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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-


review


review

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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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.

102. U.S. Food and Drug Administration. Combating counterfeit drugs: a report of the Food and Drug Administration annual update. Accessed at www.fda.gov/oc/initiatives/counterfeit/update2005.html.


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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.

114. U.S. Food and Drug Administration. HDMA commitment to patient safety through supply chain integrity: a strong record of support & ef-forts for healthcare system security. Accessed at www.72.14.253.104/search?q=cache:i9oirMjF6EQJ:www.fda.gov/ohrms/dockets/dock-ets, October 17, 2007.

115. U.S. Food and Drug Administration. FDA commends drug industry commitment to report counterfeit drugs. Accessed at www.fda.gov./bbs/topics/NEWS/2003/NEw00894.html, October 17, 2007.

116. BuySafeDrugs.info. About BuySafeDrugs.info. Accessed at www.buysafedrugs.info/About/default.aspx, October 3, 1007.

117. Pharmaceutical Research and Manufacturers of America. Elec-tronic authentication of pharmaceutical packaging and the assur-ance of public safety: position of the Pharmaceutical Research and Manufacturers of America. Accessed at http://72.14.253.104/search?q=cache:MbzjfX5tWZ8J:www.phama.org/files/2005-05-13.11, September 25, 2007.

118. International Pharmaceutical Federation. FIP statement of policy on counterfeit medicines. The Hague, Netherlands: International Phar-maceutical Federation; 2003.

119. National Association of Boards of Pharmacy and National Associa-tion of Pharmacy regulatory authorities to launch VIPPS program in Canada. Accessed at http://findarticles.com/p/articles/mi_m3374/is_3_25.ai_98488760, May 22, 2007.

120. Catizone CA. Counterfeit drugs and state’s efforts to combat the problem. Testimony before the Subcommittee on Criminal Justice,

Drug Policy and Human Resources Committee on Government Re-

form, Washington, D.C., July 11, 2006.

121. Product Safety Task Force. White Paper: the healthcare industry’s

business requirements for electronic track and trace. July 13, 2004.

122. American Society of Health-System Pharmacists. ASHP strategies to

protect against drug counterfeiting. Accessed at www.ashp.org/s_

ashp/docs/files/Anti-counterfeitingStrategies.pdf, May 22, 2007.

123. Scheckelhoff DJ. Paper presented at FDA Counterfeit Drug Task Force

Public Workshop/Vendor Display, Bethesda, Md., February 8–9, 2006.

124. Scheckelhoff DJ. Paper presented at Anti-Counterfeiting Drug

Initiative–public meeting, October 15, 2003, Bethesda, Md. Accessed

at www.fda.gov/oc/initiatives/counterfeit/oct2003meeting/panel3.

html, May 26, 2004.

125. Winkler SC. Counterfeit medications: the pharmacist’s role in pro-

tecting the integrity of the medication supply. J Am Pharm Assoc.

2003;43:666–7.

126. Gans JA. Letter to Food and Drug Administration: docket no.

2003N-0361. Accessed at www.pharmacist.com/AM/Template.cfm?

Section=Search1&section=Regulatory&template=/CM/ContentDis-

play.cfm&ContentFileID=325, April 17, 2008.

127. Gans JA. Paper presented at Anti-Counterfeiting Drug Initiative–

public meeting, October 15, 2003, Bethesda, Md. Accessed at www.

fda.gov/oc/initiatives/counterfeit/oct2003meeting/panel3.html, May

26, 2004.

128. Perlowski S. Paper presented at FDA Counterfeit Drug Task Force

Public Workshop/Vendor Display, Bethesda, Md., February 8–9, 2006.

129. BuySafeDrugs.info. An 8-step checklist for medicine safety. Accessed

at www.buysafedrugs.info/Reports/checklist.htm, October 3, 2007.

130. Partnership for Safe Medicines. Partnership For Safe Medicines joins

FDA Counterfeit Alert Network. Accessed at www.safemedicines.

org/resources/001978.php, September 20, 2007.

131. U.S. Pharmacopeia. U.S. Pharmacopeia Drug Quality and Information

Program. Accessed at www.uspdqi.org/issues/index.html, Septem-

ber 6, 2006.

132. Royal Pharmaceutical Society of Great Britain. Counterfeit medicines:

guidance for pharmacists. Accessed at www.rpsgb.org.uk/pdfs/

counterfeitmedsguid.pdf, April 13, 2007.

133. Analytical Spectral Devices, Inc. Industrial applications: detection of

counterfeit pharmaceuticals. Accessed at www.asdi.com/applica-

tions-counterfeit.asp, October 2, 2007.

134. Spies AR, Van Dusen V. Counterfeit drugs: a menace keeps

growing. Accessed at www.uspharmacist.com/index.

asp?show=article&page=8_1014.htm, May 18, 2007.

135. Larkin M. Hand-held device detects fake drugs. Lancet Infect Dis.

2002;2:5.

136. Hussain M, Alldred J, Reeves J. Counterfeit drugs: sharing findings.

Accessed at www.pjonline.com/Editorial/20040918/comment/lett01.

html, August 4, 2005.

137. Johnsen M. Industry weighs practical solutions to fulfill promise

of RFID technology. Accessed at http://findarticles.com/p/articles/

mi_m3374/is_17_27?pnum=3&opg=n16031069, April 14, 2006.

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.


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


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

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