Practice Of Pharmacovigilance Research Articles

Pharmacovigilance Practices by Healthcare Providers in Oncology: A Cross-Sectional Study

Pharmacovigilance Practices by Healthcare Providers in Oncology: A Cross-Sectional Study

Global trends in pharmacovigilance-related events: a 30-year analysis from the 2019 global burden of disease study.

Establishing effective pharmacovigilance systems globally is challenging due to the need for comprehensive epidemiological data on pharmacovigilance-related events, particularly in countries at different stages of development. This study aimed to determine magnitude and drivers of change in the global and regional burden of pharmacovigilance-related events from 1990 to 2019, analyzing variations between age groups and sex, providing data support for policymakers to adjust their pharmacovigilance policies. Pharmacovigilance-related events were defined as Adverse Effects of Medical Treatment (AEMT) and Drug Use Disorders (DUD) in the Global Burden of Diseases, Injuries, and Risk Factors Study 2019. Time trend analysis utilized joinpoint regression, age-period-cohort model, and decomposition method. Disease burden was measured in incidence, deaths, and disability-adjusted life years (DALYs). The global burden of pharmacovigilance-related events remained high, driven predominantly by population growth. Children and older adults were identified as particularly susceptible groups. Across various regions and periods of the socio-demographic index (SDI), the risk of death from AEMT showed a decreasing trend. In contrast, the incidence of AEMT and both the incidence and death rates from DUD showed a stable or worsening trend. Significant regional disparities in the burden of these diseases were noted between different SDI levels. The study underscores the critical need for robust pharmacovigilance systems worldwide. The observed trends in the burden of pharmacovigilance-related events offer a clear direction for countries to refine and strengthen their pharmacovigilance policies and practices.

Impact of Educational Intervention on Knowledge, Attitude & Practice About Pharmacovigilance in Nursing Students in A Tertiary Care Teaching Hospital in India: A Cross-Sectional Study

Background: It is crucial for healthcare professionals to know how to report adverse drug reactions (ADRs). To improve reporting rates, it is essential to improve knowledge, attitude and practice (KAP) of healthcare professionals regarding Pharmacovigilance (PV) and adverse drug reactions (ADR) reporting. According to previous studies, there has been a lack of knowledge in nursing students regarding Pharmacovigilance (PV) and reporting of adverse drug reactions (ADR). Hence, this study was planned to assess the impact of educational intervention on nursing students' knowledge, attitude, and practice of pharmacovigilance at a tertiary care teaching hospital in India. Materials and Methods: This was an interventional study conducted among 93 BSc nursing students at a tertiary care teaching hospital, India. Each participant was explained the purpose of study and asked to fill in a questionnaire about their knowledge, attitude and practice of pharmacovigilance. The post-KAP questionnaire was re-circulated among participants at the end of the intervention and data was analyzed using Chi square test. Results: The study involved 93 BSc nursing students aged 21.52 ± 1.11 years, with a male to female ratio of 1:2. All statistical calculations were performed using Graph Pad prism v10.1.0. Results showed significant differences in understanding pharmacovigilance between pre-intervention and post-intervention, and a significant change in attitudes towards pharmacovigilance due to the educational intervention. A statistically greater proportion of students learned about Pharmacovigilance and ADR reporting forms. Conclusion: The Continuing Medical Education (CME) and group discussions significantly enhanced the knowledge and attitude of nursing students regarding pharmacovigilance.

BERT-based language model for accurate drug adverse event extraction from social media: implementation, evaluation, and contributions to pharmacovigilance practices.

Social media platforms serve as a valuable resource for users to share health-related information, aiding in the monitoring of adverse events linked to medications and treatments in drug safety surveillance. However, extracting drug-related adverse events accurately and efficiently from social media poses challenges in both natural language processing research and the pharmacovigilance domain. Recognizing the lack of detailed implementation and evaluation of Bidirectional Encoder Representations from Transformers (BERT)-based models for drug adverse event extraction on social media, we developed a BERT-based language model tailored to identifying drug adverse events in this context. Our model utilized publicly available labeled adverse event data from the ADE-Corpus-V2. Constructing the BERT-based model involved optimizing key hyperparameters, such as the number of training epochs, batch size, and learning rate. Through ten hold-out evaluations on ADE-Corpus-V2 data and external social media datasets, our model consistently demonstrated high accuracy in drug adverse event detection. The hold-out evaluations resulted in average F1 scores of 0.8575, 0.9049, and 0.9813 for detecting words of adverse events, words in adverse events, and words not in adverse events, respectively. External validation using human-labeled adverse event tweets data from SMM4H further substantiated the effectiveness of our model, yielding F1 scores 0.8127, 0.8068, and 0.9790 for detecting words of adverse events, words in adverse events, and words not in adverse events, respectively. This study not only showcases the effectiveness of BERT-based language models in accurately identifying drug-related adverse events in the dynamic landscape of social media data, but also addresses the need for the implementation of a comprehensive study design and evaluation. By doing so, we contribute to the advancement of pharmacovigilance practices and methodologies in the context of emerging information sources like social media.

