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F1000Research 2019Considering that marketed drugs are not free from side effects, many countries have initiated pharmacovigilance programs. These initiatives have provided countries with... (Review)
Review
Considering that marketed drugs are not free from side effects, many countries have initiated pharmacovigilance programs. These initiatives have provided countries with methods of detection and prevention of adverse drug reactions at an earlier stage, thus preventing harm occurring in the larger population. In this review, examples of drug withdrawals due to effective pharmacovigilance programs have been provided with details. In addition, information concerning data mining in pharmacovigilance, an effective method to assess pharmacoepidemiologic data and detecting signals for rare and uncommon side effects, is also examined, which is a method synchronized with information technology and advanced electronic tools. The importance of policy framework in relation to pharmacovigilance is discussed in detail, and country experiences upon implementation of pharmacovigilance policies is highlighted.
Topics: Adverse Drug Reaction Reporting Systems; Data Mining; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 32161643
DOI: 10.12688/f1000research.21402.1 -
Indian Journal of Pharmacology 2019
Topics: Artificial Intelligence; Humans; Pharmacovigilance
PubMed: 32029958
DOI: 10.4103/ijp.IJP_814_19 -
Trends in Pharmacological Sciences Dec 2021The systematic safety surveillance of real-world use of medicinal products and related activities (pharmacovigilance) started in earnest as a scientific field only in... (Review)
Review
The systematic safety surveillance of real-world use of medicinal products and related activities (pharmacovigilance) started in earnest as a scientific field only in the 1960s. While developments have occurred over the past 50 years, adding to its complexity and sophistication, the extent to which some of these advances have positively impacted the capability for ensuring patient safety is questionable. We review how the conduct of safety surveillance has changed, highlight recent scientific advances, and argue how they need to be harnessed to enhance pharmacovigilance in the future. Specifically, we describe five changes that we believe should and will need to happen globally in the coming years: (i) better, more diverse data used for safety; (ii) the switch from manual activities to automation; (iii) removal of limited value, extraneous transactional activities and replacement with sharpened focus on scientific efforts to improve patient safety; (iv) patient-involved and focussed safety; and (v) personalised safety.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Vaccines
PubMed: 34635346
DOI: 10.1016/j.tips.2021.09.007 -
Clinical Pharmacology and Therapeutics May 2021Adverse drug reactions (ADRs) are a major concern for patients, clinicians, and regulatory agencies. The discovery of serious ADRs leading to substantial morbidity and... (Review)
Review
Adverse drug reactions (ADRs) are a major concern for patients, clinicians, and regulatory agencies. The discovery of serious ADRs leading to substantial morbidity and mortality has resulted in mandatory phase IV clinical trials, black box warnings, and withdrawal of drugs from the market. Real-world data, data collected during routine clinical care, is being adopted by innovators, regulators, payors, and providers to inform decision making throughout the product life cycle. We outline several different approaches to modern pharmacovigilance, including spontaneous reporting databases, electronic health record monitoring and research frameworks, social media surveillance, and the use of digital devices. Some of these platforms are well-established while others are still emerging or experimental. We highlight both the potential opportunity, as well as the existing challenges within these pharmacovigilance systems that have already begun to impact the drug development process, as well as the landscape of postmarket drug safety monitoring. Further research and investment into different and complementary pharmacovigilance systems is needed to ensure the continued safety of pharmacotherapy.
Topics: Adverse Drug Reaction Reporting Systems; Databases, Pharmaceutical; Electronic Health Records; Humans; Pharmacovigilance; Social Media; United States; United States Food and Drug Administration
PubMed: 33492663
DOI: 10.1002/cpt.2172 -
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 -
Bioinformatics (Oxford, England) Feb 2023Predicting molecule-disease indications and side effects is important for drug development and pharmacovigilance. Comprehensively mining molecule-molecule,...
MOTIVATION
Predicting molecule-disease indications and side effects is important for drug development and pharmacovigilance. Comprehensively mining molecule-molecule, molecule-disease and disease-disease semantic dependencies can potentially improve prediction performance.
METHODS
We introduce a Multi-Modal REpresentation Mapping Approach to Predicting molecular-disease relations (M2REMAP) by incorporating clinical semantics learned from electronic health records (EHR) of 12.6 million patients. Specifically, M2REMAP first learns a multimodal molecule representation that synthesizes chemical property and clinical semantic information by mapping molecule chemicals via a deep neural network onto the clinical semantic embedding space shared by drugs, diseases and other common clinical concepts. To infer molecule-disease relations, M2REMAP combines multimodal molecule representation and disease semantic embedding to jointly infer indications and side effects.
RESULTS
We extensively evaluate M2REMAP on molecule indications, side effects and interactions. Results show that incorporating EHR embeddings improves performance significantly, for example, attaining an improvement over the baseline models by 23.6% in PRC-AUC on indications and 23.9% on side effects. Further, M2REMAP overcomes the limitation of existing methods and effectively predicts drugs for novel diseases and emerging pathogens.
