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OLES FOR PHARMACY IN COMBATTING COUNTERFEIT DRUGS

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                        2OLES FOR PHARMACY IN COMBATTING
                        COUNTERFEIT DRUGS
                        2ONALD * :IANCE




                                                                                                       Ronald J. Ziance, PhD, is Professor of Pharma-
!BSTRACT                                                                                               ceutical Sciences, College of Pharmacy, Univer-
                                                                                                       sity of Southern Nevada, Henderson.

     Objectives: To describe (1) the international scope of counterfeit drugs, (2) interna-            Continuing education credits: See learning
                                                                                                       objectives below and assessment questions at
tional and U.S. anticounterfeiting initiatives, and (3) the enhanced roles and challenges              the end of this article, which is ACPE universal
                                                                                                       program number 202-000-08-146-H03-P in
facing pharmaceutical organizations and individual pharmacists to thwart counterfeit                   APhA’s educational programs. The CE examina-
drugs.                                                                                                 tion form is located at the end of this article.
                                                                                                       To take the CE test for this article online, go to
     Data sources: PubMed and Ovid from 1970 to 2008 using the search terms coun-                      www.pharmacist.com/education and follow the
                                                                                                       links to the APhA CE center.
terfeit drugs, counterfeit pharmaceuticals, and counterfeit medicines, with English
as the limiting term. Nonprimary literature sources included the U.S. Food and Drug                    Correspondence: Ronald J. Ziance, PhD,
                                                                                                       11 Sunset Way, Henderson, NV 89014. Fax:
Administration (FDA) Web site (www.fda.gov) from 1990 to 2008 using the search term                    702-990-4435. E-mail: rziance@usn.edu
counterfeit drugs, presentations from meetings or workshops attended or accessed via                   Disclosure: The author declares no conflicts
the Internet, and Web sites of professional organizations. Additional resources were                   of interest or financial interests in any product
                                                                                                       or service mentioned in this article, including
identified from personal bibliographies collected by the author and bibliographies of                   grants, employment, gifts, stock holdings, or
                                                                                                       honoraria.
gathered articles.
     Data synthesis: Counterfeit drugs—defined as those containing no active ingredi-                   Published concurrently in Pharmacy Today and
                                                                                                       the Journal of the American Pharmacists Asso-
ent, an incorrect amount of active ingredients, incorrect ingredient, and/or unapproved                ciation (available online at www.japha.org).
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,


   Learning objectives
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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
                                                                     T    he production and distribution of counterfeit drugs is a
                                                                          global problem that involves both developed and developing
                                                                     countries. In addition to bulk chemicals, confiscated counterfeit
important challenges involving increased expense and altered         drugs have included products labeled as brand-name and generic
business practices.                                                  prescription and nonprescription medications. Counterfeit prod-
    Keywords: Counterfeiting (drug), drug importation, phar-         ucts, which may contain no active ingredient, incorrect amount
maceutical supply chain, pedigree, radiofrequency identification,     of ingredients, incorrect ingredients, and/or unapproved labeling
Prescription Drug Marketing Act.                                     and packaging, have produced serious adverse consequences in
                     Pharmacy Today. 2008(Jun);14(6):55–75.          exposed populations.
                                                                          On a global basis, the types of counterfeit drugs vary by
    “Pharmacists and health professionals can play a major role      region of distribution. The World Health Organization (WHO)
in helping identify counterfeits and preventing their introduction   has indicated that hormones and steroids are common targets
into the distribution chain.”1                                       in developed countries. Counterfeit antibiotics, antimalarial
                                        Mark B. McClellan, MD, PhD   agents, antitubercular drugs, antiretroviral agents, vitamins,
                                         Former FDA Commissioner     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-
   At a Glance                                                       dors because their government health authorities may not have
       Synopsis: The presence of counterfeit drugs in                suitable amounts of essential drugs in stock.3,4 Drugs used to
   international drug-distribution channels is a complex,            treat dyslipidemias and hypertension are common targets in
   unquantified problem in which skilled operators take               developed European countries,5 while counterfeit drug activity
   advantage of inconsistent regulatory oversight and lack           in the United States typically involves high-volume expensive or
   of coordinated anticounterfeiting initiatives by national         recreational drug products.6
   and multinational regulatory agencies and professional                 By using punches, dies, plates, and other hardware readily
   organizations. To enhance pharmacist knowledge about              available from the Internet, in addition to sophisticated desktop
   this problem, this article describes global counterfeit           publishing and offset photography, counterfeit operations rang-
   drug activity; anticounterfeiting initiatives taken by            ing from a few people operating out of garages to well-organized
   various government agencies as well as foreign and U.S.           international criminal operations are able to manufacture and
   pharmacy-related organizations; potential enhanced                distribute counterfeit drugs, packaging, and labeling that are
   roles for pharmacists; and issues that may accompany              very difficult for pharmacists, other health care providers, and
   these enhanced roles. The U.S. Food and Drug Admin-               patients to differentiate from legitimate products. Detecting
   istration and several pharmacy-related organizations              counterfeit products is also hindered by operational complexi-
   have made important contributions to decreasing coun-             ties wherein raw materials may originate in one country but
   terfeit drug distribution, but some initiatives will not be       final dosage forms, containers, and labels are prepared in other
   realized in the short term.                                       countries.7 Although many countries participate in counterfeit-
       Analysis: Pharmacists have important roles (e.g.,             ing, leaders in the manufacture and distribution of counterfeit
   educating patients, making prudent purchases, detect-             drugs include China, India, Russia, Brazil, Pakistan, Mexico,
   ing counterfeit drugs) in evolving anticounterfeiting             as well as the Southeast Asian and Middle Eastern countries.7
   practices within the United States; however, detection of         Available information indicates that the number of counterfeit
   counterfeit drugs may be accompanied by altered busi-             drug cases in Russia has increased 10 times since 1998 and
   ness practices and added expense. The profession must             represents up to 12% of its total drug market.8,9 Increasing
   therefore work to prevent counterfeit drugs from reach-           evidence from the international front also suggests that the sale
   ing patients without negatively affecting pharmacy prac-          of counterfeit goods, including drugs, is being used to finance
   tices. Radiofrequency identification or barcode-based              terrorists.10,11
   track-and-trace systems allow products to be monitored
   throughout the complex pharmaceutical supply chain.               Objectives
   However, these attractive advancements are accompa-               The purpose of this article is to enhance pharmacist knowl-
   nied by financial (e.g., covering of start-up expenses),           edge about (1) the international scope of counterfeit drugs, (2)
   logistic (e.g. possible decreased efficiency during and            international and U.S. anticounterfeiting initiatives, and (3) the
   after initial implementation), and patient data and pri-          enhanced roles and challenges facing pharmaceutical organiza-
   vacy issues.                                                      tions and individual pharmacists.



