US Pharm. 2014;39(6)(Generic Drug Review suppl):44-46.
Counterfeit drugs have been defined as products deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product.1-4 Counterfeit medications include drugs that contain no active pharmaceutical ingredient (API), an incorrect amount of API, an inferior-quality API, a wrong API, contaminants, or repackaged expired products.1,5 Some counterfeit medications may even be incorrectly formulated and produced in substandard conditions.5
Counterfeiting can apply to both branded pharmaceuticals and their less expensive generic counterparts.6 In fact, generic drugs are sometimes confused with counterfeit medications, which may pose an obstacle to the widespread use and acceptance of generic medications. This may create a particular challenge for pharmaceutical industries in places such as India, Europe, and Japan—countries in which generic drugs are manufactured. Moreover, any impact on generic-drug use is potentially far-reaching. It is estimated that half of all prescriptions in the United States, for example, are now filled with approved generic drugs, with expenditures estimated in the billions.6
Counterfeit Drugs: A Global Problem
For years, the number of counterfeit medications that have made their way into trusted pharmacies and subsequently to patients’ medicine cabinets has been on the rise. Imagine the scenario in which a patient takes a medication for a life-threatening illness, only to become aware later that the doses contained no APIs. It is estimated that this misfortune has occurred with thousands of people worldwide and continues to happen. The growing issue of counterfeit medications is a concern not only for the patient, but also for pharmacists and pharmaceutical companies. Wertheimer et al state that the magnitude of the drug-counterfeiting problem is difficult to gauge.7 Since the crimes of producing and selling counterfeit drugs generally become known only when the perpetrators are caught, any accurate determination of prevalence is difficult.7 The World Health Organization (WHO) has estimated that 10% of global pharmaceutical commerce, or $21 billion worth, involves counterfeit drugs.7,12
Drug counterfeiting, although not a new phenomenon, has provoked greater concern because it has become so widespread in recent years.8,9 A WHO study revealed that nearly one-half (48.7%) of the documented cases of drug counterfeiting were reported in developing countries of the Western Pacific (China, the Philippines, and Vietnam), followed by developing countries grouped within WHO’s Regional Office for Africa, with 18.7%. The industrialized areas of WHO’s Regional Office for Europe came in third, with 13.6% of reported cases.10,11 It is estimated that approximately 1% of counterfeit medications are sold in the U.S, but the numbers are increasing annually.1 Most U.S. counterfeit medications are purchased online; however, others have infiltrated legitimate supply chains.
Drugs Most Often Counterfeited
High-demand, expensive medications such as various chemotherapeutic drugs, antibiotics, vaccines, erectile dysfunction drugs, weight loss aids, hormones, analgesics, steroids, antihistamines, antivirals, and antianxiety drugs are common counterfeiting targets.1,3,4 Among those deceived into buying counterfeit drugs are consumers who use medicines inappropriately or who seek to purchase medications at discounted prices. In addition to being very cheap to make, counterfeit medicines often closely resemble actual medications, with nearly identical labels and tablets, thus duping unsuspecting pharmacists and patients. It has been reported that oftentimes drug counterfeiters use cheap and sometimes harmful materials such as brick dust, sheetrock, and flour to create their bogus tablets.13 Pfizer reported discovering 14 of its counterfeited pharmaceutical products in at least 36 countries, including the U.S., in the first 9 months of 2009 and reportedly seized more than 11 million counterfeit tablets, capsules, and vials that year.1,14,15 Also in 2009, a U.S. government crackdown uncovered some 800 packages of counterfeit medications, including Viagra (sildenafil citrate), Vicodin (hydrocodone bitartrate and acetaminophen), and Claritin (loratadine).16 Mui and Ylan state that some of the drugs had as much as three times the amount of API than is typically prescribed, while others contained no API at all or harmful substances.16
Internet Sites the Largest Suppliers
Increasing access to the Internet coupled with new methods of manufacturing and distributing illegal pharmaceuticals have created new challenges to safeguarding the legitimate pharmaceutical supply chain.2 Thousands of websites openly sell unapproved and/or counterfeit drugs, as well as prescription drugs without requiring a valid prescription, all in violation of federal and state laws. Many of these sites are hosted by U.S. registrars, accept payment by U.S. payment processors, and ship their products via U.S.-based express courier companies or the U.S. Postal Service (USPS).2
Counterfeit Drugs: A Public Health Concern
Counterfeiting drugs is not only illegal, but it is also a major public health concern. Counterfeit drugs often contain the correct ingredients in incorrect quantities; however, they may also contain either a wrong API—which may even be toxic—or no active substance at all.15 Treatment with ineffective counterfeit drugs such as antibiotics can lead to the emergence of resistant organisms and may have a deleterious effect on a wide section of the population. In extreme cases, counterfeit drugs may even cause death.3 For example, it has been estimated that between 60,000 and 80,000 children in Niger with fatal falciparum malaria were treated with a counterfeit vaccine containing only chloramphenicol, an antibiotic that is generally combined with another medication, which may have resulted in more than 100 fatal infections.17, 18 As a consequence of such damaging effects, counterfeit drugs may erode public confidence in healthcare systems, healthcare professionals, the suppliers and sellers of genuine drugs, the pharmaceutical industry, and national drug regulatory authorities.4
Taking Legal Action
To disrupt and dismantle illicit networks trading these harmful counterfeit drugs in the U.S. and countries such as Africa and Asia, the White House’s Counterfeit Inter-Agency Working Group has collaborated with the FDA; the Departments of Justice, State, and Commerce; and the Agency for International Development as well as both foreign and domestic law enforcement partners such as U.S. Customs and Border Protection and U.S. Immigration and Customs Enforcement. In order to eliminate the distribution of counterfeit drugs, the combined efforts of these agencies have implemented strategies that include partnerships with the private sector to secure supply chains and share intelligence; identify, seize, forfeit, and destroy products that infringe trademarks and copyrights; and levy monetary penalties and enforce laws at the U.S. border.2 The FDA is working with law enforcement agencies and USPS inspectors to secure the global drug-supply chain by identifying drugs that are most likely to be counterfeited, contaminated, or adulterated and targeting shipments of these drugs for additional inspection.1 In addition, anticounterfeiting initiatives in other countries have been launched, including the Anti-Counterfeiting Trade Agreement—an initiative between the European Union, Japan, the U.S., and Switzerland. Other efforts to thwart counterfeiting include the World Customs Organization’s Provisional Standards Employed by Customs for Uniform Rights Enforcement, G-8 Countries’ Initiatives on Counterfeits, World Intellectual Property Organization’s Advisory Committee on Enforcement, and Security and Prosperity Partnership, an initiative between Canada, Mexico, and the U.S.6
Many anticounterfeiting technologies are being utilized by pharmaceutical companies to ensure distribution of the authentic product from the manufacturing site to the pharmacy.1 Among these technologies used by pharmaceutical manufacturers are holograms, color-shifting inks, and embedded codes, images, and dyes.1 These anticounterfeiting features allow pharmacists to identify suspicious medications as possible counterfeits.
