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1. What's in a Word? Falsified/Counterfeit/Fake Medicines - The Definitions Debate

Author

Mike Isles

Subjects
Medicine (General), R5-920
Abstract

There is a rising tide of criminal activity to manufacture and distribute falsified, counterfeit, or fake medicines. The exact size of this problem is unknown but estimates vary from US$75 billion to US$200 billion per year, and evidence clearly demonstrates it is on the increase. Depending on the world region, infiltration into the legitimate supply chain versus the illegitimate (e.g., the internet) varies greatly. However, what is certain is that the direction of travel by regulatory agents is to develop supply chains that allow access to medicines via the World Wide Web. Within this context, there has been a long-running debate about how to correctly describe the various forms of medicines that are fraudulently or otherwise manufactured and distributed. This article attempts to describe the evolution of the definitions and recommends that a consensus be formed to describe such medicines that reach the public: • Falsified medicine: This being the term used and defined in the Falsified Medicines Directive and which is primarily concerned with public health. • Counterfeit medicine: This is closely associated and legally defined within intellectual property legislation and concentrates on trademark protection. • Fake medicine: This is the term that best serves to communicate with the public to raise awareness about the phenomenon.

Published
2017
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2. Patient safety issues associated with the use of compounded medicines as alternatives to approved pharmaceutical products in Europe and how best practice can improve outcomes

Author

Mike Isles

Subjects
Quality Control, medicine.medical_specialty, Drug Compounding, Drug Storage, Best practice, Patient risk, media_common.quotation_subject, MEDLINE, 030226 pharmacology & pharmacy, 03 medical and health sciences, Patient safety, 0302 clinical medicine, Humans, Medication Errors, European market, Medicine, Quality (business), 030212 general & internal medicine, Intensive care medicine, Adverse effect, Drug Labeling, media_common, Adult patients, business.industry, Health Policy, Public Health, Environmental and Occupational Health, General Medicine, Europe, Pharmaceutical Preparations, Patient Safety, business
Abstract

Background Pharmaceutical compounding allows individuals with special requirements access to medicines. Compounding can also be used to provide cheaper alternatives to commercially produced medicines which may be less strictly regulated than those commercially produced as they do not require marketing authorisation. Objective This review describes the issues and potential risks associated with compounded medicines and equally importantly identifies best practices. Methods To establish reports about lack of effectiveness, adverse events and medication errors occurring with compounded pharmaceuticals, a literature search was conducted of PubMed, Embase and MEDLINE databases for relevant cases in European countries which were published between 2003 and 2018. Case reports/series that described instances of successful use of compounded medicines over the same period were also identified. Results Overall, 12 case reports/case series describing problems associated with compounded medicines in Europe have been identified. Sources of patient risk associated with compounded medicines include lack of quality, safety and efficacy data, preparation and labelling errors, and improper storage and handling practices. Conclusions Several case reports/series describing instances of overdose, medication errors and adverse events associated with compounded medications were reviewed. The number of affected patients was relatively small, but many were children and two adult patients experienced permanent sequelae. The number of incidents associated with compounded medicines is unknown, and so these numbers should be interpreted with caution. When licensed medicines are available, the use of compounded medicines can put patients at unnecessary risk which should be avoided. Stricter regulation is necessary to prevent similar cases from occurring in the future as the European market for compounded medications grows. Pharmacists can promote best practices in compounding through professional organisations. Future recommended actions are: 1. Stricter regulation is necessary to prevent similar cases from occurring in the future as the European market for compounded medications grows. 2. A comprehensive pan-European survey to gain a greater understanding of compounding procedures and techniques. This would provide valuable information to the benefit of hospital systems and their patients. 3. The results of the survey can then be used to improve the knowledge and quality control of compounded medicines for the good of patient safety.

