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.

 Objectives:

This research aims to identify bottlenecks and loopholes that hinder effective ADR practice in tertiary hospitals in Lagos state Nigeria. The research involved major stakeholder of pharmacovigilance activities which includes; HCPs (Doctors, Nurses, and pharmacists) and patients.

1) To assess the knowledge, attitude, and practice of HCPs towards Pharmacovigilance and ADR in Lagos state tertiary hospitals.

2) Determine HCPs' perception towards direct patient reporting of ADR.

3) To elicit patients' experience regarding ADR reporting and evaluate its impacts on pharmacovigilance structure.

4) To make sustainable recommendations which invariably will contribute to the overall pharmacovigilance system in place in the hospitals.

Methodology:

This research was modelled on a mixed-method approach that was underlined by a deductive approach and positivist philosophy. The primary data was collected using an online survey and phone interview. The survey was targeted at 450 participants, and a total of 405 respondents were obtained in return in which 270 were patients, and 135 were HCPs (doctors, nurses, and pharmacists) recording a response rate of 90%. For the interview, 12 people were scheduled to be interviewed but 6 responses were obtained which includes 2 doctors, 2 nurses, and 2 pharmacists recording a response rate of (50%).

Findings:

From the analysis conducted a significant number of HCPs participants have basic understanding of ADR but have no knowledge of causality assessment and they established that they are not sufficiently trained on how to assess and report ADR. Several bottlenecks such as lack of knowledge/awareness, lack of feedback from NPC, unavailability of ADR reporting forms, insufficient staffs, and excessive workload were established as most challenging issues. However, a highly significant number 92% are willing to update their knowledge on ADR practice and opted to make it a mandatory obligation to help resolve underreporting issues faced by the country. A significant number of Patients participants established they are not familiar with ADR and the importance of reporting, while HCPs acknowledged they are not aware that patients can report ADR directly neither do they think it’s a good idea because they are of the perception that patients can’t generate valid/quality ADR reports.

Analysis:

Although the regulatory agency in Nigeria (NAFDAC) has set in place the ideal models needed for reporting, however, their performance towards awareness and publicity of ADR was rated poorly and this in turn is a huge barrier in promoting drug safety practice and pharmacovigilance system in Nigeria. However, from reviewed literature and findings obtained from the study, it can be deduced that global underreporting issues are significantly associated with lack of knowledge and adequate resources dedicated to identify, assess, monitor, and report potential ADRs effectively. The reporting and assessing medium in Nigeria tertiary hospitals are inadequately efficient and somehow being underutilized by Nigerians including its HCPs and healthcare providers due to lack of dedicated resources to the process, and persistent focus on knowledge acquisition instead of its implementation and feasibility. The resulting effect of this act is the burden of ADR faced by the country and inability to achieve required ADR reported cases despite the high mortality and morbidity rate associated with ADR cases in the country.

Conclusions:

Nigeria is earmarked as a fast developing country and a leading nation in the future, therefore the country has to be established in all aspects especially the healthcare system starting with its HCPs and regulatory agency. Patients should be educated, encouraged, and actively involved on ADR reporting because they have the potential to add value to generated reports by providing more detailed reports which can help detect likely causality and impact on patients’ lives. Creating more awareness, organising frequent training, workshop, and seminars to update the knowledge of HCP, dedicating adequate resources, incorporating ADR module into the curriculum of HCPs during their undergraduate and orientation program when newly employed, establishing an active pharmacovigilance centres in tertiary hospitals to help monitor and guide ADR practice, educating and encouraging patients on ADR reporting and its importance, are sustainable recommendations that will improve ADR practice and contribute invariably to pharmacovigilance system in Nigeria.

