OBJECTIVE: From the considerable amount of clinical narrative text, natural language processing (NLP) researchers have developed methods for extracting ADEs and their related attributes. This work presents a systematic review of current methods.
METHODOLOGY: Two biomedical databases have been searched from June 2022 until December 2023 for relevant publications regarding this review, namely the databases PubMed and Medline. Similarly, we searched the multi-disciplinary databases IEEE Xplore, Scopus, ScienceDirect, and the ACL Anthology. We adopted the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement guidelines and recommendations for reporting systematic reviews in conducting this review. Initially, we obtained 5,537 articles from the search results from the various databases between 2015 and 2023. Based on predefined inclusion and exclusion criteria for article selection, 100 publications have undergone full-text review, of which we consider 82 for our analysis.
RESULTS: We determined the general pattern for extracting ADEs from clinical notes, with named entity recognition (NER) and relation extraction (RE) being the dual tasks considered. Researchers that tackled both NER and RE simultaneously have approached ADE extraction as a "pipeline extraction" problem (n = 22), as a "joint task extraction" problem (n = 7), and as a "multi-task learning" problem (n = 6), while others have tackled only NER (n = 27) or RE (n = 20). We further grouped the reviews based on the approaches for data extraction, namely rule-based (n = 8), machine learning (n = 11), deep learning (n = 32), comparison of two or more approaches (n = 11), hybrid (n = 12) and large language models (n = 8). The most used datasets are MADE 1.0, TAC 2017 and n2c2 2018.
CONCLUSION: Extracting ADEs is crucial, especially for pharmacovigilance studies and patient medications. This survey showcases advances in ADE extraction research, approaches, datasets, and state-of-the-art performance in them. Challenges and future research directions are highlighted. We hope this review will guide researchers in gaining background knowledge and developing more innovative ways to address the challenges.
METHODS: A systematic and comprehensive articles search strategy was carried out in different seven electronic databases (PubMed, PubMed Central, Goggle Scholar, Ovid-SP, MEDLINE, Wiley Online Library, DergiPark) from 2010 to 2020. We searched to identify existing literature about cross-sectional observational studies investigating the KAP of HCPs regarding PV and ADRs reporting in different geographical regions of Turkey. Quality assessment and risk of bias were assessed among included studies.
RESULTS: Fifteen studies were chosen for full-text analysis. Finally, according to inclusion criteria, seven research articles were selected for systematic review. Overall, the KAP of HCPs varies across the studies. The lack of a standardized validated measuring tool to evaluate the KAP and differences in questionnaire items were the main limitations in included studies. Around, 69.1% (range: 54.6-100%) of HCPs were not aware of the national pharmacovigilance center in Turkey. About, 37.5% (range: 7.1-75.7%) of HCPs believed that reporting of ADRs is not important and 87.5% (range: 69.3-100%) stated that they never reported ADR previously during their practice. The most frequently highlighted barriers to PV were lack of time, uncertainty and did not know where to report.
CONCLUSION: This systematic review revealed a major KAP gap in Turkey towards PV activities. Low ADR reporting practice of HCPs was a major identified issue. The creation of a mandatory unified PV education intervention for future HCPs to rationally report ADR of drugs are crucial for a better healthcare system.
Methods: This study analyzed all suspected ADEs related to favipiravir reported from 2015. The reports were analyzed based on age, gender, and seriousness of ADEs at the System Organ Classification (SOC) level and the individual Preferred Term (PT) level.
Results: This study is based on 194 ADEs reported from 93 patients. Most frequent ADEs suspected to be caused by the favipiravir included increased hepatic enzymes, nausea and vomiting, tachycardia, and diarrhea. Severe and fatal ADEs occurred more frequently in men and those over the age of 64 years. Blood and lymphatic disorders, cardiac disorders, hepatobiliary disorders, injury poisoning, and procedural complications were more common manifestations of severe ADEs.
Conclusion: This study revealed that favipiravir appears to be a relatively safe drug. An undiscovered anti-inflammatory activity of favipiravir may explain the improvement in critically ill patients and reduce inflammatory markers. Currently, the data is based on very few patients. A more detailed assessment of the uncommon ADEs needs to be analyzed when more information will be available.
METHODS: A modified questionnaire was sent to the PV team heads of 21 PV agencies based in the APEC countries, between June 28 and September 12, 2017, to gather information on the structure, process, and outcome of PV status in these countries.
RESULTS: Of the 21 APEC countries, 15 responded. We found harmonized laws and regulations for general PV and risk management systems. However, variations were found in PV structure: for example, 11 out of 15 countries had national regulatory representatives responsible for PV in pharmaceutical companies, while four did not. For PV process, discrepancies were also found in the source type of adverse drug reaction (ADR) reports and reporting of medication errors and therapeutic ineffectiveness in cumulative ADR reports. With respect to PV outcomes, among countries that performed active surveillance, the United States of America was more active, with hundreds of projects including additional pharmacoepidemiological studies etc. Among the nine countries that responded, Japan had the greatest number of product label changes followed by Taiwan, Malaysia, and Korea.
CONCLUSION: We have identified substantial variations in the structures, processes, and outcomes of PV status among the countries of the APEC region. Therefore, efforts to reduce variations in the PV administration and regulation are warranted for harmonization of PV within the APEC region.
