Internet Pharmacies: Some Pose Safety Risks for Consumers
(17-JUN-04, GAO-04-820).
As the demand for and the cost of prescription drugs rise, many
consumers have turned to the Internet to purchase drugs. However,
the global nature of the Internet can hinder state and federal
efforts to identify and regulate Internet pharmacies to help
assure the safety and efficacy of products sold. Recent reports
of unapproved and counterfeit drugs sold over the Internet have
raised further concerns. GAO was asked to examine (1) the extent
to which certain drugs can be purchased over the Internet without
a prescription; (2) whether the drugs are handled properly,
approved by the Food and Drug Administration (FDA), and
authentic; and (3) the extent to which Internet pharmacies are
reliable in their business practices. GAO attempted to purchase
up to 10 samples of 13 different drugs, each from a different
pharmacy Web site, including sites in the United States, Canada,
and other foreign countries. GAO determined whether the samples
contained a pharmacy label with patient instructions for use and
warnings on the labels or the packaging and forwarded the samples
to their manufacturers to determine whether they were approved by
FDA and authentic. GAO also confirmed the locations of several
Internet pharmacies and identified those under investigation by
regulatory agencies.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-04-820
ACCNO: A10540
TITLE: Internet Pharmacies: Some Pose Safety Risks for Consumers
DATE: 06/17/2004
SUBJECT: Drugs
Internet
Investigations by federal agencies
Labeling law
Safety regulation
Safety standards
Testing
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** may not resemble those in the printed version. **
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GAO-04-820
United States General Accounting Office
GAO Report to the Chairman, Permanent Subcommittee on Investigations,
Committee on Governmental Affairs, U.S. Senate
June 2004
INTERNET PHARMACIES
Some Pose Safety Risks for Consumers
a
GAO-04-820
Highlights of GAO-04-820, a report to the Chairman, Permanent Subcommittee
on Investigations, Committee on Governmental Affairs, U.S. Senate
As the demand for and the cost of prescription drugs rise, many consumers
have turned to the Internet to purchase drugs. However, the global nature
of the Internet can hinder state and federal efforts to identify and
regulate Internet pharmacies to help assure the safety and efficacy of
products sold. Recent reports of unapproved and counterfeit drugs sold
over the Internet have raised further concerns.
GAO was asked to examine (1) the extent to which certain drugs can be
purchased over the Internet without a prescription; (2) whether the drugs
are handled properly, approved by the Food and Drug Administration (FDA),
and authentic; and (3) the extent to which Internet pharmacies are
reliable in their business practices. GAO attempted to purchase up to 10
samples of 13 different drugs, each from a different pharmacy Web site,
including sites in the United States, Canada, and other foreign countries.
GAO determined whether the samples contained a pharmacy label with patient
instructions for use and warnings on the labels or the packaging and
forwarded the samples to their manufacturers to determine whether they
were approved by FDA and authentic. GAO also confirmed the locations of
several Internet pharmacies and identified those under investigation by
regulatory agencies.
www.gao.gov/cgi-bin/getrpt?GAO-04-820.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Marcia Crosse at (202)
512-7119 or Robert J. Cramer at (202) 512-7455.
June 2004
INTERNET PHARMACIES
Some Pose Safety Risks for Consumers
GAO obtained most of the prescription drugs it targeted from a variety of
Internet pharmacy Web sites without providing a prescription. GAO obtained
68 samples of 11 different drugs-each from a different pharmacy Web site
in the United States, Canada, or other foreign countries, including
Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain,
Thailand, and Turkey. Five U.S. and all 18 Canadian pharmacy sites from
which GAO received samples required a patient-provided prescription,
whereas the remaining 24 U.S. and all 21 foreign pharmacy sites outside of
Canada provided a prescription based on their own medical questionnaire or
had no prescription requirement. Among the drugs GAO obtained without a
prescription were those with special safety restrictions and highly
addictive narcotic painkillers.
GAO identified several problems associated with the handling, FDA approval
status, and authenticity of the 21 samples received from Internet
pharmacies located in foreign countries outside of Canada. Fewer problems
were identified among pharmacies in Canada and the United States. None of
the foreign pharmacies outside of Canada included required dispensing
pharmacy labels that provided instructions for use, few included warning
information, and 13 displayed other problems associated with the handling
of the drugs. For example, 3 samples of a drug that should be shipped in a
temperature-controlled environment arrived in envelopes without
insulation. Manufacturer testing revealed that most of these drug samples
were unapproved for the U.S. market; however, manufacturers found the
chemical composition of all but 4 was comparable to the product GAO
ordered. Four samples were determined to be counterfeit products or
otherwise not comparable to the product GAO ordered. Similar to the
samples received from other foreign pharmacies, manufacturers found most
of those from Canada to be unapproved for the U.S. market; however,
manufacturers determined that the chemical composition of all drug samples
obtained from Canada were comparable to the product GAO ordered.
Some Internet pharmacies were not reliable in their business practices.
Most instances identified involved pharmacies outside of the United States
and Canada. GAO did not receive six orders for which it had paid. In
addition, GAO found questionable entities located at the return addresses
on the packaging of several samples, such as private residences. Finally,
14 of the 68 pharmacy Web sites from which GAO obtained samples were found
to be under investigation by regulatory agencies for reasons including
selling counterfeit drugs and providing prescription drugs where no valid
doctorpatient relationship exists. Nine of these were U.S. sites, 1 a
Canadian site, and 4 were other foreign Internet pharmacy sites.
In commenting on a draft of this report, FDA generally agreed with its
findings and conclusions.
