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Abstract

TO ANALYSE PATTERN, PROFILE AND SERIOUSNESS OF ADRs OF CNS ACTING DRUGS IN A TERTIARY CARE HOSPITAL

*Pooja Chandran, Rahiyanath M. R., K. C. Arul Prakasam, Archana M. Nair and Sneha Thomas

ABSTRACT

Adverse drug reactions contribute to poorer patient outcomes and additional burden to the patients regarding hospitalization and increase in treatment cost. ADRs negatively affects the patient’s quality of life and confidence in taking the prescribed medication, hence it leads to poor treatment outcome. Aim: To analyse the Pattern, Profile and Seriousness of ADRs of CNS acting Drugs in a tertiary care teaching hospital in Erode. Methodology: It is a Retrospective, observational, record-based study conducted at tertiary care hospital in Erode. The Study period includes the ADR reports from 06.01.2014 to 02.12.2019 will be studied. The Sample Size of the study depends on the number of ADRs reports from the patient’s case sheet of the hospital during the above-mentioned period. All the ADR Reports of CNS acting Drugs during the specific period will be included. Complete details of ADR reports were collected from the patient’s case sheet and documented. Inclusion criteria includes any reported ADRs of CNS acting Drugs in Patients case sheet, ADR reported by healthcare professionals – Doctors, Nurses, Clinical Pharmacists and Pharmacist, ADRs reported in CDSCO-IPC suspected ADR reporting form, ADR reports which are duly completed. Report: 105 ADRs reported during the study period which include 42.8% male and 57.14% Female. Middle age population was most commonly affected with ADRs (56.19%). followed by 27.61% were Older Adult, 11.42% were Young Adult. Among the total ADRs reported the majority of the ADRs reported were Hypersensitivity Reaction(40%), followed by Hyponatremia (10.47%), Steven Jhonson Syndrome (6.66%), Nausea and Vomiting (6.66%). According to the WHO-UMC Scale, majority of the serious ADRs were categorized as Probable (70.49%) followed by Possible (29.52%) and no ADRs were reported under Unlikely and Definite. The most common affected body system was skin/soft tissue (54.28%), followed by Blood (17.14%), CNS (15.23%), GIT (10.47%), CVS (1.90%) and Respiratory (0.95%). Conclusion: Adverse Drug Reactions are a rising concern in the day today life of medical profession. The present study found that skin/soft tissue was the most commonly affected organ systems owing to ADRs caused by CNS acting drugs. The most frequently reported ADRs was hypersensitivity reaction which is induced by different class of drugs such as midazolam, pentazocine, sodium valproate, phenytoin, lorazepam, carbamazepine, levetiracetam and tramadol.

Keywords: ADRs, CNS acting, CDSCO-IPC.


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