Counterfeit drug

A counterfeit drug or a counterfeit medicine is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. For legal drugs, a counterfeit drug may be one which does not contain active ingredients, contains an insufficient quantity of active ingredients, or contains entirely incorrect active ingredients (which may or may not be harmful), and which is typically sold with inaccurate, incorrect, or fake packaging. Fake medicines and generic drugs which are deliberately mislabeled in order to deceive consumers are therefore counterfeit, while a drug which has not received regulatory approval is not necessarily so. Counterfeit drugs are also related to Pharma Fraud.

Most illegal drugs are produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness, at least to some degree. The counterfeiting ranges from drugs which do not contain any active ingredients (e.g., when a bag of lactose is sold as cocaine), to cases where the active ingredients are "cut" with a dilutant or "spiked" with a chemical "enhancer", to cases where the actual active ingredients differ from the purported active ingredients (e.g., when methamphetamine is sold as cocaine).

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 a number of dangerous consequences to their health, such as unexpected side effects, allergic reactions, or a worsening of their medical condition. A number of counterfeits do not contain any active ingredients, and instead contain inert substances, which do not provide the patient any treatment benefits. Counterfeit medications may also contain incorrect ingredients, improper dosages of the correct ingredients, or they may contain hazardous ingredients.

The extent of the problem of counterfeit drugs is unknown. Counterfeiting is difficult to detect, investigate, and quantify. So, it is hard to know or even estimate the true extent of the problem. What is known is that they occur worldwide and are said to be more prevalent in some developing countries with weak regulatory regimes. It is sometimes estimated that upwards of 10% of drugs worldwide are counterfeit, and in some countries more than 50% of the drug supply is made up of counterfeit drugs, although these claims may be substantially overstated. In 2003, the World Health Organization cited estimates that the annual earnings of counterfeit drugs were over US$32 billion [ [http://www.who.int/mediacentre/factsheets/2003/fs275/en/ WHO | Substandard and counterfeit medicines ] ] .

The high prices of patented medicines and the great divergence between manufacturing costs and prices are seen as important incentives for counterfeiting, including cases of high quality counterfeiting which can be difficult to detect. Fake antibiotics with a low concentration of the active ingredients can do damage world wide. Courses of antibiotics that are not seen through to completion allow bacteria to regroup and develop resistance.

There are several technologies that may prove helpful in combating this problem, such as 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 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) [Williams, J: "Healthcare Distributor", page 81. E.L.F. Publications, Inc., December 2006/January 2007 ] 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 anti-counterfeiting measures present concerns regarding privacy, or the possibility that drug manufactures will seek to use anti-counterfeiting technologies to undermine legitimate parallel trade in medicines. The term "counterfeit" should not be applied to generic drugs that are legally manufactured and sold, and which do not have deceptive labeling concerning the product. The BBC reported on a Nigerian woman, Dr. Dora Akunyili, who has been appointed to deal with the problem of fake drugs One woman's war with fake drugs. (2005). Retrieved on April 10, 2006, from http://news.bbc.co.uk/1/hi/programmes/this_world/4656627.stm] . According to these reports, many of the fake drugs came from the same countries that make normal drugs, especially China and India. In the case of India, while it is against the law to sell fake drugs for domestic use, there is no regulatory regime that applies to the export market.

China

Many counterfeit drugs sold in the Third World or on the Internet originate in China. The State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies. This regulatory hole, 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 effective regulation. [ [http://www.nytimes.com/2007/10/31/world/asia/31chemical.html "Chinese Chemicals Flow Unchecked to World Drug Market"] article reported by Walt Bogdanich, Jake Hooker and Andrew W. Lehren and written by Mr. Bogdanich in the New York Times October 31, 2007]

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.

Russia

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. [ [http://www.nytimes.com/2006/09/05/business/worldbusiness/05fake.html New York Times, Sept 5, 2006] ] .

India

According to a report released by the Organisation for Economic Co-operation and Development (OECD), 75 per cent of fake drugs supplied world over have some origins in India, followed by 7 per cent from Egypt and 6 per cent from China. [ [http://www.outsourcing-pharma.com/news/ng.asp?n=81178-oecd-counterfeit-drug-supply-chain New counterfeit report highlights worrying trends ] ] However, India also is a leading source of high quality drugs sold by legitimate drug manufacturers, including most leading brand name drug makers operating in the US and Europe.

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. [ [http://www.fda.gov/ola/2005/counterfeit1101.html,"Hearing on Counterfeit Drugs within the United States"] ] . 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. [ [http://imshealth.com/ims/portal/front/articleC/0,2777,6599_3665_83763126,00.html, "IMS Health Reports Global Prescription Sales Grew 6.4 Percent in 2007, to $712 Billion".] ] .

