What are counterfeit medicines?
Counterfeit drugs are illegal copies of an original product.1 This can include products without active ingredients, with incorrect quantities of active ingredients, wrong ingredients, correct quantities of active ingredients but with fake packaging or high levels of impurities and contaminants. Counterfeit drugs pose public health risks as they are manufactured illegally in unsanitary and unsafe conditions,2 their sources are unknown and their contents are unreliable.3 Contrary to the marketing efforts by counterfeiters, counterfeit drugs are not "generic" versions of branded medicines. The bottom line: There are no safe counterfeit medicines.
Have people been harmed by counterfeit medicines?
Countless deaths are caused by counterfeit drugs, with about 100,000 people dying, mostly in the poor world, annually.8
In 1995, during a meningitis epidemic in Niger, 2,500 people died after receiving a counterfeit vaccine.3
In 2008, 150 non-diabetic patients with severe hypoglycemia were admitted to five public hospitals in Singapore after taking counterfeit sexual enhancement drugs contaminated with glyburide, a medication used to treat type 2 diabetes. Seven patients remained comatose as a result of prolonged shortage of glucose in the brain, and four subsequently died.6
In 2010, a counterfeit version of Tamiflu was being sold online. This counterfeit drug was labeled as “generic” Tamiflu, but actually contained an ingredient that could cause life-threatening reactions to those allergic to penicillin.9
Estimated deaths from counterfeit drugs vary from tens of thousands to more than 200,000.11
What is the scope of the problem? How many counterfeit drugs are there, and where are they?
Counterfeit drugs are found everywhere in the world.3 While many counterfeit drugs have been traced back to countries such as India or China, shutting down production there will not solve the counterfeit problem. It takes a concerted effort of authorities and companies around the globe to reduce the number of counterfeit drugs reaching consumers.
A website may be calling itself a “Canadian pharmacy” but it may actually obtain its medications from countries in Asia, South America, or Eastern Europe, where quality standards are generally considered more lax and counterfeit medications are widespread, permitting an opportunity for counterfeit medications to make their way into a prescription order.
Additionally, prescription drugs imported from other countries are not FDA-approved and their safety and effectiveness cannot be ensured because they are outside the legal structure and regulatory resources provided by Congress.8
The opportunity to set up counterfeit operations appears greatest in those regions where the regulatory and legal oversight is weakest.
Medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases.3
What medicines are counterfeiters targeting?
Counterfeiters are increasingly targeting medicines for chronic diseases, HIV/AIDS, TB, and malaria. Any kind of product can be and has been counterfeited: expensive lifestyle and anti-cancer medicines, antibiotics, medicines for hypertension and cholesterol-lowering drugs, hormones, steroids, and inexpensive generic versions of simple pain killers and antihistamines. In developing countries, the most disturbing issue is the common availability of counterfeit vaccines and medicines for the treatment of life-threatening conditions such as malaria, tuberculosis, and HIV/AIDS.3
Is it safe to buy medicines over the Internet?
Because of the unregulated environment, anonymity and access to patients,12 the Internet is a hot spot for counterfeiters.
Sixty-two percent of medicines purchased online are fake or substandard.5
If you walk into any legitimate pharmacy, they won’t give you a prescription medication without a prescription. The same is true of legitimate online pharmacies. If an online pharmacy is willing to give you a prescription medication without a prescription, it’s not legitimate and should be avoided.13
Consumers who use their credit cards on illegitimate websites are giving their private financial information to criminals.
Consumers should ask themselves the following questions; if they answer “yes” to any of these, it could mean that the product being sold online is fake:
- Offers the product at a price that’s much lower than the price at their local pharmacy or at a price that seems “too good to be true.”
- Doesn't list a street address or contact information, especially if it's not located in the United States.
- Sells prescription medications without a prescription, or after a short online survey or review by a remotely located physician.
- Directs them to a website by sending an e-mail (Eli Lilly and Company will never send an e-mail unless a consumer asks).
- Offers higher or different product doses than the innovator. Dosages should be verified before purchasing.
