Clinical risk management of interactions between natural products and drugs

Current Drug Metabolism

Volumn 9, Issue 10, 2008, Pages 1055-1062

  De Smet, Peter A G M ^a   Floor Schreudering, Annemieke ^b   Bouvy, Marcel L ^b,c   Wensing, Michel ^a  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b SIR Institute for Pharmacy Practice and Policy   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Herb drug interactions; Risk management

Indexed keywords

ACETYLSALICYLIC ACID; ANGELICA DAHURICA EXTRACT; BAICALIN; BERBERINE; CAFFEINE; CENTELLA ASIATICA EXTRACT; CHLORZOXAZONE; CYCLOSPORIN A; FELODIPINE; GINGER EXTRACT; GINSENG EXTRACT; GLYCYRRHIZA GLABRA EXTRACT; GUANXIMIYOU; HYPERICUM PERFORATUM EXTRACT; NATURAL PRODUCT; PHENYTOIN; PINELLIA EXTRACT; PIPERINE; PLANT EXTRACT; PREDNISOLONE; PROPRANOLOL; RIFAMPICIN; ROSUVASTATIN; SAIBOKUTO; SCHISANDRA SPHENANTHERA EXTRACT; SCUTELLARIA BAICALENSIS EXTRACT; TACROLIMUS; TAMARINDUS INDICA EXTRACT; THEOPHYLLINE; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ANGELICA DAHURICA; AREA UNDER THE CURVE; DRUG ANTAGONISM; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG POTENCY; DRUG SURVEILLANCE PROGRAM; EDUCATION; FRUIT; HERB DRUG INTERACTION; HERBAL MEDICINE; HUMAN; MEDICINAL PLANT; NONHUMAN; PHARMACOEPIDEMIOLOGY; PLANT ROOT; PUBLIC HEALTH; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; RISK REDUCTION; SCHISANDRA SPHENANTHERA; SHELF LIFE; TAMARIND; INTERPERSONAL COMMUNICATION;

COMMUNICATION; HERB-DRUG INTERACTIONS; HUMANS; RISK ASSESSMENT; RISK MANAGEMENT; RISK REDUCTION BEHAVIOR;

EID: 62749122312     PISSN: 13892002     EISSN: None     Source Type: Journal    
DOI: 10.2174/138920008786927730     Document Type: Review

References (79)

1. Madar, J. Clinical risk management in newborn and neonatal resuscitation. Semin. Fetal Neonatal Med., 2005, 10 (1), 45-61.
2. Sandars, J. The theory and evidence base for clinical risk management. In Clinical Risk Management in Primary Care, Haynes, K., Thomas, M., Eds.; Radcliffe Publishing: Abingdon, 2005; pp. 45-59.
3. Hirst, C.; Cook, S.; Dai, W.; Perez-Gutthann, S.; Andrews, E. A call for international harmonization in therapeutic risk management. Pharmacoepidemiol. Drug Saf., 2006, 15 (12), 839-849.
4. De Smet, P.A. G.M. Clinical risk management of herb-drug interactions. Br.J. Clin. Pharmacol., 2007, 63 (3), 258-267.
5. Strandell, J.; Bate, A.; Lindquist, M.; Edwards, I.R. Drug-drug interactions - a preventable patient safety issue? Br.J. Clin. Pharmacol., 2008, 65 (1), 144-146.
6. Ernst, E. Second thoughts about safety of St John's wort. Lancet, 1999, 354 (9195), 2014-2016.
7. Haller, C.; Kearney, T.; Bent, S.; Ko, R.; Benowitz, N.; Olson, K. Dietary supplement adverse events: report of a one-year poison center surveillance project.J. Med. Toxicol., 2008, 4 (2), 84-92.
8. Kelly, W.N.; Arellano, F.M.; Barnes, J.; Bergman, U.; Edwards, R.I.; Fernandez, A.M.; Freedman, S.B.; Goldsmith, D.I.; Huang, K.A.; Jones, J.K.; McLeay, R.; Moore, N.; Stather, R.H.; Trenque, T.; Troutman, W.G.; van Puijenbroek, E.; Williams, F.; Wise, R.P. Guidelines for submitting adverse event reports for publication. Drug Saf., 2007, 30 (5), 367-373.