AVAILABILITY AND IMPLEMENTATION
The code is available at https://github.com/celehs/M2REMAP, and prediction results are provided at https://shiny.parse-health.org/drugs-diseases-dev/.
SUPPLEMENTARY INFORMATION
Supplementary data are available at Bioinformatics online.
Topics: Humans; Drug-Related Side Effects and Adverse Reactions; Drug Development; Electronic Health Records; Neural Networks, Computer; Pharmacovigilance
PubMed: 36805623
DOI: 10.1093/bioinformatics/btad085 -
Eastern Mediterranean Health Journal =... Jul 2021The concept of pharmacovigilance is not well known in Libya and its practice is still in the early stages.
BACKGROUND
The concept of pharmacovigilance is not well known in Libya and its practice is still in the early stages.
AIMS
This study aimed to determine the knowledge, attitudes and practices of pharmacists in Tripoli, Libya about pharmacovigilance and the reporting of adverse drug reactions.
METHODS
A cross-sectional study was conducted from October 2019 to February 2020 of working pharmacists randomly selected from pharmacies in Tripoli. Participants were eligible for inclusion if they had a degree or diploma in pharmacy from a recognized university or institute. Data were collected using a validated self-administered questionnaire.
RESULTS
Of 500 pharmacists selected, 408 completed the questionnaire. The pharmacists' knowledge of pharmacovigilance and reporting of adverse drug reactions was poor overall: only 28.9% correctly defined pharmacovigilance and 14.7% knew about the existence of a centre for pharmacovigilance in Libya. The attitudes of the pharmacists to pharmacovigilance was positive: 77.2% believed that pharmacovigilance needed to be included in the pharmacy curriculum and 73.0% said that they would practice pharmacovigilance if trained. Pharmacists depended mostly on drug information leaflets to update their knowledge on adverse drug reactions.
CONCLUSION
Given the pharmacists' low level of knowledge about pharmacovigilance but their readiness to become involved if trained, training programmes should be introduced for practising pharmacists to improve their knowledge and encourage their active participation in pharmacovigilance. Regulators need to reinforce the importance of reporting adverse drug reactions and implement pharmacovigilance policies in the Libyan health care system.
Topics: Adverse Drug Reaction Reporting Systems; Attitude of Health Personnel; Cross-Sectional Studies; Drug-Related Side Effects and Adverse Reactions; Health Knowledge, Attitudes, Practice; Humans; Libya; Pharmacists; Pharmacovigilance; Surveys and Questionnaires
PubMed: 34369584
DOI: 10.26719/2021.27.7.693 -
BMC Medical Informatics and Decision... Jun 2018A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to... (Review)
Review
BACKGROUND
A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to health products.
METHODS
Our specific research questions were (1) What social media listening platforms exist to detect adverse events related to health products, and what are their capabilities and characteristics? (2) What is the validity and reliability of data from social media for detecting these adverse events? MEDLINE, EMBASE, Cochrane Library, and relevant websites were searched from inception to May 2016. Any type of document (e.g., manuscripts, reports) that described the use of social media data for detecting health product AEs was included. Two reviewers independently screened citations and full-texts, and one reviewer and one verifier performed data abstraction. Descriptive synthesis was conducted.
RESULTS
After screening 3631 citations and 321 full-texts, 70 unique documents with 7 companion reports available from 2001 to 2016 were included. Forty-six documents (66%) described an automated or semi-automated information extraction system to detect health product AEs from social media conversations (in the developmental phase). Seven pre-existing information extraction systems to mine social media data were identified in eight documents. Nineteen documents compared AEs reported in social media data with validated data and found consistent AE discovery in all except two documents. None of the documents reported the validity and reliability of the overall system, but some reported on the performance of individual steps in processing the data. The validity and reliability results were found for the following steps in the data processing pipeline: data de-identification (n = 1), concept identification (n = 3), concept normalization (n = 2), and relation extraction (n = 8). The methods varied widely, and some approaches yielded better results than others.
CONCLUSIONS
Our results suggest that the use of social media conversations for pharmacovigilance is in its infancy. Although social media data has the potential to supplement data from regulatory agency databases; is able to capture less frequently reported AEs; and can identify AEs earlier than official alerts or regulatory changes, the utility and validity of the data source remains under-studied.
TRIAL REGISTRATION
Open Science Framework ( https://osf.io/kv9hu/ ).
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Social Media
PubMed: 29898743
DOI: 10.1186/s12911-018-0621-y -
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 -
Reumatologia Clinica 2017There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly... (Review)
Review
There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events.
Topics: Biological Therapy; Biosimilar Pharmaceuticals; Drug and Narcotic Control; Europe; Humans; Patient Safety; Pharmacovigilance
PubMed: 27372258
DOI: 10.1016/j.reuma.2016.05.013