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Counterfeit Medications
Annette Cansick Senior Clinical Data Associate/Clinical Data Coding Specialist
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Counterfeit Medications
• First documented cases of counterfeit medicines date back to 4th century BC. • For more than 2,000 years, issue of fraudulent production of medicines has mostly been ignored. • It is multi-billion-pound worldwide trade. • Estimated to lead directly to deaths of more than 500,000 people a year across the globe.
• In 1985 in Nairobi WHO adopted eradication of counterfeit drugs as a priority.
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WHO Definition of a Counterfeit Medicine
“A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with correct ingredients, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient or with fake packaging.”
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Counterfeit Medications
• Business worth £18 billion. • Estimated to double in the next two years.
• Represents about 10% of all pharmaceutical sales worldwide.
• 30% of medicines in Russia and some countries in Africa, Asia and Latin America are counterfeit. • In wealthy nations figure is one percent. • In UK equates to eight million packs of medicines worth approximately £425 million a year. • 25% of all emails - 15 billion messages a day - are spam advertising drugs. • 50% of medicines offered by websites that conceal their physical addresses are fakes. • Makes more money than cocaine and heroin
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Counterfeit Medications
• In 2005, more than 500,000 single doses of fake medicines were discovered across Europe. • Following year this number had shot up to 2.5 million. • Only because fake drugs have spread from local markets to more global outlets, aided by the rise of internet, has developed world recognised the magnitude of the problem.
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WHO and IMPACT
• In February 2006, WHO created first global partnership known as International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT). • Made up of all 193 WHO Member States on voluntary basis. • Aim to improve coordination and harmonization across and between countries so eventually production, trading and selling of fake medicines will cease. • IMPACT focuses on following key areas:
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IMPACT – Key areas
• Looks at existing laws in countries. • Provides effective models countries can use.
• Develops set of principles for establishment of appropriate legislation and penal sanctions.
• Coordinates action at local level between health authorities, police, customs, and judiciary institutions to ensure proper regulation, control, investigation and prosecution. • Helps countries with weak regulatory systems to strengthen them.
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IMPACT
• Comprised of five working groups to combat the spread of counterfeits:
– legislative and regulatory infrastructure – regulatory implementation – enforcement – technology – communication
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IMPACT
• IMPACT will help to identify and coordinate action between customs, police and judiciary of different countries to monitor borders, track counterfeit goods and apprehend counterfeiters. • By working with World Customs Agency, INTERPOL, and informal networks of enforcement officers, IMPACT facilitates communication between enforcement and health authorities.
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The UK and Counterfeit Medicines
• UK is lucrative market for counterfeiters of medicines and medical devices. • High prices, a large market, widespread internet connectivity and complex supply chain. • Counterfeits not normally manufactured in UK. • UK transit point, distribution hub and end user of counterfeit medicines. • Distributed through on-line pharmacies, most of which are outside UK.
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The UK and Counterfeit Medicines
• 50% of medicines sourced from websites that conceal their physical address are counterfeit. • These websites advertise and supply medicines illegally, with no prescriptions. • Discovered in the regulated supply chain, through licensed wholesalers, parallel traders and pharmacies. • Counterfeit medicine reached patients on nine occasions necessitating batch recalls. • Discovered at wholesale level five times.
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The UK and Counterfeit Medicines
• Counterfeit medicine available in UK originally were „lifestyle‟ medicines, including erectile dysfunction and weight-loss medicines • Counterfeiters are now also focusing on „lifesaving medicines‟ including cancer and heart medicines. • No fatalities yet have been attributed to counterfeit medicine in the UK, although numerous fatalities have occurred around the world.
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The UK and Counterfeit Medicines
• Counterfeit medicine found in UK regulated supply chain was designed to deceive pharmacists and patients into believing that it was genuine. • Often only laboratory analysis reveals counterfeit product. • Counterfeit medicines discovered in UK typically contain reduced amount of active pharmaceutical ingredient, or wrong ingredient or no ingredient. • All counterfeit medicines are dangerous.
• Also reports of counterfeit medical devices discovered in UK, or seized on their way to UK.
