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AIDS Care May 2023A quantitative descriptive study based on Brazilian Active Pharmacovigilance of Dolutegravir (DTG) Project was performed to describe the adverse drug reactions (ADRs) to...
A quantitative descriptive study based on Brazilian Active Pharmacovigilance of Dolutegravir (DTG) Project was performed to describe the adverse drug reactions (ADRs) to DTG reported and to evaluate the noncompleteness of data from DTG active pharmacovigilance in Brazil. ADRs and clinical and individual data were obtained from information from the Pharmacovigilance Questionnaire from April 2017 to August 2019. The reported ADRs were classified using the Medical Dictionary for Regulatory Activities (MedDRA). In the evaluated period, 249,066 individuals using DTG participated in the active pharmacovigilance of DTG, with 3472 (1.39%) reporting ADRs at least once. A total of 6312 ADRs were reported, of which 57.56% were persistent and 81.46% were not serious according to the individuals' reports. Most of the reported ADRs were gastrointestinal, neurological and psychiatric. ADRs related to neural tube defects and serious neuropsychiatric ADRs have been reported. Completion of more than half of the fields in the Pharmacovigilance Questionnaire was excellent. The frequency of ADR was low in relation to the number of people living with HIV (PLHIV) using DTG in Brazil, which suggests good tolerability and safety of DTG. The DTG active pharmacovigilance database in Brazil showed good data completeness.
Topics: Humans; Brazil; Pharmacovigilance; HIV Infections; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 35578399
DOI: 10.1080/09540121.2022.2062289 -
Drug Safety Jun 2022
Topics: Adverse Drug Reaction Reporting Systems; Humans; Pharmacovigilance; Public Opinion; Vaccines
PubMed: 35532845
DOI: 10.1007/s40264-022-01179-y -
Studies in Health Technology and... Aug 2019An electronic health record (EHR) contains various clinical information for pharmacovigilance studies, but they remain difficult to use. From 2016 to 2018, the ministry...
An electronic health record (EHR) contains various clinical information for pharmacovigilance studies, but they remain difficult to use. From 2016 to 2018, the ministry of food and drug safety and Korea institute of drug safety & risk management (KIDS) converted the EHRs of more than 9 million patients to a MOA common data model (CDM). KIDS developed the Medical record observation and assessment for drug safety network (MOA-Net), a web portal site to build a network between CDM data partners. Through MOA-Net, hospitals participated in pharmacovigilance studies and confirmed the usability and adequacy of the CDM.
Topics: Electronic Health Records; Hospitals; Humans; Pharmacovigilance; Republic of Korea; Risk Management
PubMed: 31438247
DOI: 10.3233/SHTI190550 -
Clinical Therapeutics Feb 2021
Topics: COVID-19; Humans; Pandemics; Pharmacovigilance; SARS-CoV-2; Workforce
PubMed: 33526311
DOI: 10.1016/j.clinthera.2020.12.019 -
Annales de Dermatologie Et de... Sep 2023
Topics: Humans; Dermatologists; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions
PubMed: 37640574
DOI: 10.1016/j.annder.2023.05.003 -
British Journal of Clinical Pharmacology Oct 2019
Topics: Adverse Drug Reaction Reporting Systems; Drug Development; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 31368147
DOI: 10.1111/bcp.14042 -
Indian Journal of Pharmacology 2015
Topics: Adverse Drug Reaction Reporting Systems; Data Mining; Humans; Models, Statistical; Pharmacovigilance
PubMed: 26069358
DOI: 10.4103/0253-7613.157102 -
Drug Safety Jun 2023
Review
Communicating for the Safe Use of Medicines: Progress and Directions for the 2020s Promoted by the Special Interest Group of the International Society of Pharmacovigilance.
Topics: Humans; Pharmacovigilance; Public Opinion; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Societies
PubMed: 37219785
DOI: 10.1007/s40264-023-01285-5 -
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 -
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