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| The Basics |
Are prescriptions filled in
Canada safe?
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Some are completely
legitimate. Others send your pills to you in a sandwich bag.
The FDA says it has no way to tell the difference, but there
are ways that consumers can.
By Kristin W. Davis,
Kiplinger's
It started
with modest troops of silver-haired bus-trippers crossing the
border into Canada to save 30% or more on Pravachol and
Prevacid. Illegal, yes, but who would begrudge Granny's trying
to keep her medicines affordable? Now it's escalated into a
full-scale election-year war involving people of all ages
attempting to save on medicines of all kinds. Seniors’ groups,
mayors, governors and members of Congress on both sides of the
aisle are pressing to legalize what an estimated 1 million
Americans are already doing openly -- filling millions of
prescriptions a year north of the border.
Prescription
meds cost far more in the United States than anywhere else in
the world because we're the only industrialized nation that
doesn't use price controls to hold down costs. Limiting drug
prices in this country -- directly or by importing
price-controlled medications from elsewhere -- would deprive
the pharmaceutical industry of billions in profits and, drug
makers contend, stifle the costly research that spawns
groundbreaking new medications.
The Pharmaceutical
Research and Manufacturers of America also has long claimed
that imported drugs are unsafe, even though many "U.S.-made"
drugs are manufactured overseas. Although the Food and Drug
Administration (FDA) has mostly ignored U.S. citizens who
illegally cross the border with personal supplies of Canadian
medications, it has sided with drug makers on the safety
issue. "We know there are good drugs and bad drugs in Canada,
but we can't tell you which ones are which," says William
Hubbard, the FDA's associate commissioner for policy and
planning. "We don't have the regulatory
reach."
Advocates of importation tend to dismiss the
FDA's safety concerns: "The agency is doing the bidding of the
administration and the bidding of the pharmaceutical
industry," says David MacKay, executive director of the
Canadian International Pharmacy Association (CIPA). Indeed,
the FDA has sometimes overreached in its warnings about the
safety of drugs that come from Canada. But as one wades into
the claims and counterclaims, some of the agency's concerns
deserve a closer look.
Legitimate vs. rogue Web sites
The
drugs you buy at a corner drugstore in the United States are
FDA-approved. That means the FDA is satisfied that the drugs
work and are safe, and that the agency has approved the drug
makers' facilities and periodically inspects the plants,
whether they're located here or in another country. Health
Canada, the Canadian federal regulatory agency, approves and
inspects drug-making facilities much as the FDA does, and
provincial pharmacy boards license and regulate pharmacies
just as state pharmacy boards do in the United
States.
No Canadian pharmacy can truthfully assure you
that you're getting FDA-approved drugs, because any drug
dispensed outside the United States is beyond the FDA's
oversight. But Canada's regulatory system is considered
comparable to ours. When you walk into a Canadian pharmacy,
you can be confident you're getting drugs approved by Health
Canada. But when you buy over the Internet, it's harder to be
sure whom you're doing business with.
Sadly, there seem
to be plenty of consumers who will order drugs off any Web
site that displays a maple leaf. For about a year, the
National Association of Boards of Pharmacy (NABP), an umbrella
group for state pharmacy regulators, has collected complaints
about drugs mail-ordered from Canada. Typical claims include
orders that are paid for but never arrive, or that arrive from
unexpected locations (including India and Thailand) and pills
that are suspected placebos or counterfeits.
Most of
the problems involve rogue Web-site operators that, despite
the Canadian flag on the home page, have no connection to a
licensed Canadian pharmacy. These are the same outfits that
are spewing spam into our e-mail boxes to tout "Vi@gra" and
"V1codin." Kiplinger's visited several of the sites that
prompted complaints to the NABP, and most bore the hallmark of
a dangerous drug source: the claim that a prescription from
your doctor isn't required.
Going north?
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Deal directly with a licensed pharmacy. The
meds should be shipped directly to you from the
pharmacy, not from a third party.
Call the provincial licensing authority to
check that the pharmacy is licensed and in good
standing. A list of licensing authorities is available
at www.napra.org.
Expect to receive your medications in sealed
factory containers rather than the prescription
bottles we're familiar with at home. This protects
against tampering and is also an extra measure of
insurance against pharmacy error.
Don't do business with any Canadian Web site
that does not require a legitimate prescription, that
dispenses controlled drugs (such as Valium and Vicodin)
or that purports to be selling FDA-approved drugs.
If you receive a substitute drug, ask your
doctor if the substitution is safe and appropriate for
your
condition.
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From, or through, Canada?
