Adverse drug reaction monitoring in psychiatry out-patient department of an Indian teaching hospital
2011

Adverse Drug Reactions in Psychiatry Outpatients

Sample size: 2000 publication Evidence: moderate

Author Information

Author(s): Gairik Sengupta, Subhrojyoti Bhowmick, Avijit Hazra, Ananya Datta, Musfikur Rahaman

Primary Institution: Institute of Postgraduate Medical Education & Research (IPGME&R)

Hypothesis

What is the profile of adverse drug reactions (ADRs) associated with psychotropic drugs in an Indian teaching hospital?

Conclusion

The study provides a representative profile of ADRs expected in psychiatry outpatients in an Indian public hospital.

Supporting Evidence

  • 429 patients were suspected of having at least one ADR.
  • 17.25% of the study population reported ADRs with at least 'possible' causality.
  • 327 ADRs (92.90%) were classified as 'probable' according to causality assessment.

Takeaway

This study looked at how many patients had bad reactions to their mental health medications, finding that many did experience issues.

Methodology

A longitudinal observational study was conducted by screening 20 consecutive patients per day for suspected ADRs over 15 months.

Potential Biases

Potential bias due to fixed screening days and exclusion of certain patient groups.

Limitations

The study was limited by screening patients on fixed days, potentially missing transient ADRs, and lacked access to certain diagnostic tests.

Participant Demographics

68.69% males, median age 34.4 years.

Statistical Information

Confidence Interval

95% confidence interval: 15.59-18.91%

Digital Object Identifier (DOI)

10.4103/0253-7613.75664

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