Awareness Of Adverse Drug Reactions Research Articles

Awareness and Knowledge of Adverse Drug Reactions and Pharmacovigilance Among Medical and Nursing Students and Staff in a Tertiary Care Hospital.

Background Pharmacovigilance is defined as the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems. Underreporting of adverse drug reactions (ADRs) is a global issue, and adequate knowledge among healthcare professionals is essential. Engaging young doctors and nursing professionals in pharmacovigilance is crucial for promoting ADR reporting. Objectives The objective of this study is to evaluate the knowledge and awareness of ADRs and pharmacovigilance among medical and nursing students and staff in a tertiary care hospital in Vijayapura, India. Methods A cross-sectional, observational, questionnaire-based study was carried out using a validated questionnaire that included a total of 19 questions related to knowledge and awareness aspects. This was distributed electronically using Google Forms. By using the convenience sampling method, a sample size of 96 participants was calculated for each group (medical and nursing), and this was rounded to 100 participants per group to account for potential dropouts and to ensure the strength of this study. All the questions were peer-reviewed by expert faculties from the Department of Pharmacology. Results The data analysis showed that medical students and staff had superior knowledge of ADRs and pharmacovigilance. Nursing students and staff exhibited greater awareness of the nearest pharmacovigilance center and ADR monitoring centers in India. Nursing students and staff were more active in ADR and pharmacovigilance awareness programs. Conclusions This study clearly shows the importance of flexible attitudes and robust education in pharmacovigilance and ADR reporting among healthcare professionals. Executing simulation-based training can strengthen the skills and confidence of both medical and nursing professionals in ADR reporting and pharmacovigilance.

The Impact of Social and Broadcast Media on Public Health Initiatives: Study of the COVID-19 Infodemics.

The COVID-19 outbreak, declared a pandemic in March 2020, lacked specific treatments until vaccine development. Medication misinformation via media caused panic, self-prescription, and drug resistance. False propaganda led to shortages. This study analyzes Google Trends for hydroxychloroquine (HCQ), azithromycin, and BCG vaccine searches across six countries. US, Brazil, and India showed interest in HCQ, while Taiwan, Japan, and South Korea focused on BCG vaccine. This article aims to raise awareness of adverse drug reactions, cautioning against self-prescription, political assumptions, and social media during future emergencies.

Exploring pharmacovigilance practices and knowledge among healthcare professionals: A cross-sectional multicenter study.

Healthcare professionals' awareness of adverse drug reaction reporting and pharmacovigilance practices differ by country. The study assesses healthcare professionals' knowledge, practice, and potential barriers to pharmacovigilance-related practices and reporting adverse drug reaction. A cross-sectional investigation was conducted in government and private healthcare settings. The study included licensed physicians, pharmacists, and nurses. To examine knowledge, practice, and potential barriers to pharmacovigilance-related practices and adverse drug reaction reporting, a 22-item validated questionnaire was used. The final analysis included 311 healthcare professionals. Most healthcare professionals, 59% (N = 182), mentioned encountering patients with adverse drug reactions during the last year. On the other hand, most healthcare professionals, 54% (n = 167), mentioned that they had not reported adverse drug reactions. A good proportion of respondents mentioned that it is essential to report adverse drug reactions (N = 288, 92.6%), availability of adverse drug reactions reporting forms in practice sites (N = 216, 69.5%), had awareness regarding how to report adverse drug reactions (N = 221, 71.1%), the necessity of reporting minor/less important adverse drug reactions (N = 265, 85.2%), and were trained on how to report adverse drug reactions (N = 201, 64.6%). Adverse drug reaction reporting program in the United Arab Emirates (N = 148, 47.6) was known to many healthcare professionals. Lack of time was the major impediment to reporting adverse drug reactions at 42.7% (N = 133). The predictor variable work experience does add to the model (p < 0.05) concerning association with filling of adverse drug reaction forms (Estimate = 0.380; SE = 0.452; p = 0.400), professional role (Estimate = 0.454; SE = 0.673; p = 0.500). In addition, the predictor variable practice setting adds to the model (p < 0.05) concerning the knowledge regarding the availability of adverse drug reaction reporting forms (Estimate = -1.229; SE = 0.298; p = 0.000), training on how to report adverse drug reactions (Estimate = -0.660; SE = 0.294; p = 0.025), and awareness regarding the adverse drug reaction reporting program in the United Arab Emirates (Estimate = -1.032; SE = 0.280; p = 0.000). Pharmacists had the most knowledge regarding adverse drug reaction reporting and pharmacovigilance. The underreporting of adverse drug reactions was documented among physicians and nurses. Lack of time was the most significant barrier to reporting adverse drug reactions, followed by uncertainty and complicated adverse drug reaction documentation forms.