According to the Pharmaceutical Research and Manufacturers of America, consumers who purchase medications online should avoid the following: sites that are located outside of the U.S. that do not indicate any physical address; sites that do not have a license by the relevant State Boards of Pharmacy; sites without a licensed pharmacist to answer questions; and websites that do not require a prescription.8,10
Consumers who wish to purchase drugs over the Internet should look for websites that have the Verified Internet Pharmacy Practice Sites seal. These sites, which are created by the National Association of Boards of Pharmacy, are licensed pharmacies selling FDA-approved medications to discourage the sale of counterfeit drugs from illegitimate online sources.5
Role of the Pharmacist
Pharmacists are vital in ensuring the safety of medications used by patients. Furthermore, they are responsible for the integrity of the supply chain, ranging from manufacturer to distributor and, ultimately, to the patient. Specifics on how pharmacists, pharmacy students, and technicians can combat counterfeit medications are shown in TABLE 1.1,11
ConclusionCounterfeit medications may be detrimental to a patient’s health status. The use of substandard drugs may result in adverse side effects, treatment failure, resistance, toxicity, and even death. It is important that pharmaceutical companies, healthcare professionals, pharmacists, and patients be educated about counterfeit medications and the laws being enforced to prevent this crime. With increased awareness and the promotion of global health, the growing threat of counterfeit medications may begin to decline.
1. Chambliss W, Carroll W, Yelvigi M, et al. Role of the pharmacist in preventing distribution of counterfeit medications. J Am Pharm Assoc. 2012;52(2): 195-199.
2. Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President of United States and to Congress. www.whitehouse.gov/sites/default/files/omb/IPEC/Pharma_Report_Final.pdf. Accessed March 29, 2014.
3. Ziance RJ. Roles for pharmacy in combatting counterfeit drugs. J Am Pharm Assoc . 2008;48:e71–e88.
4. Food and Drug Administration. Reporting serious problems to FDA. www.fda.gov/Safety/MedWatch/HowToReport/default.htm, January 6, 2011. Accessed March 29, 2014.
5. Toscan P. The dangerous world of counterfeit prescription drugs. http://usatoday30.usatoday.com/money/industries/
health/drugs/story/2011-10-09/cnbc-drugs/50690880/1. Accessed April 2, 2014.
6. Shukla N, Sangal T. Generic drug industry in India: the counterfeit spin. Journal of Intellectual Property Rights . 2009;14:236-240.
7. Wertheimer A, Chaney N, Santella T. Counterfeit pharmaceuticals: current status and future projections. J Am Pharm Assoc . 2003;43(6):710-717.
8. World Health Organization. General information on counterfeit medications. www.who.int/medicines/services/
counterfeit/overview/en/. Accessed April 1, 2014.
9. National Association of Boards of Pharmacy. Sellers of unapproved drugs proliferate online, posing a serious threat to global public health, reports NABP. www.nabp.net/news/sellers-of-unapproved-drugs-proliferate-online-posing-a-serious-threat-to-global-public-health-reports-nabp. Accessed April 1, 2014.
10. Pharmaceutical Research and Manufacturers of America. The counterfeit drug problem. www.phrma.org/counterfeit-drugs. Accessed April 2, 2014.
11. Centers For Disease Control and Prevention. Counterfeit drugs. wwwnc.cdc.gov/travel/page/counterfeit-medicine. Accessed April 2, 2014.
12. Division of Drug Management and Policies. Summary of Counterfeit Drug Database as of April 1999 [unpublished manuscript]. Geneva, Switzerland: World Health Organization; 1999.
13. FDA to CNN: Many online pharmacies selling fake medicine. www.youtube.com/watch?v=A2a1JW9qzeY. Accessed April 2, 2014.
14. Everts S. Fake pharmaceuticals. Chemical & Engineering News . 2010;88(1):27-29.
15. Howard D. A silent epidemic: protecting the safety and security of drugs. Pharm Outsourcing . 2010;July/August:16-18.
16. Mui, Ylan Q. Crackdown targets counterfeit drugs. Washington Post. November 20, 2009. www.washingtonpost.com/wpdyn/content/article/ 2009/11/19/AR2009111904229.html. Accessed 1, 2014.
17. ten Ham M. Health risks of counterfeit pharmaceuticals. Drug Saf. 2003;26(14):991-997.
18. ten Ham M. Counterfeit drugs: implications for health. Adverse Drug React Toxicol Rev . 1992;11(1):59-65.