 Objectives:

The author explored the knowledge, attitude and experience of ADR spontaneous reporting among medical doctors and pharmacists in line with established guidelines and regulations by the relevant authorities in Nigeria. Although current spontaneous reporting practices are less than optimal, this research dissertation was aimed at articulating effective strategies that could be optimally leveraged to improve the frequency and quality of reporting while driving better positive health outcomes for patients across Nigeria. An outline of the research objectives include:

1. To evaluate the knowledge and awareness of ADR reporting among healthcare professionals in Nigeria

2. To assess challenges among healthcare professionals in the practice of ADR reporting in Nigeria.

3. To make sustainable recommendations to improve ADR reporting among healthcare professionals in Nigeria.

Methodology:

Primary and secondary research methods were utilised by the author through the electronic dissemination of questionnaires, phone interviews and literature reviews. The secondary research was first carried out to explore relevant current literature from reputable research databases and journals on ADR reporting to determine the gaps as it pertains to the established research objectives. Attempts to fill these gaps were subsequently carried out through primary research by distributing questionnaires to 140 medical doctors and pharmacists (74.3% response rate), which constituted the approach for quantitative analysis. Phone interviews were further conducted for qualitative analysis with 10 highly experienced healthcare professionals (over 10 years of experience). The author applied the positivism and interpretivism philosophies to analyse the questionnaire and phone interview findings respectively.

Findings:

Both groups of healthcare professionals were compared to determine their opinions on frequency of observed and reported ADRs, reasons for high underreporting rates, awareness of ADR reporting methods, guidelines and regulations as well as the NAFDAC regulatory body responsible for handling submitted ADR reports. A total of 104 out of 140 responded to the survey, of whom 53 (75.7%) were medical doctors and 51 (72.9%) were pharmacists. 34.0% of medical doctors who responded did not know how to report ADRs compared to just 5.9% of pharmacists who responded. In ascertaining familiar ADR reporting method, 39.0% of respondents selected yellow cards/ADR forms, 11.0% of respondents selected the ADR e-reporting form while 25.0% of respondents were familiar with both methods. 25.0% of respondents were unfamiliar with any of the methods for reporting ADRs in Nigeria. 36.0% of respondents admitted having reported an ADR within the past 12 months. The majority 57.0% of respondents indicated not to have reported an ADR in the past 12 months while 7.0% of respondents were unsure if they did. An overwhelming 90.0% of respondents opted for ADR reporting being made compulsory as a professional obligation towards pharmacovigilance.

Analysis:

Analysis showed that medical doctors and pharmacists have only an average knowledge and awareness of ADR reporting in Nigeria. They can correctly identify ADRs and the criteria for reporting but effective reporting remains a challenge. Pharmacists had better knowledge, awareness and experience over medical doctors regarding ADR reporting in Nigeria. However, despite overall poor attitudes to reporting ADRs, both groups exhibited a willingness to do better if proper continuous education and training is made available. NAFDAC performed poorly in raising awareness, providing training and encouraging better drug safety practices and pharmacovigilance. Very few healthcare professionals are aware of the guidelines or regulations governing the ADR reporting system in Nigeria. The authorities rarely acknowledge or follow up on reported ADRs which results in poor reporting rates. Factors varied among both groups as the challenges faced by medical doctors does not translate to the same challenge faced by pharmacists. However, both groups of HCPs agree that ADR reporting should be made a professional obligation to improve ADR reporting in Nigeria. Despite an overwhelming acceptance of the authors' recommendations, some opposed extra remunerations for every ADR reports made as it might distract from the ideal purpose of ADR reporting and pharmacovigilance- improving drug and patient safety in Nigeria.

Conclusions:

Factors ranging from indifference to ADR reporting, poor knowledge and accessibility of reporting methods, poor awareness of guidelines surrounding the reporting procedures are to great extent the same as observed from other studies in Nigeria and other countries. While few studies on ADR reporting in Nigeria compare multiple groups of healthcare professionals, this study demonstrates that pharmacists are more predisposed to favorable outcomes regarding ADR reporting than their medical doctor counterparts. Improving ADR reporting in Nigeria would greatly reduce the healthcare costs and mortality rates and further reduce the incidence of ADRs observed. As suggested by both groups of healthcare professionals, a review of regulations to make ADR reporting compulsory as a professional obligation towards patient safety bears great potential. The course content of the medical and pharmaceutical students should be reviewed to include modules on ADR reporting and tutorials on pharmacovigilance and drug safety practices prior to graduation. Health institutions should establish ADR departments headed by ADR specialists to improve reporting rates in Nigeria and foster liaison with the National Pharmacovigilance centers.