Over the past few years it seems that talk about counterfeit drugs has gone from a whisper to a routine topic in the news. While the rate of counterfeit drugs in industrialized countries remains low (less than 1%),1 shouldn’t this rate still be a cause for concern? To put it in perspective, even if only 0.001% of the 4 billion prescriptions filled in the United States each year were compromised, 40,000 prescriptions could have questionable levels of active ingredients or toxic contaminants.2 The rate of counterfeit drugs in developing countries is estimated to be as high as 50%.3
The World Health Organization (WHO) estimates that over 50% of medicines purchased online from illegal sites that conceal their physical address are counterfeit.1 Many of these illegal websites will claim to sell approved brand name medicines, display fake licenses and certifications, and list false affiliations with reputable pharmacy retailers to deceive consumers into believing that they are buying an authentic product.4 Operation Pangea, now in its sixth year, leads the fight against illegal online sale of counterfeit and unlicensed medicines. One of Operation Pangea’s most recent initiatives seized and shut down 1,677 illegal websites in one week from June 18th to 25th 2013.4
The more serious concern, in my perspective, is the counterfeit drugs that find their way into hospitals and pharmacies. In the past year, the United States has had three separate incidents where a counterfeit version of a popular prostate cancer drug containing no active ingredients made it into the supply chain.2, 5 Fake heparin, a blood thinner, was found to be responsible for 149 deaths in the United States in 2007 and 2008.2 In developing countries, the crisis is far greater due to poor control of the supply chain. Contaminated syrups including diethylene glycol substituted for more expensive glycerin, have been implicated in eight mass poisonings in the past two decades including incidents in Panama, China, Haiti, Bangladesh, Argentina, Nigeria, and India.6
It is some comfort to know that steps are being taken to curb this mounting crisis. Interpol created the Pharmaceutical Crime Program to support health agencies, police and customs bureaus in countries around the world fight against counterfeit drug supply and distribution.2 Technology using barcodes to track chain of custody from the manufacturer to the point of dispensing is being investigated to ensure authenticity.7 This provides some relief even though there is still a long way to go to ensure that every loophole along the supply chain is secure.
1. Fact sheet N°275 on the World Health Organization (WHO), Medicines: spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines. May, 2012. Accessed from: http://www.who.int/mediacentre/factsheets/fs275/en/.
2. Bate, Roger, The deadly world of fake medicine. CNN.com. July 17, 2012. Accessed from: http://www.cnn.com/2012/07/17/health/living-well/falsified-medicine-bate.
3. FDA news release, FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies. June 27, 2013. Accessed from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm358794.htm.
4. FDA warns of new fake batch of cancer drug Avastin (Associated Press). February 6, 2013. Accessed from: http://bigstory.ap.org/article/fda-warns-new-fake-batch-cancer-drug-avastin.
5. Bogdanich, Walt, Hooker, Jake, From China to Panama, a Trail of Poisoned Medicine. The New York Times. May 6, 2007. Accessed from: http://www.nytimes.com/2007/05/06/world/06poison.html?pagewanted=3&_r=0.
6. Neergard, Lauren, Report calls for national drug-tracking system to counter growing threat of fake medications (Canadian Press). February 13, 2013. Accessed from: http://globalnews.ca/news/392240/report-calls-for-national-drug-tracking-system-to-counter-growing-threat-of-fake-medications-2/.
7. Johnson, Linda A, Drugmakers, Interpol ramp up fight against fakes (Associated Press). March 12, 2013. Accessed from: http://cnsnews.com/news/article/drugmakers-interpol-ramp-fight-against-fakes.