Pharmacovigilance of Natural Herbal Medicines Research for Efficacy, Safety and Quality Assurance of Phytomedicine Products
Article Sidebar
Published
Nov 26, 2020
Page:
21-37
Main Article Content
Estella Tembe Fokunang
Department of Pharmacotoxicology and Pharmacokinetics, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Dobgima John Fonmboh
Department of Nutrition, Food Science and Bioresource Technology, College of Technology, University of Bamenda, Cameroon.
Rose Ngono Mballa
Department of Pharmacology and Traditional Medicine, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Andrew Banin Nyuyki
Lead Scientist GE Life Sciences CYTIVA, Logan, Utah, USA.
Lovet Benyella Fokunang
Department of Pathology, New York University School of Medicine, New York, NY 10016, USA.
Nubia Kaba
Department of Clinical Research, Revance Therapeutic Incorporated, Newark California, USA.
Thérèse Bwemba Abong
National Ethics Committee for Human Health Research of Cameroon (CNERSH), Yaoundé, Cameroon.
Ralf Duerr
Department of Pharmacology and Traditional Medicine, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Ejoh Richard
Department of Nutrition, Food Science and Bioresource Technology, College of Technology, University of Bamenda, Cameroon.
Marie-Thérèse Abena Ondoua
Pediatrics, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Charles Ntungwen Fokunang
Department of Pharmacotoxicology and Pharmacokinetics, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Abstract
Improved traditional medicine/phytomedicine formulations have gained a global acceptability and popularity as therapeutic agents for many diseases in Sub-Saharan Africa. Herbal products are generally considered as safe, environmentally friendly and increasingly consumed by the community without prescription. There is a lack of systematic data on traditional medicine-associated adverse effects due to complex issues such as products with multiple ingredients, poor standardization, lack of clinical trials, variation in manufacturing processes, contamination, adulteration and misidentification of herbs. The aim of pharmacovigilance is to detect, assess, understand, and prevent the adverse effects or any other possible drug-related problems, related to herbal, traditional and complementary medicines. Pharmacovigilance for herbal medicines is in its infancy, and monitoring the safety of natural products presents unique challenges, and as such, preparations are available from a wide range of sources where limited qualified healthcare professionals are available. The ethico-legal issues and regulatory approval mechanism of herbal medicine vary from country to country. This paper also elucidates the level of challenges associated with herbal pharmacovigilance geared towards improving safety monitoring for herbal medicines in the future.
Keywords:
Pharmacovigilance, herbal medicines, improved traditional medicine, regulation, research.
Article Details
How to Cite
Fokunang, E. T., Fonmboh, D. J., Mballa, R. N., Nyuyki, A. B., Fokunang, L. B., Kaba, N., Abong, T. B., Duerr, R., Richard, E., Ondoua, M.-T. A., & Fokunang, C. N. (2020). Pharmacovigilance of Natural Herbal Medicines Research for Efficacy, Safety and Quality Assurance of Phytomedicine Products. Journal of Complementary and Alternative Medical Research, 12(1), 21-37. https://doi.org/10.9734/jocamr/2020/v12i130198
Section
Review Article
References
Fokunang CN, Tembe-Fokunang EA, Galega S, Forsuh FF, Djuidje MN, Kechia FA, Ngongang J, Abena OMT, Kaptue L. In: Advances in medicines and biology, Leon V. Berhardt Eds. Ethical implications and regulatory perspectives in the conduct of research in herbal medicine in Cameroon. Advances in Medicines and Biology, vol 138. Nova Science Publisher’s Inc, USA. 2019;1-39:270. ISBN: 978-1-53615-066-7 EBOOKS.
Kaptue L, Djuidje NM, Fokunang CN. Traditional medicine research: Ethical implications in the conduct of African traditional medicine research. In Kruger M, Ndebele P and Horn L Eds. Research Ethics in Africa a Resource for Research Ethics Committee. Sun Media Press Stellenbosch, South Africa. 2014;109-115.
Fokunang CN. Traditional medicine research in Bali Nyonga In (Titanji VKP Eds). Bali Nyonga today, roots, cultural practices and future perspectives. Spears Media Press Denver, USA. 2016;159-176.
