Reducing the noise in signal detection of adverse drug reactions by standardizing the background: A pilot study on analyses of proportional reporting ratios-by-therapeutic area

European Journal of Clinical Pharmacology

Volumn 70, Issue 5, 2014, Pages 627-635

  Grundmark, Birgitta ^a,b,c   Holmberg, Lars ^c,d   Garmo, Hans ^c,d   Zethelius, Björn ^a,b  

^a UPPSALA UNIVERSITY   (Sweden)

^b MEDICAL PRODUCTS AGENCY   (Sweden)

^c UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^d KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

ADR; Adverse drug reactions; Disproportionality analysis; Pharmacovigilance; PRR; Signal detection

Indexed keywords

ABIRATERONE; BICALUTAMIDE; METFORMIN; VILDAGLIPTIN; ANTIANDROGEN; ANTIDIABETIC AGENT;

ADVERSE DRUG REACTION; ARTICLE; DATA BASE; DRUG INDICATION; DRUG SURVEILLANCE PROGRAM; HUMAN; MALE; NOISE REDUCTION; NON INSULIN DEPENDENT DIABETES MELLITUS; PILOT STUDY; PREDICTIVE VALUE; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; SENSITIVITY AND SPECIFICITY; SIGNAL DETECTION; SIGNAL NOISE RATIO; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPEAN UNION; FACTUAL DATABASE; LABORATORY DIAGNOSIS; STANDARDS; STATISTICAL MODEL; STATISTICS AND NUMERICAL DATA;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANDROGEN ANTAGONISTS; DATABASES, FACTUAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPEAN UNION; FALSE POSITIVE REACTIONS; HUMANS; HYPOGLYCEMIC AGENTS; MODELS, STATISTICAL; PHARMACOVIGILANCE; PILOT PROJECTS;

EID: 84898882465     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-014-1658-1     Document Type: Article

References (33)

1. Finney DJ (1974) Systemic signalling of adverse reactions to drugs. Methods Inf Med 13(1):1-10
2. Bate A, Lindquist M, Edwards IR, Olsson S, Orre R, Lansner A, De Freitas RM (1998) A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 54(4):315-321
3. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001 Oct-Nov;10(6):483-6.
4. Szarfman A, Machado SG, O'Neill RT (2002) 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 25(6):381-392
5. Du Mouchel W, Smith T, Beasley R et al (2004) Association of asthma therapy and Churg-Strauss syndrome: an analysis of post-marketing surveillance. Clin Ther 26:1092-1104
6. 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 Jan-Feb;11(1):3-10.
7. Hochberg AM, Hauben M, Pearson RK, O'Hara DJ, Reisinger SJ, Goldsmith DI, Gould AL, Madigan D (2009) An evaluation of three signal-detection algorithms using a highly inclusive reference event database. Drug Saf 32(6):509-525
8. Hauben M, Reich L, Chung S (2004) Postmarketing surveillance of potentially fatal reactions to oncology drugs: potential utility of two signal-detection algorithms. Eur J Clin Pharmacol 60(10):747-750
9. Alvarez Y, Hidalgo A, Maignen F, Slattery J (2010) Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling. Drug Saf 33(6):475-487
10. CIOMS. Practical Aspects of Signal Detection in Pharmacovigilance, Report of CIOMS Working Group VIII, CIOMS, (WHO), Geneva 2010.
11. EMA, Eudravigilance, European database of suspected adverse drug reactions, http://eudravigilance.ema.europa.eu/highres.htm;.
12. EudraVigilance Expert Working Group (EVEWG). Guideline of the use of statistical signal detection methods in the EudraVigilance data anlysis system. Doc Ref EMEA/106464/2006 rev 1, London: European Medicines Agency; June 2008.
13. Hauben M, Aronson JK (2009) Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf 32(2):99-110
14. Slattery J, Alvarez Y, Hidalgo A. Choosing Thresholds for Statistical Signal Detection with the Proportional Reporting Ratio. Drug Saf. 2013 Jun
15. EMA, Eudravigilance, European database of suspected adverse drug reactions, open access; http://adrreports.eu
16. MSSO, http://www.meddramsso.com/
17. Gould AL. Practical pharmacovigilance analysis strategies. Pharmacoepidemiol Drug Saf. 2003 Oct-Nov;12(7):559-74.
18. Maignen F, Hauben M, Hung E, Van Holle L, Dogne J. Assessing the extent and impact of the masking effect of dispropoprtionality analyses on two spontaneous reporting systems databases. Pharmacoepidemiol Drug Saf 2013, [Ahead of Print], DOI: 10.1002/pds.3529
19. Ihaka R, Gentleman RR (1996) A language for data analysis and graphics. J Comput Graph Stat 5:299-314
20. R statistics tool, http://www.r-project.org/
21. Egberts TCG (2007) Signal detection: historical background, (Conference paper). Drug Saf 30(7):607-609
22. Gogolak VV. The effect of backgrounds in safety analysis: the impact of comparison cases on what you see. Pharmacoepidemiol Drug Saf. 2003 Apr-May;12(3):249-52.
23. Woo EJ, Ball R, Burwen DR, Braun MM (2008) Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS). Drug Saf 31(8):667-674
24. Zeinoun Z, Seifert H, Verstraeten T (2009) Quantitative signal detection for vaccines: effects of stratification, background and masking on GlaxoSmithKline's spontaneous reports database. Hum Vaccin 5(9):599-607
25. de Bie S, Verhamme KM, Straus SM, Stricker BH, Sturkenboom MC (2012) Vaccine-based subgroup analysis in VigiBase: effect on sensitivity in paediatric signal detection. Drug Saf 35(4):335-346
26. Almenoff JS, Pattishall EN, Gibbs TG, DuMouchel W, Evans SJ, Yuen N. Novel statistical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther. 2007 Aug;82(2):157-66. Review
27. Wang HW, Hochberg AM, Pearson RK, Hauben M (2010) An experimental investigation of masking in the US FDA adverse event reporting system database. Drug Saf 33(12):1117-1133
28. [28]Salvo F, Leborgne F, Thiessard F, Moore N, Begaud B, Pariente A. A Potential Event-Competition Bias in Safety Signal Detection: Results from a Spontaneous Reporting Research Database in France. Drug Saf. 2013.
29. Pariente A, Avillach P, Salvo F, Thiessard F, Miremont-Salame G, Fourrier-Reglat A et al (2012) Effect of competition bias in safety signal generation: analysis of a research database of spontaneous reports in france. Drug Saf 35(10):855-864
30. Pariente A, Didailler M, Avillach P, Miremont-Salame G, Fourrier-Reglat A, Haramburu F, et al. A potential competition bias in the detection of safety signals from spontaneous reporting databases. Pharmacoepidemiol Drug Saf. 2010;19(11):1166-71. Epub 2010/09/18.)
31. Foundation for National Institutes of Health. Observational Medical Outcomes Partnership (online). http://omop.fnih.org/node/22.
32. Smith SW, Hauben M, Aronson JK (2012) Paradoxical and bidirectional drug effects. Drug Saf 35(3):173-189
33. Hauben M, Patadia V, Gerrits C, Walsh L, Reich L (2005) Data mining in pharmacovigilance: the need for a balanced perspective. Drug Saf 28(10):835-842