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Objectives: To describe (1) the international scope of counterfeit drugs, (2) interna-
tional and U.S. anticounterfeiting initiatives, and (3) the enhanced roles and challenges
facing pharmaceutical organizations and individual pharmacists to thwart counterfeit
drugs.
Data sources: PubMed and Ovid from 1970 to 2008 using the search terms coun-
terfeit drugs, counterfeit pharmaceuticals, and counterfeit medicines, with English
as the limiting term. Nonprimary literature sources included the U.S. Food and Drug
Administration (FDA) Web site (www.fda.gov) from 1990 to 2008 using the search term
counterfeit drugs, presentations from meetings or workshops attended or accessed via
the Internet, and Web sites of professional organizations. Additional resources were
identified from personal bibliographies collected by the author and bibliographies of
gathered articles.
Data synthesis: Counterfeit drugs—defined as those containing no active ingredi-
ent, an incorrect amount of active ingredients, incorrect ingredient, and/or unapproved
labeling and packaging—represent an unquantified problem of international propor-
tions. The existing situation has been facilitated by inconsistent national regulatory
oversight, disparate unlinked databases, lack of unified anticounterfeiting actions, and
inability to track the distribution of domestically produced or imported drug products
between, among, and within nations. In the United States, several important anticoun-
terfeiting initiatives announced by FDA in 2004 have been implemented but the benefits
of others, such as electronic tracking of a drug’s movement through the U.S. distribution
chain to a dispensing pharmacy, will not be realized in the near future. The role of phar-
macists as patient educators, prudent purchasers, and detectors of counterfeit drugs
can typically be accomplished with minimal added expense or work; however, the impact
of electronic tracking on pharmacies’ expenses and workflow is unknown. Pharmacists
need to be included in efforts to thwart receipt of counterfeit drugs by patients, but this
must be accomplished with minimal negative impact on pharmacy practices.
Conclusion: Although consistent detection of counterfeit drugs is difficult,
2OLES�FOR�PHARMACY�IN�COMBATTING�COUNTERFEIT�DRUGS2ONALD�*��:IANCE
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Ronald J. Ziance, PhD, is Professor of Pharma-ceutical Sciences, College of Pharmacy, Univer-sity of Southern Nevada, Henderson.
Continuing education credits: See learning objectives below and assessment questions at the end of this article, which is ACPE universal program number 202-000-08-146-H03-P in APhA’s educational programs. The CE examina-tion form is located at the end of this article. To take the CE test for this article online, go to www.pharmacist.com/education and follow the links to the APhA CE center.
Correspondence: Ronald J. Ziance, PhD, 11 Sunset Way, Henderson, NV 89014. Fax: 702-990-4435. E-mail: [email protected]
Disclosure: The author declares no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria.
Published concurrently in Pharmacy Today and the Journal of the American Pharmacists Asso-ciation (available online at www.japha.org).
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!BSTRACT
56 PHARMACY TODAY�s�JUNE 2008 www.pharmacytoday.org
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pharmacists can take several reasonable measures to lessen
the chances they are dispensing counterfeit drugs. However,
the increased role of pharmacists is accompanied by several
important challenges involving increased expense and altered
business practices.
Keywords: Counterfeiting (drug), drug importation, phar-
maceutical supply chain, pedigree, radiofrequency identification,
Prescription Drug Marketing Act.
Pharmacy Today. 2008(Jun);14(6):55–75.
“Pharmacists and health professionals can play a major role
in helping identify counterfeits and preventing their introduction
into the distribution chain.”1
Mark B. McClellan, MD, PhD
Former FDA Commissioner
The production and distribution of counterfeit drugs is a
global problem that involves both developed and developing
countries. In addition to bulk chemicals, confiscated counterfeit
drugs have included products labeled as brand-name and generic
prescription and nonprescription medications. Counterfeit prod-
ucts, which may contain no active ingredient, incorrect amount
of ingredients, incorrect ingredients, and/or unapproved labeling
and packaging, have produced serious adverse consequences in
exposed populations.
On a global basis, the types of counterfeit drugs vary by
region of distribution. The World Health Organization (WHO)
has indicated that hormones and steroids are common targets
in developed countries. Counterfeit antibiotics, antimalarial
agents, antitubercular drugs, antiretroviral agents, vitamins,
painkillers, hormones, and steroids are common in develop-
ing countries,2,3 where residents may be especially likely to
unknowingly purchase counterfeit drug from unlicensed ven-
dors because their government health authorities may not have
suitable amounts of essential drugs in stock.3,4 Drugs used to
treat dyslipidemias and hypertension are common targets in
developed European countries,5 while counterfeit drug activity
in the United States typically involves high-volume expensive or
recreational drug products.6
By using punches, dies, plates, and other hardware readily
available from the Internet, in addition to sophisticated desktop
publishing and offset photography, counterfeit operations rang-
ing from a few people operating out of garages to well-organized
international criminal operations are able to manufacture and
distribute counterfeit drugs, packaging, and labeling that are
very difficult for pharmacists, other health care providers, and
patients to differentiate from legitimate products. Detecting
counterfeit products is also hindered by operational complexi-
ties wherein raw materials may originate in one country but
final dosage forms, containers, and labels are prepared in other
countries.7 Although many countries participate in counterfeit-
ing, leaders in the manufacture and distribution of counterfeit
drugs include China, India, Russia, Brazil, Pakistan, Mexico,
as well as the Southeast Asian and Middle Eastern countries.7
Available information indicates that the number of counterfeit
drug cases in Russia has increased 10 times since 1998 and
represents up to 12% of its total drug market.8,9 Increasing
evidence from the international front also suggests that the sale
of counterfeit goods, including drugs, is being used to finance
terrorists.10,11
Objectives
The purpose of this article is to enhance pharmacist knowl-
edge about (1) the international scope of counterfeit drugs, (2)
international and U.S. anticounterfeiting initiatives, and (3) the
enhanced roles and challenges facing pharmaceutical organiza-
tions and individual pharmacists.
At a Glance
Synopsis: The presence of counterfeit drugs in
international drug-distribution channels is a complex,
unquantified problem in which skilled operators take
advantage of inconsistent regulatory oversight and lack
of coordinated anticounterfeiting initiatives by national
and multinational regulatory agencies and professional
organizations. To enhance pharmacist knowledge about
this problem, this article describes global counterfeit
drug activity; anticounterfeiting initiatives taken by
various government agencies as well as foreign and U.S.
pharmacy-related organizations; potential enhanced
roles for pharmacists; and issues that may accompany
these enhanced roles. The U.S. Food and Drug Admin-
istration and several pharmacy-related organizations
have made important contributions to decreasing coun-
terfeit drug distribution, but some initiatives will not be
realized in the short term.
Analysis: Pharmacists have important roles (e.g.,
educating patients, making prudent purchases, detect-
ing counterfeit drugs) in evolving anticounterfeiting
practices within the United States; however, detection of
counterfeit drugs may be accompanied by altered busi-
ness practices and added expense. The profession must
therefore work to prevent counterfeit drugs from reach-
ing patients without negatively affecting pharmacy prac-
tices. Radiofrequency identification or barcode-based
track-and-trace systems allow products to be monitored
throughout the complex pharmaceutical supply chain.
However, these attractive advancements are accompa-
nied by financial (e.g., covering of start-up expenses),
logistic (e.g. possible decreased efficiency during and
after initial implementation), and patient data and pri-
vacy issues.
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)NTERNATIONAL�SITUATION
2EGULATORY�CONTROL
According to WHO, approximately 20% of more than 191 mem-
ber countries have well-developed regulations to control the
manufacture, importation, distribution, and sale of medications,
50% have varying levels, and 30% have very limited or no regu-
latory authority.4,12,13 Regulatory control is further compromised
by national legislation not extending beyond national borders.14
Additionally, criminals involved in production and distribution
of counterfeit drugs do not limit their activity to one country
and, when blocked by effective local efforts, promptly shift
their activity to different locations.14 Counterfeit drugs often
move through brokers or trading houses, free ports, or trade
zones where drug control is lax and repackaging and relabel-
ing (which may mask details of origin) occur under conditions
that do not comply with good manufacturing practice (GMP)
requirements.4,13 The cost of lax regulatory oversight extends
beyond just loss of drug revenue and includes reduced foreign
investment in legitimate pharmaceutical operations.8
%STIMATED�PREVALENCE
WHO estimates that counterfeit drugs account for approximately
10% of international drug trade,3 while other estimates indicate
a national level ranging from 1% to 80%.15 However, these esti-
mates are inherently inaccurate because of data inconsistencies
that arise from several factors, including the following:
N Lack of accepted international definitions that differentiate
between “counterfeit,” “illicit,” “fake,” and “substandard”12
N Underreporting of suspected cases to government authori-
ties
N Lack of validated integrated databases
In 1995 and 1996, for example, 85 children in Haiti died from
renal failure caused by a locally produced acetaminophen syrup
prepared with glycerin contaminated with 24% diethylene glycol
(DEG).16 WHO has referred to this formulation as either a fake or
contaminated product.17,18
The WHO Database on Counterfeit Pharmaceuticals was
launched in 1982 and, by 2002, contained information submit-
ted by only 5% to 15% of its member states.4,9 By April 1997,
the database contained 771 reports (average rate ~5 reports/
month since launch).19 Approximately 70% of the reports origi-
nated from developing countries,20 most were not validated,20 and
many did not distinguish between counterfeit and substandard
drugs (the latter defined by WHO as genuine medications pro-
duced by legitimate manufacturers that do not meet the quality
specifications established for the product).4 From January 1999
to October 2000, 46 reports were submitted to WHO from 20
members (average rate ~2 reports/month): 33% indicated lack of
active ingredient, 20% presence of incorrect ingredient(s), and
15% fake packaging.12
The accuracy of any counterfeit drug database is compro-
mised if decisions to report are based on disparate country-
specific definitions.14 For example, the Philippine government
defines a counterfeit drug as containing less than 80% of the
labeled amount of active ingredient.12 Thus, a drug product with
an unspecified reduced amount of active ingredient may be classi-
fied as counterfeit in some countries but not in the Philippines. In
addition, the World Trade Organization definition of “counterfeit
trademark goods” differs from international definitions of coun-
terfeit drug.14
Underreporting of counterfeit drugs is demonstrated by the
paucity of reports received by WHO: 84 between 1999 and 2002
and none from 2002 to 2004.10 However, the Counterfeit Inci-
dent System database maintained by the Pharmaceutical Secu-
rity Institute (PSI), whose membership includes 21 international
pharmaceutical companies located mainly in Europe and the
United States, lists 264 counterfeit drug incidents that occurred
in 63 countries in 200321 and 557 episodes detected in 2004.22
The current inconsistent reporting combined with the lack of com-
mon definitions and integrated databases makes it impossible to
evaluate the results of anticounterfeiting measures taken by WHO
or individual countries.