Evaluation of educational intervention on awareness of adverse drug reaction reporting among geriatric population in a tier II city of India

Background: Adverse drug reactions in the geriatric population are a growing concern, given their susceptibility to medication-related complications. However, underreporting of ADRs remains a significant challenge in India. This study aimed to evaluate the impact of an educational intervention on ADR reporting awareness among the geriatric population in a Tier II city of India. Methods: A pre-post intervention study was conducted in a Tier II city, involving a sample of geriatric individuals aged 60 and above. An educational intervention, consisting of workshops, pamphlets, and interactive sessions, was designed to enhance awareness of ADR reporting procedures. Pre-intervention and post-intervention assessments were conducted to measure changes in ADR reporting knowledge and willingness to report ADRs. Results: A total of 71 responses were received. All participants demonstrated an increased understanding of the importance of reporting ADRs and were more willing to report such incidents to health care authorities after the intervention. The educational intervention significantly improved awareness of ADR reporting procedures among the geriatric population Conclusions: The intention of the study was to assess the effectiveness of an educational programme on geriatric patients' awareness of the need to report adverse drug reactions to pharmacovigilance centres given that this age group is more prone to use multiple therapies. A large number of participants felt that increasing pharmacovigilance awareness and knowledge sharing will benefit society.

Nursing Professionals' Awareness of Adverse Drug Reactions and Pharmacovigilance in an Institute of National Importance in India: A Cross-Sectional Study.

Background Globally, there is a growing concern about adverse drug reactions (ADRs) as they can lead to increased hospital admissions and healthcare expenses, lower patient satisfaction with treatment outcomes, and even fatalities. Pharmacovigilance is crucial for minimizing the risks associated with drug therapy, but underreporting of ADRs is a prevalent issue. Nursing professionals are an important stakeholder in ADR reporting, as they are often the first point of contact for patients to identify and report adverse drug reactions. Objectives The objectives of the study were to evaluate the knowledge and practices of nursing professionals regarding ADR reporting in a tertiary care teaching institute and the factors influencing their knowledge of ADR reporting. Methodology This was a cross-sectional study involving 275 nursing officers at AIIMS Raebareli, who gave their informed consent and completed a questionnaire on demographics, knowledge, and practice domains. Multiple linear regression analysis was used to compare independent variables' influences on knowledge scores. SPSS version 26 (IBM Corp., Armonk, NY, USA) was used for statistical analysis. Results The study revealed that the mean knowledge score was 6.378 (total score of 13), with a standard deviation of 2.299 (95% CI 6.10-6.65). About 50.18% of the participants had a knowledge score below 6.5. Multiple regression analysis revealed that working experience, female gender, working in an emergency department, and previous training on ADR reporting significantly influenced the knowledge scores. Conclusion The study found that nursing professionals had limited awareness about ADR reporting, even though they worked at an Institute of National Importance. Based on the findings, it can be concluded that there is a need for improved education and training on ADR reporting and to address barriers to reporting, such as a lack of awareness about reporting procedures, and alleviate the fear of legal consequences.

