Knowledge, attitude and practices regarding pharmacovigilance among Turkish inpatients: A cross-sectional study.

An adverse drug reaction (ADR) is harm that arises from the use of a drug. Adverse drug reactions have a huge impact on the health system since they result in drug-related morbidity and mortality as well as indirect costs such as loss of productivity at work. Reporting of adverse drug reactions to a relevant authority is one of the methods of enhancing medication safety; however, underreporting of adverse drug reactions by health workers is a major challenge in enhancing medicines safety. The aim of this study was to assess the willingness, attitude, and associated factors of healthcare providers towards ADRs reporting at Mizan Tepi University Teaching Hospital (MTUTH). A cross-sectional mixed method was conducted among healthcare providers working in Mizan Tepi University Teaching Hospital from August to September 2021. A total of 190 healthcare providers and five key informants were participated in the study. The quantitative data were collected using self-administered structured questionnaires, and for the qualitative study, data from the key informant interviews were collected using a semistructured questionnaire containing open-ended questions. The collected data were coded, entered, and analyzed using a Statistical Package for Social Sciences (SPSS, version 21). Furthermore, the logistic regression model was fitted to see the association between attitude items and demographic characteristics. Variables with P value <0.05 were considered as statistically significant. Analysis of the qualitative data was done by sorting the data into categories and examining the emerging themes. The majority of individuals in the study (81.6%) were willing to report adverse drug reactions. High percent (57.9%) of the study participants knew how to report ADR to responsible body and 66 (34.7%) of the study participants believe that ADR reporting is the responsibility of all healthcare professionals. 86 (45.3%) of respondents encountered ADR cases during their professional career. It was found that the majority of participants (53.7%) had a positive attitude toward ADR reporting. The professional distribution and work experiences of healthcare professionals had a significant impact on their attitude toward ADR reporting (P < 0.05). A large percentage of study subjects were willing to report adverse drug reactions to the appropriate authorities. The majority of healthcare providers were found to have a good attitude towards ADR reporting. Professional distribution and work experiences were significantly associated with attitude of healthcare providers towards ADR reporting. In order to improve the ADR reporting practices of the healthcare professionals and increase the ADR reporting load at the national level, the national regulatory body should collaborate with health facilities.

Background: Underreporting of adverse drug reactions (ADRs) is common globally, and Nepal is not an exception to this. Health-care professionals (HCPs) play a vital role in reporting ADR during routine practice. Lack of knowledge and awareness about pharmacovigilance and reporting ADRs among HCPs may contribute to underreporting. Objective: The objective of this study was to evaluate the knowledge and perception of HCPs regarding ADR reporting and pharmacovigilance in a tertiary care teaching hospital in, Nepal. Methods: A descriptive cross-sectional study was conducted. A questionnaire was distributed to 215 HCPs (medical doctors, nurses, and pharmacists) between March and September 2018. Knowledge and perception regarding ADR reporting and pharmacovigilance were studied. Data were analyzed using IBM SPSS Statistics for Windows, Version 21.0 (IBM Corp, Armonk, New York). Results: The HCPs included 75 medical doctors, 126 nurses, and 14 pharmacists. Majority of the participants were female (67%), and the majority of participants were not aware of pharmacovigilance. Among the participants, pharmacists were found to have better knowledge regarding pharmacovigilance. However, other HCPs (doctors and nurses) strongly agreed about the necessity of having adequate knowledge about pharmacovigilance. Out of 215, 57.7% agreed that the important benefit of reporting ADR was to identify safe drugs and improve patient safety. The main reasons for not reporting were - ADR reporting was not widely promoted by relevant authorities (47%), followed by not knowing where and how to report ADR (34.9%). However, other HCPs (doctors and nurses) strongly agreed about the necessity of having adequate knowledge about pharmacovigilance. Conclusions: The knowledge of HCPs on ADR reporting and pharmacovigilance was poor. Despite a low knowledge of ADR reporting and pharmacovigilance among HCPs, there was a positive perception that ADR reporting is necessary and ADR monitoring system should be established in the hospital. This study also highlights a need for future intervention studies focusing on educating HCPs about ADR and pharmacovigilance.

