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Journal of Biomedical Informatics Apr 2015Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently... (Review)
Review
OBJECTIVE
Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media.
METHODS
We identified studies describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to extract ADR information posted by users on any publicly available social media platform. We categorized the studies according to different characteristics such as primary ADR detection approach, size of corpus, data source(s), availability, and evaluation criteria.
RESULTS
Twenty-two studies met our inclusion criteria, with fifteen (68%) published within the last two years. However, publicly available annotated data is still scarce, and we found only six studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been the most popular.
CONCLUSION
Our review suggests that interest in the utilization of the vast amounts of available social media data for ADR monitoring is increasing. In terms of sources, both health-related and general social media data have been used for ADR detection-while health-related sources tend to contain higher proportions of relevant data, the volume of data from general social media websites is significantly higher. There is still very limited amount of annotated data publicly available , and, as indicated by the promising results obtained by recent supervised learning approaches, there is a strong need to make such data available to the research community.
Topics: Adverse Drug Reaction Reporting Systems; Humans; Internet; MEDLINE; Pharmacovigilance; Public Health; Social Media
PubMed: 25720841
DOI: 10.1016/j.jbi.2015.02.004 -
Therapie Apr 2016The aim of this article is to discuss the contribution of pharmacoepidemiology to pharmacovigilance in the context of drug safety monitoring. Because this contribution...
The aim of this article is to discuss the contribution of pharmacoepidemiology to pharmacovigilance in the context of drug safety monitoring. Because this contribution requires a comparison of the approaches and a presentation of their respective merits, we have tried to show that this comparison did not necessarily mean opposing these methods, which would not serve any useful purpose. We wanted to underline the fact that the notion of contribution of one to the other implied a complementarity that we propose to demonstrate. Pharmacovigilance is essentially based on the study of spontaneous reports and the clinical and pharmaceutical analysis of the implication of given drugs in adverse drug reactions. It yields performances that are unequalled to this day when safety warning signs relate to rare adverse events or to drugs that are rarely used, or when the drug-related event has specificities that are not found for other aetiologies. Pharmacoepidemiology for its part, through its population-related studies and the possible use of a comparison group, enables a quantification of risks that is impossible to carry out using spontaneous reporting alone. It also enables the highlighting and quantification of safety signals for events that are frequent and multifactorial, where the role of a drug in individual cases can be difficult to detect, and therefore difficult to identify from spontaneous reporting. All in all, this is the major contribution of pharmacoepidemiology to pharmacovigilance, where it can be said that it complements pharmacovigilance in drug safety monitoring but in no way could replace it.
Topics: Adverse Drug Reaction Reporting Systems; Drug Monitoring; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacoepidemiology; Pharmacovigilance; Risk Assessment
PubMed: 27080840
DOI: 10.1016/j.therap.2016.02.016 -
European Journal of Clinical... Feb 2023Because patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities,...
INTRODUCTION
Because patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities, European competent authorities implemented regulations to allow direct reporting of adverse drug reactions related to medicinal products by patients in 2012.
OBJECTIVES
To describe evolution and analyze determinants of patient reporting activity in France in order to assess patient involvement in pharmacovigilance.
METHOD
Using the French national pharmacovigilance database, univariate and multivariate analyses were performed to compare the characteristics of adverse drug reaction (ADR) reports from patients and healthcare professionals (HCP) between 2011 and 2020. The relationship between regional patient ADR report activity and regional care provision and socio-professional characteristics was analyzed using the principal component analysis.
RESULTS
A significant and higher increase in ADR reports over time from patients (r = 0.89, p < 0.001) compared to HCP (r = 0.27, p = 0.002) has been observed. Patient ADR report activities compared to HCP concerned more women (80% vs. 55%, p < 0.001), younger age classes (p < 0.001), reporting through web portal (83% vs. 17%, p < 0.001), and less serious events (26% vs. 63%, p < 0.001). In the principal component analysis, regional patient reporting activity was related to socio-professional categories, age classes, and densities of hospital beds and physicians.
CONCLUSION
Our results confirm an increasing involvement of patients in ADR report activities. The determinants of patient reporting activities are not only related to drug and medical factors but also to social factors. Digital tools may also play a role in health democracy in pharmacovigilance.
Topics: Humans; Female; Patient Participation; Pharmacovigilance; Adverse Drug Reaction Reporting Systems; Physicians; France; Drug-Related Side Effects and Adverse Reactions
PubMed: 36508012
DOI: 10.1007/s00228-022-03422-y -
Therapie 2022The rapid spread of Covid-19 pandemic globally has thrust drugs safety into the spotlight and the public is now more aware of the role of healthcare professionals and...
