Knowledge 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.

Awareness, knowledge, attitude, and practice of adverse drug reaction reporting among health workers in primary health centres participating in seasonal malaria chemoprevention campaign in Nigeria in 2022: a cross-sectional survey

BackgroundEvaluating health workers’ knowledge and practice of adverse drug reaction (ADR) reporting is an important step in identifying gaps in quality ADR reporting during public health interventions like the seasonal malaria chemoprevention (SMC) campaign. Pharmacovigilance (PV) monitoring is vital in SMC due to the number of children exposed to malaria medicines for a period of 4 or 5 months during the campaign. In Nigeria more than 10 million children are exposed to SMC medicines every year. The scale of this intervention emphasised the need for efficient and effective safety monitoring during the campaign. Thus, the objective of this study was to evaluate healthcare workers’ (HCW) awareness, knowledge, attitude and practice (KAP) of ADR reporting in health facilities participating in SMC campaign to identify pharmacovigilance gaps which may suggest possible ways to ensure safety during the campaign.MethodsWorld Health Organization’s service availability and readiness assessment (SARA) recommendations were used to sample 2,598 out of 5,195 used as supervising health facilities (HFs) during the 2022 SMC campaign across nine states of the country. Out of the sampled HFs, 2,144 eligible and consented health facility workers (HFWs) were assessed for awareness, and KAP of ADR using the validated 45-item self-administered questionnaire. The data was analysed using descriptive statistics and correlation analysis at p < 0.05.ResultsThe majority of the respondents are males (n = 1,333, 62.2%). The HFWs showed good awareness (n = 2,037, 95.0%) of pharmacovigilance (PV). However, only 809 (37.7%) of them had good knowledge scores. The mean ADR reporting attitude score (85.0 ± 15.3%) was good with many of the respondents (n = 1,548, 72.2%) having a good score. However, the respondents’ ADR practice was suboptimal, only 1,356 (63.2%) of them had encounters with ADR, and a lot of negative perceived barriers to ADR reporting were identified in the study. For example, 493 (23%) believed that ADRs were not reported because they were not serious and life-threatening while 248 (11.6%) reported a fear of liability. Correlation analysis revealed female gender (r = 0.163, p < 0.001), older age (r = 0.207, p < 0.001) and years of practice (r = 0.050, p = 0.021) as factors significantly associated with ADR knowledge and attitude scores.ConclusionThe study indicated that HCWs across health facilities participating in SMC campaigns have ADR reporting knowledge and practice gaps. The study suggest training alone may not be effective in addressing gaps in ADR reporting. In addition to PV training, implementers can include continuous mentoring of health care workers or other similar interventions as part of strategy to improve ADR reporting. Also, context specific strategies to improve ADR reporting among health care worker needs to be implemented to address under-reporting of ADRs during SMC campaigns and other malaria public health interventions.

Understanding health students' knowledge of adverse drug reactions

This study investigated the knowledge of students from the Pharmacy, Nursing, Medicine, and Dentistry courses at UNITPAC regarding Adverse Drug Reactions (ADRs). A total of 111 students participated, with a percentage distribution per course of 34% in Pharmacy, 31% in Nursing, 20% in Medicine, and 15% in Dentistry. The results revealed that the majority of students acquired knowledge about pharmacovigilance and ADRs during their undergraduate studies, but there was variation among courses. Pharmacy had the highest knowledge index (71.1%) in pharmacovigilance, while Medicine had the greatest understanding of ADRs (72.7%). However, Nursing (26.5%) and Dentistry (17.6%) showed lower understanding of pharmacovigilance. Regarding knowledge about ADRs, Pharmacy (94.7%) and Medicine (72.7%) had the highest rates. In contrast, Nursing (73.5%) and Dentistry (41.2%) had lower comprehension. Polypharmacy was poorly understood, with 68.4% of Pharmacy students recognizing the term, compared to 17.6% of Dentistry students. The majority of students correctly defined ADRs, with Medicine (90.9%) and Pharmacy (89.5%) standing out. The research indicates the need for improvements in student education, especially in Nursing and Dentistry, to ensure a more comprehensive understanding and adequately prepare them to deal with ADRs in professional practice.