Pharmacovigilance in Nigeria: Addressing challenges in ensuring drug safety and monitoring adverse effects

This paper examines the specific challenges faced by Nigeria in implementing pharmacovigilance measures to ensure drug safety and monitor adverse effects. Despite the critical importance of pharmacovigilance in safeguarding public health, Nigeria grapples with several obstacles in its implementation. Through a nuanced exploration of literature and regulatory frameworks, this study sheds light on the unique hurdles encountered in pharmacovigilance practices within the Nigerian context. Challenges in Nigeria's pharmacovigilance landscape include limited awareness and understanding of pharmacovigilance principles among healthcare professionals and consumers, resulting in underreporting of adverse drug reactions. Additionally, there is a lack of robust infrastructure and resources for pharmacovigilance activities, including inadequate funding, shortage of trained personnel, and deficient pharmacovigilance databases. Regulatory enforcement and oversight are also hindered by issues such as weak regulatory frameworks, fragmented reporting systems, and suboptimal collaboration among regulatory agencies. Furthermore, Nigeria's pharmacovigilance efforts are compounded by factors such as the proliferation of counterfeit and substandard medicines, informal drug markets, and cultural beliefs influencing healthcare-seeking behaviors. These challenges pose significant barriers to effective pharmacovigilance implementation and compromise patient safety and public health outcomes in Nigeria. Addressing these challenges requires a multifaceted approach encompassing regulatory reforms, capacity building initiatives, public awareness campaigns, and collaboration with international partners. Strengthening regulatory frameworks, enhancing healthcare professional training on pharmacovigilance, establishing robust reporting systems, and fostering partnerships between regulatory agencies, healthcare institutions, and pharmaceutical companies are essential steps toward improving pharmacovigilance practices in Nigeria. Through a thorough examination of the Nigerian context, this paper aims to raise awareness of the specific challenges hindering pharmacovigilance implementation in the country and stimulate dialogue on potential solutions to enhance drug safety and monitoring of adverse effects in Nigeria's healthcare system.

Cross-sectional study of pharmacovigilance knowledge, attitudes, and practices based on structural equation modeling and network analysis: a case study of healthcare personnel and the public in Yunnan Province.

This study focuses on understanding pharmacovigilance knowledge, attitudes, and practices (KAP) in Yunnan Province, employing Structural Equation Modeling (SEM) and network analysis. It aims to evaluate the interplay of these factors among healthcare personnel and the public, assessing the impact of demographic characteristics to inform policy and educational initiatives. A cross-sectional survey was conducted in Yunnan, targeting healthcare personnel and the public. Data collection was through questionnaires, with subsequent analysis involving correlation matrices, network visualization, and SEM. The data analysis utilized SPSS 27.0, AMOS 26.0, and Gephi software for network analysis. This study evaluated pharmacovigilance KAP among 209 public participants and 823 healthcare personnel, uncovering significant differences. Public respondents scored averages of 4.62 ± 2.70 in knowledge, 31.99 ± 4.72 in attitudes, and 12.07 ± 4.96 in practices, while healthcare personnel scored 4.38 ± 3.06, 27.95 ± 3.34, and 7.75 ± 2.77, respectively. Statistically significant correlations across KAP elements were observed in both groups, highlighting the interconnectedness of these factors. Demographic influences were more pronounced among healthcare personnel, emphasizing the role of professional background in pharmacovigilance competency. Network analysis identified knowledge as a key influencer within the pharmacovigilance KAP network, suggesting targeted education as a vital strategy for enhancing pharmacovigilance engagement. The research reveals a less-than-ideal state of pharmacovigilance KAP among both healthcare personnel and the public in Yunnan, with significant differences between the two groups. SEM and network analysis confirmed a strong positive link among KAP components, moderated by demographics like age, occupation, and education level. These insights emphasize the need to enhance pharmacovigilance education and awareness, thereby promoting safer drug use.

