www.pharmacist.com JUNE 2008 sPHARMACY TODAY 55 review Go to www.pharmacist.com and take your test online for instant credit. Objectives: To describe (1) the international scope of counterfeit drugs, (2) interna- tional and U.S. anticounterfeiting initiatives, and (3) the enhanced roles and challenges facing pharmaceutical organizations and individual pharmacists to thwart counterfeit drugs. Data sources: PubMed and Ovid from 1970 to 2008 using the search terms coun- terfeit drugs, counterfeit pharmaceuticals, and counterfeit medicines, with English as the limiting term. Nonprimary literature sources included the U.S. Food and Drug Administration (FDA) Web site (www.fda.gov) from 1990 to 2008 using the search term counterfeit drugs, presentations from meetings or workshops attended or accessed via the Internet, and Web sites of professional organizations. Additional resources were identified from personal bibliographies collected by the author and bibliographies of gathered articles. Data synthesis: Counterfeit drugs—defined as those containing no active ingredi- ent, an incorrect amount of active ingredients, incorrect ingredient, and/or unapproved labeling and packaging—represent an unquantified problem of international propor- tions. The existing situation has been facilitated by inconsistent national regulatory oversight, disparate unlinked databases, lack of unified anticounterfeiting actions, and inability to track the distribution of domestically produced or imported drug products between, among, and within nations. In the United States, several important anticoun- terfeiting initiatives announced by FDA in 2004 have been implemented but the benefits of others, such as electronic tracking of a drug’s movement through the U.S. distribution chain to a dispensing pharmacy, will not be realized in the near future. The role of phar- macists as patient educators, prudent purchasers, and detectors of counterfeit drugs can typically be accomplished with minimal added expense or work; however, the impact of electronic tracking on pharmacies’ expenses and workflow is unknown. Pharmacists need to be included in efforts to thwart receipt of counterfeit drugs by patients, but this must be accomplished with minimal negative impact on pharmacy practices. Conclusion: Although consistent detection of counterfeit drugs is difficult, 2OLESFORPHARMACYINCOMBATTING COUNTERFEITDRUGS 2ONALD*:IANCE review ^ÓäänÊLÞÊÌijiÊŇiÀĶV>ŒÊ*ij>ÀŇ>VĶÃÌÃÊÃÃŖVĶ>ÌĶŖŒÊÊÊÊUÊÊÊÊÊŃŃÊÀĶ}ijÌÃÊÀiÃiÀÛi`°ÊÊÊÊÊUÊÊÊÊ*ÀĶŒÌi`ÊĶŒÊ1°-°° Ronald J. Ziance, PhD, is Professor of Pharma- ceutical Sciences, College of Pharmacy, Univer- sity of Southern Nevada, Henderson. Continuing education credits: See learning objectives below and assessment questions at the end of this article, which is ACPE universal program number 202-000-08-146-H03-P in APhA’s educational programs. The CE examina- tion form is located at the end of this article. To take the CE test for this article online, go to www.pharmacist.com/education and follow the links to the APhA CE center. Correspondence: Ronald J. Ziance, PhD, 11 Sunset Way, Henderson, NV 89014. Fax: 702-990-4435. E-mail: [email protected]Disclosure: The author declares no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Published concurrently in Pharmacy Today and the Journal of the American Pharmacists Asso- ciation (available online at www.japha.org). Learning objectives N Ê-Ì>ÌiÊÌijÀiiÊÀi>ÃŖŒÃÊvŖÀÊÌijiÊĶŒ>VVÕÀ>ÌiÊiÃÌĶŇ>ÌiÃÊŖvÊVŖÕŒÌiÀviĶÌÊ`ÀÕ}Ê«ÀiÛ>ŃiŒViÊĶŒÊÕÀŖ«iÊ>Œ`ÊÌijiÊ1ŒĶÌi`Ê-Ì>Ìið N ÊĶÃÌÊwÛiÊVŖŇ«ŃiÌi`ÊŖÀÊŖŒ}ŖĶŒ}Ê>ŒÌĶVŖÕŒÌiÀviĶÌĶŒ}Ê>VÌĶŖŒÃÊŖvÊÌijiÊ1°-°ÊŖŖ`Ê>Œ`ÊÀÕ}Ê`ŇĶŒĶÃÌÀ>ÌĶŖŒÊ-®° N ÊĶÃÌÊÌijÀiiÊ>ŒÌĶVŖÕŒÌiÀviĶÌĶŒ}Ê>VÌĶŖŒÃÊŖvÊÌijiÊ>ÌĶŖŒ>ŃÊÃÃŖVĶ>ÌĶŖŒÊŖvÊŖ>À`ÃÊŖvÊ*ij>ÀŇ>VÞÊ-*®° N ÊĶÃÌÊÌijÀiiÊŖLÃÌ>VŃiÃÊÌŖÊ`iÌiVÌĶŖŒÊŖvÊVŖÕŒÌiÀviĶÌÊ`ÀÕ}ÃÊLÞÊ«ij>ÀŇ>VĶÃÌð N ÊĶÃÌÊÌijÀiiÊ>VÌĶŖŒÃÊ«ij>ÀŇ>VĶÃÌÃÊV>ŒÊÌ>łiÊÌŖÊiŒij>ŒViÊ`iÌiVÌĶŖŒÊŖvÊVŖÕŒÌiÀviĶÌÊ`ÀÕ}ð N ÊĶÃÌÊwÛiÊ«ŖÌiŒÌĶ>ŃÊ«ÀŖLŃiŇÃÊÌij>ÌÊĶŇ«ŃiŇiŒÌ>ÌĶŖŒÊŖvÊÀ>`ĶŖvÀiμÕiŒVÞÊĶ`iŒÌĶwV>ÌĶŖŒÊÌÀ>Vłĵ>Œ`ĵÌÀ>ViÊÌiVijŒŖŃŖ}ÞÊ«ÀiÃiŒÌÊÌŖÊ «À>VÌĶVĶŒ}Ê«ij>ÀŇ>VĶÃÌð !BSTRACT
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2OLESFORPHARMACYINCOMBATTING COUNTERFEITD RUGSapha.imirus.com/pdf/2008/June_CE_exam.pdfdistribute counterfeit drugs, packaging, and labeling that are very difficult for pharmacists,
