A new report released by OpSec Security, a provider of anticounterfeiting and brand protection services, found an increased amount of illicit behavior in sales of bulk pharmaceuticals and prescription drugs over the Internet. The two-year study showed a 30% increase of bulk pharmaceuticals and active pharmaceutical ingredients (APIs) offered online on B2B trade boards, which serve companies attempting to source pharmaceutical products online and are unregulated environments.
 
In OpSec’s study, zolpidem tartrate, the API for the prescription sleep aid Ambien (sanofi aventis, Paris), was offered for sale online in 25-kilogram drum quantities. A single drum can be used to produce 2.3 million sleep aid pills with a retail value of $32 million, according to the study. It was also found that none of the wholesalers on the trade board addressed the issue of pedigree information, even when offering to ship to the United States, where pedigree data are required by the US Food and Drug Administration.
 
In terms of online pharmacies, the study reported a 65% increase in the number of Internet pharmacies that do not require a prescription or only require an online consultation. About a third of the pharmacies studied showed signs of what OpSec calls “highly suspicious behavior” that indicates counterfeit drugs may be sold. These signs include Internet pharmacies that:

• Are registered in regulated regions that do not require a prescription, or require only an online consultation
• Mask their WHOIS location and contact details
• Are included on the National Association of Boards of Pharmacy’s (NABP’s) “Not Recommended” list
• Registered outside the US but targeting a US consumer.

A 300% increase in online pharmacies offering deep discounts to consumers was noted in the report. Unaccredited Internet pharmacies featured prices up to 60–80% below the average price listed on pharmacies accredited by the NABP’s Verified Internet Pharmacy Practice Sites (VIPPS). As mentioned in a previous post, FDA recommends consumers look for the VIPPS Seal when purchasing prescription drugs online and offers guidelines for consumers on how to shop safely for pharmaceutical products. 
 
The problem of counterfeit drugs is growing in Europe as well. A recent report from the European Commission showed that the number of counterfeit drugs seized by European Union customs officers increased 118% between 2007 and 2008. Fake pharmaceuticals were the third-largest category of goods stopped at EU borders, after counterfeit CDs/DVDs and cigarettes. (See today’s ePT story about the report.) 
 
Industry, government, and consumers are all looking for ways to curb the growing counterfeit drug problem. Anticounterfeiting technologies and regulations are evolving but sometimes struggle to keep up with the speed and ease of counterfeit drug production. My colleague Angie Drakulich pointed out in a previous blog post the need for harsher penalties for people who engage in prescription drug counterfeiting as a deterrent for would-be criminals. A step in that direction is the Counterfeit Drug Prevention Act of 2009, H.R. 1450, which proposes stronger penalties for counterfeiters. Under the bill, counterfeiters could face up to 20 years in prison, or a fine, or both, and if a counterfeit drug is found to be the cause of death of a consumer, the offender could receive a life sentence. Increased penalties for wholesalers who knowingly distribute counterfeit drugs are also proposed.

Another tactic in fighting counterfeiting is to add security features at the product level, specifically, to the dosage form. This makes pharmaceutical products more difficult to copy, allows for authentication of an individual dose of a product, and allows brand owners to monitor their supply chains and identify instances of diversion. FDA issued a draft guidance, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, last week that offers recommendations on the use of physical chemical identifiers (PCIDs) such as inks, pigments, and flavors on oral dosage forms (see ePT story). The guidance also reviews procedures for supporting documentation submission if a manufacturer intends to begin using PCIDs as well as the use of PCIDs in packaging and labeling. Comments on the draft can be submitted to FDA and on regulations.gov.

Dosage-form security features and other anticounterfeiting technologies were the subject of a recent PharmTech special report. The application of such technologies is one part of the solution to combat the spread of counterfeit pharmaceuticals. Combined with regulatory and industry standards for increased supply-chain security, harsher penalties for counterfeiters, and constant vigilance by consumers, the threat of counterfeit drugs can be weakened.