9. Kelly, W.N.; Arellano, F.M.; Barnes, J.; Bergman, U.; Edwards, R.I.; Fernandez, A.M.; Freedman, S.B.; Goldsmith, D.I.; Huang, K.A.; Jones, J.K.; McLeay, R.; Moore, N.; Stather, R.H.; Trenque, T.; Troutman, W.G.; van Puijenbroek, E.; Williams, F.; Wise, R.P. Guidelines for submitting adverse event reports for publication. Pharmacoepidemiol. Drug Saf., 2007, 16, 581-587.
10. Charrois, T.L.; Hill, R.L.; Vu, D.; Foster, B.C.; Boon, H.S.; Cramer, K.; Vohra, S. Community identification of natural health product-drug interactions. Ann. Pharmacother., 2007, 41 (7), 1124-1129.
11. Kennedy, J. Herb and supplement use in the US adult population. Clin. Ther., 2005, 27 (11), 1847-1858.
12. Anonymous. Complementary and alternative medicine. Department of Health, London, 2008.
13. De Smet, P.A. G.M. Herbal medicine in Europe - relaxing regulatory standards.N. Engl. J. Med., 2005, 352, 1176-1178.
14. Anonymous. Public Assessment reports for herbal medicines. [accessed Jul 13, 2008]. Medicines and Healthcare products Regulatory Agency. London, 2008.
15. Eberhardie, C. Nutritional supplements and the EU: is anyone happy? Proc. Nutr. Soc., 2007, 66 (4), 508-511.
16. Anonymous. Directive 2002/46/EC of the European Parliament and of the The Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements [Official Journal of the European Communities 12.7.2002 L 183/51-7]. [accessed Jul 13, 2008]. European Union. Brussels, 2002.
17. Blenkinsopp, A.; Wilkie, P.; Wang, M.; Routledge, P.A. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br.J. Clin. Pharmacol., 2007, 63 (2), 148-156.
18. Vickers, K.A.; Jolly, K.B.; Greenfield, S.M. Herbal medicine: women's views, knowledge and interaction with doctors: a qualitative study. BMC. Complement. Altern. Med., 2006, 6, 40.
19. Venkataramanan, R.; Komoroski, B.; Strom, S. In vitro and in vivo assessment of herb drug interactions. Life Sci., 2006, 78 (18), 2105-2115.
20. De Smet, P.A.G.M. The interference of botanicals and nutraceuticals with the effects of antithrombotic agents. How should the available evidence be weighed? Thromb. Res., 2005, 117, 39-42.
21. Anonymous. WHO Traditional Medicine Strategy 2002-2005. [accessed Jul 17, 2008]. World Health Organization, Geneva, 2002.
22. Gallagher, N.E. Islamic and Indian medicine. In The Cambridge World History of Human Disease, Kiple, K.F., Ed.; Cambridge University Press: Cambridge, 1993; pp. 27-35.
23. Mills, E.; Wu, P.; Johnston, B.C.; Gallicano, K.; Clarke, M.; Guyatt, G. Natural health product-drug interactions: a systematic review of clinical trials. Ther. Drug Monit., 2005, 27 (5), 549-557.
24. Nicandro, J.P.; Tsourounis, C.; Frassetto, L.; Guglielmo, B.J. In vivo effect of I'm-Yunity on hepatic cytochrome P450 3A4. J. Herb. Pharmacother., 2007, 7 (1), 39-56.
25. Nakao, M.; Muramoto, Y.; Hisadome, M.; Yamano, N.; Shoji, M.; Fukushima, Y.; Saruwatari, J.; Nakagawa, K. The effect of Shoseiryuto, a traditional Japanese medicine, on cytochrome P450s, N-acetyltransferase 2 and xanthine oxidase, in extensive or intermediate metabolizers of CYP2D6. Eur.J. Clin. Pharmacol., 2007, 63 (4), 345-353.
