Catch counterfeits using unique product codes

Threats to Patient Safety
“Every year Americans fill more than 3 billion prescriptions through reputable pharmacies and assume their medications will be pure and effective - precisely what their doctors ordered. Since 2000, an increasing number of Americans who went to their pharmacies got counterfeit medicine instead. The medicine looked the same; the packaging appeared identical; the pharmacists could not tell the difference. But the medicine was different. Counterfeiters seeking profits had diluted it, replaced it with cheaper ingredients, or relabeled it to appear stronger.
The patients who wound up with the counterfeit medicine were not risk takers who sought discounts across borders or the Internet. They had bought legitimate medicine from the heart of America’s drug supply. When these patients suffered terrible side effects or when their drugs abruptly stopped working, counterfeits were often the last possibility they considered.
By 2002, federal and state investigators faced a dramatic increase in cases of pharmaceutical counterfeiting. Each incident seemed to grow in scale. One involved enough cancer medicine to treat 25,000 patients for a month; another involved a best-selling cholesterol drug that may have reached 600,000 patients.
As long as anyone walking into an American pharmacy has reason to fear counterfeit medicine, this problem is not solved. The pharmaceutical distribution channel should be closed to dangerous medicine, which includes any whose origin cannot be guaranteed.
Every patient should ask, and has a right to know if it is authentic.”
Excerpted from “Dangerous Doses” by Katherine Eban

Financial Risk
Counterfeit drugs are estimated to cost the pharmaceutical industry over $30 billion per year in lost revenues, and could be greater in the event of lawsuits.

• The FDA estimates that 1% of the drugs sold in the US are counterfeit and in the rest of the world this number is estimated to be over 10%
• A typical lawsuit for dangerously contaminated drugs could cost a pharmaceutical manufacturer at least $1 billion (estimated drop in market cap of Bausch & Lomb from contaminated ReNu eye solution)

In addition to counterfeiting, other activities such as grey market diversion, warranty and return fraud, drug re-dating, and ‘third shift’ manufacturing cost the industry undisclosed billions of dollars a year.
Complacency is an expensive choice.
Pharmaceutical manufacturers, patients, pharmacists, and customs officials often cannot tell if drugs are real or counterfeit. Faced with ineffective and sometimes expensive solutions, pharmaceutical manufacturers may be tempted to do nothing. However, doing nothing can be expensive: in 2004 Serono settled a case with customers who sued the firm after taking fake growth hormone, thinking that it was genuine Serotism. The plaintiffs claimed the company should have foreseen the possibility of counterfeits and taken precautions.

Difficult for industry to meet ePedigree deadlines
The FDA is pushing the pharmaceutical industry towards solutions that generate a pedigree or history, the digital version of which is called an ‘ePedigree’. The belief is that the paper trail accompanying a drug will assure its authenticity. However, a pedigree alone without unit level authentication does not necessarily ensure that pharmacies are distributing legitimate drugs, nor that patients are taking genuine medicines. Authentication is required to close this loophole.
Today the only practical system capable of generating an ePedigree requires the use of radio frequency identification (RFID) tags. However, full-scale RFID serialization and the enormously costly infrastructure required are at least 5 years away. Thus a true industry wide ePedigree solution that can protect all patients and drugs is going to have to wait for the RFID infrastructure to catch up.
In addition, RFID technology poses its own unique challenges around patient privacy and has raised data security concerns for some wholesalers and pharmacies. Widespread adoption will only occur once these challenges and the prohibitive costs of the technology are overcome. RFID is not a silver bullet.
While the industry slowly builds out RFID infrastructure there are other options currently available to improve safety. Both the research group Forrester and the drug industry group PhRMA agree that drug authentication technologies using mass-serialization are a good interim choice.

YottaMark’s drugID Solution
YottaMark’s drugID™ authentication solution detects and deters counterfeit drugs by using unique encrypted product codes that allow instant item level identification – also known as secure mass serialization.
YottaMark’s solution is:

Effective globally

• Users can easily verify a code with a fixed or mobile scanner, via the Internet or even with a mobile phone. Verifications can be done anywhere in the world at any time by manufacturers, distributors, customs officials, pharmacists, physicians … even patients. This ease of verification leads to increased sampling rates which dramatically increases the speed and likelihood of detecting counterfeit drugs.
  Intelligent
• Provides immediate feedback to brand owners about problems in the supply chain, allowing corrective action to be taken rapidly against counterfeits, diverted medicines, return fraud, and re-dating.
  Affordable
• Requires little infrastructure as the platform leverages existing Internet and global wireless networks - lowering total system costs.
  Easy to Implement
• Works with most types of commercially available code marking equipment running on high speed packaging lines. The exact marking system used and its specifications are based on the customer’s performance requirements and operating environment.
• Leverages the latest marking technologies and so works with almost any substrate including foils, most plastics, coated paperboard and metals. Exciting new developments include direct coding of blister pack and induction seal foils as well as cold laser marking of white HDPE bottles. Print-and-apply label implementations can add security measures such as tamper-evident labels.
• Hosted ASP service model does not require integration to an ERP or MRP system, nor are there databases to manage. Quick to start, easy to scale.

Simpler, More Secure
Most security experts recommend taking a ‘layered’ approach, with technologies tackling different aspects of the counterfeiting problem.

• Batch authentication technologies are especially effective when no data needs to be attributed at the item level. Some older technologies, such as holograms, have lost their effectiveness as counterfeiters are able to copy them quickly and convincingly. Techniques that require user training (e.g. Optical Variable Inks - OVIs) can suffer from user confusion, especially as they need to be changed regularly to stay ahead of copies. For example, it is very difficult for a pharmacist be able to keep track of which color combination OVI is the correct one for a particular product. A case in point: do you know the OVI colors on the US$20 bill?
• Unit-level authentication is especially powerful when the manufacturer wants to validate information about an individual unit, such as: plant of origin, use by date, target market, electronic pedigree. Mass serialization, or the attributing of a serial number on every product, is often proposed for unit level authentication. Without encryption, however, it is a weak security solution – being trivial to predict valid codes – and can be a cumbersome process to manage across multiple lines and plants. YottaMark uses strong encryption techniques to ensure the non-predictability and non-repeatability of each individual product code.

What can you do?
The facts show that counterfeiters are opportunistic and tend to exploit the lack of product security measures and low sampling rates for enforcement. History has shown that even simple copies of labels are good enough to fool most participants in the supply chain. Secure mass serialized codes increase the costs and complexity of a counterfeiters operation, but are easy and effective for manufacturers. With YottaMark’s dramatically increased sampling rate, any counterfeits that do enter the distribution chain are almost guaranteed to be caught … fast.
YottaMark’s drugID authentication solution is available today.

Visit our website at www.drugID.com or contact us for a demonstration at info@yottamark.com

About YottaMark
YottaMark’s drugID™ authentication solution detects and deters counterfeit or diverted drugs and lets patients, pharmacies and security officials authenticate individual drugs anytime, anywhere, at any point in the supply chain. Our threat analysis engine provides valuable intelligence from the field and an early warning of attacks on drugs.
The company is headquartered in Silicon Valley, California