메뉴 건너뛰기




Volumn 17, Issue 6, 1997, Pages 374-389

Causal or casual? The role of causality assessment in pharmacovigilance

Author keywords

[No Author keywords available]

Indexed keywords

ALGORITHM; DATA ANALYSIS; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOXICITY; INFORMATION PROCESSING; PHARMACOEPIDEMIOLOGY; PRIORITY JOURNAL; QUESTIONNAIRE; REPRODUCIBILITY; REVIEW; STANDARDIZATION;

EID: 0031472193     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-199717060-00004     Document Type: Review
Times cited : (212)

References (61)
  • 2
    • 0030787821 scopus 로고    scopus 로고
    • Principles of signal detection in pharmacovigilance
    • Meyboom RHB, Egberts ACG, Edwards IR, et al. Principles of signal detection in pharmacovigilance. Drug Saf 1997; 16: 355-65
    • (1997) Drug Saf , vol.16 , pp. 355-365
    • Meyboom, R.H.B.1    Egberts, A.C.G.2    Edwards, I.R.3
  • 3
    • 0022036232 scopus 로고
    • Unexpected or toxicdrug reaction assessment (imputation). Actualization of the method used in France
    • Bégaud B, Evreux JC, Jouglard J, et al. Unexpected or toxicdrug reaction assessment (imputation). Actualization of the method used in France. Thérapie 1985; 40: 111-8
    • (1985) Thérapie , vol.40 , pp. 111-118
    • Bégaud, B.1    Evreux, J.C.2    Jouglard, J.3
  • 4
    • 0021152997 scopus 로고
    • Aspects of standardization as applied to the assessment of drug-event associations
    • Venulet J. Aspects of standardization as applied to the assessment of drug-event associations. Drug Inf J 1984; 18: 199-210
    • (1984) Drug Inf J , vol.18 , pp. 199-210
    • Venulet, J.1
  • 7
    • 0029912661 scopus 로고    scopus 로고
    • Characteristics of topics in pharmacovigilance in the Netherlands
    • Meyboom RHB, Gribnau FWJ, Hekster YA, et al. Characteristics of topics in pharmacovigilance in the Netherlands. Clin Drug Invest 1996; 4: 207-19
    • (1996) Clin Drug Invest , vol.4 , pp. 207-219
    • Meyboom, R.H.B.1    Gribnau, F.W.J.2    Hekster, Y.A.3
  • 8
    • 0000043683 scopus 로고
    • Drug safety alerts - A review of 'Current Problems'
    • Mann RD. Drug safety alerts - a review of 'Current Problems'. Pharmacoepidemiol Drug Saf 1992; 1: 269-79
    • (1992) Pharmacoepidemiol Drug Saf , vol.1 , pp. 269-279
    • Mann, R.D.1
  • 13
    • 0030896727 scopus 로고    scopus 로고
    • Reasons for reporting adverse drug reactions - Some thoughts based on an international review
    • Biriel C, Edwards IR. Reasons for reporting adverse drug reactions - some thoughts based on an international review. Pharmacoepidemiol Drug Saf 1997; 6: 21-6
    • (1997) Pharmacoepidemiol Drug Saf , vol.6 , pp. 21-26
    • Biriel, C.1    Edwards, I.R.2
  • 14
    • 0017262083 scopus 로고
    • Tissue reactions to drugs
    • Irey N. Tissue reactions to drugs. Am J Pathol 1976; 82: 617-47
    • (1976) Am J Pathol , vol.82 , pp. 617-647
    • Irey, N.1
  • 15
    • 0017327706 scopus 로고
    • Toward the operational identification of adverse drug reactions
    • Karch F, Lasagna L. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther 1977; 21: 247-54
    • (1977) Clin Pharmacol Ther , vol.21 , pp. 247-254
    • Karch, F.1    Lasagna, L.2
  • 16
    • 0018645590 scopus 로고
    • An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use
    • Kramer MS, Leventhal JM, Hutchinson TA, et al. An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA 1979; 242: 623-31
    • (1979) JAMA , vol.242 , pp. 623-631
