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Adverse Drug Reaction Reporting Systems, India
The aim of the present study was to monitor adverse drug reactions (ADRs) in the Medicine out patient department (OPD) of a University Teaching Hospital.
Method: A prospective evaluation of the ADRs reported in the Department of Medicine of our University Teaching Hospital over a period of 4-months was conducted.
Results: During the study period, a total of 600 patients visited the Medicine OPD and 122 ADRs were reported. Out of 122 reports that were identified, a higher percentage of ADRs in males (52.4%) was observed as compared to females (47.5%). Of the 122 ADRs, 50 were found to be mild (41.0%), 49 moderate (40.2%), and 23 severe (18.2%). A total of 71 (58.0%) ADRs were observed in patients receiving 4 or more medications concurrently. Conversely 46 (37.7%) ADRs were detected in patients using 3 or less medicines. The largest number of reports were associated with antihypertensive therapy (39.3%), followed by antimicrobials (31.1%) and antidiabetics (10.7%). Amongst the organ systems affected, gastrointestinal ADRs constituted a major component (24.7%) followed by skin reactions (22.2%). On causality assessment, nearly 29.5% ADRs were considered as probable, 33.6% possible and 6.6% could not be categorised and were placed under unassessable.
Conclusion: The present work is the maiden pharmacovigilance study conducted at our university teaching hospital. The data presented here will be useful in future, long term and more extensive ADR monitoring in the hospital and in promotion of rational prescribing and drug use in the hospital.
2. Couper MR and Mehta DK, Eds., In: WHO Model Formulary 2002, 1st Edn., Geneva: World Health Organisation; 2002. 9.
3. Lazarous J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospital patients-a meta analysis of prospective study. JAMA 1998;279:1200-5.
4. Wiffen P, Gill M, Edwards J, Moore A. Adverse drug reactions in hospital patients. A systematic review of the prospective and retrospective studies. Bandolier Extra 2000:June:1-16.
5. Ghose K. Hospital bed occupancy due to drug related problems. J R Soc Med 1980;73:853-7.
6. Gosney M, Tallis R. Prescription of contraindicated and interacting drugs in elderly Patients admitted to hospital. Lancet 1984;ii:564-7.
7. Hurwitz N. Admission to hospital due to drugs. BMJ 1969;i:539-40.
8. Hurwitz N. Predisposing factors in the adverse drug reactions to drugs. BMJ 1969;i:536-9.
9. Hurwitz N, Wade OL. Intensive hospital monitoring of adverse drug reactions to drugs. BMJ 1969;i:531-6.
10. Leach S, Roy SS. Adverse drug reactions: an investigation on an acute geriatric ward. Age Aging 1986;15:241-6.
11. Williamson J, Chopin JM. Adverse reactions to prescribed drugs in the elderly: a multicentre investigation. Age Aging 1980;9:73-80.
12. Lindley CM, Tully MP, Paramsothy V, Tallis RC. Inappropriate medication is a major cause of adverse drug reactions in elderly patients. Age Aging 1992;21:294-300.
13. Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJ, Aronson JK, et al. Adverse drug reactions in a hospital general medicine unit meriting notification to the Committee on Safety of Medicines. Br J Cln Pharmacol 1996;42:423-9.
14. Kurokawa T, Correa-Nunes AM, Czarnecki A. Guidelines for setting up and running a Pharmacovigilance Centre. Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Sweden, 2000, p. 4-10.
15. Stephens MBD. The diagnosis of adverse medical events associated with drug treatment. Adverse Drug Reaction Acute Poisoning Rev 1987;1:1-35.
16. Hoddinott BC. Drug reactions and errors in admission on a medical ward. Can Med Assoc J 1967;97:1001-6.
17. Vervloet D, Durham S. ABC of allergies adverse reaction to drugs. BMJ 1998;316:1511-4.
18. Stewart RB, Cluff LE. Studies on the epidemiology of adverse drug reactions: VI. Utilization and interactions of prescription and non prescription drugs in out patients. Johns Hopkins Med J 1971;129:319-31.
19. Gurwitz JH, Field TS, Avorn J, McCormick D, Jain S, Eckler M, Benser M, Edmondson AC, Bates DW. Incidence and preventability of adverse drug events in nursing homes. Am J Med 2000;109:87-94.
20. Peyriere H, Cassan S, Floutard E, Riviere S, Blayac JP, Hillaire-Buys D, Le Quellec A, Hansel S. Adverse Drug Events associated with hospital admission. Ann Pharmacother 2003;37:5-11.