Pharmacoepidemiology and drug safety
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Pharmacoepidemiol Drug Saf · Jan 2012
Statin usage and all-cause and disease-specific mortality in a nationwide study.
The consumption of statins (HMG-CoA reductase inhibitors) in most Western countries has increased to the extent that it may affect all-cause and disease-specific mortality. ⋯ In this nationwide study, long-term use of statins is associated with the reduction in CHD mortality.
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Pharmacoepidemiol Drug Saf · Jan 2012
ReviewA systematic review of validated methods for identifying pulmonary fibrosis and interstitial lung disease using administrative and claims data.
The Food and Drug Administration's Mini-Sentinel pilot program initially aimed to conduct active surveillance to refine safety signals that emerge for marketed medical products. A key facet of this surveillance is to develop and understand the validity of algorithms for identifying health outcomes of interest (HOIs) from administrative and claims data. This paper summarizes the process and findings of the algorithm review of pulmonary fibrosis and interstitial lung disease. ⋯ Research needs to be conducted on designing validation studies to test pulmonary fibrosis and interstitial lung disease algorithms and estimating their predictive power, sensitivity, and specificity.
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Pharmacoepidemiol Drug Saf · Jan 2012
ReviewA systematic review of validated methods for identifying transfusion-related ABO incompatibility reactions using administrative and claims data.
This paper aimed to systematically review algorithms to identify transfusion-related ABO incompatibility reactions in administrative data, with a focus on studies that have examined the validity of the algorithms. ⋯ There is no information to assess the validity of algorithms to identify transfusion-related ABO incompatibility reactions. Further information on the validity of algorithms to identify transfusions would also be useful.
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Pharmacoepidemiol Drug Saf · Jan 2012
ReviewA systematic review of validated methods for identifying transfusion-related sepsis using administrative and claims data.
To systematically review algorithms to identify transfusion-related sepsis or septicemia in administrative data, with a focus on studies that have examined the validity of the algorithms. ⋯ There is no information to assess the validity of algorithms to identify transfusion-related sepsis or septicemia. Codes to identify sepsis performed well in most studies. Algorithms to identify transfusions need further research that includes a broader range of transfusion types.
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Pharmacoepidemiol Drug Saf · Jan 2012
Disproportionality analysis for signal detection of implantable cardioverter-defibrillator-related adverse events in the Food and Drug Administration Medical Device Reporting System.
The Food and Drug Administration (FDA) became aware of lead fracture and inappropriate shock events related to Sprint Fidelis leads in January 2007. The manufacturer announced a voluntary market withdrawal in October 2007. ⋯ If utilized at the time, this disproportionality analysis would have identified signals earlier for lead fractures, oversensing, high impedance, and inappropriate shock.