Global Threat of Counterfeit Drugs Gain Exposure; NABP Quarterly Progress Report Highlights Actions Taken

July 12, 2011 4:02 pm Topics: Counterfeit drugs

Originally published in the June-July 2011 NABP Newsletter

Counterfeit drugs continue to threaten the public health and safety as thousands of rogue Internet drug outlets continue to operate unhindered. These counterfeit drugs harm patients with inaccurate dose levels, contaminated, or toxic substances, and deprive patients of life-saving medications, allowing disease to spread, especially in developing countries where the incidence of counterfeit drugs is considerably higher than in the developed countries of the world. Contributing to the distribution of counterfeit drugs is the ease of access to these products over the Internet making them available to almost anyone virtually anywhere in the world.

Over the past year, awareness of rogue Internet drug outlets among the public and private sectors has considerably increased as evidenced by frequent media coverage and studies highlighting the issue. In March 2011, government officials and other security experts shared information on the growing threat of counterfeit drugs in a CBS 60 Minutes' segment. During the segment, Food and Drug Administration (FDA) discussed the regulatory challenges involved in securing the increasingly globalized drug supply chain, as many pharmaceuticals in the legitimate United States drug supply chain are manufactured overseas. Complicating the issue, many rogue Internet drug outlets obtain their drugs from unknown sources and the drugs change hands frequently along the way.

In addition, Immigration and Customs Enforcement illustrated for viewers the deceptive appearance of rogue Internet drug sites and stressed the safety issues with drugs ordered through such sites, advising consumers to purchase medications through an NABP VIPPS^® (Verified Internet Pharmacy Practice Sites^CM)-accredited online pharmacy.

Also taking action are US federal agencies who have expressed their commitment to curb prescription drug counterfeiting at home and abroad. The “Counterfeit Pharmaceutical Inter-agency Working Group Report” was prepared by various agencies to note that counterfeit pharmaceuticals are not just an issue in the US, but are also a global health problem. The report cites various counterfeit drug cases of concern, including a case in which anti-anxiety drugs were sold to US consumers over the Internet and were found to contain pentobarbital, a drug used for sedation before administering lethal injections to animals. The authors also describe a case in which counterfeits of a US company’s pneumonia vaccine distributed in El Salvador were found to be missing the essential ingredient and another case in which counterfeits of two cancer drugs trademarked by a US company were illegally manufactured in China and Indonesia and were found to lack the active ingredient for the treatment of cancer.

NABP, too, has participated in efforts to fight counterfeit drugs. In April 2011, NABP hosted a meeting with the members of the Center for Safe Internet Pharmacies (CSIP), a nonprofit organization that was established to educate the public and take voluntary enforcement action against illegal Internet drug sellers. Founding members of CSIP include 11 major American Internet commerce companies that joined with the office of the Intellectual Property Enforcement Coordinator. These well-known companies include American Express, eNom, GoDaddy, Google, MasterCard, Microsoft, Network Solutions, Neustar, PayPal, Visa, and Yahoo!

Through communication and cooperation, NABP hopes to advance the efforts of regulators and other entities seeking to curtail the online trade of illicit and counterfeit drugs. In its ongoing review of Web sites selling prescription medications, NABP continues to work with the state boards of pharmacy, federal regulators, and patient advocates to educate the public on the potential dangers of buying medications from unknown and unapproved sources over the Internet.

As of June 24, 2011, NABP has assessed 8,353 Internet drug outlets selling prescription medications and has found 8,034 (96.18%) of them to be out of compliance with state and federal pharmacy laws and practice standards. These sites are listed as Not Recommended in the “Buying Medicine Online” section, under Consumers, on the NABP Web site. Of these Not Recommended sites:

• 6,812 do not require a valid prescription
• 3,686 offer foreign or non-FDA-approved drugs
• 2,101 are located outside of the US and selling drugs illegally to patients in the US
   

Of the total 8,353 sites reviewed, 260 (3.11%) appear to be potentially legitimate in that they meet program criteria, based on information obtained by looking at the sites. Fifty-nine (0.71%) sites have been accredited through NABP’s VIPPS or Vet-VIPPS^® programs, or approved through the NABP e-Advertiser Approval^CM Program.