Journal article
Evaluation of the US Food and Drug Administration sentinel analysis tools in confirming previously observed drug‐outcome associations: The case of clindamycin and Clostridium difficile infection
Pharmacoepidemiology and drug safety, Vol.27(7), pp.731-739
07/2018
DOI: 10.1002/pds.4420
PMID: 29532543
Abstract
Purpose
The Food and Drug Administration's Sentinel System developed parameterized, reusable analytic programs for evaluation of medical product safety. Research on outpatient antibiotic exposures, and Clostridium difficile infection (CDI) with non‐user reference groups led us to expect a higher rate of CDI among outpatient clindamycin users vs penicillin users. We evaluated the ability of the Cohort Identification and Descriptive Analysis and Propensity Score Matching tools to identify a higher rate of CDI among clindamycin users.
Methods
We matched new users of outpatient dispensings of oral clindamycin or penicillin from 13 Data Partners 1:1 on propensity score and followed them for up to 60 days for development of CDI. We used Cox proportional hazards regression stratified by Data Partner and matched pair to compare CDI incidence.
Results
Propensity score models at 3 Data Partners had convergence warnings and a limited range of predicted values. We excluded these Data Partners despite adequate covariate balance after matching. From the 10 Data Partners where these models converged without warnings, we identified 807 919 new clindamycin users and 8 815 441 new penicillin users eligible for the analysis. The stratified analysis of 807 769 matched pairs included 840 events among clindamycin users and 290 among penicillin users (hazard ratio 2.90, 95% confidence interval 2.53, 3.31).
Conclusions
This evaluation produced an expected result and identified several potential enhancements to the Propensity Score Matching tool. This study has important limitations. CDI risk may have been related to factors other than the inherent properties of the drugs, such as duration of use or subsequent exposures.
Details
- Title: Subtitle
- Evaluation of the US Food and Drug Administration sentinel analysis tools in confirming previously observed drug‐outcome associations: The case of clindamycin and Clostridium difficile infection
- Creators
- Ryan M Carnahan - University of IowaJennifer L Kuntz - Kaiser Permanente Center for Health Research—NorthwestShirley V Wang - Brigham and Women's Hospital and Harvard Medical SchoolCandace Fuller - Harvard Medical School and Harvard Pilgrim Health Care InstituteJoshua J Gagne - Brigham and Women's Hospital and Harvard Medical SchoolCharles E Leonard - University of Pennsylvania Perelman School of MedicineSean Hennessy - University of Pennsylvania Perelman School of MedicineTamra Meyer - US Food and Drug AdministrationPatrick Archdeacon - US Food and Drug AdministrationChih‐Ying Chen - US Food and Drug AdministrationCatherine A Panozzo - Harvard Medical School and Harvard Pilgrim Health Care InstituteSengwee Toh - Harvard Medical School and Harvard Pilgrim Health Care InstituteHannah Katcoff - Harvard Medical School and Harvard Pilgrim Health Care InstituteTiffany Woodworth - Harvard Medical School and Harvard Pilgrim Health Care InstituteAarthi Iyer - Harvard Medical School and Harvard Pilgrim Health Care InstituteSophia Axtman - Harvard Medical School and Harvard Pilgrim Health Care InstituteElizabeth A Chrischilles - University of Iowa
- Resource Type
- Journal article
- Publication Details
- Pharmacoepidemiology and drug safety, Vol.27(7), pp.731-739
- DOI
- 10.1002/pds.4420
- PMID
- 29532543
- NLM abbreviation
- Pharmacoepidemiol Drug Saf
- ISSN
- 1053-8569
- eISSN
- 1099-1557
- Number of pages
- 9
- Grant note
- Food and Drug Administration (HHSF223200910006I)
- Language
- English
- Date published
- 07/2018
- Academic Unit
- Pharmacy; Epidemiology; Injury Prevention Research Center
- Record Identifier
- 9983996069302771
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