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The UK and Counterfeit Medical Devices
• All products, except medicines, for diagnosis, prevention, monitoring or treatment of illness or disability. • Includes contact lenses to condoms; heart valves to walking frames. • No known cases of counterfeit devices being manufactured in UK. • UK end user market or transit point for the products. • Most UK cases have involved supply of counterfeit devices direct to consumers through small retail outlets. • Devices reaching consumers include condoms, and dental material for use in fillings. • Counterfeits intercepted before reaching consumers include glucose test strips for diabetics, and corrective contact lenses.
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The UK and Counterfeit Medical Devices
• Those seized within UK are usually packaged to high standard and difficult to distinguish from genuine article. • In past 12 months, 10 reported incidents all concerning counterfeit condoms. • Counterfeit devices supplied through Internet websites. • Unlike medicines, wholesalers do not require a licence to trade in medical devices. • Counterfeit medical devices are dangerous. • Deficient in terms of quality and performance. • The MHRA to combat counterfeit medicines and devices formulated 3 year plan.
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MHRA Anti-Counterfeiting Strategy 2007-2010
• Strategy sets out three-year plan to combat counterfeit medicines and devices through communication, collaboration and regulation.
Communication • Ensures public and healthcare professionals have sufficient information about counterfeit medicines, how to avoid them, and how to report any suspicions. • 24 hour anti-counterfeiting hotline.
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MHRA Anti-Counterfeiting Strategy 2007-2010
Collaboration • Full participation in all international initiatives to tackle counterfeit medicine and medical devices which impact UK. • Linked to IMPACT. • Working relationships with appropriate law enforcement agencies and other regulatory bodies. • Works closely with pharmaceutical industry, against threat posed by counterfeiters. • Hosts Anti-Counterfeiting Stakeholders (ACS) meeting between Regulators, Law enforcement and Industry.
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MHRA Anti-Counterfeiting Strategy 2007-2010
Regulation • Intelligence unit of MHRA conducts continuous threat assessment of risk from counterfeit medicines and devices in regulated supply chain. • Maintains surveillance on supply chain of medicines most at risk from counterfeiting. • Investigates, prosecutes and confiscates assets of those involved. • Examines supply chain where counterfeits are reaching patients, makes recommendations for change.
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MHRA -Enforcement and Intelligence Group
• Made up of intelligence, investigation, prosecution and support staff, 42 in London, Welwyn Garden City and York. • Responsible for investigation of breaches of Medicines Act and associated legislation, and counterfeit medicines in regulated and unregulated supply chain. • Have statutory powers under Medicines Act 1968 to enter business and private property to seize articles suspected of being in breaches of Act. • Conducts investigations and submits recommendations for prosecution to Department of Work and Pensions solicitors
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MHRA -Enforcement and Intelligence Group
• Supports police on any prosecutions which include breaches of Medicines Act. • Involved in large Crown Court trials concerning global conspiracies to supply counterfeit medicines. • Complex investigations involving networks of companies and bank accounts often overseas.
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MHRA -Enforcement and Intelligence Group
• The Medicines and Healthcare Products Regulatory Agency evidence store in London
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MHRA -Enforcement and Intelligence Group
• It is rare for Britain to be used for manufacture, but it does happen. Allen Valentine was jailed for five-and-a-half years in 2004 for making fake Viagra in a factory in Wembley, northwest London. His plant was estimated to be capable of producing 500,000 tablets a day and up to £6 million worth had been sold but could not be traced.
Allen Valentine’s counterfeit medicine machinery in factory in Wembley
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Parallel Trade in EU
• 25 member states, 25 different pharmaceutical markets. • Price paid for drugs within each country varies widely.
• Borderless free market, drugs available cheaply in one country can legally be shifted to another with higher prices.
• Pharmaceutical companies sell drugs to 'cheap' countries in southern and eastern Europe. • Re-emerge legally in more expensive countries such as UK where manufacturers market at higher prices. • More than 140 million medicine packs parallel-traded every year. • 25% of Britain's NHS prescriptions come via this route.
• 90% of Britain's pharmacies have some product come via parallel trade.
• Hospitals and trusts, are encouraged by governments to buy as cheaply as they can.