Improvement in Adverse Drug Reaction (ADR) Knowledge: A Pre- and Post-video Intervention Study Among Doctors.

Background Adverse drug reactions (ADRs) represent a significant public health concern, contributing to mortality, morbidity, and healthcare costs worldwide. Healthcare practitioners especially doctors play a vital role in identifying and reporting ADR. This study investigates the prevalence of knowledge regarding ADR among doctors and enhances it with educational intervention. It also explores the association between demographic factors and baseline ADR awareness. Methods A prospective cross-sectional interventional study was conducted among doctors in Ahmedabad, India, to evaluate their knowledge of ADR reporting and the effectiveness of an educational video intervention. Pre- and post-intervention questionnaires were administered to assess knowledge improvement. Statistical analysis, including paired t-tests and chi-square tests, was performed to evaluate the intervention's impact and explore associations between demographic factors and ADR awareness. Results Analysis of pre- and post-intervention questionnaires revealed a significant increase in correct response rates post-intervention, indicating the effectiveness of the educational video intervention. Demographic factors, particularly age, were associated with ADR awareness. Following the intervention, participants demonstrated an improved understanding of ADR definitions, WHO causality assessment, reporting mechanisms, and challenges faced by pharmacovigilance programs. All participants found the video helpful and expressed intent to share their knowledge post-intervention. Conclusion The results of the study suggest that educational video intervention can serve as an effective tool for understanding ADRconcepts and pharmacovigilance practices. Moreover, the association of demographic factors, particularly age, with ADR awareness further emphasizes the importance of educational interventions in addressing specific population needs.

Knowledge attitude and convenience on self-medication practices among university students in Bangladesh exploration using structural equation modeling approach

Self-medication is a prevalent practice among university students globally and is a significant public health concern. However, previous research has been limited in scope, focusing primarily on adolescents or the general public, leaving a gap in understanding the causal relationships associated with self-medication; thus, this study aimed to investigate the factors influencing self-medication practices among university students in Bangladesh by developing a comprehensive causal model. Data from 417 students across five public universities were collected using the simple random walk technique by a team of 10 members. The study utilized constructs of knowledge, attitude, and convenience related to self-medication as independent variables, while self-medication practice as the dependent variable. One-way ANOVA and structural equation modeling (SEM) were employed to develop a causal model of self-medication practice among university students in Bangladesh. The findings revealed that students with better medication knowledge and adverse drug reactions (ADRs) were more likely to practice self-medication. A positive attitude towards self-medication and ADRs was also significantly associated with higher self-medication practice scores. Additionally, those who perceived self-medication as convenient and prescribed medication as inconvenient had higher self-medication practice scores. The attitude towards self-medication had the most substantial negative effect on self-medication practice, followed by the inconvenience of prescribed medication and the convenience of self-medication. The model explained 87% of the variance in self-medication practice, indicating a good fit for the data. University students in Bangladesh possess intermediate knowledge of medication and primary knowledge of ADRs. They exhibit a positive attitude towards self-medication and ADRs. Physical convenience favors self-medication, while the inconvenience of prescribed medication contributes to its lower preference. Policymakers should focus on evidence-based guidelines to reduce the extent of unnecessary self-medication practice and to enhance the quantity and accessibility of prescribed medications to address the issue effectively.

