Counterfeit medications
Encyclopedia
A counterfeit medication or a counterfeit
Counterfeit
To counterfeit means to illegally imitate something. Counterfeit products are often produced with the intent to take advantage of the superior value of the imitated product...

 drug is a medication
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...

 or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body (e.g., absorption by the body), may contain ingredients that are not on the label (which may or may not be harmful), or may be supplied with inaccurate or fake packaging and labeling. Medicines which are deliberately mislabeled to deceive consumers—including mislabeled but otherwise genuine generic drugs—are counterfeit. Counterfeit drugs are related to pharma fraud
Pharma Fraud
Pharma fraud is a term to describe several illegal activities involving the manufacturing, marketing, and distribution of pharmaceuticals.-Definition and examples:For example, Pharma fraud refers to:...

. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs.

Illegal drugs of abuse
Drug abuse
Substance abuse, also known as drug abuse, refers to a maladaptive pattern of use of a substance that is not considered dependent. The term "drug abuse" does not exclude dependency, but is otherwise used in a similar manner in nonmedical contexts...

 are often produced and sold with the intent to deceptively represent their origin, authenticity or effectiveness. An example of this would be a marijuana sample with a false claim that it came from a particular area, or has special strength. The nature of fraudulent drugs ranges from those which contain no active ingredient
Active ingredient
An active ingredient is the substance of a pharmaceutical drug or a pharmaceutical ingredient and bulk active in medicine; in pesticide formulations active substance may be used. Some medications and pesticide products may contain more than one active ingredient...

s (e.g., when a bag of powdered lactose
Lactose
Lactose is a disaccharide sugar that is found most notably in milk and is formed from galactose and glucose. Lactose makes up around 2~8% of milk , although the amount varies among species and individuals. It is extracted from sweet or sour whey. The name comes from or , the Latin word for milk,...

 is claimed to be cocaine
Cocaine
Cocaine is a crystalline tropane alkaloid that is obtained from the leaves of the coca plant. The name comes from "coca" in addition to the alkaloid suffix -ine, forming cocaine. It is a stimulant of the central nervous system, an appetite suppressant, and a topical anesthetic...

), to cases in which the active ingredients are "cut" with a less expensive dilutant (e.g., baking soda or lactose) or "spiked" with a chemical "enhancer" (e.g., PCP
Phencyclidine
Phencyclidine , commonly initialized as PCP and known colloquially as angel dust, is a recreational dissociative drug...

), to cases in which the actual active ingredients present differ from those claimed (e.g., when methamphetamine
Methamphetamine
Methamphetamine is a psychostimulant of the phenethylamine and amphetamine class of psychoactive drugs...

 is sold as cocaine).

Legitimate, correctly labeled, low-cost generic drug
Generic drug
A generic drug is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its...

s are not counterfeit or fake (although they can be counterfeited), but can be caught up in anticounterfeiting enforcement measures. In that respect, a debate is raging as to whether "counterfeit products [are] first and foremost a threat to human health and safety or [whether] provoking anxiety [is] just a clever way for wealthy nations to create sympathy for increased protection of their intellectual property
Intellectual property
Intellectual property is a term referring to a number of distinct types of creations of the mind for which a set of exclusive rights are recognized—and the corresponding fields of law...

 rights". Generic drugs are subject to normal regulations in countries where they are manufactured and sold.

Prescription and over-the-counter drugs

Counterfeit medicinal drugs include those with less or none of the stated active ingredients, with added, sometimes hazardous, adulterants, substituted ingredients, completely misrepresented, or sold with a false brand name. Otherwise, legitimate drugs that have passed their date of expiry are sometimes remarked with false dates. Low-quality counterfeit medication may cause any of several dangerous health
Health
Health is the level of functional or metabolic efficiency of a living being. In humans, it is the general condition of a person's mind, body and spirit, usually meaning to be free from illness, injury or pain...

 consequences, including side effects
Adverse drug reaction
An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dosage. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs...

 or allergic reactions
Allergy
An Allergy is a hypersensitivity disorder of the immune system. Allergic reactions occur when a person's immune system reacts to normally harmless substances in the environment. A substance that causes a reaction is called an allergen. These reactions are acquired, predictable, and rapid...

, in addition to their obvious lack of efficacy due to having less or none of their active ingredients.

Since counterfeiting is difficult to detect, investigate, quantify, or stop, the quantity of counterfeit medication is difficult to determine. Counterfeiting occurs throughout the world, although there are claims it is more common in some developing countries with weak regulatory or enforcement regimens. It is estimated that more than 10% of drugs worldwide are counterfeit, and in some countries, more than 50% of the drug supply is counterfeit. In 2003, the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

 cited estimates that the annual earnings of counterfeit drugs were over US$32 billion.