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Parallel Trade in EU
• Medicines can change hands 20 to 30 times travelling around EU. • Because original packaging and inserts are often in foreign languages, packs and literature are changed. • Vast majority of drugs that enter Britain by parallel-trade route are repackaged. • Anti-counterfeiting features such as holograms or shifting ink vanish.
• If they are not destroyed, original packaging remains available for counterfeiters to use.
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The complexity of the medicines supply chain
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Free trade zones
• Areas specially designated by countries to encourage trade. • Tariffs are waived.
• Minimal regulatory oversight.
• Haven for counterfeiters. • In 2007 counterfeit drugs found in Dubai at Euro Gulf Trading.
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Free trade zones and Dubai
• Examination of case revealed links to complex supply chain of fake drugs. • Ran from China through Hong Kong, United Arab Emirates, Britain and Bahamas, leading to Internet pharmacy whose American customers thought they were buying from Canada. • Dubai attractive because it is on the Persian Gulf between Asia, Europe and Africa. • Records show nearly one third of all counterfeit drugs confiscated in Europe last year came from United Arab Emirates.
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Pharmaceutical Companies
• Devote enormous resources to fighting counterfeiting. • Fakes make mockery of their huge research budgets, damage their reputations. • Prescribers turn to competitor products • Eli Lilly alone spends more than $1 million a day combating counterfeiters. • Pfizer is the number one victim of counterfeiters as largest company and products include Viagra and Lipitor, • Has team of former police officers spread across Europe, including two in UK.
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Pharmaceutical Companies
• However not all pharmaceutical companies are willing to talk about counterfeits. • Conflict of interest within companies • Concerned that making information on specific counterfeits public will reduce public confidence in product and reduce sales • Pharmaceutical companies and health agencies argue that the wrong message could provoke panic and credibility of healthcare system could be harmed. • Unbalanced message can frighten patients into not taking medicines that in 99.9% of cases are safe.
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U.S. and FDA
• Drug counterfeiting occurs less frequently in U.S. due to strict regulatory framework that governs production of drug products and distribution chain, and enforcement against violators. • FDA works to ensure overall quality of drug products that consumers purchase from U.S. pharmacies remains high.
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U.S. and FDA
• FDA advises pharmacists, physicians, and other healthcare professionals on drugs most likely to be counterfeited and how to identify them. • To suspect patient may have received counterfeit drug if:
– has unexplained worsening of medical condition or unexpected side effect. – patient reports drug tastes or looks different, tablets chipped or cracked. – If experiences unusual burning at injection site.
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U.S. and FDA
• FDA works with U.S. government agencies, such as the Department of Homeland Security (Customs and Border Protection) and the Department of Justice, to combat counterfeit drugs. • FDA very active in IMPACT
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U.S. and FDA
• In February 2004, FDA created Counterfeit Alert Network, a coalition of health professional and consumer groups. • In the event of confirmed counterfeit case in US, FDA will send an alert to these partners. • Agency also will send partners a notice if counterfeit incident is confirmed elsewhere in the world that could affect U.S. patients.
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U.S. and FDA
• Warns drugs bought over the Internet, may not be FDA-approved drugs reviewed for safety and effectiveness. • To ensure safe U.S. has Verified Internet Pharmacy Practice Sites (VIPPS) seal. Licensed pharmacies where FDA-approved medications can be purchased.
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The Internet
• Online pharmacies offer benefits of convenience, privacy, and often, cheaper prices • Many appear reputable and similar to legitimate retail pharmacy websites BUT sell fake pills that:
– do not contain medicine approved by regulators. – have doses that are too strong or too weak. – contain dangerous ingredients. – aren't manufactured using safe standards. – aren't labelled, packaged or shipped properly. – are out of date
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The Internet
• Flourishes because public cannot get many new medicines for cancer, dementia or influenza from publicly funded services. • Many sites connected to other sites and have multiple links making investigation difficult. • Jurisdictional challenges as regulatory and enforcement issues cross international lines. • System difficult to regulate but governments can do more to warn public of the dangers.
