-
European Journal of Clinical... Nov 2017The reporting of suspected adverse drug reactions (ADRs) is starting to become routine to nurses. The aim of this review is to underline the role of clinical and... (Review)
Review
PURPOSE
The reporting of suspected adverse drug reactions (ADRs) is starting to become routine to nurses. The aim of this review is to underline the role of clinical and community health nurses in pharmacovigilance and to promote their effective participation in ADR reporting in different countries and for patients of different ages.
METHODS
The PubMed, Scopus and ISI Web of Science databases were searched for research articles published between January 1985 and April 2017 using the search items "pharmacovigilance" AND "nurse;" "adverse drug reaction report" AND "nurse;" "community health nurse" AND "adverse drug reaction."
RESULTS
A total of 987 articles were identified using our search strategy, of which 180 articles remained over after the removal of duplicate articles. Of these 180 studies, upon full review we identified 24 which met the inclusion/exclusion criteria and included these in our review. ADR reports by clinical nurses in some countries are comparable in quality and number to those submitted by physicians or pharmacists. Data on ADRs reported by community nurses are currently not available. However, numerous publications emphasized the challenges faced by nurses in reporting ADRs and the need to include pharmacovigilance training in both clinical and community health nurse academic education.
CONCLUSIONS
Nurses are central actors in pharmacovigilance activities, particularly in identifying ADRs which remain outside the reach of other healthcare providers and in being fundamental to the preservation of the health of patients and of the entire community, with attention to the more vulnerable patients, such as children and the elderly.
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Nurse Specialists; Nurses, Community Health; Pharmacovigilance
PubMed: 28770283
DOI: 10.1007/s00228-017-2309-0 -
AMIA ... Annual Symposium Proceedings.... 2020The development of novel drugs in response to changing clinical requirements is a complex and costly method with uncertain outcomes. Postmarket pharmacovigilance is...
The development of novel drugs in response to changing clinical requirements is a complex and costly method with uncertain outcomes. Postmarket pharmacovigilance is essential as drugs often have under-reported side effects. This study intends to use the power of digital media to discover the under-reported side effects of marketed drugs. We have collected tweets for 11 different Drugs (Alprazolam, Adderall, Fluoxetine, Venlafaxine, Adalimumab, Lamotrigine, Quetiapine, Trazodone, Paroxetine, Metronidazole and Miconazole). We have compiled a vast adverse drug reactions (ADRs) lexicon that is used to filter health related data. We constructed machine learning models for automatically annotating the huge amount of publicly available Twitter data. Our results show that on average 43 known ADRs are shared between Twitter and FAERS datasets. Moreover, we were able to recover on average 7 known side effects from Twitter data that are not reported on FAERS. Our results on Twitter dataset show a high concordance with FAERS, Medeffect and Drugs.com. Moreover, we manually validated some of the under-reported side effect predicted by our model using literature search. Common known and under-reported side effects can be found at https://github.com/cbrl-nuces/Leveraging-digital-media-data-for-pharmacovigilance.
Topics: Diagnostic Tests, Routine; Drug-Related Side Effects and Adverse Reactions; Humans; Internet; Machine Learning; Pharmacovigilance; Social Media
PubMed: 33936417
DOI: No ID Found -
Drug Safety Oct 2019Pharmacovigilance currently faces several unsolved challenges. Of particular importance are issues concerning how to ascertain, collect, confirm, and communicate the... (Review)
Review
Pharmacovigilance currently faces several unsolved challenges. Of particular importance are issues concerning how to ascertain, collect, confirm, and communicate the best evidence to assist the clinical choice for individual patients. Here, we propose that these practical challenges partially stem from deeper fundamental issues concerning the epistemology of pharmacovigilance. After reviewing some of the persistent challenges, recent measures, and suggestions in the current pharmacovigilance literature, we support the argument that the detection of potential adverse drug reactions ought to be seen as a serendipitous scientific discovery. We further take up recent innovations from the multidisciplinary field of serendipity research about the importance of networks, diversity of expertise, and plurality of methodological perspectives for cultivating serendipitous discovery. Following this discussion, we explore how pharmacovigilance could be systematized in a way that optimizes serendipitous discoveries of untargeted drug effects, emerging from the clinical application. Specifically, we argue for the promotion of a trans-disciplinary responsive network of scientists and stakeholders. Trans-disciplinarity includes extending the involvement of stakeholders beyond the regulatory community, integrating diverse methods and sources of evidence, and enhancing the ability of diverse groups to raise signals of harms that ought to be followed up by the network. Consequently, promoting a trans-disciplinary approach to pharmacovigilance is a long-term effort that requires structural changes in medical education, research, and enterprise. We suggest a number of such changes, discuss to what extent they are already in process, and indicate the advantages from both epistemological and ethical perspectives.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Interdisciplinary Communication; Pharmacovigilance; Social Networking
PubMed: 31062194
DOI: 10.1007/s40264-019-00826-1 -
Pharmaceutical Medicine Feb 2020TransCelerate's Intelligent Automation Opportunities (IAO) in Pharmacovigilance initiative has been working to evaluate various pharmacovigilance processes to facilitate...