The considerable difference between the cost of manufacturing counterfeit medication and price counterfeiters charge is a lucrative incentive. Fake antibiotic
Antibiotic
An antibacterial is a compound or substance that kills or slows down the growth of bacteria.The term is often used synonymously with the term antibiotic; today, however, with increased knowledge of the causative agents of various infectious diseases, antibiotic has come to denote a broader range of...

s with a low concentration of the active ingredients can do damage world wide by stimulating the development of drug resistance
Antibiotic resistance
Antibiotic resistance is a type of drug resistance where a microorganism is able to survive exposure to an antibiotic. While a spontaneous or induced genetic mutation in bacteria may confer resistance to antimicrobial drugs, genes that confer resistance can be transferred between bacteria in a...

 in surviving bacteria. Courses of antibiotic treatment which are not completed can be dangerous or even life threatening. If a low-potency counterfeit drug is involved, completion of a course of treatment cannot be fully effective. Counterfeit drugs have even been known to have been involved in clinical drug trials.

Several technologies may prove helpful in combating the counterfeit drug problem. An example is radio frequency identification, which uses electronic devices to track and identify items, such as pharmaceutical products, by assigning individual serial number
Serial number
A serial number is a unique number assigned for identification which varies from its successor or predecessor by a fixed discrete integer value...

s to the containers holding each product. The U.S. Food and Drug Administration (FDA) is working towards an electronic pedigree (ePedigree) system to track drugs from factory to pharmacy. This technology may prevent the diversion or counterfeiting of drugs by allowing wholesalers and pharmacists to determine the identity and dosage of individual products. Some techniques, such as Raman spectroscopy
Raman spectroscopy
Raman spectroscopy is a spectroscopic technique used to study vibrational, rotational, and other low-frequency modes in a system.It relies on inelastic scattering, or Raman scattering, of monochromatic light, usually from a laser in the visible, near infrared, or near ultraviolet range...

 and energy-dispersive X-Ray diffraction (EDXRD) can be used to discover counterfeit drugs while still inside their packaging. http://news.bbc.co.uk/2/hi/health/6314287.stm

Some of the proposed anticounterfeiting measures provoke privacy concerns, or the possibility that drug manufactures will seek to use anticounterfeiting technologies to undermine legitimate parallel trade in medicines. According to these reports, many of the fake drugs came from the same countries that make normal drugs, in particular China
China
Chinese civilization may refer to:* China for more general discussion of the country.* Chinese culture* Greater China, the transnational community of ethnic Chinese.* History of China* Sinosphere, the area historically affected by Chinese culture...

 and India
India
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...

. In the case of India, while it is against the law to sell fake drugs for domestic use, there is no prohibition on export of counterfeit drugs.

China

Many counterfeit drugs originate in China. The State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies. This regulatory lack, which has resulted in considerable international news coverage unfavorable to China, has been known for a decade, but failure of Chinese regulatory agencies to cooperate has prevented improvement. On May 6, 2005, the Chinese
People's Republic of China
China , officially the People's Republic of China , is the most populous country in the world, with over 1.3 billion citizens. Located in East Asia, the country covers approximately 9.6 million square kilometres...

 press agency Xinhua
Xinhua News Agency
The Xinhua News Agency is the official press agency of the government of the People's Republic of China and the biggest center for collecting information and press conferences in the PRC. It is the largest news agency in the PRC, ahead of the China News Service...

 reported that the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

 had established Rapid Alert System, the world's first web
World Wide Web
The World Wide Web is a system of interlinked hypertext documents accessed via the Internet...

-based system for tracking the activities of drug counterfeiters, in light of the increasing severity of the problem of counterfeit drugs.

June 2009, Nigeria
Nigeria
Nigeria , officially the Federal Republic of Nigeria, is a federal constitutional republic comprising 36 states and its Federal Capital Territory, Abuja. The country is located in West Africa and shares land borders with the Republic of Benin in the west, Chad and Cameroon in the east, and Niger in...

 has seized a large consignment of fake antimalarial drugs with the label of "made in India", but found the medicines were in fact produced in China
China
Chinese civilization may refer to:* China for more general discussion of the country.* Chinese culture* Greater China, the transnational community of ethnic Chinese.* History of China* Sinosphere, the area historically affected by Chinese culture...

 and were imported into the African countries. The authorities have maintained the incident is not isolated, indicating it was just the tip of the iceberg. In 2003, the Coalition for Intellectual Property Rights, an independent Russian group, conducted a survey that found 12 percent of the prescription drugs distributed in Russia were counterfeit.

India

According to a report released by the Organisation for Economic Co-operation and Development
Organisation for Economic Co-operation and Development
The Organisation for Economic Co-operation and Development is an international economic organisation of 34 countries founded in 1961 to stimulate economic progress and world trade...

