NABP/FDA: Public Safety is at Risk with Foreign Drug Importation

January 27, 2004 12:00 AM

The National Association of Boards of Pharmacy® (NABP®) is continuing its warnings to patients about the dangers of purchasing drugs from foreign sources. A recent Food and Drug Administration (FDA) blitz examination of mail shipments of foreign drugs uncovered significant health risks and concerns. In November 2003, FDA conducted blitz exams at mail facilities in Buffalo, NY; Dallas, TX; Chicago, IL; Memphis, TN; and Cincinnati, OH, and found that although foreign sources purport, and may even appear to be shipping drugs that are FDA approved, many of the imported drugs were of unknown quality and origin.

FDA's blitz examined 1,728 drug shipments, all of which were found to be unapproved including so-called "foreign versions" of FDA-approved drugs. Other unapproved drugs discovered were:

• Potentially recalled drugs, including Serevent® "Diskus" and Flovent®.
• Drugs with risk management and/or restricted distribution programs, such as Canadian manufactured Accutane®, a drug that, in the United States, requires patient screening and monitoring to avoid serious risks such as birth defects.
• Drugs requiring initial screening or periodic monitoring to ensure safe use including Coumadin® and warfarin, Plavix®, and tamoxifen.
• Controlled substances such as ratio-Lenoltec with codeine and codeine.
• Narrow Therapeutic Index Drugs that require individual titration of the dose and very careful dosing in order to avoid serious and potentially life-threatening side effects.
• Drugs with clinically significant drug-drug interactions such as Zocor®, Lipitor®, and Viagra®.

FDA noted that although drug products were examined regardless of the country from which they were exported, Canadian parcels appeared most frequently — totaling 80% of the packages. This reinforces FDA's stance that the importation of drugs from Canada should remain illegal. In reviewing FDA's findings, NABP cited data it collected from recent reports to NABP's Verified Internet Pharmacy Practice Sites™ Certification Program. Reports included:

• Consumer complaints of fraud totaling almost $12,000; being charged for, but not receiving, products.
• Consumer complaints of counterfeit or inactive products.
• Consumer complaints regarding illegal and life-threatening access to addicting drugs.
• Consumer complaints of receiving the wrong medication.

To protect consumers from such events, NABP is partnering with FDA on a number of initiatives including modifying its Model Rules for Licensure of Wholesale Distributors, which is a part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. Proposed changes to the Model Rules create base lines for combating drug counterfeiting. NABP is also completing a study on the availability of illegal drugs on the Internet. Results of the investigation will be reported in the May/June 2004 issue of the NABP Newsletter.

Renee Renganathan