Fokunang CN, Tembe-Fokunang EA, Awah P, Djuidje Ngounoue M, Chi P, Ateudjieu J, Kaptue Lazare, Abena OMT. The role of ethics in public health clinical research. In Alfonso J Rodriguez-Morsles (Eds): Current Topics in Public Health. Intech Publishers; 2012. Intech. 2013;27:662-683. ISNB.978-953-1121-14. Available:http://dx.doi.org/10.5772/52478
Lukong MCS, Tembe Fokunang EA, Dehayen M, Ngo VN, Fokunang CN. Evaluation of the therapeutic approach and outcome of type 2 diabetes mellitus management strategies in Cameroon. Journal of Advances in Medical and Pharmaceutical Sciences. 2019;20(4):1-15. Article no.JAMPS.49004, ISSN: 2394-1111. DOI: 10.9734/JAMPS/2019/v20i430115
Njeba BB, Tembe FE, Essi MJ, Ngo VN, Fokunang CN. Pharmacovigilance: Knowledge attitude and practice within the public health actors in Yaoundé, Cameroon. Current Trends in Pharmacology and Clinical Trials. 2019;2(2):180017.
Tembe-Fokunang EA, Fokunang CN, Nubia K, Gatsing D, Agbor M, Ngadjui BT. The potential pharmacological and medicinal properties of neem (Azadirachta indica A. Juss) in the drug development of phytomedicine. Journal of Complementary and Alternative Medical Research. 2019;7(1):1-18. DOI: 10.9734/JOCAMR/2019/v7i130093
Tembe FEA, Fokunang CN, Ndikum VN, Kaba NC, Banin AN, Fokam J, Nanfack A, Duerr R, Gorny MK. Clinical pharmacokinetics concepts in the drug discovery and development process of phytomedicines in some developing countries. World Journal of Pharmaceutical and Life Sciences. 2018;4(7):22-32. SJIF Impact Factor: 5.088. Available:www.wjpls.org
Fokunang CN, Tembe-Fokunang EA, Njigou AR, Ngameni B. In vitro evaluation of the interaction between amoxicillin and hydro ethanolic extracts of Annickia chlorantha. Toxicol Open Access. 2017;3:4. ISSN: 2476-2067 1000133 DOI: 10.4172/2476-2067.1000133
Fokunang CN, Djousse NC, Tembe-Fokunang EA, Kechia FA, Ndikum V, Ngadou P, Ngono MR. Pharmacovigilance adverse drug reactions reporting: knowledge, attitude and practice study among health professionals in Yaoundé, Cameroon. Journal of Analytical & Pharmaceutical Research. 2017;4(6): 00123.
Fokunang CN, Ngameni B, Guedje NM, et al. Development of antimalaria, antibacterial, anticancer and antitumour drugs from new chemical entities from plant sources. Journal of Applied Science and Technology (JAST). 2011;16(1,2):15-23.
Fokunang CN, Ndikum V, Tabi OY, Jiofack RB, Ngameni B, Guedje NM, Tembe-Fokunang, et al. Traditional medicine: Past, present and future research and development prospects and integration in the national health system of Cameroon. African Journal of Traditional Complementary and Alternative Medicine. 2011;8(3):284-295 284. Available:http://ajol.info/index.php/ijbcs
Gossell M, Simon OR, West ME. The past and the present use of plants for medicines. West Indian Medical Journal. 2006;55:217.
WHO. World Health Organization the importance of pharmacovigilance: Safety monitoring of medicinal products. Geneva; 2002.
Adithan C, National Pharmacovigilance Programme. Indian Journal of Pharmacology. 2005;37(6):347.
Bateman DN, Chaplin S. Adverse reactions. British Medical Journal. 1988;296:761–64.
Sheibani M, Nayernouri T, Dehpour AR. Herbal medicines and other traditional remedies in Iran - A tragedy unfolds. Arch Iran Med. 2018;21(7):312-314. PMID: 30041530
Skalli S, Bencheikh RS. Pharmacovigilance of herbal medicines in Africa: Questionnaire study. J Ethnopharmacol. 2015;171:99-108. DOI: 10.1016/j.jep.2015.05.033 Epub 2015 May 28 PMID: 26027756
Awodele O, Daniel A, Popoola TD, Salami EF. A study on pharmacovigilance of herbal medicines in Lagos West Senatorial District, Nigeria. Int J Risk Saf Med. 2013;25(4):205-17. DOI: 10.3233/JRS-130604 PMID: 24305559
Rodrigues E, Barnes J. Pharmacovigilance of herbal medicines: The potential contributions of ethnobotanical and ethnopharmacological studies. Drug Saf. 2013;36(1):1-12. DOI: 10.1007/s40264-012-0005-7 PMID: 23315291
Skalli S, Soulaymani Bencheikh R. Safety monitoring of herb-drug interactions: A component of pharmacovigilance. Drug Saf. 2012;35(10):785-91. DOI: 10.1007/BF03261975 PMID: 22876741
Shaw D, Graeme L, Pierre D, Elizabeth W, Kelvin CJ. Ethnopharmacol. Pharmacovigilance of Herbal Medicine. 2012;140(3):513-8. DOI: 10.1016/j.jep.2012.01.051 Epub 2012 Feb 9 PMID: 22342381
Ioset JR, Raoelison GE, et al. Detection of aristolochic acid in Chinese phytomedicines and dietary supplements used as slimming regimens. Food Chemistry and Toxicology. 2003;41:29–36.