 (OECD), 75 percent of fake drugs supplied world over have some origins in India, followed by 7 percent from Egypt and 6 percent from China. However, India also is a leading manufacturer and exporter of high-quality generic and patent drugs.

United States

The United States has had a growing problem with counterfeit drugs; the FDA held a Congressional hearing in 2005 to review the situation. The U.S. is an especially attractive market for counterfeiters because 40 percent of worldwide annual prescription drug sales were made in the United States in 2007.

Anticounterfeit platforms

In 2007, the world's first free-to-access anticounterfeit platform was established in the West African country of Ghana. The platform, dubbed mPedigree
Mpedigree
mPedigree refers both to a world-first technology platform that interconnects GSM mobile networks in the West African republic of Ghana to a central registry wherein pedigree information of product brands belonging to participant manufacturers are stored, as well as the organisation that has...

, relies on existing GSM networks in that country to provide pharmaceutical consumers and patients with the means to verify whether their purchased medicines are from the original source through a free two-way SMS message, provided the manufacturer of the relevant medication has subscribed to a special scheme. Still in trial stages, the implementers of the platform announced in 2009 that they are in partnership with Ghana's Ministry of Health and the country's specialized agency responsible for drug safety, the Food and Drugs Board, to move the platform from pilot to full-deployment stage.

In 2010, NAFDAC in Nigeria launched an SMS-based anticounterfeiting platform using technology from Sproxil
Sproxil
Sproxil is a venture capital-backed for-profit company based in Cambridge, Massachusetts that provides a consumer SMS verification service through its Mobile Product AuthenticationTM service.-Activity:...

. That system was also adopted by GlaxoSmithKline (GSK) in February 2011. In April 2011, CNN published a video highlighting Sproxil's solution in the fight against counterfeit drugs in Nigeria. In July 2011, Kenya's Pharmacy and Poisons Board
Pharmacy and Poisons Board
Pharmacy and Poisons Board - Kenya- Pharmacy and Poisons Board :The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya....

 also adopted text message-based anticounterfeiting systems and endorsed the Sproxil solution.

An ePedigree
Epedigree
An epedigree is an electronic document which provides data on a the history of a particular batch of a drug. It satisfies the requirement for a 'drug pedigree' while using a convenient electronic form.-Pedigree:The U.S...

 is another important system for the automatic detection of counterfeit drugs. States such as California are increasingly requiring pharmaceutical companies to generate and store ePedigrees for each product they handle. On January 5, 2007 EPCglobal
EPCglobal
EPCglobal is a joint venture between GS1 and GS1 US .It is an organization set up to achieve worldwide adoption and standardization of Electronic Product Code technology....

 ratified the Pedigree Standard as an international standard that specifies an XML
XML
Extensible Markup Language is a set of rules for encoding documents in machine-readable form. It is defined in the XML 1.0 Specification produced by the W3C, and several other related specifications, all gratis open standards....

 description of the life history of a product across an arbitrarily complex supply chain.

Illegal drugs of abuse

Illegal drugs can be counterfeited easily because no standards or regulations govern them or their packaging. While some isolated examples of illegal drugs are sold under "brand names" to indicate certain standards or dosage levels were being adhered to, as in the case of 1960s-era LSD
LSD
Lysergic acid diethylamide, abbreviated LSD or LSD-25, also known as lysergide and colloquially as acid, is a semisynthetic psychedelic drug of the ergoline family, well known for its psychological effects which can include altered thinking processes, closed and open eye visuals, synaesthesia, an...

, which was sold with patterns or logos printed on blotter paper, this is the exception. Even with these rare examples of "branding", the illegal "brands" can also be counterfeited by drug dealers who want to be able to sell their products at higher prices.

Counterfeit illegal and recreational drugs range from products which do not contain any active ingredient
Active ingredient
An active ingredient is the substance of a pharmaceutical drug or a pharmaceutical ingredient and bulk active in medicine; in pesticide formulations active substance may be used. Some medications and pesticide products may contain more than one active ingredient...

s, as in cases where lactose powder is sold as heroin, or dried herbs such as oregano are sold as cannabis, to cases where the active ingredients are "cut" with a diluent (as in cases where cocaine is mixed with lactose powder), and cases where the claimed active ingredients are substituted by something cheaper (e.g., when methamphetamine
Methamphetamine
Methamphetamine is a psychostimulant of the phenethylamine and amphetamine class of psychoactive drugs...

 is sold as cocaine
Cocaine
Cocaine is a crystalline tropane alkaloid that is obtained from the leaves of the coca plant. The name comes from "coca" in addition to the alkaloid suffix -ine, forming cocaine. It is a stimulant of the central nervous system, an appetite suppressant, and a topical anesthetic...

). A common strategy is to claim a domestic or lower-grade drug is in fact a higher-priced import.

