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VOLUME 3 , ISSUE 1 ( January-March, 2020 ) > List of Articles

Original Article

Frequency of ADRs and their Economic Impact in a Tertiary Care Public Sector Hospital in South India

S Ganesan, Selvarajan Sandhiya, DK Subrahmanyam

Citation Information : Ganesan S, Sandhiya S, Subrahmanyam D. Frequency of ADRs and their Economic Impact in a Tertiary Care Public Sector Hospital in South India. 2020; 3 (1):23-31.

DOI: 10.5005/jp-journals-10082-02235

License: CC BY-NC 4.0

Published Online: 01-08-2020

Copyright Statement:  Copyright © 2020; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Background: Adverse drug reactions (ADRs) are significant causes of morbidity and mortality worldwide and also increase the healthcare cost due to hospital admission and extended hospital stay. Many countries spend 15–20% of the hospital budgets to treat drug-related problem. In India, the frequency of ADRs to individual drugs and their economic burdens are rarely evaluated. Aim: The aim of this article was to study the frequency and pattern of occurrence of ADRs and their economic impact in a hospitalized patient. Materials and methods: The prospective, observational study was carried out in four wards of the general medicine department. The WHO\'s definition of an ADR and intensive monitoring method was adopted. The direct cost imposed by ADRs was calculated using the available resources and indirect cost according to the human capital approach. The frequency and pattern of ADRs were evaluated. Results: A total of 3012 patients were intensively monitored and among them 317 patients were identified with ADRs. Among 317 patients, 8.8% of the patients developed ADRs during the hospital stay, 1.7% patients were admitted to hospital due to ADRs, death due to ADRs was 0.32%, and the overall incidence of ADR was 10.5%. The higher frequency of the ADRs was observed with methotrexate (33.33%), followed by dapsone (23.8%) and antitubercular drugs (ATT) (22.58%). The average cost per patient in the management of ADRs was ₹3367. Conclusion: Early detection and prevention of ADRs reduce the morbidity, mortality, and healthcare expenditures. The outcome of this study may be used to predict and prevent ADRs, which results in the effective healthcare budget of the hospital.


