Why Pharma's Anti-Tampering Strategies Don't Work
"We've never seen what we would consider effective tamper-detection for a drug product," says Dr. Roger Johnston, head of the Vulnerability Assessment Team as Los Alamos National Laboratories. In this exclusive interview, Johnston gives us the ten top failings of anti-tampering efforts, and solutions for improvement. Also, click the "Download Now" button at the end of the article to obtain Johnston's PowerPoint presentation on improving tamper detection systems.
Consumers who are prescribed drugs that would create enormous problems if they were fake—e.g., growth hormone or insulin—might be frequent users of a CNT system (perhaps with the encouragement of their physician), while consumers with less critical medicines might not. It would be entirely up to each individual. One attractive feature of the CNT technique is that it is consumer-oriented and is really for the benefit of the public more than just the pharmaceutical manufacturers. Consumers can choose to ignore CNT completely if they want; unlike proposed track and trace methods, nobody needs to be coerced into doing anything they don't necessarily want to do.
The CNT method might well be largely ignored by consumers until such time as there is public panic about specific fake or adulterated drugs. Then the average person would have some ability to check on the reliability of their pharmaceuticals. This will make people feel less helpless, and make them more aware of counterfeiting issues. It will also — in a time of public panic — make it look like pharmaceutical manufacturers are taking an active role in dealing with the problem.
CNT's ability to detect fakes gets better the more people that participate, but the more people that participate, the more likely there is a serious (or perceived) problem. Thus, the response is commensurate with the degree of the problem.PM:
What are some potential low-tech anti-tampering or anti-counterfeiting technologies that drug manufacturers need to look into more? Why?RJ:
More innovative designs are needed. Rather than trying to retrofit existing containers with tamper-detection or anti-counterfeiting features, the containers need to be redesigned from scratch with security in mind, and with thinking more carefully about what we can ask the customer (consumer, pharmacist, or merchant) to do if he/she is truly concerned about counterfeiting and tampering issues.PM:
How about high-tech strategies that need more consideration?RJ:
There are a lot of interesting new high-tech materials that might be produced at low cost, and that could still be read using low-tech methods (sight, touch, or smell). Anti-counterfeiting or anti-counterfeiting techniques that require high-tech readers are not going to be practical unless those high-tech readers are cheap, small, and very easy for at least a pharmacists' assistant to use.PM:
Where does RFID fit into the anti-tampering, anti-counterfeiting mix? Is it being over- or under-hyped?RJ:
RFIDs are a great method for doing inventory, and they may be able to bring down the cost of track and trace methods for monitoring the pedigree of pharmaceuticals. They are not, however, security devices. They do not improve the tamper-detection capability of seals, they actually decrease it. They are not effective as anti-counterfeiting tags. This is because RFIDs are cheap and easy to "lift" and counterfeit (as we've demonstrated at Los Alamos), and it is also easy to spoof an RFID reader without counterfeiting the RFIDs. (To "lift" an RFID tag means to remove it from one object or container and place it on another without being detected.)
Are they being over-hyped? For inventory, I would say no--although there are many practical problems associated with their widespread use that users will have to deal with at great cost and frustration. For security, yes they are being over-hyped because they provide no significant security. For track & trace, I would say they are being over-hyped only because people seem to think the RFID is the security part of the track & trace. It is not. The security comes from closing the loop with the manufacturer and providing data about where the drugs have been and who holds them now. The RFID just makes that process potentially cost-effective.PM:
What should FDA be doing to discourage tampering and counterfeiting?RJ:
Click the "Download Now" button below to download Johnston's recent PowerPoint presentation on improving tamper detection systems.
- I believe the FDA (or DHS or NIH) needs to be funding or otherwise supporting research and development on better tamper-indicating and anti-counterfeiting techniques and technologies.
- For anti-counterfeiting, I believe that the FDA's current love affair with RFIDs needs to be redirected towards the true issue: effective track and trace. RFID is just a tool for making track and trace feasible; it is not the essence of the anti-counterfeiting approach. Track and trace also needs to occur all the way down to the consumer, perhaps using something like a CNT technique; otherwise, counterfeiters will just shift their level of operation, and consumers will continue to get dangerous counterfeits.
- I think the FDA needs to forget about covert tags and fancy taggants. Secrecy is not a viable long-term security strategy, especially for consumer products that are released in enormous quantities to the public. Besides, pharmaceuticals already contain an almost “unspoofable” tag: their trace contaminants. More effort should be devoted to developing inexpensive, rapid, easy-to-use analytical methods (perhaps even for field use) to uniquely identify drugs.
- Criminal penalties for making or dealing in fake drugs are not severe enough.