But the
more difficult question is whether cautious consumers who take
the trouble to check that they're buying from a licensed
Canadian pharmacy can be sure they're getting Health
Canada-approved meds. "If you walk into a Canadian pharmacy,
you're going to get medication that is safe," says Carmen
Catizone, executive director of the NABP. "If you order from
the Internet, you have no way of knowing that's going to
occur."
Catizone is opposed to importation but says
he's in discussion with the National Association of Pharmacy
Regulatory Authorities (the NABP's counterpart in Canada)
about ways the two groups could ensure safe importation. He
worries that drug wholesalers are bringing medications from
Third World countries (where regulatory standards are looser
and counterfeits are common) into Canada and then funneling
them to pharmacies expressly for export to the United
States.
Canadian trade figures indicate that the
concern may be warranted. A Prudential Financial research
report last fall revealed that pharmaceutical exports to
Canada were up 300% from Bulgaria, 196% from Pakistan, 171%
from Argentina, 114% from South Africa and 101% from
Singapore. Although those numbers are not concrete evidence of
so-called transshipping, it suggests that it may be happening,
says Diane Duston, the analyst who co-wrote the report.
Although it is illegal for a licensed Canadian
pharmacy to export drugs that are not Health Canada-approved,
it's not clear whether anyone is monitoring compliance with
the law. Health Canada has said that it is the responsibility
of the importing country to make sure its imports are safe.
What about the provincial regulators? "If everyone is
doing what they're supposed to be doing, the products shipped
to the U.S. should be Health Canada-approved," says Ronald
Guse. Guse is the registrar of the Manitoba Pharmaceutical
Association, which licenses pharmacies in Manitoba, where
roughly half the exporting pharmacies are located. "We haven't
had any information to show that products coming from Canada
are not Health Canada-approved," Guse told Kiplinger's. "But I
can't say all products from Canada are Health
Canada-approved."
Drug makers
fight back
The pressure to feed the mounting demand
in the United States for affordable drugs is especially keen
now that several pharmaceutical companies, including
AstraZeneca, GlaxoSmith-Kline and Pfizer, are withholding
supply to Canadian pharmacies and distributors that deal
primarily with U.S. customers. "We began directly notifying a
group of Internet pharmacies last August that they would no
longer get Pfizer products," says Pfizer spokesman Jack Cox,
who adds that Canadian pharmacies are violating the terms of
their contracts when they export Pfizer drugs to the United
States. (Popular Pfizer products include Celebrex for
arthritis, Lipitor for high cholesterol, Norvasc for high
blood pressure and Zoloft for depression.)
The
crackdown has created shortages, and pharmacies that export to
the United States are scrambling to fill orders. "What we used
to locate in 15 minutes of phone calls now takes a few people
all day trying to figure out supply," says Billy Shawn,
president of The Canadian Drugstore. Internet pharmacies are
still managing to supply their U.S. customers. Some stocked up
in anticipation of being shut off, and others are quietly
buying drugs from brick-and-mortar pharmacies that primarily
cater to Canadians. But the pharmacy-to-pharmacy trade that
keeps Internet operations in stock is now threatening to
create shortages for Canadians.
Some Internet
pharmacies are telling patients to ask their doctors about
brand-name or generic alternatives to Pfizer products, says
MacKay, CIPA's executive director. Others are beginning to
steer U.S. customers to sources outside of Canada.
Crossborderpharmacy.com, for example, includes a note on its
home page inviting customers to "save even more on drugs from
the U.K." MacKay says CIPA condones such referrals as long as
the location of the source pharmacy is disclosed. And so far,
at least, U.S. drug makers apparently are not cracking down on
British pharmacies that ship to the States.
Pharmacy flaws
In May, Minnesota
became the first state to tap Canada's drug supply for state
employees, waiving co-pays for those who fill their
prescriptions through a Canadian pharmacy. The state expects
to save $1.4 million a year in drug costs. Minnesota Gov. Tim
Pawlenty has also put up a Web site to steer consumers
directly to selected licensed pharmacies, and others have
followed suit. In December, two surveyors from the Minnesota
Board of Pharmacy visited eight licensed Canadian pharmacies
to help select the ones to be included on the Web site. The
surveyors' report lists 32 examples of "poor pharmacy
practices" they observed on their tour.
Many of the
infractions were trivial, such as sending medications with the
prescription labels unattached (to avoid covering up the
manufacturer's label) and sending containers without child
safety caps (which some people don't want or need anyway). But
other shortcomings were more troubling:
- At one pharmacy with an automated prescription-filling
process, each pharmacist checked 100 to 300 prescriptions
per hour. "We have no doubt that safety would be
compromised" at that rate, the report concludes.