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Counterfeit South Asia and Far East
• Most counterfeiting takes place in South Asia and Far East, China and India biggest source. • Scale varies from small-time entrepreneurs turning out 100 tablets a day to vast factories. • Ten years ago it took counterfeiters six months to copy a product once it came on the market, and quality was very poor. • Now counterfeit products are found in countries where the legitimate drug has not even launched • New holograms copied within a month
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India
• India accounts for one third of counterfeit drugs. • EC claims India largest source of 2.7 million counterfeit drugs seized by its customs in 2006. • India number one source of counterfeit medicines, followed by UAE and China. • India‟s existing regulations pose little deterrence to unscrupulous drug vendors. • India to introduce death penalty for sale and manufacture of fake and counterfeit medicines that cause grievous harm. • Minimum prison sentence to be increased from five to10 years. • Higher fines for those convicted for trading in fake drugs.
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India
• Drug regulatory officials are often in collusion with manufacturers of fake medicines. • It is against the law to sell fake drugs for domestic use, but no regulatory regime applies to the export market. • Common fake drugs are antibiotics, drugs for tuberculosis, malaria and cough syrups. • And ingredients for lifestyle drugs
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India
• Exportation of Active Pharmaceutical Ingredient (API) plays integral role in manufacture of counterfeit medicines.
• During first six months in 2005, >250kg of sildenafil citrate, Viagra®‟s active ingredient, were exported from India to Europe.
• Out of one kilogram sildenafil citrate, approximately 14,000 tablets of counterfeit Viagra-pills can be produced.
• If sold at normal market price of genuine Viagra® a profit of up to 2,000%
could result.
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China
• In China, between 200,000 and 300,000 people are estimated to die each year because of counterfeit or substandard medicines. • China has 80,000 chemical companies, and FDA does not know how many sell ingredients used in drugs consumed by Americans. • China exports drug ingredients to customers in 150 countries. • China‟s State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies.
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China
• Corruption and lack of protection for whistleblowers undermines China's attempt to establish a more rigorous drug regulatory system. • In 2007, a series of scandals involving counterfeit pharmaceutical exports led to intense international pressure on Chinese government. • Resulted in conviction and subsequent sentencing to death of the country's two top drug regulators for accepting bribes.
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Chinese Counterfeiters
• Some counterfeiters have the same equipment used by pharmaceutical companies. • Cases have occurred of pharmaceutical laboratories that manufacture genuine drugs during business hours and produce counterfeits at night. • Counterfeiters have set up companies that provide service of disposing of expired medicines. • Obtain real expired medicines repack and relabel.
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Malaria and counterfeit medication
• In 1999 in Cambodia, 30 people died after taking counterfeit anti-malarials prepared with sulphadoxine-pyrimethamine (an older, less effective antimalarial) which were sold as artesunate. • In Cambodia, 60% of 133 drug vendors were found to be selling a fake antimalarial drug. • Of the one million deaths that occur from malaria annually, as many as 200,000 would be avoidable if the medicines available were effective, of good quality and used correctly.
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Malaria and counterfeit medication
• Many treatments no longer effective. • Malaria parasites have become resistant to drugs.
• One medicine - made from Chinese plant extract is last defence against drugresistant malaria.
• In danger of losing effectiveness due to counterfeiters. • Artesunate developed by Chinese scientists in 1970s. • Active ingredient -- artemisinin -- comes from plant called sweet wormwood. • Produced by small company Guilin Pharmaceuticals in Southern China.
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Malaria and counterfeit medication
• Fake medication contained starch and chalk • Counterfeiters now add small doses of real artesunate to fakes to fool testers.
• With low doses of active ingredients, could encourage development of drugresistant strains of parasites that are not sensitive to artesunate.
• Malaria parasites have long history of developing drug resistance in Southeast Asia and then spreading that resistance to Africa.
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HIV/AIDS
• Access to antiretroviral therapy (ART) is endorsed by UN and its member states. • Unproven AIDS 'cures' and remedies are widespread, and in some cases, have been promoted by governments directly. • President of Gambia has promoted a product which he claimed could cure AIDS, as long as patients stop taking their ART. • Iran's health minister, announced Iranian researchers had developed medicine made completely with Iranian native plants that boosts immune system and slows replication of HIV. • In South Africa both President Thabo Mbeki and his two health ministers have referred to ART as 'toxic' and promoted alternatives.