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56 PHARMACY TODAY s JUNE 2008                                                                                   www.pharmacytoday.org
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)NTERNATIONAL SITUATION                                              mised if decisions to report are based on disparate country-
                                                                     specific definitions.14 For example, the Philippine government
2EGULATORY CONTROL                                                   defines a counterfeit drug as containing less than 80% of the
According to WHO, approximately 20% of more than 191 mem-            labeled amount of active ingredient.12 Thus, a drug product with
ber countries have well-developed regulations to control the         an unspecified reduced amount of active ingredient may be classi-
manufacture, importation, distribution, and sale of medications,     fied as counterfeit in some countries but not in the Philippines. In
50% have varying levels, and 30% have very limited or no regu-       addition, the World Trade Organization definition of “counterfeit
latory authority.4,12,13 Regulatory control is further compromised   trademark goods” differs from international definitions of coun-
by national legislation not extending beyond national borders.14     terfeit drug.14
Additionally, criminals involved in production and distribution           Underreporting of counterfeit drugs is demonstrated by the
of counterfeit drugs do not limit their activity to one country      paucity of reports received by WHO: 84 between 1999 and 2002
and, when blocked by effective local efforts, promptly shift         and none from 2002 to 2004.10 However, the Counterfeit Inci-
their activity to different locations.14 Counterfeit drugs often     dent System database maintained by the Pharmaceutical Secu-
move through brokers or trading houses, free ports, or trade         rity Institute (PSI), whose membership includes 21 international
zones where drug control is lax and repackaging and relabel-         pharmaceutical companies located mainly in Europe and the
ing (which may mask details of origin) occur under conditions        United States, lists 264 counterfeit drug incidents that occurred
that do not comply with good manufacturing practice (GMP)            in 63 countries in 200321 and 557 episodes detected in 2004.22
requirements.4,13 The cost of lax regulatory oversight extends       The current inconsistent reporting combined with the lack of com-
beyond just loss of drug revenue and includes reduced foreign        mon definitions and integrated databases makes it impossible to
investment in legitimate pharmaceutical operations.8                 evaluate the results of anticounterfeiting measures taken by WHO
                                                                     or individual countries.
%STIMATED PREVALENCE
WHO estimates that counterfeit drugs account for approximately       %XAMPLES OF COUNTERFEIT DRUG EPISODES
10% of international drug trade,3 while other estimates indicate     The wide scope of counterfeit drug traffic outside the United
a national level ranging from 1% to 80%.15 However, these esti-      States is exemplified by the listings in Table 1. Moreover, coun-
mates are inherently inaccurate because of data inconsistencies      terfeiting extends beyond drugs for humans, as evidenced by the
that arise from several factors, including the following:            death of one horse and serious reactions in two additional horses
N Lack of accepted international definitions that differentiate       in Canada that were attributed to a counterfeit parenteral iron–
    between “counterfeit,” “illicit,” “fake,” and “substandard”12    sucrose veterinary product obtained from a feed store.30
N Underreporting of suspected cases to government authori-
    ties                                                             )NTERNATIONAL RESPONSES TO COUNTERFEIT DRUG PROBLEM
N Lack of validated integrated databases                             Countries have responded in various ways to identified counter-
    In 1995 and 1996, for example, 85 children in Haiti died from    feit drug threats. For example, India initiated an inspection of
renal failure caused by a locally produced acetaminophen syrup       drugs to be exported to Nigeria31 following a Nigerian threat to
prepared with glycerin contaminated with 24% diethylene glycol       ban the importation of all drugs from 30 Asian countries. Addi-
(DEG).16 WHO has referred to this formulation as either a fake or    tionally, an Indian expert committee called for fines and increased
contaminated product.17,18                                           prison terms for individuals involved in counterfeit drug trade and
    The WHO Database on Counterfeit Pharmaceuticals was              recommended the death penalty for those involved in the manu-
launched in 1982 and, by 2002, contained information submit-         facture and sale of counterfeit medications resulting in grievous
ted by only 5% to 15% of its member states.4,9 By April 1997,        harm.32 Likewise, the Philippines enacted a law that increased
the database contained 771 reports (average rate ~5 reports/         penalties from 6 months to life imprisonment plus a $25,000
month since launch).19 Approximately 70% of the reports origi-       fine.33 Argentina and Columbia also increased penalties for those
nated from developing countries,20 most were not validated,20 and    involved in drug counterfeiting.34
many did not distinguish between counterfeit and substandard
drugs (the latter defined by WHO as genuine medications pro-          7(/ ANTICOUNTERFEITING ACTIONS
duced by legitimate manufacturers that do not meet the quality       Although WHO’s attention to counterfeit drugs was evident dur-
specifications established for the product).4 From January 1999       ing a 1958 Conference of Experts on the Rational Use of Drugs,
to October 2000, 46 reports were submitted to WHO from 20            progress has been intermittent. The wide scope of WHO actions
members (average rate ~2 reports/month): 33% indicated lack of       are reflected in this partial list:
active ingredient, 20% presence of incorrect ingredient(s), and      N Initiating the Database on Counterfeit Pharmaceuticals
15% fake packaging.12                                                N Introducing a Web-based Rapid Alert System by the Western
    The accuracy of any counterfeit drug database is compro-             Region to communicate information of confirmed counterfeit


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   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



  drug episodes to national health authorities                       N Expressing the need for national wholesalers and retailers
N Studying counterfeit drug distribution in two member states             to establish licensing requirements and maintain an audit
N Adopting the World Health Assembly request to initiate pro-             trail of purchased drugs back to the original manufacturer or
  grams to detect and prevent distribution of counterfeit or sub-         wholesaler
  standard drugs                                                     N Interacting with Interpol, the U.S. Food and Drug Administra-
N Collaborating with the European Medicines Evaluation                    tion (FDA), and other international regulatory authorities
  Agency to strengthen inspection of drugs                           N Providing posters, videotape, and fact sheets to raise aware-
N Issuing guidelines for development of measures to combat                ness
  counterfeit drugs                                                  N Proposing the creation of IMPACT (International Medi-
N Publishing a draft concept report for an international frame-           cal Products Anti-Counterfeiting Taskforce), which would
  work convention to combat counterfeit drugs                             include governmental, nongovernmental, and other interna-
N Creating a multicountry working group of 10 WHO member                  tional stakeholders
  countries to improve national regulations                          N Addressing disparities of technology and reviewed existing
N Creating a network of anticounterfeiting liaison officers                national laws and regulations and methods to transmit infor-
N Presenting drug regulatory training workshops in all WHO                mation within WHO member states
  regions                                                            N Implementing the WHO certification scheme, which provides
N Organizing several international workshops, meetings, and               a mechanism for an exporting country to inform an import-
  joint projects                                                          ing country that specific products approved for domestic sale
N Providing assistance to countries to develop systems to regu-           were manufactured in accordance with GMP
  late herbal remedies                                                    Despite these efforts, distribution of counterfeit drugs actu-
N Participating in working groups of WHO, the International          ally may have been facilitated in May 2004 when nine additional
  Federation of Pharmaceutical Manufacturers and Associa-            countries were admitted to the European Union. The resultant
  tions (IFPMA), and other international pharmaceutical orga-        expanded free movement of goods across borders may increase
  nizations                                                          opportunities for drug diversion. For example, the Czech Repub-
N Sponsoring a conference titled “Combating Counterfeit Drugs:       lic has attracted counterfeit drug trade because of its central
  Building Effective International Collaboration”                    location, closure of most customs ports, and short sentences for


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58 PHARMACY TODAY s JUNE 2008                                                                                   www.pharmacytoday.org
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drug-related crimes.35 Other reasons include the Czech Republic’s    has flourished. Detection is compromised by the ability of coun-
proximity to Russia and the increased involvement of organized       terfeiters to provide high-quality bogus certificates of analysis, as
Russian-speaking drug-dealing groups within its borders.36           well as export and import licenses and customs declarations that
                                                                     accompany drug shipments through ports of entry. An apprecia-
0AN !MERICAN (EALTH /RGANIZATION                                     tion of the financial impact of counterfeit drug traffic from foreign
The Working Group on the Prevention of and Fight against Drug        sources is provided by circumstances in which, during a single
Counterfeiting (WG/FDC) of the Pan American Health Organiza-         week in 2002, FDA agents seized counterfeit drugs valued at $2
tion was convened in 2001. Its initial goals include expanding the   million in Florida, $1.7 million in Texas, and $1 million in Illi-
definition of counterfeit drug to include the concept of fraudu-      nois.39 As of 2004, drugs could enter the United States through
lent drug, dissemination of information provided by WHO, and         312 airports, seaports, and land borders, as well as 29 courier/
enhanced reporting of information to the WHO database. In 2005,      express consignment ports and 14 international mail facilities.40
the WG/FDC proposed that a pharmacist coordinate the monitor-        Approximately 10 million packages containing prescription drugs
ing and quality control of available drugs in a country and that     are estimated to enter the United States annually40; however, in
a group of pharmacist inspectors be responsible for inspecting       2004, FDA had only 450 field members and 276 laboratory ana-
suspect counterfeit drugs.37                                         lysts involved in investigative import activities.40 This staff works
                                                                     closely with U.S. Customs and Border Protection (CBP) agents,
5NITED 3TATES SITUATION                                             who seized 43,659 drug-containing parcels received by interna-
                                                                     tional mail and express consignment facilities in 2004.40 The esti-
2EGULATORY CONTROL                                                   mated cost to examine each package at the Seattle District Office
The new drug application (NDA) process to obtain FDA approval        is an estimated $267.9040; thus, a considerable financial expen-
to market a new drug product is contingent upon meeting GMP          diture is required to adequately inspect the predicted annual vol-
requirements, which include source and specifications of active       ume of drug packages received from foreign sources.
ingredients, product formulation and appearance, processing               The extent of illegal importation is suggested by results of
methods, manufacturing controls, and container and closure           joint inspections conducted by the U.S. CBP and FDA in 2003.
systems. Before and after approval of an NDA, domestic and for-      Sampling of international mail received by eight major mail facil-
eign manufacturers listed in the NDA are subject to inspection       ities and two courier hubs within the United States revealed that
by FDA for compliance to GMP requirements. The NDA process           more than 80% of 1,153 imported drug products (selected by
also supports the safe and effective use of approved drug prod-      the violation history of the exporting country) contained drugs
ucts by regulating the content and format of the professional and    that were not approved by FDA.41,42 Some of the seized drugs may
patient prescribing information and accurate labeling of the drug    have been approved in the country of origin; however, country-
container and carton.                                                specific requirements for approval may not meet those of FDA.38
    Bills currently being considered in the U.S. Congress, the       In addition to controlled narcotics, violations included shipment
Food and Drug Administration Globalization Act of 2008 and the       of improperly labeled (e.g., foreign language, absence of label)
Safeguarding America’s Pharmaceuticals Act of 2008 address           and improperly packaged (e.g., wrapped in tissue paper, loose
the problem of drug counterfeiting. Progress of such legislation     in plastic bags) drug products. Other areas of concern include
can be followed in the Government Affairs center of www.phar-        drugs with dangerous drug–drug interactions, several requiring
macist.com, the official Web site of the American Pharmacists         patient monitoring (e.g., liver function, pregnancy) before and
Association (APhA), and in future articles in Pharmacy Today         during therapy, those requiring a controlled storage environ-
(www.pharmacytoday.org).                                             ment, and drugs such as warfarin whose potency may be altered
                                                                     by minor variations in the manufacturing process.41,42 The U.S.
)LLEGAL IMPORTATION OF DRUGS                                         Immigration and Customs Enforcement (ICE), an enforcement
In the absence of foreign site inspection, FDA believes that there   arm of the Department of Homeland Security, is a member of the
is no assurance that drug safety, efficacy, purity, potency, han-     Interagency Pharmaceuticals Task Force and conducts inves-
dling, labeling, manufacturing, and storage would be identical to    tigations with FDA, the Internal Revenue Service, the Postal
products made at inspected sites. Thus, FDA considers illegal the    Inspection Service, and the Federal Bureau of Investigation.
importation of any drug that is unapproved, labeled incorrectly,     The U.S. CBP, Drug Enforcement Administration (DEA), Depart-
or dispensed without a valid prescription. In addition, although     ment of Justice, Office of National Drug Control Policy, and U.S.
a foreign manufacturer has FDA approval for a drug, the version      Postal Service are also members of the Interagency Pharma-
produced for foreign markets may not meet all requirements for       ceuticals Task Force. From 2003 to 2006, ICE initiated 178
FDA approval and may be misbranded if certain information is         criminal investigations of drug smuggling that resulted in 86
lacking or not in English.38                                         arrests and 34 convictions associated with counterfeit, adulter-
    Despite regulatory oversight, importation of counterfeit drugs   ated, misbranded, and unapproved drugs.43