Knowledge and attitude of adverse drug reaction reporting process among Indian medical undergraduates in a tertiary care teaching hospital - a questionnaire based study

Introduction: The primary objective of this study is to assess the knowledge, attitude and awareness of adverse drug reaction reporting process among Indian medical undergraduates in a tertiary care teaching hospital. Material and Methods: This is a cross sectional questionnaire based study on 250 Indian medical graduates. Phase III – Part 1 and Part 2 Medical Undergraduates at Trichy SRM Medical College Hospital & Research Centre for next 3 months were included. The students were informed in person with participant information sheet during PHASE 3 clinical posting. Those students who did not gave informed consent for participation in the study were excluded. Results: The mean age of the study participants was 20.12±1.3 years. There was male preponderance with 52% male medical graduates and 48% female medical graduates. Majority of the included subjects were in Phase III Part 1. Table 1 describe the distribution of knowledge related questions. Around 70% correctly answered the definition of pharmacovigilance, 40% answered about important purpose of pharmacovigilance, 48% on healthcare professionals are responsible for reporting ADRs, 61% on organization conducting National Pharmacovigilance Program in India, 40% on regulatory body responsible for monitoring pharmaceuticals and medical devices, 42% answered correctly on location of international centre for adverse drug reaction monitoring.Conclusion: There is requirement for continuous medical education in these students on regulations of Pharmacovigilance. This study provides baseline data of the knowledge and attitude for providing educational intervention.

Barriers and Facilitators Influencing Real-time and Digital-Based Reporting of Adverse Drug Reactions by Community Pharmacists: Qualitative Study Using the Task-Technology Fit Framework.

BackgroundMedication use can result in adverse drug reactions (ADRs) that cause increased morbidity and health care consumption for patients and could potentially be fatal. Timely reporting of ADRs to regulators may contribute to patient safety by facilitating information gathering on drug safety data. Currently, little is known about how community pharmacists (CPs) monitor, handle, and report ADRs in Australia.ObjectiveThis study aimed to identify perceived barriers to and facilitators of ADR reporting by CPs in Australia and suggest digital interventions.MethodsA qualitative study with individual interviews was conducted with CPs working across Victoria, Australia, between April 2022 and May 2022. A semistructured interview guide was used to identify perceived barriers to and facilitators of ADR reporting among CPs. The data were analyzed using thematic analysis. We constructed themes from the CP-reported barriers and facilitators. The themes were subsequently aligned with the Task-Technology Fit framework.ResultsA total of 12 CPs were interviewed. Identified barriers were lack of knowledge of both the ADR reporting process and ADR reporting systems, time constraints, lack of financial incentives, lack of organizational support for ADR reporting, inadequate IT systems, and preference to refer consumers to physicians. The proposed facilitators of ADR reporting included enhancing CPs knowledge and awareness of ADRs, financial incentives for ADR reporting, workflow-integrated ADR reporting technology systems, feedback provision to CPs on the reported ADRs, and promoting consumer ADR reporting.ConclusionsBarriers to and facilitators of ADR reporting spanned both the task and technology aspects of the Task-Technology Fit model. Addressing the identified barriers to ADR reporting and providing workplace technologies that support ADR reporting may improve ADR reporting by CPs. Further investigations to observe ADR handling and reporting within community pharmacies can enhance patient safety by increasing ADR reporting by CPs.

Pharmacists’ involvement with and pharmacy clients’ awareness of adverse drug reaction reporting in Nigeria – a mixed-methods approach

Abstract Objectives Adverse drug reactions are one of the leading causes of death, yet they are under-reported. This study assessed the involvement of community pharmacists in the identification, documentation, and reporting of adverse drug reactions and pharmacy clients’ awareness of the adverse drug reaction reporting system. Methods A cross-sectional questionnaire-guided survey was conducted among 780 pharmacy clients in six selected community pharmacies, and seven mystery clients visited 125 community pharmacies in Ibadan, Nigeria. Information on pharmacy clients’ experience of adverse drug reactions, to whom and how they were reported, was obtained. Female and male mystery clients’ performed two scripted scenarios, complaining of black patches on their thighs and blood in their faeces, respectively. The proportion of pharmacists who identified the complaints as adverse drug reactions, documented and reported them, was described. Key findings The response rate for the pharmacy clients’ survey was 98.5%. Some pharmacy clients, 385 (50.1%), had experienced adverse drug reactions; 49 (12.7%) of these pharmacy clients were hospitalised and 73 (19.0%) of them reported the adverse drug reactions to physicians or pharmacists. Most of the pharmacy clients, 706 (91.9%), did not use the available reporting system. A total of 218 mystery client visits were made. The proportion of pharmacists who recognised the mystery client complaints as adverse drug reactions was 4.9–60.3% depending on the scenario presented and up to two pharmacists documented and supposedly reported the adverse drug reactions. Conclusions Some of the pharmacy clients reported experiencing adverse drug reactions to healthcare professionals, but most did not report through the existing reporting scheme. Community pharmacists could identify adverse drug reactions but most failed to document or report them.