Contents
Letter
Results In Brief
Background
Most of the Targeted Prescription Drugs Were Purchased from
Multiple Internet Pharmacies Without Providing a Prescription Most
Problems Identified among Drug Samples Received fromOther Foreign Internet
Pharmacies Some Internet Pharmacies Were Not Reliable in Their Business
Practices Concluding Observations Agency and External Comments
1 5 8
11
14
21 23 23
Appendixes
Appendix I: Comments from the Food And Drug Administration 26
Appendix II: GAO Contact and Staff Acknowledgments 29
GAO Contact 29
Acknowledgments 29
Table 1: Prescription Drugs Selected for
Tables Purchase from Internet
Pharmacies 3
Table 2: Prescription Drugs Ordered and
Received from Internet
Pharmacies 11
Table 3: Prescription Requirements of
Pharmacies from which We
Obtained Samples 13
Table 4: Problems Observed Among Prescription
Drug Samples
Received 15
Figures Figure 1: Drug Sample Received Without Any
Warnings or Instructions 16
Figure 2: Drug Sample Received Without Any
Instructions in
English 17
Figure 3: Drug Sample Shipped Improperly 18
Figure 4: Drug Samples Shipped in 19
Unconventional Packaging
Figure 5: Drug Sample Received in Damaged 20
Packaging
Contents
Abbreviations
DEA Drug Enforcement Administration
FDA Food and Drug Administration
FDCA Federal Food, Drug, and Cosmetic Act
NABP National Association of Boards of Pharmacy
VIPPS Verified Internet Pharmacy Practice Sites
This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed in
its entirety without further permission from GAO. However, because this
work may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this material
separately.
A
United States General Accounting Office Washington, D.C. 20548
June 17, 2004
The Honorable Norm Coleman
Chairman
Permanent Subcommittee on Investigations
Committee on Governmental Affairs
United States Senate
Dear Mr. Chairman:
As both the demand for and the cost of prescription medications have
increased, the Internet has emerged as a growing marketplace for the
purchase of prescription drugs. Internet pharmacies offer benefits for
consumers, such as the convenience of shopping from home 24 hours a day
and the ability to compare prices offered by multiple vendors. Various
types of pharmacies offer prescription drugs over the Internet, including
pharmacies that sell a wide range of drugs, require a patient to provide a
prescription, and are sometimes associated with traditional chain drug
stores, and other pharmacies that issue a prescription based on an online
medical history questionnaire or have no prescription requirement.1
Like traditional pharmacies, Internet pharmacies are subject to state and
federal statutes and regulations designed to ensure the safety and
efficacy
of the medications they dispense. However, the global nature of the
Internet poses challenges for regulators. States have identified Internet
pharmacies that do not comply with state pharmacy laws, but have
reported difficulty locating, investigating, and taking action against the
pharmacies when they are located beyond state borders.2 Federal agencies
have also taken steps to stop illegal sales of prescription drugs through
Internet pharmacies, including by prosecuting Internet pharmacies that
dispense medications without a valid prescription. The Food and Drug
Administration (FDA) recently reported instances of drugs sold over the
Internet that were improperly handled, such as improperly packaged drugs,
drugs that were unapproved, and drugs that were not the authentic
products consumers intended to purchase. Consumer complaints
1 Throughout this report, we refer to each Internet Web site selling
prescription drugs as an Internet pharmacy.
2 See U.S. General Accounting Office, Internet Pharmacies: Adding
Disclosure Requirements Would Aid State and Federal Oversight, GAO-01-69
(Washington, D.C.: Oct. 19, 2000).
regarding the business practices of some Internet pharmacies have raised
further concerns associated with the use of Internet pharmacies to obtain
prescription drugs.
You asked us to assess:
1. the extent to which certain prescription drugs can be purchased over
the Internet without a prescription;
2. whether drugs sold by Internet pharmacies are handled properly, are
FDA-approved, and authentic; and
3. the extent to which Internet pharmacies are reliable in their business
practices.
To determine the extent to which certain prescription drugs can be
purchased over the Internet, we attempted to place up to 10 orders for
each of 13 drugs, each from a different online pharmacy. The 13 targeted
drugs included top selling drugs, drugs with special safety restrictions
or handling requirements, drugs that have been counterfeited in the past,
and narcotics.3,4 (See table 1.) We generally attempted to purchase each
of the 13 drugs with and without a prescription and produced our own
prescriptions to enable us to do so. 5
3 One of the drugs, Humulin N, is prescribed by physicians and is also
available without a prescription. We included it among the drugs we
ordered because of its special handling requirements.
4 The Controlled Substances Act established a classification structure for
drugs and chemicals used in the manufacture of drugs that are designated
as controlled substances. Controlled substances are classified into five
schedules on the basis of their medicinal value, potential for abuse, and
safety or dependence liability. Schedule I is reserved for the most
dangerous drugs that have no recognized medicinal use, while Schedule V is
the classification used for the least dangerous drugs. We attempted to
purchase Schedule II and Schedule III narcotics. See 21 U.S.C. S:S: 811
and 812.
5Due to the heightened regulation of controlled substances, we did not
attempt to purchase narcotics from pharmacies that required patients to
submit a prescription from their physicians.
Table 1: Prescription Drugs Selected for Purchase from Internet Pharmacies
Prescription drug Condition treated Remarks
Accutane(R) Acne Has special safety
restrictionsa
Celebrex(R) Arthritis --
Clozaril(R) Schizophrenia Has special safety
restrictionsa
Combivir(R) HIV --
Crixivan(R) HIV --
Epogen(R) Anemia Has special handling
requirements
Humulin(R) N Diabetes Has special handling
requirements
Lipitor(R) High cholesterol --
OxyContin(R) Pain Schedule II controlled
substance, narcotic
Percocet(R) Pain Schedule II controlled
substance, narcotic
Viagra(R) Male sexual --
dysfunction
Pain Schedule III controlled
Vicodin(R)/hydrocodone substance,
narcotic
Zoloft(R) Depression
Source: GAO analysis of information from drug manufacturers and the Drug
Enforcement Administration.
aDue to health risks associated with using this drug, there are special
safety restrictions imposed on its use and distribution in the United
States, such as a requirement that patients undergo certain medical tests
and restrictions on the distribution of this drug to physicians with
special training or expertise. Because of the health risks, FDA advises
consumers not to purchase this drug over the Internet.
