Herbal medicines: challenges in the modern world. Part 2. European Union and Russia

Expert Review of Clinical Pharmacology

Volumn 9, Issue 8, 2016, Pages 1117-1127

  Sammons, Helen M ^a   Gubarev, Michael I ^b   Krepkova, Lubov V ^c   Bortnikova, Valentina V ^c   Corrick, Fenella ^a   Job, Kathleen M ^d   Sherwin, Catherine M T ^d,e   Enioutina, Elena Y ^d  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^b Pentskiff Inc   (United States)

^c All Russia Science Research Institute of Medicinal and Aromatic Plants   (Russian Federation)

^d UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF UTAH   (United States)

Author keywords

European Union; Herbal medicines; legislations; regulations; Russian Federation; traditional medicines

Indexed keywords

ACUPUNCTURE; AYURVEDA; CHINESE MEDICINE; COMORBIDITY; CULTURAL ANTHROPOLOGY; DIETARY SUPPLEMENT; DRUG EFFICACY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG SAFETY; DRUG STORAGE; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; HEALTH CARE AVAILABILITY; HERB DRUG INTERACTION; HERBAL MEDICINE; HUMAN; ORIENTAL MEDICINE; PHARMACY; PRESCRIPTION; REVIEW; RUSSIAN FEDERATION; SYSTEMATIC REVIEW (TOPIC); TINCTURE; TRADITIONAL HEALER; ADVERSE EFFECTS; ANIMAL; CHEMISTRY; MEDICINAL PLANT; PHYTOTHERAPY; PROCEDURES; STANDARDS; TRADITIONAL MEDICINE;

PLANT MEDICINAL PRODUCT;

ANIMALS; DIETARY SUPPLEMENTS; EUROPEAN UNION; HERB-DRUG INTERACTIONS; HUMANS; LEGISLATION, DRUG; MEDICINE, TRADITIONAL; PHYTOTHERAPY; PLANT PREPARATIONS; PLANTS, MEDICINAL; RUSSIA;

EID: 84979210773     PISSN: 17512433     EISSN: 17512441     Source Type: Journal    
DOI: 10.1080/17512433.2016.1189326     Document Type: Review

References (54)