Cosyns JP. Aristolochic acid and Chinese herbs nephropathy: A review of the evidence to date. Drug Safety. 2003;26: 33–48.
Castot A, Larrey D. Hepatitis observed during a treatment with a drug or tea containing wild Germander. Evaluation of 26 cases reported to the Regional Centers of Pharmacovigilance. Gastroenterology and Clinical Biology. 1992;16:916–22.
Attele AS, Wu JA, Yuan CS. Ginseng pharmacology: Multiple constituents and multiple actions. Biochemical Pharmacology. 1999;58:1685–93.
Izzo AA, Carlo GD, Borrelli F, et al. Complementary pharmacotherapy and herbal medicines: The risk of drug interaction. International Journal of Cardiology. 2005;98:1–14.
Vaes LP, Chyka PA. Interaction of ginger, garlic, ginko or ginseng: Nature of evidence. The Annals of Pharmacotherapy. 2000;34:1478–82.
Fugh-Berman A. Herb-drug interactions. The Lancet. 2000;355:13438.
Roulet M. Hepato-veno-occlusive disease in newborn infant of a woman drinking herbal tea. Journal of Pediatrics. 1988;112: 433–36.
Einarson TR. Drug related hospital admissions. The Annals of Pharmacotherapy. 1993;27:832–40.
Ang-Lee MK. Herbal medicines and perioperative care. Journal of American Medical Association. 2001;286:208–216.
Barnes J, Mills SY, Abott NC, et al. Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. British Journal of Clinical Pharmacology. 1998;45:496–500.
Barnes J. Pharmacovigilance of herbal medicines: A UK perspective. Drug Safety. 2003;26:829–51.
EMEA, European Medicine Evaluation Agency. Report from the ad hoc working group on Herbal Medicinal Products; 1999.
European Commission. Commission of the European Communities. Proposal for amending the direction 2001/83/EC as regards traditional herbal medicinal products. 2002/008 (OOD). Brussels; 2002.
ICH Guideline E2D; Post-approval safety data management: Definitions and standards for expedited reporting, 3.1.1 Spontaneous Reports; 2004.
Goldman SA. Limitations and strengths of spontaneous reports data. Clinical Therapeutics. 1998;20(Suppl C):C40-C44.
Hartmann K, Doser AK, Kuhn M. Postmarketing safety information: How useful are spontaneous reports. Pharmacoepidemiology and Drug Safety. 1999;8:S65-S71.
Garcia Rodriguez LA, Perez Gutthann S. Use of the UK general practice research database for pharmacoepidemiology. British Journal of Clinical Pharmacology. 1998;45(5):419-25.
Schulz V, Hansel R, Tyler VE. Rational phytotherapy: A physician guide to herbal medicine. 4th Ed., Springer, Berlin; 2000.
Biswas P, Biswas AK. Setting standards for proactive pharmacovigilance in India: The way forward. Indian Journal of Pharmacology. 2007;39:124–28.
Mann RD, Andrews EB, (Eds.) Pharmacovigilance. John Wiley and Sons Ltd., West Sussex, England; 2002.
Pinkston V, Swain EJ. Management of adverse drug reactions and adverse event data through collection, storage and retrieval. In: Stephens M.D.B, Talbot J.C.C. and Routledge P.A. Edition, Detection of New Adverse Drug Reactions, 4th Ed., MacMillan Reference Ltd, London. 1998; 282. WHO., World Health Organization. WHO Guideline on Safety Monitoring of Herbal Medicines in Pharmacovigilance System. Geneva; 2004.
Kaptue L, Djuidje NM, Fokunang CN. Traditional medicine research: Ethical implications in the conduct of African traditional medicine research. In Kruger M, Ndebele P and Horn L Eds. Research Ethics in Africa a Resource for Research Ethics Committee. Sun Media Press Stellenbosch, South Africa. 2014;109-115.
Fokunang CN. Traditional medicine research in Bali Nyonga In (Titanji VKP Eds). Bali Nyonga today, roots, cultural practices and future perspectives. Spears Media Press Denver, USA. 2016;159-176.