Case report: a unique presentation of memantine overdose causing echolalia and hypertension

BackgroundSince 2003 when memantine was first approved for use in the management of moderate-severe Alzheimer’s dementia, its use has become more widespread and is being explored in other diseases like neuropathic pain, epilepsy, and mood disorders. Our case uniquely highlights two important adverse effects in a patient who overdosed on memantine. One is hypertension, which is easy to overlook as a medication side effect. The other is echolalia which is the repetition of words and phrases spoken by another person. It is commonly seen in children with autism spectrum disorder and has been reported in older adults with head injuries, delirium, and neurocognitive disorders. The aim of this patient story is to highlight the importance of medication reconciliation with caregivers and knowledge of adverse drug reactions in patient management. This case report has been presented previously in the form of an abstract at the American Geriatrics Society Presidential poster session in May 2023.Case presentationOur patient is an 86-year-old man with mild dementia and hypertension, who was brought to the emergency department (ED) due to abrupt onset of altered mental status and auditory hallucinations. Investigations including blood work, CT head and an electroencephalogram (EEG) did not reveal an etiology for this change in his condition. Due to elevated blood pressure on presentation, a nicardipine drip was started, and he was given IV midazolam to assist with obtaining imaging. While reviewing medications with his daughter, it was noted that sixty memantine pills were missing from the bottle. Poison control was contacted and they confirmed association of these features with memantine. With supportive care, his symptoms resolved in less than 100 h, consistent with the half-life of memantine. Notably, our patient was started on Memantine one month prior to this presentation.ConclusionsHypertensive urgency and echolalia were the most striking symptoms of our patient’s presentation. Though hypertension is a known sign of memantine overdose, it can easily be contributed to medication non-compliance in patients with dementia, being treated for hypertension. According to our literature review, this the first case of memantine overdose presenting with echolalia, a sign that is not commonly associated with adverse reactions to medications. This highlights the importance of an early medication review, especially with caregivers of people with dementia.

A cross-sectional study on knowledge, attitude, and practice of health-care professionals about adverse drug reactions reporting in a tertiary care teaching hospital of southern Rajasthan

Background: Adverse drug reaction (ADR) reporting is the integrity of healthcare professionals (HCPs) to counteract fatal outcomes aroused by the use of medications during therapy. The underreporting of ADRs imposes major problems globally. The pharmacovigilance program plays a key role in detecting and preventing ADRs. Targeting the upcoming younger generation of HCPs and sensitizing them towards ADR reporting in their clinical practice is essential. Aims and Objectives: The main objective of our study is to measure the knowledge, attitude, and practice of interns and postgraduates at our institute towards ADR reporting and pharmacovigilance. Materials and Methods: This study was a cross-sectional study conducted on interns and postgraduates of a tertiary care teaching hospital in Udaipur, Rajasthan. A set of 28 standard questions related to knowledge, attitude, and practice of pharmacovigilance and ADR reporting were distributed among 106 students after taking the ethical approval from the institute. The collected data were analyzed using SPSS (version 20) software in percentage. The Chi-square test (χ2) was used, and P &lt; 0.01* was considered significant statistically. Results: In our study, we found most of the participants were in 21–30 age groups (84.19%); male participants were (67%) in comparison with females (33%). The majority of interns showed their interest in participation (66%) rather than postgraduates (34%) in this study. The overall knowledge (14.645, P = 0.01), attitude (14.64, P = 0.01), and practice (35.712, P = 0.01) of HCPs were found to be significant. Conclusion: We conclude from this study that both interns and postgraduates have good knowledge of ADR reporting, but interns lack practice in their daily duties due to fear of heavy paper work, and postgraduates lack attitude towards ADR reporting due to heavy duty schedules. Most of the participants, i.e., interns and postgraduates, felt ADR reporting was their primary responsibility along with patient safety. Recurrent training and sensitization of upcoming medical professionals about ADR reporting will impart better patient compliance and eradicate fatal outcomes. They also suggest a separate working body needs to keep by institutions to collect the ADR reports during their busy duty schedules.

