CrossBorder Internet Pharmacy: No Place to Buy Drugs

1
Cross-Border Internet Pharmacy No Place to Buy
Drugs

• Durhane Wong-Rieger, PhD
• Consumer Advocare Network

2
Importation and the Safety of the Drug Supply
Chain
Government agencies in Canada and the United
States will not attest to the safety of drugs
re-imported into the United States. 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. Diane Gorman Assistant Deputy Minister,
Health Canada Letter to Washington Post, May 9,
2003 A growing number of Americans are
obtaining their prescription medications from
foreign locations. They often seek out Canadian
suppliers, or sources that purport to be
Canadian. As we have said in the past, FDA cannot
ensure the safety of drugs purchased from
foreign sources. Wm. K Hubbard Senior Associate
Commissioner FDA Testimony Before Senate
Committee on Commerce, Science and
Transportation, Sept. 2001
3
Safeguards that Ensure the Safety Efficacy of
the Canadas Drug Supply

• The submission review process for individual
  products
• The regulation of marketing and advertising
  practices
• Establishment licenses for legal importers
• Record retention and recall mechanisms
• Mutual recognition agreements for pharmaceutical
  GMP requirements
• Packaging and labeling requirements
• Cross-border Internet pharmacies evade the
  safeguards that ensure the high standards of
  safety and efficacy of Canadas drug supply.

4
Positions

• Canadian Pharmacists Association (CPhA) CPhA
  opposes the cross-border prescription drug trade
  based upon our concerns of the negative impact of
  this trade on Canadians, including access to
  quality care, access to prescription drugs and
  the threat to drug prices in Canada. The health
  and safety of patients is the overriding
  principle upon which this position is based.
• Canadian Medical Association If a physician
  wishes to sign a prescription for an individual
  who has not previously been his/her patient or a
  patient of his/her group practice or shared call
  group, basic principles of assessment and
  diagnosis must be applied. It is incumbent upon
  the physician to obtain an adequate history and
  perform an appropriate physical examination to
  reach a diagnosis which will ensure that the
  prescribed medications are appropriate. It is not
  acceptable for a physician to sign a prescription
  without properly assessing the patient.
• Consumer Groups Cross-border internet
  pharmacies are having an adverse impact on the
  lives of Canadians and this impact will escalate
  if left unchecked. Cross-border internet
  pharmacies must be banned.

5
The Reality of Safety Issues Associated with Mail
Order Importation

• Results of 2003 FDA Blitz at the Buffalo, Dallas,
  Chicago and Seattle mail facilities and the
  Memphis and Cincinnati courier hubs
• foreign versions of FDA-approved drugs
• drugs requiring careful dosing
• drugs with inadequate labeling
• drugs inappropriately packaged
• drugs withdrawn from the market
• drugs with dangerous interactions
• drugs requiring initial screening and/or
  periodic patient monitoring
• drugs containing addictive controlled substances

6
Patients Loss of Faith

• Patients on both sides of the border are losing
  faith that governments and healthcare
  professionals will protect their interests and
  safety.
• By continuing to allow Internet pharmacies to
  practice illegally and to sell drugs through
  unregulated channels, we are putting the safety
  of all patients at risk.
• The US FDA has stated that it is unable to
  regulate the business and is under-resourced to
  inspect individual shipments.
• Health Canada should not be using Canadian
  healthcare dollars to monitor a practice that
  does not benefit Canadian patients and, indeed,
  puts Canadian patients at risk for having access
  to safe, affordable prescription medication.