We purchased drugs from Internet pharmacies that purported or appeared to
be located in the United States, Canada, and other foreign countries.6 We
purchased drugs from Internet pharmacies with varying prescription
requirements-some required purchasers to provide a prescription; some
required purchasers to fill out an online medical history questionnaire,
based on which a physician affiliated with the pharmacy issued a
prescription; and some had no prescription requirement. We also purchased
drugs from Internet pharmacies that are licensed online
6 We determined the location of Internet pharmacies from which we received
drug samples based on information contained in the pharmacy Web sites and
the return addresses and postmarks on the packages we received. Throughout
this report, we refer to Internet pharmacies from countries other than the
United States or Canada as "other foreign Internet pharmacies."
providers of prescription drugs.7 To identify the Internet pharmacies, we
relied upon a list of Internet pharmacy Web sites compiled by a private
consultant and provided to us by FDA; used Internet search engines,
including Google, Yahoo, and Excite; and joined Internet pharmacy
members-only Web sites, which provide enrolled members with lists of Web
sites selling various prescription drugs. Because the universe of Internet
pharmacies is not known, and because we obtained only one drug sample8
from each pharmacy, our findings cannot be generalized.
To assess whether the drug samples we received were handled properly, we
identified whether the samples contained a pharmacy label9 with patient
instructions for use and whether warnings were included on the labels or
along with the packaging. We define handling as the manner in which
Internet pharmacies labeled, packaged, and shipped the prescription drug
samples we received. In addition, we made other observations about the
manner in which the drugs were handled and the condition of the
packaging.10 To assess whether the drug samples we received were
FDAapproved and authentic products, we forwarded the samples to
manufacturers of the drugs that we ordered to make these determinations11
and identify any other safety concerns associated with the drugs or their
7 We selected these Internet pharmacies from among those associated with
large drugstore chains and those certified as Verified Internet Pharmacy
Practice Sites (VIPPS) by the National Association of Boards of Pharmacy
(NABP). VIPPS certification is voluntary and indicates that the pharmacy
meets applicable state licensure requirements and certain other criteria
established by NABP.
8 This report uses the word "samples" to refer to our purchases of drugs
from Internet pharmacies rather than to those drugs provided to
practitioners and others for the purpose of promoting drug sales. See 21
U.S.C. S: 353(c)(1)(2000).
9 The Federal Food, Drug, and Cosmetic Act defines "label" as the display
of written, printed, or graphic matter upon the immediate container of any
article and information required to be on the label must also be included
on the outside container or wrapper, if any, of the retail package. See 21
U.S.C. S: 321(k).
10 We did not conduct a comprehensive review of the pharmacies' compliance
with all applicable federal and state laws and regulations.
11 FDA has noted that chemical analysis of prescription drug samples may
not always detect slight changes in the manufacturing process or different
types or amounts of inactive ingredients, which can affect the
comparability and thus therapeutic equivalence of drug samples.
handling.12 Where manufacturers commented on the adequacy of patient
instructions for use or warnings, we relied upon their assessments rather
than our own judgment. We did not disclose to the manufacturers
information concerning the source of the drug samples we purchased,
including whether the pharmacy purported to be located in the United
States, Canada, or in another foreign country.
To examine the reliability of the business practices of Internet
pharmacies, we contacted Internet pharmacy customer service staff and
several of the processing centers or brokers that handled the
transactions. We also compared the return addresses of some drug samples
received against the business addresses provided by the processing centers
or brokers and listed on the Internet Web sites. Where the packaging of
the drug samples received from foreign Internet pharmacies raised
questions, we coordinated with Drug Enforcement Administration (DEA) to
obtain information about the physical entity located at the return address
on the package and the tenants or owners of the property. Finally, we
obtained information from DEA and FDA regarding their ongoing
investigations of organizations associated with the Internet pharmacies
from which we purchased drugs.
We conducted our work from January through June 2004 in accordance with
generally accepted government auditing standards and in accordance with
the standards of the President's Council on Integrity and Efficiency.
Results In Brief We were able to obtain the majority of prescription drugs
we targeted for purchase from a wide variety of domestic and foreign
Internet pharmacies without providing a prescription. We obtained a total
of 68 drug samples- each from a different pharmacy in the United States,
Canada, or other foreign countries-representing 11 of the 13 drugs we
targeted for purchase.13 Drug samples received from other foreign
pharmacies came from Argentina, Costa Rica, Fiji, India, Mexico, Pakistan,
Philippines, Spain, Thailand, and Turkey. The samples included drugs with
special
12 We sent samples of the generic drug hydrocodone to the manufacturer of
Vicodin for testing.
13 We did not obtain samples of 2 of the 13 drugs we targeted for
purchase. We placed nine orders for one of the drugs but received none,
and we identified no source from which to purchase the other drug in a
manner consistent with our methodology's protocols.
safety restrictions and addictive narcotic painkillers. Among the Internet
pharmacies from which we obtained drugs, 5 U.S. and all 18 Canadian
pharmacies required the patient to provide a prescription, whereas the
remaining 24 U.S. and all 21 other foreign Internet pharmacies issued
prescriptions based on their own medical questionnaires or had no
prescription requirements. The availability and ease with which the drugs
could be purchased varied by drug type. Top selling drugs such as
Celebrex, Lipitor, Viagra, and Zoloft were readily available from multiple
Internet pharmacies. Other drugs, such as those with special safety
restrictions-Accutane and Clozaril-and narcotic painkillers-Percocet,
OxyContin, and Vicodin-were offered for sale by fewer Internet pharmacies
or were otherwise more difficult to obtain.
We identified several problems associated with the handling, FDA-approval
status, and authenticity of the 21 drug samples received from other
foreign Internet pharmacies, but fewer problems among the U.S. and
Canadian Internet pharmacies. None of the 21 samples from other foreign
pharmacies included dispensing pharmacy labels that provided instructions
for use, and only about one-third included warning information. Thirteen
of the 21 samples displayed other problems associated with the handling of
the drugs. For example, 3 samples of a drug that should be shipped in a
temperature-controlled environment arrived in envelopes without
insulation, and 5 samples contained tablets enclosed in punctured blister
packs, potentially exposing the tablets to damaging light or moisture.
