Counterfeit medications
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A counterfeit medication or a counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. Generic drug products or drug products whose only violation is that of patent laws are not counterfeit drug products.[who?] A counterfeit drug may contain inappropriate quantities of active ingredients, may be improperly processed within the body (e.g., absorption by the body), or may contain ingredients that are not on the label (which may or may not be harmful), and is often sold with inaccurate, incorrect, or fake packaging and labeling. Medicines which are deliberately mislabeled in order to deceive consumers are therefore counterfeit. A drug which has not received regulatory approval is not necessarily a counterfeit.[citation needed] Counterfeit drugs are also related to Pharma Fraud.
Illegal drugs 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 ingredients (e.g., when a bag of powdered lactose is claimed to be cocaine), 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., strychnine or PCP), to cases in which the actual active ingredients present differ from those claimed (e.g., when methamphetamine is sold as cocaine).
Fake drugs, i.e. dangerous or ineffective drugs, should not confused with legitimate, low-cost generics, "often the only medicines the poor can afford".[1] 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 rights".[1]
Prescription and over-the-counter drugs
Counterfeit legal drugs include falsely-labeled drugs that were previously expired, drugs where the active ingredient is fraudulently diluted, adulterated, substituted, completely misrepresented, or sold with a false brand name. An individual who uses a low quality counterfeit medication may experience any of several dangerous health consequences; examples include side effects, allergic reactions, or a worsening of their medical condition due to lack of expected clinical effect. Many counterfeits do not contain any active ingredients at all, instead being made from inert substances, which provide no clinical benefit to the patient. Counterfeit medications may also contain incorrect ingredients, improper dosages of the correct ingredients, or contain actually hazardous 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[which?] that it is more common in some developing countries with weak regulatory or enforcement regimes. It is estimated[by whom?] 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 cited estimates that the annual earnings of counterfeit drugs were over US$32 billion [2].
The considerable difference between the cost of manufacturing counterfeit medication and price that counterfeiters charge is a lucrative incentive. Fake antibiotics with a low concentration of the active ingredients can do damage world wide by stimulating the development of drug resistance 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.[citation needed]
There are several technologies that 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 numbers 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 and Energy Dispersive X-Ray Diffraction (EDXRD)[3] can be used to discover counterfeit drugs while still inside their packaging. [1]
Some of the proposed anti-counterfeiting measures provoke privacy concerns, or the possibility that drug manufactures will seek to use anti-counterfeiting technologies to undermine legitimate parallel trade in medicines. [discuss] According to these reports[which?], many of the fake drugs came from the same countries that make normal drugs, in particular China and India. 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.[4] On May 6, 2005, the Chinese press agency Xinhua reported that the World Health Organization had established Rapid Alert System (RAS), the world's first web-based system for tracking the activities of drug counterfeiters, in light of the increasing severity of the problem of counterfeit drugs.
June 2009, Nigeria has seized a large consignment of fake anti-malarial drugs with the label of 'made in India' but found that the medicines were in fact produced in China and were imported into the African countries.[5] The authorities have maintained that the incident is not isolated, indicating that 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 that 12 percent of the prescription drugs distributed in Russia were counterfeit.[6].
India
According to a report released by the Organisation for Economic Co-operation and Development (OECD), 7.5 percent of fake drugs supplied world over have some origins in India, followed by 7 percent from Egypt and 6 percent from China.[7] However, India also is a leading source of high quality generic and patent drugs in legitimate commerce worldwide.
United States
The United States has had a growing problem with counterfeit drugs, and to help address it, the U.S. Food and Drug Administration (FDA) held a Congressional hearing in 2005 to review the situation.[8] The U.S. is an especially attractive market for counterfeiters because 40 percent of worldwide annual prescription drug sales were sold in the United States in 2007.[9]
Anti-counterfeit platforms
In 2007, the world's first free to access anti-counterfeit platform[10] was established in the West African country of Ghana. The platform, dubbed mPedigree[11], 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 FDB (Food & Drugs Board), to move the platform from pilot to full-deployment stage.[10][12]
An Epedigree 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 ratified the Pedigree Standard as an international standard that specifies an XML description of the life history of a product across an arbitrarily complex supply chain.
