Objectives:

• To evaluate the knowledge and practice of ADR reporting in India.

• To assess the behavior, attitude and awareness related to PV of biological medicines among HCPs in India.

• To identify the factors and challenges in reporting ADR of biological medicines.

• To suggest methods to expand and increase the ADR reporting of biosimilars.

Methodology:

A cross-sectional observational study was carried out using a pre-designed questionnaire consisting of 24 questions. Both qualitative and quantitative approaches were chosen to investigate among 100 HCPs (doctors, nurses and pharmacists) selected by non-probability convenience sampling method in Kerala, India. The statistical analysis of the quantitative data was performed using SPSS statistics software. Association between dependent and independent variables was found by using Pearson’s Chi-Square Test were p < 0.05 was considered to be statistically significant. The responses to the qualitative questions were interpreted using coding method and thematic analysis using Pareto chart was used to draw out conclusion.
 
Findings:

The study found that the knowledge and attitude of HCPs towards ADR reporting is improving and the practice of reporting ADR is still deficient. A good proportion of the HCPs are aware about the importance of pharmacovigilance of biological medicine and biosimilars. They also know the significance of traceability of these products. However, 73% of the participants stated that they never conducted any additional monitoring for new biological medicines. Around 50% of the participants identified lack of knowledge and busy schedule as the major challenge in reporting ADR of biologicals.73 % of the participants pointed out the need for more training sessions on pharmacovigilance. It is clear from the responses that clinical pharmacists and doctors seems to have better knowledge on pharmacovigilance when compared to nurses and other pharmacists.

Analysis:

The data collected from the questionnaire were analyzed both quantitatively and qualitatively. All the quantitative analysis was performed using SPSS statistics software. The analysis included analyzing the frequency and mean of responses and also Pearson’s Chi-Square test. The open-ended questions are descriptively explained and analyzed using Pareto charts. The questionnaire were subdivided into following topics and analysed accordingly: Knowledge on PV and ADR, Reporting of ADR, PV of biologicals, Traceability of biological products ,Knowledge on PV and ADR monitoring of biologicals , Familiarity with biosimilars, Training programs, Reporting ADR of biologicals.

Conclusions:

The knowledge and attitude towards ADR reporting of biological medicines and biosimilars are gradually improving whereas the practice of reporting ADR is still deficient. A substantial proportion of doctors, nurses, and pharmacists have been found to lack trust in their own awareness of ADR reporting, demonstrating the value of ongoing pharmacovigilance education and training for HCP. The challenges identified in this study on reporting of ADR in general and that of ADR of biologicals are in agreement with the results found by different authors in different parts of the world. The majority of the respondents suggested that more frequent training sessions are required to improve knowledge on PV and ADR reporting. Among the professionals working in the hospital, the doctors and clinical pharmacists seems to have better knowledge about the PV and ADR reporting of biologicals. From the comparison of responses of HCPs, it is clear that the HCPs working in hospital set up has more exposure towards biologicals when compared to community pharmacists.