Finally, manufacturers reported that most of the drug samples from other
foreign pharmacies (19 of 21 samples) were unapproved for the U.S. market
because, for example, the labeling14 or the facilities in which they were
manufactured had not been approved by FDA; however, they reported that the
chemical composition of all but 4 of the other foreign samples was
comparable to the product we had ordered. Among the 4 exceptions, 2
samples were found to be counterfeit versions of the product we had
ordered, containing a lesser amount of the active
14 The term "labeling" is broader than the term "label" and includes all
labels and other written, printed, or graphic matter upon an article or
its container or wrapper, or that accompanies the article. See 21 U.S.C.
S: 321(m).
ingredient, and 2 samples had a significantly different chemical
composition than that of the product we had ordered.15 In contrast, all 47
of the drug samples we received from U.S. and Canadian Internet pharmacies
included dispensing pharmacy labels that generally provided patient
instructions for use, 41 included warning information, and none displayed
evidence of mishandling. Like the samples received from other foreign
pharmacies, most of those from Canada were also unapproved for the U.S.
market; however, manufacturers determined that the chemical composition of
all were comparable to the product we had ordered. Finally, manufacturer
testing identified 1 sample from a U.S. pharmacy that was inappropriately
removed from the sealed manufacturer container and dispensed in a pharmacy
bottle.
Some Internet pharmacies-mostly other foreign pharmacies-were not reliable
in their business practices. We did not receive six of the orders we
placed and paid for, five of which were placed with other foreign Internet
pharmacies and one of which was placed with a pharmacy whose location we
could not determine. Also, we determined that several of the drug samples
were sent from locations that raise questions, such as from private
residences. We also observed Internet pharmacies that obscured details
about the drugs sold, such as other foreign pharmacies from which we
ordered brand name drugs, but then received a generic or foreign version
of the drug. Finally, about 21 percent of the Internet pharmacies that
sent us samples were found to be under investigation by DEA or FDA.
Reasons for the investigations included allegations of selling
adulterated, misbranded, or counterfeit drugs and providing prescription
drugs where no valid doctor-patient relationship exists. Nine of these
pharmacies were from the United States, one from Canada, and four from
other foreign countries.
We provided a draft of this report to FDA, which generally agreed with our
findings and conclusions. We provided a draft of this report to DEA for a
technical review and it informed us it had no comments. We also provided
each manufacturer with segments of this draft report that related to its
product(s). They provided technical comments, which we incorporated where
appropriate.
15 Under federal law, counterfeit drugs include those sold under a product
name without proper authorization, which falsely purport or are
represented to be a particular product. See 21 U.S.C. S: 321(g)(2).
Counterfeit products may include products without the active ingredient,
with an insufficient quantity of the active ingredient, or with the wrong
active ingredient.
Background Three general types of Internet pharmacies sell prescription
drugs directly to consumers. First, some Internet pharmacies operate much
like traditional drugstores, selling a wide range of prescription drugs
and requiring consumers to submit a prescription from their physicians
before their orders are filled. In some instances, these Internet
pharmacies are affiliated with traditional chain drug stores. Second,
other Internet pharmacies may sell a more limited range of drugs, often
specializing in certain lifestyle medications, such as those that treat
sexual dysfunction or assist in weight control. These Internet pharmacies
typically require consumers to fill out an online medical history
questionnaire in place of a traditional examination by a physician, and
issue a prescription after a physician affiliated with the pharmacy
reviews the questionnaire. Still other Internet pharmacies dispense drugs
without a prescription.
In the United States, the practice of pharmacy is regulated by state
boards of pharmacy, which establish and enforce standards intended to
protect the public. State boards of pharmacy also license pharmacists and
pharmacies.16 To legally dispense a prescription drug, a licensed
pharmacist working in a licensed pharmacy must be presented a valid
prescription from a licensed health care professional.17 The requirement
that drugs be prescribed and dispensed by licensed professionals helps
ensure patients receive the proper dose, take the medication correctly,
and are informed about warnings, side effects, and other important
information about the drug.
16 Most states also license out-of-state pharmacies that dispense drugs to
state residents, and some states regulate Internet pharmacies in a similar
manner. See GAO-01-69.
17 States also license health care professionals, grant them prescribing
privileges, and outline standards of practice in state medical practice
laws.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended, FDA is
responsible for ensuring the safety, effectiveness, and quality of
domestic and imported drugs. To do so, FDA establishes standards for the
safety, effectiveness, and manufacture of drugs that must be met before
they are approved for the U.S. market. To gain approval, a drug
manufacturer must demonstrate that a drug is safe and effective, and that
the manufacturing methods and controls that will be used in the specific
facility where it will be manufactured meet FDA standards. The same drug
manufactured in another facility not approved by FDA-such as a foreignmade
version of an approved drug-may not be sold legally in the United States.
Drugs are subject to other statutory and regulatory standards relating to
purity, labeling, manufacturing, and packaging.18 Failure to meet these
standards could result in a drug being considered adulterated or
misbranded and therefore illegal for sale, which could result in FDA
enforcement action.19
The FDCA requires that drugs be dispensed with labels that include the
name of the prescriber, directions for use, and cautionary statements,
among other things. A drug is considered misbranded if its labeling or
container is misleading, or if the label fails to include required
information. Prescription drugs dispensed without a prescription are also
considered misbranded. In addition, if a drug is susceptible to
deterioration and must, for example, be maintained in a
temperature-controlled environment, it must be packaged and labeled in
accordance with regulations and manufacturer standards. Drugs must also be
handled to prevent adulteration, which may occur, for example, if held
under unsanitary conditions leading to possible contamination.
18See, e.g., 21 U.S.C. S:S: 351(b), 352(g), 352(h), 352(p), 355(d); 21
C.F.R. pts. 201 and 210 (2003). Additional requirements apply to
controlled substances under the Controlled Substances Act and DEA's
implementing regulations.
19 Other federal agencies also play a role with respect to the regulation
of prescription drugs under various circumstances. See GAO-01-69. GAO is
currently reviewing available data on the volume of prescription drugs
entering the United States through the Postal Service and private couriers
and the policies and practices of federal agencies charged with preventing
unapproved prescription drugs from entering the country.