%XAMPLES�OF�COUNTERFEIT�DRUG�EPISODES
The wide scope of counterfeit drug traffic outside the United
States is exemplified by the listings in Table 1. Moreover, coun-
terfeiting extends beyond drugs for humans, as evidenced by the
death of one horse and serious reactions in two additional horses
in Canada that were attributed to a counterfeit parenteral iron–
sucrose veterinary product obtained from a feed store.30
)NTERNATIONAL�RESPONSES�TO�COUNTERFEIT�DRUG�PROBLEM
Countries have responded in various ways to identified counter-
feit drug threats. For example, India initiated an inspection of
drugs to be exported to Nigeria31 following a Nigerian threat to
ban the importation of all drugs from 30 Asian countries. Addi-
tionally, an Indian expert committee called for fines and increased
prison terms for individuals involved in counterfeit drug trade and
recommended the death penalty for those involved in the manu-
facture and sale of counterfeit medications resulting in grievous
harm.32 Likewise, the Philippines enacted a law that increased
penalties from 6 months to life imprisonment plus a $25,000
fine.33 Argentina and Columbia also increased penalties for those
involved in drug counterfeiting.34
7(/�ANTICOUNTERFEITING�ACTIONS
Although WHO’s attention to counterfeit drugs was evident dur-
ing a 1958 Conference of Experts on the Rational Use of Drugs,
progress has been intermittent. The wide scope of WHO actions
are reflected in this partial list:
N Initiating the Database on Counterfeit Pharmaceuticals
N Introducing a Web-based Rapid Alert System by the Western
Region to communicate information of confirmed counterfeit
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drug episodes to national health authorities
N Studying counterfeit drug distribution in two member states
N Adopting the World Health Assembly request to initiate pro-
grams to detect and prevent distribution of counterfeit or sub-
standard drugs
N Collaborating with the European Medicines Evaluation
Agency to strengthen inspection of drugs
N Issuing guidelines for development of measures to combat
counterfeit drugs
N Publishing a draft concept report for an international frame-
work convention to combat counterfeit drugs
N Creating a multicountry working group of 10 WHO member
countries to improve national regulations
N Creating a network of anticounterfeiting liaison officers
N Presenting drug regulatory training workshops in all WHO
regions
N Organizing several international workshops, meetings, and
joint projects
N Providing assistance to countries to develop systems to regu-
late herbal remedies
N Participating in working groups of WHO, the International
Federation of Pharmaceutical Manufacturers and Associa-
tions (IFPMA), and other international pharmaceutical orga-
nizations
N Sponsoring a conference titled “Combating Counterfeit Drugs:
Building Effective International Collaboration”
N Expressing the need for national wholesalers and retailers
to establish licensing requirements and maintain an audit
trail of purchased drugs back to the original manufacturer or
wholesaler
N Interacting with Interpol, the U.S. Food and Drug Administra-
tion (FDA), and other international regulatory authorities
N Providing posters, videotape, and fact sheets to raise aware-
ness
N Proposing the creation of IMPACT (International Medi-
cal Products Anti-Counterfeiting Taskforce), which would
include governmental, nongovernmental, and other interna-
tional stakeholders
N Addressing disparities of technology and reviewed existing
national laws and regulations and methods to transmit infor-
mation within WHO member states
N Implementing the WHO certification scheme, which provides
a mechanism for an exporting country to inform an import-
ing country that specific products approved for domestic sale
were manufactured in accordance with GMP
Despite these efforts, distribution of counterfeit drugs actu-
ally may have been facilitated in May 2004 when nine additional
countries were admitted to the European Union. The resultant
expanded free movement of goods across borders may increase
opportunities for drug diversion. For example, the Czech Repub-
lic has attracted counterfeit drug trade because of its central
location, closure of most customs ports, and short sentences for
Table 1. Examples of counterfeit drugs in foreign countries
Drug product Country (date of incident) Comment
Antiretroviral agents Africa (date unspecified) Labeled drug was replaced with an antidepressant.15
Various China (2001) A government-controlled newspaper reported that 192,000
Chinese citizens died because of ingestion of counterfeit drugs.
Subsequent raids closed about 1,300 illegal manufacturing sites.23
Vaccines Niger (1995) Approximately 2,500 deaths were thought to be due to donated
vaccine lacking active ingredient.24
Amoxicillin Nepal (2004) Approximately 1,200 capsules obtained from three pharmacies
lacked active ingredient. The manufacturer listed on the label did
not exist.15
Insulin Russia (1998) 1,000 patients were hospitalized.25
Oral contraceptive Brazil (1998) Birth control pills made of wheat resulted in more than 200
reported pregnancies.26
Atorvastatin (Lipitor) Great Britain (2005) U.S. citizens may have received counterfeit drug found in the U.K.
if purchased through the Internet or storefront pharmacies.27
Various Great Britain (2004–2007) Drug alerts were issued for tadalafil (Cialis), sibutramine (Reductil,
Meridia), clopidogrel (Plavix), olanzapine (Zyprexa), bicalutamide
(Casodex), and Sensodyne toothpaste.28 Counterfeit tadalafil
(Cialis) was discovered after a patient complained of crumbled
tablets.29
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drug-related crimes.35 Other reasons include the Czech Republic’s
proximity to Russia and the increased involvement of organized
Russian-speaking drug-dealing groups within its borders.36
0AN�!MERICAN�(EALTH�/RGANIZATION
The Working Group on the Prevention of and Fight against Drug
Counterfeiting (WG/FDC) of the Pan American Health Organiza-
tion was convened in 2001. Its initial goals include expanding the
definition of counterfeit drug to include the concept of fraudu-
lent drug, dissemination of information provided by WHO, and
enhanced reporting of information to the WHO database. In 2005,
the WG/FDC proposed that a pharmacist coordinate the monitor-
ing and quality control of available drugs in a country and that
a group of pharmacist inspectors be responsible for inspecting
suspect counterfeit drugs.37
5NITED�3TATES��SITUATION
2EGULATORY�CONTROL
The new drug application (NDA) process to obtain FDA approval
to market a new drug product is contingent upon meeting GMP
requirements, which include source and specifications of active
ingredients, product formulation and appearance, processing
methods, manufacturing controls, and container and closure
systems. Before and after approval of an NDA, domestic and for-
eign manufacturers listed in the NDA are subject to inspection
by FDA for compliance to GMP requirements. The NDA process
also supports the safe and effective use of approved drug prod-
ucts by regulating the content and format of the professional and
patient prescribing information and accurate labeling of the drug
container and carton.
Bills currently being considered in the U.S. Congress, the
Food and Drug Administration Globalization Act of 2008 and the
Safeguarding America’s Pharmaceuticals Act of 2008 address
the problem of drug counterfeiting. Progress of such legislation
can be followed in the Government Affairs center of www.phar-
macist.com, the official Web site of the American Pharmacists
Association (APhA), and in future articles in Pharmacy Today
(www.pharmacytoday.org).
)LLEGAL�IMPORTATION�OF�DRUGS
In the absence of foreign site inspection, FDA believes that there
is no assurance that drug safety, efficacy, purity, potency, han-
dling, labeling, manufacturing, and storage would be identical to
products made at inspected sites. Thus, FDA considers illegal the
importation of any drug that is unapproved, labeled incorrectly,
or dispensed without a valid prescription. In addition, although
a foreign manufacturer has FDA approval for a drug, the version
produced for foreign markets may not meet all requirements for
FDA approval and may be misbranded if certain information is
lacking or not in English.38
Despite regulatory oversight, importation of counterfeit drugs
has flourished. Detection is compromised by the ability of coun-
terfeiters to provide high-quality bogus certificates of analysis, as
well as export and import licenses and customs declarations that
accompany drug shipments through ports of entry. An apprecia-
tion of the financial impact of counterfeit drug traffic from foreign
sources is provided by circumstances in which, during a single
week in 2002, FDA agents seized counterfeit drugs valued at $2
million in Florida, $1.7 million in Texas, and $1 million in Illi-
nois.39 As of 2004, drugs could enter the United States through
312 airports, seaports, and land borders, as well as 29 courier/
express consignment ports and 14 international mail facilities.40
Approximately 10 million packages containing prescription drugs
are estimated to enter the United States annually40; however, in
2004, FDA had only 450 field members and 276 laboratory ana-
lysts involved in investigative import activities.40 This staff works
closely with U.S. Customs and Border Protection (CBP) agents,
who seized 43,659 drug-containing parcels received by interna-
tional mail and express consignment facilities in 2004.40 The esti-
mated cost to examine each package at the Seattle District Office
is an estimated $267.9040; thus, a considerable financial expen-
diture is required to adequately inspect the predicted annual vol-
ume of drug packages received from foreign sources.
