Patient protection

West Point, PA-Last year, nearly four billion prescriptions were filled in the United States. Those who take these prescribed medications expect them to be authentic. However, more sophisticated counterfeiters, both inside and outside the country, as well as the importation of drugs through Internet pharmacies and fraudulently obtained pharmaceuticals all increase the potential for counterfeit drugs to end up in your medicine cabinet.

“Prescription drug counterfeiting is a threat to the health and safety of U.S. citizens. The size of the problem cannot be accurately measured but one source estimates drug counterfeiting has the potential to become a $75 billion industry by 2010. Costs in human life and increases in health care expenses due to the ingestion of counterfeit drugs cannot be predicted,” so writes John Cox, a senior advisor at the Roberts Group (Washington, DC; www.therobertsgroup.net) in “An urgent call for Congress to deploy a full armament of available technologies and resources to combat drug counterfeiting in the U.S.”

Indeed, the Food and Drug Administration’s Revitalization Act takes a significant step in requiring some of the key elements to combat counterfeiting, including RFID, nanotechnology, encryption technology, and track and trace technologies. The requirements apply to product packaging but, because of advanced technologies, can be extended to on-dosage methods as well.

Last month, Colorcon, one of the industry’s largest suppliers of pharmaceutical coatings, announced the intent to commercialize a new method to help pharmaceutical and nutritional supplement companies protect their brands from counterfeiting, prevent medication error, improve tablet traceability, and, ultimately, protect patients. The method incorporates an on-tablet laser inscription technique, DataLase Pharmamark, (licensed from DataLase; www.datalase.com), to be used on film-coated tablets.

The film coatings include a proprietary additive that induces a color change in the film coating precisely at locations on the tablet surface exposed to a low-power CO2 laser. The technique has the potential to facilitate the identification control of every single tablet, from the time it leaves the manufacturing plant until the time the patient takes it.

Theoretically, serial numbers and standardized alphanumeric identifiers, product logos, patient details, dosage information, or images can be inscribed on the dosage form itself. Laser inscribed codes can be used as a counterfeit-resistant measure alone or in combination with other industry technologies.

Current methods of marking film-coated tablets include using printing inks or debossing tablets to identify products. In addition to being a non-contact method, laser inscription eliminates the use of solvents during manufacture and provides a cleaner operation, fast changeover of production lines, and potential cost savings.

Aside from the potential benefits for anti-counterfeiting measures, the method could garner interest from hospitals, nursing homes, and other patient facilities that regularly dispense medications. Addressing medication errors became a higher priority for such institutions after a 1999 report by the Institute of Medicine (Washington, DC; www.iom.edu) that concluded more than 7000 people die annually from medication errors. A similar report in 2006, “Preventing Medication Errors,” found medication errors harmed more than 1.5 million people a year and cost hospitals at least $3.5 billion extra to correct those mistakes.

To implement the laser marking method in this application would require in-hospital or in-facility pharmacies to employ a small laser that could mark patient-specific dosage and other critical information. Already, many hospitals are using barcode technology whereby patient information (including medical history, age, weight, height, diagnosis, and drugs the patient will be taking) is captured upon admitting and is transferred to the patient’s wristband, which must be scanned before medication is administered. Personalized, laser marked drugs could provide further assurance that you’re getting the medication meant for you.-LJB

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