FDA-approved drugs manufactured in foreign countries, including those sold
over the Internet, are subject to the same requirements as domestic
drugs.20 Further, imported drugs may be denied entry into the United
States if they "appear" to be unapproved, adulterated, or misbranded,
among other things. While the importation of such drugs may be illegal,
FDA has allowed individuals to bring small quantities of certain drugs
into the United States for personal use under certain circumstances.21
Internet pharmacies pose challenges for regulators. State boards of
pharmacy in many states have reported difficulty identifying Internet
pharmacies located outside of their borders and have limited ability and
authority to investigate and act against pharmacies that do not comply
with state pharmacy laws when they are identified. In 2000, nearly half of
the state boards had identified consumer complaints against Internet
pharmacies or reported problems with Internet pharmacies not complying
with state pharmacy laws. Additionally, state medical boards have reported
receiving complaints about physicians prescribing drugs over the Internet
without performing an examination of the patient.22 Federal agencies have
taken steps to stop the illegal sales of prescription drugs and other
substances by Internet pharmacies. For example, FDA has taken enforcement
actions against Internet pharmacies; the Department of Justice has
prosecuted Internet pharmacies and physicians for dispensing medications
without a valid prescription; and DEA has investigated Internet pharmacies
for illegal distribution of controlled substances.
20 The recently enacted Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 directed the Secretary of Health and Human
Services to create a system for the importation of prescription drugs from
Canada upon certification that the implementation of the program would (1)
pose no additional risk to the public's health and safety and (2) result
in a significant reduction in the cost of covered products to the American
consumer. The act directed the Secretary to complete a study on drug
importation from Canada within 1 year of enactment. See Pub. L. No.
108-173, S:S: 1121, 1122, 117 Stat. 2066, 2464-69 (to be codified at 21
U.S.C. S:S: 384, 384 note).
21FDA guidelines indicate that agency officials may use their discretion
to allow importation if (1) the intended use is identified, is not for a
serious condition, and the product is not known to represent a significant
health risk; or (2) if the intended use is unapproved and for a serious
condition for which effective treatment may not be available domestically,
and other conditions are also met. See Chapter 9 of FDA's Regulatory
Procedures Manual. http://www.fda.gov/ora/compliance_ref/rpm/default.htm.
Downloaded June 10, 2004.
22 In 2000, 39 of 45 state medical boards responding to our survey
indicated that a physician who issued a prescription on the basis of an
online questionnaire would not satisfy the standard of good medical
practice required under their states' laws. See GAO-01-69.
Most of the Targeted Prescription Drugs Were Purchased from Multiple Internet
Pharmacies Without Providing a Prescription
We were able to obtain the majority of prescription drugs we targeted for
purchase from a wide variety of domestic and foreign Internet pharmacies
without providing a prescription. Five U.S. and all 18 Canadian pharmacies
from which we obtained drug samples required a patient-provided
prescription, whereas the remaining 24 U.S. and all 21 other foreign
pharmacies from which we obtained samples either provided a prescription
based on an online medical questionnaire or had no prescription
requirement. Although we obtained samples of most of the drugs we targeted
for purchase, some drugs, such as those with special safety restrictions
and narcotics, were available from fewer sources or were more difficult to
obtain.
Samples of 11 of 13 Targeted Drugs Obtained from Internet Pharmacies
We obtained 1 or more samples of 11 of the 13 drugs we targeted, both with
and without a patient-provided prescription. In total, we placed 90
orders-each with a different Internet pharmacy in the United States,
Canada, and other foreign countries-and received 68 samples. Drug samples
we received from other foreign pharmacies came from Argentina, Costa Rica,
Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey.
Most of the drugs-45 of 68-were obtained without a patientprovided
prescription. These included drugs for which physician supervision is of
particular importance due to the possibility of severe side effects, such
as Accutane, or the high potential for abuse and addiction, such as the
narcotic painkiller hydrocodone. (See table 2.)
Table 2: Prescription Drugs Ordered and Received from Internet Pharmacies
Drug ordered
Orders placeda
Drug samples receivedb
Drug samples obtained without a prescription provided by the patient
Accutane 10 6c
Celebrex 10 9 7
Clozaril 9 0 0
Combivir 6 5 1
Crixivan 6 6 2
Epogen 1 1 0
Humulin N 7 4 3
Lipitor 10 9 6
OxyContin 1 1 1
(Continued From Previous Page)
Orders placeda
Drug samples receivedb
Drug samples obtained without a prescription provided by the patient
Drug ordered
Percocet 0 0
Viagra 10 9
Vicodin/hydrocodone 10 9c,d
Zoloft 10 9
Total 90 68
Source: GAO.
Note: The samples were shipped by FedEx (24), UPS (3), the U.S. Postal
Service (39), and other couriers (2).
aDoes not include attempted orders that were not accepted. We did not
reach our goal of placing 10 orders for each drug because we could not
always locate 10 sources from which we could purchase the drugs in a
manner consistent with our methodology's protocols.
bWe did not receive a drug sample for every order placed. Reasons included
the drug being out of stock, a requirement that physicians prescribing
certain drugs be part of a registry, and pharmacy requests for follow-up
information we could not provide. In several instances, we could not
determine why an order placed was not received.
cIncludes one sample we could not link to an order we placed.
dAlthough we placed orders for Vicodin, we did not receive any samples of
the brand name version of the drug; all nine samples received were of the
generic equivalent hydrocodone.
Although most of the samples we received were obtained without a
patientprovided prescription, prescription requirements varied. Five U.S.
and all 18 Canadian pharmacies from which we obtained drug samples
required the patient to provide a prescription. The remaining 24 U.S.
pharmacies generally provided a prescription based on a general medical
questionnaire filled out online by the patient. Questionnaires requested
information on the patient's physical characteristics, medical history,
and condition for which drugs were being purchased. Several pharmacy Web
sites indicated that a U.S.-licensed physician reviews the completed
questionnaire and issues a prescription. The other foreign Internet
pharmacies we ordered from generally had no prescription requirements, and
many did not seek information regarding the patient's medical history or
condition. The process for obtaining a drug from many of these pharmacies
involved only selecting the desired medication and submitting the
necessary billing and shipping information. (See table 3.)