Consumers are more inclined than healthcare professionals (HCPs) to submit adverse drug reaction (ADR) reports, usually because of first-hand experience with an ADR. As consumer ADR reporting has led to important findings in other countries, the Turkish Pharmacovigilance Center (TUFAM) started accepting ADR reports directly from consumers. The purpose of this study was to, for the first time in Turkey, review and compare ADR reports from consumers and HCPs. We identified and evaluated all ADR reports that were submitted by TUFAM to VigiBase between 1 January 2014 and 31 December 2016 and fulfilled minimum reporting criteria. Minimum reporting criteria required an identifiable reporter, an identifiable patient, at least one suspected active substance/drug and at least one suspected adverse reaction. We compared ADRs submitted by either consumers or HCPs with respect to the reported sex of patients, the Medical Dictionary for Regulatory Activities preferred terms (PTs) used, designated medical event (DME) terms, the seriousness of the ADRs and the suspect drugs. We analyzed 9150 spontaneous ADR reports that fulfilled the minimum reporting criteria. Of these, 3141 were submitted by consumers and 6009 were submitted by HCPs. Annual reporting rates (RRs) and the number of consumer ADR reports showed an increasing trend over time. The male:female ratio was 0.85 for consumer reports and 0.76 for HCP reports. In total, 12 of the 20 most frequently used PTs were identical for both consumers and HCPs. For ADRs classified as serious, consumers submitted 33.3% and HCPs submitted 52.2%. Consumers used only ten Designated Medical Event (DME) terms while HCPs used 35 DME terms out of a total of 62 DME terms at least once. Consumers most frequently reported ADRs to nervous system drugs, whereas HCPs most frequently reported ADRs to anti-infective drugs for systemic use. Consumers most frequently reported ADRs linked to gastrointestinal disorders, whereas HCPs most frequently reported ADRs linked to skin and subcutaneous tissue disorders. This is the first study to compare spontaneous ADR reports from consumers and HCPs in Turkey. Our analysis indicates the reporting of ADRs by both consumers and HCPs is increasing. We found not only similarities in the two groups regarding suspect drugs and classification terms used, but also prominent differences. Consumers and HCPs had 12 of the 20 most frequently used PTs in common, but the remaining eight PTs used by consumers differed from those used by HCPs. This probably reflects the effect an ADR can have on a consumer’s daily life. HCPs also reported more serious ADRs than did consumers. Consumer reports have a secondary contribution to ADR reporting, which might then be used to improve existing pharmacovigilance systems with the consumer’s perspective in mind.

Introduction: Under-reporting of adverse drug reactions (ADRs) and low-quality reporting are a widespread phenomenon globally. 1 There is a need for more insight on the role of pharmacists and other healthcare professionals in ADR reporting. This study primarily aimed to compare the rates, quality, and characteristics of ADR reports received from different healthcare providers in Rumailah Hospital (RH) in Qatar. Methods: A retrospective descriptive analysis of ADR reports submitted by healthcare providers in RH between 1 January 2012 and 1 October 2014 was conducted. Outcome measures included rate of ADR reporting, quality, causality scores as well as characteristics of the reported ADRs. Results: A total of 92 ADR reports were submitted by different healthcare providers, of which 42% were submitted by pharmacists, 38% by physicians, and 9% by nurses. Most of the ADR reports by physicians (66%), nurses (63%) and pharmacists (41%) were judged to be of high quality (grade 2) based on WHO scheme ( p &gt;0.05%). 2 Sixty percent of the submitted ADR reports were for medications considered ‘possibly’ causing the event according to Naranjo causality score, while 30% were considered probable ( p &lt; 0.05%). Most of the ADR reports were type B (54%) and were unpreventable (64%) according to the Medication Appropriateness Index (MAI). 3 One hundred percent and 91% of nurses and physicians' ADR reports were for unpreventable events, respectively, while 41% of pharmacists' reports were definitely preventable ADRs ( p &lt; 0.05%). Conclusion: ADR reporting in RH was undertaken by different healthcare professionals and was generally of high quality. ADRs reported were often unpreventable. There were differences between characteristics and causality scores of ADR reports between different healthcare professionals.

