Monday, August 25, 2008

Track and Trace versus Inspection and Authentication Technologies?

In a comparison of Track and Trace versus Inspection and Authentication technologies it is apparent that Track and Trace solutions such as RFID, bar coding, holograms, tracing and pedigree products are not a one-size-fits-all solution to protecting the domestic and global pharmaceutical supply chain.

Track and Trace products might be sufficient, when employed throughout the Supply Chain to protect it from Drug Diversion which is one source of counterfeit activity, but these Track and Trace technologies cannot provide full protection for the product within the package. For example, how can anyone expect a Track and Trace product to determine if, either in the manufacturing or distribution process, the wrong ingredient was purposely or accidentally added into the product? Pedigree or Serialization may help, after a threat has propagated to the general public and was detected by other means, to help backtrack to the source of the problem. But by then it may be too late and the consumer will have already suffered.…

Only through the use of Inspection and Authentication technology such as XStream Systems’ XT250 Pharmaceutical Authentication System can those within the drug supply chain immediately inspect and authenticate the product within the container. Don’t let problems reach the general public. Stop the issues in their tracks.

For more information on XStream Systems and the XT250™ Pharmaceutical Authentication System, visit their website at

Monday, August 11, 2008

FDA says drug stores sold expired medications

The Medicine Shoppe, a subsidiary of Cardinal Health (one of the “Big Three Distributors”), sold expired or presumed fake prescriptions to their customers. Granted this was just two of their stores located in Baltimore, but it does make one wonder – How did this happen?

Especially troubling is that this may just be the beginning. In Europe, officials are seeing an upward trend of expired product simply being relabeled to appear good. It is estimated that 10% of medicines sold there are counterfeited or adulterated.

The Medicine Shoppe's suspect medications and the conditions they treat include:

  • Lisinopril (20 milligrams) _ hypertension
  • Guaifenesin/Dextromethorphan (600 mg and 1000 mg) _ cough
  • Gabapentin (100 mg, 300 mg and 400 mg) _ epilepsy
  • Metoprolol (50 mg) _ hypertension
  • Nifedipine (30 mg) _ hypertension
  • Diclofenac Sodium (30 mg) _ anti-inflammatory
  • Glucophage (500 mg Extended Release) _ diabetes
  • Glucovance (125 mg and 500 mg) _ diabetes
  • Glipizide/Metformin (2.50 mg/250 mg) _ diabetes
  • Furosemide (20 mg) _ diuretic
  • Tamoxifen Citrate (10 mg) _ breast cancer
  • Metformin HCl ER (500 mg) _ diabetes
  • Calcitrol (0.25 micrograms) _ osteoporosis

It has long been assumed that if product was purchased straight from the manufacturer and/or one of the major distributors, that naturally, the medicine was pristine. However, these days that assumption, sadly, is no longer valid. This year alone, we have witnessed recalls from Baxter for adulterated heparin, Ranbaxy for counterfeit HIV medications, and NOW a major drug store chain for fake or expired prescriptions.

To view the full article from Associated Press, click here.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at

Tuesday, August 5, 2008

Ranbaxy Probed Over Counterfeit Medicine

In an article that appeared in the Washington Times, the Justice Department is investigating whether Ranbaxy Laboratories Ltd., which supplies generic drugs to the U.S. market and to President Bush's global AIDS initiative, has falsified data, followed sub-par manufacturing practices and distributed counterfeit medicine.

The filing stated that "allegations from reliable sources indicate a pattern of systematic fraudulent conduct" by the company. The allegations include that in its application process, the company submitted fabricated data to the Food and Drug Administration for generic drugs to be distributed in the U.S. and anti-retroviral drugs to be distributed in other countries as part of the President's Emergency Plan for AIDS Relief.

This is yet another example of potentially counterfeit product distributed widely in the global pharmaceutical supply chain that would have passed all Track and Trace methods of interdiction. These products have been distributed and consumed because pedigree or tracing processes do not authenticate the medication inside the container.

XStream Systems XT250 would have been able to discover the fraudulent and counterfeit material before they were distributed and dispensed because the technology verifies the molecular structure of the medication inside the sealed container.

To learn more about the XT250, visit our website at

To read more of the Washington Times article click here.