Data mining on electronic health record databases for signal detection in pharmacovigilance: Which events to monitor?

Pharmacoepidemiology and Drug Safety

Volumn 18, Issue 12, 2009, Pages 1176-1184

  Trifirò, Gianluca ^a,b,c   Pariente, Antoine ^d,e,f   Coloma, Preciosa M ^a   Kors, Jan A ^a   Polimeni, Giovanni ^c   Miremont Salamé, Ghada ^d,e,f   Catania, Maria Antonietta ^b,c   Salvo, Francesco ^c,d   David, Anaelle ^d,e,f   Moore, Nicholas ^d,e,f   Caputi, Achille Patrizio ^b,c   Sturkenboom, Miriam ^a   Molokhia, Mariam ^g   Hippisley Cox, Julia ^h   Acedo, Carlos Diaz ⁱ   Van Der Lei, Johan ^a   Fourrier Reglat, Annie ^d,e,f  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b IRCCS CENTRO NEUROLESI BONINO PULEJO   (Italy)

^c UNIVERSITY OF MESSINA   (Italy)

^d INSERM U657   (France)

^e BORDEAUX UNIVERSITY HOSPITAL   (France)

^f UNIVERSITÉ DE BORDEAUX   (France)

^g LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^h UNIVERSITY OF NOTTINGHAM   (United Kingdom)

ⁱ INST MUNIC D INVESTIGACIO MEDICA   (Spain)

Author keywords

Adverse event; Data mining; Database; Drug safety; Signal detection

Indexed keywords

ACUTE HEART INFARCTION; ACUTE KIDNEY FAILURE; ANAPHYLACTIC SHOCK; ARTICLE; DATA MINING; DEATH; DRUG ERUPTION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; INTERNET; PRIORITY JOURNAL; RHABDOMYOLYSIS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATA MINING; DATABASES, FACTUAL; DRUG MONITORING; DRUG THERAPY; ELECTRONIC HEALTH RECORDS; EUROPE; HUMANS; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT;

EID: 72449176909     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1836     Document Type: Article

References (52)

