FACT SHEET Counterfeit and Substandard Drugs in Low Income Countries Counterfeit and substandard pharmaceuticals have become increasingly prevalent in almost every nation around the world. Whether a drug is considered counterfeit varies by the classifying country and/or organization.1 Because of varying definitions and methods of classification, the World Health Organization (WHO) has attempted to standardize the classification method, and defines a counterfeit drug as one that is “deliberately and fraudulently mislabeled with respect to identity source or both.â€?2 Governments and organizations have identified a plethora of categories to identify counterfeit drugs, but most fall into the following six groups: • • • • • •
Products missing active ingredients (32.1 percent of counterfeits) Products with incorrect quantities of active ingredients (20.2 percent); Products with wrong ingredients (21.4 percent); Products with correct ingredients and amounts but fake packaging (15.6 percent); Copies of original products (1 percent); And products that contain high levels of containments (8.5 percent).3
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The difference between substandard versus counterfeit pharmaceuticals is that counterfeit drugs are defined as being intentionally mislabeled or improperly made in order to mislead the consumer. Substandard pharmaceuticals, on the other hand, may be genuine products, but have not met the stringent quality specifications set for them. This is usually the result of human error, negligence, or insufficient human capital.4 In addition, a drug that chemically is correct, but the package contains an inadequate or incorrect dosage is considered substandard. Scale of the Problem While a comprehensive study of the global counterfeit drug problem has yet to be undertaken, the WHO has compiled information on the prevalence of certain counterfeit medicines in developing countries. Counterfeit and substandard pharmaceutical have been found in nations around the world, including the United States and Europe. However, the major problem resides in low income countries located in Sub-Saharan Africa and South and Southeast Asia, where drug regulatory systems are weak and availability of essential medicines are scarce and inconsistent. Recent Counterfeit Drug Cases1 &RXQWHUIHLW 0HGLFLQH 0HWDNHOILQ DQWL PDODULD 9LDJUD &LDOLV /LSLWRU $QWL GLDEHWLF 7UDGLWLRQDO &KLQHVH 0HGLFLQH
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Between 1982 and 1999, there were approximately 771 reports made to the WHO identifying counterfeit drugs, 48.4 percent of which came from the Western Pacific Region. The majority of the counterfeit cases found were in anti-infective and anti-malarial medicines. Further, samples of anti-infectives from Nigeria and Thailand were found to contain improper quantities of chemicals in 36 percent and 40 percent of cases, respectively.6 Consequences of Counterfeit and Substandard Pharmaceuticals Counterfeit and substandard pharmaceuticals have had numerous repercussions on individuals, corporations, and governments, including, but not limited too: •
• • •
Morbidity and Mortality: insufficient active compounds do not treat the disease or infection it is meant to, while higher concentrations of certain chemical compounds can have severe adverse reactions. Economic: families bear the economic costs of morbidity and mortality; legitimate pharmaceutical manufacturers lose up to US$35-44 billion per year due to counterfeit sales.7 Public confidence: people lose confidence in legitimate pharmaceuticals, drug regulation agencies, and health care systems.3 Pharmaceutical resistance: inadequate dosages or formulations of certain antibiotics could create drug resistant forms of certain diseases including HIV, malaria, and tuberculosis.
Steps to Combat Counterfeit and Substandard Drugs Most developed nations have taken drastic steps to reduce the risk of counterfeit and substandard drugs in their respective markets, such as strengthening quality standards and regulations. However, developing countries generally do not have the resources to take such measures. In 2006 the WHO created the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to try to help suppress the problem in low-income countries, focusing on five strategic areas: technology, communication, regulatory implementation, enforcement, and legislative and regulatory infrastructure. Further Reading WHO Counterfeit Medicines Program: www.who.int International Medical Products Anti-Counterfeiting Taskforce: www.who.int/entity/impact/en US Food and Drug Administration: www.fda.gov The Lancet Infectious Diseases: www.thelancet.com
JANUARY 2010
References 1. World Health Organization. Counterfeit Medicine Fact Sheet. Geneva: World Health Organization; 2010. 2. Newton P, White N. Counterfeit anti-infective drugs. The Lancet. 2006;6(9):602-13. 3. World Health Organization. General Information on counterfeit Medicines. 2010 [cited March 1, 2010]; Available from: www.who.int 4. World Health Organization. Substandard and counterfeit medicines. 2003 [cited March 1, 2010]; Available from: www.who.int 5. Lybecker KM. Economics of re-importation and risks of counterfeit pharmaceutical. Managed Care. 2003;13(3):10-3. 6. Shakoor O, Taylor RB, Berhrens RH. Tropical Medicine and International Health. Assessment of the incidence of sub standard drugs in developing countries. 1997;2:839-45. 7. Lybecker KM. Rx roulette: counterfeit pharmaceuticals in developing nations. Managerial and Decision Economics. 2007;28:509-20.
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