26. Guo, L.Q.; Chen, Q.Y.; Wang, X.; Liu, Y.X.; Chu, X.M.; Cao, X.M.; Li, J.H.; Yamazoe, Y. Different roles of pummelo furanocoumarin and cytochrome P450 3A5*3 polymorphism in the fate and action of felodipine. Curr. Drug Metab., 2007, 8 (6), 623-630.
27. Homma, M.; Oka, K.; Ikeshima, K.; Takahashi, N.; Niitsuma, T.; Fukuda, T.; Itoh, H. Different effects of traditional Chinese medicines containing similar herbal constituents on prednisolone pharmacokinetics. J. Pharm. Pharmacol., 1995, 47 (8), 687-692.
28. Xin, H.W.; Wu, X.C.; Li, Q.; Yu, A.R.; Zhu, M.; Shen, Y.; Su, D.; Xiong, L. Effects of Schisandra sphenanthera extract on the pharmacokinetics of tacrolimus in healthy volunteers. Br.J. Clin. Pharmacol., 2007, 64 (4), 469-475.
29. Dandekar, U.P.; Chandra, R.S.; Dalvi, S.S.; Joshi, M.V.; Gokhale, P.C.; Sharma, A.V.; Shah, P.U.; Kshirsagar, N.A. Analysis of a clinically important interaction between phenytoin and Shankhapushpi, an Ayurvedic preparation.J. Ethnopharmacol., 1992, 35 (3), 285-288.
30. Saruwatari, J.; Nakagawa, K.; Shindo, J.; Nachi, S.; Echizen, H.; Ishizaki, T. The in-vivo effects of sho-saiko-to, a traditional Chinese herbal medicine, on two cytochrome P450 enzymes (1A2 and 3A) and xanthine oxidase in man.J. Pharm. Pharmacol., 2003, 55 (11), 1553-1559.
31. Mustapha, A.; Yakasai, I.A.; Aguye, I.A. Effect of Tamarindus indica L. on the bioavailability of aspirin in healthy human volunteers. Eur.J. Drug Metab. Pharmacokinet., 1996, 21 (3), 223-226.
32. Fan, L.; Zhang, W.; Guo, D.; Tan, Z.R.; Xu, P.; Li, Q.; Liu, Y.Z.; Zhang, L.; He, T.Y.; Hu, D.L.; Wang, D.; Zhou, H.H. The effect of herbal medicine baicalin on pharmacokinetics of rosuvastatin, substrate of organic anion-transporting polypeptide 1B1. Clin. Pharmacol. Ther., 2008, 83 (3), 471-476.
33. Xin, H.W.; Wu, X.C.; Li, Q.; Yu, A.R.; Zhong, M.Y.; Liu, Y.Y. The effects of berberine on the pharmacokinetics of cyclosporin A in healthy volunteers. Methods Find. Exp. Clin. Pharmacol., 2006, 28 (1), 25-29.
34. Pattanaik, S.; Hota, D.; Prabhakar, S.; Kharbanda, P.; Pandhi, P. Effect of piperine on the steady-state pharmacokinetics of phenytoin in patients with epilepsy. Phytother. Res., 2006, 20 (8), 683-686.
35. Bano, G.; Raina, R.K.; Zutshi, U.; Bedi, K.L.; Johri, R.K.; Sharma, S.C. Effect of piperine on bioavailability and pharmacokinetics of propranolol and theophylline in healthy volunteers. Eur.J. Clin. Pharmacol., 1991, 41 (6), 615-617.
36. Zutshi, R.K.; Singh, R.; Zutshi, U.; Johri, R.K.; Atal, C.K. Influence of piperine on rifampicin blood levels in patients of pulmonary tuberculosis.J. Assoc. Physicians India, 1985, 33 (3), 223-224.
37. Hu, Z.; Yang, X.; Ho, P.C.; Chan, S.Y.; Heng, P.W.; Chan, E.; Duan, W.; Koh, H.L.; Zhou, S. Herb-drug interactions: a literature review. Drugs, 2005, 65 (9), 1239-1282.
