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Industry Issue: ImportationReimportation of Drugs

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Title: Industry Issue: ImportationReimportation of Drugs


1
Industry Issue Importation/Reimportation of Drugs
  • By
  • Marv Shepherd, Ph.D.
  • Director
  • Center for Pharmacoeconomic Studies
  • College of Pharmacy
  • University of Texas
  • Austin, TX 78712
  • Email marvshepherd_at_mail.utexas.edu


2
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3
Introduction
  • First an overview of the extent of drug
    importation.
  • Threats of product integrity from imported drugs.
  • Overview of counterfeit drugs.
  • Why people procure imported drugs.
  • Vulnerability points of the US drug distribution
    system.
  • Canadian Drug Market
  • Political realities

4
Introduction
  • Bringing prescription drug products into the U.S.
    from Mexico and Canada has been going on for
    decades, if not centuries.
  • With the easy access to Internet pharmacies, the
    problem of drug importation continues to grow at
    enormous proportions.

5
Myth 1
It is legal to personally import drugs into the
U.S.
6
  • Drug importation is illegal!
  • The only groups which can import drug products
    are pharmaceutical manufacturers. Personal drug
    importation is illegal.
  • However, FDA has allowed some variances.

7
Myth 2
Drug importation is a one dimensional issue. It
purely an economic issue!
8
  • Drug importation is not just a one dimensional
    issue! It is a very complicated issue.
  • The problem has many fronts. There are political
    issues, financial issues, economic/competition
    issues, international trade concerns, legal and
    liability concerns, health care issues, plus many
    social issues.

9
  • For legal importation to take place it will take
    the understanding and cooperation from many
    governmental agencies, law enforcement agencies,
    private and public organizations, consumer groups
    and associations. This cooperation cannot only
    occur in the U.S. It requires cooperation from
    exporting countries.
  • Plus, it will require additional funding for FDA
    and U.S. Customs.

10
Myth 3
Drug importation is safe. No one has ever been
hurt from imported drugs.
11
  • People have been harmed and people have died from
    imported drugs.
  • Some imported products contain the correct amount
    of active ingredients others contain no active
    ingredient, too little or too much.
  • Counterfeit drugs w/o active ingredients usually
    do not kill. It may take weeks, months or years
    to see the effects.

12
Myth 4
All foreign pharmacies doing business with
Americans are licensed and follow U.S. laws and
regulations.
13
  • There are over a thousand internet pharmacy sites
    worldwide offering a variety of drug products.
  • Many do follow regulations within their country
    but some of these regulations are weak compared
    to U.S. standards.
  • Many DO NOT abide by U.S. or state standards to
    do business with U.S. residents.

14
  • Many of these foreign pharmacy internet sites
    selling drugs to Americans are rogue, fraudulent
    sites. They pop-up one day and disappear the
    next. They are difficult to track and difficult
    to find their location.
  • Some sites are operated by felons, criminals with
    links to organized crime, and drug cartels. Many
    are not operated by pharmacists.
  • Some site dispense counterfeit, non-FDA approved
    drugs.

15
  • In an examination of 45 Canadian Internet
    pharmacy sites, 15 appeared to falsely advertise
    that their country of origin was Canada.
  • Investigations found the sites were from U.S.,
    Barbados, and Mexico.
  • For example, the site CanadaRxfree.com is from
    Mexico City. (Source Global Options)

16
  • Some sites are very deceptive. For example many
    sites have been found to use Canada in their
    domain name but the pharmacy is located in
    another country. CanadaRx.com was dispensing
    drugs out of a pharmacy in the Bahamas, when
    patients thought they were located in Canada.

17
  • To assure that the internet site is a legitimate,
    licensed pharmacy, look for the VIPPS seal on
    the opening screen.
  • The VIPPS (Verified Internet Pharmacy Provider
    Site) seal is given by the National Association
    of Boards of Pharmacy.

18
Myth 5
Americans are required to have a prescription to
get prescription drugs from a foreign pharmacy.
19
  • For many pharmacy sites you dont even need a
    prescription!!! All you need is a credit card
    number and address.
  • In fact, for many countries, such as Mexico,
    prescriptions are not necessary for many
    therapeutic categories of drugs.

20
  • In Canada, it is illegal to fill a prescription
    written by U.S. physician unless they are
    licensed in Canada. Canadian physicians are
    required to rewrite the prescription or co-signed
    the prescription.
  • Many Canadian health care practitioners,
    associations and regulators want to ban this
    co-signing of prescriptions. It is an unethical
    practice no patient contact, no examination.
  • It has been reported that Canadian internet firms
    pay physicians 10.00 per Rx rewritten.

