Counterfeit medicine

Counterfeit drugs pose a serious threat to public health. According the World Health Organization, a counterfeit medicine is one... 

Monitor the quality and safety of medicines on the market to prevent harmful, substandard and counterfeit medicines from reaching the public... 

Although even quality issues are still a problem (poor quality of starting materials including active pharmaceutical ingredients, quality problems with finished dosage forms, spreading of counterfeit medicines) it is likely that new technologies... 

The below definition needs some explanatory words (Box 5). A first aspect to consider is that counterfeiting implies the intention to cheat those who receive the medicine - either in the distribution chain or as patients. This is important because it permits to make necessary distinction between counterfeit medicines and sub-standard medicines. Counterfeit medicines are sub-standard because they are manufactured and distributed out of control and their composition is unpredictable. On the other hand, not all sub-standard medicines are counterfeits. Substandard products are genuine products, manufactured by officially licensed manufacturers, which do not meet quality specification set for them. All substandard products are manufactured without compliance with Good Manufacturing Practices (GMP) and other regulatory requirements established by the competent national regulatory authorities in order to ensure that efficacy and safety of medicines is not affected by quality problems. 

Another aspect to consider is that experiences have shown that there are so many different kinds of counterfeit medicines. Counterfeiters have targeted... 

WHO defines counterfeit medicine as one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products, and may include products with ... 

Nobody knows the precise dimensions of the counterfeit medicines problem. Counterfeits are difficult to detect, investigate, quantify. Rough estimates, mainly based on unpublished reports and studies focused on specific medicines or geographical areas, suggest that up to 10% of the medicines circulating in the world could be counterfeit. This... 

A few elements may explain why criminals engage in counterfeiting medicines ... 

It is relatively easy to hide and smuggle medicines. No country can count on customs controls specialized in combating counterfeit medicines. Customs control is not helped by liberalization of international commerce and the growing number of natural products , nutritional supplements and other products non-classified as pharmaceuticals that use packaging and forms more and more similar to those of medicines. 

IV.a.5. What Factors Make Circulation of Counterfeit Medicines Possible ... 

Criminality does not explain everything. Many factors favour the development of counterfeiting and trade of counterfeit medicines. We shall mention some of these factors with the understanding that their importance varies considerably among the different countries. 

Combating counterfeit medicines requires the collaboration, at national, regional and international level, among several institutions and several groups representing the civil society. Each has a role to play, but it is necessary that collaboration be based on free circulation of information and frank discussion of problems. 

Pharmaceutical distributors, wholesalers, importers, exporters, all those involved in the distribution chain are key players that, maybe more than others, should improve their capacity to combat counterfeit medicines. It is through the distribution chain that counterfeit medicines reach patients. It is therefore essential that distributors, wholesalers, importers, exporters develop and effectively implement business practices that make the distribution chain as impermeable as possible to counterfeits and open to appropriate verification by national authorities. It is known that in many countries unauthorized trade is widespread and that it is difficult to get unauthorized traders to respect rules and regulations. Yet, if unauthorized trade is the result of many factors, local distributors and retail pharmacists may find themselves part of the problem (for having left important areas of the country without effective supply mechanisms)... 

Counterfeiting medicines, including the entire range of activities from manufacturing to providing them to patients, is a vite and serious criminal offence that puts human lives at risk and undermines the credibility of health systems. 

Because of its direct impact on health, counterfeiting medicines should combated and punished accordingly. 

Combating counterfeit medicines requires the coordinated effort of all the different public and private stakeholders that are affected and are competent for addressing the different aspects of the problem. 

Counterfeiting medicines is widespread and has escalated to such an extent that effective coordination and cooperation at the international level are necessary for regional and national strategies to be more effective. 

National, regional and international strategies aimed at combating counterfeit medicines should be based on ... 

Other actors of the public sector and the civil society can contribute to combating counterfeit medicines. Purchasing organizations and NGOs should seriously consider the risk that their operations can be affected by counterfeits and develop appropriate procurement procedures and be vigilant on the field in order to be able to signal suspected cases. 

And what can consumers or patients do Fear all medicines they come across No, counterfeit medicines are not invariably present in all pharmacies and hospitals. Consumers should learn to go back to their pharmacist or their doctor when they feel that the medicines they regularly takes seem to work differently, when a new medicine does not work as expected, or every time they experience a side effect. In most cases there will be no counterfeit medicine to blame. However, it is important that patients know what to do when they have a doubt about a medicine. Consumers should always purchase medicines from the officially licensed outlets as there is evidence that the incidence of counterfeits medicines is much lower in licensed outlets. 

It is on this basis that WHO has lead the establishment of the International Medical Product Anti-Counterfeiting Taskforce, IMPACT (www.who.int/ impact). IMPACT aims at gathering and mobilizing all key stakeholders at the international, regional and national level in order to effectively combat counterfeit medicines within the guiding principles enshrined in the Declaration of Rome (Box 7). 

The BP Commission can also call on expertise available in the British Pharmacopoeia laboratories situated in the premises of the Laboratory of the Government Chemist in West London. The BP laboratory carries out and validates assay procedures for the Commission and in addition, is responsible for the procurement, establishment, maintenance and sale of British Pharmacopoeia Chemical Reference Substances (BPCRS). These reference substances, as their name suggests, are authentic samples of a drug or decomposition product which are used as standards in a drug assay. The BP laboratory also fulfils an important forensic role in the control of counterfeit medicines. With the advent of the internet, the public can easily gain access to supplies of prescription-only medicines online. These medicines are often adulterated, contaminated or simply counterfeit, and comparison with authentic samples is necessary to ensure that the correct preparation is supplied. 

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