Awareness of Adverse Drug Reactions and its Reporting among Third-year Undergraduate Medical Students.

Drug is a double-edged sword. Though important, Adverse Drug Reactions under-reporting is real and is mainly due to lack of awareness. No published research has ever evaluated the perspective of third year medical students towards Adverse Drug Reactions reporting. The objective of the study was to evaluate awareness of Adverse Drug Reactions and its reporting among Third-year Medical Students of BP Koirala Institute of Health Science. It was a descriptive cross-sectional questionnaire-based survey using google form conducted between 09/01/2020 to 09/28/2020. Any consenting third-year medical student of BP Koirala Institute of Health Science was eligible. Descriptive analysis of the data was performed using Microsoft Excel. Ethical clearance was obtained from Departmental-Research-Unit which is under IRC. Out of 80 eligible students, 79(98.75%) participated in the survey. 31.6(25%) had reported Adverse Drug Reactions. 36.7(29%) were aware of National Adverse Drug Reactions monitoring service. 12.7(10%) were aware of BPKIHS ADR monitoring. Again, 35(49.30%) were familiar with Adverse Drug Reactions to a particular drug whereas 29(40.85%) and 28(39.44%) were even familiar with Adverse Drug Reactions to a new product and Adverse Drug Reactions of serious (life or organ threatening) nature respectively. Regarding barriers to Adverse Drug Reactions reporting, 64(83.12%) were uncertain how to report; 39(50.65%) were unaware of existing National ADR system and 33(42.86) could not decide if it was an Adverse Drug Reactions. Regarding recommendations to improve Adverse Drug Reactions reporting, 73(94.81%) recommended education and training, 57(74.03%) stressed on collaboration among health professionals; 52(67.53%) said Adverse Drug Reactions reporting should be professional obligation whereas 51(66.23%) highlighted feedback from Monitoring Centers. We evaluated the awareness of Adverse Drug Reactions and its reporting among third-year medical Students of the institute which was relatively poor compared to other study population like doctors and pharmacists.

Assessment of adverse drug reactions of psychopharmacological drugs in patients of psychiatric disorders

Introduction: Psychopharmacological drugs are used in the treatment of different types of psychotropic disorders. These drugs are associated with a variety of adverse drug reactions (ADRs). The ADRs due to psychopharmacological drugs are a significant cause of mortality and morbidity.&#x0D; Objectives: The current study assessed the adverse drug reactions of psychopharmacological drugs in patients with psychiatric disorders.&#x0D; Methods: This study was a retrospective study. All ADR forms related to psychopharmacological drugs that were reported to the pharmacovigilance center, UCMS, and GTB Hospital, between December 2019 to February 2020, were assessed to identify the incidence and nature of important ADRs. Causality assessment was done by WHO Uppsala Monitoring Centre Global Introspection Method. A total of 150 ADR forms were analyzed.&#x0D; Results: Females (60.66 %) experienced more ADRs than males (39.33 %). ADRs were most commonly reported in the age group of 18-28 years followed by 29-39 years. Depression was the most common diagnosis in patients with psychiatric disorders. Dizziness was the most common ADR followed by headache and insomnia. Escitalopram (12.21 %) was the most commonly implicated drug causing ADRs followed by clonazepam (9.92 %). As per the WHO causality assessment method, 77 % of ADRs were possible and 23 % were probable.&#x0D; Conclusions: Therefore, early detection and awareness of ADRs are important to enable health professionals to perform alterations in the prescribed drug treatment to prevent or reduce the adverse effects due to psychotropic drugs. This will improve patient care and safety as well as promote rational use of drugs.

