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• W2012243592 abstract "Pharmacoepidemiology and Drug SafetyVolume 11, Issue 4 p. 335-340 ISPE Commentary Issues in the approval of, access to, and post-marketing follow-up of new drugs in Canada: a personal viewpoint Nigel S. B. Rawson PhD, Corresponding Author Nigel S. B. Rawson PhD [email protected] Professor of Pharmacoepidemiology, Division of Community Health, Faculty of Medicine, and School of Pharmacy Memorial University of Newfoundland, St. John's, Newfoundland, CanadaCenter for Health Care Policy and Evaluation, Division of Community Health, Faculty of Medicine and School of Pharmacy, Memorial University of Newfoundland, St John's Newfoundland, Canada.Search for more papers by this author Nigel S. B. Rawson PhD, Corresponding Author Nigel S. B. Rawson PhD [email protected] Professor of Pharmacoepidemiology, Division of Community Health, Faculty of Medicine, and School of Pharmacy Memorial University of Newfoundland, St. John's, Newfoundland, CanadaCenter for Health Care Policy and Evaluation, Division of Community Health, Faculty of Medicine and School of Pharmacy, Memorial University of Newfoundland, St John's Newfoundland, Canada.Search for more papers by this author First published: 06 June 2002 https://doi.org/10.1002/pds.740Citations: 8AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL REFERENCES 1 Sawanpanyalert P. Pharmacoepidemiology in Thailand: a personal opinion. Pharmacoepidemiol Drug Safe 2000; 9: 529– 532. 2 Ansari F. Pharmacoepidemiology in developing countries: what can ISPE do? Pharmacoepidemiol Drug Safe 2000; 9: 611– 614. 3 Park B-J. Current status of drug safety monitoring in Korea. Pharmacoepidemiol Drug Safe 2001; 10: 557– 560. 4 Napke E. In Monitoring for Drug Safety, 2nd edn, WHW Inman (ed.). MTP Press: Canada, Lancaster, 1986; 59– 69. 5 Sibbald B. Cisapride, before and after: still waiting for ADE-reporting reform. Can Med Assoc J 2001; 165: 1370. 6 Eastman HC. Report of the Commission of Inquiry on the Pharmaceutical Industry. Supply and Services Canada: Ottawa, 1985. 7 Nielsen Task Force. Health and Sports Program: A Study Team Report to the Task Force on Program Review. Supply and Services Canada: Ottawa, 1985; 95– 109. 8 Auditor General of Canada. Report to the House of Commons, Fiscal Year Ending 31 March 1987. 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Diabetes Care 1999; 22: 925– 927. 36 Park B-J, Clouse J, Shatin D, Stergachis A. Incidence of adverse oesophageal and gastric events in alendronate users. Pharmacoepidemiol Drug Safe 2000; 9: 371– 376. 37 Levy DG, Stergachis A, McFarland LV, Van Vorst K, Graham DJ, Johnson ES, Park B-J, Shatin D, Clouse JC, Elmer GW. Antibiotics and Clostridium difficile diarrhea in the ambulatory care setting. Clin Ther 2000; 22: 91– 102. 38 Drinkard CR, Shatin D, Clouse D. Postmarketing surveillance of medications and pregnancy outcomes: clarithromycin and birth malformations. Pharmacoepidemiol Drug Safe 2000; 9: 549– 556. 39 Gardner JS, Blough D, Drinkard CR, Shatin D, Anderson G, Graham D, Alderfer R. Tramadol and seizures: a surveillance study in a managed care population. Pharmacotherapy 2000; 20: 1423– 1431. 40 Kondro W. Canada needs better drug reporting, says inquest. Lancet 2001; 357: 1424. 41 Sokoloff H. Health Canada, drug firm face $100 m lawsuit. National Post, July 10, 2001: A4. 42 Action plan to address inquest recommendations for Health Canada. Therapeutic Products Directorate: Ottawa, 2001. (URL: http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/announce/actionplan_e.pdf; accessed: March 14, 2002). 43 Horton R. Lotronex and the FDA: a fatal erosion of integrity. Lancet 2001; 357: 1544– 1545. 44 Brown KR, Douglas RG. New challenges in quality control and licensure: regulation. Int J Tech Assess Health Care 1994; 10: 55– 64. 45 Rawson NSB. ‘Effectiveness’ in the evaluation of new drugs: a misunderstood concept? Can J Clin Pharmacol 2001; 8: 61– 62. 46 Rawson NSB. An acute adverse drug reaction alerting scheme using the Saskatchewan Health datafiles. Drug Invest 1993; 6: 245– 256. 47 Rawson NSB. Impact of pre-existing health conditions on the outcome of an adverse drug reaction alerting scheme: gastrointestinal disorders before piroxicam and sulindac therapy. Pharmacother 1995; 29: 676– 680. 48 Rawson NSB, Rawson MJ. An acute adverse event signalling scheme using the Saskatchewan administrative health care utilization datafiles: results for two benzodiazepines. Can J Clin Pharmacol 1999; 6: 159– 166. 49 Willison D, Gaebel KA, Borden EK, Levine MAH, Poston JW, Goldsmith CH, Wong B. Experience in the development of a postmarketing surveillance network: the Pharmacy Medication Monitoring Program. Ann Pharmacother 1995; 29: 1208– 1213. 50 Borden EK, Lee JG. A methodologic study of post-marketing drug evaluation using a pharmacy-based approach. J Chronic Dis 1982; 35: 803– 816. 51 Rawson NSB, Pearce GL, Inman WHW. Prescription-Event Monitoring: methodology and recent progress. J Clin Epidemiol 1990; 43: 509– 522. 52 Coulter DM. The New Zealand Intensive Medicines Monitoring Programme. Pharmacoepidemiol Drug Safe 1998; 7: 79– 90. 53 Fisher S. Patient self-monitoring: a challenging approach to pharmacoepidemiology. Pharmacoepidemiol Drug Safe 1995; 4: 359– 378. 54 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– 190. 55 Lewis S, Donaldson C, Mitton C, Currie G. The future of health care in Canada. BMJ 2001; 323: 926– 929. 56 Meloff K. Canadian Medicare needs choice. BMJ 2002; 324: 299. Citing Literature Volume11, Issue4June 2002Pages 335-340 ReferencesRelatedInformation" @default.
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