Development of a novel regulatory pharmacovigilance prioritisation system: An evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency

Drug Safety

Volumn 36, Issue 10, 2013, Pages 1025-1032

  Seabroke, Suzie ^a   Wise, Lesley ^a   Waller, Patrick ^b  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^b Patrick Waller Limited Consultancy in Pharmacovigilance and Pharmacoepidemiology   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; GOVERNMENT REGULATION; HEALTH CARE ORGANIZATION; PILOT STUDY; PRIORITY JOURNAL; RESOURCE ALLOCATION; SCORING SYSTEM; UNITED KINGDOM;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GOVERNMENT AGENCIES; GOVERNMENT REGULATION; GREAT BRITAIN; PHARMACEUTICAL PREPARATIONS; PHARMACOVIGILANCE; PILOT PROJECTS;

EID: 84885436268     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-013-0081-3     Document Type: Article

References (10)

1. CIOMS. Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII. Council for International Organizations of Medical Sciences; 2010.
2. Ekins-Daukes S, Kauser S, Wise L. Signal detection in the UK: the use of quantitative methods at the MHRA [Abstract]. Drug Saf. 2007;30(10):963.
3. 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.
4. Bate A, Linquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol. 1998;54:315-21.
5. van Puijenbroek EP, Diemont WL, van Grootheest K. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf. 2003;26(5):293-301.
6. Hauben M. Signal detection in the pharmaceutical industry: integrating clinical and computational approaches. Drug Saf. 2007;30(7):627-30.
7. Waller P, Heeley E, Moseley J. Impact analysis of signals detected from spontaneous adverse drug reaction reporting data. Drug Saf. 2005;28(10):843-50.
8. Heeley E, Waller P, Moseley J. Testing and implementing signal impact analysis in a regulatory setting. Drug Saf. 2005;28(10):901-6.
9. DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177-90.
10. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159-74.