Think Drugs Imported From Canadian Websites are Safe: Think Again!

Canadian internet pharmacies filling “50 percent of prescriptions” from international pharmacies – While many U.S. consumers ordering prescription medicines from Canada assume those medicines are coming from Canada, the heads of three major Canadian Internet pharmacies have confirmed this is often not the case. According to Daren Jorgenson, founder of Winnipeg-based Canadameds.com, “We're filling 50 percent of our prescriptions [from international pharmacies].”  Jorgensen’s website boasts, “Not just from Canada any more!  Choose your country and your savings.”[1]  The president and owner of CanadaRx.net has also confirmed that his medicines are not coming from only Canada.  According to Harvey Organ, “I can get drugs from all over the world.”[2]  A Bloomberg news article recently reported that CanaRx Services Inc. “has joined other Canadian Internet pharmacies in finding sources of drugs from partners in the U.K., Continental Europe, Israel, Australia and India.”[3]  This is particularly troubling since according to a study by the Temple University for Pharmaceutical Health Services Research, India is a worldwide leader in the production of counterfeit drugs with as much as 35 percent of the world’s drug counterfeiting originating in that country.[4]  CanaRx Services Inc. is an Ontario-based provider to the I-Save-Rx importation program, serving consumers in Illinois, Wisconsin, Missouri, Kansas and Vermont.

FDA Test Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake and Substandard –According to a July 2004 Food and Drug Administration (FDA) analysis of three commonly prescribed drugs purchased from a Web site advertised as Canadian, all three so-called “Canadian Generics” were fake, substandard and potentially dangerous. The products purchased were so-called “generic” versions of Viagra, Lipitor, and Ambien. None of these products has a U.S.-approved generic version.  In response to the findings, FDA Acting Commissioner Dr. Lester M. Crawford stated, “The test results of our analyses offer proof positive that buying prescription drugs online from unknown foreign sources can be a risky business. As was the case here, even where a website looks legitimate, FDA has clear evidence that the Web site is dispensing misbranded drugs that are not the same quality as those approved by the FDA for sale in the United States.”[5]

Canadian Internet Pharmacies Are Selling Drugs That Are NOT FDA-Approved– According to testimony by William Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation, FDA, prescription drugs are being imported into the U.S. from Canada Internet pharmacies that are unapproved and lack assurances of quality.  He reports, “we've [FDA] come back today with the real examples you’ve asked for, drugs that are not refrigerated that must be, that have no instructions or warnings that should, that are unapproved in the United States….I also have three drugs that someone bought over the Internet. They're not approved. We don't know what they are… one may be a Canadian version of Lipitor… We're not sure what it is… Whatever it is, it's not approved for use in the United States and there's no labeling or information on it as well …”[6] In addition, the FDA has stated previously, “Virtually all shipments of prescription drugs imported from a Canadian pharmacy will run afoul of the Act…Drugs from foreign countries do not have the same assurance of safety as drugs actually regulated by the FDA.”[7] 

Prescription drugs ARE Being Transshiped Through Canadian Internet Pharmacies –Testimony by the FDA also provided an example of transshipment of drugs via Canada into the U.S.  According to William Hubbard’s testimony, an 82-year-old man bought two drugs from a web site based in Arizona that offers to sell Canadian drugs but received drugs “made in India.”  According to Hubbard, “this gentleman apparently had prostate enlargement and epilepsy, but what he received was a Tupperware container, and in that Tupperware container… [are] drugs for prostate enlargement with no labeling, no warnings or anything and the drug for epilepsy.  But the really unique thing about this story is that it had a funny return address on it -- India. And in fact, it says on the package, made in India. He was told on that web site and when he made the phone call that he was getting a U.S. produced drug, sold in Canada and sold back to him. He got Indian drugs that are not approved, have no labeling, no information and he called the FDA and was outraged why are we letting this stuff in.”[8] 

Study finds “differences in blend uniformity” betweencholesterol-lowering drugs bought over the Internet -- A study published in the medical journal Science found that when a cholesterol-lowering drug manufactured in the United States was compared with generic copies bought over the Internet from Mexico, Thailand, India and Brazil, there were “differences in blend uniformity” -- an error that could dilute their effect. The authors concluded that “Clinically, this would have significance for a patient who was prescribed half of a tablet per day--not an uncommon practice.  In addition, drug “clumps” may affect dissolution rate, which can affect onset of effect and bioavailability.”[9]

Cholesterol-lowering tablets imported via the Internet. (Top) Photographic images. (A) U.S. innovator product; (B), (C), (D), and (E) are from Mexico, Thailand, India, and Brazil, respectively. (Bottom) Near-infrared spectroscopic images of the same tablets. Clumps of active ingredient are visible as bright spots.