    • Kramer, M.S.1    Leventhal, J.M.2    Hutchinson, T.A.3
  • 17
    • 0019799332 scopus 로고
    • A method for estimating the probability of adverse drug reactions
    • Naranjo C, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharm Ther 1981; 30: 239-45
    • (1981) Clin Pharm Ther , vol.30 , pp. 239-245
    • Naranjo, C.1    Busto, U.2    Sellers, E.M.3
  • 18
    • 0018822798 scopus 로고
    • Standardized assessment of drug-adverse reaction associations - Rationale and experience
    • Venulet J, Ciucci AG, Berneker GC. Standardized assessment of drug-adverse reaction associations - rationale and experience. Int J Clin Pharmacol 1980; 18: 381-8
    • (1980) Int J Clin Pharmacol , vol.18 , pp. 381-388
    • Venulet, J.1    Ciucci, A.G.2    Berneker, G.C.3
  • 19
    • 0019292312 scopus 로고
    • An algorithm for the classification of untoward events in large scale clinical trials
    • Emanueli A, Sacchetti G. An algorithm for the classification of untoward events in large scale clinical trials. Agents Actions 1980; 7: 318-22
    • (1980) Agents Actions , vol.7 , pp. 318-322
    • Emanueli, A.1    Sacchetti, G.2
  • 20
    • 0020173805 scopus 로고
    • Adverse drug reactions in the community health setting: Approaches to recognizing, counseling and reporting
    • Jones JK. Adverse drug reactions in the community health setting: approaches to recognizing, counseling and reporting. Fam Community Health 1982; 5: 58-67
    • (1982) Fam Community Health , vol.5 , pp. 58-67
    • Jones, J.K.1
  • 22
    • 84945702539 scopus 로고
    • An algorithm for the operational assessment of adverse drug reactions. II. Demonstration of reproducibility and validity
    • Hutchinson TA, Leventhal JM, Kramer MS, et al. An algorithm for the operational assessment of adverse drug reactions. II. Demonstration of reproducibility and validity. JAMA 1979; 242: 633-8
    • (1979) JAMA , vol.242 , pp. 633-638
    • Hutchinson, T.A.1    Leventhal, J.M.2    Kramer, M.S.3
  • 23
    • 0018612820 scopus 로고
    • An algorithm for the operational assessment of adverse drug reactions. III. Results of tests among clinicians
    • Leventhal JM, Hutchinson TA, Kramer MS, et al. An algorithm for the operational assessment of adverse drug reactions. III. Results of tests among clinicians. JAMA 1979; 242: 1991-4
    • (1979) JAMA , vol.242 , pp. 1991-1994
    • Leventhal, J.M.1    Hutchinson, T.A.2    Kramer, M.S.3
  • 24
    • 0024571264 scopus 로고
    • Assessing methods for causality assessment of suspected adverse drug reactions
    • Hutchinson TA, Lane DA. Assessing methods for causality assessment of suspected adverse drug reactions. J Clin Epidemiol 1989; 42: 5-16
    • (1989) J Clin Epidemiol , vol.42 , pp. 5-16
    • Hutchinson, T.A.1    Lane, D.A.2
  • 25
    • 0022534957 scopus 로고
    • Updating of a method for causality assessment of adverse drug reactions
    • Venulet J, Ciueci AG, Berneker GC. Updating of a method for causality assessment of adverse drug reactions. Int J Clin Pharmacol 1986; 24: 559-68
    • (1986) Int J Clin Pharmacol , vol.24 , pp. 559-568
    • Venulet, J.1    Ciueci, A.G.2    Berneker, G.C.3
  • 26
    • 0025125429 scopus 로고
    • Drug related hospital admissions: The role of definitions and intensity of data collection, and the possibility of prevention
    • Hallas J, Harvald B, Gram LF, et al. Drug related hospital admissions: the role of definitions and intensity of data collection, and the possibility of prevention. J Int Med 1990; 228: 83-90
