The occurrence of non‐anatomical therapeutic chemical‐international nonproprietary name molecules in suspected illegal or illegally traded health products in Europe: A retrospective and prospective study,Drug Testing and Analysis

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The occurrence of non‐anatomical therapeutic chemical‐international nonproprietary name molecules in suspected illegal or illegally traded health products in Europe: A retrospective and prospective study
Drug Testing and Analysis ( IF 2.6 ) Pub Date : 2021-01-16 , DOI: 10.1002/dta.3001
Eric Deconinck _{1,

2} , Celine Vanhee ₂ , Peter Keizers _{1,

3} , Pauline Guinot _{1,

4} , Albena Mihailova ₅ , Per Vidar Syversen _{1,

5} , Graziella Li-Ship _{1,

6} , Steven Young ₆ , Agata Blazewicz _{1,

7} , Magdalena Poplawska ₇ , Josephine Loasby Al-Sayed ₈ , Lone Stengelshøj Olsen _{1,

8} , Oliver El-Atma ₉ , Roman Leist _{1,

10} , Karl-Henrik Jönsson _{1,

11} , Maria Afxentiou _{1,

12} , M Mendoza Barrios _{1,

13} , I Dorronsoro Diaz ₁₃ , Marina Zemser _{1,

14} , Alla Kozokin ₁₄ , Andreas Hackl _{1,

15} , Maria-Jao Portela _{1,

16} , Nico Beerbaum ₁₇ , Marie Bertrand ₁

Affiliation

OMCL Falsified Medicines Working Group, GEON Network, EDQM-Council of Europe, Strasbourg, France.
Scientific Direction Chemical and Physical Health Risks, Service of Medicines and Health Products, Sciensano, Brussels, Belgium.
Department of Product Composition, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
Laboratory Controls Division, French National Agency for Medicines and Health Products Safety, Vendargues, France.
Laboratory, Division Reliable Supply, Norwegian Medicines Agency, Oslo, Norway.
Inspections, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency, London, UK.
Falsified Medicines and medical Devices Department, National Medicines Institute, Warsaw, Poland.
Medicines Control and Inspection Division, Danish Medicines Agency, Copenhagen, Denmark.
Medicinal Products, Chemical and Veterinary Investigation Office, Karlsruhe, Germany.
OMCL, Swissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland.
Laboratory Department, Swedish Medical Products Agency, Uppsala, Sweden.
Forensic Chemistry and Toxicology Laboratory, State General Laboratory, Nicosia, Cyprus.
Chemical and Pharmaceutical Division, Medicines for Human Use Department, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, Spain.
Institute of Standardization and Control of Pharmaceuticals, Ministry of Health Israel, Jerusalem, Israel.
Institute Assessment & Analytics, Analytics of chemical-pharmaceutical Medicinal Products, AGES-Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, Wien, Austria.
Direção de Comprovação da Qualidade, INFARMED-Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., Lisbon, Portugal.
Institut für Lebensmittel, Arzneimittel, Tierseuchen und Umwelt, Landeslabor Berlin-Brandenburg, Berlin, Germany.

The General European Official Medicines Control Laboratory (OMCL) Network (GEON), co‐ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), regularly organises market surveillance studies on specific categories of suspected illegal or illegally traded products. These studies are generally based on a combination of retrospective and prospective data collection over a defined period of time. This paper reports the results of the most recent study in this context with the focus on health products containing non‐Anatomical Therapeutic Chemical‐International Nonproprietary Name (ATC‐INN) molecules. In total 1104 cases were reported by 16 countries for the period between January 2017 and the end of September 2019. The vast majority of these samples (83%) were collected from the illegal market, while only 3% originated from a legal source. For the rest of the samples, categorisation was not possible. Moreover, 69% of all the reported samples were presented as medicines, including sexual performance enhancers, sports performance enhancers, physical performance enhancers and cognitive enhancers or nootropic molecules that act on the central nervous system (CNS). Although the popularity of anabolics, PDE‐5 inhibitors and CNS drugs in illegal products has already been reported, the study showed some new trends and challenges. Indeed, 11% of the samples contained molecules of biological origin, that is, research peptides, representing the second most reported category in this study. Furthermore, the study also clearly shows the increasing popularity of Selective Androgen Receptor Modulators and nootropics, two categories that need attention and should be further monitored.

中文翻译：

欧洲涉嫌非法或非法交易的健康产品中非解剖治疗化学国际非专利名称分子的发生：一项回顾性和前瞻性研究

欧洲官方药品控制实验室 (OMCL) 网络 (GEON) 由欧洲药品质量和医疗保健理事会 (EDQM) 协调，定期组织对特定类别的涉嫌非法或非法交易产品的市场监督研究。这些研究通常基于特定时间段内回顾性和前瞻性数据收集的组合。本文报告了在此背景下的最新研究结果，重点是含有非解剖治疗化学品-国际非专利名称 (ATC-INN) 分子的健康产品。2017 年 1 月至 2019 年 9 月底期间，16 个国家共报告了 1104 起案件。这些样本中的绝大多数 (83%) 来自非法市场，而只有 3% 来自合法来源。对于其余的样本，分类是不可能的。此外，所有报告的样本中有 69% 是作为药物提供的，包括性表现增强剂、运动表现增强剂、身体表现增强剂和认知增强剂或作用于中枢神经系统 (CNS) 的促智分子。尽管已经报道了合成代谢物、PDE-5 抑制剂和 CNS 药物在非法产品中的流行，但该研究显示了一些新的趋势和挑战。事实上，11% 的样本包含生物来源的分子，即研究肽，代表了本研究中报告的第二大类别。此外，该研究还清楚地表明选择性雄激素受体调节剂和益智药越来越受欢迎，

更新日期：2021-01-16

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