Volume : 10, Issue : 02, February – 2023

Title:

37.ASSESSMENT OF MANAGEMENT OF ADVERSE DRUG REACTIONS REPORTED IN A TERTIARY CARE HOSPITAL IN CALICUT
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Authors :

Adithya V., Archana Anilkumar, Aneena E. C., Anu Afrooza, Siraj Sundaran.

Abstract :

Aim: Adverse drug reactions are a serious problem with increasing incidence as more medicines become available and more people become exposed to them. Detection and management of adverse drug reaction is one of the major areas in the medication process, where the management is not emphasized much. This study was done to determine the difference in the management of adverse drug reactions reported in the study site with the evidence based management.
Method: Retrospective cross- sectional observational study design was followed for a period of five years. Inpatient related suspected ADRs reported by physician-in-charge or other healthcare professionals directly involved with the patient care was included as the observed. Parameters such as causality, type of reaction, severity, management given were assessed. Further the management given in the hospital was compared with standard treatment guideline or available evidence-based treatment for ADRs.
Results: Out of 59 patients 57.6% were male and 42.3% were female. As per Naranjo’s causality assessment 66.1% of reactions were probable, 28.8% were possible, 5.08% were definite. As per Modified Hartwig and Siegel severity assessment majority of the ADRs were moderate (50%) and mild (46.6%). Wills and Brown classification showed Type A (augmented) 64.4%, Type H (hypersensitivity) 30.5%, Type C (chemical) 3.38% and Type D (delivery) 1.7% reactions. Most of the patients with ADR (56.3%) completely recovered after treatment and 33.4% were recovering process. The management followed for stopping the suspected medication was 27.1% of cases and in 10.2% cases the suspected medication was stopped as well as an antidote/antagonist was also prescribed.
Conclusion: The major portions of management were not reported and many cases the outcome of management was not specified. The clinical pharmacy department should give more emphasis on the reporting standards so the that in future the references and interventions will have more clarity.
Keywords: Adverse drug reaction, Causality, Classification, Severity, Management, Evidence based medicine.

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References:

1. World Health Organization: International drug monitoring: the role of the hospital. In Technical report series no. 425. Geneva, Switzerland: World Health Organization; 1966:1-24.
2. Swamy S, Bhanuprakash, Nadig P, Mohan M, Shetty M. Profile of suspected adverse drug reaction in teaching tertiary care hospital. Journal of Pharmacology and Clinical toxicology, 2013 Aug; 1(1):1005.
3. Lazarou J, Pomeranz BH, and Corey PN. Incidence of adverse drug reactions in hospitalized patient: A meta-analysis of prospective studies. Journal of the American Medical Association, 1998; 279(15):120-25.
4. Tandon VR, Mahajan V, Khajuria V, and Gillani Z. Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India. Indian Journal of Pharmacology, 2015 Jan-Feb; 47(1): 65-71.
5. Siraj S, Anjali U, Keerthi H, Basil E, Babu G, Ashik H, Rajesh S, Vishnu P, Mohammed SS. Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients. MDPI- Pharmacy, 2018;6 (108):2-9.
6. Lihite RJ, Lahkar M, Das S, Hazarika D, Kotni M, Maqbool M, Phukan S. A study on adverse drug reactions in a tertiary care hospital of Northeast India. Alexandria Journal of Medicine, 2017; 53(2):151-156. DOI:10.1016/j.ajme.2016.05.007.
7. Lobo MGADA, Pinheiro SMB, Castro JGD, Momente VG, Pranchevicius MCS. Adverse Drug Reaction Monitoring: Support for Pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacology and Toxicology, 2013.DOI:10.1186/2050-6511-14-5
8. Macedo AF, Marques FB, Ribeiro CF, Teixeira FJ. Causality assessment of adverse drug reactions. Comparison of the result obatained from published decisional algorithms and from the evaluation of an expert panel. Pharmacoepidemiology and Drug Safety, 2005 July; 14: 885-890.
9. Dilip C., Lisa MM, Saraswathi R, Divya R. Adverse drug reaction monitoring in a tertiary level referral hospital, Kerala. Indian Journal of Pharmacy Practice, 2012 Apr-Jun; 5(2): 28-32.
10. Palaniswamy S, Kumaran KSGA, Rajasekaran A. A study of assessment, monitoring and reporting of adverse reaction in Indian hospital. Asian Journal of Pharamaceutical and Clinical Research, 2011; 4(3): 112-116.
11. Rehan HS, Chopra D, Kakkar AK. Causality assessment of spontaneously reported adverse drug events. Comparison of WHO- UMC Criteria and Naranjo Probability scale. International Journal of Risk and Safety in Medicine, 2007 Jan; 17(36): 1-5.