Drug-related deaths: An analysis of the Italian spontaneous reporting database

Drug Safety

Volumn 31, Issue 8, 2008, Pages 703-713

  Leone, Roberto ^a,c   Sottosanti, Laura ^b   Luisa Iorio, Maria ^a   Santuccio, Carmela ^b   Conforti, Anita ^a   Sabatini, Vilma ^b   Moretti, Ugo ^a   Venegoni, Mauro ^b  

^a UNIVERSITY OF VERONA   (Italy)

^b ITALIAN MEDICINES AGENCY   (Italy)

^c Clinical Pharmacology Unit   (Italy)

Author keywords

Adverse drug reactions incidence; Adverse reaction monitoring; Death, drug induced; Pharmacovigilance

Indexed keywords

ALLOPURINOL; AMIODARONE; ANALGESIC AGENT; ANTICOAGULANT AGENT; ANTICONVULSIVE AGENT; ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; ANTIPARASITIC AGENT; ANTIVIRUS AGENT; CARDIOVASCULAR AGENT; CEFTRIAXONE; CENTRAL NERVOUS SYSTEM AGENTS; CEPHALOSPORIN DERIVATIVE; CONTRAST MEDIUM; DERMATOLOGICAL AGENT; HORMONE DERIVATIVE; IMMUNOMODULATING AGENT; IMMUNOSTIMULATING AGENT; IMMUNOSUPPRESSIVE AGENT; INSECTICIDE; IODINATED CONTRAST MEDIUM; NEUROLEPTIC AGENT; NIMESULIDE; NONSTEROID ANTIINFLAMMATORY AGENT; PENICILLIN DERIVATIVE; QUINOLINE DERIVED ANTIINFECTIVE AGENT; SEX HORMONE; SIMVASTATIN; TICLOPIDINE; UNINDEXED DRUG;

ACUTE HEART INFARCTION; ACUTE KIDNEY FAILURE; ADULT; AGE DISTRIBUTION; AGED; AGRANULOCYTOSIS; ALLERGIC REACTION; ANAPHYLACTIC SHOCK; APLASTIC ANEMIA; ARTICLE; CHOLESTATIC HEPATITIS; CONGESTIVE HEART FAILURE; DATA BASE; DRUG FATALITY; DRUG INFORMATION; DRUG SURVEILLANCE PROGRAM; EXFOLIATIVE DERMATITIS; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEART ARREST; HEPATITIS; HUMAN; ITALY; KIDNEY FAILURE; LEUKOPENIA; LIVER FAILURE; LUNG FIBROSIS; MAJOR CLINICAL STUDY; MALE; MEDICAL EDUCATION; MEDICAL PRACTICE; MYOPATHY; OBSTRUCTIVE JAUNDICE; PRESCRIPTION; PRIORITY JOURNAL; PSEUDOMEMBRANOUS COLITIS; RHABDOMYOLYSIS; SKIN NECROSIS; STEVENS JOHNSON SYNDROME; THROMBOTIC THROMBOCYTOPENIC PURPURA; TOXIC EPIDERMAL NECROLYSIS;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; DATABASES, FACTUAL; DRUG THERAPY; FEMALE; HUMANS; ITALY; MALE; MIDDLE AGED; PHARMACEUTICAL PREPARATIONS; YOUNG ADULT;

EID: 47649106759     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200831080-00007     Document Type: Article

References (55)