Effects of Health Education on Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Community Pharmacists in Anambra State, Nigeria

Background: Poor reportage of adverse drug reaction has been linked o. increase in morbidity, mortality and economic burden of diseases and health related conditions.&#x0D; Objective: To determine the effects of health education on knowledge, attitude and practice of adverse drug reaction (ADR) reporting among community pharmacists practicing in Anambra State.&#x0D; Methods: This interventional study was conducted among Community Pharmacists in Anambra State. Simple random samp\ling technique was used. Pre-tested, semi-structured self-administered questionnaire was used to collect data on respondents’ socio-demographics, knowledge of, attitude to and practice of ADR reporting Associations between variables were tested using Chi-square and Binary logistic regression at 5% level of significance. Data obtained were analyzed using SPSS version 23.&#x0D; Results: The mean age of the respondents was 46.5±11.2 years. Post intervention result shows that there was an increase in knowledge of ADR reporting in the intervention group from 52% to 95.3%. There was a decrease in knowledge of ADRs reporting in the control group from 47.3% to44.7%. There was a statistically significant difference between the experimental group and the control group on their attitude towards ADR reporting (p&lt;0.05). Only 26.7% of the test group had filled a spontaneous reporting ADR form prior to this study compared to 18% from the control group and is associated with the effect of health education intervention.&#x0D; Conclusions: There was underreporting of ADRs, associated with gaps in the knowledge, attitude and practice among the community pharmacists studied. There is need for focused continuous health education interventions on ADR reporting among them.

ASSESSMENT OF KNOWLEDGE, ATTITUDE AND BEHAVIOR ON ADVERSE DRUG REACTIONS BETWEEN COMMUNITY AND HOSPITAL PHARMACISTS: A QUESTIONNAIRE-BASED STUDY

Adverse drug reactions (ADRs) are a significant drug-related cause of disease and death. Pharmacovigilance (PV) plays a key role in the management of ADRs. To assess the pharmacist’s knowledge, attitudes and behavior of ADRs among community and hospital pharmacists in Gujarat, a validated questionnaire was developed and used to assess the understanding, attitudes and behavior of community and hospital pharmacists. 166 community pharmacists and 37 hospital pharmacists agreed to complete the ADR questionnaire. According to the study, the response of male pharmacists was higher than that of female pharmacists. In response to knowledge and practice, only the proportion of community pharmacists reporting ADR was 25 %, far lower than hospital pharmacists, who reported 65 %. Factors that encouraged the pharmacist to report ADR were the incredibly potent drug reactions, responses to the new product, and also well-recognized drug reactions documented in this study. In this study, 35 (94 %) hospital and 118 (75 %) community pharmacists guided and advised patients on their side-effects; while 25 (68 %) hospital and 115 (70 %) community pharmacists advised patients on what to do if they developed side-effects. The results of this study suggest that community pharmacists and hospital pharmacists in Gujarat need to improve their knowledge of the ADR. Pharmacists, on the other hand, should be participating in ADR awareness-raising events and refresher courses.

Pharmacovigilance and Adverse Drug Reaction Reporting among the General Public in Lithuania: A Cross-Sectional Study.

Background: Despite the fact that for over ten years, Lithuanian consumers have been able to report adverse drug reactions (ADR) directly to the competent authority, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding ADRs is needed to ascertain further factors impacting their engagement in ADR reporting. This study aimed to assess consumer knowledge of, attitude toward, and practice of reporting ADRs. Methods: A questionnaire-guided cross-sectional survey among 404 consumers between October 2021 and June 2022 was conducted. The semi-structured questionnaire comprised open-ended and closed-ended questions to explore the sociodemographic characteristics and general knowledge of ADRs and pharmacovigilance. Other question items evaluated attitudes toward ADR reporting and ADR reporting practice. The data were summarised using descriptive statistics, while the chi-square test was used to assess categorical variables at p < 0.05. The overall percent score in the knowledge and attitude domains was divided into groups of "poor", "moderate", and "good" knowledge, as well as "positive" and "negative" attitudes. Results: While having a generally poor understanding, this study demonstrates that Lithuanian consumers have a favourable attitude toward pharmacovigilance, particularly regarding issues involving the requirement for reporting. The data also revealed the justifications for reporting and not reporting ADRs. Conclusions: The current study provided the first understanding of consumer awareness and ADR reporting intentions, which can help to develop educational campaigns and interventions addressing pharmacovigilance and ADR reporting.

