The issue of counterfeit medicines was mainly associated with developing countries, however it has now become of significant concern world-wide. While the exact extent of the problem is still unknown, the prevalence of counterfeit medicines is increasing, with a shift in focus from life style medicines to life saving medicines. As compared to 2005 the EU registered an increase of 380% of counterfeit medicines seized at EU borders in 2007.peer-reviewe

Cordina, Maria

OAR@UM

Issue 16  Summer 20104          Journal of the Malta College of Pharmacy PracticeIntroductionWithin the European Union counterfeiting of medicines has been identified as a significant concern for patient safety, for industry and for policy makers both at EU level and at national level.2 While counterfeit medicines have been around for some time, the original approach to dealing with this problem was to do so in a subtle manner so as not to undermine the patient’s confidence in medicines and not to cause any unnecessary harm to legitimate business.3 The approach has now changed and all stake Counterfeit medicinesMaria Cordina BPharm(Hons), PhD(QUB)Senior Lecturer, Department of Pharmacy, University of Malta, Msida, MaltaPresident, Malta College of Pharmacy PracticeEmail: maria.cordina@um.edu.mtholders are urged to become involved and give their contribution to managing and containing this global problem. Consumers and public interest groups are encouraged to participate in medicine regulation.4   Defining the problemCounterfeit medicines have been defined as ‘medicines which are deliberately and fraudulently mislabelled with respect to their identity and/or source. Counterfeiting can apply both to branded and generic products and counterfeit products may include products with the correct ingredients or the wrong ingredients, without active ingredients or with insufficient active ingredient or with fake packaging.’5Counterfeit medicines are not just substandard medicines, where in the latter case there are problems with the manufacturing process by a known manufacturer. Counterfeit medicines are made by (unknown) people with the intention to deceive and who have no regard whatsoever for patient health and safety. Engaging in the counterfeiting of medicines has the potential for making enormous profits and counterfeiters have the possibility of quickly adapting and adjusting to different situations and products to maximise their profits.6Over recent years there has been a sharp increase in counterfeit medicines seized by customs at EU borders. It is estimated that in industrialised countries counterfeit medicines have a market share of 1%.7 As evidenced by reports from various national drug agencies, initially counterfeiters targeted lifestyle medicines such as erectile dysfunction and anti-obesity drugs, however they have now shifted their focus to lifesaving drugs such as those used in the treatment of cardiovascular disease, infections and cancers to mention a few.8, 9 Apart from using the internet, counterfeiters are also now targeting the licensed distribution chain including wholesalers and pharmacies as this gives them the ability to deal in large volumes of distribution of medicine.The legitimate distribution chain is a rather complex one and offers counterfeiters a good opportunity to infiltrate the system. Once a counterfeit product has entered the legitimate system, it becomes rather difficult to detect. When considering the EU, counterfeit medicines are usually produced outside the EU and then ‘imported for export’, i.e. when these products are allegedly not placed on the market in the EU but enter customs territory under transit rules and undergo further minor processing. While they should not be made available within the EU, these medicines can be redirected and enter the legal distribution chain. As in the case with Malta, where to date no cases of counterfeits were found and reported in the legal supply chain, counterfeit drugs are often detected in T1 transit, such as in customs territory where non-EU goods are stored and handled.1The issue of counterfeit medicines was mainly associated with developing countries, however it has now become of significant concern world-wide. While the exact extent of the problem is still unknown, the prevalence of counterfeit medicines is increasing, with a shift in focus from life style medicines to life saving medicines. As compared to 2005 the EU registered an increase of 380% of counterfeit medicines seized at EU borders in 2007.1Key wordscounterfeit medicines, patient safety, burden of counterfeit medicinesEducational aims•	 To	increase	awareness	regarding	counterfeit	medicines•	 To	highlight	the	threat	to	patient	safety•	 To	dispel	common	misconceptions•	 To	encourage	health	care	professionals	to	participate	in	medicines	regulationIssue 16  Summer 2010 Journal of the Malta College of Pharmacy Practice          5Misconceptions a regarding counterfeit medicinesOne of the main misconceptions is that counterfeiting of medicines is a problem which only affects developing countries. While the areas which are the most affected are indeed developing countries, Europe and the rest of the industrialised world is increasingly being targeted as can be seen in Table 2. In developing countries antibiotics and anti-protozoals such as anti-malarial medicines are commonly counterfeited while in developed countries hormones and steroids account for the majority of the cases reported.7It is commonly thought that