Counterfeit drugs

from Wikipedia, the free encyclopedia

A drug counterfeit or counterfeit drug is a product that has been deliberately and fraudulently labeled incorrectly - with regard to its identity, its ingredients and / or its origin. Both branded and generic products can be affected. In addition, “counterfeiting of medicinal products” also means counterfeiting of a medicinal product, i. H. the fraudulent exchange of an expensive drug for a cheap one (in the Middle Ages in Latin as sophisticatio , less often referred to as adulterare ).

Counterfeit drugs include products

  • without active ingredient ,
  • with the wrong active ingredient,
  • or adulterations with too little active ingredient ("diluted", "stretched", only containing partial amounts),
  • with counterfeit packaging and / or a counterfeit package insert.

Wrong ingredients or active substances can be harmless or dangerous substances. Examples of the former include baking soda , sawdust , chalk, and (for liquid medicines) colored water . Dangerous substances can be solvents such as diethylene glycol .

Spread and extent

Cases of counterfeit drugs have been documented since ancient times . The US Food and Drug Administration (FDA) estimates that over ten percent of all drugs worldwide are counterfeit. Medicines are more often counterfeited in countries where there are poor or no drug controls and health care is generally scarce. According to the World Health Organization (WHO), in most highly developed countries with effective licensing regulations such as the USA , Japan , Australia and the EU , the proportion of counterfeits in pharmaceutical sales is below 1 percent. In developing countries in Africa , Asia and Latin America, however, it is 10 to 30 percent. This also applies to the countries of the former Soviet Union .

Medicines with high sales or prices are particularly susceptible to counterfeiting . The most counterfeit drugs in developing countries are life-saving drugs : antibiotics , chemotherapeutic drugs, anti- malaria , tuberculosis and HIV / AIDS drugs . According to the results of several studies between 2000 and 2005, between 38 and 52 percent of all artesunate products against malaria in Southeast Asia contained no active ingredient and were therefore ineffective. In the period from 1999 to 2002, according to WHO data, 28 percent of counterfeit drugs were antibiotics, 18 percent hormones , 8 percent asthma drugs and 7 percent antimalarials.

In rich countries, counterfeits of new, expensive, so-called lifestyle drugs , such as hormones, steroids and antihistamines, are the most common . According to the WHO , Viagra is the most common counterfeit drug in the world. Growth hormones to build muscle, slimming pills and sleeping pills, as well as blood pressure and cholesterol lowering drugs also play a major role. The vast majority of counterfeits (almost 90 percent) in the European Union come from India , according to the Austrian Federal Ministry of Finance .

According to a study by the German Federal Criminal Police Office , the number of counterfeit drugs in Germany is not known, but - as in other EU countries - is estimated to be low. In 2006, the German customs authorities confiscated medicines worth around 2.5 million euros, and in 2007 they were worth 8.3 million euros. In 2007 the Federal Criminal Police Office recorded 2,400 cases of counterfeit drugs in Germany, most of which were traded on the Internet . Investigations by the Austrian Medicines Agency suggest a counterfeit rate of up to 95% for online orders.

In autumn 2008, an EU-wide coordinated customs campaign took place for the first time. As part of the “Medifake” operation, targeted customs controls were carried out for two months on the basis of a uniform EU risk profile in order to prevent the importation of illegal drugs. In this operation, the customs authorities of the 27 Member States seized more than 34 million tablets. Among other things, counterfeit antibiotics, cancer and malaria drugs, cholesterol-lowering drugs and pain relievers were found .

Manufacturing

Poverty is a major cause of the increased incidence of drug copies. Ignorance, high prices for medication and a lack of health insurance prompt consumers, who pay for themselves, often in developing and emerging countries, to organize their products outside the usual supply system. Counterfeiting medicines is a lucrative business because the demand is high and the production costs are low. The production of counterfeits requires only a sparse infrastructure and can therefore take place, for example, in ordinary households or in backyards and garages.

In many countries, the manufacturers of counterfeit goods hardly take any risks, since the local fines according to the legislation - if any - are minimal. Drug control regulations are rare. In such countries, therefore, counterfeits are particularly often sold or exported abroad. "Counterfeiting pharmaceuticals is much more profitable, technically problem-free, much more difficult to discover and, above all, sanctioned with much lower penalties than the manufacture and trade of illegal narcotic substances," explained Ulrike Holzgrabe , Professor of Pharmaceutical Chemistry and former President of the German Pharmaceutical Society (DPhG).

Role of the internet

In industrialized countries, counterfeit drugs are mainly offered and sold on the Internet. Mail order sales of pharmaceuticals has been permitted in Germany since January 2004 : since then, prescription drugs can also be ordered online with a prescription issued by a doctor . However, fraudsters are difficult to distinguish from reputable providers. According to research by the University of London , around half of all Viagrat tablets offered on the Internet are counterfeit.