IMPACT OF AN EDUCATIONAL INTERVENTION ON AWARENESS OF PHARMACOVIGILANCE AND ADR REPORTING AMONGST AYURVEDIC POST-GRADUATE STUDENTS

Objective: Adverse drug reactions (ADR) are one of the major causes of morbidity and mortality. Ayurveda is one of the oldest healthcare systems, widely practiced in India and there is a misconception that AYU and H drugs are free from ADRs. Post-graduate (PG) students are fresh pass-out medical graduates and are major contributors in providing health care at tertiary care centres. The present study was planned with the aim of evaluation of knowledge, attitude and practice of pharmacovigilance amongst PG students and impact of an educational intervention on their knowledge and attitude.
 Methods: A pre-test, post-test questionnaire based cross-sectional study was conducted. 41 postgraduate students from different branches were included. An educational intervention in the form of sensitization programme, including basic knowledge of pharmacovigilance, monitoring system for pharmacovigilance andcase-based ADR reporting was conducted. A validated questionnaire consisting of questions regarding knowledge, attitude and practice of pharmacovigilance was provided as a pre-test and post-test and the results were statistically evaluated.
 Results: Scores of pre-test reveals that the participants were aware of basic knowledge of pharmacovigilance but knowledge about reporting procedure and the monitoring system was lacking. The difference in mean scores of pre and post-test was statistically significant. Most of the participants agreed that reporting ADR improves drug safety and frequent sensitization programmes should be conducted but practically, they had not undergone any training/sensitization programme.
 Conclusion: The study reveals that even with the favorable attitude towards drug safety and ADR reporting, the unawareness of PG students about the monitoring system and deficient ADR reporting indicatesa strong need for the conduction of repeated training/sensitization programmes and other suitable methods for encouraging ADR reporting.

Unveiling the future: precision pharmacovigilance in the era of personalized medicine

In the era of personalized medicine, pharmacovigilance faces new challenges and opportunities, demanding a shift from traditional approaches. This article delves into the evolving landscape of drug safety monitoring in the context of personalized treatments. We aim to provide a succinct reflection on the intersection of tailored therapeutic strategies and vigilant pharmacovigilance practices. We discuss the integration of pharmacogenetics in enhancing drug safety, illustrating how genetic profiling aids in predicting drug responses and adverse reactions. Emphasizing the importance of phase IV—post-marketing surveillance, we explore the limitations of pre-marketing trials and the necessity for a comprehensive approach to drug safety. The article discusses the pivotal role of pharmacogenetics in pre-exposure risk management and the redefinition of pharmacoepidemiological methods for post-exposure surveillance. We highlight the significance of integrating patient-specific genetic profiles in creating personalized medication leaflets and the use of advanced computational methods in data analysis. Additionally, we examine the ethical, privacy, and data security challenges inherent in precision medicine, emphasizing their implications for patient consent and data management.

Knowledge, attitude and practice of pharmacovigilance among medical students

Background: Spontaneous voluntary adverse drug reaction (ADR) reporting is the backbone for the successful functioning of the Pharmacovigilance Programme of India. The aim of pharmacovigilance is to ensure safe and rational use of medicines, once they are released for general use in the society. Targeting the younger doctor for sensitization toward pharmacovigilance is the key to ensure practice of adverse drug reactions (ADR) reporting in clinical practice. The objectives of this study are to evaluate the knowledge, attitude, and practice (KAP) of pharmacovigilance among medical students at LLRM Medical College, Meerut, a tertiary care teaching hospital. Methods: A cross-sectional study was carried out using a pretested questionnaire. The questionnaire was designed to assess the KAP regarding pharmacovigilance. The medical students (2nd year, final year, and interns) were included in the study. Only the participants who gave their consent were included in the study. Results were calculated by proper statistical analysis. Results: The current study was conducted in a LLRM Medical College, Meerut, which included a total of 250 medical students of which 40% 2nd year, 40% final year students, and 20% interns. Most of them (83%) accepted that reporting ADR is necessary, and pharmacovigilance should be taught in detail to health-care professionals. Conclusions: This study demonstrated that knowledge of pharmacovigilance among medical students is improving gradually and pharmacovigilance and ADR reporting needs to be made compulsory, have better, interesting ways to learn and understand it, so that the students can practice it with confidence in their clinical practice.

Role and Responsibilities of Various Stakeholders in Pharmacovigilance (PV).

