LOS ANGELES, April 8, 2004 (PRIMEZONE) -- Leading experts from the California Pharmacists Association, SPIRITT Family Services, Latinos Unidos and the Pacific Research Institute gathered today to warn consumers that purchasing counterfeit prescription drugs can be hazardous to their health.
"The FDA, pharmacists, and pharmacy regulatory officials across the country are increasingly concerned about the safety risks incurred by individuals who import prescription drugs from foreign countries," said Dr. Michael Negrete, Associate Vice President Clinical Affairs of the California Pharmacists Association. "Increasing access to affordable medicine is important, but not at the expense of safety. America's pharmacists, first and foremost, are committed to ensuring the safety and efficacy of prescribed medications for all of our patients."
Medicine in the U.S. is manufactured and distributed under the strict supervision of the U.S. Food and Drug Administration (FDA) and U.S.-licensed pharmacists. Imported drugs, which are illegal under federal law, are not regulated in any way. Consequently, there is no authority to check those prescriptions to make sure they aren't sub-potent, super-potent, impure, toxic, or totally lacking any active ingredient. Congress, as well as many states and cities, are considering unregulated prescription drug importation as a means for increasing access to medicine despite strong safety warnings from the U.S. Surgeon General and the FDA.
"Americans who buy foreign medicine over the border and online are playing Russian roulette with their health," said Michael Miller, member of the California Pharmacists Association and owner of the historic Fair Oaks Pharmacy. "Prescription drug importation, whether by individuals or on a large-scale, presents the very real danger of bringing counterfeit drugs into our medicine cabinets, and we can not allow that to happen."
"It is a sad state of affairs that America has more than 48 million people uninsured and underinsured and that two-thirds are working people making 200% less than the federal poverty level, and out of these people one-third are Latinos who risk their health by crossing borders to buy prescription drugs that might be unsafe," added Jaime Martinez, national chairperson of the Latinos Unidos Health Access Alliance. "These risks should sound a strong alarm throughout America, all the way from our city halls to our nations' capital."
"We are concerned that policymakers are overlooking the very real dangers to all Americans of allowing the importation of prescription drugs in order to provide increased access to medicines," said Elvia Torres, clinical director at SPIRITT Family Services, a community-based organization with a 31-year history of service through centers in five cities in Los Angeles County. "We cannot ignore the serious health and safety ramifications of such a decision. We are particularly concerned that the people most hurt by importation of medicines will be the most vulnerable in our society -- uninsured working families and low-income seniors. If large-scale importation is made legal, these are the groups who would be forced by state Medicaid programs to use foreign medicines, without knowing if they are counterfeit or mislabeled."
"It is more important than ever for consumers to obtain their medicines from a known and trusted source," said Sally Pipes, president and CEO of the Pacific Research Institute. "It's no secret that Americans are bargain hunting in Canada and at what are described as 'Canadian' Internet drug sites to get prescription medications. People assume because drugs are sold to them through Canada that Canadian regulatory systems guarantee the quality and accuracy of the medications -- this is not necessarily true. Many 'Canadian' drugs are not really from Canada at all -- they are made in places like Iran, Pakistan and Thailand and shipped through Canada to unsuspecting Americans. Misplaced trust in imported drugs creates a serious risk for American consumers."
According to Industry Canada, the Canadian government trade agency, there were significant increases in Canadian imports of pharmaceuticals from Singapore (30%), Ecuador (198%), China (43%), Iran (2,753%), Argentina (221%), South Africa (84%) and Thailand (52%) between September 2002 and September 2003. Counterfeiting rates in South Africa and Thailand are reported to be 30% or higher, and Iran has been identified by the U.S. Department of State as an active state sponsor of terrorism. None of these countries have a Mutual Recognition Agreement on Good Manufacturing Practices with Canada, which means that prescription drugs from these countries are not eligible for sale to Canadian citizens.
Canadian law specifically exempts pharmaceuticals intended for export from any regulatory oversight. Section 37 of the Canadian Food and Drug Act states: "The Act does not apply to any packaged food, drug, cosmetic or device, not manufactured for consumption in Canada and not sold for consumption in Canada."
The California Pharmacists Association is the largest state pharmacy association in the nation and is the professional society that represents California pharmacists in all practice settings. The mission of the Association is to act as the leader in advocating the role of the pharmacist as an essential provider of health care and to support pharmacists in providing optimal pharmaceutical care.