Adverse drug reaction pattern in hospitalized children of a South Indian teaching hospital

Ghosh, Siddhartha and Acharya, Leelavathi D and Rao, Padma Guru Madhva and Nair, Nidin Mohan and Palaian, Subish (2007) Adverse drug reaction pattern in hospitalized children of a South Indian teaching hospital. Pharmacologyonline. pp. 49-56.

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Infancy and childhood is a period of rapid growth and development. Although important advances have been made in pediatric clinical pharmacology, there is still a dearth of information on many aspects of Adverse Drug Reactions (ADRs) in children. The aim of the present study was to implement an ADR reporting and monitoring system in the department of pediatrics, to categorize and analyze the most common drugs and various predisposing factors attributed to the occurrence of ADRs, and to assess the causality of the same. A six months period between November 2002 and April 2003. All children aged 0- 16 years and under drug treatment, hospitalized during the study period were included in the study. A clinical pharmacist was posted in the pediatric department. Different promotional activities were carried to increase the awareness of ADR reporting among the physicians. All the ADRs were reported and documented with the help of clinicians. Documented ADRs were accessed and analyzed for different parameters like incidence, age-related variation, attributed drug class, individual drug, type of reaction, probability, severity and the outcome of the ADRs. All together 1161 patients were admitted during the study period. The number of ADRs reported was 17. The frequency of ADRs in these patients was 1.46%. The system most commonly affected was gastrointestinal (59%), hematological (12%), and the endocrine systems (12%). Prednisolone, aspirin, co-trimoxazole, erythromycin, L-asparaginase and vincristrine were the most common drugs associated with ADRs. Distributin of the ADRs according to the gender showed a female preponderance (1.4:1). According to causality, 65% of the ADRs were regarded as probable, 29% as possible and 6% as definite as per the WHO causality assessment scale. Most of the ADRs were moderate (46%), 42% were mild and 12% were severe as per the Hartwig etal scale. In most of the cases suspected drug was withdrawn. Most of the patients were recovered from the ADRs whereas 18% of the patients had their ADR continuing at the time of the study. ADRs were not common in pediatric patients, and most of them were usually mild in severity. Gastrointestinal system was the most frequently associated system and the commonly involved drugs were antibiotics and analgesics.

Item Type: Article
Uncontrolled Keywords: Adverse drug reactions, Causality assessment, Pediatrics, Severity assessment
Subjects: Pharmacy > MCOPS Manipal > Pharmacology
Pharmacy > MCOPS Manipal > Pharmacy Practice
Depositing User: KMC Manipal
Date Deposited: 11 Jul 2011 10:00
Last Modified: 08 Oct 2013 04:11

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