Pharmacovigilance (PV) is the science and practice of monitoring, evaluating, understanding, and preventing adverse drug reactions. Pharmacovigilance (PV) was established by the World Health Organization in response to the thalidomide tragedy of 1961. The main purpose of Pharmacovigilance (PV) is to ensure the safety and efficacy of drugs in clinical practice. Stakeholders: Pharmacovigilance (PV) involves various stakeholders, such as patients, pharmacists, pharmaceutical companies, healthcare professionals, and regulatory authorities. Each stakeholder has a different role and responsibility in reporting, processing, analyzing, and communicating information about adverse drug reactions. Patient engagement is a key factor for enhancing Pharmacovigilance (PV) practices. Pharmacovigilance (PV) relies on data from various sources, such as clinical trials, spontaneous reports, electronic medical records, biomedical literature, and patient-reported data in online health forums. These data sources can provide valuable insights into the real-world use and safety of drugs, as well as the preferences and needs of patients. However, these data sources also pose challenges in terms of quality, validity, reliability, and accessibility. Medicinal Chemistry: Medicinal chemistry is the branch of chemistry that deals with the design, synthesis, and evaluation of new drugs and their biological effects. Medicinal chemistry can enhance Pharmacovigilance (PV) practices by finding new therapeutic indications for existing drugs or compounds that have already been tested for safety and efficacy. Medicinal chemistry also requires careful design and evaluation of covalent inhibitors, bi-substrate inhibitors, stabilizers of protein non-effective conformations, and hydrophobic pocket modifiers to ensure their safety and efficacy. Pharmacovigilance (PV) is a dynamic and evolving discipline that requires collaboration, regulation, education, and innovation to improve patient safety and care. This review aims to provide a comprehensive overview of the potential and issues associated with Pharmacovigilance (PV) practices.

Assessment of Knowledge, Attitude, and Practice of Pharmacovigilance and Materiovigilance among Oral Health Practitioners in India

ABSTRACT Aim: This electronic survey was carried out to assess the knowledge, attitude, and practices among the oral health practitioners. Methods: A questionnaire survey was conducted among undergraduates, graduated practitioners, and specialist practitioners. A Google Form that included a specified instruction format, informed consent with a clear description of the purpose of the study, and questions in different categories were sent through Whatsapp and email. Descriptive statistics were used to analyze responses. The association of knowledge and attitude with respect to oral health professionals was analyzed with the Chi-square test. Results: The questionnaire was completed by 570 participants. Thirty percent of participants encountered ADR related to the drugs available in the market and 33.2% of participants encountered adverse reaction related to materials used in practice. ADR should be reported as soon as it is detected, according to this study about 12.1% of participants reported the ADRs, and this reporting is primarily for patient safety. Almost 66.8% of participants perceived that dental products can cause ADR owing to a lack of information about ADR and reporting procedures, or due to fear of legal concerns. Only about 9.5% of the participants had previously attended an ADR workshop. Conclusion: Oral health practitioners have a general understanding of ADR; however, there is substantial evidence of underreporting and a lack of reporting system information. Organizing an orientation program and raising awareness about ADR reporting could help improve spontaneous reporting and better patient care.

Assessment of pharmacovigilance guidelines in the Southern African Development Community: A document review.

Lack of harmonization in pharmacovigilance (PV) practice in resource-limited states in Africa has led to differentiation and marginalization, thus creating an environment where weak or absent PV systems may benefit from regional guidelines. To compare the PV guidelines of Southern African Development Community (SADC) member states to international guidelines and identify areas for improvement for aligning PV practice within the SADC region. We utilized a 73-item checklist to assess the PV guidelines of the SADC member states. Checklist parameters were rated using binary scoring. Only seven (Botswana, Mauritius, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe) of the 16 SADC member states had guidelines to assess. Of these, only four had supporting legislation. All seven national medicines regulatory authorities (NMRA)'s guidelines required reporting of local serious adverse drug reactions (ADRs). Four NMRAs implemented device vigilance; none specified submission timelines for ADRs associated with substandard or falsified medicines. Only three NMRAs required electronic transmission of individual case safety reports in the E2B format. Five NMRAs mandated safety monitoring during interventional clinical trials. Five NMRAs required aggregate reporting through periodic safety update reports. Only two NMRAs required submission of the development safety update report. Regarding risk management, four NMRAs required notification of actions taken by foreign NMRAs and four NMRAs expected to review Dear Healthcare Professional Letters before distribution by the marketing authorization holder. Areas for improvement of guidelines to establish common process standards and allow for synchronized submissions of comparable data to SADC NMRAs are provided.

