Quantifying adverse drug events: Are systematic reviews the answer?

Drug Safety

Volumn 27, Issue 11, 2004, Pages 757-761

  Etminan, Mahyar ^a,b   Carleton, Bruce ^c,d   Rochon, Paula A ^e,f,g  

^a ROYAL VICTORIA HOSPITAL   (Canada)

^b VANCOUVER GENERAL HOSPITAL   (Canada)

^c UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^d CHILDREN S AND WOMEN S HEALTH CENTRE OF BRITISH COLUMBIA   (Canada)

^e Kunin Lunenfeld Applied Research Unit and Department of Food and Nutrition Services and Baycrest Centre for Geriatric Care   (Canada)

^f UNIVERSITY OF TORONTO   (Canada)

^g INSTITUTE FOR CLINICAL EVALUATIVE SCIENCES   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; CAPTOPRIL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENALAPRIL; LEVODOPA; LISINOPRIL; PRAMIPEXOLE; RAMIPRIL; ROPINIROLE;

ADVERSE DRUG REACTION; CLINICAL RESEARCH; CLINICAL TRIAL; DRUG EFFICACY; HEADACHE; HEALTH CARE COST; HEALTH SERVICE; HUMAN; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVIEW; RISK ASSESSMENT; SOMNOLENCE; SYSTEMATIC REVIEW;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATA COLLECTION; HUMANS; RANDOMIZED CONTROLLED TRIALS; REPRODUCIBILITY OF RESULTS; REVIEW LITERATURE;

EID: 4544376630     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200427110-00001     Document Type: Review

References (32)

1. Cook DJ, Murlow CD, Haynes RB. Systematic reviews: synthesis of best evidence for clinical decisions. Ann Inter Med 1997; 126: 376-80
2. Lau J, Ioannidis JP, Schmid CH. Summing up evidence: one answer is not always enough. Lancet 1998; 351: 123-7
3. Berlin JA, Colditz GA. The role of meta-analysis in the regulatory process for foods, drugs, and devices. JAMA 1999; 28: 830-4
4. White TJ, Arakelian A, Rho JP. Counting the costs of drug-related adverse events. Pharmacoeconomics 1999; 15 (5): 445-58
5. Johnsson B. The economic impact of diabetes. Diabetes Care 1998; 21 Suppl. 3: S7-10
6. Colditz GA. Economic costs of obesity and inactivity. Med Sci Sports Exerc 1999; 31 (11 Suppl.): S663-7
7. American Heart Association. 2002 Heart and stroke statistical update. Dallas (TX): American Heart Association, 2001
8. Ernst FR. Grizzle AJ. Drug-related morbidity and mortality: updating the cost-of-illness model. J Am Pharm Assoc 2001; 41: 192-9
9. Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med 2003 Jan; 18: 57-60
10. Gibbs-Brown J. Review of the Food and Drug Administration's handling of adverse drug reaction reports. Washington, DC: US Department of Health and Human Services, Office of Inspector General; 1999 Dec 14
11. Carleton BC, Lesko A, Milton J, et al. Active surveillance systems for pediatric adverse drug reactions: an idea whose time has come. Curr Ther Res 2001; 62: 738-42
12. Fletcher AP. Spontaneous adverse drug reporting vs event monitoring: a comparison. J R Soc Med 1991; 84: 341-4
13. Bennett DA, Jull A. FDA: untapped source of unpublished trials. Lancet 2003 Apr 26; 361: 1402-3
14. Edwards JE, McQuay HJ, Moore RA. Combination analgesic efficacy: individual patient data meta-analysis of single dose oral tramadol plus acetaminophen in acute postoperative pain. J Pain Symptom Manage 2002; 23: 121: 30
15. Ross SD. Drug-related adverse events: a readers' guide to assessing literature reviews and meta-analyses. Arch Intern Med 2001; 161: 1041-6
16. Etminan M, Samii A, Takkouche B, et al. Increased risk of somnolence with the new dopamine agonists in patients with Parkinson's disease: a meta-analysis of randomised controlled trials. Drug Saf 2001; 24 (11): 863-8
17. Frucht SJ, Greene PE, Fahn S. Sleep episodes in Parkinson's disease: a wake up call. Mov Disord 2000; 15: 601-3
18. Etminan M, Levine MAH, Tomlinson G, et al. Efficacy of angiotensin II receptor antagonists in preventing headache: systematic overview and meta-regression analysis. Am J Med 2002; 112: 642-6
19. Tronvik E, Stovner LJ, Helde G, et al. Prophylactic treatment of migraine with an angiotensin II receptor blocker: a randomised controlled trial. JAMA 2003; 289: 65-9
20. Bucher HC, Guyatt GH, Griffith LE, et al. The results of direct and indirect treatment comparisons in meta-analysis of randomised controlled trials. J Clin Epidemiol 1997; 50: 683-91
21. Ioannidis JP, Cappelleri JC, Skolnik PR, et al. A meta-analysis of the relative efficacy and toxicity of Pneumocystis carinii prophylactic regimens. Arch Intern Med 1996; 1562: 177-88
22. Ernst E, Pittler MH. Systematic reviews neglect safety issues. Arch Intern Med. 2001; 161 (1): 125-6
23. Derry S, Kong Loke Y, Aronson JK. Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials. BMC Med Res Methodol 2001; 1 (1): 7
24. Yusuf S, Sleight P, Pogue J, et al. Effects of an angiotensin-converting- enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med 2000; 342: 145-53
25. Blackburn D, Hux J, Mamdani M. Quantification of the risk of corticosteroid-induced diabetes mellitus among the elderly. J Gen Intern Med 2002; 17: 717-20
26. Anderson P, Green S, Higgins JPT, editors. What type of outcomes. Cochrane Reviewers' Handbook 4.2.3. section 4. The Cochrane Library; (1): Chichester: John Wiley & Sons, 2004
27. Ioannidis JP, Lau J. Can quality of clinical trials and meta-analyses be quantified? Lancet 1998 Aug 22; 352 (9128): 590-1
28. Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 1998 Aug 22; 352 (9128): 609-13
29. Huston P, Moher D. Redundancy, desegregation, and the integrity of medical research. Lancet 1996; 347: 1024-6
30. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001; 285: 437-43
31. Lingjaerde O, Ahlfors UG, Bech P, et al. The UKU side effect rating scale: a new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl 1987; 334: 1-100
32. Moher D, Jones A, Lepage A. Use of the CONSORT statement and quality of reports of randomised trials: a comparative before-and-after evaluation. JAMA 2001; 285: 1992-5