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The Internet
Obtaining prescription drugs from Canada and other countries              Table 2. Counterfeit drug cases opened by FDA,
via the Internet is an appealing option for U.S. citizens. Boards of      by year
pharmacy in several states have inspected and licensed several
Canadian pharmacies that provide pharmacist–patient consulta-             Year                           No. cases opened
tion and have approved specific Internet sites from which state
residents may order FDA-approved prescription drugs.44                    2000                                     6
     By contrast, U.S. citizens may submit a legal prescription to        2001                                    21
a storefront pharmacy that arranges for signature of a Canadian           2002                                    27
physician who never saw or examined the patient and processes             2003                                    30
the order to an Internet pharmacy that may provide no pharma-             2004                                    58
cist consultation with the patient. The results of FDA’s “Opera-          2005                                    32
tion Bait and Switch” inspection of drugs ordered from Internet           2006                                    54
sites claiming to be of Canadian origin indicated that 85% of the         2007                                    31
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-            Another perspective of U.S. activity has been provided by PSI,
net sites, FDA has issued a consumer safety guide and several          which indicated that, in 2005, based on reported cases of coun-
warnings to educate consumers of the risks associated with the         terfeit drugs seized or discovered, the United States ranked sixth
purchase of prescription drugs via the Internet.46 Distribution of     below Russia, China, South Korea, Peru, and Colombia.22
counterfeit drugs via the Internet is an international concern, as         The opportunity to uncover additional cases by “data min-
evidenced by the recommendation that the Committee of Minis-           ing” is hampered by a lack of coding for injuries associated
ters of the Council of Europe issued to its 47 member countries.       with suspected counterfeit drug products by injury databases
Implementation of the recommendations would ensure that mail           such as those operated by the Centers for Disease Control and
order shipment of prescription medications occurs only from            Prevention, WHO (International Classification of Diseases),
pharmacies that are open to the public and are under the super-        the Consumer Product Safety Commission, the U.S. National
vision of a pharmacist, that the pharmacist is responsible for the     Center for Injury Prevention and Control, the National Elec-
proper delivery of any mail-order shipment, and that the quality       tronic Injury Surveillance System, the National Center for
assurance delivery system ensures the possibility of tracking          Health Statistics, the U.S. Poison Control Centers, and, until
and tracing deliveries.47                                              recently, FDA.50

Estimated prevalence                                                   Examples of counterfeit drug episodes
Similar to global estimates, the prevalence of counterfeit drug        As described in the examples cited in Tables 3 and 4, episodes
activity in the United States is unknown; however, the number          of counterfeit drug products in the United States have involved
of suspected cases opened annually by FDA’s Office of Criminal          products that contained no active ingredient, an incorrect
Investigation, as indicated in Table 2, has served as an index of      amount of active ingredient, or incorrect ingredients. Counter-
this activity.48                                                       feit drug containers and labels were also discovered in many
     These data, which quantify FDA’s awareness of cases, may          episodes. Many of the physical anomalies would be very difficult
not directly correlate with actual trends of counterfeit drug activ-   for pharmacists, other health care professionals, and patients
ity. The increase since 2000 may be partly a result of increased       to detect consistently.
awareness within the drug distribution network and subsequent               In addition to prescription drugs, counterfeiters have
reporting to manufacturers and/or FDA, as well as enhanced             recently targeted toothpaste typically sold at low-cost “bar-
coordination of information within federal and state govern-           gain” retail outlets. After being informed in May 2007 that con-
ments.49 The decline of cases investigated in 2005 may be due          taminated dental products were found in Panama and several
to the discovery that some were related to the large number of         other countries, FDA discovered 41 toothpaste products from
existing cases. FDA’s limited awareness of cases is also explained     10 Chinese manufacturers that contained up to 3% to 4% DEG,
by the fact that, before 2004, it was not generally acknowledged       which is used in antifreeze and as a solvent.79 One month later, a
that suspected counterfeit drug episodes could be reported to          popular U.S.-brand toothpaste that was possibly manufactured
FDA’s MedWatch system. By 2005, the MedWatch reporting form            in South Africa contained DEG and was reportedly distributed
(3500A) and associated instructions were revised in an effort to       from several “dollar”-type discount stores in four states.80 The
enhance reporting of suspect counterfeit drugs, as well as poor-       product carton contained the misspelled words “isclinically,”
quality labeling or packaging of drug products.                        “SOUTH AFRLCA,” and “South African Dental Assoxiation.”81


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   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        2004: Counterfeit transdermal patches obtained from India and three other Internet
   Evra)                             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



FDA has expressed concern that accidental swallowing may           $RUG DISTRIBUTION IN THE 5NITED 3TATES
pose a health risk to children and individuals with kidney or      Revision of distribution practices is essential to the integrity of
liver disease.79                                                   drug delivery within the United States.82 Direct point-to-point
    Contributing factors include illegal importation of drugs      distribution from manufacturers reduces the risk of counterfeit
that have not been approved by FDA into the United States          drugs reaching pharmacies; however, in the United States, most
through a plethora of entry points, inconsistent detection         drugs travel through a complex discount-driven system that
resulting from an inadequate number of inspectors, and poorly      includes 3 large full-line primary wholesalers (AmerisourceBer-
tracked distribution of FDA-approved drugs through multiple        gen, Cardinal Health, and McKesson), approximately 16 regional
layers of a complex matrix of diverse domestic distributors.       wholesalers, more than 6,000 smaller secondary wholesalers,
                                                                   and a small number of specialty wholesalers.83,84


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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          2002: Counterfeit Combivir labels were placed on authentic bottles of Ziagen tablets. In
   (Combivir) and abacavir          addition, authentic white tablets contained in Combivir-labeled bottles were replaced with
   (Ziagen)                         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              The Fagan case. The Fagan case, which occurred in 2001,
provide approximately 90% of wholesale distributed drugs,              describes the complex movement of a drug that was counter-
purchase the majority of their drugs in large quantities directly      feited (relabeled) after leaving the U.S. manufacturer and even-
from manufacturers with whom they have formal written distri-          tually dispensed from a U.S. pharmacy. Epoetin alfa (Epogen)
bution contracts.83,84 These wholesalers are considered autho-         vials manufactured to contain 2,000 units/mL were relabeled
rized distributors of record (ADRs) and, to address shortages,         as 40,000 units/mL and dispensed to a 16-year-old resident of
may purchase a small percentage of their drugs from secondary          Long Island, N.Y. After sale by the manufacturer, the sequen-
wholesalers.83,85,86                                                   tial trail appears to have included two primary wholesalers, a
                                                                       pharmacy, a “go between,” a counterfeiter who relabeled the
Regional wholesalers. Regional wholesalers distribute a nearly         vials, several secondary wholesalers, a regional wholesaler, the
complete line of drugs and typically do not have written distri-       distribution center of a primary wholesaler, and eventually the
bution contracts with manufacturers; therefore, most are not           community chain pharmacy that dispensed the counterfeit drug.
recognized as ADRs.83 Typical clients include community inde-          The journey may have included storage in a beer cooler at a
pendent pharmacies, community chain pharmacy warehouses,               Miami adult-entertainment club.75 In all, approximately 100,000
hospitals, nursing homes, clinics, physician offices, surgical and      vials of epoetin alfa may have been “uplabeled” with a potential
dialysis centers, and secondary wholesalers.83,86                      profit in excess of $42 million.75

