E-ISSN 2231-3206 | ISSN 2320-4672
 

Original Research 


An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study

Atul J Rajpara, Neeta J Kanani.

Abstract
Background: Adverse drug reactions (ADRs) have been evolved as a serious and major health-care problem affecting the quality of life of patients and increasing burden over the health-care system. Studying the pattern and spectrum of ADRs can help to find measures to address the problem and possibly prevent it effectively.

Aims and Objectives: The study aimed to intensively monitor ADRs in indoor patients of medicine wards and estimate the incidence rate with documentation of the spectrum of ADRs in studied patients in terms of causality, severity, and preventability.

Materials and Methods: This was prospective, observational, and single-center study, conducted at internal medicine wards of Sir Sayajirao General Hospital, Vadodara, over a duration of 8 months, after taking prior permission from the Institutional Ethics Committee. The necessary data were obtained and recorded on a pre-designed “case record form” and “Indian Pharmacopoeia Commission-ADR reporting form” after taking written informed consent and analyzed with Microsoft Excel-2016.

Results: A total 11,400 admissions recorded during the study period in all nine wards of medicine department, of which 66 patients developed 88 ADRs with the incidence of 0.5789%. They were classified into Group A (38, 57.58%), ADR developed after hospitalization and Group B (28, 42.42%), ADR is the reason for hospitalization. The most common category of causality assessment was “probable” according to both WHO-UMC criteria (53, 54.65%) and Naranjo scale (54, 55.68%). According to modified Hartwig-Siegel scale majority, ADRs (43, 48.32%) fall into “moderate” category, and according to modified Thornton and Schumock criteria, the “preventable” ADRs were (29, 30.85%).

Conclusion: The drug safety seems to be well considered in this setup with lower incidence rate found in our study, but there is still a need for improvement to reduce the huge portion of preventable ADRs.

Key words: Drug Safety; Intensive Adverse Drug Reaction Monitoring; Medicine Indoor Patients; Pharmacovigilance


 
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Pubmed Style

Rajpara AJ, Kanani NJ. An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study. Natl J Physiol Pharm Pharmacol. 2019; 9(8): 723-730. doi:10.5455/njppp.2019.9.0516616052019


Web Style

Rajpara AJ, Kanani NJ. An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study. http://www.njppp.com/?mno=46316 [Access: August 23, 2019]. doi:10.5455/njppp.2019.9.0516616052019


AMA (American Medical Association) Style

Rajpara AJ, Kanani NJ. An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study. Natl J Physiol Pharm Pharmacol. 2019; 9(8): 723-730. doi:10.5455/njppp.2019.9.0516616052019



Vancouver/ICMJE Style

Rajpara AJ, Kanani NJ. An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study. Natl J Physiol Pharm Pharmacol. (2019), [cited August 23, 2019]; 9(8): 723-730. doi:10.5455/njppp.2019.9.0516616052019



Harvard Style

Rajpara, A. J. & Kanani, . N. J. (2019) An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study. Natl J Physiol Pharm Pharmacol, 9 (8), 723-730. doi:10.5455/njppp.2019.9.0516616052019



Turabian Style

Rajpara, Atul J, and Neeta J Kanani. 2019. An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study. National Journal of Physiology, Pharmacy and Pharmacology, 9 (8), 723-730. doi:10.5455/njppp.2019.9.0516616052019



Chicago Style

Rajpara, Atul J, and Neeta J Kanani. "An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study." National Journal of Physiology, Pharmacy and Pharmacology 9 (2019), 723-730. doi:10.5455/njppp.2019.9.0516616052019



MLA (The Modern Language Association) Style

Rajpara, Atul J, and Neeta J Kanani. "An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study." National Journal of Physiology, Pharmacy and Pharmacology 9.8 (2019), 723-730. Print. doi:10.5455/njppp.2019.9.0516616052019



APA (American Psychological Association) Style

Rajpara, A. J. & Kanani, . N. J. (2019) An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, multisource observational study. National Journal of Physiology, Pharmacy and Pharmacology, 9 (8), 723-730. doi:10.5455/njppp.2019.9.0516616052019





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