Canadian drugs ---- a good deal?

North County Times
San Diego
By: BRADLEY J. FIKES - Staff Writer | Saturday, April 22, 2006

Buy your prescription drugs from Canada and save money. That's the promise of Canada U.S. Senior Services, an Oceanside store that sells prescription and over-the-counter drugs through its Canadian owner.

The walk-in storefront brings to North County a new twist in a debate that has raged for years over alternatives to American medications, which are often costlier than those sold elsewhere.

No longer do residents in North County and Southwest Riverside County have to drive to Mexico or get on the Internet to find these bargains. They can walk into a store and get their prescription filled. And Canada, a nation with living standards and laws comparable to the United States, has a more reliable image than does Mexico.

The federal government and pharmacists' and doctors' groups paint quite a different picture. When you buy drugs from a foreign source, they say, you lack the protection of U.S. regulations. And it's illegal.

But despite frequent warnings and federal crackdowns on storefronts for Canadian pharmacies, people still keep buying. And these outlets show no signs of going away.

Cost


The savings from buying Canadian are often substantial. Consumer Reports, a respected consumer magazine, tried in an October 2005 article (available on the Web at http://tinyurl.com/7en6r) to quantify just how much.

"When we compared the lowest prices of five well-known, brand-name drugs from both Canadian and U.S. sources, the Canadian pharmacies saved consumers between $72 and $226 per prescription (including shipping charges)," the article stated.

Legality


Sellers of Canadian medicines to U.S. customers operate in a gray area. There are plenty of professionals and government officials who have strong opinions on the subject, but they often disagree. The result: stalemate.

The U.S. Food and Drug Administration, which regulates the sale of drugs, contends the practice is nearly certain to violate one regulation or another about drug safety. But the agency has refrained from prosecuting individual customers who buy drugs for their own personal use. That's a nod to political reality: People such as fixed-income seniors who have difficulty affording their medications make sympathetic subjects.

As for the storefronts themselves, the FDA stops short of categorically saying they are illegal by definition.

"We look at each situation on a case-by-case basis," FDA spokeswoman Laura Alvey said.

She declined specific comment on Canada U.S. Senior Services.

Alvey cited a Feb. 18, 2004, warning letter sent to Fairmont, W.Va.-based Discount Prescriptions From Canada Inc., which also helped consumers buy drugs from Canada.

"Canadian and other foreign versions of FDA-approved drugs are generally considered unapproved in the United States because FDA approvals are manufacturer-specific, product-specific, and include many requirements relating to the product, such as manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance," the letter stated, citing the Federal Food, Drug and Cosmetic Act.

"Frequently, drugs sold outside of the United States are not manufactured by a firm that has FDA approval for that drug. Moreover, even if the manufacturer has FDA approval, the version produced for foreign markets usually does not meet all of the requirements of the U.S. approval, and thus it is unapproved in this country."

Cronin agreed.

"It's not legal," Cronin said flatly. The storefront operations continue to operate because they must be prosecuted individually, and that takes time, he said.

States rebel


However, Robicheaux said his store is strictly legal, as is a sister store in Orange County that has been open for years.

"My boss operates a store in Laguna Hills," Robicheaux said. "He's in his fourth year."

So far, the FDA doesn't appear to have acted. Alvey said the FDA's Web site, which lists enforcement actions, doesn't have any listed for any Canadian storefront pharmacy in Southern California.

Even more strikingly, a number of states are openly helping patients buy drugs from Canada. Illinois developed such a program, I-Save-Rx, also open to residents of Wisconsin, Kansas, Missouri and Vermont. The states contract with Canadian pharmacies, who supply the drugs to those taking part in the program.

This state role, with monitoring of drug quality, is meant to answer the FDA's contention that the Canadian drugs are of unproven safety. Go to www.i-saverx.net for more information.

Minnesota's Rx Connect program doesn't go so far. But it lists recommended Canadian pharmacies, along with cautionary instructions.

"(T)o our knowledge, the U.S. government generally does not stop individual U.S. residents from buying small amounts of prescription drugs for their own personal use, or that of a family member, and the FDA has made statements to the media that they do not plan to interfere with such small individual purchases," the program's Web site states at http://tinyurl.com/rqhnv.

However, the FDA has occasionally seized packages mailed into the United States from legitimate Canadian and British pharmacies. In these cases, the FDA usually sent a letter to the person purchasing the medication and took no other action against the purchasers. The pharmacies affiliated with this Web site will replace any medications seized in this manner if a copy of the FDA letter is faxed to them.

Safety


The FDA and some doctors warn that drugs imported from foreign sources are not inspected to make sure the drug is as ordered, and that it is cared for properly.

"The drugs shipped to people in the U.S. are not subject to Health Canada's regulation," said Dr. Bryan A. Liang, referring to Canada's health agency. That means if the drugs are bad, there's no one enforcement authority the consumer can appeal to. Liang is co-director of the San Diego Center for Patient Safety at UCSD School of Medicine. Liang is also executive director and professor of law at the Institute of Health Law Studies at Cal Western School of Law.

And Canadian doctors who rewrite prescriptions for patients they've never seen are acting contrary to medical ethics, he said.

Liang advises patients to buy from a local pharmacist so they can discuss medications with the pharmacist face-to-face. If they do buy from an Internet source, patients should choose vendors who subscribe to the standards of VIPPS (Verified Internet Pharmacy Practice sites).

However, the Consumer Reports article maintains there is no evidence that Canadian drugs are less safe than their American counterparts.

"In a June 2004 report, the U.S. Government Accountability Office said that all of the prescription drugs it ordered from Canadian Internet pharmacies contained the proper chemical compositions, were shipped in accordance with special handling requirements, and arrived undamaged," the article stated.

The article also cited an October 2003 study by an Illinois state agency that found Canada's system is less vulnerable to drug counterfeiting than the American system.

"Drugs in the U.S. typically move through multiple vendors (manufacturers, wholesalers, repackagers, retailers, second repackagers, etc.) before reaching the patient," the article stated. "In Canada, medications are dispensed mainly in typical dosages and shipped in sealed packages directly from manufacturer to pharmacy."

Legal or illegal. Safe or unsafe. Like so many decisions in health care, the question of whether to buy imported Canadian medicines is in the hands of the public.

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