Secondary wholesalers. Drug distribution may not be the main           Restricted distribution. To minimize the possibility of coun-
focus of secondary wholesalers that have a narrow geographic,          terfeit drugs entering the drug supply chain, manufacturers,
customer, and product focus and, similar to regional wholesal-         wholesalers, and community chain pharmacies have restricted
ers, typically do not have written distribution contracts with         their distribution policies. Several U.S. manufacturers no lon-
manufacturers.83 Secondary wholesalers, which typically are            ger sell drugs to wholesalers that purchase their products from
not authorized ADRs, frequently purchase ahead of expected             external sources,85 and Octapharma, a global manufacturer of
price increases (arbitrage) and may build inventory with drugs         intravenous immunoglobulin, limits its U.S. distribution to five
nearing expiration dates.77,83,85 In addition to purchasing extra      ADRs.88 At about the same time, Cardinal Health eliminated its
stock from manufacturers and primary wholesalers, secondary            trading unit that purchased discounted and overstocked drugs
wholesalers buy and sell drugs among themselves or primary             from secondary wholesalers,89 and, in 2003, McKesson indicated
wholesalers, as well as selling to pharmacies.83                       that 99.5% of its drug products were purchased directly from
    In addition to being a source in which counterfeit drugs can       pharmaceutical manufacturers.90 Similarly, AmeriSourceBergen
enter the U.S. distribution system,84–86 the smaller secondary         reported that it purchases less than 0.5% of its medications from
wholesalers may participate in the “gray market” (i.e., distribution   sources other than the manufacturer.91 Also, in December 2005,
of drugs that are diverted from the intended market).77,84             FFF Enterprises, an ADR, initiated a policy to purchase plasma
                                                                       products and injectable biologics only from manufacturers and
Closed-door pharmacies. Because counterfeited drugs are                ship only to health care providers.88
often associated with diversion,85,87 the National Association             The large community chain pharmacy CVS announced in
of Boards of Pharmacy (NABP) is concerned about the drug               2005 that it will only purchase drugs directly from manufactur-
distribution practices of closed-door pharmacies, which may            ers or wholesalers that certify that they do not purchase drugs
consist of a desk, fax machine, and a few shelves. Closed-door         from the secondary drug market.92
pharmacies, whose clients do not include walk-in customers,
are able to purchase large orders of steeply discounted pre-           53 ANTICOUNTERFEITING ACTIONS
scription drugs from manufacturers for sale to nursing homes           Prescription Drug Marketing Act of 1987. The Prescription
and other health care institutions. The latter businesses sign         Drug Marketing Act of 1987 (PDMA) was enacted because of
contracts pledging not to resell the drugs on the open market;         concern over wholesale drug diversion submarkets that obscured
however, diverters mark up prices and resell these gray-market         routine knowledge of actual sources of prescription drugs distrib-
drugs to small wholesalers that may add another markup and             uted within the United States. PDMA requires state licensure of
sell to other wholesalers.                                             prescription drug wholesalers, regulates the distribution of drug
     Legitimate drugs diverted from intended markets may be            samples, and bans reimportation of prescription human drugs
repackaged to hide their origin and provide opportunities for          manufactured in the United States, except when reimported by
counterfeiters to produce near-perfect copies that may be sold         the manufacturer. PDMA also stipulated that, before each whole-
as the authentic product or comingled with an authentic prod-          sale distribution of a prescription drug, each person who is not the
uct.77,87                                                              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                 of 2006,101 which would, by December 31, 2010, require the fol-
     address of all parties to each prior sale, purchase, or trade of   lowing:
     the drug                                                           N Packaging of any prescription drug must incorporate radiof-
N Date(s) of each prior transaction                                         requency identification (RFID) or functionally similar track-
N The proprietary and established name, dose form, dosage,                  and-trace technology to enable pedigree authentication by
     container size, number of containers, and lot or control num-          members of the drug supply chain
     ber                                                                N Using blister product packaging (when possible)
     ADRs have an ongoing relationship with a manufacturer (i.e.,       N Including tamper-indicating technologies into the packaging
a written agreement to distribute either specific or all drug prod-          of any prescription drug
ucts of the manufacturer for a period of time or number of ship-            The bill recommends, rather than requires, use of visible overt
ments). Authorized wholesalers are exempt from the pedigree             counterfeit-resistant technologies in drug packaging.
requirement whereas unauthorized distributors are not.
     On several occasions FDA stayed implementation of the              FDA. The FDA Counterfeit Drug Task Force report, issued in Feb-
PDMA pedigree requirements because of the need to clarify the           ruary 2004,1 defined several critical anticounterfeiting actions.
definition of authorized wholesaler and determine whether the            The following had been completed as of May 2005102:
pedigree starts with the manufacturer or extends to the most            N Enhanced reporting of suspected counterfeit drug cases to
recent authorized distributor. Additional factors included the dif-         FDA’s MedWatch system
ficulty some wholesalers had in obtaining written distribution           N Enhanced FDA response to reports of suspected counterfeit
agreements from manufacturers and authorized wholesalers and                drugs
possible revision of pedigree requirements.94 In June 2006, FDA         N Developing the Counterfeit Alert Network (CAN), which com-
announced that it intended to implement the pedigree require-               prises consumers, pharmacists, other health professionals,
ments effective December 1, 2006, and would give high priority              and wholesalers. CAN’s activities include disseminating infor-
to enforcement of pedigrees involving drugs with a high market              mation on specific counterfeit medications and on methods to
value and high sales volume and/or price, a history of being coun-          minimize exposure to and report suspected cases of counter-
terfeited or diverted in the United States, and a history of false          feit medications. As of April 2006, the 15 members included
pedigrees.95 However, in response to a suit filed by several sec-            APhA, the American Society of Health-System Pharmacists
ondary wholesalers against the Department of Health and Human               (ASHP), the Academy of Managed Pharmacy Care, the Ameri-
Services, a federal district court judge issued an injunction that          can College of Clinical Pharmacy, the National Community
has thus far stayed implementation of the pedigree requirements.            Pharmacists Association (NCPA), the Partnership for Safe
FDA has appealed the injunction.96                                          Medicines, and HDMA.103
     In addition, PDMA permits states to enact pedigree require-            The following FDA anticounterfeiting actions were ongoing
ments beyond those required by federal law; however, many states        as of May 2005.102
have initiated pedigree legislation with divergent requirements.        N Facilitate implementation of RFID as a key component of an
For example, Florida (H.B. 371) required the use of paper or elec-          e-pedigree.
tronic pedigree (e-pedigree) by July 1, 2006, and California (S.B.      N Facilitate implementation of overt (e.g., color-shifting inks,
1476) initially required an e-pedigree for all products by January          holograms, watermarks on packaging) and covert (e.g.,
1, 200997 (this was later delayed to January 1, 2011). As of June           invisible barcodes or fluorescent inks and dyes on packag-
2007, final rules had been adopted in 5 states (Florida, Indiana,            ing, chemical taggants within a drug product) authentication
Nevada, New Jersey, and Oregon), legislation had been proposed              technologies.
or enacted in 28, legislation was vetoed in 1 state, and no legisla-    N Enhance secure business practices within the drug supply
tion had been proposed in 16 states.97 Several states have pro-             chain.
posed legislation that requires e-pedigrees only for products dis-      N Increase criminal penalties associated with drug counterfeit-
tributed outside of the “normal distribution channel,” which was            ing.
initially defined as manufacturer to wholesaler to pharmacy but          N Educate pharmacists and other health professionals regard-
has evolved in different states to include intracompany transfers,          ing their role in identifying counterfeit drugs, minimizing
third-party providers, other individuals authorized to dispense,            exposure to counterfeit drugs, and reporting suspected coun-
and office-based health care practitioners.97 Implementation of a            terfeit drug episodes to FDA and the public about risks of
federal pedigree standard across states has been recommended                counterfeit drugs and protection against these risks.
by FDA, APhA, NABP, and the Healthcare Distribution Manage-             N Work with WHO, Interpol, and other international public
ment Association (HDMA).95,98–100                                           health and law-enforcement agencies to implement global
     Realization of this possibility may be enhanced by the bipar-          anticounterfeiting strategies.
tisan-supported Reducing Fraudulent and Imitation Drugs Act                 In 2006, FDA conducted a Counterfeit Drug Task Force


