Counterfeit medications

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. 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. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs.^[1]

Illegal drugs of abuse 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., PCP), to cases in which the actual active ingredients present differ from those claimed (e.g., when methamphetamine is sold as cocaine).

Legitimate, correctly labeled, low-cost generic drugs are not counterfeit or fake (although they can be counterfeited), but can be caught up in anticounterfeiting enforcement measures.^[2] 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".^[2] Generic drugs are subject to normal regulations in countries where they are manufactured and sold.

Prescription and over-the-counter drugs

Bulk bag of counterfeit Viagra

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 consequences, including side effects or allergic reactions, 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^[which?] it is more common in some developing countries with weak regulatory or enforcement regimens. 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.^[3]

The considerable difference between the cost of manufacturing counterfeit medication and price 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]}

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 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)^[4] can be used to discover counterfeit drugs while still inside their packaging. [2]

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. ^[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

Further information: Pharmaceutical industry in 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.^[5] On May 6, 2005, the Chinese press agency Xinhua reported that the World Health Organization had established Rapid Alert System, 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 antimalarial drugs with the label of "made in India", but found the medicines were in fact produced in China and were imported into the African countries.^[6] 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.^[7]

India

According to a report released by the Organisation for Economic Co-operation and Development (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.^[8] 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.^[9] 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.^[10]

Anticounterfeit platforms

In 2007, the world's first free-to-access anticounterfeit platform^[11] was established in the West African country of Ghana. The platform, dubbed mPedigree,^[12] 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.^[11][13]

In 2010, NAFDAC in Nigeria launched an SMS-based anticounterfeiting platform using technology from Sproxil.^[14][15] That system was also adopted by GlaxoSmithKline (GSK) in February 2011.^[16] In April 2011, CNN published a video highlighting Sproxil's solution in the fight against counterfeit drugs in Nigeria.^[17] In July 2011, Kenya's Pharmacy and Poisons Board also adopted text message-based anticounterfeiting systems and endorsed the Sproxil solution.^[18]

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 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, 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 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 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 is sold as cocaine). A common strategy is to claim a domestic or lower-grade drug is in fact a higher-priced import.^{[citation needed]}

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."^[19] 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."^[20] "Diluents and adulterants are often added to No. 3 heroin", including sugar, quinine, barbital and caffeine, some of which "can cause serious side effects."^[21] 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.^[22]

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, 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",^[23] 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.^[24]

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
• Health care fraud
• Drug fraud
• Pharmaceutical fraud
• Counterfeit consumer goods
• Authentication
• Security printing
• VAWD
• Epedigree

References

1. ^ Mark Davison, "Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs", Wiley, 2011, 426pp
2. ^ ^{a b} Kaitlin Mara, Coverage Of Anti-Counterfeit Policy Debate Varies Widely Across Global Media, Intellectual Property Watch, 2 August 2010. Consulted on August 11, 2010.
3. ^ WHO | Substandard and counterfeit medicines
4. ^ Williams, J: "Healthcare Distributor", page 81. E.L.F. Publications, Inc., December 2006/January 2007
5. ^ "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
6. ^ India lodges protest with China over Indian tag on fake drugs
7. ^ Kramer, Andrew E. (5 September 2006). "Drug Piracy: A Wave of Counterfeit Medicines Washes Over Russia". The New York Times: p. 1. http://www.nytimes.com/2006/09/05/business/worldbusiness/05fake.html. Retrieved 3 February 2011. 
8. ^ New counterfeit report highlights worrying trends
9. ^ "Hearing on Counterfeit Drugs within the United States"
10. ^ "IMS Health Reports Global Prescription Sales Grew 6.4 Percent in 2007, to $712 Billion".
11. ^ ^{a b} http://www.mPedigree.net
12. ^ Sample news report here: http://news.myjoyonline.com/health/200803/14868.asp
13. ^ allAfrica.com: Ghana: Country to Use SMS to Fight Fake Drugs (Page 1 of 1)
14. ^ "Sproxil fight against counterfeit drugs"
15. ^ [1]
16. ^ "GSK protects Ampiclox using Sproxil technology"
17. ^ "CNN.com Video". CNN. http://edition.cnn.com/video/?/video/international/2011/04/04/mpa.purefoy.drugs.battle.cnn. 
18. ^ "Kenya plans national roll-out of mobile anti-counterfeiting tech"
19. ^ NCJRS Abstract - National Criminal Justice Reference Service
20. ^ Office of National Drug Control Policy - Publications - Pulse Check: Trends in Drug Abuse, Summer 1997
21. ^ Opium and Heroin production in Burma-Part1 |GlobalHangoverGuide
22. ^ Tr, Joseph B. (September 4, 1994). "Potent New Blend of Heroin Ends 8 Very Different Lives". The New York Times. http://query.nytimes.com/gst/fullpage.html?res=9906E3D81238F937A3575AC0A962958260&sec=&spon=&pagewanted=2. Retrieved April 30, 2010. 
23. ^ http://www.ncjrs.gov/txtfiles/p_5wpuls.txt
24. ^ http://www.drugscope.org.uk/resources/mediaguide/ecstasymyths.htm

• New Scientist - September 9, 2006

External links

• Counterfeit Drugs Market-Havocscope Black Markets
• Chinese passing off fake drugs as "Made in India"
• 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 Canada