S3149 Does Gender Play a Role in How Gastroenterology Patients View Adverse Effects of Proton Pump Inhibitors?

INTRODUCTION: Proton Pump Inhibitors (PPIs) are generally considered to be safe. Recent observational studies have associated PPI use with potential adverse drug reactions (ADRs) including chronic kidney disease, dementia, and vitamin deficiencies. Patient awareness of potential ADRs and its effect on continued use of PPIs have received little attention in the medical literature. Our group previously reported initial data showing that the majority of gastroenterology patients taking PPIs are unaware of associated ADRs, but when alerted to ADRs, 60% expressed some degree of concern. We now report new findings on the effect of gender on knowledge and concern about PPI-related ADRs, and likelihood of discontinuing PPIs. METHODS: An anonymous survey with 15 multiple choice questions regarding PPI use (2 questions allowing more than 1 answer) was distributed to adults from our single community outpatient endoscopy center at Advocate Lutheran General Hospital from June 2019 to January 2020. It included demographic information, indication and duration of PPI use, awareness of PPI ADRs, level of concern for ADRs, and drug discontinuation. RESULTS: 3775 surveys were returned, of which 537 patients (14%) [male (M) n = 248 (46%), female (F) n = 289 (54%)], were current PPI users and are the subject of this analysis. The most common indications for PPI usage were heartburn (M n = 137, F n = 161) and GERD (M n = 124, F n = 149). Females were more aware of individual PPI-associated ARDs than males (Figure 1). The most common patient-identified ADRs related to PPI use by women was osteoporosis (F n = 53, M n = 18) and in men was vitamin B12 deficiency (M n = 25, F n = 37)Figure 1.: The graph depicts the most common patient identified potential ADRs by gender group. The most frequently identified potential ADRs by women are osteoporosis, low calcium absorption, and B12 deficiency. The most frequently identified potential ADRs by men are Vitamin B12 deficiency, kidney disease, and low iron absorption.Figure 2.: The graph depicts the overall concern of patients by gender related to PPI ADRs. Although women were more concerned than men, the majority are all somewhat concerned regarding PPI related ADRs.Figure 3.: The graph depicts the reason patients, by gender, discontinued their PPI. More women discontinued their PPI due to concern regarding ADRs rather than men.. Of 377 patients (70%) who expressed concern regarding ADRs, 21% expressed extreme concern (F = 58%), 23% moderate concern (F = 69%), 41% were somewhat concerned (F = 51%), and 15% were hardly concerned (F = 61%) (Figure 2). Of 168 patients (32%, M n = 66, F n = 102) who attempted to stop their PPI, 41 patients (24%, M n = 15, F n = 26) reported stopping secondary to ADRs concern (Figure 3). CONCLUSION: The majority of GI patients consuming PPIs are unaware of PPI-related ADRs. Our study data suggests that females are more aware of ADRs and are attentive a variety of ADRs. Females express a greater degree of concern regarding PPI use, and are more likely to discontinue their PPI therapy compared to males.

Evaluating the knowledge, attitudes and practices of healthcare workers towards adverse drug reaction reporting at a public tertiary hospital in Johannesburg