1. World Health Organization. WHO traditional medicine strategy: 2014-2023; [cited 2016 Mar20]. Available from: http://apps.who.int/iris/bitstream/10665/92455/1/9789241506090_eng.pdf
2. DSM Group, Pharmaceutical Market in Russia. 2014 [cited 2016 Mar20]. Available from: http://www.dsm.ru/docs/analytics/spravka_may_2014.pdf. Russian.
3. R.D.E.Sewell, M.Rafieian-Kopaei The history and ups and downs of herbal medicines usage. J HerbMed Pharmacol. 2014;3(1):1–3.
4. N.Nissen, S.Evans. Exploring the practice and use of Western herbal medicine: perspectives from the social science literature. J Herbal Med. 2012;2(1):6–15.
5. UK Medicines and Healthcare Products Regulatory Agency. In 2008 MHRA commissioned Ipsos MORI to research the public’s perception of herbal medicines, the findings may help doctors and pharmacists when considering how to advise patients; 2009 [cited 2016 Mar20]. Available from: https://www.gov.uk/drug-safety-update/public-perception-of-herbal-medicines
6. T.J.Zuzak, J.Bonkova, D.Careddu, et al. Use of complementary and alternative medicine by children in Europe: published data and expert perspectives. Complement Ther Med. 2013;21(Suppl 1):S34–S47.
7. Official Journal of the European Union. Directive 2004/24/Ec of the European Parliament and of the Council; 2004 [cited 2016 Mar20]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0085:0090:en:PDF
8. Directive 2001/83/ec of the european parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. 2001 [cited 2016 Mar 20]. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
9. Bapna V on behalf of International Ayurveda Foundation, UK, India and Switzerland, 2008. Presentation at the International Ayurveda Foundation: “Impact of the Traditional Herbal Medicinal Products Directive (THNPD), the new challenge for global Ayurveda”; [cited 2016 Mar20]. Available from: http://iaf-ngo.org/pdf/WAC%20SPEECH%20BY%20DR.%20VIDHI%20BAPNA%20(No.%2017).pdf
10. European Medicines Agency. Uptake of the traditional use registration scheme and implementation of the provisions of directive 2004/24/EC in EU member states; [updated 2014 Dec 31; cited 2016 Mar20]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/05/WC500106706.pdf
11. S.M.Giveon, N.Liberman, S.Klang, et al. Are people who use “natural drugs” aware of their potentially harmful side effects and reporting to family physician? Patient Educ Couns. 2004;53(1):5–11.
12. R.Woodfield. Senecio species in unlicensed herbal remedies (Letter). London: Medicines Control Agency; 2002.
13. P.Posadzki, L.K.Watson, E.Ernst. Adverse effects of herbal medicines: an overview of systematic reviews. Clin Mead (Blond). 2013;13(1):7–12.• This overview of 50 systematic reviews provides insight into the diversity of adverse effects and interactions associated with the 50 different herbal medicine products. The authors’ discussion around limitations of this overview also emphasizes the issue of limited high quality evidence available for research into herbal medicines.
14. R.Rahimi, M.Abdollahi. An update on the ability of St. John’s wort to affect the metabolism of other drugs. Expert Opin Drug Metab Toxicol. 2012;8(6):691–708.
15. C.Gulian, J.Barnes, F.Sally-Anne. Types and preferred sources of information concerning herbal medicinal products: face-to-face interviews with users of herbal medicinal products. Int J Pharm Pract. 2002;10(S1):R33.
16. D.Shaw, L.Graeme, D.Pierre, et al. Pharmacovigilance of herbal medicine. J Ethnopharmacol. 2012;140(3):513–518.
17. J.Talbot, J.K.Aronson, editors. Stephens’ detection and evaluation of adverse drug reactions: principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2011.
18. O.F.Kunle, H.O.Egharevba, P.O.Ahmadu. Standardization of herbal medicines - a review. Int J Biodiversity Conservation. 2012;4(3):101–112. [cited 2016 Mar20]. Available at: http://www.academicjournals.org/IJBC
19. K.Chan, D.Shaw, M.S.Simmonds, et al. Good practice in reviewing and publishing studies on herbal medicine, with special emphasis on traditional Chinese medicine and Chinese materia medica. J Ethnopharmacol. 2012;140(3):469–475.
20. L.Teng, D.Shaw, J.Barnes. Characteristics and practices of traditional chinese medicine retail shops in London, UK: a cross-sectional study using an observational approach. J Ethnopharmacol. 2015;173:318–329.