Dangers to the consumer

In the best-case scenario, the regular intake of counterfeit drugs leads to a lack of therapeutic benefit. However, unexpected side effects , allergic reactions or a deterioration in the state of health can also occur. In the worst case, counterfeit drugs can lead to death. In 1996, 89 children in Haiti died of a cough syrup that had been diluted with the toxic solvent diethylene glycol. During a meningitis - epidemic were in Niger in 1995, more than 50,000 people a fake vaccine , which contained no active ingredient. 2500 people died as a result. The WHO estimates that one fifth of all deaths from malaria would be preventable if the antimalarial drugs available were all effective and used correctly. In numbers, this means 200,000 fewer deaths each year.

Economic impact

In 2003, the World Health Organization stated that manufacturers of counterfeit drugs around the world generated over $ 32 billion annually. According to a report by the Center for Medicines in Public Interest in the USA, the trend is rapidly increasing. The experts predict that worldwide sales of counterfeit drugs will total 75 billion US dollars by 2010, an increase of more than 90 percent compared to 2005. According to the Federal Ministry of Education and Research (BMBF), the German economy is created by counterfeit drugs every year an estimated loss of around five billion euros.

The counterfeits not only threaten health, safety and jobs, they also endanger competitiveness, trade and investment in research and innovation.

Combating counterfeit medicines

The WHO calls for targeted intervention by political decision-makers: They should develop strategies to reduce corruption and enforce stricter regulations. The WHO urges the police , customs and courts to cooperate more closely to curb the trade in counterfeit drugs. Greater cooperation at international level is also required.

legal framework

United States

Since 2004, the FDA in the USA has required that every single pharmaceutical packaging should be labeled in order to identify counterfeit drugs more easily ( e-pedigree ). The state of California was planning a corresponding law for 2009, postponed the start date initially to January 2011, now to 2015: According to the law, all individual products must then be given a unique number. Other US states are also in the process of drafting corresponding laws.

European Union

In the European Union (EU), measures are taken as a consequence of the pharmaceutical package , which are intended to make it even more difficult to bring counterfeit pharmaceuticals into circulation. At the European level, EFPIA , the European Association of the Research-Based Pharmaceutical Industry, deals with the implementation of individual packaging labeling and the effects on the supply chain .

Practical implementation with e-pedigree

With E-Pedigree , an “electronic drug family tree”, drugs should be able to be clearly identified and traced over their entire life cycle. This enables counterfeit drugs to be identified quickly. For this purpose, each individual drug pack is electronically marked with a unique serial number. The serial numbers are attached to the medication in coded form, read out if necessary and stored in the company's own databases .

Verification process

In Germany, an initiative made up of representatives from pharmacists , pharmaceutical wholesalers and the pharmaceutical industry is developing the securPharm system to protect against counterfeit drugs being placed on the market. A fictional drug tripapolon was created for this purpose . During verification process the packages to test and demonstrate the will of the counterfeit protection Directive 2011/62 / EU of the European Union used prescribed test systems. When the data matrix code of the drug pack is scanned in the pharmacy, the data contained therein is recorded: batch , expiry date , central pharmaceutical number and serial number . During the inquiry process, which is forwarded to the pharmacy server, this data is supplemented by the pharmacy's data, so that it is ensured that only real pharmacies use the system. The status of the pack stored in the manufacturer's database is checked and reported back to the pharmacy. If the package is not verified, it must be classified as potentially counterfeit.

IT'S TRUE

The IT'S TRUE system is a database-supported security system that has been in use in Germany since 2009 and is also suitable for medication. It offers in addition to securing the supply chain via an end-to-end control of the end user the option of using a smart phone - app or Internet - or SMS query to check whether a product is genuine. In addition, the IT'S TRUE seal also covers the manipulation protection of the packaging (tamper-evident) required by the EU . A similar system was tested in Ghana in 2007 as part of the mPedigree project to identify counterfeit drugs: the customer sends a free SMS to the platform with the serial number of the drug purchased . He receives a text message back confirming the authenticity of the preparation. A first two-month test in the cities of Kumasi and Accra took place in early 2008. In cooperation with Ghana's Ministry of Health, Ghana's Food and Drugs Board, mobile phone providers in Africa and the leading associations of the pharmaceutical industry, the SMS system is to be gradually expanded.

Methods of Identifying Counterfeit Medicines

Chromatography

Thin-layer chromatography (TLC) can be used to provide quick, easy and inexpensive evidence of whether counterfeit drugs contain the wrong, no or too little active substance. For this purpose, the results of the DC with regard to identity and content are compared with the information on the drug package. If there is no agreement or if it is inconclusive, the drug concerned is sorted out and further forensic examinations, e.g. B. the high pressure liquid chromatography (HPLC) fed. The need for the use of thin-layer chromatography as a rapid screening method to protect patients from counterfeit drugs is growing, especially in developing countries. Appropriately prefabricated kits ready for air delivery already exist for international health aid.

