Performance of the standardised MedDRA® queries for case retrieval in the French spontaneous reporting database

Drug Safety

Volumn 37, Issue 7, 2014, Pages 537-542

  Géniaux, Hélène ^a,b,c   Assaf, Denise ^a   Miremont Salamé, Ghada ^b,d   Raspaud, Bénédicte ^a,b   Gouverneur, Amandine ^a,b   Robinson, Philip ^e,f   Pariente, Antoine ^a,b,d   Salvo, Francesco ^a,b,e  

^a UNIVERSITÉ DE BORDEAUX   (France)

^b BORDEAUX UNIVERSITY HOSPITAL   (France)

^c HÔPITAL PELLEGRIN   (France)

^d INSERM   (France)

^e ADERA   (France)

^f Centre of Clinical Investigation Clinical Epidemiology   (France)

Author keywords

[No Author keywords available]

Indexed keywords

AGRANULOCYTOSIS; ARTICLE; BONE NECROSIS; DATA BASE; DEMYELINATION; DRUG SURVEILLANCE PROGRAM; GOLD STANDARD; HUMAN; INFORMATION RETRIEVAL; MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES; PATIENT ADVOCACY; PREDICTIVE VALUE; PRIORITY JOURNAL; PSYCHOSIS; SENSITIVITY AND SPECIFICITY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FACTUAL DATABASE; FRANCE; ORGANIZATION AND MANAGEMENT; PROCEDURES; STANDARDS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATABASES, FACTUAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FRANCE; HUMANS; INFORMATION STORAGE AND RETRIEVAL; PHARMACOVIGILANCE;

EID: 84904763109     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0187-2     Document Type: Article

References (21)

1. Harrison J, Mozzicato P. MedDRA: The tale of a terminology: side effects of drugs essay. In: Aronson JK, editor. Side effects of drugs annual. Amsterdam: Elsevier; 2009. pp. 33-51.
2. Brown EG. Effects of coding dictionary on signal generation: a consideration of use of MedDRA compared with WHO-ART. Drug Saf. 2002;25(6):445-52. (Pubitemid 34729144)
3. Pearson RK, Hauben M, Goldsmith DI, Gould AL, Madigan D, O'Hara DJ, et al. Influence of the MedDRA hierarchy on pharmacovigilance data mining results. Int J Med Inform. 2009;78(12):e97-103. doi:10.1016/j.ijmedinf.2009.01.001.
4. Brown EG, Douglas S. The concept of searches with defined sensitivity and specificity was described in tabulation and analysis of pharmacovigilance data using MedDRA. Pharmacoepidemiol Drug Saf. 2000;9:479-89.
5. MedDRA Maintenance and Support Services Organization. Introductory Guide for Standardised MedDRA Queries (SMQs) Version 15.0. Chantilly (VA): International Federation of Pharmaceutical Manufacturers and associations; 2012. http://www.meddra.org/sites/default/files/guidance/file/smq-intguide-15-0- english.pdf. Accessed 1 May 2014
6. Mozzicato P. Standardised MedDRA queries: their role in signal detection. Drug Saf. 2007;30(7):617-9. (Pubitemid 47037323)
7. Andrews E, Moore N. Mann's pharmacovigilance, 3rd ed. New York: Wiley; 2014.
8. SMQs: development and rational use of Standardised MedDRA queries. Report of CIOMS Working Group. Geneva: CIOMS; 2004.
9. Décret no 2011-655 du 10 juin 2011 relatif aux modalités de signalement par les patients ou les associations agréées de patients d'effets indésirables susceptibles d'être liés aux médicaments et produits mentionnés à l'article L. 5121-1 du code de la santé publique. JORF. 2011;no0136, 13.
10. Bénichou C. Adverse drug reactions: a practical guide to diagnosis and management. New York: Wiley; 1994.
11. Council for International Organizations of Medical Sciences (CIOMS). Reporting adverse drug reactions. Definitions of terms and criteria for their use. Geneva: CIOMS; 1999.
12. van Puijenbroek EP, Bate A, Leufkens HG, Lindquist M, Orre R, Egberts AC. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002;11(1):3-10. doi:10.1002/pds.668. (Pubitemid 34269590)
13. Bannwarth B. Drug-induced musculoskeletal disorders. Drug Saf. 2007;30:27-46. (Pubitemid 46072356)
14. American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 5th ed. Arlington: American Psychiatric Association; 2013. http://dsm.psychiatryonline.org. Accessed 1 Jan 2014.
15. Dupuch M, Dupuch L, Hamon T, Grabar N. Exploitation of semantic methods to cluster pharmacovigilance terms. J Biomed Semant. 2014;5:18. doi:10.1186/2041-1480-5-18.
16. Dupuch M, Dupuch L, Perinet A, Hamon T, Grabar N. Grouping the pharmacovigilance terms with a hybrid approach. Stud Health Technol Inform. 2012;180:235-9.
17. Dupuch M, Lerch M, Jamet A, Jaulent MC, Fescharek R, Grabar N. Grouping pharmacovigilance terms with semantic distance. Stud Health Technol Inform. 2011;169:794-8.
18. Jaulent MC, Alecu I. Evaluation of an ontological resource for pharmacovigilance. Stud Health Technol Inform. 2009;150:522-6.
19. List of SMQ topics for development by CIOMS Working Group for SMQs. 2013. http://www.meddra.org/sites/default/files/page/documents/list-of-smq-topics- for-website-sep-2013.pdf. Accessed 14 Feb 2014.
20. ICH Working Group. MedDRA® data retrieval and presentation: points to consider. ICH-endorsed guide for MedDRA users on data output. 2012. http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/MedDRA/ MedDRA-Documents/MedDRA-Data-Retrieval-and-Presentation/Release-3.4-based-on-v. 15.1/DataRetrieval-PTC-R3-4-October.2012.pdf. Accessed 13 Jan 2014.
21. Chen G, Shen D. Practice of SMQs for adverse events in analysis of safety data and pharmacovigilance. http://www.pharmasug.org/proceedings/2013/HO/ PharmaSUG-2013-HO02.pdf Accessed 12 Jan 2014.