CANADA’S ADVERSE DRUG REACTION REPORTING SYSTEM: A FAILING GRADE
Main Article Content
Keywords
CANADA’S ADVERSE DRUG, FAILING GRADE
Abstract
An article in the National Post on suicidal effects associated with varenicline (Champix) highlights deficiencies in the Canadian spontaneous reporting system (SRS) for adverse drug reactions (ADRs). The issues of under-reporting, poor quality information, duplication of reports and lack of a population denominator of drug use are discussed. Canada’s SRS is deficient. There are immediate and medium-term actions that could be instituted that would improve pharmacovigilance in Canada. However, education about appropriate prescribing, the recognition of ADRs, and the duty to report them is a key long- term strategy to improving the pharmacovigilance system and should be included at every opportunity in the training of healthcare professionals so that life -long habits are developed. In addition to changes at Health Canada, greater emphasis needs to be placed on training in therapeutics, understanding drug safety, and the responsibility of healthcare providers in reporting risks in the curricula of medical and nursing schools.
References
1. Culbert C, Carman T. Smoking gun? National Post 2015, Jan 10:A16.
2. Inman WHW, Vessey MP. Investigation of deaths from pulmonary, coronary and cerebral thrombosis and embolism in women of child-bearing age. BMJ 1968;2:193 -9.
3. Inman WHW. Role of drug- reaction monitoring in the investigation of thromboembolism and “the pill.” Br Med Bull 1970; 26:248 -56.
4. Inman WHW, Vessey MP, Westerholm B, Engelund A. Thromboembolic disease and the steroidal content of oral contraceptives: a report to the Committee on Safety of Drugs. BMJ 1970;2:203- 9.
5. Böttiger LE, Westerholm B. Drug-induced blood dyscrasias in Sweden. BMJ 1973;3:339 -43.
6. Inman WHW. Study of fatal bone marrow depression with special reference to phenylbutazone and oxyphenbutazone. BMJ 1977;1:1500- 5.
7. Van der Kroef C. Reactions to triazolam. Lancet 1979;2:526.
8. Fagius J, Osterman PO, Sidén A, Wih olm BE. Guillain -Barré syndrome following zimeldine treatment. J Neurol Neurosurg Psychiatry 1985;48:65 -9.
9. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions. Drug Saf 2006;29: 385 -96.
10. Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy 2004;24:743 - 9.
11. Inman WHW. Thalidomide, practolol: what next? In: Colombo F, Shapiro S, Slone D, Tognoni G, eds. Epidemiological Evaluation of Drugs. Amsterdam: Elsevier/North-Holland, 1977:231- 40.
12. Inman WHW. Assessment of drug safety problems. In: Gent M, Shigematsu I, eds. Epidemiological Issues in Reported Drug-Induced Illnesses: SMON and Other Examples. Hamilton: McMaster University Library Press, 1978:17 -24.
13. Inman WHW, Weber JCP. The United Kingdom. In: Inman WHW, ed. Monitoring for Drug Safety. 2nd ed. Lancast er: MTP Press, 1986: 13-47.
14. Edwards IR, Lindquist M, Wiholm BE, Napke E. Quality criteria for early signals of possible adverse reactions. Lancet 1990;336: 156 -8.
15. Suveges LG, Gesy KF, Wallace SM, Blackburn JL, Appel WC. Adverse drug reaction reporting part II: evaluation of the Saskatchewan pilot project for a regional reporting program in Canada. Drug Inform J 1995;29:581 -9.
16. Gesy KF. Effectiveness of a regional reporting program in improving quality of adverse drug reaction case reports. MSc thesis. Saskatoon: University of Saskatchewan, 1997.
17. Liu BA, Knowles SR, Mittmann N, Einarson T, Shear NH. Reporting of fatal adverse drug reactions. Can J Clin Pharmacol 2001;8: 84-8.