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www.pharmacist.com JUNE 2008 s�PHARMACY TODAY 55
review
Go to www.pharmacist.com and take your test online for instant credit.
Objectives: To describe (1) the international scope of counterfeit drugs, (2) interna-
tional and U.S. anticounterfeiting initiatives, and (3) the enhanced roles and challenges
facing pharmaceutical organizations and individual pharmacists to thwart counterfeit
drugs.
Data sources: PubMed and Ovid from 1970 to 2008 using the search terms coun-
terfeit drugs, counterfeit pharmaceuticals, and counterfeit medicines, with English
as the limiting term. Nonprimary literature sources included the U.S. Food and Drug
Administration (FDA) Web site (www.fda.gov) from 1990 to 2008 using the search term
counterfeit drugs, presentations from meetings or workshops attended or accessed via
the Internet, and Web sites of professional organizations. Additional resources were
identified from personal bibliographies collected by the author and bibliographies of
gathered articles.
Data synthesis: Counterfeit drugs—defined as those containing no active ingredi-
ent, an incorrect amount of active ingredients, incorrect ingredient, and/or unapproved
labeling and packaging—represent an unquantified problem of international propor-
tions. The existing situation has been facilitated by inconsistent national regulatory
oversight, disparate unlinked databases, lack of unified anticounterfeiting actions, and
inability to track the distribution of domestically produced or imported drug products
between, among, and within nations. In the United States, several important anticoun-
terfeiting initiatives announced by FDA in 2004 have been implemented but the benefits
of others, such as electronic tracking of a drug’s movement through the U.S. distribution
chain to a dispensing pharmacy, will not be realized in the near future. The role of phar-
macists as patient educators, prudent purchasers, and detectors of counterfeit drugs
can typically be accomplished with minimal added expense or work; however, the impact
of electronic tracking on pharmacies’ expenses and workflow is unknown. Pharmacists
need to be included in efforts to thwart receipt of counterfeit drugs by patients, but this
must be accomplished with minimal negative impact on pharmacy practices.
Conclusion: Although consistent detection of counterfeit drugs is difficult,
Ronald J. Ziance, PhD, is Professor of Pharma-ceutical Sciences, College of Pharmacy, Univer-sity of Southern Nevada, Henderson.
Continuing education credits: See learning objectives below and assessment questions at the end of this article, which is ACPE universal program number 202-000-08-146-H03-P in APhA’s educational programs. The CE examina-tion form is located at the end of this article. To take the CE test for this article online, go to www.pharmacist.com/education and follow the links to the APhA CE center.
Correspondence: Ronald J. Ziance, PhD, 11 Sunset Way, Henderson, NV 89014. Fax: 702-990-4435. E-mail: [email protected]
Disclosure: The author declares no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria.
Published concurrently in Pharmacy Today and the Journal of the American Pharmacists Asso-ciation (available online at www.japha.org).
Go to www.pharmacist.com and take your test online for instant credit.
review
feiting initiatives by various national and multinational regulatory
agencies and professional organizations. In the United States,
several pharmacy-related organizations have made important
contributions to decreasing the distribution of counterfeit drugs.
Individual pharmacists will have important roles in the evolving
anticounterfeiting practices within the United States; however,
these opportunities will be accompanied by altered business
practices, as well as likely added expense. Pharmacists must take
an active role in evaluating and implementing both revised and
new responsibilities that further protect patient safety without
affecting pharmacy practice adversely.
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