    • (1990) J Int Med , vol.228 , pp. 83-90
    • Hallas, J.1    Harvald, B.2    Gram, L.F.3
  • 27
    • 0023502654 scopus 로고
    • The causality assessment of adverse drug reactions using a Bayesian approach
    • Lane DA, Kramer MS, Hutchinson TA, et al. The causality assessment of adverse drug reactions using a Bayesian approach. Pharm Med 1987; 2: 265-83
    • (1987) Pharm Med , vol.2 , pp. 265-283
    • Lane, D.A.1    Kramer, M.S.2    Hutchinson, T.A.3
  • 28
    • 6844219625 scopus 로고
    • Approaches to evaluating causation of suspected drug reactions
    • Strom BL, Velo G, editors. New York; Plenum Press
    • Jones JK. Approaches to evaluating causation of suspected drug reactions. In: Strom BL, Velo G, editors. Drug epidemiology and post-marketing surveillance. New York; Plenum Press, 1992: 103-13
    • (1992) Drug Epidemiology and Post-marketing Surveillance , pp. 103-113
    • Jones, J.K.1
  • 30
    • 0028300446 scopus 로고
    • Computer-assisted evaluation of adverse events using a Bayesian approach
    • Lanctôt KL, Naranjo CA. Computer-assisted evaluation of adverse events using a Bayesian approach. J Clin Pharmacol 1994; 34: 142-7
    • (1994) J Clin Pharmacol , vol.34 , pp. 142-147
    • Lanctôt, K.L.1    Naranjo, C.A.2
  • 31
    • 0028846787 scopus 로고
    • Essentials of Bayesian diagnostic reasoning
    • Lubsen J. Essentials of Bayesian diagnostic reasoning. Neth J Med 1995; 47: 252-9
    • (1995) Neth J Med , vol.47 , pp. 252-259
    • Lubsen, J.1
  • 32
    • 0021734420 scopus 로고
    • Testing the methods of assessment for adverse drug reactions
    • Girard M. Testing the methods of assessment for adverse drug reactions. Adv Drug React Ac Pois Rev 1984; 4: 237-44
    • (1984) Adv Drug React Ac Pois Rev , vol.4 , pp. 237-244
    • Girard, M.1
  • 33
    • 0022458267 scopus 로고
    • Computerized comparison of six adverse drug reaction assessment procedures
    • Pere JC, Bégaud B, Haramburu F, et al. Computerized comparison of six adverse drug reaction assessment procedures. Clin Pharmacol Ther 1986; 40: 451-61
    • (1986) Clin Pharmacol Ther , vol.40 , pp. 451-461
    • Pere, J.C.1    Bégaud, B.2    Haramburu, F.3
  • 37
    • 6844247514 scopus 로고
    • The Netherlands
    • Inman WHW, Gill EP, editors. Lancaster: MTP Press
    • Meyboom RHB. The Netherlands. In: Inman WHW, Gill EP, editors. Monitoring for drug safety. Lancaster: MTP Press, 1986: 107-17
    • (1986) Monitoring for Drug Safety , pp. 107-117
    • Meyboom, R.H.B.1
  • 38
    • 0026488185 scopus 로고
    • Reasonable possibility: Causality and postmarketing surveillance
    • Johnson JM. Reasonable possibility: causality and postmarketing surveillance. Drug Inf J 1992; 26: 553-8
    • (1992) Drug Inf J , vol.26 , pp. 553-558
    • Johnson, J.M.1
  • 39
    • 0028049067 scopus 로고
    • Harmonisation in pharmacovigilance
    • Edwards IR, Biriell C. Harmonisation in pharmacovigilance. Drug Saf 1994; 10: 93-102
    • (1994) Drug Saf , vol.10 , pp. 93-102
    • Edwards, I.R.1    Biriell, C.2
  • 40
    • 0025776608 scopus 로고
    • Adverse drug reactions: Scope and limitations of causality assessment and the use of algorithms
    • Castle W. Adverse drug reactions: scope and limitations of causality assessment and the use of algorithms. Int J Risk Safety Med 1991; 2: 185-92
    • (1991) Int J Risk Safety Med , vol.2 , pp. 185-192
    • Castle, W.1
  • 41
    • 0020607740 scopus 로고