21
Myth 6
Although drug importation is a hot political
issue, few drugs are coming from other countries.
22
Extent of Drug Importation
  • At a U.S. House Congressional open hearing (June
    24, 2003), Rep. Greenwood reported that 30,000
    drug packages arrive each day at the Miami
    international mail facility.
  • Over 10,000 parcels arrive daily at the Carson
    City mail facility here in California.
  • 40,000 parcels arrive daily at the JFK airport.

Each package contained chewable sildenafil
(Viagra).
Many parcels contain more than one drug.  
23
All these shipments in brown and white envelops
were from Honduras, UK or Belize. All were
labeled Valium. This bin is 3x4x3 feet. This is
one days shipment. Miami International Mail
Branch.
Fake Valium shipments
24
Counterfeit Valium shipments for one dayMiami
International Mail Branch, March 2004.
25
Drugs are from all over the world. The true
manufacturing site is unknown on many. Container
size suggest more than 90 day personal use.
26
Teddy bears stuffed with counterfeit Viagra being
shipped to a carpet cleaning business in Ohio.
27
  • It is estimated that 20 million packages
    containing drugs arrive annually via
    international U.S. mail. This is an increase of
    1000 in just two years and it continues to grow.
    These estimates do not include Fed Express, UPS
    or other delivery mechanisms.
  • The HHS Drug Importation study released in
    December 2004 estimates that 12 million
    prescriptions were sold by Canada to U.S.
    residents. This was approximately a 700 million
    transaction.

28
  • More current estimates indicate that Canadians
    export an estimated 1.1 billion (U.S. dollars)
    of drugs to U.S residents. Considering that the
    total Canadian drug market is just 8 to 10
    billion, this constitutes a major business for
    Canada.
  • Mexico sells 800 million just from border
    farmacias.

29
Myth 7
Imported drug products are safe and effective
products.
30
Partially true! Some drugs are of good quality
some are not. Few are FDA approved. Problem it
is difficult to determine what is good what is
bad.
Source www.fda.gov/news/2003/new00948.html
31
What is troubling is that the vast majority of
the pharmaceutical products coming into the U.S.
are NOT approved by the FDA. Many are
substandard products or fake products. Source
www.fda.gov/news/2003/new00948.html
32
FDA has determined that imported drug products
may
  • Contain no active ingredient, too little or too
    much active ingredient.
  • Be expired or have a false expiration date.
  • Be contaminated.
  • Be stored at the wrong temperature or under
    unsafe conditions.

33
  • Be a counterfeit or fake medicine.
  • Be fraudulently or inadequately labeled.
  • Be a product which has been withdrawn from the
    market.
  • Be animal drugs not for approved human use.
  • Be inappropriately packaged.

34
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35
Continuation of Myth 7
Imported drugs are safe and effective.
36
Threat of Counterfeit Pharmaceuticals
CAUTION MEDICINE MAY BE FAKE
WARNING MAY BE EXPIRED,WATERED DOWNED OR
MISLABELED
DIRECTIONS TAKE WITH HEALTHY DOSE OF SKEPTISM
37
Definition of Counterfeit Prescription Drugs
  • Counterfeit medication is one which is
    deliberately and fraudulently mislabeled with
    respect to identity and/or source.
  • Counterfeiting can apply to both brand and
    generic products.
  • Counterfeit products may include products with
    correct ingredients, wrong ingredients, without
    active ingredients, with insufficient quantities
    of active ingredient or with fake packaging.

38
Trend in Number of FDA Counterfeit Drug Cases
Source FDA Counterfeit Drug Report, February
2004, the 2004 figure came from Business Week,
February 7, 2005.
39
  • Counterfeit drugs continue to be a growing
    concern. It is anticipated that the number of
    counterfeit drugs will continue to increase.
    Since 1996, 73 fake pharmaceutical cases have
    been opened in the U.S. Legal results show 44
    arrests and 27 convictions. In 2003 there were
    22 fake drug cases opened by the FDA.

