SPONTANEOUS ADVERSE DRUG REACTION REPORTING IN A TERTIARY CARE HOSPITAL IN CALICUT

Siraj Sundaran; Abhijith P S; Aleena Alex; Amrutha Krishnan; Angel Tisa Jacob; G Babu; Sudeep Balakrishnan

doi:10.22159/ajpcr.2018.v11i8.26026

Authors

Siraj Sundaran Department of Pharmacy Practice, Devaki Amma Memorial College of Pharmacy, Malappuram, South India.
Abhijith P S Department of Pharmacy Practice, Devaki Amma Memorial College of Pharmacy, Malappuram, South India.
Aleena Alex Department of Pharmacy Practice, Devaki Amma Memorial College of Pharmacy, Malappuram, South India.
Amrutha Krishnan Department of Pharmacy Practice, Devaki Amma Memorial College of Pharmacy, Malappuram, South India.
Angel Tisa Jacob Department of Pharmacy Practice, Devaki Amma Memorial College of Pharmacy, Malappuram, South India.
G Babu Department of Pharmacy Practice, Devaki Amma Memorial College of Pharmacy, Malappuram, South India.
Sudeep Balakrishnan Department of Neurology, PVS Hospital (P) Ltd, Calicut, South India.

DOI:

https://doi.org/10.22159/ajpcr.2018.v11i8.26026

Keywords:

Adverse drug reaction, Spontaneous reporting, Type, Severity, Preventability

Abstract

Objective: The study was conducted to assess the adverse drug reactions (ADRs) reported in a tertiary care hospital in Calicut.

Methods: Spontaneous ADR reporting method was followed for the study. The ADRs reported by the health-care professionals, or the patients were confirmed with the physician-in-charge. Further, the assessments of type, severity, and preventability of reported ADRs were done using Wills and Brown classification, modified Schumock and Thornton severity scale, and modified Hartwig and Siegel preventability scale.

Results: A total of 30 ADRs were reported. A study found that the incidence of ADRs was more in males (1.14%) when compared to females (0.79%). Geriatric patients showed more incidences of ADRs (1.04%) when compared to pediatrics (0.69%) and adults (1.02%). More number of ADRs was associated with antibiotics (23.33%) and anticonvulsants (23.33%) than another category of drugs. Based on type or mechanism involved 80% of ADRs were pharmacologically related (Augmented) ADRs. Severity assessment showed that 50% were mild, 46.67% were moderate, and 3.33% were severe. Assessment of preventability showed that 63.33% of ADRs were not preventable, 30% were preventable, and 6.67% were probably preventable.

Conclusion: The study was useful in finding the age category and drugs that were more prone to ADRs. This will render precautions and monitoring in the future. The importance of ADR monitoring unit and aid of clinical pharmacist in the monitoring and assessment were very well considered during the study.

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Author Biography

Siraj Sundaran, Department of Pharmacy Practice, Devaki Amma Memorial College of Pharmacy, Malappuram, South India.

Professor and Head,

Dept. of Pharmacy Practice

References

World Health Organizations. A Guide to Detecting and Reporting Adverse Drug Reactions. Safety of Medicines. Geneva: World Health Organizations; 2002.

Swamy S, Bhanuprakash NP, Muralimohan SM. Profile of suspected adverse drug reaction in teaching tertiary care hospital. J Pharmacol Clin Toxicol 2013;1:1005.

Rana DA, Bhadiyadara SN, Shah HJ, Malhotra S, Pal VJ. Consistency between causality assessments obtained with various scales and their agreement for adverse drug events reported in paediatric population. J Young Pharm 2015;7:89-95.

Dilip C, Lisa MM, Saraswathi R, Divya R. Adverse drug reaction monitoring in a tertiary level referral hospital, Kerala. Indian J Pharm Pract 2012;5:28-32.

Shamna M, Dilip C, Ajmal M, Mohan L, Shinu C, Jafer CP, et al. Aprospective study on adverse drug reactions of antibiotics in a tertiary care hospital. Saudi Pharm J 2014;22:303-8.

Ramakrishna P, Barman AK, Mahanda PJ, Lahkar M, Ramaiah M. Collection, detection, assessment, monitoring and prevention of adverse drug reactions in the nephrology department of guwahati medical college and hospital, Assam, India. Glob J 2014;14:29-31.

Raut A, Pawar A, Pankaj M, Srivastava P, Mishra A. Clinical pattern and severity of cutaneous adverse drug reaction. Int J Pharm Pharm Sci 2013;5:612-6.

Surjeet S, Wafai ZA. Adverse drug reaction monitoring at tertiary care hospital S.K.I.M.S. Srinagar. JK Pract 2012;17:58-63.

Ponnusankar S, Tejaswini M, Chaitanya M. Assessment of adverse drug reaction based on spontaneous signals at secondary care public hospital. Indian J Pharm Sci 2015;7:490-3.

Mandavi K, Dâ€™ Cruz S, Sachdev A, Tiwari P. Adverse drug reaction and their risk factors among Indian ambulatory elderly patient. Indian J Med Res 2012;136:404-10.

Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in a tertiary care teaching hospital. Pharmacol Res 2006;54:226-33.

Padmaja SY, Palanisamy S. A study on assessment, monitoring and documentation of adverse drug reactions. Int J Pharm Teach Pract 2012;3:253-6.

Adepu R, Srikanth MS. Adverse drug reaction monitoring and reporting by community pharmacists. World J Pharm Res 2014;3:1223-33.

Kumar DA, Subbaiah MV, Purushothaman M. Evaluation of adverse drug reactions in a tertiary care teaching hospital. World J Pharm Pharm Sci 2015;4:1192-202.

Nahar N, Karim A, Paul PC, Khan TH. Response of reporting adverse drug reactions among medical practitioners. Bangladesh Med J 2011;40:13-8.

Srinivasan R, Ramya G. Adverse drug reaction- Causality assessment. Int J Res Pharm Pharm Pract 2011;1:606-12.

Kumar L. Pharmacovigilance/reporting adverse effect reactions: An approach to enhance health surveillance and extending market share by minimizing the chances of drug withdrawal. Int J Pharm Pharm Sci 2015;7:1-7.