    • Reasons for disagreement in the standardized assessment of suspected adverse drug reactions
    • Hutchinson TA, Flegel KM, Ho Pingkong H, et al. Reasons for disagreement in the standardized assessment of suspected adverse drug reactions. Clin Pharmacol Ther 1983; 34: 421-6
    • (1983) Clin Pharmacol Ther , vol.34 , pp. 421-426
    • Hutchinson, T.A.1    Flegel, K.M.2    Ho Pingkong, H.3
  • 42
    • 0019408577 scopus 로고
    • Comparaison de quatre méthodes d'imputabilité des effects indésirable médicamenteux
    • Bégaud B, Boisseau A, Albin H, et al. Comparaison de quatre méthodes d'imputabilité des effects indésirable médicamenteux. Thérapie 1981; 36: 65-70
    • (1981) Thérapie , vol.36 , pp. 65-70
    • Bégaud, B.1    Boisseau, A.2    Albin, H.3
  • 43
    • 0020546506 scopus 로고
    • Imputation médicament par médicament en pharmacovigilance. Essai de comparaison de différentes méthodes
    • Lagier G, Vincens M, Lefebvre B, et al. Imputation médicament par médicament en pharmacovigilance. Essai de comparaison de différentes méthodes. Thérapie 1983; 38: 295-302
    • (1983) Thérapie , vol.38 , pp. 295-302
    • Lagier, G.1    Vincens, M.2    Lefebvre, B.3
  • 44
    • 0019564950 scopus 로고
    • Etude comparative de quatre méthodes d'imputabilité
    • Leroy O, Bégaud B, Dangoumau J, et al. Etude comparative de quatre méthodes d'imputabilité. Thérapie 1981; 36: 223-7
    • (1981) Thérapie , vol.36 , pp. 223-227
    • Leroy, O.1    Bégaud, B.2    Dangoumau, J.3
  • 45
    • 0020397680 scopus 로고
    • Comparison of two recently published algorithms for assessing the probability of adverse drug reactions
    • Busto U, Naranjo CA, Sellers EM. Comparison of two recently published algorithms for assessing the probability of adverse drug reactions. Br J Clin Pharmacol 1982; 13: 223-7
    • (1982) Br J Clin Pharmacol , vol.13 , pp. 223-227
    • Busto, U.1    Naranjo, C.A.2    Sellers, E.M.3
  • 46
    • 0022398154 scopus 로고
    • A study of adverse reaction algorithms in a drug surveillance program
    • Louik C, Lacouture PG, Mitchell AA, et al. A study of adverse reaction algorithms in a drug surveillance program. Clin Pharmacol Ther 1985; 183-7
    • (1985) Clin Pharmacol Ther , pp. 183-187
    • Louik, C.1    Lacouture, P.G.2    Mitchell, A.A.3
  • 47
    • 0018423801 scopus 로고
    • Judgements of trained observers on adverse drug reactions
    • Blanc S, Leuenberger P, Berger JP, et al. Judgements of trained observers on adverse drug reactions. Clin Pharm Ther 1979; 25: 493-8
    • (1979) Clin Pharm Ther , vol.25 , pp. 493-498
    • Blanc, S.1    Leuenberger, P.2    Berger, J.P.3
  • 48
    • 0031016847 scopus 로고    scopus 로고
    • Algorithms used in adverse drug event reports: A comparative study
    • Frick PA, Cohen LG, Rovers JP. Algorithms used in adverse drug event reports: a comparative study. Ann Pharmacother 1997; 31: 164-7
    • (1997) Ann Pharmacother , vol.31 , pp. 164-167
    • Frick, P.A.1    Cohen, L.G.2    Rovers, J.P.3
  • 49
    • 0029589194 scopus 로고
    • Comparison of the Bayesian approach and a simple algorithm for assessment of adverse drug events
    • Lanctôt KL, Naranjo CA. Comparison of the Bayesian approach and a simple algorithm for assessment of adverse drug events. Clin Pharmacol Ther 1995; 58: 692-8
    • (1995) Clin Pharmacol Ther , vol.58 , pp. 692-698
    • Lanctôt, K.L.1    Naranjo, C.A.2
  • 50
    • 0027339955 scopus 로고
    • Does proof of causality ever exist in pharmacovigilance?