The extent of illegal importation is suggested by results of
joint inspections conducted by the U.S. CBP and FDA in 2003.
Sampling of international mail received by eight major mail facil-
ities and two courier hubs within the United States revealed that
more than 80% of 1,153 imported drug products (selected by
the violation history of the exporting country) contained drugs
that were not approved by FDA.41,42 Some of the seized drugs may
have been approved in the country of origin; however, country-
specific requirements for approval may not meet those of FDA.38
In addition to controlled narcotics, violations included shipment
of improperly labeled (e.g., foreign language, absence of label)
and improperly packaged (e.g., wrapped in tissue paper, loose
in plastic bags) drug products. Other areas of concern include
drugs with dangerous drug–drug interactions, several requiring
patient monitoring (e.g., liver function, pregnancy) before and
during therapy, those requiring a controlled storage environ-
ment, and drugs such as warfarin whose potency may be altered
by minor variations in the manufacturing process.41,42 The U.S.
Immigration and Customs Enforcement (ICE), an enforcement
arm of the Department of Homeland Security, is a member of the
Interagency Pharmaceuticals Task Force and conducts inves-
tigations with FDA, the Internal Revenue Service, the Postal
Inspection Service, and the Federal Bureau of Investigation.
The U.S. CBP, Drug Enforcement Administration (DEA), Depart-
ment of Justice, Office of National Drug Control Policy, and U.S.
Postal Service are also members of the Interagency Pharma-
ceuticals Task Force. From 2003 to 2006, ICE initiated 178
criminal investigations of drug smuggling that resulted in 86
arrests and 34 convictions associated with counterfeit, adulter-
ated, misbranded, and unapproved drugs.43
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The Internet
Obtaining prescription drugs from Canada and other countries
via the Internet is an appealing option for U.S. citizens. Boards of
pharmacy in several states have inspected and licensed several
Canadian pharmacies that provide pharmacist–patient consulta-
tion and have approved specific Internet sites from which state
residents may order FDA-approved prescription drugs.44
By contrast, U.S. citizens may submit a legal prescription to
a storefront pharmacy that arranges for signature of a Canadian
physician who never saw or examined the patient and processes
the order to an Internet pharmacy that may provide no pharma-
cist consultation with the patient. The results of FDA’s “Opera-
tion Bait and Switch” inspection of drugs ordered from Internet
sites claiming to be of Canadian origin indicated that 85% of the
latter drugs were manufactured in 27 different countries and
32 of 1,700 parcels contained counterfeit drugs.45 In addition
to taking regulatory action against operators of several Inter-
net sites, FDA has issued a consumer safety guide and several
warnings to educate consumers of the risks associated with the
purchase of prescription drugs via the Internet.46 Distribution of
counterfeit drugs via the Internet is an international concern, as
evidenced by the recommendation that the Committee of Minis-
ters of the Council of Europe issued to its 47 member countries.
Implementation of the recommendations would ensure that mail
order shipment of prescription medications occurs only from
pharmacies that are open to the public and are under the super-
vision of a pharmacist, that the pharmacist is responsible for the
proper delivery of any mail-order shipment, and that the quality
assurance delivery system ensures the possibility of tracking
and tracing deliveries.47
Estimated prevalence
Similar to global estimates, the prevalence of counterfeit drug
activity in the United States is unknown; however, the number
of suspected cases opened annually by FDA’s Office of Criminal
Investigation, as indicated in Table 2, has served as an index of
this activity.48
These data, which quantify FDA’s awareness of cases, may
not directly correlate with actual trends of counterfeit drug activ-
ity. The increase since 2000 may be partly a result of increased
awareness within the drug distribution network and subsequent
reporting to manufacturers and/or FDA, as well as enhanced
coordination of information within federal and state govern-
ments.49 The decline of cases investigated in 2005 may be due
to the discovery that some were related to the large number of
existing cases. FDA’s limited awareness of cases is also explained
by the fact that, before 2004, it was not generally acknowledged
that suspected counterfeit drug episodes could be reported to
FDA’s MedWatch system. By 2005, the MedWatch reporting form
(3500A) and associated instructions were revised in an effort to
enhance reporting of suspect counterfeit drugs, as well as poor-
quality labeling or packaging of drug products.
Another perspective of U.S. activity has been provided by PSI,
which indicated that, in 2005, based on reported cases of coun-
terfeit drugs seized or discovered, the United States ranked sixth
below Russia, China, South Korea, Peru, and Colombia.22
The opportunity to uncover additional cases by “data min-
ing” is hampered by a lack of coding for injuries associated
with suspected counterfeit drug products by injury databases
such as those operated by the Centers for Disease Control and
Prevention, WHO (International Classification of Diseases),
the Consumer Product Safety Commission, the U.S. National
Center for Injury Prevention and Control, the National Elec-
tronic Injury Surveillance System, the National Center for
Health Statistics, the U.S. Poison Control Centers, and, until
recently, FDA.50
Examples of counterfeit drug episodes
As described in the examples cited in Tables 3 and 4, episodes
of counterfeit drug products in the United States have involved
products that contained no active ingredient, an incorrect
amount of active ingredient, or incorrect ingredients. Counter-
feit drug containers and labels were also discovered in many
episodes. Many of the physical anomalies would be very difficult
for pharmacists, other health care professionals, and patients
to detect consistently.
In addition to prescription drugs, counterfeiters have
recently targeted toothpaste typically sold at low-cost “bar-
gain” retail outlets. After being informed in May 2007 that con-
taminated dental products were found in Panama and several
other countries, FDA discovered 41 toothpaste products from
10 Chinese manufacturers that contained up to 3% to 4% DEG,
which is used in antifreeze and as a solvent.79 One month later, a
popular U.S.-brand toothpaste that was possibly manufactured
in South Africa contained DEG and was reportedly distributed
from several “dollar”-type discount stores in four states.80 The
product carton contained the misspelled words “isclinically,”
“SOUTH AFRLCA,” and “South African Dental Assoxiation.”81
Table 2. Counterfeit drug cases opened by FDA,
by year
Year No. cases opened
2000 6
2001 21
2002 27
2003 30
2004 58
2005 32
2006 54
2007 31
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FDA has expressed concern that accidental swallowing may
pose a health risk to children and individuals with kidney or
liver disease.79
Contributing factors include illegal importation of drugs
that have not been approved by FDA into the United States
through a plethora of entry points, inconsistent detection
resulting from an inadequate number of inspectors, and poorly
tracked distribution of FDA-approved drugs through multiple
layers of a complex matrix of diverse domestic distributors.
$RUG�DISTRIBUTION�IN�THE�5NITED�3TATES
Revision of distribution practices is essential to the integrity of
drug delivery within the United States.82 Direct point-to-point
distribution from manufacturers reduces the risk of counterfeit
drugs reaching pharmacies; however, in the United States, most
drugs travel through a complex discount-driven system that
includes 3 large full-line primary wholesalers (AmerisourceBer-
gen, Cardinal Health, and McKesson), approximately 16 regional
wholesalers, more than 6,000 smaller secondary wholesalers,
and a small number of specialty wholesalers.83,84
Table 3. Examples of counterfeit drugs involving lack of active ingredient(s) or incorrect amount of active ingredient(s)
Drug product Comments
Dextromethorphan 2005: Five men died after ingesting misbranded product taken as a drug of abuse. Two
men obtained ingredients from India and manufactured the final product, which was
sold over the Internet as a drug for research. Both were sentenced to 77 months in
prison.51
Hepatitis B vaccine (Energix-B) Date unspecified: Nonsterile vials from Pakistan did not contain vaccine. The label was
easily distinguished from the authentic product.52
Influenza vaccine (Fluzone) 2004: Counterfeit vaccine was administered to 46 attendees of a college vaccine clinic.
Two authentic vials were diluted with saline, and a licensed practical nurse was sen-
tenced to 9 months in prison.53
Atorvastatin (Lipitor) 2003: Eleven individuals, a repacker, and two wholesalers were indicted for involvement
in a $42 million conspiracy to smuggle counterfeit Lipitor from Central America.54 By
2006, one defendant was sentenced to 9 years, 6 months in a federal prison and the oth-
ers were awaiting trial.55 More than 18 million tablets were recalled. In another episode,
patients noted that the tablets had a bitter taste, were thicker, and dissolved faster than
the authentic product.56
Contraceptive patch (Ortho
Evra)
2004: Counterfeit transdermal patches obtained from India and three other Internet
sites were shipped in plastic zip-locked bags lacking lot numbers, expiration dates, or
other product information. The counterfeit was easily distinguished from the authentic
product.57,58
Oral contraceptive (Ovulen-21) 1984: Sixteen lots containing more than 2 million tablets imported from Spain,
Guatemala, and Panama had subpotent or no estrogen. Many tablets were shipped from
Spain to intermediate countries before smuggling into the United States. A Guatemalan
company shipped 12,000 cycles of the drug to the United States, and the proceeds were
deposited in a Panamanian bank.59
Lamivudine (3TC) 1999: Tablets from Hong Kong with no active ingredient were distributed with accurate
replication of cartons, labels, leaflets, bottles, and closures.52
Sildenafil (Viagra) 2003: Counterfeit Viagra from two lots was dispensed from two pharmacies located in
different California cities. Although the product had an authentic lot number and expira-
tion date, the tablets had a different debossing font, more pronounced tablet edges, and
a lighter blue film coat.60
2005: A California resident imported ingredients from China and India and manufactured
about 700,000 tablets worth $5.65 million.61
2005: Chinese investigators arrested 11 individuals and found 600,000 counterfeit tab-
lets and packaging, plus 260 kg of raw materials.61
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Table 4. Examples of counterfeit drugs involving incorrect active ingredient(s)
Drug product Comments
Antibiotics 1985–1991: An investigation by U.S. Customs and Border Protection found unapproved bulk
oxytetracycline, gentamicin sulfate, and sulfamethazine that were purchased from various
Chinese manufacturers. The repackaged products, which were sold for human and animal
use, contained fraudulent manufacturer name, labels, and certificate of analysis. An indi-
vidual was sentenced to 2 years in prison and fined a total of $1 million.59
Lamivudine + zidovudine
(Combivir) and abacavir
(Ziagen)
2002: Counterfeit Combivir labels were placed on authentic bottles of Ziagen tablets. In
addition, authentic white tablets contained in Combivir-labeled bottles were replaced with
yellow Ziagen tablets, which are associated with life-threatening hypersensitivity reactions
in approximately 8% of patients.62,63 Replacement of Combivir, which contains two antiviral
drugs, with Ziagen, a single antiviral, may result in decreased efficacy. In March 2007, the
manufacturer issued a letter to inform pharmacists that two bottles of counterfeit Combivir
had been recently detected in one California pharmacy.64
Ceftazidime (Fortaz) Date unspecified: Vials from Vietnam contained streptomycin instead of ceftazidime.
