Consideration of the desirable features and possible forms of practical indicators of the performance of pharmacovigilance centres

International Journal of Risk and Safety in Medicine

Volumn 22, Issue 2, 2010, Pages 59-66

  Kshirsagar, Nilima A ^a,b   Olsson, Sten ^c   Ferner, Robin E ^d,e  

^a MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES   (India)

^b KEM HOSPITAL   (India)

^c UPPSALA MONITORING CENTRE   (Sweden)

^d CITY HOSPITAL   (United Kingdom)

^e UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERSE OUTCOME; AFRICA; ARTICLE; CLINICAL PRACTICE; DRUG CONTROL; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; FUNDING; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HEALTH CENTER; MEDICAL DECISION MAKING; MODEL; OUTCOME ASSESSMENT; PATIENT SAFETY; PERFORMANCE MEASUREMENT SYSTEM; PRESCRIPTION; PROFESSIONAL PRACTICE; UNITED STATES;

EID: 77954729580     PISSN: 09246479     EISSN: None     Source Type: Journal    
DOI: 10.3233/JRS-2010-0495     Document Type: Article

References (18)

1. C. Anton, A.R. Cox and R.E. Ferner, Targetted follow-up of spontaneous ADR reports to improve follow-up rates, Drug Safety 29(10) (2006), 996.
2. E.D. Belay, J.S. Bresse, R.C. Holman, A.S. Khan, A. Shahriari and E.B. Schonberger, Reyes syndrome in the United States from 1981 through 1997, N Eng I Med 340 (1999), 1377-1382.
3. A.R. Cox, Reporters' attitudes to the Yellow Card Scheme, PhD Thesis, University of Aston, 2008.
4. A.R. Cox, J.F. Marriott, K.M.G. Wood and R.E. Ferner, General practitioners' attitudes towards adverse drug reaction reporting: A qualitative study, Drug Safety 29(10) (2006), 952.
5. I.R. Edwards, S. Olsson, M. Lindquist and B. Hugman, Global drug surveillance, in: Pharmacoepidemiology, 4th ed. B.L. Strom, ed., John Wiley and Sons Ltd., 2005, pp. 161-184.
6. S.J. Evans, P.C. Waller and S. Davis, Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports, Pharmacoepidemiol Drug Safety 10(6) (2001), Oct-Nov, 483-486.
7. R.E. Ferner and J.K. Aronson, National differences in publishing reports of adverse drug reactions, Br J Clin Pharmacol 59 (2005), 108-111.
8. M. Hauben and J.K. Aronson, Defining a "signal of harm" and its subtypes in pharmacovigilance, Drug Safety (2008) in press.
9. K. Hawton, E. Townsend, J. Deeks, L. Appleby, D. Gunnell, O. Bennewith and J. Cooper, Effects of legislation restricting pack size of paracetamol and galicylate on self poisoning in the United Kingdom before and after study, BMJ 322 (2001), 1-7.
10. G. Honigfeld, F. Arenallo, J. Sethi, A. Bianchini and J. Schein, Reducing clozapine related morbidity and mortality 5 years of experience with the clozaril National Registry, J Clin Psychiatry 59 (Suppl. 3) (1998), 3-7.
11. House of Commons Health Committee, The Influence of the Pharmaceutical Industry, 22-23-2005.
12. N.A. Kshirsagar,The pharmacovigilance system in India, Drug Safety, 28 (2005), 2-3.
13. N.A. Kshirsagar and N.J. Gogtay, Call for spontaneous reports of adverse drug events from Indian physicians - need of the hour, The Journal of the Association of Physicians of India 55 (2007), 597-598.
14. M. Lindquist, M. Stahl, A. Bate, I.R. Edwards and R.H. Meyboom, A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international data base, Drug Safety 23 (2000), 533-542.
15. M. Lindquist and I.R. Edwards, Adverse drug reactions reporting in Europe: Some problems of comparison, Int J Risk Safety Med 4 (1993), 35-46.
16. E.J. Topol, Failing the public health - Rofecoxib, Merck, and the FDA, New England Journal of Medicine 351 (2004), 1707-1709.
17. J.C.P. Weber, Mathematical models in adverse drug reaction assessment, in: Iatrogenic Diseases, 3rd ed. P.F. D'Arcy, J.P. Griffin, eds, Oxford University Press, Oxford, 1986, pp. 102-107.
18. World Health Organization, The importance of Pharmacovigilance, Safety monitoring of medicinal products, 2002.