Knowledge, Attitude and Practice of Adverse Drug Reactions (ADRS) Reporting in Nursing Staffs of Tertiary Care Hospital

Background Adverse Drug Reactions (ADRs) are adverse consequences of drug therapy and are a major cause of morbidity and mortality. Approximately 2.9-5.6% of all hospital admissions are due to ADRs and up to 35% of hospitalized patients experience ADRs during their hospital stay. Therefore, the study assesses nurses’ knowledge, attitudes and practices (KAP) for monitoring and reporting spontaneous adverse drug reactions (ADRs). Methods In this observational study, 155 professional nurses with Proficiency Certificate Level (PCL), Bachelor Nurses and Masters working in various hospitals and academic institutes in Janakpur Municipality were selected to complete 19 pre-validated questionnaires on knowledge, attitudes and practice of ADR monitoring and reporting’ response. The data were converted by a predetermined scoring method and subjected to statistical analysis. Results Most participants from PCL Nursing (52.25%), participants from Bachelor Nursing (35.48%) and the fewest participants from Master Nursing (12.25%) were between 26 and 35 years old. Regarding ADRs knowledge, the majority of the Master Nurses (86.18%) answered the question correctly. ADR that reported regularly, most certificate nurses disagreed (33.3%) and more certificate nurses were neutral (38.2%) and some certificate nurses were agreed (28.3%). Most master nurses (63.1%) had patients with ADRs, but bachelor nurses (52.7%) and certificate nurses (64.2%) had not experienced any patients with ADRs in the past year. Master nurses (78.9%) were aware of the response to ADRs reporting and monitoring, but most certificate nurses (83.9%) and bachelor nurses (65.5%) were unaware of the ADRs reporting and monitoring response. Conclusion We conclude that KAP of ADRs in nurses is not sufficient especially in certificate and bachelor nurses. But master level nurses responded well. This is due to their knowledge, attitude and practices on ADRs reporting and monitoring.

Knowledge of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and their Adverse Effects among Medical and Non-Medical Students

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are the common analgesics, antipyretics, and anti-inflammatory drugs. Though, their frequent consumption cause peptic ulcer disease (PUD) and other unfavorable side effects. This study aimed to compare the knowledge and attitude of Karachi medical and non-medical students about NSAIDs and their adverse effects. Methods: A comparative cross-sectional study was conducted from June 2021-2022, including 344 students from four universities in Karachi, with an equal ratio of medical (n=172) and non-medical (n=172). The study participants were requested to fill out the questionnaire based on the usage of NSAIDs, over-the-counter availability, side effects, etc. The knowledge of adverse drug reactions, reasons for self-medication, and NSAID prescriptions were compared using the Chi-square/Fisher Test. Results: The results showed that about 88.4% of students had some previous knowledge of NSAIDs, of which 98.2% were from the medical sector and 78.4% were from the non-medical sector. 68.6% of students were familiar with the NSAIDs’ adverse effects, 90.1% were medical students, and 47.1% were non-medics. Only 47.7% of the total population was aware of PUD, with 80.2% attending medical universities. While most of the self-medicating students were non-medical 84.7%. Conclusion: Medical students of Karachi possessed more knowledge about NSAID use and its adverse effects. The most known prevalent adverse was PUD, which indicates GI bleeding. It is recommended that there is a dire need for awareness concerning the usage, safety and adverse effects of NSAIDs. Keywords: NSAIDs; Peptic Ulcer Disease; Medical Students; Non-medical Students.

Individual Pharmacotherapy Management (IPM)-IV: Optimized Usage of Approved Antimicrobials Addressing Under-Recognized Adverse Drug Reactions and Drug-Drug Interactions in Polypharmacy.