The rapid spread of Covid-19 pandemic globally has thrust drugs safety into the spotlight and the public is now more aware of the role of healthcare professionals and health regulators. The present study aimed to measure the global research landscape on pharmacovigilance (PV) indexed in Scopus database for eleven years period spanning from 2010-2020. The study has sought to use quantitative and visualization technologies for data analysis and interpretation. The search strategy accumulated a total of 2052 global publications data on PV. The findings disclose that the global research productivity on PV registered 8.74% average growth rate (AGR) and 7.38% compound average growth rate (CAGR). The mean relative growth rate (RGR) and doubling time (DT) of PV global publications for the 11 years is 0.27 and 3.03, respectively. The average number of authors per paper (AAPP) is 1.52 and average productivity per author (PPA) is 0.68. The authorship patterns in PV research shows collaborative trend as most of the publications have been published by multiple authors (80.75%). The mean values of degree of collaboration (DC), collaboration index (CI), collaboration coefficient (CC) and modified collaboration coefficient (MCC) during the selected period of study are 0.79, 2.74, 0.72, and 0.73, respectively which highly significant and indicates the better authorship collaborations. France is the bellwether in PV related scientific research as produced the highest number of publications.
Topics: Authorship; Biomedical Research; COVID-19; Humans; Pandemics; Pharmacovigilance
PubMed: 34972583
DOI: 10.1016/j.therap.2021.11.011 -
The Indian Journal of Medical Research Nov 2015
Topics: Drug-Related Side Effects and Adverse Reactions; Female; Gastritis; Humans; Male; Pharmacovigilance
PubMed: 26658601
DOI: No ID Found -
Drug Safety May 2022Effective identification of previously implausible safety signals is a core component of successful pharmacovigilance. Timely, reliable, and efficient data ingestion and...
Effective identification of previously implausible safety signals is a core component of successful pharmacovigilance. Timely, reliable, and efficient data ingestion and related processing are critical to this. The term 'black swan events' was coined by Taleb to describe events with three attributes: unpredictability, severe and widespread consequences, and retrospective bias. These rare events are not well understood at their emergence but are often rationalized in retrospect as predictable. Pharmacovigilance strives to rapidly respond to potential black swan events associated with medicine or vaccine use. Machine learning (ML) is increasingly being explored in data ingestion tasks. In contrast to rule-based automation approaches, ML can use historical data (i.e., 'training data') to effectively predict emerging data patterns and support effective data intake, processing, and organisation. At first sight, this reliance on previous data might be considered a limitation when building ML models for effective data ingestion in systems that look to focus on the identification of potential black swan events. We argue that, first, some apparent black swan events-although unexpected medically-will exhibit data attributes similar to those of other safety data and not prove algorithmically unpredictable, and, second, standard and emerging ML approaches can still be robust to such data outliers with proper awareness and consideration in ML system design and with the incorporation of specific mitigatory and support strategies. We argue that effective approaches to managing data on potential black swan events are essential for trust and outline several strategies to address data on potential black swan events during data ingestion.
Topics: Automation; Humans; Pharmacovigilance; Retrospective Studies
PubMed: 35579807
DOI: 10.1007/s40264-022-01169-0 -
Israel Journal of Health Policy Research Jun 2019The Israeli Ministry of Health has set up the foundations of a National Pharmacovigilance System. The next step is to adopt the best of the international ideas, trends...
The Israeli Ministry of Health has set up the foundations of a National Pharmacovigilance System. The next step is to adopt the best of the international ideas, trends and approaches which are shaping the future of pharmacovigilance. Specifically: 1) The risk management approach requires proactively preventing or minimizing risks, starting in early clinical development and extending all along the lifecycle of a pharmaceutical. 2) Drug safety is a multidisciplinary discipline where all stakeholders should be involved. 3) Clinical trials provide an ideal safety profile limited to the restrictive conditions of the trial. Only real-world data, from the post marketing period, will reveal the real risk/benefit balance for the use of a pharmaceutical in regular clinical care. 4) Artificial intelligence is needed to analyze the large amount of data collected through the post-marketing studies, electronic medical records and the internet. Many AI tools have been developed to support better use of pharmaceuticals. 5) Quality-oriented, thorough inspections and audits are critical for achieving patient safety. 6) Patients should be recognized as active players in their treatment who can, and should, have access to safety information through the major agencies' websites.Israel can benefit from several of its key assets to reach a higher level of pharmacovigilance: 1) Israel's four HMOs are organized in a way that allows them to have quick and efficient dialogue with healthcare professionals and with patients. Moreover, a new project named, Big Data in Health, will pool the epidemiologic databases of the HMOs, providing precious information for understanding risk factors, detecting alerts, and developing personalized medicine. 2) Formal risk management activities have long been part of the culture of hospitals and should be applied increasingly to ensuring drug safety.Israel has the organizational, scientific, technological and cultural resources needed to quickly overcome the challenges and go beyond its current state to build a unique pharmacovigilance system which could serve as an example for other countries.
