By Brian Mayo
While the pharmaceutical industry struggles with counterfeiting and adulteration of drugs, most of the proposed solutions focus on track-and-trace methods, like 2-D bar codes, holograms, RFID devices, and pedigrees. Each of these methods adds a level of authentication to the outside of the packaging containing the product.
Over time, so many variations of these have spread throughout the industry, which now screams for standardization. The evolution of track-and-trace technologies has become so complex that the industry is almost in analysis paralysis. Even with a myriad of anticounterfeiting choices, counterfeiting is expected to rise to $75 billion next year. One needs a daily scorecard to just keep up with the progress that is going on with anticounterfeiting methods, and many websites, such as www.securepharmachain.blogspot.com, do exactly that. Maybe the industry should instead just step back a bit and take a completely different perspective on the same problem. Management training has drilled into our brains to “think outside the box” to come up with the best solution to our problems. Perhaps it’s time we stop thinking outside the box and start looking inside the box for the best solution.
If we think about it, the solution for counterfeiting has always been right in front of us. Where? It’s already in each bottle of prescription drugs. That drug inside the container possesses all the information we need to know. We don’t have to add anything to the drug itself in the form of taggants, nor do we need to add anything to the packaging outside. Everything we need to know is already contained within the drug itself. The key is how does one go about “reading” that drug, especially if it’s in a sealed container? Molecular screening is the key to unlocking how to read a drug to make sure it is authentic.
Bringing The Lab To The Drug
Molecular screening is the ability to examine a pharmaceutical drug, read the molecular fingerprint of that drug, and verify its authenticity. Forensic laboratories perform this analytical process every day. This technique has been, and continues to be, the most reliable method to authenticate drugs. The significant turning point, which only happened recently, is when analytical testing evolved to the point where it can be deployed anywhere along the supply chain. Instead of bringing the drug to the laboratory, the laboratory has come to the drug.
Current laboratory processing requires highly trained personnel to interpret complex results before reaching a conclusion. It would be far too expensive to try and deploy the multitude of required scientists all along the supply chain. Secondly, there are not enough scientists available to screen our entire pharmaceutical supply chain. Even if there were enough scientists, the testing process usually requires hours of preparation, data collection, and analysis for a single result. The last reason that analytical methods were not considered along the supply chain was that testing methods, such as gas chromatography and mass spectrometry, were typically destructive. All of these issues steered the industry toward investigating today’s various track-and-trace methods.
Molecular screening represents the newest generation of security measures against counterfeiting. It allows you to perform nondestructive testing anywhere along the supply chain, and it easily scales to match a distributing, repackaging, returns logistics, or dispensing company’s needs. Solutions from companies like XStream Systems, Ahura, and Centice allow nonscientific personnel to easily analyze drugs and detect counterfeits. Moreover, molecular screening can analyze the drug inside any sealed container for proper formulation, correct dosage, contamination, or adulterations, all without requiring any changes to existing drug products. Since each drug has a unique molecular fingerprint, you can use that molecular fingerprint to accurately identify the drug.
Where To Deploy
The first obvious place to deploy molecular screening is at the dispensers, including pharmacies and hospitals, but it should be deployed throughout the entire supply chain. Dispensers represent the last line of defense against counterfeits. However, if molecular screening were deployed only at dispensers, this alone would not put a stop to counterfeiting. By the time the counterfeit drugs make their way to the dispensers and are discovered to be counterfeit, the counterfeiters have long walked away, counting their money on the way to the bank. To combat this, molecular screening should be deployed at incoming receiving areas along the supply chain. Incoming drugs should be molecular-screened before being paid for and placed into inventory.
Molecular screening can be deployed in a phased approach across the pharmaceutical distribution industry. In other words, it can be deployed at specific geographic locations, like the suspected 80% of counterfeits in Nigeria or the estimated 40% of counterfeits in Mexico. It can also be used to protect particularly vulnerable drug classes like expensive cancer and AIDS drugs or used to monitor key choke points, such as at customs border points to protect against questionable suppliers from India and China.
Getting Started With Molecular Screening
The best way to get started with a molecular screening effort is to start somewhere of particular interest, whether it be a suspect supplier, drug, or region, and then keep growing the protective network from there. As more screening points are added, the scope of the protective network grows geometrically. A molecular screening protective network is built from the ground up one system at a time, rather than a whole infrastructure that needs to be set up first. This allows a pay-as-you-go pricing model, which suits tight budgets particularly well.
As a molecular screening protective network is developed, it can even adapt to further strengthen the overall protection. For example, as a new type of counterfeit drug is discovered, it can be compared against a known list of counterfeits and documented as to where this particular counterfeit first appeared. Then, by mapping all the places where this same counterfeit shows up, investigators can gain knowledge of the likely source of the new counterfeit drug. So, as each new counterfeit type of drug is discovered, this information can be shared to all other molecular screening systems, and geographical information can start being collected to help isolate the source of the new counterfeit.
So how did companies, like XStream Systems, Ahura, and Centice, overcome those original issues (scientific expertise, interpretation of results, and destructive nature) and extract some of those analytical methods out of the laboratory? First, they essentially integrated a scientist within their products. They discovered what algorithms the scientists used to evaluate testing results, and designed automated software to do the same. Each company discovered a laboratory technology that was nondestructive and provided rapid answers. All of a sudden, all those issues that kept forensic analysis in the laboratory were no longer an issue. Drugs can now be molecular-screened anywhere along the supply chain, even when sealed in their original packaging, for counterfeits, adulterations, dosage differences, and contaminations.
Molecular screening works for everyone along the supply chain. Pharmaceutical manufacturing companies do not have to change anything with their products to support molecular screening. Repackagers and mail-order facilities can ensure that they have not only received valid inventory, but that their own processes have functioned properly. Dispensers, the last point in the supply chain, can verify their received inventory before passing it along to the patient. Even returns logistics can benefit from molecular screening by verifying whether the drugs being returned are valid or not.
In these instances, each test sample costs only a few pennies compared to hundreds of dollars if they had to send the drug to a forensic laboratory. They have successfully stopped looking “outside the box” and instead are authenticating the drug itself with molecular screening.
About The Author
Brian Mayo, president, CTO, and cofounder of XStream Systems, has more than 25 years experience in the electronics industry in designing networking, monitoring, and airport security solutions. He has held senior management positions at companies including Cisco, Texas Instruments, Digital Equipment Corp., Teradyne, and Nortel Networks.