Doctors purchasing medicines for patient prescriptions should be wary of a rise in "rogue" wholesale drug distributors selling unapproved or fake medications, U.S. officials say.
The U.S. Food and Drug Administration warned doctors to be suspicious of offers seeming too good to be true as the wholesale distributors engage in aggressive marketing campaigns peddling their counterfeit or unapproved drugs.
Some distributors have been faxing offers to doctors of discounts of 75 percent on drugs that turn out to be fake or unapproved foreign versions of expensive injectable drugs like Botox and cancer drugs, the FDA said.
"They are targeting doctors and medical clinics and using these aggressive marketing tactics to offer medications at discount rates," says Ilisa Bernstein, acting director of the FDA's office of compliance.
The FDA says warning signs that drugs aren't FDA approved may include labels in a language other than English, missing safety information, unfamiliar dosage information or a drug name close to but different from the FDA-approved product name.
Such drugs have been found to contain unidentified or harmful ingredients, and the conditions under which they are manufactured, stored or transported are often not safe, the agency said.
The problems has become so prevalent, the FDA said, it is starting a "Know Your Source" program to remind doctors and healthcare providers of proper procedures for purchasing drugs.
The program urges doctors to purchase prescription drugs only from wholesale distributors that are licensed in the state where the doctor practices to lessen the risk of prescribing ineffective or dangerous drugs to their patients.
Under a law going into effect in 2015, all wholesalers will be required to be licensed by the state in which they operate.
Sales of counterfeit, contaminated, ineffective or otherwise illegal drugs amount to $430 billion annually around the globe, according to estimates by the World Health Organization.
In some developing countries, as much as half of the drugs supplied to patients may be fake, many times the level in developed countries, WHO says.
While the FDA calls the drug supply chain for U.S. healthcare "the most sophisticated and secure in the world," it says a growing network of rogue distributors, often operating on the Internet, are increasingly attempting to push fake or unapproved drugs into doctor's offices, hospitals and pharmacies.
Diligent purchasing practice by doctors and pharmacies can ensure they are receiving only FDA-approved products and that patients are not being exposed to potentially unsafe drugs, it says.
