Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA)

Drug Safety

Volumn 26, Issue 3, 2003, Pages 145-158

  Brown, Elliot G ^a  

^a Elliot Brown Consulting Ltd   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIBLIOGRAPHIC DATABASE; DATA ANALYSIS; DATA BASE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; INFORMATION RETRIEVAL; NOMENCLATURE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REGULATORY MECHANISM; REVIEW; UTILIZATION REVIEW;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATABASES, FACTUAL; DICTIONARIES, MEDICAL; HUMANS; INFORMATION STORAGE AND RETRIEVAL; MEDICAL INFORMATICS COMPUTING; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; TERMINOLOGY;

EID: 0037218258     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200326030-00002     Document Type: Review

References (8)

1. Eudralex Collection. The rules governing medicinal products in the European Union. Vol. 9, Pharmacovigilance. Eudralex collection [online]. Available from URL: http://pharmacos.eudra.org/F2/eudralex/vol-9/home.htm [Accessed 2002 Aug 31]
2. The ICH process for harmonization of guidelines [online]. Available from URL: http://www.ifpma.org [Accessed 2002 Aug 31]
3. MedDRA®. Term selection points to consider, release 3.0. Application to adverse drug reactions/adverse events and medical and social history [online]. Available from URL: http://www.MedDRA®msso.com [Accessed 2002 Aug 31]
4. Brown EG, Douglas S. Tabulation and analysis of pharmacovigilance data using the Medical Dictionary for Regulatory Activities. Pharmacoepidemiol Drug Saf 2000; 9: 479-89
5. Fescharek R, Dechert G, Reichert D, et al. Overall analysis of spontaneously reported adverse events: a worthwhile exercise or flogging a dead horse? Pharmaceutical Med 1996; 10: 71-86
6. Goldman SA. Adverse event reporting and standardizing medical terminologies: strengths and limitations. Drug Inf J 2002; 36: 439-44
7. Brown EG. Effects of coding dictionary on signal general on: a consideration of use of MedDRA compared with WHO-ART. Drug Saf 2002; 25 (6): 445-52
8. New CIOMS Working Group: rational use of MedDRA terminology for drug safety database searches. Current programme and planned activities [online]. Available from URL: http://www.cioms.ch [Accessed 2002 Aug 31]