Data quality; Electronic health records; Postmarketing surveillance; Triggered adverse event reporting
Indexed keywords
ADVERSE DRUG EVENTS SPONTANEOUS TRIGGERED EVENT REPORTING;
DRUG FATALITY;
DRUG MARKETING;
DRUG SAFETY;
DRUG SURVEILLANCE PROGRAM;
ELECTRONIC MEDICAL RECORD;
FOOD AND DRUG ADMINISTRATION;
HUMAN;
INCIDENT REPORT;
INFORMATION PROCESSING;
LABORATORY TEST;
MEDICAL INFORMATION SYSTEM;
PATIENT INFORMATION;
PILOT STUDY;
POSTMARKETING SURVEILLANCE;
PRIORITY JOURNAL;
QUALITY CONTROL;
REVIEW;
TIME;
UNITED STATES;
ADVERSE DRUG REACTION REPORTING SYSTEMS;
DATABASES, FACTUAL;
PILOT PROJECTS;
QUALITY ASSURANCE, HEALTH CARE;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
FDA guidance for industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), March ; (accessed 16. December 2011)
FDA guidance for industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), March 2005; (accessed 16. December 2011)
(2005)
3
84862265158
MedWatch form can be downloaded at: MedWatch the FDA safety information and adverse event reporting program - reporting serious problems to FDA (accessed 16. December)
MedWatch form can be downloaded at: MedWatch the FDA safety information and adverse event reporting program - reporting serious problems to FDA (accessed 16. December 2011)
(2011)
4
77957332662
Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008
McMahon AW, Pratt RG, Hammad TA, et al. Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008. Pharmacoepidemiol Drug Saf 2010; 19: 921-933.
Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting
DOI: 10.1002/pds.2027
Linder JA, Haas JS, Iyer A, et al. Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Pharmacoepidemiol Drug Saf 2010; 19: 1211-1215. DOI: 10.1002/pds.2027
Commentary on "Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting" by Linder J, DOI: 10.1002/pds.205010.
Dal Pan, GJ. Commentary on "Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting" by Linder J, et al. Pharmacoepidemiol Drug Saf 2010; 19: 1216-1217. DOI: 10.1002/pds.205010.
Adverse Event Reporting System (AERS), (accessed 16. December)
Adverse Event Reporting System (AERS), (accessed 16. December 2011)
(2011)
8
84862254520
FDA guidance for industry on Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), August ; (accessed 16. December 2011)
FDA guidance for industry on Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), August 1997; (accessed 16. December 2011)
(1997)
9
84862248627
Code of Federal Regulations Title 21 Section 314.80 Postmarketing reporting of adverse drug experiences (a) Definitions, accessed 16. December)
Code of Federal Regulations Title 21 Section 314.80 Postmarketing reporting of adverse drug experiences (a) Definitions, (accessed 16. December 2011)
(2011)
10
79851477307
Executive Office of the President: Washington DC, December (accessed 16. December 2011)
Realizing the full potential of health information technology to improve healthcare for Americans: the path forward, Executive Office of the President: Washington DC, December 2010 (accessed 16. December 2011)
