found that 80-90 percent of reviewed ads from drug sellers did not require a prescription or were acting unlawfully, verifying Liang and Mackey's observations, and contradicting Cooperman and Levitt’s claim about PharmacyChecker’s "rigorous monitoring" of search engine online drug sellers.

The PSM stands by Dr. Liang and Mr. Mackey as well as the accuracy and legitimacy of their paper. Furthermore, our colleagues should be commended for encouraging collaboration on these critical issues rather than combativeness.

Read the full letters [PDF] in Vol. 35 No. 4 of the American Journal of Law & Medicine.

Last week, we brought you part one of our interview with Martin VanTrieste, vice president of quality assurance at Amgen, a biotechnology company, and the co-founder of Rx-360, a global consortium formed to address weaknesses in the pharmaceutical supply chain. Now we bring you the conclusion of our interview.

PSM: It might surprise some that while a medication is manufactured in the U.S., its ingredients may come from overseas where there is less oversight and fewer regulations. Is there anything consumers can do to protect themselves from compromised ingredients?

Martin VanTrieste: Consumers must demand that everyone who influences the workings of the supply chain implement the necessary safeguards to protect them from compromised ingredients. This includes legislators, regulators and pharmaceutical companies.

PSM: You outline three-year objectives on your Web site, including the creation of an information infrastructure to share data. What kind of data would be shared between manufacturers and suppliers?

MVT: The consortium is working on a system that will not only make supplier audits more thorough, but that will allow firms to share audit findings and corrective actions. The idea is to reduce the number of audits at a particular supplier but increase the effectiveness of the audits performed. These shared audits will provide the pharmaceutical manufacturer more information than they obtain today and allow them to make better decisions on a supplier's acceptability as it pertains to each individual company's policies, practices and product requirements.

To learn more about Rx-360 or become a member of the consortium, visit their web site, Rx-360.org.

From drug manufacturing to delivery, weaknesses in the pharmaceutical supply chain have been long documented—and introduce opportunities for substandard and counterfeit medications to be passed along to consumers.

To mitigate this global threat, a group of companies and associations from all facets of the pharmaceutical industry have teamed up to form Rx-360, an international consortium aimed at securing the performance of the supply chain and making it easier for suppliers to share and receive information.

Martin VanTrieste is the vice president of quality assurance at Amgen, a biotechnology company, and the co-founder of Rx-360. Mr. VanTrieste recently spoke with the Partnership for Safe Medicines (PSM) about the consortium's efforts and visions for the future.

PSM: Rx-360 is a consortium of volunteers from the pharmaceutical and biotech industry. Who are some your members? How can other organizations get involved?

Martin VanTrieste: One of the mantras of Rx-360 is to be inclusive and transparent. So we have designed Rx-360 to be accessible and easy to join. Currently, we have 28 members ranging from biopharmaceutical manufacturers like AstraZenica, Merck and Sanofi; to suppliers like West, Merck, KGaA and SAFC; to observers—a status granted to trade organizations and independent auditing firms—like the European Generic Medicines Associations.

Anyone interested in getting involved should visit the membership section of the Rx-360 Web site.

PSM: How is this collaboration essential to the strengthening of the drug supply chain?

MVT: Issues within the raw pharmaceutical supply chain are complex and global in nature. Add to that the issue of unethical players and criminals who have entered into the supply chain to turn a quick profit…it is hard for any one organization, regulatory body or company to quickly and effectively address all of these challenges.

A global consortium compliments the efforts of regulators and others who are developing standards and local measures to curtail these activities and mitigate their impact—as well as to deliver a level of global consistency that local measures alone cannot achieve. If we all work collaboratively, then we will have the highest probability of success.

Coming up: the conclusion of our interview with Martin VanTrieste, including his advice for consumers on protecting themselves from compromised ingredients in prescription drugs.

This is concludes our interview with Garth Bruen, co-founder of KnujOn, an internet compliance company, on the subjects of counterfeit drugs sold online, search engine advertising what’s needed from regulators to protect Web users.

PSM: FDA is preparing to receive public remarks regarding the online promotion of medical products and adverse event reporting. What recommendations will you/have you given?

GB: We’ve had many good discussions with the FDA and we are always ready to provide advice and support. The most critical item at present is the lack of enforcement. For 10 years, the Internet Corporation for Assigned Names and Numbers (ICANN) has been the focus of enforcement expectations, but they have taken minimal steps to hold their contracted parties (registrars) accountable.

ICANN is unwilling to tackle the problem of internet drug trafficking even when the specific issues are within their mandate to enforce. This is why we have told law enforcement and regulatory agencies that if an internet company is in the United States, dealing with ICANN is unnecessary and prolongs the problem. If someone is facilitating illegal drug sales, as some registrars are, that person should be treated no differently than someone selling drugs on a street corner.

To learn more about KnujOn, visit their Web site at KnujOn.com.

Read previous installments of this interview:
Part 1 | Part 2 | Part 3 | Part 4

This is part four of our interview with Garth Bruen, co-founder of KnujOn, an internet compliance company. We talked to him about the KnujOn system, search engine advertising and what’s needed from regulatory bodies to protect Web users from counterfeit and substandard drug solicitations online.

Read:
Part 1 | Part 2 | Part 3

PSM: In your estimation, how many advertisers have been shut down due to the KnujOn system?

GB: This can be difficult to quantify. We can count the number of illicit domains we’ve terminated, which is in the hundreds of thousands.

The advertisers, however, belong to complex networks that are fairly nimble but ultimately depend on the tacit cooperation of established service providers. The public perception is that e-crime is run by secretive persons outside the infrastructure. While that is partially true, we are seeing more and more corruption within the internet infrastructure. We’ve reported on several internet companies that were apparently partnered with criminal groups or accepted large amounts of money from them. Until these companies are issued fines or shut down completely they will continue to provide services to criminal networks.

Coming up: The conclusion of our interview with Garth, and his recommendations for policymakers.