    • Auriche M, Loupi E. Does proof of causality ever exist in pharmacovigilance? Drug Saf 1993; 9: 230-5
    • (1993) Drug Saf , vol.9 , pp. 230-235
    • Auriche, M.1    Loupi, E.2
  • 51
    • 0004075491 scopus 로고
    • Guidelines for good clinical practice (GCP) for trials on pharmaceutical products
    • Geneva: World Health Organization
    • Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. WHO Technical Report Series, No. 850. Geneva: World Health Organization, 1995
    • (1995) WHO Technical Report Series , Issue.850
  • 52
    • 0007807937 scopus 로고
    • Causality assessment of adverse drug reactions using decision support and informatics tools
    • Hoskins RE, Mannino S. Causality assessment of adverse drug reactions using decision support and informatics tools. Pharmacoepidemiol Drug Saf 1992; 1: 235-50
    • (1992) Pharmacoepidemiol Drug Saf , vol.1 , pp. 235-250
    • Hoskins, R.E.1    Mannino, S.2
  • 53
    • 0025330184 scopus 로고
    • Quality criteria for early signals of possible adverse drug reactions
    • Edwards IR, Lindquist M, Wiholm BE, et al. Quality criteria for early signals of possible adverse drug reactions. Lancet 1990; 336: 156-8
    • (1990) Lancet , vol.336 , pp. 156-158
    • Edwards, I.R.1    Lindquist, M.2    Wiholm, B.E.3
  • 54
    • 0031001444 scopus 로고    scopus 로고
    • Harmonizing the use of adverse reaction terms. Definitions of terms and minimum requirements for their use: Respiratory disorders and skin disorders [special communication]
    • Harmonizing the use of adverse reaction terms. Definitions of terms and minimum requirements for their use: respiratory disorders and skin disorders [special communication]. Pharmacoepidemiol Drug Saf 1997; 6: 115-27
    • (1997) Pharmacoepidemiol Drug Saf , vol.6 , pp. 115-127
  • 55
    • 0030879777 scopus 로고    scopus 로고
    • Good practice in the postmarketing surveillance of medicines
    • Meyboom RHB. Good practice in the postmarketing surveillance of medicines. Pharmacy World Sci. Pharm World Sci 1997; 19: 186-90
    • (1997) Pharmacy World Sci. Pharm World Sci , vol.19 , pp. 186-190
    • Meyboom, R.H.B.1
  • 56
    • 0023805003 scopus 로고
    • Hepatic injury associated with the use of nitrofurans: A clinicopathological study of 52 reported cases
    • Stricker BHC, Blok APR, Claas FHJ, et al. Hepatic injury associated with the use of nitrofurans: a clinicopathological study of 52 reported cases. Hepatology 1988; 8: 559-606
    • (1988) Hepatology , vol.8 , pp. 559-606
    • Stricker, B.H.C.1    Blok, A.P.R.2    Claas, F.H.J.3
  • 58
    • 0023158144 scopus 로고
    • Hepatic reactions associated with ketoconazole in the United Kingdom
    • Lake-Bakaar G, Scheuer PJ, Sherlock S. Hepatic reactions associated with ketoconazole in the United Kingdom. BMJ 1987; 294: 419-22
    • (1987) BMJ , vol.294 , pp. 419-422
    • Lake-Bakaar, G.1    Scheuer, P.J.2    Sherlock, S.3
  • 59
    • 0021838250 scopus 로고
    • The role of metabolite-specific antibodies in nomifensine-dependent immune hemolytic anemia
    • Salama A, Mueller-Eckhardt C. The role of metabolite-specific antibodies in nomifensine-dependent immune hemolytic anemia. N Engl J Med 1985; 313: 469-74
    • (1985) N Engl J Med , vol.313 , pp. 469-474
    • Salama, A.1    Mueller-Eckhardt, C.2
  • 60
    • 85022847781 scopus 로고
    • International drug monitoring
    • Aronson JK, Van Boxtel CJ. Amsterdam: Elsevier Science Publishers
    • Edwards IR. International drug monitoring. In: Aronson JK, Van Boxtel CJ. Side effects of drugs annual. Vol 19. Amsterdam: Elsevier Science Publishers, 1995: 450-5
    • (1995) Side Effects of Drugs Annual , vol.19 , pp. 450-455
    • Edwards, I.R.1
  • 61
    • 0007979276 scopus 로고
    • Causality assessment of suspected adverse drug reactions, a transatlantic view
    • Jones JK. Causality assessment of suspected adverse drug reactions, a transatlantic view. Pharmacoepidemiol Drug Saf 1992; 1: 251-60
    • (1992) Pharmacoepidemiol Drug Saf , vol.1 , pp. 251-260
    • Jones, J.K.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.