A large number of adverse drug reaction (ADR) reports are collected yearly through the spontaneous report system (SRS). However, experienced experts from ADR monitoring centers (ADR experts, hereafter) reviewed only a few reports based on current policies. Moreover, the causality assessment of ADR reports was conducted according to the official approach based on the WHO-UMC system, a knowledge- and labor-intensive task that highly relies on an individual’s expertise. Our objective is to devise a method to automatically assess ADR reports and support the efficient exploration of ADRs interactively. Our method could improve the capability to assess and explore a large volume of ADR reports and aid reporters in self-improvement. We proposed a workflow for assisting the assessment of ADR reports by combining an automatic assessment prediction model and a human-centered interactive visualization method. Our automatic causality assessment model (ACA model)—an ordinal logistic regression model—automatically assesses ADR reports under the current causality category. Based on the results of the ACA model, we designed a warning signal to indicate the degree of the anomaly of ADR reports. An interactive visualization technique was used for exploring and examining reports extended by automatic assessment of the ACA model and the warning signal. We applied our method to the SRS report dataset of the year 2019, collected in Guangdong province, China. Our method is evaluated by comparing automatic assessments by the ACA model to ADR reports labeled by ADR experts, i.e., the ground truth results from the multinomial logistic regression and the decision tree. The ACA model achieves an accuracy of 85.99%, a multiclass macro-averaged area under the curve (AUC) of 0.9572, while the multinomial logistics regression and decision tree yield 80.82%, 0.8603, and 85.39%, 0.9440, respectively, on the testing set. The new warning signal is able to assist ADR experts to quickly focus on reports of interest with our interactive visualzation tool. Reports of interest that are selected with high scores of the warning signal are analyzed in details by an ADR expert. The usefulness of the overall method is further evaluated through the interactive analysis of the data by ADR expert. Our ACA model achieves good performance and is superior to the multinomial logistics and the decision tree. The warning signal we designed allows efficient filtering of the full ADR reports down to much fewer reports showing anomalies. The usefulness of our interactive visualization is demonstrated by examples of unusual reports that are quickly identified. Our overall method could potentially improve the capability of analyzing ADR reports and reduce human labor and the chance of missing critical reports.

Adverse drug reactions (ADRs) are a growing important public health problem; however, underreporting of ADRs is very common. The aim of the current study was to explore the effect of an intervention program on the knowledge and attitudes among physicians and nurses regarding ADRs reporting. A multicentre study consisted of three phases: filling out a questionnaire; an intervention program; filling out the same questionnaire again. The intervention program consisted of posters, lectures, and distant electronic learning. The questionnaire contained questions about personal/professional demographic variables, and statements regarding knowledge and attitudes regarding ADR reporting. The data revealed that the intervention program significantly elevated the "Objective knowledge" (P < 0.01) and "Practical knowledge" (P < 0.02) score as compared to the control group, while no significant differences were found regarding "Acquired knowledge" (P = 0.14). Seniority (P = 0.01) and experience in internal medicine (P = 0.05) were demonstrated as significant factors determining the knowledge of the staff. Obligation was the main motive for reporting in 80% of participants. After the intervention, no differences were found in the "Attitude related to the motive for reporting" or "Attitude related to the commitment to report", between the two groups. However, "Attitude related to the need to report" score significantly improved after the intervention (P = 0.04). The intervention program increased knowledge and attitudes regarding ADRs reports. Seniority had the most effect on the influence of the intervention program. The data from this study encourages the necessity to hold ongoing intervention programs in order to improve ADRs reporting rate.

