A Descriptive study of Adverse Drug Reactions with Causality Assessment and Potential Drug Interactions in the Outpatients of the Psychiatric Department at SMS Hospital Jaipur.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- 1. To report and evaluate patterns of Adverse Drug Reactions (ADRs) occurring due
Study Overview
Brief Summary
Under-reporting is a problem with ADRs occurring due to psychotropic drugs. The need for this study is for observation and analysis of the ADRs occurring due to psychotropic drugs and then assessing all the reported ADRs for Causality using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale. Also, studying the potential drug-drug interactions (pDDIs) amongst different psychotropic drugs as well as between psychotropic drugs and other co-prescribed drugs by using Medscape software (online) (http://reference.medscape.com/drug-interactionchecker) will aid clinicians to achieve optimal therapeutic outcomes in patients by increasing awareness of clinically relevant psychotropic drug interactions. It will also help to sensitize the healthcare workers as well as the patients and their attendant for reporting of ADRs occurring due to psychotropic medications.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients attending the Psychiatric OPD for follow up, who were diagnosed to be suffering from any psychiatric illness and prescribed at least one psychotropic drug.
- •Patients of either sex.
- •Patients in the age group of 18 years to 60 years.
- •Patients who will give informed consent.
Exclusion Criteria
- •Patients having mental and behavioural disorders due to psychoactive substance use.
- •Patients who are pregnant/ lactating women.
- •Patients who are part of any other study.
- •Patients who will be non-co-operative.
Outcomes
Primary Outcomes
1. To report and evaluate patterns of Adverse Drug Reactions (ADRs) occurring due
Time Frame: 6 Months
to psychotropic drugs.
Time Frame: 6 Months
2. To assess all the reported ADRs for Causality using WHO-UMC scale.
Time Frame: 6 Months
3. To study the potential drug-drug interactions (pDDIs) among different
Time Frame: 6 Months
psychotropic drugs as well as between psychotropic drugs and other co-prescribed
Time Frame: 6 Months
drugs by using Medscape software (online) (http://reference.medscape.com/druginteractionchecker).
Time Frame: 6 Months
Secondary Outcomes
- 1. To process the reported ADRs to Indian Pharmacopoeia Commission (IPC)(Ghaziabad by using VIGIFLOW software.)
Investigators
Dr Kapil Goyal
SMS Medical College