Illegal drugs
Illegal drugs can be counterfeited easily because the illegal drug market is an unregulated underground economy that rarely adheres to quality norms or safety standards. While there are some isolated examples of illegal drugs being sold under "brand names" that indicated that certain standards or dosage levels were being adhered to, as in the case of 1960s-era LSD 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 product at a higher price.
For illegal and recreational drugs, counterfeit drugs range from products which do not contain any active ingredients, 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 dilutant (as in cases where cocaine is mixed with lactose powder), to cases where the actual active ingredients differ from the purported active ingredients (e.g., when methamphetamine is sold as cocaine). A common strategy is to claim that a domestic or lower-grade drug is in fact a higher-priced import.[citation needed]
All of these strategies are commonly used in the illegal drug market. Cutting drugs with dilutants increases the bulk of the drug, which increases the profit margin for the drug dealer. Substitution is often done to replace a more expensive or hard-to-produce drug with a less expensive drug.[citation needed]
The use of dilutants in illegal drugs reduces the quality and potency of the drugs, and makes it hard for users to determine the appropriate dosage level. Dilutants include "foodstuffs (flour and baby milk formula), sugars (glucose, lactose, maltose, and mannitol), and inorganic materials such as powder." [13] The type of dilutants that are used often depend on the way that the drug purchasers will typically consume the drug in a given part of the illegal market. Drug dealers that are selling heroin to users who will inject the drug dilute the drug with different products than dealers that are selling to users who will smoke or insufflate the drug; the same dilutant 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 dilutants for the purpose of injection, the "...dilutants can produce serious abscesses and pain if the user misses the vein and injects into muscle tissue." [14] "Dilutants and adulterants are often added to No. 3 heroin", including sugar, quinine, barbital and caffeine, some of which "can cause serious side effects."[15] Dr. Hirsch, the New York Medical Examiner, claimed that buying illegal drugs is "... like playing Russian roulette," 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.[16]
The most dangerous types of counterfeiting for recreational drug users are the use of chemical "enhancers" and the mis-representing of drugs. When poor-quality cannabis is "spiked" with a dissassociative drug such as PCP, the user may experience extreme reactions. In cases where the actual active ingredients differ from the purported active ingredients, a user expecting one drug actually consumes a different drug. "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",[17] 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 anti-drug pamphlets, are largely unsubstantiated.[18]
See also
- Regulation of therapeutic goods
- NAFDAC - Nigerian organization opposing rampant drug counterfeiting.
- Gentamicin — example of a drug with drastic health consequences if not appropriately prescribed[citation needed], or unknowlingly prescribed in counterfeit form[citation needed].
- Robert Courtney — American pharmacist who dispensed diluted cancer drugs between 1991 and 2001.
- Counterfeit
- Drug fraud
- Counterfeit consumer goods
- Authentication
- Security printing
References
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External links
www.dir-technologies.com pharmaceutical quality assurance
- [2] Chinese passing off fake drugs as "Made in India"
- [3] The Irish Patients Association
- MSNBC Dateline feature, June 2006
- Counterfeit Drugs - Questions and Answers - by FDA
- Drug Regulation: Counterfeits Experience of Countries
- Xinhua article
- Article on Dr. Dora's crackdown on counterfeit drugs - by Independent Online Edition
- World Health Organization Fact Sheet on Counterfeit Drugs
- New Scientist
- The hunt for counterfeit medicine from the April 1, 2007 issue of Analytical Chemistry
- EPCglobal's Pedigree Standard an XML description of the life history of a product
- White Paper: Surface Analysis Exposes Counterfeit Medicines - by CERAM Surface and Materials Analysis, September 2008
- EDQM Committee of Experts on counterfeit medicines The anti-counterfeiting activities of Council of Europe and EDQM (European Directorate for the Quality of Medicines and Healthcare)
- Counterfeit Pharmaceuticals in Canadanl:Vervalst geneesmiddel
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- Drugs
- Pharmaceutical industry
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