Background: Adverse drug reactions (ADRs) are global problems of major concern. Healthcare professional's knowledge and attitudes to ADR and ADR reporting play vital role to report any cases of ADR. Positive attitudes may favour ADR reporting practices by healthcare professionals. Objective: This study was aimed to investigate the KAP towards ADR reporting among HCPs working at primary outpatient care in Kuala Muda District Health Office, Kedah, Malaysia. Methodology: A cross sectional study was done by survey using a self-administered structured questionnaire. The questionnaire was distributed to all healthcare professionals working at primary outpatient care in Kuala Muda District Health Office, Kedah, Malaysia. Result and Discussion: The overall response rate was 87.4%. The mean knowledge score was 66.9% ± 19.86 for doctors and 76.9% ± 13.87 for pharmacists (p=0.03). 43.8% of the healthcare professionals did not aware of the blue card reporting system in Malaysia. Almost all of the respondents agreed that ADR reporting should be made mandatory and they recognized that it's their professional obligation to report any ADR. However, only 51.9% of doctors and 70.8 % of pharmacist had reported. Half of the respondents professed that ADR forms are too complex to fill and almost all of the respondents (90.4% doctors and 87.5% pharmacists) declared that they are lacking of time to fill in the report. 69.2% of doctors expressed that they have not been trained on ADR reporting which was contradicting with the pharmacists (12.5%) (p<0.001). Almost all respondents (82.7 % doctors and 95.8 pharmacists) concurred that ADR reporting should be taught in details to them. Conclusion: Respondents reflected inadequate knowledge on ADR reporting. The prevalence of unsatisfactory practices and attitudes among these HCPs contributed to failure to report ADR even if the ADR was identified. Educational intervention strategies can be introduced in order to promote ADR reporting.

Objective: 1. To determine a. Statistically, the Knowledge, Attitude and Practice (KAP) related variables responsible for underreporting of ADRs in India, using Logistic Regression Analysis (LRA) Model, b. Extent of under reporting of ADRs at the current KAP levels of Medical Practitioners (MPs). 2. To recommend measures at National level to reduce underreporting of ADRs Methods: The results of survey on KAPs of MPs in India towards underreporting of ADRs were published. In the survey, the information was provided on number of ADRs observed during medical practice and number of ADRs reported to ADR monitoring center by 116 MPs. MPs reported less than 25% of ADRs was assumed to contribute to underreporting. Thus, dependent variable ‘underreporting’ was measured on binary scale as ‘Yes’ or ‘No’. Similarly, six independent variables were also measured on a binary scale as ‘Yes’ or ‘No’. The six 2×2 contingency tables were prepared with ‘underreporting’ as dependent variable and each of the 6 independent variables. However, contingency table assumes the levels of all other independent variables to be the same, which is unrealistic and thus fails to estimate the true odds ratio. Hence, Logistic Regression Analysis was used to analyze the data. Results: 2×2 contingency tables revealed that each independent variable was significantly associated with ‘underreporting’. The odds ratio was statistically significant with all six variables. Stepwise LRA applied to data of 116 MPs, picked up 4 variables as statistically significant (P<0.05). Conclusion: At the current level of KAP of MPs, there is high probability of continuing the problem of underreporting of ADRs. To reduce the rate of underreporting it is recommended to develop appropriate training modules at National level to create awareness among all healthcare professionals and design simple ADR forms and procedures for ADR reporting.