18. McMorran M, McEnaney J . Adverse reaction and incident reporting – 2012. Can Adverse React Newsl 2013;23(3): 2-5.
19. Dunlop H . Infliximab (Remicade) and etanercept (Enbrel): serious infections and tuberculosis. Can Adverse React Newsl 2004;14(4): 2-3.
20. Lexchin J. Is there still a role for spontaneous reporting of adverse drug reactions? CMA J 2006;174:191 -2.
21. Kondro W . Canada needs better drug reporting, says inquest. Lancet 2001;357: 1424.
22. Gagnon D. Working in Partnerships: Drug Review for the Future. Ottawa: Health and Welfare Canada, 1992.
23. Romanow RJ. Building on Values: The Future of Health Care in Canada. Saskatoon: Commission on the Future of Health Care in Canada, 2002.
24. LeBrun M, DiMuzio J, Beauchamp B, Reid S, Hogan V. Evaluating the health literacy burden of Canada’s public advisories: a comparative effectiveness study on clarity and readability. Drug Saf 2013;36:1179 -87.
25. Rawson NSB. New drug approval times and safety warnings in the United States and Canada, 1992 - 2011. J Popul Ther Clin Pharmacol 2013;20:e67 -81.
26. Recent summary safety reviews. Ottawa: Health Canada, 2015. http://www.hc -sc.gc.ca/dhp - mps/medeff/reviews -examens/index -eng.php (May 25, 2015) .
27. What is the Protecting Canadians from Unsafe Drugs Act (Va nessa’s Law)? Ottawa: Health Can ada, 2014. http://www.hc -sc.gc.ca/dhp - mps/legislation/unsafedrugs -droguesdangereuses -faq - eng.php (May 25 , 2015).
28. Bäckström M, Mjörndal T, Dahlqvist R. Under-reporting of serious adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf 2004; 13:483 - 7.
29. Appel WC. Adverse drug reaction reporting controversy. CMAJ 2002;166: 884- 5.
30. Hohl C, Lexchin JR, Balka E. Can reporting of adverse drug reactions crea te safer systems while improving health data? CMAJ 2015;187:789 -90.
31. Wiktorowicz ME, Lexchin J, Moscou K, Silversides A, Eggertson L. Keeping an eye on prescription drugs, keeping Canadians safe. Toronto: Health Council of Canada, 2010. http://www.healthcouncilcanada.ca/rpt_det.php?id=1 53 (May 25, 2015).
32. Drug Safety and Effectiveness Network. Ottawa: Canadian Institutes of Health Research, 2012. http://www.cihr -irsc.gc.ca/e/40269.html (May 25 , 2015).
33. Brown C. Is Canada’s drug safety network effective? CMAJ 2015;187:553 -4.
34. Inman B. Don’t Tell the Patient: Behind the Drug Safety Net. Los Angeles: Highland Park Producti ons, 1999.
35. Rawson NSB, West R, Appel WC. Could conditional release of new drugs provide the information required to study drug effectiveness? A discussion paper. Can J Clin Pharmacol 2000;7:185 -90.
36. Willison D, Gaebel KA, Borden EK, et al. Experience in th e development of a postmarketing surveillance network: the Pharmacy Medication Monitoring Program. Ann Pharmacother 1995;29:1208 -13.
37. Dal Pan GJ. Ongoing challenges in pharmacovigilance. Drug Saf 2014;37:1 -8.
38. Figueiras A, Herdeiro MT, Polónia J, Gestal -Otero JJ. An educational intervention to improve physician reporting of adverse drug reactions: a cluster - randomized controlled trial. JAMA 2006;296:1086 - 93.
39. Herdeiro MT, Polónia J, Gestal -Otero JJ, Figueiras A. Improving the reporting of adverse drug rea ctions: a cluster -randomized trial among pharmacists in Portugal. Drug Saf 2008;31:335 -44.