FDA Questions Legitimacy of ‘CANADIAN’ Internet pharmacies – Internet pharmacies that claim to be Canadian based may have no ties to Canada whatsoever.  According to William Hubbard, “Some web sites are actually ordering services that take orders from consumers that are then fulfilled by supposed Canadian pharmacies.”[10] Although drugs may be ordered through a Canadian Internet pharmacy, there is no telling whether the drug is from Canada and simply shipped via a Canadian pharmacy into the U.S.  According to Hubbard, “The FDA has noticed a proliferation of websites that offer drugs purportedly from Canada.  Some websites purport to offer ‘U.S. approved’ drugs, however, it is highly unlikely that the drugs are in fact approved by the FDA.[11]  Many drugs obtained from foreign sources that purport and appear to be the same as U.S. approved prescription drugs have been of unknown quality.”[12] 

Canada Has Confirmed It Will NOT Guarantee The Safety Of Illegal Drug Imports– According to Diane Gorman, Assistant Deputy Minister, Health Canada, “The Government of Canada has never stated that it would be responsible for the safety and quality of prescription drugs exported from Canada into the United States, or any other country for that matter.”[13]  Even if Canada did regulate exports, its regulatory system would be quickly overwhelmed.  Currently, the Canadian drug market is less than 10% of the U.S. drug market. 

Canadian and U.S. Phamacists Against Importation Of Drugs From Canadian Internet Pharmacies– On May 13, 2003, the Canadian Pharmacists Association (CPhA) joined the American Pharmacists Association (APhA) to endorse a landmark Cross-Border Communique between the U.S.-based National Association of Boards of Pharmacy (NABP) and the Canadian National Association of Pharmacy Regulatory Authorities (NAPRA) on the issue of illegal crossborder importation of prescription drugs. According to John A. Gans, PharmD, Executive Vice President of APhA, “With the Internet, it’s definitely a buyer-beware situation. There is no substitute for the pharmacist-patient relationship in securing effective medication management. Some of the web sites may not be pharmacies at all, in that no licensed pharmacist is at the helm.” Gans also noted that not all medications sold under the Canadian flag – e.g., via Internet pharmacies claiming to operate in Canada – actually originate in Canada. Such products could be contaminated or could have been degraded due to poor storage and shipment conditions, or could even be counterfeit altogether.  “Cheaper isn’t better, if the price-tag includes compromising patient safety. Taking the pharmacist out of the picture – a situation directly related to, and worsened by, illegal importation -- is something we all agree is harmful.”[14]

Pharmacy Board Warns Against purchasing prescription drugs from Canadian Internet Pharmacies or Storefront Operations – On May 9, 2003, the Arizona Board of Pharmacy issued a letter to the Arizona Better Business Bureau asking it to warn consumers about the risks of purchasing prescription drugs illegally from Canada and other foreign countries.  According to Hal Wand, incoming Executive Director of the Arizona Board of Pharmacy, “State and federal regulators cannot ensure that consumers are being served by reputable licensed professionals who can guarantee safe, untampered with, non-counterfeit prescription drugs from a reliable source.”[15]

FDA Finds, Few Online 'Canadian Pharmacies' Based in Canada– According to a 2005 study commissioned by the FDA's Office of Criminal Investigations that examined some 11,000 Internet pharmacies, only about one thousand of those Web sites actually sold prescription drugs and that fewer than 25 percent were registered to or hosted by companies or individuals in Canada.  The report concluded that most of the sites referred visitors to 1,009 online stores, 86 percent of which are currently hosted by companies located in the United States.  In response to the finding, Tom McGinnis, director of pharmacy affairs for the FDA stated, "We want consumers to be aware that when they order online from these sites ... for the most part no one is overseeing that -- not the state boards of pharmacy, not the FDA -- and that they're the ones responsible for taking a look at the quality of these sites and their offerings." [16]