Caution Fake
  • Most recent counterfeit drugs found in the U.S.
  • Procrit
  • Lipitor
  • Serostim
  • Neupogen
  • Epogen
  • Combivir
  • Zyprexa
  • Viagra
  • Diflucan
  • Ortho Evra
  • Ambien
  • Botox

40
Extent of Counterfeit Drugs and Major Sources
  • It has been estimated by the WHO that counterfeit
    drugs comprise 8 percent of the world market.
  • For some countries (African, Latin) counterfeits
    comprise 40 to 50 percent of the market.
  • Estimated to be 20 to over a 40 billion market.
    (WHO)
  • Sources of Counterfeit Drugs
  • Indiait is estimated at 15 to 20 drugs are
    fake. (Script, April 16, 2003)
  • China
  • Brazil (40 to 50 fake)
  • Mexico (25 fake)
  • Pakistan
  • Belize
  • Chile
  • Southeast Asia Countries (30 to 50)

41
The extent of counterfeit drugs in the U.S. has
not been determined. Some commonly heard
estimates are that it is less than 1. However,
with the proliferation of internet drug sites and
the number of drug entering the U.S. from other
countries, this estimate may be low.
42
  • Often times the counterfeit product is mixed with
    legitimate products to confuse investigators. The
    counterfeit Lipitor found in the U.S. last summer
    was mixed with authentic product.
  • Makes it difficult to determine the extent of
    counterfeiting.

43
Lipitor (atorvastatin calcium) Which one is the
counterfeit Lipitor?
Source Pfizer Inc.
44
Lipitor (atorvastatin calcium) Which one is the
counterfeit Lipitor?
FAKE
AUTHENTIC
Source Pfizer Inc.
45
Celebrex (celecoxib) Which one is the fake
Celebrex?
Source Pfizer Inc.
46
Celebrex (celecoxib) Which one is the fake?
COUNTERFEIT
AUTHENTIC
Source Pfizer Inc.
47
Counterfeit Gabantin
Drugs purchased over the Internet by an American
patient who was told that the products were
manufactured in the United States and were being
sold from Canada. The drugs he actually received
are fake knockoffs from India.
48
Counterfeit Zantac
Manufactured in Taiwan, discovered in United
Kingdom. Excellent packaging of counterfeit, even
includes counterfeit package insert.
Source Pharmaceutical Research Manufacturers
Association
49
Counterfeit Ponstan
Ponstan is an anti-inflammatory product. This
counterfeit was found in Columbia. First is the
yellow powder it consist of boric acid, floor
wax, yellow highway paint. Pressed into tablets
and placed in foil packs with labeling.
Source Pharmaceutical Manufacturer Research
Association
50
Counterfeit Patchno active ingredient
Authentic Ortho Evra Contraceptive Patch and
packaging
51
Counterfeit Viagra is a worldwide problem. The
University of London reported in September, 2004
that half the men buying Viagra online are
getting a counterfeit drug. Many having no active
ingredient, wrong active ingredient, or wrong
quantity. (BBC, September 28, 2004) Countries
exporting fake Viagra are India, China, Israel,
Thailand, Costa Rica, Belize, Mexico.
52
Viagra (sildenafil) Which one is the fake drug?
53
Viagra (sildenafil) Which one is the fake drug?
AUTHENTIC
FAKE
54
Manufacturing Facility for Counterfeit Panadol
This facility depicts the conditions in which
many counterfeits are manufactured. This
counterfeit lab was found in South East Asia.
Source Pharmaceutical Research Manufacturers
Association
55
Recent Fake Drugs From Alleged Canadian Web Site
  • Counterfeit Ambien, Viagra and Lipitor were
    found coming into the U.S.
  • All three products were so-called generic
    versions. However, none of these products have
    approved generic versions.
  • Tests showed that the drugs were the wrong
    strength, didnt dissolve properly and contained
    contaminants.

56
  • Ambien was found to be double the labeled
    strength listed.
  • The generic Lipitor was found to be
    sub-potent. On average, only 57 of the active
    ingredient was found.
  • Some tablets of Viagra had both too little and
    too much active ingredient. Viagra failed the
    dissolution tests and tablets had unacceptable
    levels of impurities.

Source FDA.gov/bbs/topics/news/2004 accessed
July 20, 2004
57
  • In April, it was reported that a Vancouver
    Internet Pharmacy operator (www.canadapharmacytrus
    t.com )is openly selling Viagra (Sildenafil),
    Cilalis (tadalafil) and Levitra (vardenafil)
    which are not approved by the Health Canada nor
    the U.S. FDA.
  • These counterfeit drugs were coming from Mexico.

Source Scrip, (PJB Publications) April 9, 2004.
58
Best Pharmacists Strategy
  • Know your suppliers!!!! Deal only with
    trustworthy reputable wholesalers. Just because a
    wholesaler has a license doesnt necessarily mean
    they can be trusted!
  • Be careful of the Good Deal. If it appears to
    be too good to be true, you may have a problem.
    Be very careful, especially if it from a new
    source. Due diligence is needed to check on
    suppliers
  • Be careful of fax and email deals.

