Harmonising adverse drug reaction terminology

Drug Safety

Volumn 19, Issue 3, 1998, Pages 165-172

  Venulet, Jan ^a   Bankowski, Zbigniew ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERSE DRUG REACTION; ARTICLE; DRUG INDUSTRY; NOMENCLATURE; PRIORITY JOURNAL;

HUMANS; INTERNATIONAL COOPERATION; PHARMACEUTICAL PREPARATIONS; TERMINOLOGY;

EID: 0031664957     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-199819030-00001     Document Type: Article

References (24)

1. Venulet J. The WHO Drug Monitoring Programme: the formative years (1968-1975) in drug surveillance: past, present and future. In: Bankowski Z, Dunne JF, editors. Geneva: CIOMS, 1994: 13-21
2. Venulet J. The practicing physician as generator and user of adverse reaction data. Int J Clin Pharmacol Ther Toxicol 1986; 24: 385-9
3. Venulet J, Blattner R, von Bülow J, et al. How good are articles on adverse drug reactions. BMJ 1982; 284: 252-4
4. Venulet J. Informativity of adverse drug reactions data in medical publications. Drug Inf J 1985; 19: 357-65
5. Venulet J. Incomplete information as a limiting factor in causality assessment of adverse drug reactions and its practical consequences. Drug Inf J 1986; 20: 423-31
6. International Reporting of International Adverse Drug Reactions. 1989. Final Report of a CIOMS Working Group 1. Geneva: CIOMS, 1990
7. International Reporting of Periodic Drug-Safety Update Summaries, 1992. Final Report of CIOMS Working Group II. Geneva: CIOMS, 1992
8. The Core Safely Date Sheet: standards for good clinical safety labeling practice. 1994. Final Report of CIOMS Working Group III. Geneva: CIOMS, 1995
9. Wood KL. The Medical Dictionary for Drug Regulatory Affairs (MEDDRA). Pharmacoepidemiol Drug Saf 1994; 3: 7-13
10. International Statistical Classification of Disease and Related Health Problems (ICD-10). Geneva: World Health Organization, 1992
11. Bénichou C, Danan G. Réunion de consensus sur les définitions en pharmacovigilance. Thérapie 1987; 42: 347-50
12. Standardization of definitions and criteria of causality assessment of adverse drug reactions: drug-induced liver disorders. Int J Clin Pharmacol Ther Toxicol 1990; 28: 317-22
13. Standardization of definitions and criteria of causality assessment of adverse drug reactions: drug-induced cytopenia. Int J Clin Pharmacol Ther Toxicol 1991; 29: 75-81
14. Basic requirements for the use of terms for reporting adverse drug reactions: anaphylactic shock, arrhythmia, cardiac failure, hypertension, thrombosis and embolism. Pharmacoepidemiol Drug Saf 1992; 1: 39-45
15. Basic requirements for the use of terms for reporting adverse drug reactions: colitis, gastrointestinal haemorrhage, hepatocellular damage, peptic ulcer, pancreatitis. Pharmacoepidemiol Drug Saf 1992; 1: 133-7
16. Basic requirements for the use of terms for reporting adverse drug reactions (III): aplastic anaemia, bone marrow depression, coagulation disorder, thrombophlebitis. Pharmacoepidemiol Drug Saf 1992; 1: 191-6
17. Basic requirements for the use of terms for reporting adverse drug reactions (IV): dyskinesia, depression, myopathy, neuropathy, paralysis, convulsions. Pharmacoepidemiol Drug Saf 1993; 2: 149-53
18. Basic requirements for the use of terms for reporting adverse drug reactions (V): vision abnormal, keratitis, cataract, retinal disorder, acidosis. Pharmacoepidemiol Drug Saf 1993; 2: 189-93
19. Definitions of adverse drug reactions and minimum requirements for their use: cardiovascular disease terms. Pharmacoepidemiol Drug Saf 1993; 2: 591-602
20. Harmonizing the use of adverse drug reaction terms: definitions of terms and minimum requirements for their use: respiratory disorders and skin disorders. Pharmacoepidemiol Drug Saf 1997; 6: 115-27
21. Basic requirements for the use of terms for reporting adverse drug reactions (VIII): renal and urinary system disorders. Pharmacoepidemiol Drug Saf 1947; 6: 203-11
22. Definitions and basic requirements for the use of terms for reporting adverse drug reactions (IX): central and peripheral nervous system terms. Pharmacoepidemiol Drug Saf 1998; 7: 39-49
23. Basic requirements for the use of terms for reporting adverse drug reactions (X): gastrointestinal system disorders. Pharmacoepidemiol Drug Saf. In press
24. Basic requirements for the use of terms for reporting adverse drug reactions (XI): cardiovascular system disorders. Pharmacoepidemiol Drug Saf. In press