Knowledge, attitude, and practice of pharmacovigilance among undergraduate medical students in a tertiary care teaching hospital of Northern Maharashtra

Background: Adverse drug reactions (ADRs) contribute significantly among underlying reasons of morbidity and mortality in the health-care system. ADR reporting is the core of pharmacovigilance program but still insufficient reporting by health professionals exists in various part of our country. Aims and Objectives: The study was designed to evaluate the knowledge, attitude, and practice (KAP) of undergraduate medical students about ADR and pharmacovigilance. Materials and Methods: It was a cross-sectional study. Questionnaire was comprising 21 questions to evaluate the KAP of pharmacovigilance among undergraduate medical students. Descriptive statistics were analyzed and analysis of variance test was applied for statistical difference between the groups. Results: One hundred and eighty-six students participated in the study. The average score of 2nd year, 3rd year, and 4th year for knowledge was (4.50, 5.15, and 4.59) and for attitude was (5.37, 5.70, and 5.59) and for practice was (1.14, 1.78, and 1.36). There is a significant difference in average score between groups for knowledge and attitude, but not for practice. They have higher attitude and knowledge, but poor practice regarding pharmacovigilance. Conclusion: Respondent of the study was not completely aware of pharmacovigilance and ADR reporting. There is an increased need to create awareness and to train students about pharmacovigilance.

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 < 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.

A study on knowledge, attitude, and practice of pharmacovigilance and adverse drug reactions awareness among health-care students in a tertiary care teaching hospital, Telangana, India

Background: The training of health-care students in pharmacovigilance (PV) fulfills curriculum requirements as well as providing early exposure for a secured use of medications in the future. Active participation of health-care professionals ensures successful implementation of PV. Aims and Objectives: To assess the knowledge, attitude, and practice of PV among health-care students. Materials and Methods: A cross-sectional, questionnaire-based study was conducted at Mamata Academy of Medical Sciences, Bachupally, between May 1st, 2023, and October 31st, 2023. After obtaining permission from the Institutional Ethics Committee, all health care students were provided with a study questionnaire in Google Docs. Results: Medical undergraduates (57.45%) were a majority of the 369 respondents (79.35%) enrolled. PharmDs had the highest response rate (84.76%), followed by medical (78.52%), and nursing (75.56%). The knowledge of PV terminologies was good among 50.47% of medical students, whereas 48.31% pharm ds were aware of adverse drug reactions (ADR) reporting systems and concerned regulatory authorities. 66.51% of medical students and 57.3% of Pharmds had a positive attitude toward PV. However, most of the nursing students had poor knowledge and expressed a negative attitude. Around 33% of the study participants had encountered ADRs, and 33% of the encountered ADRs were reported. Medical undergraduates had significantly better knowledge and attitude, with a mean (standard deviation) total score of 8.03 (2.08) and 3.78 (0.84), respectively (P < 0.01). Conclusion: The disparity of knowledge and attitude from the practice of PV among medical students and PharmDs consequently emphasizes to enroute our strategic initiatives to address the practical difficulties and foster a better reporting culture in the future.

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.

Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation.

To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible through Individual Case Safety Reports (ICSRs), which are the reports of organized and processed data. Globally, the International Council for Harmonisation (ICH) E2B guideline suggests harmonized activities for the ICSR electronic content and transmission. In America, the Pan American Health Organization (PAHO) is the agency responsible to implement cooperation among its members, which are recognized as National Regulatory Authorities of Reference (NRARs) such as Argentina, Brazil, Canada, Chile, Colombia, Cuba, Mexico, and the United States. PAHO published the 'Good Pharmacovigilance Practices for the Americas' suggesting improvement and harmonization in the region. After reviewing the regulatory framework, it is assumed that all NRARs have a regulated ICSR transmission system (i.e. a systematic vigilance system for collecting, analyzing, and disseminating information from ADRs). However, significant differences exist, such as the requirement for social media vigilance, expedited and non-expedited ICSRs, coding, severity, and transmission. The volume of ICSRs has significantly increased, due to using electronic standards managed by the NRAs, which facilitates early identification of new ADRs, allowing the implementation of novel minimization activities, contributing to the continuous assessment of the benefit-risk balance of medicines. Nevertheless, there is still area for improvement, especially in Latin America.