Published
2020
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3. Global access to quality-assured medical products: the Oxford Statement and call to action

Author

Paul N Newton, Katherine C Bond, Paul Newton, Katherine Bond, Victor Abiola, Khadijah Ade-Abolade, Moji Adeyeye, Aria Ahmad, Tahani Ahmed, Pablo Alcocer Vera, Marie Amsilli, Marie Antignac, Chimezie Anyakora, Ayenew Ashenef, Adam Aspinall, Ghulam Rahim Awab, Zaheer-Ud-Din Babar, Wilbert Bannenberg, Jon Bastow, Carine Baxerres, Fred Behringer, Daniel Bempong, Chris Bird, Phonepasith Boupha, Kem Boutsamay, Jason Bower, Beth Boyer, Hazel Bradley, Joel Breman, Céline Caillet, Kashi Barbara Carasso, Phaik Yeong Cheah, Lester Chinery, Aubrey Clark, Erin Coonahan, Rachel Cooper, Philip Coyne, Andre Daher, Nicholas Day, Olivier De Santi, Fulgence Djorou Kouame, Kim Doyle, Ines du Plessis, Catherine Dujardin, Chioma Ejekam, Latifa El Hadri, Facundo Fernandez, Alessandra Ferrario, Clark Freifeld, Assma Gafur Omargy, Naira Mohamed Ali Ghanem, Marie Gill, Mike Grijseels, Philippe Guerin, Nhomsai Hagen, Heather Hamill, Georgina Joan Harigwo, Amalia Hasnida, Matthew Hassett, Cathrin Hauk, Lutz Heide, Peter Horby, Tsatsral Ichinkhorloo, Mike Isles, Richard Wilhelm Otto Jähnke, Alice Jamieson, Roslyn Jones, Tomoko Kakio, Mohga Kamal-Yanni, Harparkash Kaur, Pierre Claver Kayumba, Irina Kazaryan, Matthew Keller, Kalynn Kennon, Felix Khuluza, Stephen Kigera, Kazuko Kimura, Patricia Kingori, Joseph Kitukulu, Tineke Kleinhout-Vliek, Chaitanya Koduri, Maarten Kok, Mirza Lalani, Marie Lamy, Marya Lieberman, Rui Liu, Paul Lotay, Nantasit Luangasanatip, Murray Lumpkin, Susanne Lundin, Tim Mackey, Keiko Maekawa, Marissa Malchione, Boravann Mam, Roland Marini Djang'eing'a, Aronrag Meeyai, Talieh Mirsalehi, Gamal Mohamed Ali, Andria Mousa, Mirfin Mpundu, Immaculee Mukankubito, Ambwene Mwakalobo, Sheilah Catherine Nabukeera, Kris Natarajan, Bernard Naughton, Theophilus Ndorbor, Ariadna Nebot, Phillip Nguyen, Adina-Loredana Nistor, Bah Ngoh Nyaah Fidelis, Piero Olliaro, Eugenia Olliaro, Alberto Olliaro, Kenneth Onu, Sophie Ouvrard, Sachiko Ozawa, Michael Parker, Koray Parmaksiz, Anushka Patel, Daniel Pawson, Andrew Payne, Koen Peeters Grietens, Elizabeth Pettit, Souly Phanouvong, Elizabeth Pisani, Aline Plançon, Oksana Pyzik, Lembit Rägo, Mohammad Sofiqur Rahman, Eurek Ranjit, Raffaella Ravinetto, Joseph M. Redd, David Richmond, Pierre-Yves Sacré, Simon Schäfermann, Sauman Singh, Tariro Sithole, Andrea Stewart, Anita Svadzian, Patricia Tabernero, Fatima Tauqeer, Fiona Theunissen, Emmanuel Yaovi Tossou, Zahra Anita Trippe, Farouk Umaru, Ali Umoru, Serena Vickers, Vayouly Vidhamaly, Andrea Vogt, Lisa White, Nicholas White, Benjamin Wilson, Veronika J. Wirtz, Jessie Hui Zhen Wong, Owen Wood, Jing Xu, Jingying Xu, Shunmay Yeung, Muhammad Zaman, Monique Zambo Biloa, and Zuzaan Zulzaga

Subjects
Statement (computer science), business.industry, media_common.quotation_subject, MEDLINE, Developing country, General Medicine, Public relations, Global Health, Health Services Accessibility, United Kingdom, Call to action, Pharmaceutical Preparations, Global health, Humans, Quality (business), business, Developing Countries, media_common
Published
2019

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