Physical abnormalities included stained cartons and labels, as well as puncture marks and
yellow stains on the rubber vial plug.52
Actra-Rx 2004: A dietary supplement to treat erectile dysfunction sold without a prescription and via
the Internet contained prescription-strength quantities of sildenafil (Viagra).65,66
Axcil 2007: A dietary supplement obtained via the Internet contained sildenafil plus two of its
analogs.67
Azathioprine (Imuran) Date unspecified: Tablets labeled “Azothiroping” did not dissolve after 4 hours in water
(authentic product dissolved within 45 min).52
Filgrastim (Neupogen) 2001: A distributor noticed an unusual appearance of vials that contained saline instead of
the authentic product and had incorrect lot numbers and expiration dates.68 In addition to
particles in solution, a crusty white substance was found beneath the flip caps. 68 The type
font and print quality were not authentic, and the prescribing information was printed on
paper of incorrect weight.69
Gabapentin (Neurontin) 2004: In response to two undercover purchases from an Internet site claiming to be of
Canadian origin, FDA received two unapproved drugs that had been made in India.70,71 A
patient received a 1-year supply that expired within 1 month of the package stamp date.
Somatropin (Nutropin AQ) 2001: Eight vials from two lots contained insulin and sample vials from two additional lots
contained no active ingredient. Counterfeit product was dispensed from four pharmacies.
Adverse events included swelling, itching, and injection site pain. The manufacturer’s track-
ing system identified a distributor that did not have a distribution agreement.72
Somatropin (Serostim) 2002–2003: Vials contained white powder instead of authentic white lyophilized “cake”
ingredient; some lots contained human chorionic gonadotropin, some contained a pediat-
ric dose of growth hormone, and some contained no active ingredient.73–75 Some patients
experienced slight swelling and skin rash upon injection.76 Some labels had an incorrect lot
number, expiration date, and straight-cut (rather than rounded) corners.74 The circuitous
distribution trail appears to have included stops in Arizona, Florida, Nevada, New York,
Kentucky, and Puerto Rico.77 The manufacturer restricted direct sales to a limited number of
pharmacies.77 Some of the product was found in community pharmacies.73
Acetaminophen (Panadol) 2000: Capsules from Australia contained strychnine and were withdrawn from the market.
This episode was associated with a $1-million extortion demand.52
Abbreviation used: FDA, Food and Drug Administration.
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Primary wholesalers. Full-line primary wholesalers, which
provide approximately 90% of wholesale distributed drugs,
purchase the majority of their drugs in large quantities directly
from manufacturers with whom they have formal written distri-
bution contracts.83,84 These wholesalers are considered autho-
rized distributors of record (ADRs) and, to address shortages,
may purchase a small percentage of their drugs from secondary
wholesalers.83,85,86
Regional wholesalers. Regional wholesalers distribute a nearly
complete line of drugs and typically do not have written distri-
bution contracts with manufacturers; therefore, most are not
recognized as ADRs.83 Typical clients include community inde-
pendent pharmacies, community chain pharmacy warehouses,
hospitals, nursing homes, clinics, physician offices, surgical and
dialysis centers, and secondary wholesalers.83,86
Secondary wholesalers. Drug distribution may not be the main
focus of secondary wholesalers that have a narrow geographic,
customer, and product focus and, similar to regional wholesal-
ers, typically do not have written distribution contracts with
manufacturers.83 Secondary wholesalers, which typically are
not authorized ADRs, frequently purchase ahead of expected
price increases (arbitrage) and may build inventory with drugs
nearing expiration dates.77,83,85 In addition to purchasing extra
stock from manufacturers and primary wholesalers, secondary
wholesalers buy and sell drugs among themselves or primary
wholesalers, as well as selling to pharmacies.83
In addition to being a source in which counterfeit drugs can
enter the U.S. distribution system,84–86 the smaller secondary
wholesalers may participate in the “gray market” (i.e., distribution
of drugs that are diverted from the intended market).77,84
Closed-door pharmacies. Because counterfeited drugs are
often associated with diversion,85,87 the National Association
of Boards of Pharmacy (NABP) is concerned about the drug
distribution practices of closed-door pharmacies, which may
consist of a desk, fax machine, and a few shelves. Closed-door
pharmacies, whose clients do not include walk-in customers,
are able to purchase large orders of steeply discounted pre-
scription drugs from manufacturers for sale to nursing homes
and other health care institutions. The latter businesses sign
contracts pledging not to resell the drugs on the open market;
however, diverters mark up prices and resell these gray-market
drugs to small wholesalers that may add another markup and
sell to other wholesalers.
Legitimate drugs diverted from intended markets may be
repackaged to hide their origin and provide opportunities for
counterfeiters to produce near-perfect copies that may be sold
as the authentic product or comingled with an authentic prod-
uct.77,87
The Fagan case. The Fagan case, which occurred in 2001,
describes the complex movement of a drug that was counter-
feited (relabeled) after leaving the U.S. manufacturer and even-
tually dispensed from a U.S. pharmacy. Epoetin alfa (Epogen)
vials manufactured to contain 2,000 units/mL were relabeled
as 40,000 units/mL and dispensed to a 16-year-old resident of
Long Island, N.Y. After sale by the manufacturer, the sequen-
tial trail appears to have included two primary wholesalers, a
pharmacy, a “go between,” a counterfeiter who relabeled the
vials, several secondary wholesalers, a regional wholesaler, the
distribution center of a primary wholesaler, and eventually the
community chain pharmacy that dispensed the counterfeit drug.
The journey may have included storage in a beer cooler at a
Miami adult-entertainment club.75 In all, approximately 100,000
vials of epoetin alfa may have been “uplabeled” with a potential
profit in excess of $42 million.75
Restricted distribution. To minimize the possibility of coun-
terfeit drugs entering the drug supply chain, manufacturers,
wholesalers, and community chain pharmacies have restricted
their distribution policies. Several U.S. manufacturers no lon-
ger sell drugs to wholesalers that purchase their products from
external sources,85 and Octapharma, a global manufacturer of
intravenous immunoglobulin, limits its U.S. distribution to five
ADRs.88 At about the same time, Cardinal Health eliminated its
trading unit that purchased discounted and overstocked drugs
from secondary wholesalers,89 and, in 2003, McKesson indicated
that 99.5% of its drug products were purchased directly from
pharmaceutical manufacturers.90 Similarly, AmeriSourceBergen
reported that it purchases less than 0.5% of its medications from
sources other than the manufacturer.91 Also, in December 2005,
FFF Enterprises, an ADR, initiated a policy to purchase plasma
products and injectable biologics only from manufacturers and
ship only to health care providers.88
The large community chain pharmacy CVS announced in
2005 that it will only purchase drugs directly from manufactur-
ers or wholesalers that certify that they do not purchase drugs
from the secondary drug market.92
5�3��ANTICOUNTERFEITING�ACTIONS
Prescription Drug Marketing Act of 1987. The Prescription
Drug Marketing Act of 1987 (PDMA) was enacted because of
concern over wholesale drug diversion submarkets that obscured
routine knowledge of actual sources of prescription drugs distrib-
uted within the United States. PDMA requires state licensure of
prescription drug wholesalers, regulates the distribution of drug
samples, and bans reimportation of prescription human drugs
manufactured in the United States, except when reimported by
the manufacturer. PDMA also stipulated that, before each whole-
sale distribution of a prescription drug, each person who is not the
manufacturer or ADR must provide the purchaser with pedigree
information, which identifies the following93:
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N� Starting with the manufacturer, the business name and
address of all parties to each prior sale, purchase, or trade of
the drug
N� Date(s) of each prior transaction
N� The proprietary and established name, dose form, dosage,
container size, number of containers, and lot or control num-
ber
ADRs have an ongoing relationship with a manufacturer (i.e.,
a written agreement to distribute either specific or all drug prod-
ucts of the manufacturer for a period of time or number of ship-
ments). Authorized wholesalers are exempt from the pedigree
requirement whereas unauthorized distributors are not.
