Adverse event reporting for herbal medicines: A result of market forces

Healthcare Policy

Volumn 4, Issue 4, 2009, Pages 77-90

  Walji, Rishma ^a   Boon, Heather ^a   Barnes, Joanne ^b   Austin, Zubin ^a   Baker, G Ross ^c   Welsh, Sandy ^a  

^a UNIVERSITY OF TORONTO   (Canada)

^b UNIVERSITY OF AUCKLAND   (New Zealand)

^c UNIVERSITY OF TORONTO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

HERBACEOUS AGENT;

ADVERSE DRUG REACTION; ARTICLE; CANADA; DRUG INDUSTRY; DRUG MARKETING; HEALTH BELIEF; HEALTH CARE POLICY; INFORMATION SYSTEM;

EID: 67650567280     PISSN: None     EISSN: 17156572     Source Type: Journal    
DOI: 10.12927/hcpol.2009.20820     Document Type: Article

References (38)

1. Alvarez-Requejo, A., A. Carvajal, B. Begaud, Y. Moride, T. Vega and L. Arias. 1998. "Under-reporting of Adverse Drug Reactions. Estimate Based on a Spontaneous Reporting Scheme and Sentinel System." European Journal of Clinical Pharmacology 54(6): 483-488 (Pubitemid 28418817)
2. Barnes, J. 2003. "Pharmacovigilance of Herbal Medicines: A UK Perspective." Drug Safety 26(12): 829-851
3. Barnes, J., S.Y. Mills, N.C. Abbot, M. Willoughby and E. Ernst. 1998. "Different Standards for Reporting ADRs to Herbal Remedies and OTC Medicines: Face-to-Face Interviews with 515 Users of Herbal Remedies." British Journal of Clinical Pharmacology 45: 496-500. (Pubitemid 28228730)
4. Canadian Health Food Association (CHFA). 2005. "Natural Health Products State of the Industry Report 2005: Backgrounder." Toronto: Author.
5. Charrois, T.L., R.L. Hill, D. Vu, B.C. Foster, H.S. Boon, K. Cramer and S. Vohra. 2007. "Community Identification of Natural Health Product-Drug Interactions." Annals of Pharmacotherapy 41(7): 1124-1129 (Pubitemid 47122548)
6. Che, Y.-K. 1996. "Customer Return Policies for Experience Goods." Journal of Industrial Economics 44(March): 17-24. (Pubitemid 126326377)
7. Citizen Petition. 2008. "Consumer Healthcare - Treat Weight Loss Claims for Dietary Supplements as Disease Claims." American Dietetic Association, The Obesity Society, Shaping America's Health and GlaxoSmithKline Consumer Healthcare - Citizen Petition. Retrieved March 23, 2009. 〈http://www.regulations.gov/fdmspublic/component/main?main= DocumentDetail&o=0900006480511d9b〉.
8. Creswell, J. 1998. Qualitative Inquiry and Research Design: Choosing among Five Traditions. London, UK: Sage.
9. Fletcher, A.P. 1991. "Spontaneous Adverse Drug Reaction Reporting vs Event Monitoring: A Comparison." Journal of the Royal Society of Medicine 84(6): 341-344
10. Glisson, J.K., H.E. Rogers, E.A. Abourashed, R. Ogletree, C.D. Hufford and I. Khan. 2003. "Clinic at the Health Food Store? Employee Recommendations and Product Analysis." Pharmacotherapy 23(1): 64-72. (Pubitemid 36077366)
11. Green, C.F., D.R. Mottram, P.H. Rowe and M. Pirmohamed. 2001. "Attitudes and Knowledge of Hospital Pharmacists to Adverse Drug Reaction Reporting." British Journal of Clinical Pharmacology 51: 81-86. (Pubitemid 32118823)
12. Guest, G., A. Bunce and L. Johnson. 2006. "How Many Interviews Are Enough? An Experiment with Data Saturation and Variability." Field Methods 18: 59-82.
13. Hammond, I.W., D.S. Rich and T.G. Gibbs. 2007. "Effect of Consumer Reporting on Signal Detection: Using Disproportionality Analysis." Expert Opinion on Drug Safety 6(6): 705-712 (Pubitemid 351308282)
14. Harvey, K., V. Korczak, L. Marron and D. Newgreen. 2008. "Commercialism, Choice and Consumer Protection: Regulation of Complementary Medicines in Australia." Medical Journal of Australia 188(1): 21-25.
15. Hazell, L. and S.A.W. Shakir. 2006. "Under-reporting of Adverse Drug Reactions: A Systematic Review." Drug Safety 29(5): 385-396 (Pubitemid 43752541)
16. Healey, B., C. Burgess, R. Siebers, R. Beasley, M. Weatherall and S. Holt. 2002. "Do Natural Health Food Stores Require Regulation?" New Zealand Medical Journal 115(1161): U165.
17. Health Canada. 2007. Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Adverse Reaction Database. Retrieved March 23, 2009. 〈http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php〉.
