A PROSPECTIVE OBSERVATIONAL STUDY OF MONITORING AND REPORTING OF ANTIMICROBIAL DRUGS ASSOCIATED ADVERSE DRUG REACTIONS AND THEIR SIGNIFICANCE ON PATIENTS SAFETY AND HEALTH-CARE OUTCOMES
DOI:
https://doi.org/10.22159/ajpcr.2024v17i10.51948Keywords:
Pharmacovigilance,, Adverse Drug Reaction, Antimicrobial agents, Patient Safety,, Assessment of ADRAbstract
Objective: Adverse drug reaction (ADR) surveillance and reporting practices are at an early stage of development within the Indian context. The pharmacovigilance rate in India falls below 1%, which is notably lower compared to the global average of 5%. India holds the position of being the fourth most significant contributor to the pharmaceutical industry worldwide. Therefore, there exists a pressing demand to enhance the pharmacovigilance framework for safeguarding the health of the Indian population. ADR is defined as the unintended, obnoxious, and unwanted reaction due to the use of a drug. The administration of antimicrobial agents causes various ADR that has been analyzed throughout the study. The main objective of the research is to monitor and report the adverse drug reaction caused by antimicrobial drugs
Methods: A prospective observational study was carried out in the various departments of the hospital with duration of 3 months including 100 patients using patient profile form and ADR reporting forms and analyzing with the scales for causality, severity, and preventability assessment.
Results: During the study, 29 ADRs were found among 100 patients, with an incidence rate of 9.6%, more common in females (52%) than in males (48%). ADRs were most frequently reported in the age group of 35–51 years (34%), then 18–34 years (28%), and 1–17 years (24%). The general medicine department reported the highest number of ADRs (66%), followed by the pediatric department (24%). Cephalosporins caused the most ADRs (35%). Common ADRs included constipation, diarrhea (34%) and rashes, nausea, and vomiting (34%). Naranjo scale indicated that the causality of ADRs was probable (52%). Hartwig severity scale showed 55% ADRS to be mild. Schumock and Thornton method found that 76% of ADRs were preventable.Management of most of ADRs included drug withdrawal (52%).
Conclusion: The majority of cephalosporin-related side effects, which included constipation, diarrhoea, and rashes, were observed. Most of the patients got better with the help of ADR monitoring and management. Finding and treating drug-related problems early make patients feel better and keep them safe. This study shows health-care system why it is important to monitor and report ADR caused by drugs.
Downloads
References
Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: An overview. Online J Public Health Inform. 2015 Jul 1;7(2):e223. doi: 10.5210/ojphi.v7i2.5595, PMID 26392851
Jeetu G, Anusha G. Pharmacovigilance: A worldwide master key for drug safety monitoring. J Young Pharm. 2010 Jul;2(3):315-20. doi: 10.4103/0975-1483.66802, PMID 21042493
World Health Organization. International Drug Monitoring: The Role of National Centers. (Technical Report Series No. 498). Geneva: World Health Organization; 1972.
Shah R, Parajuli SB, Pokharel S. Knowledge of adverse drug reactions reporting among doctors and nurses in a tertiary Care Hospital: A descriptive cross-sectional study. J Nepal Med Assoc. 2021 Jan 31;59(233):22-5. doi: 10.31729/jnma.5386, PMID 34508460
Nankervis H, Thomas KS, Delamere FM, Barbarot S, Rogers NK, Williams HC. Scoping Systematic Review of Treatments for Eczema. Southampton, UK: Nihrational Institute on Handicapped Research Journals Library; 2016.
Purssell E. Antimicrobials. Understanding Pharmacol Nurs Pract 2020;1:147-65.
Britannica T. Editors of Encyclopaedia. Antimicrobial Agent. United States: Encyclopedia Britannica; 2024.
Kumar S, Singh RK, Seth RN, Sinha RI. A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital. Int J Basic Clin Pharmacol. 2022;12(1):58-63. doi: 10.18203/2319-2003. ijbcp20223355
Rani S, Sharma BT, Kumar S, Saini RT, Kumar S, Saini R. Antibiotics-related adverse drug reactions at a tertiary care hospital in North India. Int J Basic Clin Pharmacol. 2019;8(10):2288-93. doi: 10.18203/2319- 2003.ijbcp20194273
Singh A, Jain A, Soni M, Shukla P, Lahon J, Verma AK. Pattern of adverse drug reactions reported at a tertiary care teaching hospital in northern India. Int J Basic Clin Pharmacol. 2020;9(4):625-32. doi: 10.18203/2319-2003.ijbcp20201189
Patel TK, Bhabhor PH, Desai N, Shah S, Patel PB, Vatsala E, et al. Adverse drug reactions in a psychiatric department of tertiary care teaching hospital in India: Analysis of spontaneously reported cases. Asian J Psychiatry. 2015 Oct;17:42-9. doi: 10.1016/j.ajp.2015.07.003, PMID 26216702
Alam MS, Pillai KK, Abdi SA, Kapur P, Pillai PK, Nagarajan K. Adverse drug reaction monitoring during antimicrobial therapy for septicemia patients at a university in New Delhi. Adverse drug reaction monitoring during antimicrobial therapy for septicemia patients at a university hospital in New Delhi. Korean J Intern Med. 2018 Nov;33(6):1203-9. doi: 10.3904/kjim.2016.001, PMID 28874042
Belhekar MN, Tondare SB, Pandit PR, Bhave KA, Patel TC. A prospective study on causality, severity and preventability assessment of adverse drug reactions in a tertiary care hospital in India. Int J Basic Clin Pharmacol. 2018;8(1):104-10. doi: 10.18203/2319-2003. ijbcp20185166
Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, et al. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4, PMID 28178770
Published
How to Cite
Issue
Section
Copyright (c) 2024 zeenath unnissa, Maher unnisa, shaista khan, Naziya Thasleem, Nikhath Fatima
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