On several occasions FDA stayed implementation of the
PDMA pedigree requirements because of the need to clarify the
definition of authorized wholesaler and determine whether the
pedigree starts with the manufacturer or extends to the most
recent authorized distributor. Additional factors included the dif-
ficulty some wholesalers had in obtaining written distribution
agreements from manufacturers and authorized wholesalers and
possible revision of pedigree requirements.94 In June 2006, FDA
announced that it intended to implement the pedigree require-
ments effective December 1, 2006, and would give high priority
to enforcement of pedigrees involving drugs with a high market
value and high sales volume and/or price, a history of being coun-
terfeited or diverted in the United States, and a history of false
pedigrees.95 However, in response to a suit filed by several sec-
ondary wholesalers against the Department of Health and Human
Services, a federal district court judge issued an injunction that
has thus far stayed implementation of the pedigree requirements.
FDA has appealed the injunction.96
In addition, PDMA permits states to enact pedigree require-
ments beyond those required by federal law; however, many states
have initiated pedigree legislation with divergent requirements.
For example, Florida (H.B. 371) required the use of paper or elec-
tronic pedigree (e-pedigree) by July 1, 2006, and California (S.B.
1476) initially required an e-pedigree for all products by January
1, 200997 (this was later delayed to January 1, 2011). As of June
2007, final rules had been adopted in 5 states (Florida, Indiana,
Nevada, New Jersey, and Oregon), legislation had been proposed
or enacted in 28, legislation was vetoed in 1 state, and no legisla-
tion had been proposed in 16 states.97 Several states have pro-
posed legislation that requires e-pedigrees only for products dis-
tributed outside of the “normal distribution channel,” which was
initially defined as manufacturer to wholesaler to pharmacy but
has evolved in different states to include intracompany transfers,
third-party providers, other individuals authorized to dispense,
and office-based health care practitioners.97 Implementation of a
federal pedigree standard across states has been recommended
by FDA, APhA, NABP, and the Healthcare Distribution Manage-
ment Association (HDMA).95,98–100
Realization of this possibility may be enhanced by the bipar-
tisan-supported Reducing Fraudulent and Imitation Drugs Act
of 2006,101 which would, by December 31, 2010, require the fol-
lowing:
N Packaging of any prescription drug must incorporate radiof-
requency identification (RFID) or functionally similar track-
and-trace technology to enable pedigree authentication by
members of the drug supply chain
N Using blister product packaging (when possible)
N Including tamper-indicating technologies into the packaging
of any prescription drug
The bill recommends, rather than requires, use of visible overt
counterfeit-resistant technologies in drug packaging.
FDA. The FDA Counterfeit Drug Task Force report, issued in Feb-
ruary 2004,1 defined several critical anticounterfeiting actions.
The following had been completed as of May 2005102:
N Enhanced reporting of suspected counterfeit drug cases to
FDA’s MedWatch system
N Enhanced FDA response to reports of suspected counterfeit
drugs
N Developing the Counterfeit Alert Network (CAN), which com-
prises consumers, pharmacists, other health professionals,
and wholesalers. CAN’s activities include disseminating infor-
mation on specific counterfeit medications and on methods to
minimize exposure to and report suspected cases of counter-
feit medications. As of April 2006, the 15 members included
APhA, the American Society of Health-System Pharmacists
(ASHP), the Academy of Managed Pharmacy Care, the Ameri-
can College of Clinical Pharmacy, the National Community
Pharmacists Association (NCPA), the Partnership for Safe
Medicines, and HDMA.103
The following FDA anticounterfeiting actions were ongoing
as of May 2005.102
N Facilitate implementation of RFID as a key component of an
e-pedigree.
N Facilitate implementation of overt (e.g., color-shifting inks,
holograms, watermarks on packaging) and covert (e.g.,
invisible barcodes or fluorescent inks and dyes on packag-
ing, chemical taggants within a drug product) authentication
technologies.
N Enhance secure business practices within the drug supply
chain.
N Increase criminal penalties associated with drug counterfeit-
ing.
N Educate pharmacists and other health professionals regard-
ing their role in identifying counterfeit drugs, minimizing
exposure to counterfeit drugs, and reporting suspected coun-
terfeit drug episodes to FDA and the public about risks of
counterfeit drugs and protection against these risks.
N Work with WHO, Interpol, and other international public
health and law-enforcement agencies to implement global
anticounterfeiting strategies.
In 2006, FDA conducted a Counterfeit Drug Task Force
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Public Workshop/Display to evaluate widespread adoption of
RFID, obtain comments on implementation of PDMA pedigree
requirements, and be informed of technology solutions to imple-
ment electronic track and trace.
Track-and-trace technology. Many stakeholders, including
FDA, support implementing electronic track-and-trace technol-
ogy to replace easily falsified paper pedigrees. FDA considers
RFID the most promising technology to apply a unique identifier
on each drug package (mass serialization) and acknowledges that
two-dimensional (2D) barcodes may serve this function.95
Initially, FDA anticipates applying RFID tags to the pallet,
case, packaging, and individual dose forms of approximately 30
drugs most likely to be counterfeited and, eventually, to most drug
products intended for use in the United States. FDA acknowledges
that hybrid electronic/paper pedigrees will be needed during
the transition period95 and, rather than mandating use of RFID,
intends to focus on removing regulatory hurdles and other activi-
ties to facilitate implementation of RFID.1,95 RFID tags contain
an electronic product code (EPC), which is a unique 96-bit num-
ber that readily accommodates basic elements of an e-pedigree
such as product, item, National Drug Code (NDC) number, date,
transaction, and trading partner information. When scanned by a
reader at each distribution point, the e-pedigree tracks movement
of a product from a manufacturer through a complex distribution
system to a dispensing pharmacy. The e-pedigree system includes
a certification (via electronic signature) by the sender that the
RFID tag information is accurate, followed by an electronic sig-
nature by the recipient that authenticates the accuracy of pedi-
gree information. Use of RFID may identify possible introduction
of a suspected counterfeit or diverted drug (e.g., mismatch or
absence of valid case or unit EPC) or theft (e.g., absence of a unit
EPC within a case). In each instance, RFID records identify the
site of last possession. The e-pedigree system also may facilitate
product returns and transfers of prescription drugs among phar-
macies and product recalls issued by FDA.
Examples of e-pedigree application by manufacturers include
the following:
N Since 2004, Purdue Pharma has incorporated RFID technol-
ogy into unit level packaging of Schedule II drugs.104
N Pfizer included RFID and 2D barcode tags on all cases and
individual item–level packaging of sildenafil (Viagra).105
N In 2006, Cephalon Pharmaceuticals initiated a pilot program
involving shipment of RFID-tagged pallets and cases to mul-
tiple RFID-enabled facilities.106
N Also in 2006, GlaxoSmithKline began shipping RFID-tagged
bottles of abacavir/lamivudine/zidovudine (Trizivir) and
planned to evaluate applying RFID technology to other prod-
ucts.107
Examples among distributors include the following:
N Wal-Mart has required RFID tags on Schedule II drugs dis-
tributed within their network.108
N In 2004, FFF Enterprises initiated a nationwide e-pedigree
system to track distribution of vaccines and human plasma
products.88
N Since 2005, the “Big Three” distributors have initiated pilot
RFID programs to track movement of selected products
through portions of their distribution system.109–111
HDMA. In 2003, HDMA, which represents approximately 46
national, regional, and small wholesalers, modified its bylaws in
an effort to identify legitimate wholesalers and enhance assur-
ance that their sources of prescription drugs present little risk of
distributing counterfeit drugs. HDMA worked closely with NABP
to develop the Model Rules for Licensure of Wholesale Drug Dis-
tributors, which calls for wholesalers to evaluate wholesaler busi-
ness partners for evidence of stability, solid business practices,
and physical site standards. In addition, the HDMA Research and
Education Foundation established a research project with Rutgers
University112 to develop requirements for data management and
sharing in the health care supply chain. Also, in conjunction with
the National Association of Chain Drug Stores (NACDS), HDMA
cosponsored the RFID Healthcare Adoption Summit for several
years. HDMA also worked with NACDS, NCPA,113 and the Phar-
maceutical Research and Manufacturers of America (PhRMA)
on supply chain integrity and counterfeiting issues and, in sup-
port of RFID adoption, provided input to EPCglobal, a company
that develops standards to support use of RFID. Other activities
include, but are not limited to, membership in Jump Start, an
industrywide project to establish the business case for RFID.114
PhRMA. PhRMA is a U.S.-based advocacy organization whose
membership includes more than five dozen domestic and foreign
pharmaceutical/biotechnology companies and their subsidiar-
ies. In May 2003, PhRMA initiated a voluntary program in which
participating pharmaceutical companies and their subsidiaries
agreed to notify FDA’s Office of Criminal Investigations within
5 business days of determining that a likely counterfeited prod-
uct discovered in the United States or another country may be
intended for distribution in the United States.115 PhRMA has spon-
sored BuySafeDrugs.info, which, in addition to informing patients
of risks associated with imported drugs, provides information on
legal ways to save money on prescription drugs.116 In addition to
forming an anticounterfeiting working group, PhRMA issued a
White Paper in 2005 that indicated the following:
N Implementing track-and-trace capability throughout the sup-
ply chain likely will take 5 years or more.
N In the interim, patients will benefit by a barcode or RFID
authentication system that initially includes the manufacturer
and dispensing pharmacy. After successful demonstration of
authentication at the pallet, case, and items levels at the dis-
pensing pharmacy, the system could be expanded to include
other supply chain members.117
PhRMA also called for a summit of pharmaceutical
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companies, FDA, DEA, CBP, and the Public Policy Steering Com-
mittee of EPCglobal, which develops standards to support use
of RFID.
