Counterfeit Drug Investigations: Techniques, Challenges, and the Role of Abductive Reasoning

Abstract

Variable types of investigations exist regarding counterfeit drug detection, disruption, and regulation. Counterfeit drugs are spurious drugs, falsely labelled, falsified, substandard, unregistered/unlicensed, and infringe trademarks. Counterfeit drugs can mimic both legitimate and illegitimate drugs and are often distributed in virtual environments, such as illicit online pharmacies, the surface web, and the dark web. Counterfeit drug operators and operations are the typically corrupt and/or criminal individuals, groups, and techniques by which counterfeit drugs are produced and distributed. The manufacture and distribution of counterfeit drugs are ever-changing, which results in the need for investigative techniques that are equally adaptable and collaborative. Counterfeit drug investigations can be defined according to four categories: medical investigations in hospitals and through autopsies, chemical and non-chemical drug investigations in forensic toxicology laboratories, various track-and-trace technologies used in pharmaceutical industry investigations, and national and global coordinated investigations. Due to the diverse counterfeit drug investigations present, the logic and practice of abduction are highlighted as a primary part of the investigative element to counter ongoing efforts by offenders to evade detection. Abductive rationalities are prioritized in that they are contrary to an increasing reliance on technoscientific modes of data production alone. Rather, abductive reasoning plays a central role in counterfeit drug investigations at the levels of instigating and directing investigations, as well as interpreting and responding to evidential findings.

Keywords

Counterfeit drugs / Investigations / Forensic toxicology / Pharmaceutical industry / Criminal networks / Corruption / Abductive logic

Ethics Statement

Not applicable.

Informed Consent Statement

Not applicable.

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Not applicable.

Funding

This research received no external funding.

Declaration of Competing Interest

The author declares that they have no competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

[1] Ziavrou K, Noguera S, Boumba V. Trends in counterfeit drugs and pharmaceuticals before and during the COVID-19 pandemic. Forensic Sci. Int. 2022, 338, 11382-11382.

[2] Gopikarani N, Gayathri B, Praja S, Sridharan S. Safemedchain—Drug counterfeit prevention and recommendation using blockchain and machine learning. J. Intell. Fuzzy Syst. 2023, 44, 499-517.

[3] OECD/EUIPO. Trade in Counterfeit Pharmaceutical Products: Illicit Trade. 2020. Available online: https://www.oecd.org/content/dam/oecd/en/publications/reports/2020/03/trade-in-counterfeit-pharmaceutical-products_9404e892/a7c7e054-en.pdf (accessed on 3 January 2025).

[4] Barry E, Merkebu J, Varpio L. State-of-the-art literature review methodology: A six-step approach for knowledge synthesis. Perspect. Med. Educ. 2022, 11, 281-288.

[5] IQVIA Institute.The global Use of Medicine in 2019 and Outlook to 2023: Forecasts and Areas to Watch. 2019. Available online: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023 (accessed on 4 January 2025).

[6] Clark F. Rise in online pharmacies sees counterfeit drugs go global. Lancet 2015, 386, 1327-1328.

[7] Elkins K. (Ed.). Trends in Counterfeit Drugs; CRC Press: Boca Raton, FL, USA, 2024.

[8] Kammrath B, Leary P, Crocombe R. Detection and analysis of counterfeit drugs. In Trends in Counterfeit drugs; Elkins K, Ed.; CRC Press: Boca Raton, FL, USA, 2024; pp. 87-144.

[9] Pichini S, Solimini R, Berretta P, Pacifici R, Busardo F. Acute intoxications and fatalities from illicit fentanyl and analogues: An update. Ther. Drug Monit. 2018, 40, 38-51.

[10] Trecki J, Gerona R, Ellison R, Thomas C, Mileusnic-Polchan D. Increased incidence of fentanyl-related deaths involving para-fluorofentanyl or metonitazene. Morb. Mortal. Wkly. Rep. 2022, 71, 153-155.

[11] Mills D. Cybermedicine: The benefits and risks of purchasing drugs over the Internet. J. Technol. Law Policy 2000, 5, 51.

[12] Myshko D. Online Pharmacies That Sell Counterfeit Drugs Grew During the Pandemic. Formulary Watch. 2021. Available online: https://www.managedhealthcareexecutive.com/view/online-pharmacies-that-sell-counterfeit-drugs-grew-during-the-pandemic (accessed on 4 January 2025).

[13] Koenraadt R, Van de Ven K. The Internet and lifestyle drugs: An analysis of demographic characteristics, methods and motives of online purchasers of illicit lifestyle drugs in the Netherlands. Drugs Educ. Prev. Policy 2017, 25, 345-355.

[14] Fincham J. Negative consequences of the widespread and inappropriate easy access to purchasing prescription medications on the Internet. Am. Health Drug Benefits 2021, 14, 22-28.

[15] Soldner F, Kleinberg B, Johnson S. Counterfeits on dark markets: A measurement between Jan-2014 and Sep-2015. Crime Sci. 2023, 12, 18.

[16] Interpol. Interpol and Pharmaceutical Industry Launch Global Initiative to Combat Fake Medicines. 2013. Available online: https://www.interpol.int/en/News-and-Events/News/2013/INTERPOL-and-pharmaceutical-industry-launch-global-initiative-to-combat-fake-medicines (accessed on 3 January 2025).

[17] Hall A, Koenraadt R, Antonopoulous G. Illicit pharmaceutical networks in Europe: Organising the illicit medicine market in the United Kingdom and the Netherlands. Trends Organised Crime 2017, 3, 296-315.