METHODS: This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database.
RESULTS: Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015).
CONCLUSIONS: Four participating countries had functional PV systems. PV capacity, functionality, and legislative framework varied depending on local healthcare ecosystem networks. Implementing effective communication strategies and/or technical assistance from the advisory committee are needed to strengthen PV in ASEAN. Copyright © 2016 John Wiley & Sons, Ltd.
Methods: A systematic search was conducted in PubMed, Web of Science, Google Scholar, Scopus and Nepal Journal Online (NepJOL) databases. 'Adverse Drug Reactions' or 'ADRs' or 'ADR' or 'Adverse drug reaction' or 'AE' or 'Adverse Event' or 'Drug-Induced Reaction' or 'Pharmacovigilance' or 'PV' and 'Nepal'. The search covered 15 years (January 2004 to December 2018) of study on ADRs and PV in Nepal. Only articles retrieved from databases were included, whereas published/unpublished drug bulletins, pharmacy newsletters and thesis were excluded. The articles thus retrieved were recorded, and thereafter analyzed. Word count code was used for the analysis of keywords used in the retrieved articles.
Results: A total of 124 articles were retrieved, with the highest rate of publications in 2006 and 2007, with 16 papers each. Among the articles, 10 (8.1%) were published in Kathmandu University Medical Journal (KUMJ). Single papers were published in 38 different journals. Brief reports (1.6%), case reports (31.2%), case series (0.8%), education forums (0.8%), letters to the editor (5.6%), original research articles (41.9%), review articles (9.7%), short communications and short reports (8.1%) on ADRs and PV were recorded. Out of 124 papers, 52 (41.9%) were original research publications. The majority (74.1%) of research was done in the category of ADR incidence, types, prevention, and management, followed by policy and suggestions for strengthening national and regional pharmacovigilance centers of Nepal (14.5%).
Conclusions: During the study years, there was an increase in scientific publications on drug safety. A total of 124 published articles were found during bibliometric analysis of ADRs and PV research activities in Nepal.
RESEARCH DESIGN AND METHODS: All suspected ADEs associated with tocilizumab between April to August 2020 were analyzed based on COVID-19 patients' demographic and clinical variables, and severity of involvement of organ system.
RESULTS: A total of 1005 ADEs were reported among 513 recipients. The majority of the ADEs (46.26%) were reported from 18-64 years, were males and reported spontaneously. Around 80%, 20%, and 64% were serious, fatal, and administered intravenously, respectively. 'Injury, Poisoning, and Procedural Complications' remain as highest (35%) among categorized ADEs. Neutropenia, hypofibrinogenemia were common hematological ADEs. The above 64 years was found to have significantly lower odds than of below 45 years. In comparison, those in the European Region have substantially higher odds compared to the Region of Americas.
CONCLUSION: Neutropenia, superinfections, reactivation of latent infections, hepatitis, and cardiac abnormalities were common ADEs observed that necessitate proper monitoring and reporting.
Methods: A qualitative approach was used to conduct this study. A semi-structured interview guide was developed, 10 hospital pharmacists were recruited and interviewed through convenience sampling technique. All interviews were audio-taped, transcribed verbatim, and were then analyzed for thematic contents analysis.
Results: Thematic content analysis of the interviews resulted in 6 major themes, including (1) Familiarity with medication safety & adverse drug reaction concept (2) Current system of practice and reporting of adverse drug reaction in hospital setting, (3) Willingness to accept the practice change (4) Barriers to adverse drug reaction reporting, (5) Policy change needs and (6) The recognition of the role. Majority of the hospital pharmacists were familiar with the concept of medication safety and ADR reactions reporting however they were unaware of the existence of national ADR reporting system in Pakistan. Several barriers hindering ADR reporting were identified including lack of awareness and training, communication gap between the hospitals and regulatory authorities.
Conclusion: The study revealed that that hospital pharmacists were good in understanding of medication safety and ADR reporting; however they don't practice this in real sense. The readiness of the hospital pharmacist towards the practice change has indicated that they are all set to be actively involved in the provision of medication safety in hospital setting. Involvement of key stake holders from ministry of health, academia, pharmaceutical industry and healthcare professionals is warranted to promote safe and effective use of medicines.
METHODS: Literature search using electronic databases including PubMed, Google Scholar and National Medical Research Register was conducted. Additional articles were identified by reviewing the bibliography of the retrieved articles. The articles were searched with any of the Medical Subject Headings (MeSH) terms in the title: adverse drug reaction, attitude, awareness, behaviour, experience, knowledge, Malaysia, perspectives, pharmacovigilance, practice and view. Studies were selected based on fulfilment of inclusion and exclusion criteria. The articles were scrutinised using thematic analysis.
KEY FINDINGS: Nine studies conducted among doctors, pharmacists and nurses met the inclusion criteria. Five themes emerged which included knowledge, attitude, practice, barriers and facilitators of adverse drug reaction reporting among healthcare professionals.
CONCLUSION: In general, healthcare professionals in Malaysia have good knowledge on and positive attitudes towards adverse drug reaction reporting. However, the practice of adverse drug reaction reporting was found to be unsatisfactory among healthcare professional in Malaysia. The approaches taken to enhance ADR reporting among Malaysian healthcare professionals should focus on alleviating lethargy and ignorance associated with ADR reporting.