21. P.E.Kummervold, C.E.Chronaki, B.Lausen, et al. eHealth trends in Europe 2005-2007: a population-based survey. J Med Internet Res. 2008;10(4):e42.
22. S.Wiesener, T.Falkenberg, G.Hegyi, et al. Legal status and regulation of complementary and alternative medicine in Europe. Forsch Komplementmed. 2012;19 Suppl 2:29–36.• This review of the legal status of complementary and alternative medicine in 39 states across Europe highlights the complicated heterogeneity of legal approaches taken to the practice of CM in neighboring countries. The authors discuss the possible impact of this situation on patients, practitioners and researchers.
23. A.Dixon. Regulating complementary medical practitioners. Case studies. MEDICINE King’s fund; 2008 [cited 2016 Mar20]. Available from: http://www.kingsfund.org.uk/sites/files/kf/regulating-complementary-medical-practitioners-case-studies-anna-dixon-mar08.pdf•• This report presents the regulations governing CM practitioners (not products) in 16 case study countries across four continents. This provides an extremely useful and interesting counterpoint and companion resource to the current review.
24. A.N.Shikov, O.N.Pozharitskaya, V.G.Makarov, et al. Medicinal plants of the Russian pharmacopoeia: their history and applications. J Ethnopharmacol. 2014;154(3):481–536.• This article describes the history of HMs in Russia, some aspects of HM regulation and unique medicinal plants used by Russian Medicine.
25. V.A.Solovieva. Narodnye Metody Ukreplenija Zdorovja [Traditional methods of the health promotion]. St. Petersburg: Izdatel’skiy dom “Neva”; 2005.
26. K.F.Blinova, G.P.Yakovlev. Botanical and pharmacognostic dictionary. M.: High. School. 1990. ISBN 5-06-000085-0. Russian.
27. L.Braun. Principles of herbal medicine. In: K.Phelps, C.Hassed, editors. General practice: the integrative approach. Chatswood: Elsevier; 2011.
28. G.Dragendorff. Plant analysis: qualitative and quantitative. Translated from German by Greenish H.G. New York: G.E. Stecher; 1921.
29. B.Wood, F.Bache, J.P.Remington, et al. The dispensatory of the United States of America. 16th ed. Philadelphia: J.P. Lipincott; 1892.
30. VILAR history. [cited 2016 Mar20]. Available from: http://vilarnii.ru/about/. Russian.
31. N.Mamedov, N.P.Mehdiyeva, L.E.Craker. Medicinal plants used in traditional medicine of the caucasus and North America. J Medicinally Active Plants. 2015;4(3–4):42–66. [cited 2016 Mar20]. Available from: http://scholarworks.umass.edu/jmap/vol4/iss3/5• Describes use of medicinal plants by Russian medicine.
32. VILAR progress. [cited 2016 Mar20]. Available from: http://vilarnii.ru/about/progress/. Russian.
33. Ministry of Healthcare of the Russian Federation. Stater registry of medicines; [cited 2016 Mar20]. Available from: http://grls.rosminzdrav.ru/grls.aspx. Russian.
34. A.A.Karpeev. Traditional medicine in Russia: state and perspectives. Applied kinesiotherapy; 2007 [cited 2016 May5]. Available from: http://www.kinesio.ru/book/st0028.html
35. L.V.Krepkova, V.V.Bortnikova, E.V.Arzamastsev, et al. Specifics of toxicological studies of the herbal based medicines. Questions Biol Med Pharmacol Chem. 2009;5:75–78. Russian.• This article discusses some aspects of toxicological studies and analyzes adverse reactions of plat-based medicines.
36. L.V.Krepkova, E.V.Arzamastsev, O.N.Tolkachev. Herbal medicines: place in the modern pharmacotherapy, regulations of the production, circulation, control of efficacy and safety. Non-Traditional Natural Resources, Innovative Technologies and Products: Collection of Research Monographs. RA NS. 2013;21:124–138. Russian.• This publication raises questions regarding the production and regulation of HM in Russia.
37. Capital Medical. What are the BAS? General information; [cited 2016 Mar20. Available from: http://old.smed.ru/guides/goodsgroup/Biologicheski-aktivnye-dobavki-k-pishhe-BAD/40187/#article. Russian.
38. V.A.Tutel’ian, B.P.Sukhanov. [Food supplements: modern approaches to quality and safety]. Vopr Pitan. 2008;77(4):4–15. Russian.