BACKGROUND
TransCelerate's Intelligent Automation Opportunities (IAO) in Pharmacovigilance initiative has been working to evaluate various pharmacovigilance processes to facilitate systematic innovation with intelligent automation across the entire area. The individual case safety report (ICSR) process was the first process selected for evaluation because of its resource-intensive nature, risk of errors, and operational inefficiencies.
OBJECTIVES
TransCelerate's IAO in Pharmacovigilance initiative initially worked to articulate an end-to-end ICSR process that would generically apply to various pharmacovigilance organizations, despite organizational variations in specific ICSR process steps. This paper aims to address the need for a systematic review framework for automation of the ICSR process from the value, impact, perceived risk, and opportunity point of view.
METHODS
The generic ICSR process, which starts with receipt of an adverse event report, was grouped into three process blocks: case intake, case processing, and case reporting. Each of these was then further detailed in individual process steps. A total of 19 TransCelerate member companies were invited to complete a survey designed to facilitate understanding of automation opportunities across the ICSR process. Heat maps of the current level of effort, expected benefit of automation, and perceived risk of automation were compiled from responses to identify intelligent automation opportunities for specific ICSR process steps. Relevant experts on the TransCelerate evaluation team analyzed and interpreted the anonymized and aggregated results.
RESULTS
In total, 15 TransCelerate member companies responded to the survey and indicated that ICSR process steps with current high effort, expected high automation benefit, low or manageable automation risk, and low levels of current automation present the best opportunities for future automation. Such steps include language translations, case verification, in-line quality control, prioritization/triage, data entry, alerts for cases of interest, workflow management, and monitoring. Some steps (e.g., submission) have been automated for a number of years and appear on the heat map as having low potential for further automation. The survey responses implied that, despite successful use of intelligent automation technologies in other areas, adoption within pharmacovigilance and the ICSR process in particular remains limited. The perceived high risk to patient safety is expected to decrease with additional successful applications in pharmacovigilance.
CONCLUSIONS
Our results highlight the areas of greatest opportunity for intelligent automation based on the potential benefits of applying intelligent automation and the perceived risks associated with each ICSR process step. Responding TransCelerate member companies already automate many steps to varying degrees. However, a significant opportunity remains for automation to penetrate further. Additionally, the pharmacovigilance industry culture needs to change in order to reduce the perceived risk of automation and to encourage a more progressive approach to intelligent automation. Increased automation is crucial to empower agile and efficient pharmacovigilance.
Topics: Adverse Drug Reaction Reporting Systems; Automation; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Technology Assessment, Biomedical
PubMed: 32036574
DOI: 10.1007/s40290-019-00320-0 -
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 -
BMJ Open Apr 2024Pharmacovigilance databases play a critical role in monitoring drug safety. The duplication of reports in pharmacovigilance databases, however, undermines their data... (Review)
Review
OBJECTIVES
Pharmacovigilance databases play a critical role in monitoring drug safety. The duplication of reports in pharmacovigilance databases, however, undermines their data integrity. This scoping review sought to provide a comprehensive understanding of duplication in pharmacovigilance databases worldwide.
DESIGN
A scoping review.
DATA SOURCES
Reviewers comprehensively searched the literature in PubMed, Web of Science, Wiley Online Library, EBSCOhost, Google Scholar and other relevant websites.