Background: Community Pharmacists are one of healthcare professionals who can play an important role in the reporting of Adverse Drug Reactions (ADRs) due to the advantageous position in terms of direct contact with the patients and specialization in medicine. Nevertheless, literatures indicated that ADRs under-reporting are common among com- munity pharmacists in both developed and developing countries. Objectives: To assess the knowledge and perception of community pharmacists in Malaysia towards the reporting of ADRs and to evaluate the effectiveness of an educational program for improving pharmacist knowledge in ADRs report- ing. Methods: A cross-sectional study employing pre and post intervention design was undertaken with a sample of 42 com- munity pharmacists. Changes in scores before and after the completion of the training program in knowledge and percep- tion were measured. Statistical analysis: The data were analyzed by using SPSS version 17.0 software package (SPSS Inc., Chicago, IL, USA). Both descriptive and inferential statistics were used when ever appropriate. Frequencies and per- centages were used to describe the respondents' demographic information and professional characteristics. Wilcoxon Signed ranks test, Paired sample t test and The McNemar � 2 test were applied to compare the differences in knowledge and perception before and after the educational program whenever appropriate. Results: Forty-two community pharmacists (CPs) were enrolled in this study. A comparison of CPs knowledge before and immediately after the implementation of the education program showed significant differences. The participating CPs' mean+SD total scores in the knowledge of pharmacovigilance and ADRs reporting significantly increased com- pared to the baseline following the intervention 4.6+1.9 to 8.3+1.4 (p<0.001), the possible score in knowledge do- main ranged from zero to10. Only a few (n=3, 7%) participants reported that they do not have any ideas of how to report ADR to the relevant authorities in Malaysia compared to pre-intervention case (n= 22, 50%). Upon comple- tion of the education program, more than forty of the respondents (n=19, 45%) believed that they were confident of their knowledge in detection and performing ADRs reporting, in contrast with pre-intervention frequencies, slightly more than fifty percent of the participants agreed that their knowledge in ADR limit their ability to detect and report of ADRs (n= 32, 55%), (N=42, P = 0.004). Conclusion: The finding of the study indicates the need for designing educational programs for community pharmacists, in order to improve the level of knowledge towards the pharmacovigilance and ADRs reporting process locally.

To evaluate the characteristics and quality of adverse drug reaction (ADR) reports submitted by pharmacists, and thereby assess the possible contribution of pharmacists to the spontaneous reporting system for ADRs in Norway. An open, prospective study was conducted where dispensing pharmacists from 39 pharmacies were encouraged to report ADRs over a 3-month period. The submitted ADR reports were compared to reports by physicians from the same time period. All reports were evaluated for selected characteristics, that is distribution of Anatomical Therapeutic Chemical (ATC) classification codes of suspected drugs, distribution of ADRs according to system-organ classes and the quality of the reports. A total of 118 reports covering 274 ADRs received from the pharmacists were compared to 109 ADR reports with 304 ADRs submitted by physicians. Pharmacists more often reported ADRs related to cardiovascular drugs, alimentary tract and metabolism drugs and respiratory drugs, whereas physicians more frequently reported ADRs related to musculoskeletal drugs and antineoplastic and immunomodulating agents. ADRs reported by pharmacists more frequently described gastrointestinal reactions while physicians reported more ADRs in relation to the cardiovascular and blood system. Whereas 68% of the physicians' reports were classified as serious, only 5% of the pharmacists' reports were serious. More than 50% of the reports submitted by pharmacists concerned ADRs following a generic substitution, in contrast to only 2% of the physicians' reports. The pharmacists' reports were found to be of a lower documentation grade. However, there was no substantial difference in a subjective assessment of the quality of information in the reports submitted by the two categories of health professionals. Pharmacists submit valuable ADR reports which provide information complimentary to physicians' reports. This emphasises that pharmacist ADR reporting might constitute an important addition to the spontaneous reporting system.

