Pharmacy Career Info. As if the pharmaceutical companies and the pharmacists at drug stores need something more to worry about, the latest issue is drug counterfeiting. While this issue in the United States is still rare, the number of investigations are on the rise. According to the Food and Drug Administration (FDA), the number of counterfeit drug investigations has risen from an average of five per year in the 1990s to more than 20 per year since 2000 (Genuario, 2004, p. 54). Anyone entering the pharmaceutical industry today will hear a great deal of information about this topic over the next several years to come.

This problem becomes even more complicated when introducing online sales of prescription products. How is it possible to make sure that the authentic product is being purchased, plus at the right quantity and correct price? Another problem is buying from other countries. In July 2004, according to a report issued by the FDA, counterfeit versions of Merck's cholesterol medication Zocor (simvastatin), as well as carisoprodol, a genetic muscle relaxer, were imported from Mexico by Americans looking for cheap prescription drugs. Tests on the drugs, however, showed the counterfeit Zocor did not contain any active ingredients, and the counterfeit carisoprodol differed in potency compared with the authentic product (Kirsche, p.6).

"Counterfeiting is a huge problem for the pharmaceutical industry as it relates to direct liability. The drug companies annually loose billions of dollars to very clever counterfeiters. From a cost standpoint, if they could reduce the amount of counterfeit drugs in the marketplace, that will help them with their bottom line," says Bob Piefke, business development manager for Appleton in Dayton, Ohio.

Last year, federal officials stalked counterfeit versions of Procrit, which helps people with cancer and AIDS combat anemia. In addition, there was a major recall of 150,000 bottles of Lipitor a cholesterol-busting drug due to tampering, says an article in Medical Devices & Surgical Technology Week (2004).

When looking at the vast numbers of pharmaceuticals that move around every day, it is overwhelming. Drug Store News (2004) indicates that to get an idea of McKesson Corporation's...

Then imagine delivering those products to 21,000 or more locations daily by means such as truck, courier and air. Most importantly, consider achieving an order-picking accuracy rate of 99.96% across all those distribution channels each day.
Within the pharmaceutical industry, some companies are deciding to go with a security triangle, which is a three tiered approach to security measures in packaging.

Level one consists of overt features such as holograms. This is the most important level, because so many tampering and counterfeiting problems are discovered by the consumer. Levels two and three include covert aspects; the former may be similar to deterrents on currency such as pen reactive inks and the latter could move into the arena of forensic technology (Genuario, 2004, p.55).

According to Obesity, Fitness and Wellness Week (2004), one of the more questionable approaches to establishing authenticity has most recently been developed by FFF Enterprises called the Verified Electronic Pedigree (VEP) system. Drug pedigrees consists of following documentation of who has handled a particular unit of a drug as it travels through the supply chain.

However, the FDA has postponed implementation of federal drug pedigree rules three times since first calling for it in the 1987 Prescription Drug Marketing Act (PDMA). While several states have passed pedigree legislation or are considering it, the approaches vary and verification of the pedigrees has been unsuccessfully addressed.

Over the past year, the FDA had been working a developing a detailed plan on how to combat counterfeiting and tampering. In June of this year, the FDA's Counterfeit Drug Task Force issued a report highlighting critical elements that will help keep the U.S. drug supply safe and secure. According to FDA Consumer (2004, p. 13), this included the following measures:

New technologies. The FDA believes radio frequency identification (RFID) tagging of products, which is feasible by 2007, could be an effective way to track and trace…