Antimicrobial therapy is often a life-saving medical intervention for inpatients and outpatients. Almost all medical disciplines are involved in this therapeutic procedure. Knowledge of adverse drug reactions (ADRs) and drug-drug interactions (DDIs) is important to avoid drug-related harm. Within the broad spectrum of antibiotic and antifungal therapy, most typical ADRs are known to physicians. The aim of this study was to evaluate relevant pharmacological aspects with which we are not so familiar and to provide further practical guidance. Individual pharmacotherapy management (IPM) as a synopsis of internal medicine and clinical pharmacology based on the entirety of the digital patient information with reference to drug information, guidelines, and literature research has been continuously performed for over 8 years in interdisciplinary intensive care and trauma and transplant patients. Findings from over 52,000 detailed medication analyses highlight critical ADRs and DDIs, especially in these vulnerable patients with polypharmacy. We present the most relevant ADRs and DDIs in antibiotic and antifungal pharmacology, which are less frequently considered in relation to neurologic, hemostaseologic, hematologic, endocrinologic, and cardiac complexities. Constant awareness and preventive strategies help avoid life-threatening manifestations of these inherent risks and ensure patient and drug safety in antimicrobial therapy.

A Data-Driven Reference Standard for Adverse Drug Reaction (RS-ADR) Signal Assessment: Development and Validation.

BackgroundPharmacovigilance using real-world data (RWD), such as multicenter electronic health records (EHRs), yields massively parallel adverse drug reaction (ADR) signals. However, proper validation of computationally detected ADR signals is not possible due to the lack of a reference standard for positive and negative associations.ObjectiveThis study aimed to develop a reference standard for ADR (RS-ADR) to streamline the systematic detection, assessment, and understanding of almost all drug-ADR associations suggested by RWD analyses.MethodsWe integrated well-known reference sets for drug-ADR pairs, including Side Effect Resource, Observational Medical Outcomes Partnership, and EU-ADR. We created a pharmacovigilance dictionary using controlled vocabularies and systematically annotated EHR data. Drug-ADR associations computed from MetaLAB and MetaNurse analyses of multicenter EHRs and extracted from the Food and Drug Administration Adverse Event Reporting System were integrated as “empirically determined” positive and negative reference sets by means of cross-validation between institutions.ResultsThe RS-ADR consisted of 1344 drugs, 4485 ADRs, and 6,027,840 drug-ADR pairs with positive and negative consensus votes as pharmacovigilance reference sets. After the curation of the initial version of RS-ADR, novel ADR signals such as “famotidine–hepatic function abnormal” were detected and reasonably validated by RS-ADR. Although the validation of the entire reference standard is challenging, especially with this initial version, the reference standard will improve as more RWD participate in the consensus voting with advanced pharmacovigilance dictionaries and analytic algorithms. One can check if a drug-ADR pair has been reported by our web-based search interface for RS-ADRs.ConclusionsRS-ADRs enriched with the pharmacovigilance dictionary, ADR knowledge, and real-world evidence from EHRs may streamline the systematic detection, evaluation, and causality assessment of computationally detected ADR signals.

Assessment of knowledge, practices, and barriers to pharmacovigilance among nurses at a teaching hospital, Ghana: a cross‑sectional study

BackgroundPharmacovigilance may be defined as the continuous monitoring of the reaction between a drug agent or combination of drugs a patient took and steps taken to prevent any associated risk. Clinical trials conducted before drug approval cannot uncover every aspect of the health hazards of approved drugs. People with carefully selected characteristics are monitored for the safety and efficacy of the drug; hence, common adverse drug reactions (ADRs) following proper use of the medication can be detected. This calls for continuous monitoring of drugs to report any undocumented ADRs during the clinical trial. The study aimed to assess the knowledge, practice, and barriers to pharmacovigilance among nurses at a teaching hospital.MethodsThe study was a descriptive cross-sectional study, and a stratified sampling technique was used to select 125 nurses within the three units: medical, surgical, and pediatric wards. A structured questionnaire was developed and used for data collection based on the study's objectives and reviewed literature.ResultsThe majority (67.2%) of the respondents were females, and 32.8% were males. Most (71.2%) of the nurses had low knowledge of ADR reporting procedures. Also, 84.8% of the nurses knew the purpose of reporting ADRs. The purpose of ADR reporting, as perceived by respondents, was to identify safe drugs (80.8%) and calculate the incidence of ADR (75.2%). Additionally, among the nurses who reported having nursed a patient with ADRs, 52.54% stated they reported the case, while 47.46% did not report it. The most cited reason for not reporting ADRs was that nurses considered the reaction normal and commonly associated with that medicine (35.7%). In comparison, 28.5% of the nurses said they did not know they were supposed to report the adverse drug reaction. There was no statistically significant difference between ranks of nurses, ward, attending in-service training, and pharmacovigilance practice.ConclusionIn conclusion, nurses in this study had inadequate knowledge of pharmacovigilance and its reporting procedure. The study found that most nurses fear that reporting ADRs may be wrong because most of the nurses in the study did not have any form of pharmacovigilance training.

