361
Views
5
CrossRef citations to date
0
Altmetric
Original Articles

Automated Method for Detecting Increases in Frequency of Spontaneous Adverse Event Reports over Time

, , , , &
Pages 161-177 | Received 01 Oct 2011, Accepted 30 Jul 2012, Published online: 18 Jan 2013

REFERENCES

  • Almenoff , J. S. , Powell , G. , Schaaf , R. , Fram , D. , Fitzpatrick , J. M. , Pendleton , A. , Payvandi , N. , Yuen , N. ( 2007 ). Online signal management: A systems-based approach that delivers new analytical capabilities and operational efficiency to the practice of Pharmacovigilance . Drug Information Journal 41 : 779 – 789 .
  • Bate , A. , Lindquist , M. , Edwards , I. R. , Orre , R. ( 2002 ). A data mining approach for signal detection and analysis . Drug Safety 25 : 393 – 397 .
  • Chambers , J. , Cleveland , W. , Kleiner , B. , Tukey , J. ( 1983 ). Graphical Methods for Data Analysis . Belmont , CA : Wadsworth .
  • Clark , J. A. , Klincewicz , S. L. , Stang , P. E. ( 2001 ). Spontaneous adverse event signaling methods: Classification and use with health care treatment products . Epidemiology Reviews 23 ( 2 ): 191 – 210 .
  • DuMouchel , W. , Pregibon , D. ( 2001 ). Empirical Bayes screening for multi-item associations. In: 7th ACM SigKDD International Conference on Knowledge Discovery & Data Mining. San Francisco: ACM Press .
  • Evans , S. , Waller , P. C. , Davis , S. ( 2001 ). Use of PRR for signal generation from spontaneous ADR reports . Pharmacoepidemiology and Drug Safety 10 : 483 – 486 .
  • Food and Drug Administration. (1992). Guideline for postmarketing reporting of adverse drug experiences. Federal Register 57(248):61437.
  • Food and Drug Administration . ( 2008 ). Information on Adverse Event Reports and Heparin. Available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformation forPatientsandProviders/ucm112669.htm (accessed September 8, 2011) .
  • Hillson , E. M. , Reeves , J. H. , McMillan , C. A. ( 1998 ). A statistical signaling model for use in surveillance of adverse drug reaction data . Journal of Applied Statistics 25 : 23 – 40 .
  • Lao , C. S. , Kessler , L. G. , Gross , T. P. ( 1998 ). Proposed statistical methods for signal detection of adverse medical device events . Drug Information Journal 32 : 183 – 191 .
  • Payvandi , N. ( 2010 ). Overall performance of a signal management system—What does the data tell us. Drug Information Association Euro Meeting. March 8–10, Monaco .
  • Praus , M. , Schindel , F. , Fescharek , R. , Schwarz , S. ( 1993 ). Alert systems for post-marketing surveillance of adverse drug reactions . Statistics in Medicine 12 : 2383 – 2393 .
  • Ryan , P. B. , Powell , G. E. , Pattishall , E. N. ( 2008 ). Observational screening: A novel approach to analyzing observational data to supplement post-approval signal detection. Pharmacoepidemiol and Drug Safety 17:S179 (Abstract 408) .
  • Sonesson , C. , Bock , D. ( 2003 ). A review and discussion of prospective statistical surveillance in public health . Journal of Royal Statistical Society A 166 ( 1 ): 5 – 21 .
  • Stroup , D. F. , Thacker , S. B. ( 1993 ). A Bayesian approach to the detection of aberrations in public health surveillance data . Epidemiology 4 : 435 – 443 .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.