38. Guo, L.Q.; Taniguchi, M.; Chen, Q.Y.; Baba, K.; Yamazoe, Y. Inhibitory potential of herbal medicines on human cytochrome P450-mediated oxidation: properties of umbelliferous or citrus crude drugs and their relative prescriptions. Jpn.J. Pharmacol., 2001, 85 (4), 399-408.
39. Guo, L.Q.; Yamazoe, Y. Inhibition of cytochrome P450 by furanocoumarins in grapefruit juice and herbal medicines. Acta Pharmacol. Sin., 2004, 25 (2), 129-136.
40. Foster, B.C.; Vandenhoek, S.; Tang, R.; Budzinski, J.W.; Krantis, A.; Li, K.Y. Effect of several Chinese natural health products of human cytochrome P450 metabolism.J. Pharm. Pharm. Sci., 2002, 5 (2), 185-189.
41. Takahashi, K.; Uejima, E.; Morisaki, T.; Takahashi, K.; Kurokawa, N.; Azuma, J. In vitro inhibitory effects of Kampo medicines on metabolic reactions catalyzed by human liver microsomes.J. Clin. Pharm. Ther., 2003, 28 (4), 319-327.
42. Nose, M.; Tamura, M.; Ryu, N.; Mizukami, H.; Ogihara, Y. Sho-saiko-to and Saiko-keisi-to, the traditional Chinese and Japanese herbal medicines, altered hepatic drug-metabolizing enzymes in mice and rats when administered orally for a long time.J. Pharm. Pharmacol., 2003, 55 (10), 1419-1426.
43. Jinping, Q.; Peiling, H.; Yawei, L.; Abliz, Z. Effects of the aqueous extract from Salvia miltiorrhiza Bge on the pharmacokinetics of diazepam and on liver microsomal cytochrome P450 enzyme activity in rats.J. Pharm. Pharmacol., 2003, 55 (8), 1163-1167.
44. Ueng, Y.F.; Tsai, T.H.; Don, M.J.; Chen, R.M.; Chen, T.L. Alteration of the pharmacokinetics of theophylline by rutaecarpine, an alkaloid of the medicinal herb Evodia rutaecarpa, in rats.J. Pharm. Pharmacol., 2005, 57 (2), 227-232.
45. Liu, K.H.; Kim, M.J.; Jeon, B.H.; Shon, J.H.; Cha, I.J.; Cho, K.H.; Lee, S.S.; Shin, J.G. Inhibition of human cytochrome P450 isoforms and NADPH-CYP reductase in vitro by 15 herbal medicines, including Epimedii herba.J. Clin. Pharm. Ther., 2006, 31 (1), 83-91.
46. Lee, S.S.; Zhang, B.; He, M.L.; Chang, V.S.; Kung, H.F. Screening of active ingredients of herbal medicine for interaction with CYP450 3A4. Phytother. Res., 2007, 21 (11), 1096-1099.
47. van den Bout-van den Beukel, C.J.; Koopmans, P.P.; Van der Ven, A.J.; De Smet, P.A.; Burger, D.M. Possible drug-metabolism interactions of medicinal herbs with antiretroviral agents. Drug Metab. Rev., 2006, 38 (3), 477-514.
48. Babb, D.A.; Pemba, L.; Seatlanyane, P.; Charalambous, S.; Churchyard, G.J.; Grant, A.D. Use of traditional medicine by HIV-infected individuals in South Africa in the era of antiretroviral therapy. Psychol. Health Med., 2007, 12 (3), 314-320.
49. Mills, E.; Foster, B.C.; Van Heeswijk, R.; Phillips, E.; Wilson, K.; Leonard, B.; Kosuge, K.; Kanfer, I. Impact of African herbal medicines on antiretroviral metabolism. AIDS, 2005, 19 (1), 95-97.
50. Nair, V.D.; Foster, B.C.; Thor, A.J.; Mills, E.J.; Kanfer, I. In vitro evaluation of human cytochrome P450 and P-glycoprotein-mediated metabolism of some phytochemicals in extracts and formulations of African potato. Phytomedicine, 2007, 14 (7-8), 498-507.