59
What if you suspect something is wrong?
  • Contact FDA at http//www.fda.gov/medwatch
  • Or call FDA at 1-800-FDA-1088
  • Also contact the manufacturer.

60
Myth 8
The only reason people obtain their
pharmaceuticals from a foreign pharmacy is to
save money.
61
Saving money is partially correct. There are
other reasons why people import medicines.
62
Reasoning for Going Outside the U.S.
  • The primary reason why Americans go to Canada to
    obtain drugs is because of the cheaper price.
  • The primary reason why Americans go to Mexico to
    obtain drugs is because of the cheaper price and
    easy access.
  • The primary reason why Americans use a foreign
    internet site is because of the cheaper price,
    easy access and convenience.
  • Other reasons are to avoid the law, obtain
    controlled substances without a prescription, and
    dont have to see a physician to get a
    prescription.

63
  • One frightening thing about the open door to drug
    importation is the purchasing of controlled
    substances. Narcotics are flowing freely into
    this country via foreign internet sites.
  • As pointed out in a recent Washington Post series
    of articles on importation, when children can
    order controlled substances from their homes with
    a credit card number, without a prescription, and
    have drugs delivered to their home--we have a
    problem.

64
Terrorist Group Involvement
  • Terrorist groups such as IRA, Homas, Hezbollah
    and Al Queda have been linked to counterfeit drug
    production and distribution.
  • IRA manufactured counterfeit Ivomec and other
    fake hormone products in Florida.
  • Hezbollah smuggled large quantities of
    pseudoephredrine from Canada to make
    methamphetamine.
  • The link between terrorists groups, organized
    crime, narcotic cartels and counterfeit drugs is
    extremely strong.

65
Myth 9
Canada can meet the prescription drug needs of
U.S. residents.
66
Source AARP Bulletin, February 3, 2005, 3.
67
Canadians Cannot Meet U.S. Drug Demands
  • Canadas population is 32 million compared the
    290 million in the U.S.
  • The number of U.S. elderly are greater than the
    total Canadian population.
  • The Canadian drug supply would last the 38 days
    in the U.S.
  • To supply just half of the U.S. elderly, Canada
    would have increase their total annual drug
    supply 2.5 times.

68
U.S. Demands are a Threat to Canadian Drug Supply
  • New York Times (Oct. 16, 2004) reported that many
    in Canada are concerned about the lack of drug
    supplies in Canada.
  • It is completely untenable to think that Canada
    could supply their (U.S.) needs and our own for
    even one month let alone on an on going basis.
    Canadian Treatment Action Council and Best
    Medicine Coalition (Globe Technology, Associated
    Press, Oct. 19, 2004)

69
In December, the Health Minister of Canada, Mr.
Ujjal Dosanjh spoke out against Americans getting
drugs from Canada. He stated We cannot be the
drugstore for the United States. Furthermore he
stated, I want to make sure that we dont
have250 million Americans buying drugs in
Canada. Source Television interview, CTV
Television, December 12, 2004.
70
Script recently reported that Canadameds.com is
now filling about half of their prescriptions
with products from outside of Canada.
Canadameds.com has pharmacies in more than 30
countries, approximately 10,000 prescriptions a
week are coming into the US from these foreign
pharmacies. Source Script, World
Pharmaceutical News, February 11, 2005.
71
Myth 10
All drugs for export by Canada are approved by
Health Canada and manufactured in Canada.
72
  • Approximately 60 of the drugs used in Canada are
    imported, the remaining are manufactured in
    Canada. Canada imports drugs from more than 80
    foreign countries. (4.5 billion are imported,
    4.4 billion manufactured, but Canadian
    manufacturers export 1.5 billion).

73
Concerns About Canadian Drugs
  • Canada is on record of saying that they will NOT
    assure the quality of the products coming into
    the U.S.
  • Canadian Internet operators are on record of
    saying that they will obtain drugs from other
    sources (countries) if supplies become limited.
    Our research shows that Canada is importing drugs
    from 80 countries.