Fokunang CN, Tembe-Fokunang EA, Awah P, Djuidje Ngounoue M, Chi P, Ateudjieu J, Kaptue Lazare, Abena OMT. The role of ethics in public health clinical research. In Alfonso J Rodriguez-Morsles (Eds): Current Topics in Public Health. Intech Publishers; 2012. Intech. 2013;27:662-683. ISNB.978-953-1121-14. Available:http://dx.doi.org/10.5772/52478
Lukong MCS, Tembe Fokunang EA, Dehayen M, Ngo VN, Fokunang CN. Evaluation of the therapeutic approach and outcome of type 2 diabetes mellitus management strategies in Cameroon. Journal of Advances in Medical and Pharmaceutical Sciences. 2019;20(4):1-15. Article no.JAMPS.49004, ISSN: 2394-1111. DOI: 10.9734/JAMPS/2019/v20i430115
Njeba BB, Tembe FE, Essi MJ, Ngo VN, Fokunang CN. Pharmacovigilance: Knowledge attitude and practice within the public health actors in Yaoundé, Cameroon. Current Trends in Pharmacology and Clinical Trials. 2019;2(2):180017.
Tembe-Fokunang EA, Fokunang CN, Nubia K, Gatsing D, Agbor M, Ngadjui BT. The potential pharmacological and medicinal properties of neem (Azadirachta indica A. Juss) in the drug development of phytomedicine. Journal of Complementary and Alternative Medical Research. 2019;7(1):1-18. DOI: 10.9734/JOCAMR/2019/v7i130093
Tembe FEA, Fokunang CN, Ndikum VN, Kaba NC, Banin AN, Fokam J, Nanfack A, Duerr R, Gorny MK. Clinical pharmacokinetics concepts in the drug discovery and development process of phytomedicines in some developing countries. World Journal of Pharmaceutical and Life Sciences. 2018;4(7):22-32. SJIF Impact Factor: 5.088. Available:www.wjpls.org
Fokunang CN, Tembe-Fokunang EA, Njigou AR, Ngameni B. In vitro evaluation of the interaction between amoxicillin and hydro ethanolic extracts of Annickia chlorantha. Toxicol Open Access. 2017;3:4. ISSN: 2476-2067 1000133 DOI: 10.4172/2476-2067.1000133
Fokunang CN, Djousse NC, Tembe-Fokunang EA, Kechia FA, Ndikum V, Ngadou P, Ngono MR. Pharmacovigilance adverse drug reactions reporting: knowledge, attitude and practice study among health professionals in Yaoundé, Cameroon. Journal of Analytical & Pharmaceutical Research. 2017;4(6): 00123.
Fokunang CN, Ngameni B, Guedje NM, et al. Development of antimalaria, antibacterial, anticancer and antitumour drugs from new chemical entities from plant sources. Journal of Applied Science and Technology (JAST). 2011;16(1,2):15-23.
Fokunang CN, Ndikum V, Tabi OY, Jiofack RB, Ngameni B, Guedje NM, Tembe-Fokunang, et al. Traditional medicine: Past, present and future research and development prospects and integration in the national health system of Cameroon. African Journal of Traditional Complementary and Alternative Medicine. 2011;8(3):284-295 284. Available:http://ajol.info/index.php/ijbcs
Gossell M, Simon OR, West ME. The past and the present use of plants for medicines. West Indian Medical Journal. 2006;55:217.
WHO. World Health Organization the importance of pharmacovigilance: Safety monitoring of medicinal products. Geneva; 2002.
Adithan C, National Pharmacovigilance Programme. Indian Journal of Pharmacology. 2005;37(6):347.
Bateman DN, Chaplin S. Adverse reactions. British Medical Journal. 1988;296:761–64.