[18] Rees V. The Impact of Counterfeit Drugs in South and South-East Asia. 2019. Available online: https://www.europeanpharmaceuticalreview.com/article/92194/the-impact-of-counterfeit-drugs-in-south-and-south-east-asia/ (accessed on 6 January 2025).

[19] Lemos N. Coordinated responses to poisonings and fatalities from counterfeit tablets. In Trends in Counterfeit Drugs; Elkins K, Ed.; CRC Press: Boca Raton, FL, USA, 2024; pp. 223-234.

[20] Glidden E, Gladden M, Dion C, Spyres M, Seth P, Aldy K, et al.Suspected counterfeit M-30 oxycodone pill exposures and acute withdrawals reported from a single hospital—Toxicology investigators consortium core registry, U.S. census bureau western region, 2017-2022. Morb. Mortal. Wkly. Rep. 2024, 73, 642-647.

[21] Adatsi F. Forensic toxicology. In Encyclopedia of Toxicology; Wexler P, Ed.; Elsevier Inc.: Amsterdam, The Netherlands, 2014; pp. 647-652.

[22] Wankhade T, Ingale S, Mohite P, Bankar N. Artificial intelligence in forensic medicine and toxicology: The future of forensic medicine. Cureus 2022, 14, e28376.

[23] Volonnino G, De Paola L, Spadazzi F, Serri F, Ottaviani M, Zamponi M, et al. Artificial intelligence and future perspectives in forensic medicine: A systematic review. Clin. Ter. 2024, 175, 193-202.

[24] Soria M. The improvements in forensic toxicology and its role in the forensic process. Span. J. Leg. Med. 2023, 49, 107-117.

[25] Friederich L, Cox M, Hyson B, Bishop-Freeman S. Suspected North Carolina counterfeit-pill involved deaths, 2020-2022. J. Anal. Toxicol. 2024, 48, 242-251.

[26] Chemistry World. Fighting fake medicines. 2019. Available online: https://www.chemistryworld.com/news/fighting-fake-medicines/3010498.article (accessed on 21 March 2025)

[27] Da Costa J, Aguiar-Oliveira M, Brown D, Bermudez J, Netto E, Leitao O, et al. Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil. Vaccine 2023, 14, 100343.

[28] OECD/EUIPO. Trade in Counterfeit and Pirated Goods: Mapping the Economic Impact. 2016. Available online: https://www.oecd.org/content/dam/oecd/en/publications/reports/2016/04/trade-in-counterfeit-and-pirated-goods_g1g65d0c/9789264252653-en.pdf (accessed on 3 January 2025).

[29] Abbas K, Afaq M, Khan T, Song W. A blockchain and machine-learning based drug supply chain management and recommendation system for smart pharmaceutical industry. Electronics 2020, 9, 852.

[30] Pathak A, Shrivastava S, Vardhini P, Meka A, Swami D, Hussain Z. Blockchain Technology in Pharmaceutical Supply Chain Management. 2022. Available online: https://ieeexplore.ieee.org/document/10008335 (accessed on 2 April 2025).

[31] Paththinige P,Chathura R. Evaluating the factors that affect the adoption of blockchain technology in the pharmaceutical supply chain—A case study. In Proceedings of the 2022 International Research Conference on Smart Computing and Systems Engineering. 2022. Available online: https://ieeexplore.ieee.org/document/9905114 ( accessed on 2 April 2025).

[32] Raj A, Yadav T, Patil S, Kalra A, Sardana S, Nirbhavane P. Counterfeit medicine: A major public health concern and effective remedies for combatting the crisis. Discov. Pharm. Sci. 2025, 1, 4.

[33] Mackey T, Liang B. Improving global health governance to combat counterfeit medicines: A proposal for a UNODC-WHO-Interpol trilateral mechanism. BMC Med. 2013, 11, 233.

[34] Peirce C. Illustrations on the Logic of Science; Open Court: Chicago, IL, USA, 2014.

[35] Danesi M. Introducing forensic semiotics in criminal investigations. In Research Handbook on Legal Semiotics; Wagner A, Marusek S, Eds.; Elgaronline: Cheltenham, England, 2023; pp. 237-253.

[36] Vila-Henninger L, Dupuy C, Van Ingelgom V, Caprioli M, Teuber F, Pennetreau D, et al. Abductive coding: Theory building and qualitative (re)analysis. Sociol. Methods Res. 2022, 53, 968-1001.

[37] Crispino F. Towards a forensic semiotics. Forensic Sci. Int. 2024, 357, 1-5.

[38] Pauling L. The Nature of the Chemical Bond and the Structure of Molecules and Chemistry: An Introduction to Modern Structural Chemistry; Cornell University Press: Ithaca, NY, USA, 1960.

[39] Popper K. The Logic of Scientific Discovery; Routledge: London, UK, 2002.

[40] Ignatow G. Sociological Theory in the Digital Age; Routledge: London, UK, 2020.

[41] Ginzburg C. Clues: Roots of a scientific paradigm. Theory Soc. 1979, 7, 273-288.

[42] Saetre A, Van de Ven A. Abductive theorizing is more than idea generation: Disciplined imagination and a prepared mind. Acad. Manag. Rev. 2024, 49, 454-457.

[43] Patokorpi E, Ahvenainen M. Developing an abduction-based method for futures research. Futures 2009, 41, 126-139.