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  1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279(15):1200–1205. DOI: 10.1001/jama.279.15.1200.
  2. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BMJ 2004;329(7456):15–19. DOI: 10.1136/bmj.329.7456.15.
  3. Tatonetti NP, Ye PP, Daneshjou R, Altman RB. Data-driven prediction of drug effects and interactions. Sci Transl Med 2012;4(125):125–131. DOI: 10.1126/scitranslmed.3003377.
  4. Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in south Indian hospital-their severity and cost involved. Pharmacoepidemiol Drug Safe 2003;12(8):687–692. DOI: 10.1002/pds.871.
  5. Davis P, Lay-Yee R, Briant R, Ali R, Scott A, Schug S. Adverse events in New Zealand public hospitals I: occurrence and impact. N Z Med J 2009;115(1167):U271.
  6. Lagnaoui R, Moore N, Fach J, Longy-Boursier M, Bégaud B. Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence, direct costs and avoidability. Eur J Clin Pharmacol 2000;56(2):181–186. DOI: 10.1007/s002280050738.
  7. Rajakannan T, Mallayasamy S, Guddattu V, Kamath A, Vilakkthala R, Rao PG, et al. Cost of adverse drug reactions in a south Indian tertiary care hospital. J Clin Pharmacol 2012;52(4):559–565. DOI: 10.1177/0091270011398867.
  8. UNODC, World Drug Report 2012 (United Nations publication, Sales No. E.12.XI.1).
  9. Pattanaik S, Dhamija P, Malhotra S, Sharma N, Pandhi P. Evaluation of cost of treatment of drug-related events in a tertiary care public sector hospital in Northern India: a prospective study. Br J Clin Pharmacol 2009;67(3):363–369. DOI: 10.1111/j.1365-2125.2008.03346.x.
  10. Raut A, Diwan A, Patel C, Patel P, Pawan A. Incidence, severity and financial burden associated with adverse drug reactions in medicine inpatients. Asian J Pharm Clin Res 2011;4:107–111.
  11. Geer MI, Koul PA, Tanki SA, Shah MY. Frequency, types, severity, preventability and costs of adverse drug reactions at a tertiary care hospital. J Pharmacol Toxicol Methods 2016;81:323–334. DOI: 10.1016/j.vascn.2016.04.011.
  12. Adithan C. National pharmacovigilance programme. Indian J Pharmacol 2005;37:347. DOI: 10.4103/0253-7613.19069.
  13. World Health Organization. International drug monitoring: the role of national centers. Report of WHO meeting. World Health Organ Tech Rep Ser 1972;498:1-25.
  14. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30(2):239–245. DOI: 10.1038/clpt.1981.154.
  15. Meyboom RH, Hekster YA, Egberts AC, Gribnau FW, Edwards IR. Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf 1997;17(6):374–389. DOI: 10.2165/00002018-199717060-00004.
  16. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49(9):2229–2232. DOI: 10.1093/ajhp/49.9.2229.
  17. Wills S, Brown D. A proposed new means of classifying adverse drug reactions to medicines. Pharm J 1999;262:163–165.
  18. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Post-approval Safety Data Management—Definitions and standards for Expedited Reporting, E2D. Geneva, Switzerland: International Conference on Harmonisation; 2003.
  19. Hurwitz N, Wade OL. Intensive hospital monitoring of adverse reactions to drugs. Br Med J 1969;1(5643):531–536. DOI: 10.1136/bmj.1.5643.531.
  20. Giardina C, Cutroneo PM, Mocciaro E, Russo GT, Mandraffino G, Basile G, et al. Adverse drug reactions in hospitalized patients: results of the FORWARD (facilitation of reporting in hospital ward) study. Front Pharmacol 2018;9:350. DOI: 10.3389/fphar.2018.00350.
  21. OECD (2017), Health at a Glance 2017: OECD Indicators, OECD Publishing, Paris. [Internet]. Available from: http://dx.doi.org/10.1787/health_glance-2017-en, cited on 2020 Apr 23.
  22. Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol 2007;65(2):210–216. DOI: 10.1111/j.1365-2125.2007.02993.x.
  23. Sriram S, Ghasemi A, Ramasamy R, Devi M, Balasubramanian R, Ravi TK, et al. Prevalence of adverse drug reactions at a private tertiary care hospital in south India. J Res Med Sci 2011;16(1):16–25.
  24. Malhotra S, Jain S, Pandhi P. Drug-related visits to the medical emergency department: A prospective study from India. Int J Clin Pharmacol Ther 2001;39(1):12–18. DOI: 10.5414/CPP39012.
  25. Patidar D, Rajput MS, Nirmal NP, Savitri W. Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India. Interdiscip Toxicol 2013;6(1):41–46. DOI: 10.2478/intox-2013-0008.
  26. Peter JV, Varghese GH, Alexander H, Tom NR, Swethalekshmi V, Truman C, et al. Patterns of adverse drug reaction in the medical wards of a teaching hospital: a prospective observational cohort study. Curr Drug Saf 2016;11(2):164–171. DOI: 10.2174/1574886311666160225150106.
  27. Darji NH, Jadav S, Doshi C, Hedamba R, Mistry R, Trivedi H, et al. An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital. Int J Basic Clin Pharmacol 2016;5(3):742–747. DOI: 10.18203/2319-2003.ijbcp20161512.
  28. Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998;45(3):301–308. DOI: 10.1046/j.1365-2125.1998.00667.x.
  29. Zopf Y, Rabe C, Neubert A, Gabmann KG, Rascher W, Hahn EG, et al. Women encounter ADRs more often than do men. Eur J Clin Pharmacol 2008;64(10):999–1004. DOI: 10.1007/s00228-008-0494-6.
  30. Venu Gopal M, Sujitha K, Santoshini A, Sankeerthana M. Adverse drug reaction monitoring at a tertiary care hospital in South India. Int J Cur Res 2017;9:52622–52629.
  31. Padmaja U, Adhikari P, Pereira P. A prospective analysis of adverse drug reactions in a South Indian hospital. Online J Health Allied Sci 2009;8:12.
  32. Prajapati K, Desai M, Shah S, Panchal J, Kapadia J, Dikshit R. An analysis of serious adverse drug reactions at a tertiary care teaching hospital. Perspect Clin Res 2016;7(4):181–186. DOI: 10.4103/2229-3485.192044.
  33. Lombardi N, Crescioli G, Bettiol A, Marconi E, Vitiello A, Bonaiuti R, et al. Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study. BMC Pharmacol Toxicol 2018;19(1):16. DOI: 10.1186/s40360-018-0207-4.
  34. Prosser TR, Kamysz PL. Multidisciplinary adverse drug reaction surveillance programme. Am J Hosp Pharm 1990;47(6):1334–1339.
  35. Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res 2006;54(3):226–233. DOI: 10.1016/j.phrs.2006.05.003.
  36. Suh DC, Woodall BS, Shin SK, Hermes-De Santis ER. Clinical and economic impact of adverse drug reactions in hospitalized patients. Ann Pharmacother. 2000;34(12):1373–1379. DOI: 10.1345/aph.10094.
  37. Pedros C, Quintana B, Rebolledo M, Porta N, Vallano A, Arnau JM. Prevalence, risk factors and main features of adverse drug reactions leading to hospital admission. Eur J Clin Pharmacol 2014;70(3):361–367. DOI: 10.1007/s00228-013-1630-5.
  38. Gupta R, Sheikh A, Strachan D, Anderson HR. Increasing hospital admissions for systemic allergic disorders in England: analysis of national admissions data. BMJ 2003;327(7424):1142–1143. DOI: 10.1136/bmj.327.7424.1142.
  39. Stausberg J. International prevalence of adverse drug events in hospitals: an analysis of routine data from England, Germany and the USA. BMC Health Serv Res 2014;14:125. DOI: 10.1186/1472-6963-14-125.
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