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Influenza
• In January 2006, FDA issued alert about fraudulent flu remedies, including counterfeit prescription oseltamivir (Tamiflu) medication. • Dutch Healthcare Inspectorate warned consumers in early 2006 not to buy Tamiflu through Internet, after counterfeit capsules found in The Netherlands contained lactose and vitamin C, and no active substance. • In UK, officials seized 5,000 packets of counterfeit Tamiflu in early 2006, worth £500,000.
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Nigeria a Success Story
• In 1993 National Agency for Food and Drug Administration and Control (Nadfac) set up to combat counterfeits in regulated drugs.
• In 2001 Professor Dora Akunyili became Director General as result of her diabetic sister Vivian dying from fake insulin.
• Then 80% of drugs in country‟s hospitals and pharmacies fake.
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Nigeria a Success Story
• Built team of female inspectors as less likely tempted by bribes • Prosecuted importers of fake drugs.
• Restrict pharmaceutical imports to just two airports and two seaports, staffed by NAFDAC officials.
• Agency made list of 19 Indian and Chinese companies indicted manufacturing fake drugs and banned their products.
• Placed analysts in India and China to stop counterfeits manufactured there being shipped to Nigeria.
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Nigeria a Success Story
• NAFDAC went on offensive back home, conducting nearly 800 raids on drugdistribution outlets and 90 "destruction exercises" on counterfeit or substandard medicines. • 80% drop in fake drugs • Criminal gangs peddling counterfeit drugs wanted her dead. • NAFDC was burnt down.
• Received death threats
• In 2003 she survived a shooting.
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Identifying Counterfeit Drugs
• Pharmacists eyes and ears for regulatory bodies and drug manufacturers they look for:
– Signs removal or switched product label. – Altered expiry date. – Subtle changes in packaging from previous purchase. – Variations in size of container from previous purchase.
– Cracks in product, irregular or odd borders, chips, differences in width, colours or dyes.
• Before drugs reach pharmacist, the following identification methods are employed:
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Technology
• Radio frequency identification (RFID) chips and taggants. • Radio waves used to automatically read RFID tags contained on products.
• Tags have individual serial numbers on each product, allows product to be tracked and traced through supply chain.
• Allows wholesalers, distributors and pharmacies to authenticate product handled by legitimate, licensed entities in drug supply chain.
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Technology
• Pfizer‟s unique V tag placed on each bottle of Viagra® during production and web-based system permits pharmacist to verify authenticity.
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Technology
• One option IMPACT is looking into is to give each packet of drugs a code number that can only be read when the seal is broken. • Consumer can phone factory with the number to check their medicine is genuine.
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Technology
• Raman Spectroscopy analyses changes in laser light bouncing off molecules to indicate their chemical composition
– can be used with battery operated hand –held instruments.
• Disadvantage is that it does not work through all packaging or with nontransparent plastic bottles • But Spatially Offset Raman Spectrometry can investigate contents of blister packs and plastic bottles without opening them. • Shows up chemical composition of drugs
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Technology
• Immunochemists devised range of nanoscale materials to be embedded in drug packaging or pills to distinguish from counterfeits. • In pills odourless, colourless, tasteless and safe
– Detected by field test similar to a pregnancy test.
• On packaging it is mixed into inks and coatings and applied onto labels, cartons, closure seals, vial crimps and tops.
– Detected with light of specific wave length.
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Technology
Field Tests • In China, 200 mobile vans set up with NIR (Near infrared) spectroscopy, TLC, and colorimetry instruments. • Vans go to rural areas of China, to screen all medicines in local clinics and drugstores. • Any suspicious drugs, sent to centralized laboratories for conclusive analyses. • Researchers built up a database of 300 NIR spectrums
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Technology
• Colour shifting ink logo difficult to copy or reproduce being introduced by Pfizer • Also more complex holograms being introduced
Fake and genuine holograms for anti-malarial Artesunate
N o r t h A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n A m e r i c a • A f r i c a
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FDA and Bioterrorism
• Counterfeit drugs and bioterrorism may be related. • At present FDA has no reason to believe drugs are being manufactured for any reason other than making a profit. • The FDA is not currently aware of activity where use of counterfeit drugs is connected with terrorism. • FDA working with Department of Health and Human Services and Department of Homeland Security to ensure if any such threat appears, it will be immediately identified and addressed.