Table 3: Prescription Requirements of Pharmacies from which We Obtained
Samples
Prescription requirement
U.S. Internet pharmacies
Canadian Internet pharmacies Other foreign Internet pharmacies
Prescription from patient's
physician must be provided 5 18
Web site provides prescription
based on questionnaire 24 0
No prescription required 0 0
Source: GAO.
The Availability and Ease of Purchase Varied by Drug
While we obtained samples of most of the drugs we targeted for purchase on
the Internet, certain drugs were more widely available and easier to
purchase than others. The top selling drugs Celebrex (a pain reliever),
Lipitor (a cholesterol-lowering drug), Viagra (a medication for male
sexual dysfunction), and Zoloft (an antidepressant) were available from
multiple pharmacies. We placed 10 orders for each of these four drugs with
little difficulty.
Other drugs were available from fewer sources or were more difficult to
obtain. Some of our orders for drugs with special safety restrictions were
more closely scrutinized. For example, one order we placed for Accutane
was declined by a U.S. pharmacy. Accutane is an acne medication that may
cause birth defects and serious mental disturbances leading to suicide
among some users. The pharmacy indicated that it declined our order
because the physician was not included on a national registry of qualified
prescribers.23 Similarly, one U.S. and one Canadian Internet pharmacy
declined our order for Clozaril. According to its manufacturer, patients
taking Clozaril, an antipsychotic medication, must have ongoing blood
tests to monitor for the development of a fatal blood disorder that can
occur during treatment. The U.S. pharmacy that declined our order
indicated that Clozaril should not have been offered for sale on its Web
site, and the Canadian pharmacy indicated that more stringent prescription
23 Risk management protocols developed by the manufacturer in agreement
with FDA prohibit U.S. pharmacies from accepting electronic prescriptions
for this drug.
requirements prevented it from dispensing the drug to patients outside of
Canada.
Narcotic pain medications-OxyContin, Percocet, and Vicodin-were also less
readily available. Despite extensive searching of Internet pharmacy sites,
we found few that sold these drugs without a prescription. Other factors
also hindered our ability to purchase these drugs. For example, some
pharmacies that advertised the narcotics did not actually sell them.
Rather, they attempted to substitute a different, often less potent and
nonnarcotic drug once the order was placed. In addition, several
pharmacies that offered narcotics required payment by means that were
beyond our scope, such as check, bank transfers, or "e-gold" exchanges.24
We were able to place orders for the generic version of Vicodin at several
U.S. pharmacies; however, some of these pharmacies required not only an
online medical questionnaire, but also a telephone consultation with a
pharmacy-designated physician in order to obtain a prescription. Finally,
we were able to place only one order for a drug purporting to be
OxyContin, and only after locating the source by paying a membership fee
and joining an Internet pharmacy drug club, which referred us to the site.
Most Problems Identified among Drug Samples Received from Other Foreign
Internet Pharmacies
We identified several problems associated with the handling, FDA-approval
status, and authenticity of the 21 drug samples we received from other
foreign Internet pharmacies. None included required pharmacy labels that
provided patient instructions for use, and few provided warning
information. Thirteen were shipped improperly, were packaged
unconventionally, or arrived damaged. Manufacturers reported that most of
the samples they reviewed at our request from other foreign pharmacies
were not approved by FDA for the United States-although most had a
comparable chemical composition to the product we ordered-and 4 were
either counterfeit products or otherwise not comparable to the product we
ordered. While most of the samples received from Canadian Internet
pharmacies were unapproved for the U.S. market, they otherwise had a
comparable chemical composition, and the samples from U.S. and Canadian
pharmacies exhibited few problems otherwise. Table 4 summarizes the
problems we identified among the 68 samples we received.
24 "e-gold" is a system where sellers and buyers can establish accounts
and electronically exchange values or amounts of gold in order to complete
Internet transactions.
Table 4: Problems Observed Among Prescription Drug Samples Received
No pharmacy Counterfeit
or
label with Improperly Not otherwise
approved not
instructions No warning shipped or Unconventional Damaged for U.S. comparable
to
Pharmacy for use information dispensed packaging packaging market product
ordered
location (21 (4 (5 (35
(23 samples) samples) samples) (6 samples) samples) samples) (4 samples)
Canadian Celebrex (2) Accutane (3)
Zoloft (2) Combivir (3)
Crixivan (3)
Humulin N (1)
Lipitor (2)
Viagra (1)
Zoloft (3)
Other Accutane Accutane Humulin Accutane Accutane Accutane Accutane
(3) (2) N (3) (1) (2) (2) (1)
foreign Celebrex Celebrex Celebrex Celebrex Celebrex OxyContin
(3) (3) (1) (1) (3) (1)
Combivir Crixivan Crixivan Crixivan Combivir Viagra
(1) (2) (2) (1) (1) (2)
Crixivan Lipitor OxyContin Lipitor Crixivan
(2) (3) (1) (1) (1)
Humulin N OxyContin Viagra Humulin N
(3) (1) (1) (3)
Lipitor Viagra Lipitor
(3) (2) (3)
OxyContin Zoloft OxyContin
(1) (2) (1)
Viagra Viagra
(2) (2)
Zoloft Zoloft
(3) (3)
U.S. Celebrex Lipitor Crixivan
(1) (1) (1)
Zoloft Zoloft
(1) (1)
Source: GAO and drug manufacturers.
Notes:
Drug names indicated are those that GAO ordered. The samples we received
were not the brand name drugs we ordered in all instances.
Drug samples do not add to 68 because some samples exhibited more than one
problem.
