Comments on “ePedigree: Using the Gift of Time Wisely”

The comment below is in response to PharmTech's July 2008 Viewpoint article, “ePedigree: Using the Gift of Time Wisely.”

Reader Edward V Rodriguez writes:

As I was reading Viewpoint regarding prescription drug tracking requirements the issues of identification, authenticity and counterfeit come to mind also.
 
Here at Vardex we have been conducting R&D to place 2D data matrix codes directly onto the surface of a prescription pharmaceuticals for the purposes of anti-counterfeiting, product identification and enhanced supply chain security.
 
The only way to truly identify any product is to have its surface coded with a data matrix code since the small size of the code and data that it can hold makes it the ideal code for pharmaceutical safety.
 
Medication error kills thousands each year and many lives can be saved by a simple scan of medications prior to a patient taking meds, a study and pilot programs in Europe cut medication error by over 55% in five (5) hospitals. By coding all medications and linking the same code to the patients file, wristband and the correct medication delivered.
 
In opinion e-pedigree cannot be achieved unless the product in question is identifiable.
 
Counterfeit products continue to enter the supply chain and will continue to do so until each individual pharmaceutical is coded at the point of manufacture with a machine-readable code.
 
There are many benefits to both consumers and manufactures if the identification codes were on a product and not just the box or wrapper. After all, we are not consuming the package we are consuming the product therefore logic would say that the product is what should be identifiable.
 
Vardex has filed a response to the FDA’s request for comments on prescription drug identification standardization and also on technologies to help combat counterfeit drugs. If you would care for a copy of the submission please contact Edward V Rodriguez.
 
Thank you, 
Edward V Rodriguez 
Vardex laser Solutions
773-521-7911

Dear Mr. Rodriguez:

Thank you for writing and sharing your opinion with us. I’m hoping you can
clarify a point for me. When you say “each individual pharmaceutical is
coded at the point of manufacture,” you mean that each pill, say, should be
encoded (as opposed to the package containing the pills)?
If so, I can see how that would be useful for solid dosage forms. What would
you do to track liquids, powders, or even semisolid gels and films? Is there
anything that you can foresee that might be useful in tagging those
materials?

- Michelle Hoffman

Edward V Rodriguez responds:

To clarify the point of each individual pill, capsule, tablet being coded for identification, that is exactly what I’m stating, currently there are several technologies that can deliver a scannable 2D data matrix code to the surface of each individual dose medication at the point of manufacture.
 
I am not opposed to the package being marked for identification or information, I cannot understand why the industry and legislators are not making the product itself identifiable and focusing all of their action on packaging which is being copied as fast as they put it out.

Serialization of medications will save thousands of lives.
 
To answer your questions pertaining to other materials to be marked let me address them one at a time please.
 
1. Liquids. Liquids pose a little more challenge but receive the same solution a liquid can come in a glass vial, jar or a pouch, a seal placed on the cap with a 2D data matrix code on it would be a start. By placing a rubber or plastic safety seal on it and coding it with a serialized code. In some cases liquids are freeze dried and liquid added by patient, any foreign matter coming in contact with freeze dried med would color react warning of any possible tampering.
 
2. Gels are also being laser coded, there are several companies that do the surface marking of gel capsules.
 
3. Powder I believe would most likely be packaged and would require covert markings in order to try to combat counterfeit but identification of any product must be achieved.
 
Only mandates from regulators can make pharmaceutical safety a reality-until you have each individual dose coded you will never have a secure supply chain.
 
Currently e-pedigree and electronic signature is the new form of protection, but it still does not identify the product only where the package and shipment have been. Even with RFID counterfeit products have shown up in shipments.
 
Many studies have also shown that RFID damages some products, furthermore the commissioner of the FDA stated that he cannot rely solely on RFID to protect the supply chain and that what is needed a blanket approach.
 
I strongly believe that a parent-child type of relation needs to be put in place, meaning that the pharmaceutical itself and the packaging need to be coded. This would address the issue of counterfeit medications entering the supply chain through the repackaging process and would also address expired medications being distributed and cut into medication error. Finally this would give regulators from around the world a chance to spot check and scan on site, medications in 3rd world countries are 65% counterfeit.