Counterfeit drug

From Wikipedia, the free encyclopedia

1 Overview
2 Chinese counterfeit drugs
3 Russian counterfeit drugs
4 Counterfeit drugs in India
5 Counterfeit drugs in the United States
6 Bacterial Resistance
7 Television
8 See also
9 References
10 External links

A counterfeit drug or a counterfeit medicine is a medication which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. The common street term for counterfeit drug is "beat bag" or "bunk bag". 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.

[edit] Overview

Counterfeit drugs can generally be classified by the following characteristics:

falsely-labeled drugs that were previously expired, defective or otherwise deemed unfit for use;
falsely-labeled drugs wherein the active ingredient is fraudulently diluted;
falsely-labeled drugs wherein the active ingredient is adulterated;
falsely-labeled drugs wherein the active ingredient is substituted;
falsely-labeled substances of any composition wherein the active ingredient is completely misrepresented; or
falsely-labeled drugs where the name of the manufacture is fraudulently misrepresented, but where the active ingredient is of high quality;

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 ^[1].

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.

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)^[2] can be used to discover counterfeit drugs while still inside their packaging. [1]

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.

[edit] Chinese counterfeit drugs

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.^[3]

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.

[edit] Russian counterfeit drugs

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. ^[4].

[edit] Counterfeit drugs in 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. ^[5] 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.

[edit] Counterfeit drugs in the 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. ^[6]. 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. ^[7].

[edit] Bacterial Resistance

Fake antibiotics with a low concentration of the active ingredients can do damage world wide. Courses of antibiotics that aren't seen through to completion allow bacteria to regroup and develop resistance.

[edit] Television

The BBC, along with many other news outlets, reported on a Nigerian woman, Dr. Dora Akunyili, who has been appointed to deal with the problem of fake drugs ^[8]. 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.

[edit] 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