All Drug Samples Received from Other Foreign Pharmacies Exhibited Problems
Associated with Their Handling
None of the 21 prescription drug samples we received from other foreign
Internet pharmacies included a dispensing pharmacy label that provided
patient instructions for use, and only 6 of the samples came with warning
information.25 Lack of instructions and warnings on these drugs leaves
consumers who take them at risk for potentially dangerous drug
interactions or side effects from incorrect or inappropriate use. For
example, we received 2 samples purporting to be Viagra, a drug used to
treat male sexual dysfunction, without any warnings or instructions for
use. (See fig. 1.) According to its manufacturer, this drug should not be
25 One of the samples we received from other foreign pharmacies included a
dispensing pharmacy label; however, this label lacked patient instructions
for use.
prescribed for individuals who are currently taking certain heart
medications, as it can lower blood pressure to dangerous levels.
Additionally, 2 samples of Roaccutan, a foreign version of Accutane,
arrived without any instructions in English. (See fig. 2.) As noted,
possible side effects of this drug include birth defects and severe mental
disturbances. Compounding the concerns regarding the lack of warnings and
patient instructions for use, none of the other foreign pharmacies ensured
patients were under the care of a physician by requiring that a
prescription be submitted before the order is filled.
Figure 1: Drug Sample Received Without Any Warnings or Instructions
Source: GAO.
Note: Sample purporting to be Viagra(R) arrived without any warning information
or instructions for use.
Figure 2: Drug Sample Received Without Any Instructions in English
Source: GAO.
Note: Sample of Roaccutan(R), a foreign version of Accutane(R), arrived
without instructions for use in English.
We observed other evidence of improper handling among 13 of the 21 drug
samples we received from other foreign Internet pharmacies. For example,
three samples of Humulin N were not shipped in accordance with
manufacturer handling specifications. Despite the requirement that this
drug be stored under temperature-controlled and insulated conditions, the
samples we received were shipped in envelopes without insulation. (See
fig. 3.) Similarly, 6 samples of other drugs were shipped in
unconventional packaging, in some instances with the apparent intention of
concealing the actual contents of the package. For example, the sample
purporting to be OxyContin was shipped in a plastic compact disc case
wrapped in brown packing tape-no other labels or instructions were
included, and a sample of Crixivan was shipped inside a sealed aluminum
can enclosed in a box labeled "Gold Dye and Stain Remover Wax." (See fig.
4.) Additionally, 5
samples we received were damaged and included tablets that arrived in
punctured blister packs, potentially exposing pills to damaging light or
moisture. (See fig. 5.) One drug manufacturer noted that damaged packaging
may also compromise the validity of drug expiration dates.
Figure 3: Drug Sample Shipped Improperly
Source: GAO.
Note: Despite the requirement that Humulin(R)N be stored under
temperature-controlled and insulated conditions, samples we received were
shipped in an envelope without insulation.
Figure 4: Drug Samples Shipped in Unconventional Packaging
Source: GAO.
Note: Sample purporting to be OxyContin(R) was shipped in a plastic
compact disc case wrapped in brown packing tape-no other labels or
instructions were included.
Source: GAO.
Note: Sample of Crixivan(R) was shipped inside a sealed aluminum can
enclosed in a box labeled "Gold Dye and Stain Remover Wax."
Figure 5: Drug Sample Received in Damaged Packaging
Among the 21 drug samples from other foreign pharmacies, manufacturers
determined that 19 were not approved for the U.S. market for various
reasons, including that the labeling or the facilities in which they were
manufactured had not been approved by FDA.26 For example, the manufacturer
of one drug noted that 2 samples we received of that drug were packaged
under an alternate name used for the Mexican market. The manufacturer of
another drug found that 3 samples we received of that drug were
manufactured at a facility unapproved to produce drugs for the U.S.
market. In all but 4 instances, however, manufacturers determined that the
chemical composition of the samples we received from other foreign
Internet pharmacies was comparable to the chemical composition
26 The manufacturer of one of the remaining two samples determined it was
approved for the U.S. market and the manufacturer of the other sample
could not make a determination.
Source: GAO.
Note: Sample of Crixivan(R), a moisture sensitive drug, arrived in punctured
blister packs.
Most Drug Samples Received from Other Foreign Pharmacies Were Unapproved,
Four Were Not Authentic
of the drugs we had ordered. Two samples of one drug were found by the
manufacturer to be counterfeit and contained a different chemical
composition than the drug we had ordered. In both instances the
manufacturer reported that samples had less quantity of the active
ingredient, and the safety and efficacy of the samples could not be
determined. Manufacturers also found 2 additional samples to have a
significantly different chemical composition than that of the product we
had ordered.
Drugs Received from Canadian and U.S. Internet Pharmacies Exhibited Fewer
Problems
All 47 of the prescription drug samples we received from Canadian and U.S.
Internet pharmacies included labels from the dispensing pharmacy that
generally provided patient instructions for use and 87 percent of these
samples (41 of 47) included warning information. Furthermore, all samples
were shipped in accordance with special handling requirements, where
applicable, and arrived undamaged. Manufacturers reported that 16 of the
18 samples from Canadian Internet pharmacies were unapproved for sale in
the United States, citing for example unapproved labeling and packaging.
However, the samples were all found to be comparable in chemical
composition to the products we ordered. Finally, the manufacturer found
that 1 sample of a moisture-sensitive medication from a U.S. pharmacy was
inappropriately removed from the sealed manufacturer container and
dispensed in a pharmacy bottle.
Some Internet We observed questionable characteristics and business
practices of some
of the Internet pharmacies from which we received drugs. Most, but
notPharmacies Were Not all, involved other foreign pharmacies. These
included pharmacies that Reliable in Their accepted payment but did not
provide the drugs ordered, shipments of Business Practices drugs with
questionable return addresses, pharmacies that obscured
details about the drugs sold, and pharmacies that were under investigation
by regulatory agencies.
