ADVERSE DRUG REACTION MONITORING OF PSYCHOTROPIC DRUGS AND ITS ECONOMICAL IMPACT ON PATIENTS IN A TERTIARY CARE MEDICAL HOSPITAL A PROSPECTIVE STUDY INTRODUCTION Psychiatric diseases are most prevalent modern world problem with high mortality and morbidity Approximately 50 million people are estimated to be suffering from moderate to severe psychotic disorders in India 1 Virtual explosion in psychotropic drugs like antipsychotics antidepressants anti anxiety drugs mood stabilizers in market have been identified as leading cause for cost burden on the patient 2 Due to this proliferation of new drugs in treatment of mental illness newer rare and unreported adverse drug reactions ADRs are expected Prevalence of ADRs due to psychotropic drugs varies from 3 6 to 91 globally which is the root cause of 10 100 patient days in a hospital 3 Reasons for ADR can be attributed to difference in pharmacokinetic and pharmacodynamic parameters drug interactions and various drug metabolites 4 Detection and prevention of ADR at the earliest helps in timely treatment of the disease reducing the cost of treatment improving the compliance and quality of life 5 6 Hence monitoring of ADRs due to psychotropic drugs is very much essential as appropriate therapeutic regimen an be tailored to the patients Estimating the direct cost involved in treating these ADRs is need of the hour as there is scarcity of data on these issues for future improvement in prescription practices of healthcare providers OBJECTIVES

The present study will be conducted with the following primary objectives 1 To study the rate of prevalence of ADRs with psychotropic drugs 2 To assess the causality using WHO UMC scale severity with modified Hartwig Seigel scale and preventability with modified Schumock Thornton preventability criteria of reported ADRs 7 8 9 3 To estimate the direct cost associated with treating the reported ADRs METHODOLOGY Study will be initiated after obtaining permission from Institutional Ethics Committee This is a prospective observational study Study will be conducted in collaboration with psychiatry department of our institution for a stipulated period of 2 months All patients initial or follow up of either sex and of any age visiting out patients or admitted to psychiatry ward in patient as per the International Classification of Diseases 10 psychiatric diagnosis receiving atleast one psychotropic agent will be included in the study Inclusion Criteria 1 Patients of either sex of any age who visits or admitted in psychiatry department as per International classification of Disease 10 psychiatric diagnosis and on at least one psychotropic drugs 2 Causality relationship of ADR with certain probable or possible only will be included Exclusion criteria 1 Adverse events due to overdose substance abuse suicidal or accidental intake of drugs and another system of medicines Ayurveda Homeopathy Unani 2 Patients treated in other department or in consultation liaison with psychiatry department 

3 Those not willing to give consent for study All patients on their initial visit to psychiatry department will be given a pamphlet with information regarding disease process possibility of adverse drug reactions patient responsibility to inform ADRs to doctor contact numbers of the staff in charge will be provided in the pamphlet which will be bilingual English and regional language will be distributed to the patients This pamphlet will be validated by pharmacologist and psychiatrist and approved by hospital authorities Content of the pamphlet will also be explained to the newly enrolled patients Those patients admitted to the psychiatry ward will be monitored during their stay in the hospital Outpatients will be reviewed on their hospital visit Every patients will be intensively monitored by telephonic interview to detect symptom related to adverse event Any reaction noted will be document in the data collection form and ADRs with causality relationship of probable possible and certain with drug intake will be considered for cost analysis Severity of ADR using Hartwig Siegel scale and Preventability using Schumock Thornton criteria will be assessed All the suspected reactions will be filled in the Suspected Adverse Drug Reaction reporting form recommended by Indian Pharmacopoeia Commission and data will be entered into vigiflow ADR management strategies like medications costs hospital bed charges laboratory investigation charges doctor consultation fees and other charges will be noter and assessed Direct cost will be calculated and analyzed STASTICAL ANALYSIS Data collected will be entered in MS excel sheet and analyzed using SPSS 24 version The data will be interpreted in frequencies and percentages Chi square test and regression analysis will be applied wherever necessary IMPLICATIONS Understanding the pattern of ADRs due to psychotropic drugs would help in identifying drug safety signals at earliest decreasing the incidence and severity of ADRs and improve the patient compliance Thorough knowledge regarding direct cost involved in treating ADRs would help in selection of drug outweighing benefit over risk associated with initial therapy rather than increasing the cost burden in treating those ADRs as these costs are borne only by patient and his caregivers in India

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