Medication safety among children represents an underrecognized public health concern worldwide, yet little evidence was found in China. This study aimed to examine trends in rates of pediatric adverse drug reaction (ADR) reports in Jiangsu Province of China with a catchment population of more than 11 million children. Data for children aged under 15 years were extracted from the spontaneous reporting system of ADR surveillance in Jiangsu Province. Suspected therapeutic agents for ADRs were coded using the Anatomical Therapeutic Chemical classification system. We used the Chinese modification of the International Classification of Diseases, Tenth Revision, to group primary diseases, and the Medical Dictionary for Regulatory Activities to classify the manifestation of ADRs. We used Joinpoint to estimate age-adjusted ADR rates stratified by sex from July 2010 to June 2019, and further by specific features, including patient characteristics, main suspected therapeutic medications, primary diseases, and ADRs. We used the percentage change annualized estimator to evaluate trends over time. A total of 79,903 ADR reports were identified among children aged under 15 years, which accounted for 11.4% of all ADRs reported in Jiangsu Province during the same period. The age-adjusted ADR report rates increased significantly from 66.20 to 96.76 per 100,000 children during the period July 2010-June 2019, with an annual increase of 4.9% (95% confidence interval 1.3-8.5%; p value 0.014). Of all ADR reports, there were 47,774 (59.8%) boys and 32,129 (40.2%) girls. Children aged 0-4 years accounted for more than half of the ADR reports (n=47,680, 59.7%). Skin and subcutaneous tissue disorders were the most frequently reported ADRs (45,773, 57.3%). Respiratory diseases were the most commonly observed medical conditions in relation to pediatric ADRs, accounting for 68.8% (n=54,940) of all ADR reports, and anti-infectives for systemic use consistently represented over time the most common medication group, contributing to 69.8% of all reports. A reduction in ADR report rates was observed for vaccines, with an annual decrease of 19% in children. ADRs remain a public health challenge among the vulnerable pediatric populations. Findings from the present study call for continuing efforts in ADR prevention and medication safety improvement in children.

Background:Under-reporting of adverse drug reactions (ADRs) by the prescribers is a common public health problem. Monitoring of factors that influence ADR reporting will reduce risks associated with drug use; improve patients care, safety and treatment outcome. The aim of this study was to determine the factors associated with the reporting of ADRs by health workers in Nnewi Nigeria.Methods:A cross-sectional study of 372 health workers in different health facilities in Nnewi North Local Government Area of Anambra state, selected using multistage sampling technique was done. Data collection employed pretested, self-administered structured questionnaires. Data were analyzed using Statistical Package for Social Sciences version 17. Tests of statistical significance were carried out using Chi-square tests for proportions. A P < 0.05 was considered significant.Results:Out of the 372 respondents studied, 255 (68.5%) were females, and 117 (31.5%) were males. The modal age range (37.6%) was 31–40 years. Factors related by the respondents to influence ADR reporting include: Unavailability of electronic reporting (83.6%), unavailability of reporting forms (66.4%) and ignorance (58.2%). The difference among medical practitioners who related unavailability of electronic reporting process as obstacle to ADR reporting was not significant (P = 0.18).Conclusions:The study results revealed the factors associated with the reporting of ADRs among health workers in Nnewi Nigeria. It is desirable to initiate electronic reporting process, training programs on ADR reporting and make reporting forms/guidelines available to relevant health workers.

Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries. The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana. A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, 2016 to 20 September, 2016 with 442 patients aged 18years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana. Reasons and opinions on patients' reporting on adverse drug reactions were surveyed using a 5-point Likert scale. The Pearson chi-square test was used to determine associations between background variables and responses on knowledge of adverse drug reaction reporting. Responses from 434 patients (86.7%) were included in the analysis. Among those interviewed, there was a high level of awareness regarding the existence of the National Pharmacovigilance Centre (81.6%). Approximately half of the respondents (49.5%) were aware that patients were able to report adverse drug reactions associated with medicinal products directly to the National Pharmacovigilance Centre. Of the respondents, 46.3% stated that they had an adverse drug reaction to their medicines in the past; of these, 53.2% reported to healthcare professionals and 36.9% failed to report because they stopped their medication. The three main reasons for patients' reporting were desire for extra information (92.4%), desire to share experiences with other people (91.7%) and expectation for the National Pharmacovigilance Centre to inform others about the possible adverse drug reactions (88.0%). Patients' opinions were to contribute to research/knowledge (96.5%) and improvements in drug safety (96.5%). Patients' behaviour towards adverse drug reaction reporting was affected by the likely consequences of reporting, influence of others and the ease of reporting. Patients have a positive attitude and good knowledge on adverse drug reaction reporting to the National Pharmacovigilance Centre and report because they expect extra information and to contribute to drug safety. Patients' positive attitude towards adverse drug reaction reporting could be sustained by hosting periodic public awareness campaigns addressing the importance of adverse drug reaction reporting and by providing timely feedback to patients on regulatory decisions taken as a result of the reports that they submitted.