Raman Spectroscopy

With the help of Raman spectroscopy , the chemical composition of a drug can be checked. The technology also identifies tablets within a blister with low sensitivity ; it cannot be used with non-transparent plastic bottles. In addition, this method only records the surface of a tablet. To grasp the inside, the tablet must be broken in two. A modern variant of Raman spectroscopy , Spatially Offset Raman Spectroscopy (SORS), enables the contents of blisters and plastic bottles to be identified with high sensitivity without opening them.

NIR microscopy ( Near infrared microscopy )

Using NIR microscopy , scientists at the University of London were able to distinguish fake from real Viagratablets.

EDXRD

The company X streams system brought in 2007 for the first time a EDXRD system ( Energy Dispersive X-Ray Diffraction ) on the market that the chemical composition of drugs in their packaging with the help of X-rays identified.

Web links

Individual evidence

  1. ↑ forgery . Duden
  2. ↑ Konrad Goehl : Observations and additions to the 'Circa instans'. In: Medical historical messages. Journal for the history of science and specialist prose research. Volume 34, 2015 (2016), pp. 69–77, here: pp. 69–73.
  3. ↑ Ernst W. Stieb: Drug adulteration and its detection in the writings of Theophrastus, Dioscorides and Pliny. In: Journal Mondial de Pharmacie. Volume 2, 1985, pp. 117-134.
  4. ^ Robert Cockburn, Paul N Newton, and a .: The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers. In: PLoS Medicine. 2, 2005, p. E100, doi: 10.1371 / journal.pmed.0020100 .
  5. ↑ WHO publication on counterfeit drugs November 2006 (PDF; 75 kB)
  6. ↑ a b c d e f g h WHO factsheet on counterfeit drugs 2003 ( Memento of April 28, 2012 in the Internet Archive ).
  7. ^ Paul N Newton, Rose McGready et al. a .: Manslaughter by Fake Artesunate in Asia — Will Africa Be Next ?. In: PLoS Medicine. 3, 2006, p. E197, doi: 10.1371 / journal.pmed.0030197 .
  8. ^ Counterfeit Drugs kill . (PDF; 3.9 MB) WHO brochure.
  9. ^ Report on product piracy by the Austrian Federal Ministry of Finance ( Memento from December 6, 2008 in the Internet Archive ) (PDF; 1.8 MB)
  10. ↑ ( Page no longer available , search in web archives: Drug crime - a growth market? An exploratory investigation from a police perspective )@1@ 2Template: Dead Link / www.bka.de
  11. ↑ Christoph Baumgärtel: Counterfeit drugs from the Internet . In: Austrian Pharmacists Association, Association of Employed Pharmacists Austria (Ed.): Österreichische Apotheker-Zeitung . tape 68 , no. 6 . Österreichische Apotheker-Verlagsgesellschaft, Vienna March 17, 2014, p. 15–17 ( AGES fakes [PDF; accessed on March 18, 2014]).
  12. ↑ Press release EU Commission (PDF)
  13. ↑ quoted from: Arzneimittel-Fälchungen , lecture by Prof. Harald Schweim at the University of Bonn, 2007.
  14. ↑ Article in ABC Science September 2004
  15. ↑ 21st Century Healthcare Terrorism - The Perils of international drug counterfeiting ( Memento of March 17, 2012 in the Internet Archive ) (PDF; 174 kB)
  16. ↑ BMBF press release ( Memento from March 30, 2009 in the Internet Archive )
  17. ↑ FDA website on the subject of ePedigree ( Memento from May 13, 2009 in the Internet Archive )
  18. ↑ Article on ePedigree in California on FDAlediglativewatch.com ( Memento from April 20, 2008 in the Internet Archive ).
  19. ↑ Coding & Identification. ( Memento of March 18, 2009 in the Internet Archive ) European Federation of Pharmaceutical Industries and Associations (EFPIA)
  20. ↑ secur Pharm
  21. ↑ Article on IT'S TRUE. Abendblatt.de
  22. ↑ Application of the IT'S TRUE code in practice
  23. ↑ Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of December 15, 2010 (PDF)
  24. ↑ website of mPedigree
  25. ^ Website of the Global Pharma Health Fund
  26. ^ Website of the Science and Technology Facilities Council
  27. ↑ Article.  ( Page no longer available , search in web archives )  Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. Photonics.com@1@ 2Template: Dead Link / www.photonics.com  
  28. ↑ Central Laser Facility Annual Report 2006/2007  ( page no longer available , search in web archives )  Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice.@1@ 2Template: Dead Link / www.clf.rl.ac.uk  
  29. ↑ Article on News-Medical.net
  30. ↑ Press release X Streams System .