In addition to standards for serialization and data elements
of RFID tags or barcodes, PhRMA recognizes the need for a
central data port and for agreement on operating rules, data
management, and security issues.8
Roles of pharmacy organizations
A partial list of international pharmacy–related organizations
that have taken anticounterfeiting measures includes the Coun-
terfeit Pharmaceuticals Initiative, IFPMA, the Parenteral Drug
Association, the International Federation of Pharmaceutical
Wholesalers, and PSI. In 2003, the International Pharmaceuti-
cal Federation (FIP) established the Working Group on Coun-
terfeit Medicines, which is composed of pharmacists from mem-
ber nations and aims to implement the FIP policy statement on
counterfeit medicines. The FIP policy statement indicates that
pharmacists have responsibility to purchase medicinal products
from only reputable sources; to be alert for differences in pack-
aging, labeling, and physical appearance of medications; and to
report suspicious cases to the manufacturer and their national
regulatory authority.118
NABP. Because of concern over the safety of drugs obtained
from Internet pharmacies, NABP introduced the Verified Inter-
net Pharmacy Practices Sites (VIPPS) program to accredit and
certify online pharmacies that comply with criteria such as
transmission of prescription information, patient data and pri-
vacy rights, authentication of prescription drug orders, adher-
ence to a recognized quality assurance policy, and provision
of meaningful consultation between patients and pharmacists.
Locations of VIPPS Internet pharmacies are available from the
VIPPS site at www.nabp.net. Additionally, in 2003, the Canada
National Association of Pharmacy Regulatory Authorities, in
concert with NABP, launched VIPPS Canada, which identi-
fied accredited Canadian Internet pharmacies for Canadian
patients.119 In 2004, NABP updated its Model Rules for the Licen-
sure of Wholesale Distributors to create the Verified Accredited
Wholesale Distributors (VAWD) program to accredit domestic
and foreign wholesale distributors of prescription drugs and
medical devices.120 VAWD accreditation is based on background
checks, verification of domestic licensure, verification of product
sellers and buyers, evaluation of policies and procedures, and
on-site inspection to evaluate facility security, authentication of
pedigrees, and product quarantine logistics. Also in 2004, NABP
convened a National Drug Advisory Coalition made up of repre-
sentatives of industry and state and national governments. The
coalition developed a national list of 31 high-cost prescription
drug products (“Specified List of Susceptible Products”) that
are particularly prone to counterfeiting, diversion, or adultera-
tion and developed criteria to include or remove drugs from the
list. Members of the group advocate that initial widespread use
of anticounterfeiting technologies such as RFID be restricted
to this list. In 2005, an NABP task force recommended data
elements to be included on e-pedigrees and also recommended
that an e-pedigree contain all transactions from manufacturer
to dispensing pharmacy.120
Product Safety Task Force. The Product Safety Task Force
(PSTF), whose development was facilitated by HDMA, includes
ASHP, NACDS, and NCPA. In addition to recommending formation
of a steering committee consisting of all aspects of pharmacy
practice, manufacturers, and distributors, PSTF recommended
an RFID phase-in plan with unspecified timelines.121 Details of
the plan are presented in Table 5.
ASHP. ASHP approved an anticounterfeiting policy during its
2006 summer meeting. Additionally, the ASHP Web site pro-
vides a list of strategies (www.ashp.org/s_ashp/docs/files/
Anti-counterfeitingStrategies.pdf) that pharmacists can take
to prevent acquiring counterfeit drug products and to report
suspected counterfeit drug episodes. These include, but are not
limited to, evaluating current security practices, developing
training materials to educate pharmacy and product-receiving
staff on screening of product packaging, and providing a course
of action when a suspicious product is found.122,123 ASHP has
identified the following RFID issues123,124:
Table 5. Product Safety Task Force RFID implementation plan
Phase RFID application Responsible parties
I Case and pallet Validated by supply chain
II Item level: some products Most manufacturers and distributors; some use by pharmacies
III Item level: all products Most manufacturers and distributors; substantial use by pharmacies
IV All products Full use; pharmacies authenticate the pedigree
Abbreviation used: RFID, radiofrequency identification.
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N Barcodes, not RFID, should remain the first-priority hospital
drug administration verification technology.
N RFID introduction should not hinder the implementation of
barcode technology by hospital pharmacies.
N FDA should consider the business implications of RFID tech-
nology on hospitals.
N To avoid disposing active RFID tags in dumpsters, RFID tags
must be deactivated from all drug containers after a patient’s
dose is prepared.
N Hospital pharmacists must have timely access to RFID data,
regardless of data ownership.
N FDA should set a target date by which either electronic or
paper pedigree is mandatory.
N A national pedigree requirement policy is needed to resolve
varying requirements of individual states.
ASHP also supports the following considerations:
N Pharmacists should be the focal point for patient contact,
education, and follow-up concerning counterfeit drugs.
N Anticounterfeiting technologies used at the pharmacy must
be reasonable and inexpensive.
N New regulations should not present new barriers to the legiti-
mate return of unused drug products from pharmacies.
N ASHP is willing to inform members of suspected counterfeit
drugs.
N Purchase of high-risk drugs should not be shifted among
wholesalers.
APhA. APhA believes that the anticounterfeiting activities of
pharmacists should include their roles as prudent purchasers
of drugs, patient educators, protectors to ensure the security of
drugs within the pharmacy, and reporters of suspected counter-
feit cases to FDA and manufacturers of the legitimate products
that are being counterfeired.125
APhA supports the following anticounterfeiting consider-
ations98,126,127:
N A cost–benefit analysis should precede implementation of an
e-pedigree system.
N Practicing pharmacists should have the opportunity to evalu-
ate anticounterfeiting technologies that may be used at the
pharmacy level.
N Additional costs to implement anticounterfeiting technologies
must not be a financial or administrative burden.
N Pharmacists must understand the role they play in preventing
counterfeit drugs from reaching patients.
N FDA should inform pharmacies and pharmacists of counter-
feit drug episodes before informing the rest of the health care
system.
N Pharmacists should be authorized to modify prescribed quan-
tities to facilitate tracking of each patient-use package.
N Both overt and covert technologies should be used to differ-
entiate legitimate and counterfeit products.
N Legal liability should focus on counterfeiters and not on phar-
macists whose efforts were defeated by criminals.
N Penalties for producing and distributing counterfeit drugs
should be increased.
N A nationwide e-pedigree that preempts state requirements
should be implemented.
N FDA should be a leader to manage use of anticounterfeiting
technologies and clarify the roles of major stakeholders.
N FDA and private stakeholders should collaborate to standard-
ize and coordinate anticounterfeit communications.
N FDA must have sufficient funding to support an infrastruc-
ture that provides timely and accurate information to phar-
macists.
N APhA should work with FIP to devise international anticoun-
terfeiting activities.
N The APhA Web site (www.pharmacist.com) may be used to
inform pharmacists of counterfeit drugs and facilitate report-
ing of suspected counterfeits to FDA’s MedWatch system.
NACDS. The NACDS Leadership Council hired an external con-
sultant to identify multiple methods that could be adopted to
address the counterfeit drug problem. NACDS also participated
in the Jump Start multicompany project, which evaluated RFID
functionality in the pharmaceutical supply chain.128 Recommen-
dations of an NACDS task force include the following128:
N Enforce existing importation laws.
N Identify high-risk products.
N Enhance wholesaler licensing requirements.
N Codify trading partner agreements.
N Define and use best practices to purchase drugs.
N Use a layered packaging to enhance evidence of tampering.
N Enhance public education awareness programs.
N Establish a standardized counterfeit alert communication
system.
Partnership for Safe Medicines. The Partnership for Safe Medi-
cines (www.safemedicines.org) is a coalition of approximately
50 domestic patient, physician, pharmacist, university, industry,
and other professional organizations. Its SAFE DRUG checklist
helps consumers identify and protect against counterfeits,129 and
the SafeMeds Alert System, which is part of FDA’s CAN, informs
enrollees of counterfeit alerts announced by FDA and other health
agencies.130 An abridged form of relevant weekly news is also avail-
able electronically. The temptation to obtain drugs from nontradi-
tional sources may be reduced by the Partnership’s SafeSavings
Consumer Guide, which informs patients of various methods to
save on medications within the normal U.S. distribution system.
Additional initiatives of the Partnership are described below in
the “Proactive actions” section.
United States Pharmacopeia. Based on ongoing review of
published information, the United States Pharmacopeia (USP)
issues a quarterly matrix of drug quality problems, including
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counterfeits, reported in more than 30 countries. USP also
developed Ensuring the Quality of Medicines in Resource-Limited
Countries: An operational guide.131 Additionally, in April 2006,
USP hosted a seminar titled Anti-Counterfeiting: Domestic and
International Measures and cosponsored, with FDA, the 2007
Detecting Counterfeit Drugs Workshop.
Roles of pharmacists
Prudent purchasers of drugs. The following good business prac-
tices are intended to reduce the chance of purchasing counterfeit
drugs:
N Limit or eliminate purchases from secondary wholesalers
unless they are ADRs that purchase directly from the manu-
facturer, are in good standing with their State Board of Phar-
macy, and comply with the HDMA voluntary guidelines for
pharmaceutical system integrity.
N Do not shift purchase of high-risk drugs among wholesalers.
N Determine how “your” wholesalers protect their drug sup-
ply.
N Be aware of drug security practices of pharmacies from which
you purchase drugs.
N Reevaluate pharmacy department security measures.
N Establish written procedures and train employees to inspect
drug packages and cartons for evidence of tampered covert
and overt tamper-resistant features.
N Contact the manufacturer to determine if the packaging of a
suspect product is legitimate.
N Be aware of NABP’s list of susceptible products that are prone
to counterfeiting, diversion, or adulteration.