1. Ståhl M, Edwards IR, Bowring G, Kiuru A, Lindquist M. Assessing the impact of drug safety signals from the WHO database presented in 'SIGNAL': results from a questionnaire of National Pharmacovigilance Centres. Drug Saf 2003; 26: 721-727.
2. The Uppsala Monitoring Centre. Practical Pharmacovigilance. Signal Definition. http://www.who-umc.org/DynPage.aspx?id=22676#signaldef (accessed on 5 February 2009).
3. Rodriguez EM, Staffa JA, Graham DJ. The role of databases in drug postmarketing surveillance. Pharmacoepidemiol Drug Saf 2001; 10: 407-410. (Pubitemid 33138463)
4. Meyboom RH, Lindquist M, Egberts AC, Edwards IR. Signal selection and follow-up in pharmacovigilance. Drug Saf 2002; 25: 459-465.
5. Avorn J. Evaluating drug effects in the post-Vioxx world: there must be a better way. Circulation 2006; 113: 2173-2176. (Pubitemid 43755139)
6. Wadman M. Experts call for active surveillance of drug safety. Nature 2007; 446: 358-359. (Pubitemid 46474580)
7. Edwards IR. The accelerating need for pharmacovigilance. J R Coll Physicians Lond 2000; 34: 48-51.
8. EMEA. European Risk Management Strategy: 2008-2009 work programme adopted. London, 2 January 2008. http://www.hma.eu/uploads/ media/ERMS-2008- 2009-work-programme-adopted.pdf (accessed on 3 February 2009).
9. FDA. The Future of Drug Safety-Promoting and Protecting the Health of the Public. January 2007. http://www.fda.gov/oc/reports/ iom013007.pdf (accessed on 3 February 2009).
10. Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol 2005; 58: 323-337. (Pubitemid 40601980)
11. Brown JS, Kulldorff M, Chan KA, et al. Early detection of adverse drug events within population-based health networks: application of sequential testing methods. Pharmacoepidemiol Drug Saf 2007; 16: 1275-1284. (Pubitemid 350303439)
12. Vandenbroucke JP, Psaty BM. Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects. JAMA 2008; 300: 2417-2419.
13. Vandenbroucke JP. What is the best evidence for determining harms of medical treatment? CMAJ 2006; 174: 645-646.
14. Kaufman DW, Shapiro S. Epidemiologic assessment of drug-induced disease. Lancet 2000; 356: 1339-1343.
15. Vray M, Hamelin B, Jaillon P, Round Table No. 2, Giens XX. The respective roles of controlled clinical trials and cohort monitoring studies in the pre- and postmarketing assessment of drugs. Therapie 2005; 60: 339-349.
16. Brown JS, Kulldorf M, Petronis KR, et al. Early adverse drug event signal detection within population-based health networks using sequential methods: key methodologic considerations. Pharmacoepidemiol Drug Saf 2009; 18: 226-234.
17. Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004; 364: 2021-2029. (Pubitemid 39593078)
18. McClellan M. Drug safety reform at the FDA-pendulum swing or systematic improvement? New Engl J Med 2007; 356: 1700-1702.
19. Platt R. The future of drug safety: challenges for FDA. Presented at the Institute of Medicine Forum. Washington DC, 12 March 2007.
20. Edwards IR. Adverse drug reactions: finding the needle in the haystack. Br Med J 1997; 315: 500.
21. Bate A, Lindquist M, Orre R, Edwards IR, Meyboom RH. Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs. Eur J Clin Pharmacol 2002; 58: 483-490.
22. Hauben M, Zhou X. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Saf 2003; 26: 159-186. (Pubitemid 36308102)
23. Wilson AM, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. Br J Clin Pharmacol 2004; 57: 127-134. (Pubitemid 38223524)
24. Hauben M, Madigan D, Gerrits CM, et al. The role of data mining in pharmacovigilance. Expert Opin Drug Saf 2005; 4: 929-948.
25. i3 Aperio® signal detection and assessment tool. http://www.i3global. com/Solutions/PharmaInformatics/i3Aperio/ (accessed on 3 February 2009).
26. Hauben M, Reich L, Van Puijenbroek EP, Gerrits CM, Patadia VK. Data mining in pharmacovigilance: lessons from phantom ships. Eur J Clin Pharmacol 2006; 62: 967-970. (Pubitemid 44657632)
27. Smyth P. Data mining: data analysis on a grand scale? Stat Methods Med Res 2000; 9: 309-327.
28. Moore N, Hall G, Sturkenboom M, Mann R, Lagnaoui R, Begaud B. Biases affecting the proportional reporting ratio (PRR) in spontaneous reports pharmacovigilance databases: the example of sertindole. Pharmacoepidemiol Drug Saf 2003; 12: 271-281. (Pubitemid 36700601)
29. Platt R, Madre L, Reynolds R, Tilson H. Active drug safety surveillance: a tool to improve public health. Pharmacoepidemiol Drug Saf 2008; 17: 1175-1182.
30. European Medicines Agency. Valdecoxib withdrawal. http://www.emea. europa.eu/pdfs/human/press/pus/20480204en.pdf (accessed on 20 November 2008).
31. Lexchin J. Drug withdrawals from the Canadian market for safety reasons, 1963-2004. CMAJ 2005; 172: 765-767.
32. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med 2005; 165: 1363-1369.
33. Mockenhaupt M, Viboud C, Dunant A, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: assessment of medication risks with emphasis on recently marketed drugs. The EuroSCAR-study. J Invest Dermatol 2008; 128: 35-44. (Pubitemid 350249390)
34. Valeyrie-Allanore L, Poulalhon N, Fagot JP, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis induced by amifostine during head and neck radiotherapy. Radiother Oncol 2008; 87: 300-303.
35. Roujeau JC, Stern RS. Severe adverse cutaneous reactions to drugs. N Engl J Med 1994; 331: 1272-1285. (Pubitemid 24333193)
36. Valeyrie-Allanore L, Sassolas B, Roujeau JC. Drug-induced skin, nail and hair disorders. Drug Saf 2007; 30: 1011-1030. (Pubitemid 350036602)
37. Thomsen LA, Winterstein AG, Søndergaard B, Haugbølle LS, Melander A. Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Ann Pharmacother 2007; 41: 1411-1426. (Pubitemid 47311361)
38. Trifirò G, Calogero G, Ippolito FM, et al. Adverse drug events in emergency department population: a prospective Italian study. Pharmacoepidemiol Drug Saf 2005; 14: 333-340. (Pubitemid 40716326)
39. Lagnaoui R, Moore N, Fach J, Longy-Boursier M, Bégaud B. Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence, direct costs and avoidability. Eur J Clin Pharmacol 2000; 55: 181-186. (Pubitemid 30341394)
40. Budnitz DS, Pollock DA,Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006; 296: 1858-1866.
41. Gandhi TK, Weingart SN, Borus J, et al. Adverse drug events in ambulatory care. N Engl J Med 2003; 348: 1556-1564. (Pubitemid 36437933)
42. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. Br Med J 2004; 329: 15-19. (Pubitemid 38869995)
43. Bonn D. Adverse drug reactions remain a major cause of death. Lancet 1998; 351: 1183.
44. Chyka PA. How many deaths occur annually from adverse drug reactions in the United States? Am J Med 2000; 109: 122-1230.
45. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalised patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200-1205. (Pubitemid 28193431)
46. Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother 2008; 42: 1017-1025.
47. Davies EC, Green CF, Mottram DR, Pirmohamed M. Adverse drug reactions in hospitals: a narrative review. Curr Drug Saf 2007; 2: 79-87. (Pubitemid 46723172)
48. Barrow P, Waller P, Wise L. Comparison of hospital episodes with 'drug-induced' disorders and spontaneously reported adverse drug reactions. Br J Clin Pharmacol 2005; 61: 233-237.
49. FDA Center for Drug Evaluation and Research 2005 Report to the Nation-Improving Public Health through Human Drugs. http:// www.fda.gov/CDER/ reports/rtn/2005/rtn2005.PDF (accessed on 3 February 2009).
50. Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. Br Med J 1998; 316: 1295-1298.
51. Lee A, Rawlins MD. Adverse drug reactions. In Clinical Pharmacy and Therapeutics (3rd edn), Walker R, Edwards C (eds). Churchill Livingstone: London, 2002; 33-46.
52. Olivier P, Montastruc JL. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiol Drug Saf 2006; 15: 808-812. (Pubitemid 44767097)