Adverse drug reaction monitoring in psychiatric outpatient department of a Tertiary Care Hospital.

Background:Pharmacovigilance in psychiatry units can play vital role in detecting adverse drug reactions (ADRs) and alerting physician to such events, thereby protecting the user population from avoidable harm. Objective: To assess the suspected ADRs profile of psychotropic drugs in psychiatry OPD of a tertiary care hospital and its comparison with available literature data as well as to create awareness among the consultant psychiatrists to these ADRs profile. Materials and Methods: A prospective study was conducted in the psychiatry OPD. Thirty five consecutive patients per day were screened irrespective of their psychiatric diagnosis for suspected ADRs on 3 fixed days in a week from January 2011 to December 2011. CDSCO form was used to record the ADRs. Causality was assessed by WHO causality assessment scale while severity was assessed using Hartwig and Siegel scale. Results: Out of 4410 patients were screened, 383 patients were suspected of having at least one ADR. Thus, 8.68 % of our study population reported ADRs. Of 407 events recorded, 369(90.60%) were “probable” and rest “possible” according to WHO-UMC causality assessment scale. According to Hartwig and Siegel scale, 268 ADRs (65.85%) were “moderate” category. Twenty one different kinds of ADRs were noted. Conclusion: This study enables to obtain information on the incidence and frequency of ADRs in the local population that allows opportunity for education to the physicians to improve the patient’s quality of life.

Pattern of adverse events following immunization in an Indian teaching hospital.

Background: Vaccination is an essential component of the public health programs and among most cost effective medical intervention. Vaccines like other pharmaceutical product are not entirely risk free; while most known side effects are mild and non-serious. But some vaccines have been associated with very rare but serious side effect. So, there is a need of a surveillance program to monitor and record such events. Aims & Objective: To detect adverse events following immunizations (AEFI) in children and find vaccine responsible for them. Material and Methods: A one year, prospective, vaccine safety study was undertaken in 2011 covering a pediatric population who were administered vaccines. A two-phase telephone survey of all patients was conducted, comprising of an initial call at 1 week and a follow-up call at 30 days after the vaccine administration date. All AEFI were recorded in Vaccine Adverse Event Reporting System (VAERS) form. Results: Of a total sample of 4320 children, ranging in age from 0 to 14 years, 10110 vaccine doses were given. Each child received 2.34 vaccines on an average. Out of 4320 children, 899 children (20.8%) suffered 1003 AEFI. The most frequent types of adverse reactions to vaccines were fever (34.33 per 1000 doses), excessive crying (30.95 per 1000 doses) and injection site swelling (18.57 per 1000 doses). AEFI rate per 1000 doses was 99.2%. Conclusion: Most of the adverse events reported were mild and non-serious. Establishment of national AEFI database can be a worthy long term goal in Indian context.