Knowledge, attitude and practice among consumers about adverse drug reaction reporting

Background: Background: Adverse Drug Reaction (ADR) reporting by consumers is quite low in India. Assessing knowledge and attitude of consumers regarding ADR reporting and observing practice of ADR reporting among them can help explore probable causes for underreporting of ADRs by consumers.Methods: This was a cross-sectional study conducted in a tertiary care teaching hospital using investigator-administered questionnaire and interviewing indoor patients of Surgery, Medicine, Obstetrics & Gynaecology and Dermatology departments. The questionnaire was prepared to assess knowledge, attitude and practice of consumers about ADR reporting. Data was analysed using mean, standard deviation and percentages.Result: A total of 820 consumers of medicines were included. It was found that 32.2% consumers were not aware that a drug can produce adverse effects. After being explained about adverse drug reactions, 94.6% consumers felt that adverse drug reactions should be reported. However, 98.8% consumers were not aware of Pharmacovigilance Programme of India. After consulting about consumer reporting programme, majority of respondents (96.1%) felt that the direct consumer reporting programme helps reporting of ADRs. Moreover, 93.7% of consumers were willing to use it to report ADRs in future. Consumers preferred the Telephonic method with a Toll free number for ADR reporting followed by informing a health care professional.Conclusion: Poor knowledge and awareness about ADR reporting is the major factor for low to nearly absent ADR reporting by consumers in India.

Pattern of adverse drug reactions into psychiatric patients

Background: To analyse adverse drug reactions (ADRs) reported in patients prescribed psychiatric medications at tertiary care hospital.Methods: ADRs reported in psychiatric patients between January 2011 to June 2017 were analyzed for demographic details, causal drugs, system organ classification, causality assessment (WHO-UMC criteria and Naranjo’s scale), preventability (Modified Schumock and Thorton’s criteria) and severity (Hartwing scale).Results: A total 4368 ADRs were reported during study period, out of which 658 (15.06%) were in psychiatric patients. The mean age of patients was 38±13.34 years and men (57.3%) were most commonly affected than women (42.7%). The most common causal drug groups were antidepressants (29.48%) followed by antipsychotics (23.12%) which include drug fluoxetine (33.9%) and olanzapine (34.3%) respectively. The most common system involved were central nervous system (32.8%) followed by gastrointestinal system (22.8%). Most of ADRs (42.7%) were observed after one month of therapy and showed possible (77%) causal relation with drug therapy. Majority of ADRs (77.4%) were not preventable and mild in nature (83.3%).Conclusions: ADRs are commonly seen in psychiatric patients. Hence, their monitoring and assessment in these patients who require multidrug and long-term therapy may help improve patient management.