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Public Workshop/Display to evaluate widespread adoption of             N In 2004, FFF Enterprises initiated a nationwide e-pedigree
RFID, obtain comments on implementation of PDMA pedigree                 system to track distribution of vaccines and human plasma
requirements, and be informed of technology solutions to imple-          products.88
ment electronic track and trace.                                       N Since 2005, the “Big Three” distributors have initiated pilot
                                                                         RFID programs to track movement of selected products
Track-and-trace technology. Many stakeholders, including                 through portions of their distribution system.109–111
FDA, support implementing electronic track-and-trace technol-
ogy to replace easily falsified paper pedigrees. FDA considers          HDMA. In 2003, HDMA, which represents approximately 46
RFID the most promising technology to apply a unique identifier         national, regional, and small wholesalers, modified its bylaws in
on each drug package (mass serialization) and acknowledges that        an effort to identify legitimate wholesalers and enhance assur-
two-dimensional (2D) barcodes may serve this function.95               ance that their sources of prescription drugs present little risk of
     Initially, FDA anticipates applying RFID tags to the pallet,      distributing counterfeit drugs. HDMA worked closely with NABP
case, packaging, and individual dose forms of approximately 30         to develop the Model Rules for Licensure of Wholesale Drug Dis-
drugs most likely to be counterfeited and, eventually, to most drug    tributors, which calls for wholesalers to evaluate wholesaler busi-
products intended for use in the United States. FDA acknowledges       ness partners for evidence of stability, solid business practices,
that hybrid electronic/paper pedigrees will be needed during           and physical site standards. In addition, the HDMA Research and
the transition period95 and, rather than mandating use of RFID,        Education Foundation established a research project with Rutgers
intends to focus on removing regulatory hurdles and other activi-      University112 to develop requirements for data management and
ties to facilitate implementation of RFID.1,95 RFID tags contain       sharing in the health care supply chain. Also, in conjunction with
an electronic product code (EPC), which is a unique 96-bit num-        the National Association of Chain Drug Stores (NACDS), HDMA
ber that readily accommodates basic elements of an e-pedigree          cosponsored the RFID Healthcare Adoption Summit for several
such as product, item, National Drug Code (NDC) number, date,          years. HDMA also worked with NACDS, NCPA,113 and the Phar-
transaction, and trading partner information. When scanned by a        maceutical Research and Manufacturers of America (PhRMA)
reader at each distribution point, the e-pedigree tracks movement      on supply chain integrity and counterfeiting issues and, in sup-
of a product from a manufacturer through a complex distribution        port of RFID adoption, provided input to EPCglobal, a company
system to a dispensing pharmacy. The e-pedigree system includes        that develops standards to support use of RFID. Other activities
a certification (via electronic signature) by the sender that the       include, but are not limited to, membership in Jump Start, an
RFID tag information is accurate, followed by an electronic sig-       industrywide project to establish the business case for RFID.114
nature by the recipient that authenticates the accuracy of pedi-
gree information. Use of RFID may identify possible introduction       PhRMA. PhRMA is a U.S.-based advocacy organization whose
of a suspected counterfeit or diverted drug (e.g., mismatch or         membership includes more than five dozen domestic and foreign
absence of valid case or unit EPC) or theft (e.g., absence of a unit   pharmaceutical/biotechnology companies and their subsidiar-
EPC within a case). In each instance, RFID records identify the        ies. In May 2003, PhRMA initiated a voluntary program in which
site of last possession. The e-pedigree system also may facilitate     participating pharmaceutical companies and their subsidiaries
product returns and transfers of prescription drugs among phar-        agreed to notify FDA’s Office of Criminal Investigations within
macies and product recalls issued by FDA.                              5 business days of determining that a likely counterfeited prod-
     Examples of e-pedigree application by manufacturers include       uct discovered in the United States or another country may be
the following:                                                         intended for distribution in the United States.115 PhRMA has spon-
N Since 2004, Purdue Pharma has incorporated RFID technol-             sored BuySafeDrugs.info, which, in addition to informing patients
     ogy into unit level packaging of Schedule II drugs.104            of risks associated with imported drugs, provides information on
N Pfizer included RFID and 2D barcode tags on all cases and             legal ways to save money on prescription drugs.116 In addition to
     individual item–level packaging of sildenafil (Viagra).105         forming an anticounterfeiting working group, PhRMA issued a
N In 2006, Cephalon Pharmaceuticals initiated a pilot program          White Paper in 2005 that indicated the following:
     involving shipment of RFID-tagged pallets and cases to mul-       N Implementing track-and-trace capability throughout the sup-
     tiple RFID-enabled facilities.106                                      ply chain likely will take 5 years or more.
N Also in 2006, GlaxoSmithKline began shipping RFID-tagged             N In the interim, patients will benefit by a barcode or RFID
     bottles of abacavir/lamivudine/zidovudine (Trizivir) and               authentication system that initially includes the manufacturer
     planned to evaluate applying RFID technology to other prod-            and dispensing pharmacy. After successful demonstration of
     ucts.107                                                               authentication at the pallet, case, and items levels at the dis-
Examples among distributors include the following:                          pensing pharmacy, the system could be expanded to include
N Wal-Mart has required RFID tags on Schedule II drugs dis-                 other supply chain members.117
     tributed within their network.108                                      PhRMA also called for a summit of pharmaceutical


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   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.




companies, FDA, DEA, CBP, and the Public Policy Steering Com-           Wholesale Distributors (VAWD) program to accredit domestic
mittee of EPCglobal, which develops standards to support use            and foreign wholesale distributors of prescription drugs and
of RFID.                                                                medical devices.120 VAWD accreditation is based on background
    In addition to standards for serialization and data elements        checks, verification of domestic licensure, verification of product
of RFID tags or barcodes, PhRMA recognizes the need for a               sellers and buyers, evaluation of policies and procedures, and
central data port and for agreement on operating rules, data            on-site inspection to evaluate facility security, authentication of
management, and security issues.8                                       pedigrees, and product quarantine logistics. Also in 2004, NABP
                                                                        convened a National Drug Advisory Coalition made up of repre-
Roles of pharmacy organizations                                         sentatives of industry and state and national governments. The
A partial list of international pharmacy–related organizations          coalition developed a national list of 31 high-cost prescription
that have taken anticounterfeiting measures includes the Coun-          drug products (“Specified List of Susceptible Products”) that
terfeit Pharmaceuticals Initiative, IFPMA, the Parenteral Drug          are particularly prone to counterfeiting, diversion, or adultera-
Association, the International Federation of Pharmaceutical             tion and developed criteria to include or remove drugs from the
Wholesalers, and PSI. In 2003, the International Pharmaceuti-           list. Members of the group advocate that initial widespread use
cal Federation (FIP) established the Working Group on Coun-             of anticounterfeiting technologies such as RFID be restricted
terfeit Medicines, which is composed of pharmacists from mem-           to this list. In 2005, an NABP task force recommended data
ber nations and aims to implement the FIP policy statement on           elements to be included on e-pedigrees and also recommended
counterfeit medicines. The FIP policy statement indicates that          that an e-pedigree contain all transactions from manufacturer
pharmacists have responsibility to purchase medicinal products          to dispensing pharmacy.120
from only reputable sources; to be alert for differences in pack-
aging, labeling, and physical appearance of medications; and to         Product Safety Task Force. The Product Safety Task Force
report suspicious cases to the manufacturer and their national          (PSTF), whose development was facilitated by HDMA, includes
regulatory authority.118                                                ASHP, NACDS, and NCPA. In addition to recommending formation
                                                                        of a steering committee consisting of all aspects of pharmacy
NABP. Because of concern over the safety of drugs obtained              practice, manufacturers, and distributors, PSTF recommended
from Internet pharmacies, NABP introduced the Verified Inter-            an RFID phase-in plan with unspecified timelines.121 Details of
net Pharmacy Practices Sites (VIPPS) program to accredit and            the plan are presented in Table 5.
certify online pharmacies that comply with criteria such as
transmission of prescription information, patient data and pri-         ASHP. ASHP approved an anticounterfeiting policy during its
vacy rights, authentication of prescription drug orders, adher-         2006 summer meeting. Additionally, the ASHP Web site pro-
ence to a recognized quality assurance policy, and provision            vides a list of strategies (www.ashp.org/s_ashp/docs/files/
of meaningful consultation between patients and pharmacists.            Anti-counterfeitingStrategies.pdf) that pharmacists can take
Locations of VIPPS Internet pharmacies are available from the           to prevent acquiring counterfeit drug products and to report
VIPPS site at www.nabp.net. Additionally, in 2003, the Canada           suspected counterfeit drug episodes. These include, but are not
National Association of Pharmacy Regulatory Authorities, in             limited to, evaluating current security practices, developing
concert with NABP, launched VIPPS Canada, which identi-                 training materials to educate pharmacy and product-receiving
fied accredited Canadian Internet pharmacies for Canadian                staff on screening of product packaging, and providing a course
patients.119 In 2004, NABP updated its Model Rules for the Licen-       of action when a suspicious product is found.122,123 ASHP has
sure of Wholesale Distributors to create the Verified Accredited         identified the following RFID issues123,124:


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N Barcodes, not RFID, should remain the first-priority hospital           macists whose efforts were defeated by criminals.
  drug administration verification technology.                          N Penalties for producing and distributing counterfeit drugs
N RFID introduction should not hinder the implementation of              should be increased.
  barcode technology by hospital pharmacies.                           N A nationwide e-pedigree that preempts state requirements
N FDA should consider the business implications of RFID tech-            should be implemented.
  nology on hospitals.                                                 N FDA should be a leader to manage use of anticounterfeiting
N To avoid disposing active RFID tags in dumpsters, RFID tags            technologies and clarify the roles of major stakeholders.
  must be deactivated from all drug containers after a patient’s       N FDA and private stakeholders should collaborate to standard-
  dose is prepared.                                                      ize and coordinate anticounterfeit communications.
N Hospital pharmacists must have timely access to RFID data,           N FDA must have sufficient funding to support an infrastruc-
  regardless of data ownership.                                          ture that provides timely and accurate information to phar-
N FDA should set a target date by which either electronic or             macists.
  paper pedigree is mandatory.                                         N APhA should work with FIP to devise international anticoun-
N A national pedigree requirement policy is needed to resolve            terfeiting activities.
  varying requirements of individual states.                           N The APhA Web site (www.pharmacist.com) may be used to
  ASHP also supports the following considerations:                       inform pharmacists of counterfeit drugs and facilitate report-
N Pharmacists should be the focal point for patient contact,             ing of suspected counterfeits to FDA’s MedWatch system.
  education, and follow-up concerning counterfeit drugs.
N Anticounterfeiting technologies used at the pharmacy must            NACDS. The NACDS Leadership Council hired an external con-
  be reasonable and inexpensive.                                       sultant to identify multiple methods that could be adopted to
N New regulations should not present new barriers to the legiti-       address the counterfeit drug problem. NACDS also participated
  mate return of unused drug products from pharmacies.                 in the Jump Start multicompany project, which evaluated RFID
N ASHP is willing to inform members of suspected counterfeit           functionality in the pharmaceutical supply chain.128 Recommen-
  drugs.                                                               dations of an NACDS task force include the following128:
N Purchase of high-risk drugs should not be shifted among              N Enforce existing importation laws.
  wholesalers.                                                         N Identify high-risk products.
                                                                       N Enhance wholesaler licensing requirements.
APhA. APhA believes that the anticounterfeiting activities of          N Codify trading partner agreements.
pharmacists should include their roles as prudent purchasers           N Define and use best practices to purchase drugs.
of drugs, patient educators, protectors to ensure the security of      N Use a layered packaging to enhance evidence of tampering.
drugs within the pharmacy, and reporters of suspected counter-         N Enhance public education awareness programs.
feit cases to FDA and manufacturers of the legitimate products         N Establish a standardized counterfeit alert communication
that are being counterfeired.125                                           system.
     APhA supports the following anticounterfeiting consider-
ations98,126,127:                                                      Partnership for Safe Medicines. The Partnership for Safe Medi-
N A cost–benefit analysis should precede implementation of an           cines (www.safemedicines.org) is a coalition of approximately
     e-pedigree system.                                                50 domestic patient, physician, pharmacist, university, industry,
N Practicing pharmacists should have the opportunity to evalu-         and other professional organizations. Its SAFE DRUG checklist
     ate anticounterfeiting technologies that may be used at the       helps consumers identify and protect against counterfeits,129 and
     pharmacy level.                                                   the SafeMeds Alert System, which is part of FDA’s CAN, informs
N Additional costs to implement anticounterfeiting technologies        enrollees of counterfeit alerts announced by FDA and other health
     must not be a financial or administrative burden.                  agencies.130 An abridged form of relevant weekly news is also avail-
N Pharmacists must understand the role they play in preventing         able electronically. The temptation to obtain drugs from nontradi-
     counterfeit drugs from reaching patients.                         tional sources may be reduced by the Partnership’s SafeSavings
N FDA should inform pharmacies and pharmacists of counter-             Consumer Guide, which informs patients of various methods to
     feit drug episodes before informing the rest of the health care   save on medications within the normal U.S. distribution system.
     system.                                                           Additional initiatives of the Partnership are described below in
N Pharmacists should be authorized to modify prescribed quan-          the “Proactive actions” section.
     tities to facilitate tracking of each patient-use package.
N Both overt and covert technologies should be used to differ-         United States Pharmacopeia. Based on ongoing review of
     entiate legitimate and counterfeit products.                      published information, the United States Pharmacopeia (USP)
N Legal liability should focus on counterfeiters and not on phar-      issues a quarterly matrix of drug quality problems, including


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counterfeits, reported in more than 30 countries. USP also             N Report new adverse effects to a pharmacist and prescribing
developed Ensuring the Quality of Medicines in Resource-Limited          health professional.
Countries: An operational guide.131 Additionally, in April 2006,
USP hosted a seminar titled Anti-Counterfeiting: Domestic and          Obstacles to identifying suspect counterfeit drugs. Phar-
International Measures and cosponsored, with FDA, the 2007             macists and pharmacy technicians are well positioned to identify
Detecting Counterfeit Drugs Workshop.                                  suspect counterfeit drugs; however, the ability to detect minor
                                                                       abnormal physical features of a drug product and its labels,
Roles of pharmacists                                                   packaging, and/or prescribing information is compromised by
Prudent purchasers of drugs. The following good business prac-         the large number of products dispensed on a daily basis and the
tices are intended to reduce the chance of purchasing counterfeit      technical expertise of counterfeiters. PhRMA acknowledges that
drugs:                                                                 a wide variety of overt and covert packaging and labeling features,
N Limit or eliminate purchases from secondary wholesalers              such as color-shifting inks, holograms, microprinting, and chemi-
    unless they are ADRs that purchase directly from the manu-         cal taggants imbedded in individual dose forms, make counter-
    facturer, are in good standing with their State Board of Phar-     feiting more difficult; however, assuming that pharmacists will
    macy, and comply with the HDMA voluntary guidelines for            consistently be aware of specific features used on thousands of
    pharmaceutical system integrity.                                   different drug products, especially when these features are peri-
N Do not shift purchase of high-risk drugs among wholesalers.          odically revised to thwart counterfeiters, is not realistic.117 The
N Determine how “your” wholesalers protect their drug sup-             labeling of counterfeit drug products may contain incorrect lot
    ply.                                                               numbers; however, in the absence of easily accessible databases,
N Be aware of drug security practices of pharmacies from which         such discrepancies are difficult to detect, especially if different
    you purchase drugs.                                                lots of a product are intermingled in the pharmacy before dis-
N Reevaluate pharmacy department security measures.                    pensing. Detection may also be compromised by rogue repacking
N Establish written procedures and train employees to inspect          operations that mix counterfeit and authentic products before
    drug packages and cartons for evidence of tampered covert          shipping.
    and overt tamper-resistant features.
N Contact the manufacturer to determine if the packaging of a          Proactive actions. The Partnership for Safe Medicine SAFE
    suspect product is legitimate.                                     Sourcing program provides guidelines for pharmacists to avoid,
N Be aware of NABP’s list of susceptible products that are prone       detect, and report unsafe drug products, packaging, and labeling,
    to counterfeiting, diversion, or adulteration.                     as well as suspected counterfeit vendors, and identifies Internet
N Routinely access the Web sites of FDA (www.fda.gov) or pro-          resources providing additional information.
    fessional organizations that provide alert messages to mem-             The Royal Pharmaceutical Society of Great Britain, in col-
    bers.                                                              laboration with the Medicines and Healthcare Regulatory Prod-
    Additional measures are described in the Partnership for Safe      ucts Agency—the United Kingdom’s equivalent of the U.S. FDA—
Medicine’s Simple Steps for SAFE Sourcing program (www.safe-           issued guidelines for pharmacists to detect counterfeit drugs.132
medicines.org/north_america/pharmacy/resources.php).                   These guidelines are similar to those of the Partnership for Safe
                                                                       Medicines and, when combined, include the following:
Educate consumers. Patient education requires timely access to         N Develop a list of key drugs that will not be purchased from
accurate information of threats or documented cases and actions        sources other than the manufacturer or authorized distribution
recommended by FDA and manufacturers. Information should               channel.
be provided in a nonalarming manner that can be understood             N Be suspicious of products with an unusually low price.
by consumers with limited English skills. A pharmacist should          N Be suspicious of vendors that do not provide a listed physical
also be prepared to discuss information consumers are likely           address or landline telephone number, accept cash-only payment,
to receive from the communication media. Patients should be            or offer a product list that is constantly modified.
encouraged to:                                                         N Look for evidence of a removed or switched product label. A
N Be familiar with size, shape, color, taste, and odor of medica-      tacky residue on the container may result if lighter fluid or another
    tions (at the time of dispensing, explain to patients any physi-   organic solvent is used to remove the original label. The label
    cal change initiated by manufacturers).                            may be discolored along the edges because of contact with the
N Promptly report suspect counterfeit drug products to a phar-         solvent.
    macist and/or health care provider.                                N Look for subtle changes in packaging such as paper texture,
N Provide a sample of the suspect counterfeit drug for inspec-         size and thickness of labels, paper gloss, fonts, font size, misspell-
    tion within the pharmacy and forwarding to FDA and/or the          ing, print color or raised print, breaks, tears, or unusual location
    manufacturer.                                                      of the sealing tape or seals.