BackgroundSpontaneous reporting of adverse drug reactions is a method of monitoring the safety of drugs post-marketing, providing a way to discover new, rare or unnoticed adverse drug reactions. Despite its importance, there is widespread underreporting of adverse drug reactions by health care professionals in South Africa. The study assessed the knowledge, attitudes and practices of health care professionals on adverse drug reaction reporting at a tertiary public-sector hospital in Johannesburg, South Africa. MethodsA descriptive quantitative study using a questionnaire was conducted at a tertiary public-sector hospital in Johannesburg. A stratified sampling method was used to distribute questionnaires to doctors, nurses and pharmacists at the institution from July to November 2016. ResultsOf the 338 questionnaires sent out, 297 health care professionals responded to the questionnaire (87.87% response rate). Half of the participants knew about reporting adverse drug reactions, and pharmacists were the most likely group to know how to report (82.61%) (p < 0.001). Ninety-seven percent of participants who had previously received adverse drug reaction training knew how to report them. Patient management, lack of knowledge and the time-consuming requirement of reporting featured as discouraging factors. Although, 58.59% of participants had encountered adverse drug reactions, only 16.50% had reported (p < 0.001). ConclusionsDespite an awareness of adverse drug reactions, participants were unlikely to report adverse drug reactions due to time constraints and a lack of knowledge. Adverse drug reaction reporting is essential to ensuring patient safety. The benefits of reporting should be emphasized by encouraging continuous professional development in pharmacovigilance and, placing more emphasis on adverse drug reactions at an undergraduate level.

Awareness, knowledge, attitude and practice of adverse drug reaction reporting among health workers and patients in selected primary healthcare centres in Ibadan, southwestern Nigeria

BackgroundHigher incidence of adverse drug reactions (ADRs) is a global health problem requiring attention of all stakeholders regardless of the practice settings. This study therefore aimed to evaluate awareness, knowledge, attitude and practice of ADR reporting among health workers and patients in 10 primary healthcare centres (PHCs) in Ibadan, southwestern Nigeria.MethodsQuestionnaire-guided cross-sectional survey among 80 health workers and 360 patients enrolled from the selected PHCs between October and December 2018. The semi-structured questionnaires generally comprised open-ended and closed-ended questions to explore general knowledge and awareness of ADRs and pharmacovigilance, while other question-items evaluated attitude towards ADR reporting and ADR reporting practice. Overall percent score in the knowledge and attitude domains for the health workers was developed into binary categories of > 80 versus ≤80% for “adequate” and “inadequate” knowledge, as well as “positive” and “negative” attitude, respectively. Data were summarised using descriptive statistics, while Chi-square test was used to evaluate categorical variables at p < 0.05.ResultsOverall, 58(72.5%) health workers had heard of pharmacovigilance, but only 3(5.2%) correctly understood the pharmacovigilance concept. Twelve (15.0%) showed adequate knowledge of ADRs, while 37(46.2%) demonstrated positive attitude towards ADR reporting. Thirty (37.5%) health workers had come across ADR reporting form, while 79(98.8%) expressed willingness to report all ADRs encountered. Of the patients, 31(8.6%) had heard of pharmacovigilance, 143(39.7%) correctly cited ADR definition, while 67(18.6%) reported the previously experienced ADRs. Informing healthcare professional (38; 38.8%) was the most common measure taken by patients when they experienced reaction(s). Nurses significantly had adequate knowledge of ADRs (p < 0.001) compared to other cadres.ConclusionsHealth workers in the selected PHCs were largely aware of pharmacovigilance but show low level of knowledge about ADRs and pharmacovigilance concept, with moderately positive attitude towards ADR reporting. Patients on the other hand demonstrate low level of awareness of pharmacovigilance and ADR reporting, with less than one-fifth who reported the previously experienced ADRs. This perhaps underscores a need for regular mandatory education and training on ADRs/pharmacovigilance concept among the PHC health workers, while continuous public enlightenment and awareness campaign on spontaneous reporting of ADRs is advocated in order to enhance reporting rate.

