Imported Drugs Safety : Internet Challenges

by Food and Drug Administration (FDA)

(Page 3 of 3)

When it comes to buying prescription drugs online, Canada is dealing with some of the same regulatory challenges that occur in the United States. In May, the Ontario College of Pharmacists announced that it laid charges against The Canadian Drug Store Inc. for operating an illegal Internet pharmacy based in Toronto. The store, which was filling prescriptions written by U.S. doctors for U.S. residents, was charged along with one of its directors with unlawfully operating an unaccredited pharmacy without registered pharmacists.

NAPRA has signed an agreement with the National Association of Boards of Pharmacy (NABP) in the United States, and recently developed a program in Canada modeled after the NABP's Verified Internet Pharmacy Practice Sites (VIPPS), a voluntary certification program.

A VIPPS seal of approval indicates that an online pharmacy complies with state licensing and inspection requirements, along with other VIPPS criteria dealing with such areas as patient rights to privacy and authentication of orders.

NABP developed the service in 1999 after consumers complained to state pharmacy boards about rogue sites posing as legitimate pharmacies. Sites can pop up overnight and disappear just as quickly, and there is little the U.S. government can do if you get swindled. The FDA suggests you steer clear of foreign Web sites. If you buy medicine from a domestic site, remember that the legitimate ones require a valid prescription.

The FDA sends warning letters over the Internet to suspicious sites. About 30 percent of Internet sites that receive the FDA's letters stop their illegal activity. The FDA also sends copies of the letters to the home governments of the Web sites when the locations can be identified.

"We seek out the cooperation of foreign governments because we have limited reach in a foreign land," says David Horowitz, director of the Office of Compliance for the FDA's Center for Drug Evaluation and Research. "That is one of the major challenges of Internet enforcement."

How the FDA Works With the U.S. Customs Service

The exact amount of imported drugs that come into the United States is hard to track, and the high volume makes it impossible to examine them all. In one pilot program last year, the Food and Drug Administration and the U.S. Customs Service examined 1,908 packages of drug products from 19 countries that came through a mail facility in Carson, Calif., during a five-week period.

The FDA estimates that a total of 16,500 packages could have been set aside if there were enough resources to handle them. Of the 1,908 packages, 721 were detained and the addressees were notified that the products appeared to violate the Federal Food, Drug, and Cosmetic Act.

The FDA's enforcement efforts focus on drugs for commercial use, fraudulent drugs, and products that pose an unreasonable health risk.

• If a bag or package arouses suspicion, customs will set it aside and contact the nearest office of the FDA or the Drug Enforcement Agency for advice on whether to release or detain the drug product.
• Even though your bag may not be checked, it is against the law not to properly declare imported medications to customs. Failure to declare products could result in penalties.
• Possession of certain medications without a prescription from a licensed physician may violate federal, state, and local laws.
• Prescription drugs should be stored in their original containers, and you should have a copy of your doctor's prescription or letter of instruction
.
• If a drug is detained, the FDA is required by law to send you a written notice asking whether you can show that the product meets legal requirements. If you can't, the drug could be destroyed or returned to the sender.

Potential Health Risks With Imported Drugs

Quality assurance concerns. Medications that have not been approved for sale in the United States may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.

Counterfeit potential. Some imported medications — even those that bear the name of a U.S.-approved product — may, in fact, be counterfeit versions that are unsafe or even completely ineffective.

Presence of untested substances. Imported medications and their ingredients, although legal in foreign countries, may not have been evaluated for safety and effectiveness in the United States. These products may be addictive or contain other dangerous substances.

Risks of unsupervised use. Some medications, whether imported or not, are unsafe when taken without adequate medical supervision. You may need a medical evaluation to ensure that the medication is appropriate for you and your condition. Or, you may require medical checkups to make sure that you are taking the drug properly, it is working for you and that you are not having unexpected or life-threatening side effects.

Labeling and language issues. The medication's label, including instructions for use and possible side effects, may be in a language you do not understand or may make medical claims and suggest specific uses that have not been adequately evaluated for safety and effectiveness.

Lack of information. An imported medication may lack information that would permit you to be promptly and correctly treated for a dangerous side effect caused by the drug.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.