18. Herdiero, M.T., J. Polonia, J.J. Gestal-Otero and A. Figueiras. 2004. "Factors That Influence Spontaneous Reporting of Adverse Drug Reactions: A Model Centralized in the Medical Professional." Journal of Evaluation in Clinical Practice 10(4): 483-489 (Pubitemid 39469031)
19. Inman, W.H. 1985. "Under-reporting of Adverse Drug Reactions." British Medical Journal 290(6478): 1355.
20. Jarernsiripornkul, N., J. Krska, R.M. Richards and P.A. Capps. 2003. "Patient Reporting of Adverse Drug Reactions: Useful Information for Pain Management?" European Journal of Pain 7(3): 219-224 (Pubitemid 36565923)
21. Mann, R. and E. Andrews 2002. "Introduction." In R. Mann and E. Andrews, eds., Pharmacovigilance (pp. 3-10). Chichester, UK: Wiley.
22. McNeill, J. 1999. "Interactions between Herbal and Conventional Medicines." Canadian Journal of CME (December): 97-113.
23. McWilliams, B. and E. Gerstner. 2006. "Offering Lower Price Guarantees to Improve Customer Retention." Journal of Retailing 82(2): 105-113
24. Medawar, C. and A. Herxheimer. 2004. "A Comparison of Adverse Drug Reaction Reports from Professionals and Users Relating to Risk of Dependence and Suicidal Behaviour with Paroxetine." International Journal of Risk and Safety in Medicine 16: 5-19. (Pubitemid 37475764)
25. Medawar, C., A. Herxheimer, A. Bell and S. Jofre. 2002. "Paroxetine, Panorama and User Reporting of ADRs: Consumer Intelligence Matters in Clinical Practice and Post-Marketing Drug Surveillance." International Journal of Risk and Safety in Medicine 15: 161-169 (Pubitemid 36566706)
26. Mills, E., R. Singh, M. Kawasaki, L. Bast, J. Hart, A. Majlesi, P. Kiani and K. Wilson. 2003. "Emerging Issues Associated with HIV Patients Seeking Advice from Health Food Stores." Canadian Journal of Public Health 94(5): 363-366 (Pubitemid 37321666)
27. Mitchell, A.S., D.A. Henry, I.L. Sanson-Fisher and D.L. O'Connell. 1988. "Patients as a Direct Source of Information on Adverse Drug Reactions." British Medical Journal 297: 891-893 (Pubitemid 18234574)
28. Moride, Y., F. Haramburu, A.A. Requejo and B. Begaud. 1997. "Under-reporting of Adverse Drug Reactions in General Practice." British Journal of Clinical Pharmacology 43(2): 177-181 (Pubitemid 27085369)
29. Natural Health Products Directorate (NHPD). 2003. Natural Health Products Regulations. Health Canada. SOR/2003-196. Retrieved March 23, 2009. 〈http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng. php〉.
30. Natural Health Products Directorate (NHPD). 2005. Baseline Natural Health Products Survey among Consumers, 2005. Retrieved March 23, 2009. 〈http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/eng-cons-survey-e.html〉.
31. Pittler, M.H. and E. Ernst. 2003. "Systematic Review: Hepatotoxic Events Associated with Herbal Medicines." Alimentary Pharmacology and Therapeutics 18(5): 451-471 (Pubitemid 37152286)
32. Richards, L. and T. Richards. 2002. NVivo 2.0 [Software for Qualitative Research]. Melbourne: QSR Solutions.
33. Rogers, A.S., E. Israel, C.R. Smith, D. Levine, A.M. McBean, C. Valente and G. Faich. 1988. "Physician Knowledge, Attitudes, and Behavior Related to Reporting Adverse Drug Events." Archives of Internal Medicine 148(7): 1596-1600. (Pubitemid 18174245)
34. Sweis, D. and I.C.K. Wong. 2000. "Adverse Drug Reaction Reporting According to Hospital Pharmacists in Great Britain." Drug Safety 23(2): 165-172
35. Wheaton, A., H. Blanck, Z. Gizlice and M. Reyes. 2005. "Medicinal Herb Use in a Population-Based Survey of Adults: Prevalence and Frequency of Use, Reasons for Use, and Use among Their Children." Annals of Epidemiology 15: 678-685 (Pubitemid 41266972)
36. Winslow, L. and H. Shapiro. 2002. "Physicians Want Education about Complementary and Alternative Medicine to Enhance Communication with Their Patients." Archives of Internal Medicine 162: 1176-1181 (Pubitemid 34522407)
37. Woo, J.J. 2007. "Adverse Event Monitoring and Multivitamin- Multimineral Dietary Supplements." American Journal of Clinical Nutrition 85(1): 323S-324S. (Pubitemid 46067657)
38. World Health Organization (WHO). 1995. Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. CPMP/ICH.377/95. Geneva: Author.