39. V.A.Tutel’yan, B.P.Sukhanov. The modern approaches to quality and safety of the biologically active supplements to food. Moscow Pharmacies. 4. Russian. [cited 2016 Mar20]. Available from: http://rudoctor.net/medicine2009/bz-dw/med-emsef.htm(2008)
40. The Customs Union. Technical regulations of the customs union TP TC 021/2011 “Safety of the Food Products”. Russian. 2011 Dec [cited 2016 Mar 20]. Available from: http://www.tsouz.ru/db/techreglam/Documents/TR%20TS%20PishevayaProd.pdf
41. The Ministry of Healthcare of the Russian Federation, Chief State Sanitary Inspector of the Russian Federation. Resolution 36, 2001 Nov 14. On implementing sanitary rules; [cited 2016 Mar 20]. Available from: http://www.fodevarestyrelsen.dk/NR/rdonlyres/27A7BB2A-D250-4B36-AA27-D5592D13D010/0/SanPin2_3_2107801_consolidated_en_1.pdf
42. The Ministry of Healthcare of the Russian Federation. Order N117, 1997 Apr 15. Concerning the procedures for the examination and health certification of biologically active dietary supplements to food; Russian. [cited 2016 Mar20]. Available from: https://www.lawmix.ru/prof/75898
43. Agricultural and Agri-food Canada, International Markets Bureau. Market analysis report, January 2011: “Health and Wellness Trends in Russia”. [cited Mar20, 2016]. Available from: http://www5.agr.gc.ca/resources/prod/Internet-Internet/MISB-DGSIM/ATS-SEA/PDF/5696-eng.pdf
44. Russian Agency of Medico-social Information. State Duma prepares the law changing principles of governing BAS market; Russian. 2015 Sep [cited 2016 Mar 20]. Available from: http://ria-ami.ru/read/16250
45. Electronic version of the 13th edition of Russian pharmacopeia has been published. Pharmaceutical messenger; 2015 [cited 2016 Mar20]. Available from: http://www.pharmvestnik.ru/publs/lenta/v-rossii/opublikovana-elektronnaja-versija-xiii-izdanija-gosudarstvennoj-farmakopei-rossii.html#.Vti2z_krKUm
46. The Ministry of Healthcare of the Russian Federation. Federal Electronic Medical Library. Russian pharmacopeia 13th edition, Russian. [cited 2016 Mar 13]. Available from: http://www.femb.ru/feml
47. Federal Law “On Circulation of Medicines. № 61-FZ”. Adopted by the Russian federation state Duma on March 24, 2010 2010 Apr 12. [cited 2016 Mar 20]. Available from: https://www.unodc.org/res/cld/document/rus/federal-law-on-circulation-of-medicines_html/Russian_Federation_Federal_Law_On_Circulation_of_Medicines_61-FZ_EN.pdf
48. Federal law “ About changes to the Federal law ‘On Circulation of Medicines’ “ N429-ФЗ, adopted by the Russian federation sate Duma. December 9, 2014. Russian; [cited 2016 Mar20]. Available from: http://base.consultant.ru/cons/cgi/online.cgi?req=doc;base=LAW;n=182797;fld=134;dst=1000000001,0;rnd=0.4952516600023955
49. The guidelines on conducting pre-clinical trials of medicines, Part 1 and Part 2. in Russian. [cited 2016 Mar20]. Available from: http://www.regmed.ru/Content/Page.aspx?id=30e5e2b2-74a6-4616-9624-b796f00d0a9b (ed. Mironov, AN) (Grif and Co., Moscow, 2012).
50. The Russian Federation. Law N1034-1 “Sanitary and Hygienic Well-being of the Russian Federation Population”; 1991 April 19 [cited 2016 Mar 20]. Available from: http://base.consultant.ru/cons/cgi/online.cgi?req=doc;base=LAW;n=8443;fld=134;from=14778-9;rnd=189271.16416219458915293;;ts=01892710967886452563107. Russian.
51. The Eurasian Economic Union. 2014. Unified principals and rules of medicinal products’ circulation in the Eurasian economic union. [cited 2016 Mar20]. Available from: https://docs.eaeunion.org/docs/ru-ru/0149563/itia_24122014_doc
52. The Ministry of Healthcare of the Russian Federation. President of the Russian Federation signed the law intended to increase safety of medicines, medical products and BAS. Published: 2016 Jan 4, Last revised 2016 Jan 16 [cited 2016 Mar 20]. Available from: http://www.rosminzdrav.ru/news/2015/01/04/2193-prezidentom-rf-podpisan-zakon-povyshayuschiy-bezopasnost-lekarstvennyh-sredstv-meditsinskih-izdeliy-i-badov. Russian.
53. D.Runkevich, E.Malay. Federal government and Duma are not happy regarding recent scandals associated with BAS; [cited Mar 2016]. Available from: http://izvestia.ru/news/590930. In: Izvestia. (Moscow, 2015).
54. R.Corey, K.T.Werner, A.Singer, et al. Acute liver failure associated with Garcinia cambogia use. Ann Hepatol. 2016;15(1):123–126.