1. Ives TJ, Bentz EJ, Gwyther RE. Drug-related admissions to a family medicine inpatient service. Arch Intern Med 1987; 147: 1117-20
2. Stoukides CE, D'Agostino PR, Kaufman MB. Adverse drug reaction surveillance in an emergency room. Am J Hosp Pharm 1993; 50: 712-4
3. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalised patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200-5
4. Muehlberger N, Schneeweiss S, Hasford J. Adverse drug reaction monitoring-cost and benefit considerations. Part I: frequency of adverse drug reactions causing hospital admissions. Pharmacoepidemiol Drug Saf 1997; 6 Suppl. 3: S71-7
5. Lagnaoui R, Moore N, Fach J, et al. Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence, direct costs and avoidability. Eur J Clin Pharmacol 2000; 56: 181-6
6. Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 2002; 24: 46-54
7. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BMJ 2004; 329: 15-9
8. Samoy LJ, Zed PJ, Wilbur K, et al. Drug-related hospitalizations in a tertiary care internal medicine service of a Canadian hospital: a prospective study. Pharmacotherapy 2006; 26: 1578-86
9. van der Hooft CS, Sturkenboom M, van Grootheest K, et al. Adverse drug reaction-related hospitalisations: a nationwide study in the Netherlands. Drug Saf 2006; 29: 161-8
10. Porter J, Jick H. Drug-related deaths among medical inpatients. JAMA 1977; 237: 879-81
11. Bains N, Hunter D. Adverse reporting on adverse reactions. CMAJ 1999; 160: 350-1
12. Zoppi M, Braunschweig S, Kuenzi UP, et al. Incidence of lethal adverse drug reactions in the comprehensive hospital drug monitoring, a 20-year survey, 1974-1993, based on the data of Berne/St Gallen. Eur J Clin Pharmacol 2000; 56: 427-30
13. Ebbesen J, Buajordet I, Erikssen J, et al. Drug-related deaths in a department of internal medicine. Arch Intern Med 2001; 161: 2317-23
14. Juntti-Patinen L, Neuvonen PJ. Drug-related deaths in a university central hospital. Eur J Clin Pharmacol 2002; 58: 479-82
15. WHO. International drug monitoring: the role of the hospital. Geneva: WHO, 1966. Technical report series N. 425
16. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med 1999; 340: 1888-99
17. Mittmann N, Liu BA, Iskedjian M, et al. Drug-related mortality in Canada (1984-1994). Pharmacoepidemiol Drug Saf 1997; 6: 157-68
18. Wester K, Jönsson A, Spigset O, et al. Spontaneously reported fatal suspected adverse drug reactions: a 10-year survey from Sweden. Pharmacoepidemiol Drug Saf 2007; 16: 173-80
19. Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch Intern Med 2007; 167: 1752-9
20. Agenzia Italiana del Farmaco. Pharmacovigilance [online]. Available from URL: http://www.agenziafarmaco.it/ [Accessed 2007 Apr 16]
21. Bousquet C, Lagier G, Lillo-Le Louet A, et al. Appraisal of the MedDRA conceptual structure for describing and grouping adverse drug reactions. Drug Saf 2005; 28: 19-34
22. Uppsala Monitoring Centre. Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre. Uppsala: The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, 2000
23. van der Heijden PG, van Puijenbroek EP, van Buuren S, et al. On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios. Stat Med 2002; 21: 2027-44
24. Thiessard F, Roux E, Miremont-Salamé G, et al. Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001). Drug Saf 2005; 28: 731-40
25. Onder G, Pedone C, Landi F, et al. Adverse drug reactions as cause of hospital admissions: results from the Italian Group of Pharmacoepidemiology in the Elderly (GIFA). J Am Geriatr Soc 2002; 50: 1962-8
26. Tiaden JD, Wenzel E, Berthold HK, et al. Adverse reactions to anticoagulants and to antiplatelet drugs recorded by the German spontaneous reporting system. Semin Thromb Hemost 2005; 31: 371-80
27. Chyka PA. How many deaths occur annually from adverse drug reactions in the United States? Am J Med 2000; 109: 122-30
28. Liu BA, Knowles SR, Mittmann N, et al. Reporting of fatal adverse drug reactions. Can J Clin Pharmacol 2001; 8: 84-8
29. Repertorio Farmaceutico Italiano [CD ROM]. 15th ed. Milan: Masson, 2006
30. Baldo BA, Pham NH, Zhao Z. Chemistry of drug allergenicity. Curr Opin Allergy Clin Immunol 2001; 1: 327-35
31. Vaccheri A, Castelvetri C, Esaka E, et al. Pattern of antibiotic use in primary health care in Italy. Eur J Clin Pharmacol 2000; 56: 417-25