51. Shalansky, S.; Lynd, L.; Richardson, K.; Ingaszewski, A.; Kerr, C. Risk of warfarin-related bleeding events and supratherapeutic international normalized ratios associated with complementary and alternative medicine: a longitudinal analysis. Pharmacother., 2007, 27 (9), 1237-1247.
52. Van Roon, E.N.; Flikweert, S.; le Comt, M.; Langendijk, P.N.; Kwee-Zuiderwijk, W.J.; Smits, P.; Brouwers, J.R. Clinical relevance of drug-drug interactions: a structured assessment procedure. Drug Saf., 2005, 28 (12), 1131-1139.
53. O'Brien, M.A.; Rogers, S.; Jamtvedt, G.; Oxman, A.D.; Odgaard-Jensen, J.; Kristoffersen, D.T.; Forsetlund, L.; Bainbridge, D.; Freemantle, N.; Davis, D.A.; Haynes, R.B.; Harvey, E.L. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane. Database. Syst. Rev., 2007, (4), CD000409.
54. Beyer, M.; Gerlach, F.M.; Flies, U.; Grol, R.; Krol, Z.; Munck, A.; Olesen, F.; O'Riordan, M.; Seuntjens, L.; Szecsenyi, J. The development of quality circles/peer review groups as a method of quality improvement in Europe. Results of a survey in 26 European countries. Fam. Pract., 2003, 20 (4), 443-451.
55. Pham, P.A. Drug-drug interaction programs in clinical practice. Clin. Pharmacol. Ther., 2008, 83 (3), 396-398.
56. Buurma, H.; De Smet, P.A.; Egberts, A.C. Clinical risk management in Dutch community pharmacies: the case of drug-drug interactions. Drug Saf., 2006, 29 (8), 723-732.
57. Indermitte, J.; Erba, L.; Beutler, M.; Bruppacher, R.; Haefeli, W.E.; Hersberger, K.E. Management of potential drug interactions in community pharmacies: a questionnaire-based survey in Switzerland. Eur.J. Clin. Pharmacol., 2007, 63 (3), 297-305.
58. Lapane, K.L.; Waring, M.E.; Schneider, K.L.; Dube, C.; Quilliam, B.J. A mixed method study of the merits of e-prescribing drug alerts in primary care. J. Gen. Intern. Med., 2008, 23 (4), 442-446.
59. Grizzle, A.J.; Mahmood, M.H.; Ko, Y.; Murphy, J.E.; Armstrong, E.P.; Skrepnek, G.H.; Jones, W.N.; Schepers, G.P.; Nichol, W.P.; Houranieh, A.; Dare, D.C.; Hoey, C.T.; Malone, D.C. Reasons provided by prescribers when overriding drug-drug interaction alerts. Am.J. Manag. Care, 2007, 13 (10), 573-578.
60. Van der Sijs, H.; Aarts, J.; Van Gelder, T.; Berg, M.; Vulto, A. Turning off frequently overridden drug alerts: limited opportunities for doing it safely.J. Am. Med. Inform. Assoc., 2008, 15 (4), 439-448
61. Ko, Y.; Abarca, J.; Malone, D.C.; Dare, D.C.; Geraets, D.; Houranieh, A.; Jones, W.N.; Nichol, W.P.; Schepers, G.P.; Wilhardt, M. Practitioners' views on computerized drug-drug interaction alerts in the VA system.J. Am. Med. Inform. Assoc., 2007, 14 (1), 56-64.
62. Taylor, L.K.; Tamblyn, R. Reasons for physician non-adherence to electronic drug alerts. Stud. Health Technol. Inform., 2004, 107 (Pt 2), 1101-1105.
63. Anonymous. SPC Hyperiplant tabletten. Accessed Jul 12, 2008. Medicines Evaluation Board, The Hague, The Netherlands, 2007.
64. Stevenson, F.A.; Barry, C.A.; Britten, N.; Barber, N.; Bradley, C.P. Doctor-patient communication about drugs: the evidence for shared decision making. Soc. Sci. Med., 2000, 50 (6), 829-840.