Anti-Counterfeit Platforms

In 2007, the world's first free to access anti-counterfeit platform was established in the West African country of Ghana. The platform 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 recently 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. [http://www.mPedigree.org] [ [http://allafrica.com/stories/200806200817.html allAfrica.com: Ghana: Country to Use SMS to Fight Fake Drugs (Page 1 of 1) ] ]

An Epedigree is another important system for the automatic detection of counterfeit drugs. States such as California are increasingly requiring pharmasuitical companies to generate and store [http://www.pharmacy.ca.gov/about/e_pedigree.shtml ePedigrees for each product they handle] . On January 5th, 2007 EPCglobal ratified the [http://www.epcglobalinc.org/standards/pedigree 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 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) or an "enhancer" (e.g., when poor-quality cannabis is "spiked" with PCP or methamphetamine), to cases where the actual active ingredients differ from the purported active ingredients (e.g., when methamphetamine is sold as LSD; when PCP is sold as "Ecstasy" or "pure THC"). A common strategy is to claim that a domestic or lower-grade drug is in fact a higher-priced import, as in the case where locally-grown hydroponic marijuana is marketed as expensive "Acapulco Gold", or when dealers claim that low-grade heroin is pure "China White".

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. "Spiking" drugs allows dealers to sell a product that creates a stronger psychoactive effect, or which camouflages the low potency of the ostensible product. For example, a low grade of psilocybin mushrooms that has very little active ingredients can be sprinkled with PCP. Substitution is often done to replace a more expensive or hard-to-produce drug with a less expensive drug.

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." [ [http://www.ncjrs.gov/App/publications/Abstract.aspx?id=182672 NCJRS Abstract - National Criminal Justice Reference Service ] ] 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 "sniff" 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 crack 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." [ [http://www.whitehousedrugpolicy.gov/publications/drugfact/pulsechk/summer97/pctrend2.html Office of National Drug Control Policy - Publications - Pulse Check: Trends in Drug Abuse, Summer 1997 ] ] "Dilutants and adulterants are often added to No. 3 heroin", including sugar, quinine, barbital and caffeine, some of which "can cause serious side effects." [ [http://hangoverguide.com/factbook/opi_burma.html Opium and Heroin production in Burma-Part1 |GlobalHangoverGuide® ] ] 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. [ [http://query.nytimes.com/gst/fullpage.html?res=9906E3D81238F937A3575AC0A962958260&sec=&spon=&pagewanted=2 Potent New Blend of Heroin Ends 8 Very Different Lives - New York Times ] ] 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 andmarijuana mixtures in some areas is highlighted by the report fromDelaware that many teens who report they only use marijuana aresurprised when they also test positive for PCP on urinalysis", [http://www.ncjrs.gov/txtfiles/p_5wpuls.txt] because without their knowledge, the drug dealer had sprinkled PCP on the cannabis that they were purchasing to enhance its psychoactive effects.

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 prescribedFact|date=August 2007, or unknowlingly prescribed in counterfeit formFact|date=August 2007.
* Robert Courtney — American pharmacist who dispensed diluted cancer drugs between 1991 and 2001.
* Counterfeit
* Drug fraud

References

* New Scientist - September 9, 2006

External links

* [http://www.pharmaceutical-manufacturingnews.com/news_index.php?itemID=84Anti-counterfeiting-tools-emerging Reorienting the anti counterfeiting tools in emerging nations] - Pharmaceutical Manufacturing News, 23/05/2008
* [http://www.pharmaceutical-manufacturingnews.com/perspectives_article.php?itemID=3counterfeit_drug_manufacturers-the_future_of_global-drug_safety-pharmaceutical_overview_perspectives Counterfeit drug - The Future of Global Drug Safety] - by Pharmaceutical Manufacturing News, 01/02/08
* [http://www.irishpatients.ie/] The Irish Patients Association
* [http://msnbc.msn.com/id/13099555/ "MSNBC Dateline" feature, June 2006]
* [http://www.fda.gov/oc/initiatives/counterfeit/qa.html Counterfeit Drugs - Questions and Answers] - by FDA
* [http://mednet3.who.int/prequal/documents/GMPWorkshop/1 Drug Regulation: Counterfeits Experience of Countries]
* [http://news.xinhuanet.com/english/2005-05/06/content_2922995.htm "Xinhua" article]
* [http://news.independent.co.uk/world/africa/article331948.ece Article on Dr. Dora's crackdown on counterfeit drugs] - by Independent Online Edition
* [http://www.who.int/mediacentre/factsheets/2003/fs275/en/ World Health Organization Fact Sheet on Counterfeit Drugs]
* [http://www.newscientist.com/search.ns?doSearch=true&query=fake+drugs New Scientist]
* [http://pubs.acs.org/subscribe/journals/ancham/79/i07/pdf/0407feature_mukhopadhyay.pdf The hunt for counterfeit medicine] from [http://pubs3.acs.org/acs/journals/toc.page?incoden=ancham&indecade=0&involume=79&inissue=7 the April 1, 2007 issue of "Analytical Chemistry"]
* [http://www.epcglobalinc.org EPCglobal's] [http://www.epcglobalinc.org/standards/pedigree Pedigree Standard] an XML description of the life history of a product
* [http://www.csma.ltd.uk/pharmaceutical/counterfeit-drugs.htm White Paper: Surface Analysis Exposes Counterfeit Medicines] - by CERAM Surface and Materials Analysis, September 2008