N Routinely access the Web sites of FDA (www.fda.gov) or pro-
fessional organizations that provide alert messages to mem-
bers.
Additional measures are described in the Partnership for Safe
Medicine’s Simple Steps for SAFE Sourcing program (www.safe-
medicines.org/north_america/pharmacy/resources.php).
Educate consumers. Patient education requires timely access to
accurate information of threats or documented cases and actions
recommended by FDA and manufacturers. Information should
be provided in a nonalarming manner that can be understood
by consumers with limited English skills. A pharmacist should
also be prepared to discuss information consumers are likely
to receive from the communication media. Patients should be
encouraged to:
N Be familiar with size, shape, color, taste, and odor of medica-
tions (at the time of dispensing, explain to patients any physi-
cal change initiated by manufacturers).
N Promptly report suspect counterfeit drug products to a phar-
macist and/or health care provider.
N Provide a sample of the suspect counterfeit drug for inspec-
tion within the pharmacy and forwarding to FDA and/or the
manufacturer.
N Report new adverse effects to a pharmacist and prescribing
health professional.
Obstacles to identifying suspect counterfeit drugs. Phar-
macists and pharmacy technicians are well positioned to identify
suspect counterfeit drugs; however, the ability to detect minor
abnormal physical features of a drug product and its labels,
packaging, and/or prescribing information is compromised by
the large number of products dispensed on a daily basis and the
technical expertise of counterfeiters. PhRMA acknowledges that
a wide variety of overt and covert packaging and labeling features,
such as color-shifting inks, holograms, microprinting, and chemi-
cal taggants imbedded in individual dose forms, make counter-
feiting more difficult; however, assuming that pharmacists will
consistently be aware of specific features used on thousands of
different drug products, especially when these features are peri-
odically revised to thwart counterfeiters, is not realistic.117 The
labeling of counterfeit drug products may contain incorrect lot
numbers; however, in the absence of easily accessible databases,
such discrepancies are difficult to detect, especially if different
lots of a product are intermingled in the pharmacy before dis-
pensing. Detection may also be compromised by rogue repacking
operations that mix counterfeit and authentic products before
shipping.
Proactive actions. The Partnership for Safe Medicine SAFE
Sourcing program provides guidelines for pharmacists to avoid,
detect, and report unsafe drug products, packaging, and labeling,
as well as suspected counterfeit vendors, and identifies Internet
resources providing additional information.
The Royal Pharmaceutical Society of Great Britain, in col-
laboration with the Medicines and Healthcare Regulatory Prod-
ucts Agency—the United Kingdom’s equivalent of the U.S. FDA—
issued guidelines for pharmacists to detect counterfeit drugs.132
These guidelines are similar to those of the Partnership for Safe
Medicines and, when combined, include the following:
N Develop a list of key drugs that will not be purchased from
sources other than the manufacturer or authorized distribution
channel.
N Be suspicious of products with an unusually low price.
N Be suspicious of vendors that do not provide a listed physical
address or landline telephone number, accept cash-only payment,
or offer a product list that is constantly modified.
N Look for evidence of a removed or switched product label. A
tacky residue on the container may result if lighter fluid or another
organic solvent is used to remove the original label. The label
may be discolored along the edges because of contact with the
solvent.
N Look for subtle changes in packaging such as paper texture,
size and thickness of labels, paper gloss, fonts, font size, misspell-
ing, print color or raised print, breaks, tears, or unusual location
of the sealing tape or seals.
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N Look for differences in the length, thickness, diameter,
shape, and color of containers and in the thickness, texture, color,
and markings of tablets and capsules.
N Look for an altered expiration date.
N Compare any color-shifting inks and holograms with previ-
ously purchased product.
N Weigh the product if wide variations are apparent.
In addition to these observational methods, FIP has urged
national governments to implement analytical methods and train-
ing programs that enable pharmacists to analyze suspect drug
products.118 Possible devices include a portable near-infrared
scanner, which was developed for use by mail-service pharma-
cies and by customs and border control agents. Near-infrared
scanners compare the spectra of a suspect drug within a dispens-
ing vial with approximately 700 reference samples.133 In addi-
tion, researchers at the University of London School of Pharmacy
anticipate that small affordable near-infrared scanners, with
sensitivity sufficient to distinguish between the same drug manu-
factured in different plants in Europe, may be placed in pharma-
cies and other settings to expand testing for counterfeit drugs.134
Other devices include an inexpensive hand-held refractometer
that determines the specific gravity and quantity of active ingredi-
ent contained in drug products dissolved in alcohol.134
In 2006, the portable GPHF Mini-Lab (the development of
which was facilitated by donations from 19 pharmaceutical com-
panies) was introduced. This system includes visual inspection,
tablet and capsule disintegration, color reactions, and thin-layer
chromatography procedures for 41 drugs commonly used in
developing countries.135
Report suspected or confirmed counterfeits. FDA’s CAN
outlines the roles of pharmacists, other health care providers,
and consumers in identifying and reporting suspected counter-
feit drugs via FDA’s MedWatch or Counterfeit Drugs Web pages.
Initial reports will likely lack sufficient information to adequately
evaluate a case; thus, pharmacists may, in consultation with FDA
and the manufacturer, assist in identifying, obtaining, and for-
warding relevant follow-up information.
After receiving information verified by FDA or the manufac-
turer, promptly identifying and informing patients who likely
receive the counterfeit product is essential. Surprisingly, this
intuitive action is not supported by an audit of 23 pharma-
cies in the United Kingdom to determine their response after
receiving a patient-level alert for two counterfeit drug prod-
ucts. All checked their stock, only two searched medication
records, and a minority of surveyed pharmacists did not think
it was their responsibility to contact patients.136
Don’t make it easy. Intact items may be used by counterfeiters
to reconstruct genuine-looking packaging and labeling; thus, dis-
carding packaging, vials, labels, and prescribing information in
a manner that prevents retrieval of intact items from waste con-
tainers is important. In addition, deactivating RFID tags attached
to drug containers intended for trash disposal will reduce the
opportunity for criminals to obtain empty containers with active
RFID tags for redistribution of counterfeit products.
4RACK AND TRACE�CHALLENGES�TO�PHARMACY
A pharmacist’s active participation in an RFID or barcode-based
track-and-trace system is accompanied by several logistic and
financial issues:
N How much in start-up expenses will be required? Although the
costs have yet to be defined, estimates indicate that, based on
2005 dollars, approximately $20,000 will be needed to equip
a pharmacy with RFID capability.137 Who pays for what parts
of the RFID system? Will this expense be offset by savings
associated with improved inventory management, improved
recall efficiency, and reduced paperwork burdens?
N What will be the effect on pharmacy workflow, including pos-
sible decreased efficiency during and after initial implementa-
tion?
N How much data will be included on an RFID or barcode tag?
Who will define the required data and when?
N Will a pharmacy need to communicate with separate e-ped-
igree databases maintained by various manufacturers and
wholesale distributors?
N What is the potential negative impact if a pharmacy’s track-
and-trace data are stored in one central database or in a
distributive system wherein the data are shared with other
systems?
N Should the NDC be included in the unique EPC? Will its
absence require a pharmacist to interact with a different
database to link the EPC to the NDC number?
N Who owns and maintains the aggregate massive amount of
pedigree data? Which members of the supply chain may be
subject to litigation if patient harm is alleged to be caused by
an undetected counterfeit drug?
N Should patients be told that a dispensed drug product pack-
age contains an RFID tag?
N What is the role of pharmacists to educate consumers about
use of RFID-tagged drug products?
N What mechanism(s) will prevent unauthorized disclosure of
confidential information if an RFID-tagged drug product is
dispensed to a patient?
N Should the RFID tag be deactivated at the point of dispens-
ing?
N What are the privacy concerns if the NDC contained on an
RFID tag is accessed inappropriately?
#ONCLUSION
The production and distribution of counterfeit drugs is a complex,
unquantified problem of international proportions. The existing
situation has been facilitated by skilled practitioners, inconsis-
tent regulatory oversight, and lack of coordinated anticounter-
70 PHARMACY TODAY�s�JUNE 2008 www.pharmacytoday.org
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feiting initiatives by various national and multinational regulatory
agencies and professional organizations. In the United States,
several pharmacy-related organizations have made important
contributions to decreasing the distribution of counterfeit drugs.
Individual pharmacists will have important roles in the evolving
anticounterfeiting practices within the United States; however,
these opportunities will be accompanied by altered business
practices, as well as likely added expense. Pharmacists must take
an active role in evaluating and implementing both revised and
new responsibilities that further protect patient safety without
affecting pharmacy practice adversely.
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88. Gressit K-B. Why we are for strict pedigree rules, and against second-ary distribution. Accessed at www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=676, September 30, 2007.
89. Saul S. Large drug wholesaler to close its secondary trading opera-tion. Accessed at www.nytimes.com/2005/05/06/business/06health.html?ex1273032000&en=c89f2fe, May 23, 2005.
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92. CVS Caremark. CVS takes additional steps to ensure the con-tinued integrity of the pharmaceutical supply chain. Accessed at http://investor.cvs.com/phoenix.zhtml?c=99533&p=irol-newsArticle&ID=713267, April 4, 2007.
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95. U.S. Food and Drug Administration. FDA Counterfeit Drug Task Force Report: 2006 update. Accessed at www.fda.gov/oc/initiatives/coun-terfeit/report6_06.html.
96. Pharmaceutical Commerce. FDA will appeal pedigree injunction. Accessed at www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=431, October 15, 2007.
97. Gallenagh EA. The pedigree puzzle. Paper presented at HDMA 2007 Distribution Management Conference and Technology EXPO, Boston, June 10–13, 2007.
