EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

DETECTING AND ANALYZING ADVERSE DRUG REACTIONS IN HOSPITALIZED PEDIATRICS THROUGH INTENSIVE PHARMACOVIGILANCE PROGRAMME TO IMPROVE DRUG SAFETY

Purushothama Reddy K.*, Dr. Rajesh Asija, Dr. M. Purushothaman and Dr. S. Arshiya Banu

ABSTRACT

Background: Adverse Drug Reactions (ADRs) are the harmful, accidental and unwanted effect of a drug which occurs at the dosages used in humans for prophylaxis, diagnosis or therapy. The pediatric population is one of the most vulnerable groups to ADRs. The WHO Global Individual Case Safety Report (ICSR) database (VigiBase®) reported that the rate of ADRs in 7.7% in children was seen from 0 to 17 years. The aim of this study was to detect and analyze Adverse Drug Reactions (ADRs) in hospitalized pediatric patients through the Intensive Pharmacovigilance programme (IPvP) to improve the drug safety. Methods: A prospective cross-sectional study was performed in the pediatric hospital in Nellore in order to assess the hospitalized children from 1 day to 18 years old. Based on the inclusion criteria patients were enrolled. Results: From a total of 1083 hospitalized patients, 19 ADR’s were recorded. The average age of patients in years was 7.2 (±5.9). The causality assessment in this study showed that most of the ADRs were probable (68.4 %) and 4 certain (8.2 %). The most severe ADR’s found were hemolysis and toxic epidermal necrolysis. Conclusions: IPvP was an effective tool for ADR prevention, detection, and evaluation of the treatment in hospitalized patients. The intensive monitoring approach in pharmacovigilance amplifies ADR detection and this translates into the improvement of drug safety in children.

Keywords: Adverse drug reaction, Intensive pharmacovigilance Programme, Drug safety.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database Academia