- In one pharmacy (the only one not aware the surveyors
were coming), the ratio of six technicians processing
prescriptions to one pharmacist on duty far exceeded
provincial standards, which would have allowed just two
technicians.
- Only one pharmacy had a thermometer in its refrigerator
to check that labeled storage requirements were being met
for refrigerated products.
The report concluded that
one pharmacy, Total Care Pharmacy, in Calgary, Alberta, "far
surpassed the other seven in many aspects of overall pharmacy
practice." Three others "may provide acceptable pharmacy
services to Minnesota residents with some modifications to
their current practices." But four "would not currently
provide acceptable pharmacy services to Minnesota residents."
Gov. Pawlenty chose to list two pharmacies on his site: Total
Care and Granville Pharmacy, in Vancouver, B.C.
Substitute drugs
Patients who fill
their prescriptions in Canada sometimes get drugs equivalent
to, but not exactly the same as, the drugs they would get at a
U.S. pharmacy. In some cases, the difference is in name only:
The heartburn and acid-reflux drug called Prilosec in the
United States, for example, is called Losec in Canada, but
both are the brand-name drug produced by AstraZeneca.
(Prilosec was a popular export to the United States until it
became available over the counter here last year.)
But
patients sometimes receive generic equivalents, such as
pravastatin for Pravachol and sertraline for Zoloft, that are
not available as generics in the United States. Such Canadian
generics are Health Canada-approved but do not bear the FDA's
stamp of approval. If an FDA-approved generic does exist,
however, you can probably buy it cheaper at a local pharmacy
than across the border.
Scare
tactics
Although there are clearly reasons to be
cautious about ordering drugs online from Canada, the FDA
tends to overplay the dangers, which undermines the
credibility of its safety warnings. In a three-day "blitz"
inspection last year, the FDA intercepted 1,982 packages at
mail facilities and courier hubs around the United States. The
examinations turned up 1,728 "unapproved" drugs. Unapproved
includes all drugs that have been handled outside the FDA's
regulatory system, including "foreign versions" of
FDA-approved drugs, such as drugs approved by Health Canada.
In testimony before Congress in March, however, FDA
Commissioner Mark McClellan (who now heads the Centers for
Medicare and Medicaid Services) emphasized the worst offenses,
such as "drugs shipped loose in sandwich bags, tissue paper or
envelopes," along with controlled substances, steroids and
drugs that have been withdrawn from the U.S.
market.
Are those products coming from licensed
Canadian pharmacies? "We don't know how much of what we see is
from licensed pharmacies," says Hubbard. But packages sent
from legitimate Canadian pharmacies are labeled with a
pharmacy name and address. If the FDA wanted to differentiate
between what was coming from legitimate pharmacies and what
was coming from elsewhere, it could. The agency seems content,
however, to leave the impression that the risk of ordering
meds from a questionable Web site is the same as the risk of
ordering from a licensed pharmacy. "I don't know if the risk
of getting inferior drugs is 1% or 10% or 90%," Hubbard says,
"but it's a risk, and it's not fair that senior citizens have
to take it."
Those knowledgeable enough to seek out
legitimate Canadian pharmacies see the risk differently.
"Everything we do, including getting out of bed in the
morning, entails risk," says David Funderburk, legislative
counsel for the TREA Senior Citizens League. "Seniors should
have the right to assume the minuscule risk of using a drug
obtained from Canada rather than suffer the risk of not having
the prescription drug to take at all."
The endgame
The U.S. House of
Representatives has already passed legislation to legalize
imports for personal use. But even if importation becomes
legal, Canada isn't the answer to the larger problem of how to
meet the needs of the many Americans who can't afford the
drugs that have been prescribed to them. "Canada cannot just
be a big drugstore for the U.S.," says David Certner, director
of federal affairs for AARP. "Canada is still a small country,
and it's not that difficult for the drug industry to limit
supply."
The real objective, importation advocates in
the States say, is to put pressure on pharmaceutical companies
to lower prices in the United States. Although the Medicare
prescription-drug benefit set to take effect in 2006 will help
some seniors, there is little confidence it will solve the
problem. "For those who can't afford drugs here, there is
already a health-safety issue," says Certner. "We need to
balance the FDA's concerns against the fact that hundreds of
thousands, if not millions, right now are going to Canada or
purchasing drugs over the Internet."
--Reporter: Amy Esbenshade © Copyright 2004 The
Kiplinger Washington Editors, Inc.
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