We ultimately did not receive six of the orders we placed and paid for,
suggesting the potential fraudulent nature of some Internet pharmacies or
entities representing themselves as such.27 The six orders were for
Clozaril, Humulin N, and Vicodin, and cost over $700 in total. Five of
these orders were placed with non-Canadian foreign pharmacies and one was
placed with a pharmacy whose location we could not determine. We followed
up with each pharmacy in late April and early May of 2004 to determine the
status. Three indicated they would reship the product, but as of June 10,
2004, we had not received the shipments. Three others did not respond to
our inquiry.28
We determined that at least eight of the return addresses included on
samples we received from other foreign Internet pharmacies were shipped
from locations that raise questions about the entities that provided the
samples. For example, we found a shopping mall in Buenos Aires, Argentina,
at the return address provided on a sample of Lipitor. Authorities
assisting us in locating this address found it impossible to identify
which, if any, of the many retail stores mailed the package. The return
address for a sample of Celebrex was found to be a business in Cozumel,
Mexico, but representatives of that business informed authorities that it
had no connection to an Internet pharmacy operation. Finally, the return
addresses on samples of Humulin N and Zoloft were found to be private
residences in Lahore, Pakistan.
Certain practices of Internet pharmacies may render it difficult for
consumers to know exactly what they are buying. Some non-Canadian foreign
Internet pharmacies appeared to offer U.S. versions of brand name drugs on
their Web sites, but attempted to substitute an alternative drug during
the order process. In some cases, other foreign pharmacies substituted
alternative drugs after the order was placed. For example, one Internet
pharmacy advertised brand name Accutane, which we ordered. The sample we
received was actually a generic version of the drug made by an overseas
manufacturer.
27 NABP has reported receiving complaints from consumers who state they
have provided payment to various Internet pharmacies, but have not
received the products ordered.
28We received no notice from federal agencies indicating that our drug
samples had been seized, nor did the Internet pharmacies we contacted
about unreceived shipments indicate they had received such notification.
About 21 percent of the Internet pharmacies from which we received drugs
(14 of 68) were under investigation by regulatory agencies. The reasons
for the investigations by DEA and FDA include allegations of selling
controlled substances without a prescription; selling adulterated,
misbranded, or counterfeit drugs; selling prescription drugs where no
doctor-patient relationship exists; smuggling; and mail fraud. The
pharmacies under investigation were concentrated among the U.S. pharmacies
that did not require a patient-provided prescription (9) and other foreign
(4) pharmacies. One Canadian pharmacy was also included among those under
investigation.
Concluding Consumers can readily obtain many prescription drugs over the
Internet without providing a prescription-particularly from certain U.S.
and
Observations foreign Internet pharmacies outside of Canada. Drugs
available include those for which patients should be monitored for side
effects or where the potential for abuse is high. For these types of drugs
in particular, a prescription and physician supervision can help ensure
patient safety. In addition to the lack of prescription requirements, some
Internet pharmacies can pose other safety risks for consumers. Many
foreign Internet pharmacies outside of Canada dispensed drugs without
instructions for patient use, rarely provided warning information, and in
four instances provided drugs that were not the authentic products we
ordered. Consumers who purchase drugs from foreign Internet pharmacies
that are outside of the U.S. regulatory framework may also receive drugs
that are unapproved by FDA and manufactured in facilities that the agency
has not inspected. Other risks consumers may face were highlighted by the
other foreign Internet pharmacies that fraudulently billed us, provided
drugs we did not order, and provided false or questionable return
addresses. It is notable that we identified these numerous problems
despite the relatively small number of drugs we purchased, consistent with
problems recently identified by state and federal regulatory agencies.
Agency and External In commenting on a draft of this report, FDA generally
agreed with our findings and conclusions and made suggestions to clarify
or expand upon
Comments its contents (see app. II). FDA commented that, while the draft
report noted Internet pharmacy Web sites purported or appeared to be from
various countries, the draft did not demonstrate that the drug samples we
received were actually sent from those countries, such as by discussing
return addresses and postmarks on the samples. FDA suggested we indicate
the methods we used to determine the samples' origins. We modified the
report to indicate that we determined the location of the Internet
pharmacy Web sites from which we received drug samples based on
information contained in the pharmacy Web sites and the return addresses
and postmarks on the packages we received. FDA also commented that our
finding that certain unapproved drugs were chemically equivalent to the
brand name products we ordered was misleading. FDA noted that chemical
equivalence testing may not always determine whether a drug is comparable
in all respects to the FDAapproved drug and therefore fully
therapeutically equivalent. We relied on manufacturers to determine
whether the drug samples we received were comparable to their own
FDA-approved brand name version of the drug, and manufacturers conducted a
range of tests to make this determination. Nevertheless we modified the
final report to note the potential limitations to chemical equivalence
testing. FDA also made several observations about the practices of
Internet pharmacies and provided technical comments, which we incorporated
where appropriate.
We also provided a draft of this report to DEA for technical comments and
to ensure information we reported did not compromise its ongoing
investigations. The agency responded that it had no comments.
Finally, we provided segments of the draft report to the manufacturer of
each drug sample we received. Each manufacturer reviewed the segments of
the draft report relating to its own product(s), and provided technical
comments, which we incorporated as appropriate.
As agreed with your office, unless you publicly announce this report's
contents, we plan no further distribution until 30 days after its issue
date. At that time, we will send copies to the Acting Commissioner of FDA,
the Administrator of DEA, and others upon request. In addition, this
report will be available at no charge at the GAO Web site at
http://www.gao.gov.
Please call Marcia Crosse at (202) 512-7119 or Robert Cramer at (202)
5127455 if you have any questions. Another contact and other major
contributors are listed in appendix I.
Sincerely yours,
Marcia Crosse Director, Health Care-Public Health and Military Health Care
Issues
Robert J. Cramer Managing Director, Office of Special Investigations
Appendix I
Comments from the Food And Drug Administration
Appendix I
Comments from the Food And Drug
Administration
Appendix I
Comments from the Food And Drug
Administration
Appendix II
GAO Contact and Staff Acknowledgments
GAO Contact Randy M. DiRosa, (312) 220-7671
Acknowledgments Major contributors to this report were Margaret Smith,
Corey Houchins-Witt, Andrew O'Connell, Ramon Rodriguez, Julian Klazkin,
Helen Desaulniers, Robert Copeland, and Harold Lewis.
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