ELIGIBILITY CRITERIA
Peer-reviewed publications and grey literature, without language restriction, describing duplication and/or methods relevant to duplication in pharmacovigilance databases from inception to 1 September 2023.
DATA EXTRACTION AND SYNTHESIS
We used the Joanna Briggs Institute guidelines for scoping reviews and conformed with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Two reviewers independently screened titles, abstracts and full texts. One reviewer extracted the data and performed descriptive analysis, which the second reviewer assessed. Disagreements were resolved by discussion and consensus or in consultation with a third reviewer.
RESULTS
We screened 22 745 unique titles and 156 were eligible for full-text review. Of the 156 titles, 58 (47 peer-reviewed; 11 grey literature) fulfilled the inclusion criteria for the scoping review. Included titles addressed the extent (5 papers), prevention strategies (15 papers), causes (32 papers), detection methods (25 papers), management strategies (24 papers) and implications (14 papers) of duplication in pharmacovigilance databases. The papers overlapped, discussing more than one field. Advances in artificial intelligence, particularly natural language processing, hold promise in enhancing the efficiency and precision of deduplication of large and complex pharmacovigilance databases.
CONCLUSION
Duplication in pharmacovigilance databases compromises risk assessment and decision-making, potentially threatening patient safety. Therefore, efficient duplicate prevention, detection and management are essential for more reliable pharmacovigilance data. To minimise duplication, consistent use of worldwide unique identifiers as the key case identifiers is recommended alongside recent advances in artificial intelligence.
Topics: Pharmacovigilance; Humans; Databases, Factual; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 38684275
DOI: 10.1136/bmjopen-2023-081990 -
International Journal of Environmental... Dec 2021All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is... (Review)
Review
All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs' safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; European Union; Health Personnel; Humans; Pharmacovigilance
PubMed: 35010673
DOI: 10.3390/ijerph19010413 -
Semergen 2018
Topics: Humans; Pharmacovigilance; Practice Patterns, Physicians'; Primary Health Care
PubMed: 29478464
DOI: 10.1016/j.semerg.2018.01.007 -
Drug Safety Feb 2024
Topics: Humans; Pharmacovigilance; Risk Assessment; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 38114758
DOI: 10.1007/s40264-023-01375-4 -
Orphanet Journal of Rare Diseases Sep 2023The aims of this paper is to search and explore publications in the field of pharmacovigilance for rare diseases and to visualize general information, research hotspots,... (Review)
Review
OBJECTIVES
The aims of this paper is to search and explore publications in the field of pharmacovigilance for rare diseases and to visualize general information, research hotspots, frontiers and future trends in the field using the bibliometric tool CiteSpace to provide evidence-based evidence for scholars.
METHODS
We searched the Web of Science Core Collection (WoSCC) for studies related to pharmacovigilance for rare diseases, spanning January 1, 1997-October 25, 2022. CiteSpace software was utilized to discuss countries/regions, institutions, authors, journals, and keywords.
RESULTS
After screening, a total of 599 valid publications were included in this study, with a significant upward trend in the number of publications. These studies were from 68 countries/regions with the United States and the United Kingdom making the largest contributions to the field. 4,806 research scholars from 493 institutions conducted studies on pharmacovigilance for rare diseases. Harvard University and University of California were the top two productive institutions in the research field. He Dian of the Affiliated Hospital of Guizhou Medical University and Peter G.M. Mol of the University of Groningen, The Netherlands, were the two most prolific researchers. The Cochrane Database of Systematic Reviews and the New England Journal of Medicine were the journals with the highest number of articles and co-citation frequency respectively. Clinical trial, therapy and adverse event were the top three most cited keywords.
CONCLUSIONS
Based on keywords co-occurrence analysis, four research topics were identified: orphan drug clinical trials, postmarketing ADR surveillance for orphan drugs, rare diseases and orphan drug management, and diagnosis and treatment of rare diseases. Immune-related adverse reactions and benefit-risk assessment of enzyme replacement therapy were at the forefront of research in this field. Treatment outcomes, early diagnosis and natural history studies of rare diseases may become hotspots for future research.
Topics: Male; Humans; Rare Diseases; Pharmacovigilance; Systematic Reviews as Topic; Bibliometrics; Databases, Factual
PubMed: 37752556
DOI: 10.1186/s13023-023-02915-y