Prescription drugs imported by patients into the United States may be unsafe

May 19 2004

Prescription drugs imported by patients into the United States may be unsafe, ineffective, adulterated, misbranded, expired or counterfeit, and could result in harm or death, according to AMA Trustee Rebecca J. Patchin, MD, who testified before the Department of Health and Human Services (HHS) Task Force on Drug Importation on May 14.

As an anesthesiologist and a pain management specialist in Riverside, Calif., Dr. Patchin shared her deep concerns about the safety of her patients who cross the border into Mexico to try to buy the medications she prescribes more cheaply. Those and other safety concerns were the primary reasons the AMA's House of Delegates chose not to adopt a resolution supporting prescription drug importation in 2003. The AMA also opposed H.R. 2427, the "Pharmaceutical Market Access Act of 2003," primarily because the bill lacked a provision that would have required the Secretary of HHS to certify the safety of imported drugs.

"We are concerned because when patients go outside the country to purchase their drugs, there is no way for physicians to be certain that the drugs we prescribe for them are the drugs they are going to receive," said Dr. Patchin.

The only way to assure the safety of imported drugs is to make certain that all drugs for sale to patients in the United States are approved by the Food and Drug Administration (FDA), which requires that: the drug has been reviewed and approved by the FDA for safety and efficacy; the drug manufacturer has met all U.S. laws and regulations for good manufacturing practices; the FDA has the authority to inspect all manufacturing facilities; the drug has met all FDA labeling and packaging requirements and that the drug's chain of custody can be assured and traced.

The AMA is also concerned about drug counterfeiting entering the well-protected U.S drug distribution system. In a recent FDA report, drug counterfeiting outside the United States was described as "widespread and affecting the drug supply of both developing and developed countries." In some instances, counterfeit drugs accounted for more than half of a country's drug supply.

If the United States allows importation, the distribution system must be closed, and all drugs must be subject to reliable, electronic track and trace technology – to secure the integrity of the drug supply chain – and to prevent the importation of counterfeit drugs, said Dr. Patchin. http://www.ama-assn.org