Sheibani M, Nayernouri T, Dehpour AR. Herbal medicines and other traditional remedies in Iran - A tragedy unfolds. Arch Iran Med. 2018;21(7):312-314. PMID: 30041530
Skalli S, Bencheikh RS. Pharmacovigilance of herbal medicines in Africa: Questionnaire study. J Ethnopharmacol. 2015;171:99-108. DOI: 10.1016/j.jep.2015.05.033 Epub 2015 May 28 PMID: 26027756
Awodele O, Daniel A, Popoola TD, Salami EF. A study on pharmacovigilance of herbal medicines in Lagos West Senatorial District, Nigeria. Int J Risk Saf Med. 2013;25(4):205-17. DOI: 10.3233/JRS-130604 PMID: 24305559
Rodrigues E, Barnes J. Pharmacovigilance of herbal medicines: The potential contributions of ethnobotanical and ethnopharmacological studies. Drug Saf. 2013;36(1):1-12. DOI: 10.1007/s40264-012-0005-7 PMID: 23315291
Skalli S, Soulaymani Bencheikh R. Safety monitoring of herb-drug interactions: A component of pharmacovigilance. Drug Saf. 2012;35(10):785-91. DOI: 10.1007/BF03261975 PMID: 22876741
Shaw D, Graeme L, Pierre D, Elizabeth W, Kelvin CJ. Ethnopharmacol. Pharmacovigilance of Herbal Medicine. 2012;140(3):513-8. DOI: 10.1016/j.jep.2012.01.051 Epub 2012 Feb 9 PMID: 22342381
Ioset JR, Raoelison GE, et al. Detection of aristolochic acid in Chinese phytomedicines and dietary supplements used as slimming regimens. Food Chemistry and Toxicology. 2003;41:29–36.
Cosyns JP. Aristolochic acid and Chinese herbs nephropathy: A review of the evidence to date. Drug Safety. 2003;26: 33–48.
Castot A, Larrey D. Hepatitis observed during a treatment with a drug or tea containing wild Germander. Evaluation of 26 cases reported to the Regional Centers of Pharmacovigilance. Gastroenterology and Clinical Biology. 1992;16:916–22.
Attele AS, Wu JA, Yuan CS. Ginseng pharmacology: Multiple constituents and multiple actions. Biochemical Pharmacology. 1999;58:1685–93.
Izzo AA, Carlo GD, Borrelli F, et al. Complementary pharmacotherapy and herbal medicines: The risk of drug interaction. International Journal of Cardiology. 2005;98:1–14.
Vaes LP, Chyka PA. Interaction of ginger, garlic, ginko or ginseng: Nature of evidence. The Annals of Pharmacotherapy. 2000;34:1478–82.
Fugh-Berman A. Herb-drug interactions. The Lancet. 2000;355:13438.
Roulet M. Hepato-veno-occlusive disease in newborn infant of a woman drinking herbal tea. Journal of Pediatrics. 1988;112: 433–36.
Einarson TR. Drug related hospital admissions. The Annals of Pharmacotherapy. 1993;27:832–40.
Ang-Lee MK. Herbal medicines and perioperative care. Journal of American Medical Association. 2001;286:208–216.
Barnes J, Mills SY, Abott NC, et al. Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. British Journal of Clinical Pharmacology. 1998;45:496–500.
Barnes J. Pharmacovigilance of herbal medicines: A UK perspective. Drug Safety. 2003;26:829–51.
EMEA, European Medicine Evaluation Agency. Report from the ad hoc working group on Herbal Medicinal Products; 1999.
European Commission. Commission of the European Communities. Proposal for amending the direction 2001/83/EC as regards traditional herbal medicinal products. 2002/008 (OOD). Brussels; 2002.
ICH Guideline E2D; Post-approval safety data management: Definitions and standards for expedited reporting, 3.1.1 Spontaneous Reports; 2004.
Goldman SA. Limitations and strengths of spontaneous reports data. Clinical Therapeutics. 1998;20(Suppl C):C40-C44.
Hartmann K, Doser AK, Kuhn M. Postmarketing safety information: How useful are spontaneous reports. Pharmacoepidemiology and Drug Safety. 1999;8:S65-S71.
Garcia Rodriguez LA, Perez Gutthann S. Use of the UK general practice research database for pharmacoepidemiology. British Journal of Clinical Pharmacology. 1998;45(5):419-25.
Schulz V, Hansel R, Tyler VE. Rational phytotherapy: A physician guide to herbal medicine. 4th Ed., Springer, Berlin; 2000.
Biswas P, Biswas AK. Setting standards for proactive pharmacovigilance in India: The way forward. Indian Journal of Pharmacology. 2007;39:124–28.
Mann RD, Andrews EB, (Eds.) Pharmacovigilance. John Wiley and Sons Ltd., West Sussex, England; 2002.
Pinkston V, Swain EJ. Management of adverse drug reactions and adverse event data through collection, storage and retrieval. In: Stephens M.D.B, Talbot J.C.C. and Routledge P.A. Edition, Detection of New Adverse Drug Reactions, 4th Ed., MacMillan Reference Ltd, London. 1998; 282. WHO., World Health Organization. WHO Guideline on Safety Monitoring of Herbal Medicines in Pharmacovigilance System. Geneva; 2004.