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N Look for differences in the length, thickness, diameter,             tainers is important. In addition, deactivating RFID tags attached
shape, and color of containers and in the thickness, texture, color,   to drug containers intended for trash disposal will reduce the
and markings of tablets and capsules.                                  opportunity for criminals to obtain empty containers with active
N Look for an altered expiration date.                                 RFID tags for redistribution of counterfeit products.
N Compare any color-shifting inks and holograms with previ-
ously purchased product.                                               4RACK
AND
TRACE CHALLENGES TO PHARMACY
N Weigh the product if wide variations are apparent.                   A pharmacist’s active participation in an RFID or barcode-based
    In addition to these observational methods, FIP has urged          track-and-trace system is accompanied by several logistic and
national governments to implement analytical methods and train-        financial issues:
ing programs that enable pharmacists to analyze suspect drug           N How much in start-up expenses will be required? Although the
products.118 Possible devices include a portable near-infrared             costs have yet to be defined, estimates indicate that, based on
scanner, which was developed for use by mail-service pharma-               2005 dollars, approximately $20,000 will be needed to equip
cies and by customs and border control agents. Near-infrared               a pharmacy with RFID capability.137 Who pays for what parts
scanners compare the spectra of a suspect drug within a dispens-           of the RFID system? Will this expense be offset by savings
ing vial with approximately 700 reference samples.133 In addi-             associated with improved inventory management, improved
tion, researchers at the University of London School of Pharmacy           recall efficiency, and reduced paperwork burdens?
anticipate that small affordable near-infrared scanners, with          N What will be the effect on pharmacy workflow, including pos-
sensitivity sufficient to distinguish between the same drug manu-           sible decreased efficiency during and after initial implementa-
factured in different plants in Europe, may be placed in pharma-           tion?
cies and other settings to expand testing for counterfeit drugs.134    N How much data will be included on an RFID or barcode tag?
Other devices include an inexpensive hand-held refractometer               Who will define the required data and when?
that determines the specific gravity and quantity of active ingredi-    N Will a pharmacy need to communicate with separate e-ped-
ent contained in drug products dissolved in alcohol.134                    igree databases maintained by various manufacturers and
    In 2006, the portable GPHF Mini-Lab (the development of                wholesale distributors?
which was facilitated by donations from 19 pharmaceutical com-         N What is the potential negative impact if a pharmacy’s track-
panies) was introduced. This system includes visual inspection,            and-trace data are stored in one central database or in a
tablet and capsule disintegration, color reactions, and thin-layer         distributive system wherein the data are shared with other
chromatography procedures for 41 drugs commonly used in                    systems?
developing countries.135                                               N Should the NDC be included in the unique EPC? Will its
                                                                           absence require a pharmacist to interact with a different
Report suspected or confirmed counterfeits. FDA’s CAN                       database to link the EPC to the NDC number?
outlines the roles of pharmacists, other health care providers,        N Who owns and maintains the aggregate massive amount of
and consumers in identifying and reporting suspected counter-              pedigree data? Which members of the supply chain may be
feit drugs via FDA’s MedWatch or Counterfeit Drugs Web pages.              subject to litigation if patient harm is alleged to be caused by
Initial reports will likely lack sufficient information to adequately       an undetected counterfeit drug?
evaluate a case; thus, pharmacists may, in consultation with FDA       N Should patients be told that a dispensed drug product pack-
and the manufacturer, assist in identifying, obtaining, and for-           age contains an RFID tag?
warding relevant follow-up information.                                N What is the role of pharmacists to educate consumers about
     After receiving information verified by FDA or the manufac-            use of RFID-tagged drug products?
turer, promptly identifying and informing patients who likely          N What mechanism(s) will prevent unauthorized disclosure of
receive the counterfeit product is essential. Surprisingly, this           confidential information if an RFID-tagged drug product is
intuitive action is not supported by an audit of 23 pharma-                dispensed to a patient?
cies in the United Kingdom to determine their response after           N Should the RFID tag be deactivated at the point of dispens-
receiving a patient-level alert for two counterfeit drug prod-             ing?
ucts. All checked their stock, only two searched medication            N What are the privacy concerns if the NDC contained on an
records, and a minority of surveyed pharmacists did not think              RFID tag is accessed inappropriately?
it was their responsibility to contact patients.136
                                                                       #ONCLUSION
Don’t make it easy. Intact items may be used by counterfeiters         The production and distribution of counterfeit drugs is a complex,
to reconstruct genuine-looking packaging and labeling; thus, dis-      unquantified problem of international proportions. The existing
carding packaging, vials, labels, and prescribing information in       situation has been facilitated by skilled practitioners, inconsis-
a manner that prevents retrieval of intact items from waste con-       tent regulatory oversight, and lack of coordinated anticounter-


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www.pharmacist.com                                                                                     JUNE 2008 s PHARMACY TODAY 69
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                                                                                ington Post. August 30, 2002:A1.
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70 PHARMACY TODAY s JUNE 2008                                                                                               www.pharmacytoday.org
                                                                                                                                            review

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    February 13, 2001.                                                        95. U.S. Food and Drug Administration. FDA Counterfeit Drug Task Force
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70. U.S. Food and Drug Administration. FDA takes action against com-          96. Pharmaceutical Commerce. FDA will appeal pedigree injunction.
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    Accessed at www.fda.gov/bbs/topics/news/2004/new01142.html,                    php?idSeccion=431, October 15, 2007.
    March 21, 2006.                                                           97. Gallenagh EA. The pedigree puzzle. Paper presented at HDMA 2007
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    nies under the scanner. Accessed at www.businsessworldindia.com./              June 10–13, 2007.
    Nov1703/news11.asp, February 25, 2004.                                    98. Winckler SC. Statement of the American Pharmacists Association
72. Dear Growth Hormone Patient letter. South San Francisco, Calif.:               (APhA) submitted to the House Committee on Government Reform
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    U.S. House of Representatives hearing on ”A system overwhelmed:                display.cfm&contentid=6894, June 8, 2007.
    the avalanche of imported, counterfeit, and unapproved drugs in the       99. Bolin JM. State and federal efforts to curb counterfeit drugs. Paper
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    counterfeit Serostim. Accessed at www.fda.gov/MedWatch/SAFE-              100. The Pink Sheet. National licensing standard for wholesale distribu-
    TY/2001/serostim.htm, March 17, 2006.                                          tors gains momentum. Rockville, Md.: FDC Reports; November 21,
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76. Peterson M. Three fake drugs are found in pharmacies. Accessed at              109th Congress, 1st session. Washington, D.C.; February 22, 2006.
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77. Mathews AW, Tesoriero HW. Bogus medicines put spotlight on world               at www.fda.gov/oc/initiatives/counterfeit/update2005.html.



