Pharmacovigilance: An active surveillance system to proactively identify risks for adverse events

Population Health Management

Volumn 16, Issue 3, 2013, Pages 147-149

  Moses, Christopher ^a   Celi, Leo A ^a,b   Marshall, John ^b  

^a HARVARD MIT DIVISION OF HEALTH SCIENCES AND TECHNOLOGY   (United States)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AZITHROMYCIN; CHLORAMPHENICOL; CYCLOOXYGENASE 2 INHIBITOR; ROFECOXIB; ROSIGLITAZONE; SEROTONIN UPTAKE INHIBITOR;

BONE MARROW SUPPRESSION; CARDIOVASCULAR RISK; DATA BASE; DATA MINING; DRUG APPROVAL; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG INDUCED DISEASE; DRUG LEGISLATION; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HEART DEATH; HEART FAILURE; HEART INFARCTION; HUMAN; JOINT DEGENERATION; LAW; LONG TERM CARE; MEDICAL DEVICE; MEDICATION ERROR; NOTE; PATIENT SAFETY; PHARMACOEPIDEMIOLOGY; RISK ASSESSMENT; SUICIDE; VOLUNTARY REPORTING;

HUMANS; PHARMACOVIGILANCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84878841331     PISSN: 19427891     EISSN: 19427905     Source Type: Journal    
DOI: 10.1089/pop.2012.0100     Document Type: Note

References (10)

1. US Food and Drug Administration. Analysis and recommendations for agency action regarding nonsteroidal antiinflammatory drugs and cardiovascular risk. J Pain Palliat Care Pharmacother 2005;19:83-97.
2. Singh S, Yoon LK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: A meta analysis. JAMA 2007;298:1189-1195.
3. Moynihan R. FDA advisory panel calls for suicide warnings over new antidepressants. BMJ 2004;328:303.
4. Ray WA, Murray KT, Hall K, Arbogast PG, Stein CM. Azithromycin and the risk of cardiovascular death. N Engl J Med 2012;366:1881-1890.
5. US Food and Drug Administration. Milestones of drug regulation in the United States. http://www.fda.gov/About FDA/WhatWeDo/History/FOrgsHistory/CDER/ Centerfor DrugEvaluationandResearchBrochureandChronology/ucm 114463.htm. Accessed July 11, 2012.
6. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions. Arch Intern Med 2005;165:1363-1369.
7. Institute of Medicine. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: The National Academies Press; 2012.
8. Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: Cumulative meta-analysis. Lancet 2004;364:2021-2029.
9. Saeed M, Villarroel M, Reisner AT, et al. Multiparameter Intelligent Monitoring in Intensive Care II (MIMIC-II): A public-access intensive care unit database. Crit Care Med 2011;39:952-960.
10. Celi LA, Lee J, Scott DJ, Panch T, Mark RG. Collective experience: A database-fuelled, interdisciplinary team-led learning system. J Computing Sci Engin 2012;6:51-59.