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. 1 Counterfeit drugs pose public health risks as they are manufactured illegally in unsanitary and unsafe conditions,9 their sources are unknown and their contents are unreliable.4 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?
An estimated 700,000 deaths have been attributed to counterfeit drugs.10
- In 1995, during a meningitis epidemic in Niger, 2,500 people died after receiving a counterfeit vaccine.4
- 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.2
- 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.11
- In 2011, contaminated IV fluid was suspected in the deaths of at least 12 pregnant women in India. The women fell critically ill after being given the fluid in the maternity ward; initial tests showed that the fluid was contaminated with bacteria and fungus. 12
- In 2012, The British Regulatory Agency discovered antimalarials with 14 times the quantity of active ingredient being used in Pakistan. These medicines are being blamed for the deaths of up to 112 patients. 12
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.4 India, the world’s largest manufacturer of generic drugs, may have as much as 12 percent to 25 percent of their supply contaminated with substandard and counterfeit medicines, and up to 40% of the drug supply in some African nations may contain counterfeits.10 An estimated 36 million Americans purchased at least one prescription drug online without a prescription in 2010.13
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.14
The opportunity to set up counterfeit operations appears greatest in those regions where regulatory and legal oversight is weakest.
Sixty-two percent of medicines purchased online are fake or substandard.8
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.4
Is it safe to buy medicines over the Internet?
Because of the unregulated environment, anonymity and access to patients, 15 the Internet is a hot spot for counterfeiters.
Sixty-two percent of medicines purchased online are fake or substandard.8
The vast majority of online pharmacy websites do not require a valid prescription to sell a medicine; others issue an on-the-spot “prescription” after patients answer a simple questionnaire.7 This atmosphere provides the perfect haven for counterfeiters to sell illegitimate medicines.
Consumers who use their credit cards on illegitimate websites are giving their private financial information to criminals.
Beware of any online pharmacies that:
- Allow you to buy drugs without a prescription from your doctor
- Offer deep discounts or cheap prices that seem too good to be true
- Send spam or unsolicited email offering cheap medicines
- Are located outside of your country
- Are not licensed in your country
A safe online pharmacy will:
- Always require a doctor’s prescription
- Provide a physical address and telephone number
- Offer a pharmacist to answer your questions
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 35 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 www.nabp.net. Additionally, www.LegitScript.com 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 www.LegitScript.com.
Why would people manufacture counterfeit medicines?
Counterfeiting is big business. Counterfeit drug sales generated an estimated $200 billion in illicit profits in 2011 alone.6
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.16 Likewise, in Russia, it is estimated that counterfeits equal between five and 10 percent of the total market.16
In the United States, criminal penalties for counterfeiting prescription drugs are significantly lower than those for trafficking street drugs.17
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 August 19, 2013.
- Kao, S. L., et al. An Unusual Outbreak of Hypoglycemia. The New England Journal of Medicine. Feb. 12, 2009;360;7. Pages 734-736.
- 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.
- World Health Organization. Counterfeit medicines, Fact Sheet No. 275. Revised May 2012. http://www.who.int/mediacentre/factsheets/fs275. Accessed August 19, 2013.
- American Enterprise Institute. The Deadly World of Fake Drugs. http://www.aei.org/files/2012/02/27/-appendix-a-master-2_170026856632.pdf. Accessed August 19, 2013.
- World Economic Forum. Global Risks 2011. Sixth Edition. An Initiative of the Risk Response Network. January 2011.
- National Association of Boards of Pharmacy. Buying Medicine Online. URL: http://www.nabp.net/programs/consumer-protection/buying-medicine-online/. Accessed August 19, 2013.
- European Alliance for Access to Safe Medicines. The Counterfeiting Superhighway. 2008. URL: http://counterfeiting.unicri.it/docs/Counterfeiting%20Superhighway.%20EAASM%202008.pdf. Accessed August 19, 2013.
- Pharmaceutical Security Institute. Counterfeit Situation: Definitions. http://www.psi-inc.org/counterfeitSituation.cfm. Accessed August 19, 2013.
- Safemedicines.org. Counterfeit Drug Incident Encyclopedia. http://www.safemedicines.org/counterfeit-drug-incident-encyclopedia.html. Accessed August 19, 2013.
- FDA Sounds Alarm on Phony Tamiflu. June 17, 2010. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm216009.htm. Accessed October 13, 2011.
- United States Pharamcopeia. Media Reports on Medicine Quality: Focusing on USAID-assisted Countries. Updated February 2013. http://www.usp.org/sites/default/files/usp_pdf/EN/PQM/pqm-media-reports.pdf. Accessed August 19, 2013.
- Consumer Reports. http://www.consumerreports.org/cro/news/2010/12/1-in-6-americans-have-purchased-drugs-online-without-a-prescription/index.htm. Accessed August 19, 2013.
- Food and Drug Administration. Safety of Prescription Drugs From Foreign Sources. Statement of William K. Hubbard Associate Commissioner for Policy and Planning before the Subcommittee on Human Rights and Wellness House Committee on Government Reform. June 12, 2003. http://www.fda.gov/NewsEvents/Testimony/ucm161056.htm. Accessed August 19, 2013.
- 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 August 21, 2013.
- 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 August 21, 2013.
- U.S. Sentencing Commission. Preliminary Quarterly Data Report. 2nd Quarter Release Preliminary Fiscal Year 2013 Data through March 31, 2013. http://www.ussc.gov/Data_and_Statistics/Federal_Sentencing_Statistics/ Quarterly_Sentencing_Updates/USSC_2013_Quarter_Report_2nd.pdf Accessed August 21, 2013.