65. Pound, P.; Britten, N.; Morgan, M.; Yardley, L.; Pope, C.; ker-White, G.; Campbell, R. Resisting medicines: a synthesis of qualitative studies of medicine taking. Soc. Sci. Med., 2005, 61 (1), 133-155.
66. Rust, G.; Kondwani, K.; Martinez, R.; Dansie, R.; Wong, W.; Fry-Johnson, Y.; Woody, R.M.; Daniels, E.J.; Herbert-Carter, J.; Aponte, L.; Strothers, H. A crash-course in cultural competence. Ethn. Dis., 2006, 16 (2 Suppl 3), 29-36.
67. Betancourt, J.R. Cultural competency: providing quality care to diverse populations. Consult. Pharm., 2006, 21 (12), 988-995.
68. Anonymous. Kaloba Oral Drops, Solution THR 05332/0003 - UK Public Assessment Report. accessed Jul 13, 2008. Medicines and Healthcare products Regulatory Agency, London, 2008.
69. Charpiat, B.; Allenet, B.; Roubille, R.; Escofier, L.; Bedouch, P.; Juste, M.; Rose, F.X.; Conort, O. Facteurs à prendre en considération pour la gestion des interactions médicamenteuses en pratique clinique. Presse. Med., 2008, 37 (4 Pt 2), 654-664.
70. Abarca, J.; Colon, L.R.; Wang, V.S.; Malone, D.C.; Murphy, J.E.; Armstrong, E.P. Evaluation of the performance of drug-drug interaction screening software in community and hospital pharmacies.J. Manag. Care Pharm., 2006, 12 (5), 383-389.
71. Gaikwad, R.; Sketris, I.; Shepherd, M.; Duffy, J. Evaluation of accuracy of drug interaction alerts triggered by two electronic medical record systems in primary healthcare. Health Informatics J., 2007, 13 (3), 163-177.
72. Kemper, K.J.; Gardiner, P.; Gobble, J.; Woods, C. Expertise about herbs and dietary supplements among diverse health professionals. BMC. Complement Altern. Med., 2006, 6, 15.
73. Semple, S.J.; Hotham, E.; Rao, D.; Martin, K.; Smith, C.A.; Bloustien, G.F. Community pharmacists in Australia: barriers to information provision on complementary and alternative medicines. Pharm. World Sci., 2006, 28 (6), 366-373.
74. Alte, D.; Weitschies, W.; Ritter, C.A. Evaluation of consultation in community pharmacies with mystery shoppers. Ann. Pharmacother., 2007, 41 (6), 1023-1030.
75. Sarino, L.V.; Dang, K.H.; Dianat, N.; Djihanian, H.; Natanian, N.; Hudmon, K.S.; Ambrose, P.J. Drug interaction between oral contraceptives and St. John's Wort: appropriateness of advice received from community pharmacists and health food store clerks.J. Am. Pharm. Assoc. (2003), 2007, 47 (1), 42-47.
76. Buurma, H.; Schalekamp, T.; Egberts, A.C.; De Smet, P.A. Compliance with national guidelines for the management of drug-drug interactions in Dutch community pharmacies. Ann. Pharmacother., 2007, 41 (12), 2024-2031.
77. Malone, D.C.; Abarca, J.; Skrepnek, G.H.; Murphy, J.E.; Armstrong, E.P.; Grizzle, A.J.; Rehfeld, R.A.; Woosley, R.L. Pharmacist workload and pharmacy characteristics associated with the dispensing of potentially clinically important drug-drug interactions. Med. Care, 2007, 45 (5), 456-462.
78. Indermitte, J.; Beutler, M.; Bruppacher, R.; Meier, C.R.; Hersberger, K.E. Management of drug-interaction alerts in community pharmacies.J. Clin. Pharm. Ther., 2007, 32 (2), 133-142.
79. Shaw, B.; Cheater, F.; Baker, R.; Gillies, C.; Hearnshaw, H.; Flottorp, S.; Robertson, N. Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane. Database. Syst. Rev., 2005, (3), CD005470.