32. Agenzia Italiana del Farmaco. Drug utilization in Italy: National Report year 2005 [online]. Available from URL: http://www.agenziafarmaco.it/ [Accessed 2007 Feb 14]
33. Ortqvist A. Antibiotic treatment of community-acquired pneumonia in clinical practice: a European perspective. J Antimicrob Chemother 1995; 35: 205-12
34. Gulbinovic J, Myrback KE, Bytautiene J, et al. Marked differences in antibiotic use and resistance between university hospitals in Vilnius, Lithuania, and Huddinge, Sweden. Microb Drug Resist 2001; 7: 383-9
35. Bremon AR, Ruiz-Tovar M, Gorricho BP, et al. Non-hospital consumption of antibiotics in Spain: 1987-1997. J Antimicrob Chemother 2000; 45: 395-400
36. Mazzaglia G, Arcoraci V, Greco S, et al. Prescribing habits of general practitioners in choosing an empirical antibiotic regimen for lower respiratory tract infections in adults in Sicily. Pharm Res 1999; 40: 47-52
37. Vaccheri A, Bjerrum L, Resi D, et al. Antibiotic prescribing in general practice: striking differences between Italy (Ravenna) and Denmark (Funen). J Antimicrob Chemother 2002; 50: 989-97
38. Elseviers MM, Ferech M, Vander Stichele RH, et al. Antibiotic use in ambulatory care in Europe (ESAC data 1997-2002): trends, regional differences and seasonal fluctuations. Pharmacoepidemiol Drug Saf 2007; 16: 115-23
39. WHO. WHO Global Strategy for Containment of Antimicrobial Resistance [online]. Available from URL: http://www.who.int/csr/resources/publications/ drugresist/WHO_CDS_CSR_DRS_2001_2_EN/en/ [Accessed 2007 May 10]
40. Centers for Disease Control and Prevention. A public health action plan to combat antimicrobial resistance [online]. Available from URL: http://www.cdc.gov/drugresistance/actionplan/aractionplan.pdf [Accessed 2007 May 10]
41. Bennett CL, Davidson CJ, Raisch DW, et al. Thrombotic thrombocytopenic purpura associated with ticlopidine in the setting of coronary artery stents and stroke prevention. Arch Intern Med 1999; 159: 2524-8
42. Bennett CL, Weinberg PD, Rozenberg-Ben-Dror K, et al. Thrombotic thrombocytopenic purpura associated with ticlopidine: a review of 60 cases. Ann Intern Med 1998; 128: 541-4
43. Bennett CL, Kiss JE, Weinberg PD, et al. Thrombotic thrombocytopenic purpura after stenting and ticlopidine. Lancet 1998; 352: 1036-7
44. Venegoni M, Conforti A, Cocci A, et al. Spontaneous reports of ticlopidine-associated thrombotic thrombocytopenic purpura from two Italian regions [letter]. Arch Intern Med 1999; 159: 2227
45. Fialova D, Topinkova E, Gambassi G, et al. Potentially inappropriate medication use among elderly home care patients in Europe. JAMA 2005; 293: 1348-58
46. Onder G, Landi F, Liperoti R, et al. Impact of inappropriate drug use among hospitalized older adults. Eur J Clin Pharm 2005; 61: 453-9
47. Motola D, Vaccheri A, Silvani MC, et al. Pattern of NSAID use in the Italian general population: a questionnaire based survey. Eur J Clin Pharmacol 2004; 60: 731-8
48. Bergman U, Andersen M, Vaccheri A, et al. Deviations from evidence based prescribing of non-steroidal anti-inflammatory drugs in three European regions. Eur J Clin Pharmacol 2000; 56: 269-72
49. Traversa G, Bianchi C, Da Cas R, et al. Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs. BMJ 2003; 327: 18-22
50. Pascual E, Sivera F. Therapeutic advances in gout. Curr Opin Rheumatol 2007; 19: 122-7
51. Roujeau JC, Kelly JP, Naldi L, et al. Medication use and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis. N Engl J Med 1995; 333: 1600-7
52. Gutierrez-Macias A, Lizarralde-Palacios E, Martinez-Odriozola P, et al. Fatal allopurinol hypersensitivity syndrome after treatment of asymptomatic hyperuricaemia. BMJ 2005; 331: 623-4
53. Zhang W, Doherty M, Bardin T, et al. EULAR evidence based recommendations for gout. Part II: management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2006; 65: 1312-24
54. Caro JJ, Trindade E, McGregor M. The risks of death and of severe non fatal reactions with high vs low-osmolality contrast media: a meta-analysis. AJR Am J Roentgenol 1991; 156: 825-32
55. Meth MJ, Maibach HI. Current understanding of contrast media reactions and implications for clinical management. Drug Saf 2006; 29: 133-41