74
It is important to realize that under Canadian
Drug Law, drugs which are intended for export may
not be regulated by Health Canada. In other
words, drugs which are for export by Canada do
NOT have to have approval from Health Canada.
75
Canadian Food and Drug Act, 37.(1)
This 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, if the package is marked
in distinct overprinting with the word Export
or Exportation and a certificate that the
package and its contents do not contravene any
known requirement of the law of the country to
which it is or about to be consigned has been
issued in respect of the packaging and its
contents in prescribed form and manner.
76
This also explains why many American politicians
proclaim that Canadian drugs are just as safe as
U.S. drugs. They say show me the Canadian
bodies. There will not be Canadian bodies
because drugs sold in Canadian brick and mortar
pharmacies have a different standard than some
drugs sold by internet exporting companies.
77
To emphasize this point, papers filed in Canadian
federal court late last month by CanadaRX.com has
asked the judge to prevent Health Canada
inspectors from visiting their facilities,
calling the proposed inspection invalid and
unlawful and a violation of the companys
charter rights. Their basis is that since they do
not dispense drugs to Canadians they legally
cannot inspect their facilities.
78
  • Increase in Canadian Pharmaceutical Imports from
    Selected Countries for Drugs Packaged for Retail
    Use
  • 2002 vs. 2003
  • U.S. 1.7 billion to 2.1 billion
    23.5
  • India 25.2m to 26.1m 3.5
  • China 2.3m to 2.9m 26.1
  • Ecuador 1.5m to 2.7m 80.0
  • Mexico 15.8m to 25.3m 60.1
  • Singapore 1.4m to 4.9m
    250 .0
  • All countries 3.7 billion to 4.7 billion
    27.0
  • Sourcehttp//strategis.gc.ca/sc_mrkti/ 03/3/04

79
Myth 11
Drug importation is free trade.
80
Many argue, including legislators, that drug
importation is a free trade issue. The flaw
with this argument is that countries where they
want to import drugs have price controls. This is
NOT free trade. We are importing price controls
not pharmaceuticals. We are imposing foreign
price controls on American goods in a U.S. market.
81
Myth 12 All drugs outside the U.S. are cheaper
than U.S. drugs.
82
  • Wrong!!
  • Generic drug products which constitute 50 of all
    drugs dispensed in the U.S. are cheaper in the
    U.S.
  • Sources exist in the U.S. to obtain lower cost
    pharmaceuticals, including brand name drugs
    without the added risk foreign drugs have.

83
Safe Saving Sources
  • www.Helpingpatients.org
  • Access to 275 public and private patient
    assistance programs.
  • 1-800-762-4636
  • www.RxOutreach.com
  • Prescription assistance program run by Express
    scripts
  • 1-800-769-3880
  • www.TogetherRx.com
  • 10 PRMA Companies offering over 150 FDA-approved
    drugs
  • Savings from 20 to 40
  • www.Safemedines.org
  • Provides links to various drug savings programs

84
When a patient is not progressing well on their
drug regimen, possible questions you may want to
ask are
  • Where are you obtaining your prescription drugs
    or a specific drug?
  • Are you using a pharmacy internet provider site
    for your medications? What is the site?
  • Is the pharmacy site a foreign site? (Remember
    sometimes it is difficult to determine.)
  • Is the patient using medications you are not
    aware?

85
If patients are using an out-of-country
pharmacy other questions are
  • Who is monitoring the patients drug therapy for
  • Drug interactions?
  • Proper drug use?
  • Inappropriate therapies?
  • Drug adherence monitoring?
  • Who does the patient call if they have drug
    therapy questions?
  • Who is counseling the patients on their
    therapies?

86
Concerns---continued
  • When patients use an out-of-country Internet
    provider for chronic care needs and use a local
    community pharmacy for acute care needs, the
    result is an incomplete patient drug profile.
  • The community pharmacist may not be aware of the
    chronic medications the patient is taking. This
    raises the risks of drug interactions or drug
    misadventures.

87
  • This raises the question of liability. What can
    an American do if they get hurt?
  • Is the foreign internet pharmacy provider liable?
  • Remember patients who use Canadian sites are
    required to sign a waiver of their rights.
  • What are the patients chances in suing a
    pharmacy located in Pakistan, China, etc?
  • For Canada is the U.S. doctor or the Canadian
    doctor responsible?
  • Is the manufacturer liable?
  • Remember the U.S. drugs sold to Canada are for
    Canadian use ONLY and Canada will not assure
    quality of the products shipped to U.S.

88
Demand for Foreign Drugs Continues
  • Demand for cheaper pharmaceuticals continues
    people appear to be blind to the hazards-just
    give them cheap drugs.
  • The pressure continues to mount to legalize drug
    importation despite the fact that FDA and the
    White House say they cannot assure safety and
    effectiveness of foreign drug products.

89
Conclusions from the HHS Drug Importation Task
Force
It would be extraordinarily difficult and costly
for personal importation to be implemented in a
way that ensures the safety and effectiveness of
imported drugs. national savings from
legalized commercial importation will likely be a
small percentage (1 to 2) of the total drug
spending and developing and implementing such a
program would incur significant costs and require
significant additional authorities.
90
Thanks So Much!Hope you gained from the
presentation.Marv Shepherd, Ph.D.
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