You Bet Your Life: The Fakes. A Lesson For You In Loss Prevention.
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).
You Bet Your Life: Brand Piracy. 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. 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. In 2003, the World Health Organization cited estimates that the annual earnings of counterfeit drugs were over $32 billion (US).
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.
Above Photo: Which are real and which are fake? Without traceability and authentication, how do you know? Would “You Bet Your Life” on not knowing?
You Bet Your Life: Some Solutions (RFID & Mass Serialization).
There are several technologies that may prove helpful in combating this problem, such as radio frequency identification (RFID). These are 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 spectroscopy and Energy Dispersive X-Ray Diffraction (EDXRD) can be used to discover counterfeit drugs while still inside their packaging.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. According to BBC 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.
Graph Above: The top 5 anti-counterfeiting techniques are date codes, various printing, tamper evident, UPC codes, and mass serialization.
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.
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
A few years ago, 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.
India
According to a report released by the Organization 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. It must be noted that 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) holds regular hearings to review trends and problems. 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.
You Bet You Life: 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.
An Epedigree is another important system for the automatic detection of counterfeit drugs.
Photo Above: Hard copy of typical pedigree papers.
Photo Above: Pedigree papers can provide traceability of your prescription medications.
States such as California are increasingly requiring pharmaceutical companies to generate and store ePedigrees for each product they handle. On January 5th, 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.
You Bet Your Life: 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, this is the exception. The illegal “brands” can also be counterfeited by drug dealers who want to be able to sell their product at a higher price.
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.” 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. Dr. Hirsch, the New York Medical Examiner, claimed that buying illegal drugs is “… like playing Russian roulette.”
This is why we say that if you take prescription medications without “drug authentication”, you are playing a dangerous game of “You Bet Your Life“.
End.
Below: Article break. Are prices “sky high”?