446 Do GI Patients Care About Adverse Effects of Proton Pump Inhibitors?

INTRODUCTION: Proton Pump Inhibitors (PPIs) are generally considered to be safe. Recently, several observational studies have associated PPI use with potential adverse drug reactions (ADRs) including chronic kidney disease (CKD), dementia, and cardiovascular disease. Other potential ADRs such as osteoporotic fractures and increased risk of community acquired pneumonias and Clostridium difficile infection have been known for a longer period of time. Patient awareness of potential ADRs and its effect on continued use of PPIs have received little attention in the medical literature. AIM: To survey patients at a single community-setting outpatient endoscopy center to assess and understand gastrointestinal (GI) patient opinions about ADRs from PPI use. METHODS: An anonymous survey with 15 multiple choice questions regarding PPI use (two questions allowing for more than one answer) was distributed to all adult outpatient endoscopy patients at Advocate Lutheran General Hospital from January to March 2019. The survey questioned indication and duration of PPI use, awareness of PPI ADRs, level of concern for ADRs, and drug discontinuation. RESULTS: Of 2,288 patients surveyed, 1,689 (74%) returned the survey. Of these, 342 patients (20%) were current PPI users and were the subject of this analysis. The most common indications (multiple could be selected) for PPI usage were heartburn (n = 162), GERD (n = 155), and stomach/abdominal pain (n = 78) (Table 1). The most commonly identified ADRs related to PPI use were osteoporosis (n = 43) and CKD (n = 35) (Figure 1). However, 181 (53%) patients reported that they were not aware of any ADRs from PPIs. Of 218 (64%) patients who expressed concern regarding ADRs, 47 (14%) selected extreme concern, 57 (17%) with moderate concern, 88 (26%) somewhat concerned, and 26 (7%) hardly concerned (Figure 2). No concern was selected by 48 (14%), and 76 (22%) felt there were no ADRs from PPIs. There were 91 (27%) patients who attempted to stop their PPI treatment, but only 17 (5%) stopped because of concerns about ADRs. CONCLUSION: The majority of GI patients consuming PPIs are unaware of PPI-associated ADRs. However, when patients are alerted to these side effects, only approximately 60% of these patients express some degree of concern. More importantly, concern and awareness of these side effects does not appear to be a common cause for discontinuation for PPI therapy amongst GI patients.

A comparative analysis of the pharmacovigilance systems of Brazil, Spain, the European Union and the United States based on the information provided by their regulatory agency websites

Pharmacovigilance (PV) plays an essential role in monitoring and raising awareness of adverse drug reactions (ADRs). Increasingly, ADRs are reported and PV information and activities are circulated via the Internet. PV actions are carried out by the Regulatory Agencies (RAs) responsible for medicinal products in each country. The objective of this study is to ascertain and assess the operation and areas of competence of the PV system in Brazil and to compare them with those of Spain, the European Union (EU) and the United States (USA), through the information available on the websites of the RAs in each country. A search of the information provided on the websites of these countries' RAs, establishing indicators to assess how far the information is available and accessible. The RAs we studied are similarly organised and they complied with most of the 38 indicators we defined to obtain and assess the information they provide on PV procedures and their systems for electronic reporting of ADRs. Brazil's RA, ANVISA, complied with 100% of the areas of competence analysed and with 92.11% of the indicators established for the study. Brazil's PV system, through ANVISA, achieves a good level of performance, both in itself and compared to the other RAs. There is room for improvement in three of the indicators analysed.

Knowledge of pharmacovigilance among the health-care professionals at Bidar Institute of Medical Sciences

Background: The reporting of adverse drug reaction (ADR) is essential, and pharmacovigilance (PV) system should be practiced by the health-care professionals. Aims and Objectives: The aim is to study about the knowledge improvement, attitudes toward, and PV observation among health-care professionals and to evaluate the reasons of underreporting of ADRs required to be well assessed by the medical society. Materials and Methods: This descriptive cross-sectional study was evaluated by distributing a questionnaire. This study was conducted at Bidar Institute of Medical Sciences, Bidar. Health-care professionals including physicians, dentists, pharmacists, physiotherapist, nurses, and Ayush doctors were invited to take part in the study. The questionnaire covered matters regarding awareness of PV and reporting of ADRs. Results: Overall, 100 questionnaires were circulated to the health-care professionals. The health-care professionals comprised 46 physicians, 2 dentists, 6 pharmacists, 4 Ayush doctors, 4 physiotherapist, and 38 nurses. Maximum 70% of health-care professionals were aware of the term PV and only 10% were aware of ADRs. Conclusion: There is not much awareness and practice of PV and ADR reporting by health-care professionals working at Bidar Institute of Medical Sciences.

