Counterfeit and Adulterated Prescription Drugs

Pharmacy Times
Volume 0

Several years ago, I attended the annual conference of the National Association of Drug Diversion Investigators (NADDI) in Tennessee. The speaker, who was the head of corporate security for a large pharmaceutical company, displayed photos of 1 of its prescription drugs on the large screen designed for viewing by over 200 attendees. The familiar logo of the pill, its color, and other identifiers were prominently shown.

He presented 3 slides overall, each with 2 pills displayed side by side. He asked the audience to decide which pill was the legitimate product, and which was the labor of counterfeiters. I was certainly confident that I could identify the counterfeit substance on each slide, or at least 2 out of the 3 examples. However, when the presentation was over, I had failed on all 3 slides, as I picked the counterfeit pill each time.

The speaker went on to say that not only were the drugs displayed only a copy of the color and logo of the real product, but that in most cases none of the active ingredients were present. Of course in addition to this being an elaborate scam, patient health is a major issue when pharmaceutical drugs are counterfeited and/ or adulterated.

More sophisticated criminals have found that the profits in counterfeiting and adulterating high-priced noncontrolled substances far outweigh the diversion of scheduled drugs that are sold on the street. Drugs singled out for this type of diversion include Procrit, Epogen, Lipitor, Serostim, Zyprexa, the AIDS drugs Combivir and Retrovir, and others.

One of the main problems is with unscrupulous wholesalers and the ease with which they can obtain licenses to distribute pharmaceuticals to pharmacies and hospitals. The ability of some to replicate manufacturer?s labels in exact detail increases the chance of counterfeit substances making their way to the unsuspecting patient.

Florida Gov Jeb Bush recently signed the Prescription Drug Protection Act that targets the problem of counterfeiting and adulterating pharmaceuticals. Florida?s SB2312 provides new criminal offenses and increases the penalties on existing crimes related to the wholesale drug industry.

The bill also requires that wholesale drug distributors must keep and maintain a detailed written record referred to as a ?pedigree paper.? This paper will be mandatory for each drug processed. The hope is that this paper will better ensure the integrity of the drug being distributed.

Wholesalers will also have to undergo stricter background checks and higher bonding requirements, and they will be required to designate a contact person who will be responsible for all the transactions for the drugs they distribute.

The bill also increases the regulatory authority of the Florida Department of Health. It allows the department to shut down wholesalers in violation of their rules and to confiscate drugs that may be creating a danger to the general public.

Although most experts agree that this problem currently affects only a very small percentage of pharmaceuticals distributed in the United States, the fear is that the problem may grow to more epidemic proportions.

Huge profit is the driving force for this type of diversion, but experts also agree that if the leaks are not patched, it could become an inviting crime for those interested in undermining and terrorizing our country. The thought of a large-scale, deliberate adulteration of our nation?s drug supply, is a scary one.

This is a growing problem of drug diversion that law enforcement, regulators, health professionals, and elected officials need to better address. Florida has taken significant steps to attempt to curb this problem, and it is time for all of us to become better educated on the issue, and to take action to prevent disaster.

John Burke, director of the Warren County, Ohio, drug task force and retired commander of the Cincinnati Police Pharmaceutical Diversion Squad, is a 32-year veteran of law enforcement. For information, he can be reached by e-mail at, by phone at 513-336-0070, or via the Web site

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