40. Figueiras A, Tato F, Fontaiñas J, Gestal -Otero JJ . Influence of physicians’ attitudes on reporting adverse drug events: a case -control study. Med Care 1999;37: 809 -14.
41. Herdeiro MT, Figueiras A, Polónia J, Gestal -Otero JJ. Physicians' attitudes and adverse drug reaction reporting: a case -control study in Portugal. Drug Saf 2005;28:825 -33.
42. Herdeiro MT, Figueiras A, Polónia J, Gestal -Otero JJ. Influence of pharmacists' attitudes on adverse drug reaction reporting : a case -control study in Portugal. Drug Saf 2006;29:331 -40.
2. Inman WHW, Vessey MP. Investigation of deaths from pulmonary, coronary and cerebral thrombosis and embolism in women of child-bearing age. BMJ 1968;2:193 -9.
3. Inman WHW. Role of drug- reaction monitoring in the investigation of thromboembolism and “the pill.” Br Med Bull 1970; 26:248 -56.
4. Inman WHW, Vessey MP, Westerholm B, Engelund A. Thromboembolic disease and the steroidal content of oral contraceptives: a report to the Committee on Safety of Drugs. BMJ 1970;2:203- 9.
5. Böttiger LE, Westerholm B. Drug-induced blood dyscrasias in Sweden. BMJ 1973;3:339 -43.
6. Inman WHW. Study of fatal bone marrow depression with special reference to phenylbutazone and oxyphenbutazone. BMJ 1977;1:1500- 5.
7. Van der Kroef C. Reactions to triazolam. Lancet 1979;2:526.
8. Fagius J, Osterman PO, Sidén A, Wih olm BE. Guillain -Barré syndrome following zimeldine treatment. J Neurol Neurosurg Psychiatry 1985;48:65 -9.
9. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions. Drug Saf 2006;29: 385 -96.
10. Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy 2004;24:743 - 9.
11. Inman WHW. Thalidomide, practolol: what next? In: Colombo F, Shapiro S, Slone D, Tognoni G, eds. Epidemiological Evaluation of Drugs. Amsterdam: Elsevier/North-Holland, 1977:231- 40.
12. Inman WHW. Assessment of drug safety problems. In: Gent M, Shigematsu I, eds. Epidemiological Issues in Reported Drug-Induced Illnesses: SMON and Other Examples. Hamilton: McMaster University Library Press, 1978:17 -24.
13. Inman WHW, Weber JCP. The United Kingdom. In: Inman WHW, ed. Monitoring for Drug Safety. 2nd ed. Lancast er: MTP Press, 1986: 13-47.
14. Edwards IR, Lindquist M, Wiholm BE, Napke E. Quality criteria for early signals of possible adverse reactions. Lancet 1990;336: 156 -8.
15. Suveges LG, Gesy KF, Wallace SM, Blackburn JL, Appel WC. Adverse drug reaction reporting part II: evaluation of the Saskatchewan pilot project for a regional reporting program in Canada. Drug Inform J 1995;29:581 -9.
16. Gesy KF. Effectiveness of a regional reporting program in improving quality of adverse drug reaction case reports. MSc thesis. Saskatoon: University of Saskatchewan, 1997.
17. Liu BA, Knowles SR, Mittmann N, Einarson T, Shear NH. Reporting of fatal adverse drug reactions. Can J Clin Pharmacol 2001;8: 84-8.
18. McMorran M, McEnaney J . Adverse reaction and incident reporting – 2012. Can Adverse React Newsl 2013;23(3): 2-5.
19. Dunlop H . Infliximab (Remicade) and etanercept (Enbrel): serious infections and tuberculosis. Can Adverse React Newsl 2004;14(4): 2-3.
20. Lexchin J. Is there still a role for spontaneous reporting of adverse drug reactions? CMA J 2006;174:191 -2.
21. Kondro W . Canada needs better drug reporting, says inquest. Lancet 2001;357: 1424.
22. Gagnon D. Working in Partnerships: Drug Review for the Future. Ottawa: Health and Welfare Canada, 1992.
23. Romanow RJ. Building on Values: The Future of Health Care in Canada. Saskatoon: Commission on the Future of Health Care in Canada, 2002.