In the United States, there are two places where consumers can go to identify safe, legal online pharmacies. First, the National Association of Boards of Pharmacy (NABP) has its Verified Internet Pharmacy Practice Sites (VIPPS) program that has certified 42 online pharmacies out of more than 12,000, including major chain pharmacy sites. The VIPPS certification is based on compliance with licensing and inspection requirements and on verified authenticity of product, purchasing security, patient privacy rights, and provision of patient-pharmacist consultation. The VIPPS database can be accessed by visiting the National Association of Boards of Pharmacy website. Additionally, Legal Script is an Internet pharmacy verification service that adheres to NABP’s standards. It is a leading source of information for patients and others who need to know if an Internet pharmacy is acting in accordance with the law and accepted standards of ethics and safety. LegitScript’s database can be accessed at the Legal Script website.
Why would people manufacture counterfeit medicines?
Counterfeiting is big business. Counterfeit drug sales generated an estimated $75 billon USD in 2010.7
The counterfeit drug trade in Mexico is estimated to be valued at $650 million per year - equal to around 10 percent of total drug sales.14 Likewise, in Russia, it is estimated that counterfeits equal between five and 10 percent of the total market.14
In the United States, criminal penalties for counterfeiting prescription drugs are a fraction of those for trafficking street drugs.15
How can patients avoid getting counterfeit medicine?
Buying through established channels – for instance, obtaining a prescription from an in-person meeting with a physician and filling it at a reputable pharmacy – is the first step to help ensure patients obtain safe products.
Patients should also check the packaging and look for any changes in the shape and color of the medicine.
If patients suspect a counterfeit or tampered product, they should report it to their pharmacy, health care provider and the manufacturer. Patients should also save the medicine so that it can be tested. If patients have additional questions or concerns about the safety of any of their Lilly medicines, please call 1-800-LillyRx.
World Health Organization. International Medical Products Anti-Counterfeiting Taskforce. Counterfeits Drugs Kill! URL: http://www.who.int/impact/FinalBrochureWHA2008a.pdf. Accessed October 13, 2011.
Pharmaceutical Security Institute. Counterfeit Situation: Definitions. http://www.psi-inc.org/counterfeitSituation.cfm. Accessed October 13, 2011.
World Health Organization. Counterfeit medicines, Fact Sheet No. 275. Revised November 2006. http://www.who.int/mediacentre/factsheets/fs275. Accessed October 11, 2011.
Jackson, G. Faking it: the Dangers of Counterfeit Medicine on the Internet. The International Journal of Clinical Practice. 63.2, pp 181-184. February 2009.
European Alliance for Access to Safe Medicine. The Counterfeiting Superhighway. 2008. Page 9. http://v35.pixelcms.com/ams/assets/312296678531/455_EAASM_counterfeiting%20report_020608.pdf. Last accessed October 13, 2011.
Kao, S. L., et al. An Unusual Outbreak of Hypoglycemia. The New England Journal of Medicine. Feb. 12, 2009;360;7. Pages 734-736.
Pitts, Peter. 21st Century Healthcare Terrorism: The Perils of International Drug Counterfeiting. Center for Medicines in Public Interest. Sept. 20, 2005.
Poison pills: Counterfeit drugs used to be a problem for poor countries. Now they threaten the rich world, too. The Economist. September 2, 2010. http://www.economist.com/node/16943895. Accessed October 13, 2011.
FDA Sounds Alarm on Phony Tamiflu. June 17, 2010. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm216009.htm. Accessed October 13, 2011.
National Association of Boards of Pharmacy (NABP). FAQs. URL: http://www.nabp.net/programs/consumer-protection/buying-medicine-online/idoi-faq/. Accessed October 13, 2011.
McNeil D. A growing epidemic of fake medications in Asia. International Herald Tribune. February 20, 2007. http://www.nytimes.com/2007/02/20/health/20iht-drugs.4656560.html. Accessed October 13, 2011.
Organisation for Economic Co-Operation and Development. The Economic Impact of Counterfeiting and Piracy: Executive Summary. 2007. http://www.oecd.org/dataoecd/13/12/38707619.pdf. Page 14, Box 1. Accessed October 13. 2011.
Longbottom, B. Eli Lilly and Company Anti-Counterfeiting Office. Nov. 9, 2009.
Morris J and Stevens P. Counterfeit medicines in less developed countries: Problems and solutions. International Policy Network and the Campaign for Fighting Diseases. http://counterfeiting.unicri.it/docs/Ctf%20medicines%20in%20less%20developed%20countries.pdf. Accessed October 13, 2011.
U.S. Sentencing Commission. 2008 Datafile. USSCFY08. http://www.albany.edu/sourcebook/pdf/t5312007.pdf. Accessed October 13, 2011.