Topics: Delivery of Health Care; Drug Industry; Humans; Israel; Pharmacovigilance
PubMed: 31217025
DOI: 10.1186/s13584-019-0319-3 -
BMJ Global Health May 2021This paper explores the pipeline of new and upcoming vaccines as it relates to monitoring their safety. Compared with most currently available vaccines, that are... (Review)
Review
This paper explores the pipeline of new and upcoming vaccines as it relates to monitoring their safety. Compared with most currently available vaccines, that are constituted of live attenuated organisms or inactive products, future vaccines will also be based on new technologies. Several products that include such technologies are either already licensed or at an advanced stage of clinical development. Those include viral vectors, genetically attenuated live organisms, nucleic acid vaccines, novel adjuvants, increased number of antigens present in a single vaccine, novel mode of vaccine administration and thermostabilisation. The Global Advisory Committee on Vaccine Safety (GACVS) monitors novel vaccines, from the time they become available for large scale use. GACVS maintains their safety profile as evidence emerges from post-licensure surveillance and observational studies. Vaccines and vaccine formulations produced with novel technologies will have different safety profiles that will require adapting pharmacovigilance approaches. For example, GACVS now considers viral vector templates developed on the model proposed by Brighton Collaboration. The characteristics of those novel products will also have implications for the risk management plans (RMPs). Questions related to the duration of active monitoring for genetic material, presence of adventitious agents more easily detected with enhanced biological screening, or physiological mechanisms of novel adjuvants are all considerations that will belong to the preparation of RMPs. In addition to assessing those novel products and advising experts, GACVS will also consider how to more broadly communicate about risk assessment, so vaccine users can also benefit from the committee's advice.
Topics: Advisory Committees; Humans; Pharmacovigilance; Risk Assessment; Vaccines
PubMed: 34011500
DOI: 10.1136/bmjgh-2020-003403 -
International Journal of Clinical... Aug 2023Only 5-10% of all adverse drug reactions (ADRs) are reported. Mechanisms to support patient and public reporting offer numerous advantages to health care systems... (Review)
Review
BACKGROUND
Only 5-10% of all adverse drug reactions (ADRs) are reported. Mechanisms to support patient and public reporting offer numerous advantages to health care systems including increasing reporting rate. Theory-informed insights into the factors implicated in patient and public underreporting are likely to offer valuable opportunity for the development of effective reporting-interventions and optimization of existing systems.
AIM
To collate, summarize and synthesize the reported behavioral determinants using the theoretical domains framework (TDF), that influence patient and public reporting of ADRs.
METHOD
Cochrane, CINAHL, Web of science, EMBASE and PubMed were systematically searched on October 25th, 2021. Studies assessing the factors influencing public or patients reporting of ADRs were included. Full-text screening, data extraction and quality appraisal were performed independently by two authors. Extracted factors were mapped to TDF.
RESULTS
26 studies were included conducted in 14 countries across five continents. Knowledge, social/professional role and identity, beliefs about consequences, and environmental context and resources, appeared to be the most significant TDF domains that influenced patient and public behaviors regarding ADR reporting.
CONCLUSION
Studies included in this review were deemed of low risk of bias and allowed for identification of key behavioural determinants, which may be mapped to evidence-based behavioral change strategies that facilitate intervention development to enhance rates of ADR reporting. Aligning strategies should focus on education, training and further involvement from regulatory bodies and government support to establish mechanisms, which facilitate feedback and follow-ups on submitted reports.
Topics: Humans; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Patients; Government; Pharmacovigilance
PubMed: 37247158
DOI: 10.1007/s11096-023-01591-z -
Drug Safety Jul 2022
Topics: Adverse Drug Reaction Reporting Systems; China; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Societies
PubMed: 35751833
DOI: 10.1007/s40264-022-01195-y