The use of diluents in illegal drugs reduces the potency of the drugs and makes it hard for users to determine the appropriate dosage level. Diluents include "foodstuffs (flour and baby milk formula), sugars (glucose, lactose, maltose, and mannitol), and inorganic materials such as powder." The diluents used often depend on the way drug purchasers consume particular drugs. Drug dealers selling heroin to users who inject dilute the drug with different products from dealers selling to users who smoke or insufflate the drug; diluents which can easily form a solution with water for injecting heroin can be problematic for users who are sniffing the powder. When cocaine is mixed with diluents for the purpose of injection, the "...diluents can produce serious abscesses and pain if the user misses the vein and injects into muscle tissue." "Diluents and adulterants are often added to No. 3 heroin", including sugar, quinine, barbital and caffeine, some of which "can cause serious side effects." Dr. Hirsch, the New York Medical Examiner, claimed that buying illegal drugs is "... like playing Russian roulette
Russian roulette
Russian roulette is a potentially lethal game of chance in which participants place a single round in a revolver, spin the cylinder, place the muzzle against their head and pull the trigger...

," because "there is no way of knowing just what a heroin dealer has slipped into the packets." In some cases, if a dealer does not take the time to dilute the drug with lactose or other fillers, a "very potent blend of heroin" is sold, which can lead to overdoses.

The most dangerous types of counterfeiting for recreational drug users are the use of chemical "enhancers" and the misrepresenting of drugs. When poor-quality cannabis is "spiked" with a dissassociative drug such as PCP
Phencyclidine
Phencyclidine , commonly initialized as PCP and known colloquially as angel dust, is a recreational dissociative drug...

, the user may experience extreme reactions. "The popularity of PCP and marijuana mixtures in some areas is highlighted by the report from Delaware that many teens who report they only use marijuana are surprised when they also test positive for PCP on urinalysis", because without their knowledge, the drug dealer had sprinkled PCP on the cannabis that they were purchasing to enhance its psychoactive effects. Claims that illegal drugs are routinely cut with substances such as rat poison and crushed glass, often cited in antidrug pamphlets, are largely unsubstantiated.

See also

  • Regulation of therapeutic goods
    Regulation of therapeutic goods
    The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency...

  • NAFDAC - Nigerian organization opposing rampant drug counterfeiting
  • Gentamicin
    Gentamicin
    Gentamicin is an aminoglycoside antibiotic, used to treat many types of bacterial infections, particularly those caused by Gram-negative organisms. However, gentamicin is not used for Neisseria gonorrhoeae, Neisseria meningitidis or Legionella pneumophila...

     — example of a drug with drastic health consequences if not appropriately prescribed, or unknowlingly prescribed in counterfeit form
  • Robert Courtney
    Robert Courtney
    Robert Ray Courtney is a former pharmacist who owned and operated Research Medical Tower Pharmacy in Kansas City, Missouri. In 2002 he was convicted of pharmaceutical fraud and sentenced to federal prison.-Early life and education:...

     — American pharmacist who dispensed diluted cancer drugs between 1991 and 2001
  • Counterfeit
    Counterfeit
    To counterfeit means to illegally imitate something. Counterfeit products are often produced with the intent to take advantage of the superior value of the imitated product...

  • Health care fraud
    Health care fraud
    Health Care Fraud includes health insurance fraud, drug fraud, and medical fraud.Health insurance fraud occurs when a company or an individual defrauds an insurer or government health care program, such as Medicare or equivalent State programs. The manner in which this is done varies, and persons...

  • Drug fraud
    Drug fraud
    Drug fraud is a type of fraud in which drugs, legal or illegal, are cut or altered in such a way that diminishes their value below that which they are sold for.- Illegal drug fraud :...

  • Pharmaceutical fraud
    Pharmaceutical fraud
    Pharmaceutical Fraud is activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company. The manner in which this is done varies, and persons engaging in fraud are always seeking new...

  • Counterfeit consumer goods
    Counterfeit consumer goods
    Counterfeit consumer goods, commonly called knock-offs, are counterfeit or imitation products offered for sale. The spread of counterfeit goods has become global in recent years and the range of goods subject to infringement has increased significantly...

  • Authentication
    Authentication
    Authentication is the act of confirming the truth of an attribute of a datum or entity...

  • Security printing
    Security printing
    Security printing is the field of the printing industry that deals with the printing of items such as banknotes, passports, tamper-evident labels, product authentication, stock certificates, postage stamps and identity cards...

  • VAWD
    VAWD
    The Verified-Accredited Wholesale Distributors program was established in 2004 to help protect the public from thethreat of counterfeit drugs. The VAWD program was developed and is administered by the National Association of Boards ofPharmacy...

  • Epedigree
    Epedigree
    An epedigree is an electronic document which provides data on a the history of a particular batch of a drug. It satisfies the requirement for a 'drug pedigree' while using a convenient electronic form.-Pedigree:The U.S...


External links

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