these are harmless copies or concern issues not affecting the health of the patient but just intellectual property since it is erroneously assumed that only branded products are targeted. As can be seen from the definition, this is not the case as both generics and branded products may be targeted for counterfeiting. Counterfeiters target medicines that can provide them with the largest profit and lucrative markets i.e. high consumption and expensive medicines are main targets.Another misconception is that it is easy to tell the difference between a counterfeit medicine and an authentic medicine. This is not the case at all. With the technology currently available counterfeiters are able to make their product nearly identical to the original both in the case of the appearance of the medicine itself as well as the packaging. It often requires laboratory analysis to determine if a product is counterfeit.Threat to patient safetyThe threat to patient safety is significant. Counterfeit medicines could possibly not contain the correct active ingredient or contain the correct active ingredient in sub-therapeutic quantities alternatively they may contain toxic materials which result in the patient being poisoned. In 2009 during the Influenza A (H1N1) pandemic significantly more reports were registered regarding the increased occurrence of counterfeit medicines. Counterfeiters identified this as a window of opportunity to sell fraudulent, adulterated or unauthorized antiviral medication or vaccines, via the Internet. 11  Currently the over-the-counter anti-obesity drug,  Alli®, has been targeted by counterfeiters and is available over the internet. The FDA has warned that instead of the registered active ingredient orlistat, the preparation contains sibutramine, with patients taking up to twice the recommended maximum dose of the latter drug if they are following dosing instructions for Alli®. When taken in excess, sibutramine can lead to elevated blood pressure, stroke and cardiac arrest in persons with a history of cardiovascular disease and healthy individuals can experience anxiety, nausea, palpitations, insomnia and slight increase in blood pressure.10The case of counterfeit anti-diabetic traditional medicine reported in China found the preparations to contain six times the normal dose of glibenclamide which leads to the death of two individuals and hospitalization of nine people.7 A number of cases have been documented within EU member states. A document published in 2008 provides examples of cases reported during 2006/2007.  A seizure of counterfeit heparin (Belgium/Germany) was found to contain a heparin like contaminant which was added to heparin resulting in allergic reactions and possibly caused deaths in 81 cases and side-effects in hundreds of patients.1This document also lists Malta as having ‘various’ counterfeit cases of hundreds of packs relating to several diseases.1  As clearly demonstrated, the use of counterfeit medicines may result in therapeutic failure leading to increased morbidity and possibly mortality, which not only translates into a negative effect on the patient’s health and quality of life but also leads to additional medical interventions, prolonged hospital stays, additional costs for treatment translating into an increased burden on the national health care service, on the patient and carers.Unless an effective means of addressing this problem is found, once counterfeit medicines enter the legal supply chain, estimates indicate that they will be a significant burden to the EU as indicated by the following estimates: 1Main costs - direct costs•	 Costs	of	hospitalisations	as	a	consequence of treatment using counterfeit medicines: Projected base line until 2020 of avoidable hospital admissions is Table 1. What encourages counterfeiting of medicines?4•	 Medicines	attractive	for	counterfeiting•	 Lack	of	political	will	and	commitment	to	establish	a	strong	national	medicines	authority•	 Lack	of	appropriate	medicine	legislation•	 Absence	of,	or	weak	national	medicines	regulatory	agency•	 Weak	enforcement	including	corruption	and	conflict	of	interest•	 Shortage	or	erratic	supply	of	medicines•	 Inappropriate	use	of	medicines•	 Price	differentials•	 Inefficient	co-operation	between	stake	holders•	 Lack	of	control	over	export	medicines•	 Trade	through	several	intermediaries•	 Trade	through	free-trade	zones/free	portsTable 2. Reported cases of counterfeit medicines7,8,10UKCialis 20mgReductil 15mgLipitor 20mgZyprexia 10mgPlavix 75mgCasodex 50mgSeretide 250 Evohaler 8ml pressurised inhalersSensodyne original Sensodyne Mint 50ml tubesUSAXenical AlliUnited Republic of TanzaniaMetakelfin (anti-malarial)China Anti-diabetic traditional medicineIssue 16  Summer 20106          Journal of the Malta College of Pharmacy Practiceestimated to cost the EU between 1.8bn EUR-22bn EUR•	 Costs	occurring	in	an	ambulatory	setting for treating the consequences of a treatment involving counterfeit medicines:  Projected base line until 2020 of avoidable medical treatment at community level by primary health care doctors is estimated to cost the EU between 93m EUR and 1.1bn EURMain costs - indirect costsUsing Quality Adjusted Life Years (QUALYs), which combine effects on life expectancy and quality of life within a single measure, with 1 QUALY being equal to one year of life expectancy in full health, the projected base line cost until 2020 is expected to lay between 7.65bn EUR and 93bn EUR.Combating counterfeit medicinesAll