ADVERSE DRUG REACTIONS AMONG PATIENTS IN DEPARTMENT OF MEDICINE IN A TERTIARY CARE TEACHING HOSPITAL, KOLLAM
DOI:
https://doi.org/10.22159/ajpcr.2023.v16i12.48901Keywords:
Adverse drug reaction, Medicine, Pharmacovigilance, ADR reporting, Patient safetyAbstract
Objectives: Pharmacovigilance practices are still in the infancy in India, more so in South India. adverse drug reactions (ADRs) are often underreported and the risks are higher in adults and elderly due to the association of comorbidities, self-medication, combination of indigenous systems of medicines and modern medicine, and so on. The present study was done with the objective to analyze the ADRs among patients in the general medicine department, Government Medical College, Kollam. The primary objective is to determine the prevalence and nature of ADRs and secondary objective to assess the causality, severity, and preventability of the ADRs.
Methods: In this cross-sectional study done in the Department of Medicine, Government Medical College, Kollam, 1000 patients of either sex were analyzed using CDSCO ADR reporting forms and the approved scales for causality, severity, and preventability.
Results: Among 1000 patients studied, the prevalence of ADRs was 7.6%. The most common system involved were dermatological (41%) followed by cardiovascular (18%) and gastrointestinal and neurology (16% each). Majority of the ADRs came under probable (48.7%) with a Naranjo score of 5 (40.8%), of moderate severity (65.8%) and not preventable (71.1%).
Conclusion: ADRs pose a major problem needing hospital stay or prolonging the duration of stay. Developing an ongoing ADR reporting system with continuous motivation and creating awareness among the healthcare professionals for reporting suspected ADRs will help to continue reporting and improving the patient safety. Improved communication of health-care professionals with the pharmacovigilance centers should be promoted for better patient healthcare.
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References
Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: A review of published literature and international experience. Br J Clin Pharmacol 2007;63:148-56. doi: 10.1111/j.1365-2125.2006.02746.x, PMID 17274788
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;16:16-25. PMID 21448378
Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res 2006;54:226-33. doi: 10.1016/j.phrs.2006.05.003, PMID 16781163
Angamo MT, Curtain CM, Chalmers L, Yilma D, Bereznicki L. Predictors of adverse drug reaction-related hospitalisation in Southwest Ethiopia: A prospective cross-sectional study. PLoS One 2017;12:e0186631. doi: 10.1371/journal.pone.0186631, PMID 29036230
Naidu VB, Tharun B. A prospective Study on pattern of adverse drug reactions to antibiotics commonly prescribed in general medicine department of tertiary care teaching hospital. Int J Sci Res 2016;5:2009-12.
Ramanath KV, Prabhu MM, Nandakumar K, Pai KS. Monitoring of adverse reactions in geriatric south Indian patients in a tertiary care teaching hospital: A prospective study. Res J Pharm Biol Chem Sci 2016;7:1381-7.
Shareef J, Vincen M, Shastry CS. A prospective Study on adverse drug reactions in general medicine department in a tertiary care teaching hospital. Am J PharmTech Res 2013;3.
Bushipaka R, Karthik M, Ramani JU, Phanisatyavathi N, Radadiya M. A pharmaceutical care practice-drug related problems in in-patients of a tertiary care teaching hospital. World J Pharm Res 2015;4: 2588-98.
Raut AL, Patel P, Patel C, Pawar A. Preventability, predictability and seriousness of adverse drug reactions amongst medicine inpatients in a teaching hospital: A prospective observational study. Int J Pharm Chem Sci 2012;1.
Lazarou J, Pomeranz BH, Corey PN. The incidence of adverse drug reactions in hospitalized patients-a meta-analysis of prospective studies. JAMA 1998;279:1200-5. doi: 10.1001/jama.279.15.1200, PMID 9555760
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;30:239-45. doi: 10.1038/clpt.1981.154, PMID 7249508
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229-32. doi: 10.1093/ajhp/49.9.2229, PMID 1524068
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992;27:538. PMID 10118597
Feely J, Moriarty S, O’Connor P. Stimulating reporting of adverse drug reactions by using a fee. BMJ 1990;300:22-3. doi: 10.1136/ bmj.300.6716.22, PMID 2105117
Baniasadi S, Fahimi F, Shalviri G. Developing an adverse drug reaction reporting system at a teaching hospital. Basic Clin Pharmacol Toxicol 2008;102:408-11. doi: 10.1111/j.1742-7843.2008.00217.x, PMID 18312492
Palaniswami S, Kumaran KS, Rajasekaran AP. A study on assessment, monitoring, documentation and reporting of adverse drug reactions at a multi-specialty tertiary care teaching hospital in south India. Int J PharmTech Res 2009;1:1509-22.
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Copyright (c) 2023 Dr Beena JS, 2. Dr. Rakesh Praveen Raj MR, Dr Reeja R, Dr Bindulatha Nair R, Dr Reshma L Pavithran
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