Assessing the problem of counterfeit medications in the United Kingdom G. Jackson, 1 S. Patel, 2 S. Khan 3 Introduction A full 5% of consumers suspect that they have received a counterfeit prescription drug, and 1% believe that they definitely have, according to a mar- keting survey of more than 5000 consumers across five European countries, including the United King- dom (1). Given these results, as many as 12.8 million consumers may have been exposed to counterfeit drugs in those markets (1). The World Health Organization (WHO) defines counterfeit medications as ‘deliberately and fraudu- lently mislabelled 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 ingredient(s) or with fake packaging’ (2). Some tested counterfeit medications contain excessive amounts of active ingredients (3,4), the effects of which may be harmful. We performed an Internet search for articles about counterfeit medication; major sources included Pub- Med and news, government, and organisational web- sites. The search focused on articles describing counterfeit medication in the United Kingdom or in Europe to assess the size of the problem, the associ- ated safety risks and current legislation to address the problem. What is the size of the problem? • Illicit activity is difficult to quantify, but multiple data sources suggest increased counterfeiting. • The United Kingdom, in particular, is not immune to these burgeoning numbers. SUMMARY Counterfeit medicines pose an ever-increasing threat to public health, although precise tracking of illegal counterfeit prescription drug activity is difficult. Available data indicate that all types of medications have been targeted. Adverse health effects, including death, have resulted from using counterfeit medications; consum- ers who self-medicate without appropriate interactions with the healthcare system rarely receive adequate healthcare. The Internet provides a large, convenient route for counterfeiters to reach potential buyers with unregulated, often dangerous, products. The majority of medicines purchased via unverified Internet sites are counterfeit; often, these products lack the purported drug compound or have vari- able concentrations of active ingredients and sometimes contain dangerous toxins. Although many consumers acknowledge some degree of risk with purchasing medi- cations via the Internet, speed, convenience and cost often prompt these pur- chases. Counterfeit medications also have been detected in the legitimate supply chain, but represent a significantly smaller proportion of sales than those pur- chased via the Internet. Pilot programmes in Europe have demonstrated that prod- uct verification systems prevent penetration of counterfeit products into the legitimate supply chain. Significant EU legislation, including stronger penalties for counterfeiting, is in development. In the United Kingdom, the Medicines and Healthcare Products Regulatory Agency (MHRA) launched an initiative against counterfeit medication. Healthcare professionals should report suspected cases of counterfeit medication to the MHRA, be alert to threats to the medicine supply, and provide practical advice to patients about ordering medications online, includ- ing avoiding unregulated Internet pharmacies, and being suspicious of sites offer- ing substantial discounts and prescription-only medication without a prescription. Review Criteria We performed an Internet search for articles about counterfeit medication; major sources included PubMed and news, government, and organisational websites. We focused the search on articles describing the problem in the United Kingdom or in Europe to assess the size of the problem, the associated safety risks, and current legislation to address the problem. Message for the Clinic Counterfeit medication is a growing concern. Physicians and other healthcare professionals should report all suspected cases of counterfeit medication to health authorities and provide practical advice to patients about ordering medications online. Patients should be advised to avoid unregulated Internet pharmacies and to be suspicious of sites offering prescription-only medication without a prescription or at substantial discounts. 1 Cardiac Department, St. Thomas Hospital, London, UK 2 Medical Department, Pfizer Ltd, Walton Oaks, UK 3 Primary Care, Pfizer Inc, New York, NY, USA Correspondence to: Graham Jackson, MD, London Bridge Hospital, 27 Tooley St., Suite 301 Emblem House, London, SE1 2PR, UK Tel.: + 44 (207) 407 5887 Fax: + 44 (207) 357 7408 Email: gjcardiol@talk21.com Disclosures Graham Jackson is president of the World Congress of Men’s Health 2010 ⁄ 2011, a board member of the International Society of Men’s Health, and chairman of the Sexual Advice Association; a consultant for Lilly and Pfizer; and a meeting participant for Lilly, Pfizer, and Bayer; Seema Patel and Saima Khan are employees of Pfizer. Linked Comment: Kirby and Kirby. Int J Clin Pract 2012; 66: 229–31. REVIEW ARTICLE ª 2011 Blackwell Publishing Ltd Int J Clin Pract, March 2012, 66, 3, 241–250. doi: 10.1111/j.1742-1241.2011.02826.x 241