stake holders are encouraged to actively participate in combating counterfeit medicines. Patients, who are usually the first to notice something wrong with their medicine e.g. different taste, unusual colour, novel side-effects when compared to their regular medicines, are encouraged to make a report. Pharmacists are expected to be aware and vigilant, purchasing their medicines only from a reputable source. The publication entitled ‘Counterfeit medicines: Advice for health care professionals’ provides an excellent guide for pharmacists.12 Medical doctors are strongly advised not to encourage patients to obtain their medicines outside the legitimate supply chain, which in Malta, are only licensed pharmacies.At a global level The World Health Organisation set up the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) which is comprised of international organizations, non-governmental organizations, enforcement agencies, pharmaceutical manufacturers associations and drug and regulatory authorities. Its aim is to halt the production, trading and selling of fake medicines around the globe.13At a national level Malta is actively participating in the Council of Europe Working group on the Pharma package where one of its’ pillars is the topic of counterfeit medicines. This group’s aim in the Pharma-package pillar is to submit a proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC with regards to the prevention of entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source. Once approved by the EU parliament this directive amending directive 2001/83 will be transposed into national legislation leading to all EU member states having harmonised legislation with regards to counterfeit medicines.14 ConclusionIt is essential that healthcare Key points•	 Counterfeit	medicines	are	medicines	that	are	deliberately	and	fraudulently	mislabelled	with respect to identity and/or source•		 Use	of	counterfeit	medicines	can	result	in	treatment	failure	or	even	death	•	 Erosion	of	public	confidence	in	health-delivery	systems	may	result	following	use	and/or	detection of counterfeit medicines•	 Both	branded	and	generic	products	are	subject	to	counterfeiting•	 Patients	should	never	be	encouraged	to	obtain	medicines	outside	the	legitimate	supply	chainReferences1 Commission of the European Communities. Commission staff working document accompanying document to the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source. 2008. Available at: http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/pharmacos/pharmpack_12_2008/counterfeit-ia_en.pdf (Accessed 3 June 2010)2. Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use. Key ideas for better protection of patients against the risk of counterfeit medicines. European commission, Enterprise and Industry Directorate General, consumer goods, pharmaceuticals. 20083. Cockburn R, Newton PN, Agyarko EK,Akunyili D, White NJ.The global threat of counterfeit drugs: Why industry and governments must communicate the dangers.  PLoS Med. 2008;2(4): e1004. World Health Organisation. Counterfeit medicines FAQs. WHO.  Available at: http://www.who.int/medicines/services/counterfeit/faqs/15/en/index.html (Accessed 3 June 2010).5. Wondemagegnehu E. Counterfeit and substandard drugs in Myanmar and Viet Nam. WHO/EDM/QSM/99.3. Geneva: World Health Organization 19996. World Health Organisation. Counterfeit medicinal products. Report by the Secretariat. Sixty-third World Health Assembly. Provisional agenda item 11.20.  April 2010professional be well informed regarding the significant threats posed by the availability of counterfeit medicines. In their practice they should seek to educate the general public about the matter and in addition should never encourage patients to obtain their medicines in a way which could jeopardise their health and well being.7. World Health Organisation. Counterfeit medicines Fact Sheet. WHO . Available at: http://www.who.int/mediacentre/factsheets/fs275/en/ (Accessed 3 June 2010).8. Medicine and Healthcare Products Regulatory Agency. MHRA. Available at: http://www.mhra.gov.uk/PrintPreview/DefaultSplashPP/CON019608?ResultCount=10&DynamicListQuery=&DynamicListSortBy=xCreationDate&DynamicListSortOrder=Desc&DynamicListTitle=&PageNumber=1&Title=Counterfeit%20medicines%20and%20devices. (Accessed 3 June 2010).9. The Irish Medicines Board. Available at: http://www.imb.ie/search.aspx?q=counterfeit%20medicines (Accessed 3 June 2010).10. US Food and Drug Administration. FDA. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm198557.htm (Accessed 3 June 2010).11. European Medicines Agency. EMEA Available at: http://www.ema.europa.eu/Inspections/Counterfeits.html (Accessed 3 June 2010).12. Royal Pharmaceutical Society of Great Britain, Dispensing Doctors Association, Medicines and Health Regulatory Agency. Counterfeit medicines: Advice for health care professionals. Available at: http://www.mhra.gov.uk/PrintPreview/DefaultSplashPP/CON019608?ResultCount=10&DynamicListQuery=&DynamicListSortBy=xCreationDate&DynamicListSortOrder=Desc&DynamicListTitle=&PageNumber=1&Title=Counterfeit%20medicines%20and%20devices. (Accessed 3 June 2010).13. International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Available at: http://www.who.int/impact/about/en/ (Accessed 3 June 2010).14. Medicines Authority, Malta. Personal communication. June 2010.

Counterfeit medicines

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Counterfeit medicines

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