Evaluation of Awareness and Knowledge of Pharmacovigilance amongst Final Year Students of Rivers State College of Health Science and Technology, Nigeria

Adverse drug reactions (ADRs) till date are still considered as one of the main problems of drug therapy. Pharmacovigilance is the monitoring of drug safety by means of spontaneous adverse-effect reporting systems, case control and cohort studies.&#x0D; This study evaluated the levels of awareness and knowledge of pharmacovigilance (i.e., ADR reporting) amongst final year students of Rivers State College of Health Science and Technology, Port Harcourt, Nigeria. It was a cross sectional awareness and knowledge survey amongst 200 students from the eight Schools of the institution. Specially adapted and structured questionnaires were administered to the students to obtain information on their levels of awareness and knowledge on reporting of ADRs. Simple descriptive statistics was used to analyze the data that were obtained. The result showed that over 72% of the students from each of the Schools had good knowledge of ADR, about 62% were aware of ADR reporting system, while less than 50% had knowledge of the process of reporting ADRs.&#x0D; Final year students of College of Health Science and Technology, Port Harcourt have good knowledge of ADR. However, their awareness of the reporting system and particularly the process of reporting (pharmacovigilance) is poor and needs improvement.&#x0D; Keywords: Awareness, adverse drug reaction, pharmacovigilance

A study on use of over-the-counter drugs among 2nd year medical students - A cross-sectional study

Background: Over-the-counter (OTC) drug is a medicine that is available without a prescription, and hence also referred to as “nonprescription drug.” The sale of OTC medicines from pharmacies can help individual’s self-manage symptoms. However, some OTC medicines may be abused, with addiction and harms being increasingly recognized and found to be more common in undergraduate medical students. Aim and Objective: Objective of this study to analyze the use of OTC drugs among 2nd year medical students. Materials and Methods: A prospective, cross-sectional, and questionnaire based study was conducted among 2nd year medical students of Belagavi Institute of Medical Sciences Belagavi. Details and purpose of the study were explained to students and informed consent was taken. Questionnaires consist of 25 questions related to use of OTC drugs, their knowledge and attitude toward OTC drugs. Questionnaires are then collected back from students on the spot after 15 min. All the data pooled and results are analyzed in descriptive statistics. Results: A total of 88 respondents were analyzed, 87.5% participants knew the definition of OTC and 69.5% use medication without prescription. All the students practiced self-medication however only 37.5% students agree with practice. Fever, cold, and headache are the most common condition for using OTC drugs. Analgesic, antipyretics, and antihistamines are the highest among OTC stocked at home. About 61.3% students have knowledge of Adverse Drug Reactions associated with OTC drugs. Conclusion: Use of OTC drugs is common form of health care having potential benefits and health hazards. Awareness should be created among students to restrict the use of self-medication and pharmacists toward sale of drugs without prescription.

Teaching Pharmacovigilance to Undergraduate Students: Our Experience in Poor-Resource Setting.

