Using MedDRA: Implications for risk management

Drug Safety

Volumn 27, Issue 8, 2004, Pages 591-602

  Brown, Elliot G ^a  

^a Elliot Brown Consulting Ltd   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADALAT CC; AMPHOTERICIN B; AMPHOTERICIN B LIPID COMPLEX; DONEPEZIL; FEXOFENADINE; LANSOPRAZOLE; MELOXICAM; NIFEDIPINE; ONDANSETRON; PAROXETINE; SIMVASTATIN; SUMATRIPTAN; SUMATRIPTAN SUCCINATE; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ANOREXIA; ASTHENIA; BACKACHE; CLINICAL TRIAL; CONSTIPATION; DATA BASE; DIARRHEA; DIZZINESS; DRUG ERUPTION; DRUG INFORMATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DYSPEPSIA; EDEMA; FATIGUE; FLATULENCE; HEADACHE; HUMAN; INFECTION; INSOMNIA; MEDICAL INFORMATION; NAUSEA; PAIN; PRIORITY JOURNAL; PRURITUS; REVIEW; RISK MANAGEMENT; SEDATION; SIGNAL DETECTION; SOMNOLENCE; SWEATING; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

CLINICAL TRIALS; DICTIONARIES, MEDICAL; DRUG THERAPY; HUMANS; PHARMACOEPIDEMIOLOGY; TERMINOLOGY;

EID: 3042609851     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200427080-00010     Document Type: Review

References (27)

1. Wood KL. The Medical Dictionary for Drug Regulatory Affairs (MEDDRA) Project. Pharmacoepidemiol Drug Saf 1994; 3: 7-13
2. Brown EG, Wood KL, Wood SM. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999; 20 (2): 109-17
3. Maintenance and Support Services Organization. Medical dictionary for regulatory activities (MedDRA®) introductory guide, MedDRA Version 6.1, 2003
4. European Commission. The rules governing medicinal products in the European Union, Vol. 9. Pharmacovigilance. European Commission, Dec 2001
5. Tawaragi T. Updates of regulatory requirements in Japan. 6th International Conference on Harmonisation; 2003 Nov 12; Osaka, Japan [online]. Available from URL: http://www.meddramsso.com/newweb2003/docs [Accessed 2004 Apr 11]
6. Food and Drugs Administration. 21 CFR Parts 310, 312, etc. Safety reporting requirements for human drug and biological products; proposed rule. Fed Regist 2003 Mar 14, 12405-97
7. ICH Harmonised Tripartite Guideline. The common technical document for the registration of pharmaceuticals for human use: efficacy -M4e [online]. Available from URL: http://www.ich.org [Accessed 2004 Apr 11]
8. International Conference on Harmonisation. Draft consensus guideline. Pharmacovigilance Planning (PvP) E2E. 2003 Nov 11
9. Brown DR, Brown EG, Moulvad TB. A comparison of two medical terminologies in coding and analysing clinical trial safety data. Int J Pharm Med 1997; 11: 85-9
10. Tremell LT, Scarpone L. Using MedDRA for adverse events in cancer trials: experience, caveats and advice. Drug Inf J 2001; 35: 845-53
11. Rawlins MD, Mann RD. Monitoring adverse events and reactions. In: Mann RD, Rawlins MD, Auty RM, editors. A textbook of pharmaceutical medicine. Carnforth: The Parthenon Publishing Group, 1993
12. Physicians Desk Reference, 2003. Accessed via MICROMEDEX® Healthcare Series Vol. 118, http://micromedex.prioinfo.se
13. 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
14. MedDRA Term Selection: points to consider release 3.2. 2003 Nov 10. Available from URL: http://www.meddramsso.com [Accessed 2004 Apr 11]
15. Brown EG. Points to consider about MedDRA. Int J Pharm Med 2000; 14: 200
16. International Conference On Harmonisation. Harmonised tripartite guideline: clinical safety data management, periodic safety update reports for marketed drugs. 1996 Nov
17. Brown EG. Methods and pitfalls in searching drug safety databases utilising the medical dictionary for regulatory activities (MedDRA). Drug Saf 2003; 26 (3): 145-58
18. Edwards R, Lindquist M, Wiholm BE. Quality criteria for early signals of possible adverse drug reactions. Lancet 1990; 336: 156-8
19. Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf 2002; 25 (6): 381-92
20. Bate A, Lindquist M, Edwards IR, et al. A data mining approach for signal detection. Drug Saf 2002; 25 (6): 393-7
21. Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001; 10: 483-6
22. Fescharek R, Dechert G, Reichert D, et al. Overall analysis of spontaneously reported adverse events: a worthwhile exercise or flogging a dead horse? Pharmaceut Med 1996; 10: 71-86
23. Goldman SA. Adverse event reporting and standardizing medical terminologies: strengths and limitations. Drug Inf J 2002; 36: 439-44
24. Brown EG, Douglas S. Tabulation and analysis of pharmacovigilance data using the Medical Dictionary for Regulatory Activities. Pharmacoepidemiol Drug Saf 2000, 89
25. Brown EG, Clark E. Evaluation of MEDDRA in representing medicinal product data sheet information. Pharmaceut Med 1996; 10: 1-8
26. White C. A preliminary assessment of the impact of MEDDRA on adverse event reports and product labelling. Drug Inf J 1998; 32: 347-62
27. Notice to Applicants. Vol. 2. A guideline on summary of products characteristics. European Commission, 1999 Dec