Under-reporting of ADR may be associated with poor knowledge, attitudes and practices to pharmacovigilance. This study evaluated knowledge, attitudes and practices of healthcare professionals about ADR monitoring and reporting following interventions. This longitudinal study included 36 healthcare professionals participating in ART program in a tertiary hospital. Interventions included group training on pharmacovigilance (PV) and provision of ADR reporting forms amongst others. Assessments were conducted at months 0 and 6 post-interventions using study-specific Likert-type instruments. Mean attitude scores above midpoint of 3.6 on 5-point scale were regarded as positive and below as negative. P<0.05 used to determine statistical significance. Mean age of participants was 36.6 (95%CI, 34.5–38.7) years; 61.1% males; 44.4% doctors, 13.9% pharmacists, 19.4% nurses, 8.3% laboratory scientists, 8.3% record officers and 5.6% welfare officers. None had received training on PV previously. Mean knowledge test score increased from 53.6% (95%CI, 44.6–63.6) at pre-intervention to 77.1% (95%CI, 72.8–81.4) at post-intervention with a mean change of 146.9% (95%CI, 60.5–233.3; p=0.000). Mean rated attitude scores increased from 3.6 (95%CI, 3.4–3.8) at pre-intervention to 4.2 (95%CI, 4.0–4.4) at post-intervention; the difference was statistically significant (p=0.000). 75.8% reported that ADR reporting forms were not readily available at pre-intervention compared to 18.2% at postintervention; 15.2% had reported ADR previously at pre-intervention compared to 69.7% at post-intervention; 12.1% reported providing information regarding ADRs and its management always at pre-intervention compared to 45.5% at post-intervention; these differences were statistically significant (p<0.05). Lack/inadequate knowledge, unavailability of reporting forms and negative attitudes were barriers identified; and addressing them resulted in significant improvement in this setting. Scaling up these interventions to other hospitals can better the situation of under-reporting of ADRs in Nigeria.

Background: The benefits of using social media for Adverse Drug Reaction (ADR) reporting are slowly becoming recognised, not just amongst regulatory authorities but also the pharmaceutical industry stakeholders and Healthcare Professionals (HCPs). If utilized correctly, ADR reporting and monitoring via social media could potentially prove to be an efficient and expeditious means of post-market safety surveillance and overcome limitations of traditional ADR reporting systems such as under-reporting. Objectives: The purpose of the study was to determine the attitude and behaviour of the pharmaceutical industry, HCPs and the general public towards the concept of using social media as a tool for ADR reporting and monitoring. Methods: A cross-sectional study was carried out on 17 pharmaceutical companies, 46 HCPs, and 100 members of the general public. Surveys were distributed, comprising of questions designed to elicit significant responses from the participants, in relation to the concept of using social media for Pharmacovigilance purposes. Results: 83% of the general public participants agreed that patients would be more inclined to report suspected ADRs via social media, if the correct measures were in place. 63% of the HCPs believed that the concept of utilising social media for patient safety purposes would be feasible. 71% of the pharmaceutical companies stated they would consider this concept feasible from a legislative and industry perspective. Ethical and confidentiality issues were of the most common concerns amongst the various populations. Conclusion: The results from the study indicate that a collaborative effort is required between the pharmaceutical industry, HCPs and the public before social media can reach its full beneficial potential as a tool in Pharmacovigilance. The study also shows that there is still a need to promote the importance of ADR reporting to the general public while additional regulatory guidelines may also be required to ensure the engagement of HCPs and pharmaceutical companies in reporting and monitoring ADRs on social media.