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Terrorism Links
• However in the past there are claims of associations with terrorist groups –
– In Turkey a cyanide-laced skin cream was linked to al-Qa'eda operation. – In America FBI linked sales of fake Ivermectin, an anti-parasite medication, to IRA arms purchasing scheme. – Canadian authorities linked counterfeit pseudoephedrine to Hizbollah.
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Why Counterfeit
• Production need not be in large infrastructures or facilities. • Lucrative due to continued high demand for medicines and low production costs. • Absence of deterrent legislation encourages counterfeiters. • No fear of being apprehended and prosecuted. • When prices of medicines are high and price differentials between identical products exist there is greater incentive for consumers to seek medicines outside normal supply system. • Poverty, and lack of official supply chain, are major factors in creating markets for counterfeit products.
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Counterfeiters
• Counterfeiters not only sell in countries with ineffective drug regulation but they are also involved in exporting or re-exporting chain. • Counterfeiters and their allies aggressively seek to avoid detection. • They engage in elaborate conspiracies to disguise their activities. • They establish fictitious businesses and front companies. • They exploit weaknesses in border control whenever governments try to promote world commerce by reducing border inspections. • They use false documents to obtain essential active pharmaceutical ingredients, as well as manufacturing equipment to replicate genuine products.
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Summary
• Counterfeit medicine:
– endangers lives and well-being of patients. – undermines confidence of medical profession in quality, safety, and efficacy of products they prescribe.
– damages public trust.
– reduces investment in pharmaceutical industry. – damages business of manufacturer whose products are copied, with loss of both revenue and confidence.
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Counter the Counterfeiters
• Shorten the medicine supply chains between pharmaceutical manufacturers and pharmacies. • Use 'track and trace' technologies that could allow product movements to be followed more closely by regulatory agencies. • Subsidise real versions of drugs so that they price counterfeiters out of market.
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Conclusion
• Cause of death in many parts of world.
• Contributor to emergence of new drug resistant strains of tuberculosis, malaria, and HIV. • West latest region affected by fake drug epidemic. • Lifestyle and lifesaving counterfeit drugs flood European and American markets. • Developed world and international community and authorities must learn from successful action taken by certain countries and organisations to tackle issues surrounding fake drug trade.
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Conclusion
No one cares about people dying from counterfeit pharmaceuticals in the third world, but this will change when individuals start dying in large numbers in Los Angeles, New York, London or Tokyo.
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Predicted counterfeit drug sales will reach US$75 billion globally in 2010, increase of more than 90% from 2005
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References
References (including illustrations) • WHO Nov 2006 Counterfeit Medications • • • • • • • • • • • • • • • • • • • • • • • • • WHO - IMPACT MHRA Anti-Counterfeiting Strategy 2007-2010 MHRA Counterfeit medicines guidance for pharmacists Student BMJ Bad Medicine Counterfeit medicines a threat to public health and Safety by Frank Vanderdonck - Pfizer The Hunt for Counterfeit medicine by Rajendrani Mukhopadhyay Chanel 4 news: Counterfeit drugs ring smashed Globalization and Health - Dangerous medicines: Unproven AIDS cures and counterfeit antiretroviral drugs Science Daily – New method for detecting fake drugs without opening the package Science Daily – Counterfeit drugs can kill Nanotechnology fingerprints can certify authenticity FDA Radiofrequency Identification technology: Protecting the drug supply BBC news Fake drugs caught inside the pack BBC news – Fake medicines „a growing menace‟ BBC news – Pills for Profit FDA news FDA warns consumers about counterfeit drugs from multiple internet sellers FDA: Use Caution buying medical products online BBC 2 One woman‟s war with fake drugs The Independent Dr Dora, the scourge of Nigeria‟s drug fakers is honoured CDC Malaria – Counterfeit and Substandard anti-malarial drugs The World: Malaria Part 3: The Danger of Counterfeit Drugs Chanel 4 news: China‟s deadly trade in fake drugs New York Times Chinese chemicals flow unchecked onto world drug market Hindu business line: India turning capital for counterfeit drugs Economic Times: India hub of counterfeit drugs BMJ: India to introduce death penalty for peddling fake drugs
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Real people. Real results.®
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