Using medicines associated with adverse drug reactions (ADRs) might cause serious health complications. The pharmacist plays a unique role in monitoring ADRs, either by themselves or with the assistance of other health-care professionals, to diminish the hazards of ADRs by distinguishing, reporting, and evaluating any proposed ADRs. To train future pharmacists who have adequate knowledge of ADRs and related aspects, it is highly recommended to introduce the WHO-ISoP pharmacovigilance (PV) in the core curriculum. In this article, we shared the suggested curriculum in Aden University. It is based on comprehensive outlines and reference books that offer a broad view of all aspects related to PV. A brief student course evaluation was carried out. Fifty students participated in the survey. Students expressed the importance of the course and indicated that they wanted to know more about the types of ADRs and common medication errors. Some of them lacked an understanding of the causal relationship between ADRs and risk assessment and not familiar with the reporting forms. They suggested for PV awareness programs for health-care staff and public. The curriculum should be tailored according to the country's needs because each country has its own medication safety issues and PV program. To reach the ultimate objective, this article reports the initiative to develop PV proficiencies in a university setting.

Adverse drug reactions reporting practice and associated factors among community health extension workers in public health facilities, Southwest, Nigeria.

Introductiontimely adverse drug reactions (ADRs) reporting has contributed immensely towards public health safety. Community health extension workers (CHEWs) provides basic medical care in rural areas. This study assessed the knowledge, attitude, practice, and determinants of ADRs reporting among CHEWs in public health institutions, Southwest, Nigeria.Methodsa cross-sectional survey of 333 CHEWs randomly selected from public health facilities using self-administered questionnaires. The questionnaire sought information on the knowledge, attitude and practice of CHEWs towards ADRs reporting. The knowledge and attitude questions were scored and categorized. The association between dependent and independent variables assessed with bivariate and multivariate logistic regressions, and p < 0.05 considered statistically significant.Resultsamong 333 respondents, 205 (61.6%) had encountered patients with ADRs but only 26 (12.6%) had reported it with yellow forms. About half, 169 (50.8%), and 191 (57.4%) respondents had a positive attitude and inadequate knowledge of ADRs reporting respectively. Sex (aOR: 2.84, 95% CI: 2.10-7.10; p < 0.0001), working in Ogbomoso area (aOR: 3.3, 95% CI: 1.34-8.21; p=0.01), and training (aOR: 2.01, 95% CI: 1.20-3.42; p = 0.01) were factors associated with adequate knowledge. The determinant of ADRs reporting was training (aOR: 3.63, 95% CI: 1.13-11.63; p = 0.03).Conclusionthough CHEWs had a slightly positive attitude, they had inadequate knowledge and poor ADRs reporting. The determinant of inadequate ADRs reporting knowledge and under reporting was lack of training. There is an urgent need for educational intervention programmes towards improving knowledge and practices of ADRs reporting among CHEWs.

Barriers to adverse drug reaction reporting in Malaysia: a narrative review based on theoretical domains framework

Abstract Objectives This review aims to determine the common barriers to adverse drug reaction (ADR) reporting in Malaysia based on theoretical domains framework (TDF). Methods Three online databases, PubMed (Medline), Scopus and Web of Science, were searched from 2000 to 2020 to identify related quantitative and qualitative studies. Key findings Eleven articles were reviewed – nine quantitative and two qualitative studies. Three domains from TDF were identified as the most common: (1) knowledge, (2) skills and (3) environmental context and resources. Lack of awareness of an ADR reporting system, lack of clinical and ADR knowledge and lack of time were identified as the main barriers. Additionally, assumption of healthcare professionals (HCPs) of ADR to be too insignificant or too well known and unavailability of the ADR form were also reported as barriers for reporting an ADR. Conclusions The findings from this narrative review could be useful for the policymakers in planning strategies at the national level to improve the reporting rate of ADR in Malaysia. It is necessary to promote and publicize pharmacovigilance activities and to enhance communication and engagement between the Malaysian ADR Advisory Committee and the HCPs and consumers. There is also a need to increase training and continuous education related to ADR and pharmacovigilance system and making ADR reporting compulsory for all HCPs.