Evaluation of knowledge and awareness of adverse drug reaction reporting among patients visiting a tertiary care hospital in northern India

Evaluation of knowledge and awareness of adverse drug reaction reporting among patients visiting a tertiary care hospital in northern India

Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting.

BackgroundAdverse drug reactions (ADRs) have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system.MethodsSemi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261) completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history.ResultsGroup 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found between rheumatology patients with and without neurological comorbidities regarding their awareness of ADRs. The majority of patients reported ADRs of cytotoxic drugs. The most reported ADRs were moderate gastrointestinal discomforts.ConclusionWe may draw a profile of rheumatological patients willing to report ADRs: 1) The majority of them suffer from systemic inflammatory diseases and are slightly more prone to neurological comorbidities. 2) They are predominantly aware of their diagnosis but less able to identify the drugs that may cause their ADRs. 3) They tend to report mainly moderate gastrointestinal ADRs; that is, other cohorts of patients and other types of ADRs remain mainly undetected in such a reporting, which could represent a bias. Counseling and education of patients as well as developing a network for online communication might improve patients’ reporting of potential ADRs.

Awareness of adverse drug reactions reporting among doctors in a tertiary care centre

Background: Adverse drug reactions (ADR) are more commonly observed during treatment course in a substantial number of patients. Though we have a functioning pharmacovigilance programme in India, we have only fewer number of adverse drug reactions being reported indicating lack of awareness, the unsure attitude and reluctance in reporting adverse drug reactions.Methods: We conducted a cross sectional pretested questionnaire based study for a period of six months. 600 questionnaires were distributed. 521 responded back to the questionnaire of which 29.6% were interns, 56.8% were junior residents, 5.2% doctors were senior residents, and 8.4% were Assistant professors. Awareness on ADR reporting, ADRs encountered in practice, common causative drugs for ADR, and awareness on the functions of Pharmacovigilance programme of India were assessed.Results: 44.9% were not aware of the pharmacovigilance programme; 59.5% of the study population were not aware of the voluntary reporting of ADRs. 100% of the doctors who participated actively in the study responded that have not reported any ADR so far under pharmacovigilance programme of India. 88.1% of the doctors who participated in the study were willing to undergo a training on ADR reporting and pharmacovigilance.Conclusions: This study concludes that serious measures have to be taken to educate the doctors on ADR reporting and pharmacovigilance. By means of involving pharmacovigilance as a part of the undergraduate programme and by organising regular workshops, group discussion and continuous medical education, we can improve the awareness among doctors regarding ADR reporting and pharmacovigilance.

Awareness of adverse drug reactions in third M.B.B.S students practicing self-medication

Background: Students self-medicate but the extent of their knowledge regarding potential adverse drug reactions (ADRs) to drugs consumed by them is not known. This has many implications. This study has attempted to evaluate this knowledge in third MBBS students practicing self-medication. Methods: In this cross-sectional study, a self-designed, pretested questionnaire was presented to third MBBS students in a teaching hospital. Information sought:-Demographic data, self-medication drugs used within last one month, indication, duration, awareness and expected ADRs for the drugs consumed. Results were calculated as percentages. Results: 79 out of 87 third MBBS students present on the day of study were presented with questionnaire all attempted it; giving a response rate of 100%. Within the last one month 31 (39.24%) had self-medicated. There was no significant difference in self-medication between male and female students. Medication was used for adequate duration (93.87%) and for apparently correct indications (81.6%) by most students. Main group of drugs consumed were NSAIDs including antipyretics (42.59%), antibiotics (18.53%) and antihistaminics (16.66%). Fourteen (45.16%) students said they were aware of potential ADRs to the consumed drugs and 13 (43.93%) listed expected ADRs correctly .Although a wide range of drugs were consumed, the number of ADRs mentioned were few and its spectrum limited. 11 (35.48%) students mentioned only one ADR. No student mentioned more than two ADRs. Dyspepsia (56.25%) was most common ADR stated. Conclusions: Considering the wide range of drugs consumed, the numbers of ADRs mentioned were few and their spectrum limited indicating scope for improvement.