Practical considerations in developing an automated signaling program within a pharmacovigilance department

Drug Information Journal

Volumn 38, Issue 3, 2004, Pages 293-300

  Yee, Chuen L ^a   Klincewicz, Steve L ^a   Knight, John F ^a   Thomas, Adrian P ^a   Wilson, Rick ^a  

^a LLC   (United States)

Author keywords

Drug safety; Pharmacovigilance; Postmarketing surveillance; Signal detection; Signaling program

Indexed keywords

ALGORITHM; AUTOMATION; COMPUTER ANALYSIS; DATA BASE; DRUG MONITORING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; REVIEW; STATISTICAL ANALYSIS; UNITED STATES; WORLD HEALTH ORGANIZATION;

EID: 4344692582     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150403800309     Document Type: Review

References (24)

1. 21 CFR, § 310.305; 312.32, and 314.80.
2. International Conference on Harmonisation. Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs. Availability Notice, Federal Register. (Docket No. 96D-0041) Federal Register. Vol. 62, 27470-27476.
3. Committee for Proprietary Medicinal Products. CPMP Position Paper on Compliance with Pharmacovigilance Obligations. London, United Kingdom: Committee for Proprietary Medicinal Products; September 2001, CPMP/PhVWP /1618/01.
4. European Agency for the Evaluation of Medicinal Products. EU Pharmacovigilance Rules for Human and Veterinary Medicinal Products. Vol 9: Pharmacovigilance Version. London, United Kingdom: European Agency for the Evaluation of Medicinal Products; December 2001.
5. Committee for Proprietary Medicinal Products. Conduct of Pharmacovigilance for Centrally Authorized Products. London, United Kingdom: Committee for Proprietary Medicinal Products; April 15, 1997, CPMP/183/97.
6. Committee for Proprietary Medicinal Products. Note for Guidance on Procedure for Competent Authorities on the Undertaking of Pharmacovigilance Activities. London, United Kingdom: Committee for Proprietary Medicinal Products; February 25, 1998, CPMP/PhVWP/175/95 Rev 1.
7. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRS) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Safety. 2001;10:483-486.
8. 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 Safety. 2002;25(6):381-392.
9. Bate A, Lindquist M, Edwards IR, Orre R. A data mining approach for signal detection and analysis. Drug Safety. 2002;25(6):393-397.
10. Purcell P, Barty S. Statistical techniques for signal generation: The Australian experience. Drug Safety. 2002;25(6):415-421.
11. Heeley E, Wilton LV, Shakir SAW. Automated signal generation in prescription-event monitoring. Drug Safety. 2002;25(6):423-432.
12. Coulter DM. Signal generation in the New Zealand Intensive Medicines Monitoring Programme: A combined clinical and statistical approach. Drug Safety. 2002;25(6):433-439.
13. Clark JC, Klincewicz SL, Stang PG. Spontaneous Adverse event signaling methods: classification and use with health care treatment products. Epidemiologic Rev. 2001;23(2):191-207.
14. van Puijenbroek EP, Grootheest KV, Diemont WL, Leufkens HGM, Egberts ACG. Determinants of signal selection in a spontaneous reporting system for adverse drug reactions. Br J Clin Pharmacol. 2001;52:579-586.
15. Meyboom RHB, Lindquist M, Egberts ACG, Edwards IR. Signal selection and follow-up in pharmacovigilance. Drug Safety 2002;25(6): 459-465.
16. Hauben M, Zhou X. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Safety. 2003;26(3):159-186.
17. Hauben M. A brief primer on automated signal detection. Ann Pharmacother. 2003 July/August 37:1117-1123.
18. Gould AL. Practical pharmacovigilance analysis strategies. Pharmacoepidemiol Drug Safety. 2003;12(7):559-574.
19. van Puijenbroek EP; Bate A, Leufkens HGM, et al. A comparison of the measures of disproportionality for signal detection in spontaneous reporting systems. Pharmacoepidemiol Drug Safety. 2002;11:3-10.
20. Moore N, Hall G, Sturkenboom M, Mann R, Lagnaoui R, Begaud B. Biases affecting the proportional reporting ratio (PRR) in spontaneous reports pharmacovigilance databases: the example of Sertindole. Pharmacoepidemiol Drug Safety. 2003;12:271-281.
21. Almenoff JS, DuMouchel W, Kindman A, Yang X, Fram D. Disproportionality analysis using empirical Bayes data mining: A tool for the evaluation of drug interactions in the post-marketing setting. Pharmacoepidemiol Drug Safety. 2003;12:517-521.
22. Lindquist M, Stahl M, Bate A, Edwards IR, Meyboom RHB. A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Safety. 2000;23(6):533-542.
23. Fucik H, Edwards R. Impact and credibility of the WHO adverse reaction signals. Drug Inf J. 1996 30:461-463.
24. Egberts ACG, Meyboom RHG, van Puijenbroek EP. Use of measures of disproportionality in pharmacovigilance: Three Dutch examples. Drug Safety. 2002:25(6):453-458.