The periodic safety update report as a pharmacovigilance tool

Drug Safety

Volumn 27, Issue 8, 2004, Pages 569-578

  Klepper, Michael J ^a  

^a Integrated Safety Systems Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; PARACETAMOL;

ACUTE KIDNEY FAILURE; ACUTE RESPIRATORY FAILURE; AGRANULOCYTOSIS; ANAPHYLAXIS; APLASTIC ANEMIA; BRADYCARDIA; CLINICAL TRIAL; CONGENITAL MALFORMATION; DIZZINESS; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HEART VENTRICLE FIBRILLATION; HUMAN; HYPOTENSION; LIVER FAILURE; LIVER NECROSIS; LUNG FIBROSIS; MALIGNANT HYPERTENSION; NAUSEA; ORTHOSTATIC HYPOTENSION; PRIORITY JOURNAL; PUBLIC HEALTH; PULMONARY HYPERTENSION; RASH; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SCLEROSIS; SEIZURE; STANDARDIZATION; SYNCOPE; TORSADE DES POINTES; TOXIC EPIDERMAL NECROLYSIS; UNCONSCIOUSNESS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DOCUMENTATION; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 3042513494     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200427080-00008     Document Type: Review

References (23)

1. Council for International Organizations of Medical Sciences (CIOMS). International Working Group I. International reporting of periodic drug-safety update summaries. CIOMS, Geneva, Switzerland 1990
2. Clinical safety data management: periodic safety update reports for marketed drugs E2C. ICH Expert Working Group, November 1996. Available from URL: http://www.ich.org/MediaServer.jser?.@_ID=477&@_MODE=GLB [Accessed 2004 Jan 20]
3. Council for International Organizations of Medical Sciences (CIOMS). International Working Group V. Current challenges in pharmacovigilance: pragmatic approaches. CIOMS, Geneva, Switzerland 2001
4. Addendum to ICH E2C Clinical safety data management periodic safety update reports for marketed drugs. ICH Expert Working Group, February 2003. Available from URL: http://www.ich.org/MediaServer.jser?.@_ID=478&@_MODE=GLB [Accessed 2004 Jan 20]
5. Department of Health and Humans Services, the US Food and Drug Administration. Proposed safety regulations March 2004 [online]. Available from URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5204.pdf [Accessed 2004 Jan 20]
6. Directive 2001/20/EC of the European Parliament and the Council, 4 April 2001. Available from URL: http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/1_121/ 1_12120010501en00340044.pdf [Accessed 2004 Jan 20]
7. Concept Paper. Risk assessment of observational data: good pharmacovigilance practices and pharmacoepidemiologic assessment (draft) March 2003. Available from URL: http://www.fda.gov/cder/meeting/groupIIIfinal.pdf [Accessed 2004 Jan 20]
8. ICH Working Group. Post-approval safety data management: definitions and standards for expedited reporting E2D. November 2003. Available from URL: http://www.ich.org/MediaServer.jser?.@_ID=631&@_MODE=GLB [Accessed 2004 Jan 20]
9. Koch-Weser J, Sidel VW, Sweet RH, et al. Factors determining physician reporting of adverse drug reactions: comparison of 2000 spontaneous reports with surveillance studies at the Massachusetts General Hospital. N Engl J Med 1969 Jan; 280 (1): 20-6
10. Strom BL, Tugwell P. Pharmacoepidemiology: current status, prospects, and problems. Ann Intern Med 1990; 113: 179-81
11. Scott HD, Rosenblaum SE, Waters WJ, et al. Rhode Island physicians' recognition and reporting of adverse drug reactions. R I Med J 1987; 70: 311-6
12. Sachs RM, Bortnichak EA. An evaluation of spontaneous adverse drug reaction monitoring systems. Am J Med 1986; 81 Suppl. 5B: 49-55
13. Weber JP. Epidemiology of adverse drug reactions to nonsteroidal anti-inflammatory drugs. In: Rainsford KD, Velo GP, editors. Advances in inflammatory research. Vol. 6. New York: Raven Press, 1984: 1-7
14. Begaud B, Moride Y, Tibert-Bitter P, et al. False-positives in spontaneous reporting: should we worry about them? Br J Clin Pharmacol 1994; 38: 401-4
15. Serradell J, Bjornson DC, Hartzema AG. Drug utilization study methodologies: national and international perspectives. Drug Intell Clin Pharm 1987; 21: 994-01
16. Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher than expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf 2002; 25 (6): 381-92
17. Lindquist M, Stahl M, Bate A, et al. A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in WHO international database. Drug Saf 2002; 23 (6): 533-42
18. Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmcoepidemiol Drug Saf 2001 Oct-Nov; 10 (6): 483-6
19. World Health Organization (WHO) Adverse Reaction Terminology: critical term list. WHO Collaborating Center for International Drug Monitoring, Uppsala, Sweden. Available from URL: http://www.who-umc.org [Accessed 2004 Mar 22]
20. FDA Working Group CDER-PhRMA-AASLD Conference 2000, Clinical White Paper, November 2000 Available from URL: http://www.fda.gov/cder/livertox/clinical.pdf [Accessed 2004 Jan 20]
21. Benichou C, editor. Adverse drug reactions: a practical guide to diagnosis and management. Chichester, England: John Wiley & Sons Ltd, 1994
22. Venulet J, Ciucci A, Berneker GC. Standardized assessment of drug-adverse reaction associations: rationale and experience. Int J Clin Pharmacol Ther 1980; 18 (9): 381-8
23. MedDRA® term selection: points to consider, November 2003. Available from URL: http://www.meddramsso.com/New-Web2003/Docs/ptc_3.2_final.pdf [Accessed 2004 Jan 20]