By: Azia Tariq, Staff Editor
With the sale of counterfeit drugs reaching an alarmingly higher rate than ever, The U.S Food and Drug Administration (FDA) in collaboration with the Skoll Global Threats Fund, the U.S. Pharmacopeia (USP), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the multi-agency President’s Malaria Initiative (PMI), employed a new method for detecting these fake medications last April. The new tool, called CD-3, will serve to identify contaminated or substandard anti-malarial medications.1 There are huge implications for this new technology, as it could play a pivotal role in FDA’s fight against counterfeit drugs.
A counterfeit drug is defined by the World Health Organization (WHO) as “…one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”2 The sale of counterfeit medicine is a lucrative global industry. According to the WHO, worldwide sales of counterfeit medications reached $75 billion in 2010.3 U.S. Attorney Barry Grissom reported that the FDA’s Office of Criminal Investigation uncovered an internet pharmacy that had sold approximately $1.4 million worth of misbranded and counterfeit drugs, including controlled substances.4 The site offered more than forty prescription drugs such as Zoloft® (eertraline HCl), Lipitor® (atorvastatin calcium), Cialis® (tadalafil), Viagra® (sildenafil citrate), and Xanax® (alprazolam).
Counterfeit pharmaceutical products appear nearly identical to genuine medications so that it is often impossible to discern the authenticity of the product with the naked eye, even for a licensed professional. Because of this, patients can be at risk of exposure to medicines that may be contaminated or improperly stored and transported, even with vigilant inspection. Furthermore, the medications could be advertized as one drug, but actually be mislabeled or have a completely different active ingredient. The drugs could be expired, have a different strength than advertized, or not have any active ingredient. In Singapore, 150 people were admitted to the hospital for severe hypoglycaemia, four of which died and seven of which suffered severe brain damage.3 They had reportedly taken counterfeit drugs promising to treat erectile dysfunction (ED), but instead contained a high dose of glyburide, a powerful anti-hyperglycemic for diabetes.
Some of the most abundantly sold counterfeit drugs are under the guise of ED treatments such as Viagra® (sildenafil citrate), Levitra® (vardenafil HCl), and Cialis® (tadalafil).5 Consumers order these prescription drugs from websites they are not familiar with and unknowingly put themselves in danger. The motives can be explained easily enough. While an in-person consultation with a doctor may be embarrassing for the patient, buying the drug from an online pharmacy provides anonymity. Similarly, the social stigma often associated with having an STD may drive a person to order a drug online. The high cost of a medication may also attract people to these counterfeit sites that offer “the same” drug at a lower price.
The counterfeit detection device CD-3 was developed by scientists at the FDA’s Forensic Chemistry Center in Cincinnati, Ohio. It is a handheld, battery-operated tool that illuminates a product with a variety of wavelengths of light.1 Minimal technical background is needed to operate the device, as it easily provides a visual comparison of an unverified malarial drug with an authentic sample. Inspectors are able to readily identify suspicious products and prevent their distribution. The substandard medications compromise public health initiatives aimed at the eradication of malaria, as the drugs contain an ineffective dose or lack the active ingredient. Inadequate treatment may then lead to resistant strains of the disease. FDA Commissioner Margaret A. Hamburg, M.D, states that “Fake or substandard anti-malarial drugs cause double damage: without adequate, prompt treatment, the malaria parasite can kill a person in a matter of days, and inadequate treatment can also lead to the development of drug resistance, potentially rendering all treatment ineffective.”1
In addition to CD-3, researchers at the University of Montreal have developed a rapid, quantitative liquid chromatography-mass spectrometry screening (LC-MS/MS) method to expose counterfeit drugs for ED.5 The new method distinguishes 71 ED drugs and 11 natural ingredients usually found in adulterated samples in suspected products.6 To test the potential of the LC-MS/MS, 32 pharmaceutical and natural products were analyzed and compared with the results from conventional methods.6 Published in the Journal of Chromatography, results indicated that LC-MS/MS takes 10 minutes rather than 50 minutes required by Health Canada’s current methods.5 Furthermore, the new method identifies compounds not previously detected, even in very low concentrations. Its high success led Health Canada to it into their counterfeit monitoring process shortly after its development.6
With the introduction of new advancements like these, tools to globally combat counterfeit drugs and their hazards show promise. The new technology can revolutionize the effectiveness of targeting counterfeit medications and, more importantly, protect public health and safety.
- FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool. FDA Website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm349195.htm. Published April 24, 2013. Accessed August 3, 2014.
- General information on counterfeit medicines. WHO Website. http://www.who.int/medicines/services/counterfeit/overview/en/. Accessed August 3, 2014.
- Growing threat from counterfeit medicines. Bulletin of the World Health Organization. 2010; 88(4): 241-320. http://www.who.int/bulletin/volumes/88/4/10-020410/en/.
- January 21, 2011: Internet Pharmacy Sold Counterfeit Viagra, Misbranded Drugs. FDA Website. http://www.fda.gov/ICECI/CriminalInvestigations/ucm240823.htm. Published January 21, 2011. Accessed August 3, 2014.
- New method to detect counterfeit drugs. Lab News Website. http://www.labnews.co.uk/news/new-method-to-detect-counterfeit-drugs/. Published June 9, 2014. Accessed August 3, 2014.
- Lebel P, Gagnon J, Furthos A, Waldron KC. A rapid, quantitative liquid chromatography-mass spectrometry screening method for 71 active and 11 natural erectile dysfunction ingredients present in potentially adulterated or counterfeit products. J Chromatogr A. 2014; 1343: 143-151.
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