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103. U.S. Food and Drug Administration. Counterfeit Alert Network.                  Drug Policy and Human Resources Committee on Government Re-
     Accessed at www.fda.gov/oc/initiatives/counterfeit/network.html,               form, Washington, D.C., July 11, 2006.
     October 16, 2007.                                                         121. Product Safety Task Force. White Paper: the healthcare industry’s
104. Unisys. SupplyScape and Unisys pilot pharmaceutical industry’s first            business requirements for electronic track and trace. July 13, 2004.
     electronic pedigree system for commercial drugs. Accessed at www.         122. American Society of Health-System Pharmacists. ASHP strategies to
     unisys.com/about__unisys/news_a_events/05318546.htm, Novem-                    protect against drug counterfeiting. Accessed at www.ashp.org/s_
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                                                                                    ashp/docs/files/Anti-counterfeitingStrategies.pdf, May 22, 2007.
105. RFID Update. Pfizer shipping RFID-tagged Viagra. Accessed at www.
     rfidupdate.com/articles/index.php?id=1027, October 16, 2007.               123. Scheckelhoff DJ. Paper presented at FDA Counterfeit Drug Task Force
106. O’Connor M.C. Cephalon to tag cancer drug at point of manufacture.             Public Workshop/Vendor Display, Bethesda, Md., February 8–9, 2006.
     Accessed at www.rfidjournal.com/article/articleview/3185, October          124. Scheckelhoff DJ. Paper presented at Anti-Counterfeiting Drug
     17, 2007.                                                                      Initiative–public meeting, October 15, 2003, Bethesda, Md. Accessed
107. Bacheldor B. GlaxoSmithKline remains committed to RFID. Accessed               at www.fda.gov/oc/initiatives/counterfeit/oct2003meeting/panel3.
     at www.rfidjournal.com/article/view/3584, October 16, 2007.                     html, May 26, 2004.
108. Thompson CA. Radio frequency tags for identifying legitimate drug         125. Winkler SC. Counterfeit medications: the pharmacist’s role in pro-
     products discussed by tech industry. Am. J Health Syst Pharm.                  tecting the integrity of the medication supply. J Am Pharm Assoc.
     2004;61:1430–2.                                                                2003;43:666–7.
109. AmerisourceBergen. AmerisourceBergen announces innova-                    126. Gans JA. Letter to Food and Drug Administration: docket no.
     tive track and trace program in pharmaceutical supply channel.                 2003N-0361. Accessed at www.pharmacist.com/AM/Template.cfm?
     Accessed at www.amerisourcebergen.com/investor/phoenix.                        Section=Search1&section=Regulatory&template=/CM/ContentDis-
     zhtml?c=61181&p=irol-newsArticle, May 8, 2007.
                                                                                    play.cfm&ContentFileID=325, April 17, 2008.
110. O’Connor MC. McKesson starts RFID pilot for Viagra. Accessed at
     www.rfidjournal.com/article/articleview/2157/1/1, May 17, 2007.            127. Gans JA. Paper presented at Anti-Counterfeiting Drug Initiative–
111. HealthLeaders Media. Cardinal Health announces plans to deploy                 public meeting, October 15, 2003, Bethesda, Md. Accessed at www.
     RFID technology in California. Accessed at www.healthleadersmedia.             fda.gov/oc/initiatives/counterfeit/oct2003meeting/panel3.html, May
     com/technology/viewcontent/89547.html, May 17, 2007.                           26, 2004.
112. Gray JM. Paper presented at FDA Counterfeit Drug Task Force Public        128. Perlowski S. Paper presented at FDA Counterfeit Drug Task Force
     Workshop/Vendor Display, Bethesda, Md., February 8–9, 2006.                    Public Workshop/Vendor Display, Bethesda, Md., February 8–9, 2006.
113. The Pink Sheet. HDMA Foundation gets new mission: supply chain            129. BuySafeDrugs.info. An 8-step checklist for medicine safety. Accessed
     research, education. Rockville, Md.: FDC Reports; October 17, 2005.            at www.buysafedrugs.info/Reports/checklist.htm, October 3, 2007.
114. U.S. Food and Drug Administration. HDMA commitment to patient             130. Partnership for Safe Medicines. Partnership For Safe Medicines joins
     safety through supply chain integrity: a strong record of support & ef-        FDA Counterfeit Alert Network. Accessed at www.safemedicines.
     forts for healthcare system security. Accessed at www.72.14.253.104/           org/resources/001978.php, September 20, 2007.
     search?q=cache:i9oirMjF6EQJ:www.fda.gov/ohrms/dockets/dock-
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115. U.S. Food and Drug Administration. FDA commends drug industry                  Program. Accessed at www.uspdqi.org/issues/index.html, Septem-
     commitment to report counterfeit drugs. Accessed at www.fda.gov./              ber 6, 2006.
     bbs/topics/NEWS/2003/NEw00894.html, October 17, 2007.                     132. Royal Pharmaceutical Society of Great Britain. Counterfeit medicines:
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     buysafedrugs.info/About/default.aspx, October 3, 1007.                         counterfeitmedsguid.pdf, April 13, 2007.
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     tronic authentication of pharmaceutical packaging and the assur-               counterfeit pharmaceuticals. Accessed at www.asdi.com/applica-
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     and Manufacturers of America. Accessed at http://72.14.253.104/           134. Spies AR, Van Dusen V. Counterfeit drugs: a menace keeps
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     files/2005-05-13.11, September 25, 2007.                                        asp?show=article&page=8_1014.htm, May 18, 2007.
118. International Pharmaceutical Federation. FIP statement of policy on       135. Larkin M. Hand-held device detects fake drugs. Lancet Infect Dis.
     counterfeit medicines. The Hague, Netherlands: International Phar-
                                                                                    2002;2:5.
     maceutical Federation; 2003.
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     tion of Pharmacy regulatory authorities to launch VIPPS program in             Accessed at www.pjonline.com/Editorial/20040918/comment/lett01.
     Canada. Accessed at http://findarticles.com/p/articles/mi_m3374/                html, August 4, 2005.
     is_3_25.ai_98488760, May 22, 2007.                                        137. Johnsen M. Industry weighs practical solutions to fulfill promise
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     problem. Testimony before the Subcommittee on Criminal Justice,                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       6. Which type of pharmaceutical business typically has
   involves which of the following types of drugs?                   a formal written distribution agreement with a drug
    a. Antimalarials                                                 manufacturer?
    b. Expensive or recreational drugs                               a. Primary wholesaler
    c. Antihypertensive agents                                       b. Secondary wholesaler
    d. Vitamins                                                      c. Regional wholesaler
                                                                     d. Closed-door pharmacy
2. By what mechanism does a European exporting coun-
   try inform an importing country that the drug product          7. Which of the following can legally reimport an FDA-
   to be imported was manufactured in accordance with                approved prescription drug into the United States?
   good manufacturing practice (GMP) requirements?                   a. The U.S. manufacturer that exported the drug
   a. World Health Organization (WHO) Rapid Alert System             b. A primary authorized distributor of record (ADR) whole-
   b. WHO Counterfeit Drug Database                                     saler
   c. WHO Certification Scheme                                        c. A community chain pharmacy
   d. European Medicines Evaluation Agency notice                    d. A secondary wholesaler

3. What is the approximate estimated cost (in U.S. cur-           8. The Prescription Drug Marketing Act of 1987 (PDMA)
   rency) for a U.S. Customs and Border Protection agent             requires that a drug pedigree contain which of the fol-
   to examine a suspect imported drug package?                       lowing data elements?
   a. $25                                                             a. Date(s) of each prior sale
   b. $75                                                             b. Manufacturer name
   c. $150                                                            c. Number of containers
   d. $270                                                            d. All of the above alternatives are correct.

4. By which year did the Food and Drug Administration             9. Which of the following describes a requirement of
   (FDA) facilitate reporting of suspected counterfeit               PDMA?
   drug episodes to its MedWatch system?                             a. An ADR wholesaler must provide pedigree information
   a. 1987                                                              to a purchasing pharmacy.
   b. 2003                                                           b. A non-ADR wholesaler must provide pedigree informa-
   c. 2005                                                              tion to a purchasing pharmacy.
   d. 2007                                                           c. A wholesaler with an ongoing relationship with a manu-
                                                                        facturer must inform the manufacturer of all sales of
5. If swallowed, the Chinese counterfeit toothpaste dis-                their drugs.
   covered in 2007 may be a health hazard to which of the            d. Pedigree requirements of all states must be identical.
   following populations?
    a. Healthy adult men
    b. Individuals with liver disease
    c. Individuals with epilepsy
    d. Teenagers




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10. Which of the following describes a characteristic of the       15. Which of the following is not a recommendation of the
    Reducing Fraudulent and Imitation Drugs Act of 2006?               American Pharmacists Association?
    a. Permits only use of radiofrequency identification (RFID)         a. Legal liability should focus on counterfeiters and not on
       technology to satisfy the pedigree requirements of                 pharmacists.
       PDMA                                                            b. Implementation of anticounterfeiting technologies
    b. Requires use of tamper-evident technologies in the                 should not be a financial burden.
       packaging of all prescription drug products                     c. All pharmacies should implement RFID pedigrees by
    c. Requires use of covert technology in the packaging of all          January 1, 2009.
       prescription drug products                                      d. FDA should clarify the anticounterfeiting roles of major
    d. Prevents the use of blister product packaging of any pre-          stakeholders.
       scription drug product
                                                                   16. Which of the following is not a good business practice
11. Which of the following states enacted final rules for               to reduce the distribution of counterfeit drugs?
    pedigree requirements by June 2007?                                a. Purchase high-risk drugs from many wholesalers.
    a. Indiana                                                         b. Establish written procedures for employees to inspect
    b. Pennsylvania                                                        drug packages.
    c. Montana                                                         c. Be aware of the National Association of Boards of Phar-
    d. Colorado                                                            macy list of susceptible drug products.
                                                                       d. Be aware of security practices of pharmacies from
12. FDA has completed which one of the following of its                    which you purchase drugs.
    anticounterfeiting actions?
    a. Increased criminal penalties associated with drug coun-     17. Approximately what percentage of WHO members have
       terfeiting.                                                     well-developed regulations to reduce the risk of dis-
    b. Developed the Counterfeit Alert Network.                        tributing counterfeit drugs?
    c. Required the implementation of RFID as a key compo-             a. 75%
       nent of an electronic pedigree.                                 b. 50%
    d. Required the implementation of both overt and covert            c. 20%
       technologies.                                                   d. 10%

13. A patient asks you to indicate what actions he or she          18. Which of the following will facilitate detection of coun-
    can take to reduce the risk of taking a counterfeit                terfeit drugs by a pharmacist?
    drug. What is your response?                                       a. Be suspicious of products with an unusually low price
    a. Prior to ingestion, determine if a drug has a different         b. Look for subtle changes in the packaging of a drug
       color or smell than prior doses.                                   product
    b. Promptly inform a pharmacist of any drug suspected to           c. Look for altered color-shifting inks and halograms
       be a counterfeit.                                               d. All of the above alternatives are correct.
    c. Provide a sample of the suspect drug to a pharmacist.
    d. All of the above alternatives are correct.                  19. Which of the following is not a recommendation of the
                                                                       National Association of Chain Drug Stores?
14. Which of the following is a recommendation of the                  a. Define best practices to purchase drugs.
    Product Safety Task Force?                                         b. Enhance public awareness programs.
    a. Implement an RFID e-pedigree system by January 1,               c. Enforce existing importation laws.
       2009.                                                           d. Barcodes must be used as part of an e-pedigree.
    b. Initiate RFID e-pedigree requirements for all products at
       the same time.                                              20. Which of the following is not part of GMP require-
    c. Omit manufacturers and pharmacies from the RFID                 ments?
       pedigree requirement.                                           a. Source of active ingredients
    d. Require pharmacists to eventually authenticate the pedi-        b. Product formulation and appearance
       gree of all drug products.                                      c. Manufacturing controls
                                                                       d. Distribution to primary wholesalers




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74 PHARMACY TODAY s JUNE 2008                                                                                www.pharmacytoday.org

				
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