98. Winckler SC. Statement of the American Pharmacists Association (APhA) submitted to the House Committee on Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resourc-es hearing on “Pharmaceutical Supply Chain Security.” Accessed at www.aphanet.org/am/templateredirect.cfm?template=/cm/content-display.cfm&contentid=6894, June 8, 2007.
99. Bolin JM. State and federal efforts to curb counterfeit drugs. Paper presented at Council of State Governments 2006 Annual State Trends and Leadership Forum, Phoenix, Ariz., December 2, 2006.
100. The Pink Sheet. National licensing standard for wholesale distribu-tors gains momentum. Rockville, Md.: FDC Reports; November 21, 2005.
101. Bill H.R. 4829: Reducing Fraudulent and Imitation Drugs Act of 2006. 109th Congress, 1st session. Washington, D.C.; February 22, 2006.
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72 PHARMACY TODAY�s�JUNE 2008 www.pharmacytoday.org
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103. U.S. Food and Drug Administration. Counterfeit Alert Network. Accessed at www.fda.gov/oc/initiatives/counterfeit/network.html, October 16, 2007.
104. Unisys. SupplyScape and Unisys pilot pharmaceutical industry’s first electronic pedigree system for commercial drugs. Accessed at www.unisys.com/about__unisys/news_a_events/05318546.htm, Novem-ber 28, 2007.
105. RFID Update. Pfizer shipping RFID-tagged Viagra. Accessed at www.rfidupdate.com/articles/index.php?id=1027, October 16, 2007.
106. O’Connor M.C. Cephalon to tag cancer drug at point of manufacture. Accessed at www.rfidjournal.com/article/articleview/3185, October 17, 2007.
107. Bacheldor B. GlaxoSmithKline remains committed to RFID. Accessed at www.rfidjournal.com/article/view/3584, October 16, 2007.
108. Thompson CA. Radio frequency tags for identifying legitimate drug products discussed by tech industry. Am. J Health Syst Pharm. 2004;61:1430–2.
109. AmerisourceBergen. AmerisourceBergen announces innova-tive track and trace program in pharmaceutical supply channel. Accessed at www.amerisourcebergen.com/investor/phoenix.zhtml?c=61181&p=irol-newsArticle, May 8, 2007.
110. O’Connor MC. McKesson starts RFID pilot for Viagra. Accessed at www.rfidjournal.com/article/articleview/2157/1/1, May 17, 2007.
111. HealthLeaders Media. Cardinal Health announces plans to deploy RFID technology in California. Accessed at www.healthleadersmedia.com/technology/viewcontent/89547.html, May 17, 2007.
112. Gray JM. Paper presented at FDA Counterfeit Drug Task Force Public Workshop/Vendor Display, Bethesda, Md., February 8–9, 2006.
113. The Pink Sheet. HDMA Foundation gets new mission: supply chain research, education. Rockville, Md.: FDC Reports; October 17, 2005.
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CE Credit:
To obtain 2.0 contact hours of continuing education credit (0.2 CEUs) for “Roles for pharmacy in combatting counterfeit
drugs,” complete the assessment exercise, fill out the CE examination form at the end of this article, and return to APhA.
You can also go to www.pharmacist.com and take your test online for instant credit. CE processing is free for APhA mem-
bers and $15 for nonmembers. A Statement of Credit will be awarded for a passing grade of 70% or better. Pharmacists who
complete this exercise successfully before June 1, 2011, can receive credit.
The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a
provider of continuing pharmacy education. The ACPE Universal Program Number assigned to the program by the
accredited provider is 202-000-08-146-H03-P.
“Roles for pharmacy in combatting counterfeit drugs” is a home-study continuing education program for pharmacists devel-
oped by the American Pharmacists Association.
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!SSESSMENT�1UESTIONS
Instructions: You may take the assessment test for this program on paper or online. For each question, circle the letter on the
answer sheet corresponding to the answer you select as being the correct one. There is only one correct answer to each ques-
tion. Please review all your answers to be sure that you have circled the proper letters. To take the CE test for this article
online, go to www.pharmacist.com, and click Education. Once you are on the Education welcome page, search for this article
with the search function, using “CE” and a keyword. Follow the online instructions to take and submit the assessment test. This
CE will be available online at www.pharmacist.com after June 31, 2008. You can also find it on www.pharmacytoday.org.
1. Counterfeit drug activity in the United States typically
involves which of the following types of drugs?
a. Antimalarials
b. Expensive or recreational drugs
c. Antihypertensive agents
d. Vitamins
2. By what mechanism does a European exporting coun-
try inform an importing country that the drug product
to be imported was manufactured in accordance with
good manufacturing practice (GMP) requirements?
a. World Health Organization (WHO) Rapid Alert System
b. WHO Counterfeit Drug Database
c. WHO Certification Scheme
d. European Medicines Evaluation Agency notice
3. What is the approximate estimated cost (in U.S. cur-
rency) for a U.S. Customs and Border Protection agent
to examine a suspect imported drug package?
a. $25
b. $75
c. $150
d. $270
4. By which year did the Food and Drug Administration
(FDA) facilitate reporting of suspected counterfeit
drug episodes to its MedWatch system?
a. 1987
b. 2003
c. 2005
d. 2007
5. If swallowed, the Chinese counterfeit toothpaste dis-
covered in 2007 may be a health hazard to which of the
following populations?
a. Healthy adult men
b. Individuals with liver disease
c. Individuals with epilepsy
d. Teenagers
6. Which type of pharmaceutical business typically has
a formal written distribution agreement with a drug
manufacturer?
a. Primary wholesaler
b. Secondary wholesaler
c. Regional wholesaler
d. Closed-door pharmacy
7. Which of the following can legally reimport an FDA-
approved prescription drug into the United States?
a. The U.S. manufacturer that exported the drug
b. A primary authorized distributor of record (ADR) whole-
saler
c. A community chain pharmacy
d. A secondary wholesaler
8. The Prescription Drug Marketing Act of 1987 (PDMA)
requires that a drug pedigree contain which of the fol-
lowing data elements?
a. Date(s) of each prior sale
b. Manufacturer name
c. Number of containers
d. All of the above alternatives are correct.
9. Which of the following describes a requirement of
PDMA?
a. An ADR wholesaler must provide pedigree information
to a purchasing pharmacy.
b. A non-ADR wholesaler must provide pedigree informa-
tion to a purchasing pharmacy.
c. A wholesaler with an ongoing relationship with a manu-
facturer must inform the manufacturer of all sales of
their drugs.
d. Pedigree requirements of all states must be identical.
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10. Which of the following describes a characteristic of the
Reducing Fraudulent and Imitation Drugs Act of 2006?
a. Permits only use of radiofrequency identification (RFID)
technology to satisfy the pedigree requirements of
PDMA
b. Requires use of tamper-evident technologies in the
packaging of all prescription drug products
c. Requires use of covert technology in the packaging of all
prescription drug products
d. Prevents the use of blister product packaging of any pre-
scription drug product
11. Which of the following states enacted final rules for
pedigree requirements by June 2007?
a. Indiana
b. Pennsylvania
c. Montana
d. Colorado
12. FDA has completed which one of the following of its
anticounterfeiting actions?
a. Increased criminal penalties associated with drug coun-
terfeiting.
b. Developed the Counterfeit Alert Network.
c. Required the implementation of RFID as a key compo-
nent of an electronic pedigree.
d. Required the implementation of both overt and covert
technologies.
13. A patient asks you to indicate what actions he or she
can take to reduce the risk of taking a counterfeit
drug. What is your response?
a. Prior to ingestion, determine if a drug has a different
color or smell than prior doses.
b. Promptly inform a pharmacist of any drug suspected to
be a counterfeit.
c. Provide a sample of the suspect drug to a pharmacist.
d. All of the above alternatives are correct.
14. Which of the following is a recommendation of the
Product Safety Task Force?
a. Implement an RFID e-pedigree system by January 1,
2009.
b. Initiate RFID e-pedigree requirements for all products at
the same time.
c. Omit manufacturers and pharmacies from the RFID
pedigree requirement.
d. Require pharmacists to eventually authenticate the pedi-
gree of all drug products.
15. Which of the following is not a recommendation of the
American Pharmacists Association?
a. Legal liability should focus on counterfeiters and not on
pharmacists.
b. Implementation of anticounterfeiting technologies
should not be a financial burden.
c. All pharmacies should implement RFID pedigrees by
January 1, 2009.
d. FDA should clarify the anticounterfeiting roles of major
stakeholders.
16. Which of the following is not a good business practice
to reduce the distribution of counterfeit drugs?
a. Purchase high-risk drugs from many wholesalers.
b. Establish written procedures for employees to inspect
drug packages.
c. Be aware of the National Association of Boards of Phar-
macy list of susceptible drug products.
d. Be aware of security practices of pharmacies from
which you purchase drugs.
17. Approximately what percentage of WHO members have
well-developed regulations to reduce the risk of dis-
tributing counterfeit drugs?
a. 75%
b. 50%
c. 20%
d. 10%
18. Which of the following will facilitate detection of coun-
terfeit drugs by a pharmacist?
a. Be suspicious of products with an unusually low price
b. Look for subtle changes in the packaging of a drug
product
c. Look for altered color-shifting inks and halograms
d. All of the above alternatives are correct.
19. Which of the following is not a recommendation of the
National Association of Chain Drug Stores?
a. Define best practices to purchase drugs.
b. Enhance public awareness programs.
c. Enforce existing importation laws.
d. Barcodes must be used as part of an e-pedigree.
20. Which of the following is not part of GMP require-
ments?
a. Source of active ingredients
b. Product formulation and appearance
c. Manufacturing controls
d. Distribution to primary wholesalers