Improving drug safety: Active surveillance systems should be paramount

Pharmaceutical Medicine

Volumn 23, Issue 3, 2009, Pages 127-130

  McClure, David L ^a  

^a KAISER PERMANENTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

VACCINE;

DIAGNOSTIC ACCURACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; FUNDING; GOVERNMENT; HUMAN; HYPOTHESIS; NOTE; OUTCOMES RESEARCH; POPULATION EXPOSURE; PRACTICE GUIDELINE; PRIORITY JOURNAL; SENTINEL EVENT; SPONTANEOUS REPORTING SYSTEM; STANDARDIZATION; STATISTICAL ANALYSIS; UNITED STATES; VALIDATION PROCESS;

EID: 69249101673     PISSN: 11782595     EISSN: 11791993     Source Type: Journal    
DOI: 10.1007/bf03256760     Document Type: Note

References (20)

1. Härmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future prospects. Eur. J Clin Pharmacol 2008; 64: 743-752
2. Strom BL. How the US drug safety system should be changed. JAMA 2006; 295 (17): 2072-2075 (Pubitemid 44794008)
3. Arlett P, Moseley J, Seligman PJ. A view from regulatory agencies. In: Strom BL, editor. Pharmacoepidemiology. 4th ed. Sussex: John Wiley & Sons, 2005
4. Fletcher AP. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med 1991; 84: 341-344
5. Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther 1998; 20 Suppl. C: C40-4
6. Hughes ML, Whittlesea CM, Luscombe DK. Review of national spontaneous reporting schemes: strengths and weaknesses. Adverse Drug React Toxicol Rev 2002; 21 (4): 231-241
7. Stephenson WP, Hauben M. Data mining for signals in spontaneous reporting databases: proceed with caution. Pharmacoepidemiol Drug Saf 2007 Apr; 16 (4): 359-365
8. Weaver J, Willy M, Avigan M. Informatic tools and approaches in postmarketing pharmacovigilance used by FDA. APPS J 2008; 10: 35-41
9. Graham DJ, Staffa JA, Shatin D, et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA 2004; 292: 2585-2590 (Pubitemid 39577514)
10. Budnitz DS, Pollcok DA, Weidenbach KN, et al. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006; 296: 1858-1866
11. Bousquet PJ, Demoly P, Romano A, et al. Pharmacovigilance of drug allergy and hypersensitivity using the ENDA-DAHD database and the GALEN platform: the Galenda project. Allergy 2009 Feb; 64 (2): 194-203
12. DeStefano F, Vaccine Safety Datalink Research Group. The Vaccine Safety Datalink project. Pharmacoepidemiol Drug Saf 2001 Aug-Sep; 10 (5): 403-406
13. Kramarz P, France EK, Destefano F, et al. Population-based study of rotavirus vaccination and intussusception. Pediatr Infect Dis J 2001; 20 (4): 410-416 (Pubitemid 32294750)
14. Hambidge SJ, Glanz JM, France EK, et al. Safety of trivalent inactivated influenza vaccine in children 6 to 23months old. JAMA2006; 296 (16): 1990-1997
15. Lieu TA, Kulldorff M, Davis RL, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care 2007; 45: S89-95
16. Tata LJ, West J, Smith C, et al. General population based study of the impact of tricyclic and selective serotonin reuptake inhibitor antidepressants on the risk of acute myocardial infarction. Heart 2005; 91 (4): 465-471 (Pubitemid 40432771)
17. Platt R, Madre L, Reynolds R, et al. Active drug safety surveillance: a tool to improve public health. Pharmacoepidemiol Drug Saf 2008; 17: 1175-1182
18. Kuehn BM. FDA turns to electronic "Sentinel" to flag prescription drug safety problems. JAMA 2008; 300 (2): 156-157
19. US Food and Drug Administration. The Sentinel Initiative: a national strategy for monitoring medical product safety [online]. Available from URL: http:// www.fda.gov/oc/initiatives/advance/reports/report0508.html [Accessed 2009 Apr 17]
20. Ray WA, Stein CM. Reform of drug regulation: beyond an independent drugsafety board. N Engl J Med 2006 Jan 12; 354 (2): 194-201