ADVERSE DRUG REACTIONS AMONG PATIENTS IN DEPARTMENT OF MEDICINE IN A TERTIARY CARE TEACHING HOSPITAL, KOLLAM

Objectives: Pharmacovigilance practices are still in the infancy in India, more so in South India. adverse drug reactions (ADRs) are often underreported and the risks are higher in adults and elderly due to the association of comorbidities, self-medication, combination of indigenous systems of medicines and modern medicine, and so on. The present study was done with the objective to analyze the ADRs among patients in the general medicine department, Government Medical College, Kollam. The primary objective is to determine the prevalence and nature of ADRs and secondary objective to assess the causality, severity, and preventability of the ADRs. Methods: In this cross-sectional study done in the Department of Medicine, Government Medical College, Kollam, 1000 patients of either sex were analyzed using CDSCO ADR reporting forms and the approved scales for causality, severity, and preventability. Results: Among 1000 patients studied, the prevalence of ADRs was 7.6%. The most common system involved were dermatological (41%) followed by cardiovascular (18%) and gastrointestinal and neurology (16% each). Majority of the ADRs came under probable (48.7%) with a Naranjo score of 5 (40.8%), of moderate severity (65.8%) and not preventable (71.1%). Conclusion: ADRs pose a major problem needing hospital stay or prolonging the duration of stay. Developing an ongoing ADR reporting system with continuous motivation and creating awareness among the healthcare professionals for reporting suspected ADRs will help to continue reporting and improving the patient safety. Improved communication of health-care professionals with the pharmacovigilance centers should be promoted for better patient healthcare.

Model for measuring the impact of good pharmacovigilance practices of COVID-19 patients on hcp reactivity: Morocco case study

This paper presents a conceptual model used to evaluate how the improvement of good pharmacovigilance practices by patients during COVID-19 period influences the reactivity of the healthcare professionals (HCPs) in the Draa Tafilalet region in Morocco, concerning the reporting of adverse drug reactions (ADRs) through barriers that influence the reporting from both patients and HCPs. The empirical study is based on a survey submitted to a sample of a total of 180 HCP and on the application of latent variable structural modelling through the partial least squares (PLS) method. The 2017 version of the XL-STAT software served to perform the statistical calculations. The study investigates the reliability and validity of the proposed model. Our conclusions show that the improvement of good pharmacovigilance practices impact positively the reactivity of HCP in terms of ADRs reporting. The reliability of the measurement was &gt; 0.7, which allowed us to test the internal and external validity of our conceptual model. 11 hypotheses were validated against two invalid derivative hypotheses. Spontaneous ADRs reporting is the cornerstone of any pharmacovigilance system aiming to maintain patient safety. Our findings indicate the necessity firstly, to initiate a training program on reporting for all HCPs, and secondly, to inform the general public about the national pharmacovigilance center, where ADRs can be reported. Both initiatives aim to keep the culture of ADR reporting perennial.

Assessment of knowledge, attitude and practice of pharmacovigilance and ADR reporting in health care professionals

Background: Lack of awareness among healthcare professionals is cited as one of the main reasons along with under reporting of adverse drug reactions. Knowledge, attitude, and practice (KAP) studies can help to understand various issues and improve pharmacovigilance system.&#x0D; Objectives: The present study was undertaken to assess the knowledge, attitude, and practices (KAP) regarding pharmacovigilance and ADR reporting among healthcare professionals at the various departments of hospitals in Northern Kerala to get an insight into the causes of under-reporting of ADRs.&#x0D; Materials and Methods: The data was collected using a pre-designed questionnaire. A total of 25multiple choice questions related to knowledge, attitude and practice. There were 6 Knowledge based 7 Attitude and 12 Practice based questions. The participants were graded in three categories as good, fair and poor depending on the mean score. The data were interpreted by calculating the frequencies, one-way ANOVA test.&#x0D; Results: A total of 300 healthcare professionals who completed the questionnaire were considered of which 110 were doctors, 98 were nurses and 92were pharmacist. Among them, doctors have relatively better score than nurses and pharmacists in knowledge and attitude. Most healthcare professionals have showed fair practice in pharmacovigilance and ADR reporting and the pharmacists being the best performers.&#x0D; Conclusion: To facilitate the culture of reporting and creating awareness among health professionals, CME, workshops, conferences, post training reminders such as periodic E-mails and SMS alerts should be conducted. Pharmacovigilance is being taught to some degree in theory, but the knowledge on the practical method is lacking. The existing academic curriculum can be amended to incorporate the application of pharmacovigilance in the medical practice.