24. LeBrun M, DiMuzio J, Beauchamp B, Reid S, Hogan V. Evaluating the health literacy burden of Canada’s public advisories: a comparative effectiveness study on clarity and readability. Drug Saf 2013;36:1179 -87.
25. Rawson NSB. New drug approval times and safety warnings in the United States and Canada, 1992 - 2011. J Popul Ther Clin Pharmacol 2013;20:e67 -81.
26. Recent summary safety reviews. Ottawa: Health Canada, 2015. http://www.hc -sc.gc.ca/dhp - mps/medeff/reviews -examens/index -eng.php (May 25, 2015) .
27. What is the Protecting Canadians from Unsafe Drugs Act (Va nessa’s Law)? Ottawa: Health Can ada, 2014. http://www.hc -sc.gc.ca/dhp - mps/legislation/unsafedrugs -droguesdangereuses -faq - eng.php (May 25 , 2015).
28. Bäckström M, Mjörndal T, Dahlqvist R. Under-reporting of serious adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf 2004; 13:483 - 7.
29. Appel WC. Adverse drug reaction reporting controversy. CMAJ 2002;166: 884- 5.
30. Hohl C, Lexchin JR, Balka E. Can reporting of adverse drug reactions crea te safer systems while improving health data? CMAJ 2015;187:789 -90.
31. Wiktorowicz ME, Lexchin J, Moscou K, Silversides A, Eggertson L. Keeping an eye on prescription drugs, keeping Canadians safe. Toronto: Health Council of Canada, 2010. http://www.healthcouncilcanada.ca/rpt_det.php?id=1 53 (May 25, 2015).
32. Drug Safety and Effectiveness Network. Ottawa: Canadian Institutes of Health Research, 2012. http://www.cihr -irsc.gc.ca/e/40269.html (May 25 , 2015).
33. Brown C. Is Canada’s drug safety network effective? CMAJ 2015;187:553 -4.
34. Inman B. Don’t Tell the Patient: Behind the Drug Safety Net. Los Angeles: Highland Park Producti ons, 1999.
35. Rawson NSB, West R, Appel WC. Could conditional release of new drugs provide the information required to study drug effectiveness? A discussion paper. Can J Clin Pharmacol 2000;7:185 -90.
36. Willison D, Gaebel KA, Borden EK, et al. Experience in th e development of a postmarketing surveillance network: the Pharmacy Medication Monitoring Program. Ann Pharmacother 1995;29:1208 -13.
37. Dal Pan GJ. Ongoing challenges in pharmacovigilance. Drug Saf 2014;37:1 -8.
38. Figueiras A, Herdeiro MT, Polónia J, Gestal -Otero JJ. An educational intervention to improve physician reporting of adverse drug reactions: a cluster - randomized controlled trial. JAMA 2006;296:1086 - 93.
39. Herdeiro MT, Polónia J, Gestal -Otero JJ, Figueiras A. Improving the reporting of adverse drug rea ctions: a cluster -randomized trial among pharmacists in Portugal. Drug Saf 2008;31:335 -44.
40. Figueiras A, Tato F, Fontaiñas J, Gestal -Otero JJ . Influence of physicians’ attitudes on reporting adverse drug events: a case -control study. Med Care 1999;37: 809 -14.
41. Herdeiro MT, Figueiras A, Polónia J, Gestal -Otero JJ. Physicians' attitudes and adverse drug reaction reporting: a case -control study in Portugal. Drug Saf 2005;28:825 -33.
42. Herdeiro MT, Figueiras A, Polónia J, Gestal -Otero JJ. Influence of pharmacists' attitudes on adverse drug reaction reporting : a case -control study in Portugal. Drug Saf 2006;29:331 -40.