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Therapie 2024The psychiatric risks associated with drugs are sometimes one of the few restrictions on the use of certain drug classes, such as corticosteroids in patients with a...
The psychiatric risks associated with drugs are sometimes one of the few restrictions on the use of certain drug classes, such as corticosteroids in patients with a history of severe psychotic episodes associated with this drug class. In this non-exhaustive review, we propose to deal with the most recent issues concerning psychiatric disorders induced by drugs and encountered in doctors' clinical practice. Firstly, we look at depressive disorders and suicide risks, secondly at psychotic and manic disorders and thirdly at anxiety and sleep disorders. While lot of drugs are associated with psychiatric disorders, the confounding by indication represents an important methodological gap since information on the psychiatric profile of patients is not always available. This is particularly the case for serotonin reuptake inhibitors and esketamine used as antidepressants. Recent pharmacovigilance concerns of psychiatric disorders emerged with montelukast, orexin receptor antagonists or cystic fibrosis transmembrane regulator (CFTR) modulators.
Topics: Humans; Pharmacovigilance; Mental Disorders; Antidepressive Agents; Selective Serotonin Reuptake Inhibitors
PubMed: 37957053
DOI: 10.1016/j.therap.2023.09.007 -
Therapeutic Innovation & Regulatory... Mar 2021In this publication, the authors, having gained several decades of experience in Pharmacovigilance departments, both in pharmaceutical companies as well as in service... (Review)
Review
In this publication, the authors, having gained several decades of experience in Pharmacovigilance departments, both in pharmaceutical companies as well as in service providers companies, describe the reason why and the way how a guideline for outsourcing was created. While outsourcing in pharmacovigilance has become the rule rather than the exception in the last decade, a consensus guideline, based on best practice, appears to be missing. A group of committed professionals have given their time and knowledge to an iterative process of writing and reviewing drafts of such a guideline. One of the authors was closely involved with the writing as well as presenting the draft guidance at conferences. The other author was managing the process, including discussions, periodically reviewing the result, as well as responding to the reviewers' comments. In this publication, a high-level overview of the guideline is provided. The key message is that outsourcing in PV requires both a detailed preparation, including risk assessments of the various elements, as well as close contact with the service provider.
Topics: Outsourced Services; Pharmacovigilance
PubMed: 33118144
DOI: 10.1007/s43441-020-00229-w -
Sultan Qaboos University Medical Journal May 2021
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Oman; Pharmacovigilance
PubMed: 34221460
DOI: 10.18295/squmj.2021.21.02.001 -
Drug Safety May 2022Authors' views on the role of artificial intelligence and machine learning in pharmacovigilance. (MP4 139807 kb).
Authors' views on the role of artificial intelligence and machine learning in pharmacovigilance. (MP4 139807 kb).
Topics: Artificial Intelligence; Humans; Machine Learning; Pharmacovigilance
PubMed: 35579805
DOI: 10.1007/s40264-022-01177-0 -
The International Journal of... Feb 2024
Topics: Humans; Ritonavir; Pharmacovigilance; Lactams; Leucine; Nitriles; Proline
PubMed: 38303038
DOI: 10.5588/ijtld.23.0326 -
Zhongguo Fei Ai Za Zhi = Chinese... Jul 2022In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance...
In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance Quality Management Standard of China was released. The proposal and implementation of pharmacovigilance were the initial stage in China, and it needed to improve the aspects of pharmacovigilance include institution, monitoring mechanism and database construction. The number of new diagnosed cancer patients in China ranked first in the world. In recent years, the marketing speed of novel antitumor drugs was accelerated, and there were many clinical trials. Therefore, antitumor pharmacovigilance was imperative. In this article, we summarized pharmacovigilance of the origin, clinical practice objectives, procedures, methods. We described the difficulties in antitumor pharmacovigilance and current characteristics of pharmacovigilance in China, aiming to provide reference for the development of antitumor pharmacovigilance. .
Topics: China; Humans; Lung Neoplasms; Pharmacovigilance
PubMed: 35899454
DOI: 10.3779/j.issn.1009-3419.2022.101.33 -
Drug Safety May 2022Monitoring adverse drug events or pharmacovigilance has been promoted by the World Health Organization to assure the safety of medicines through a timely and reliable... (Review)
Review
Monitoring adverse drug events or pharmacovigilance has been promoted by the World Health Organization to assure the safety of medicines through a timely and reliable information exchange regarding drug safety issues. We aim to discuss the application of machine learning methods as well as causal inference paradigms in pharmacovigilance. We first reviewed data sources for pharmacovigilance. Then, we examined traditional causal inference paradigms, their applications in pharmacovigilance, and how machine learning methods and causal inference paradigms were integrated to enhance the performance of traditional causal inference paradigms. Finally, we summarized issues with currently mainstream correlation-based machine learning models and how the machine learning community has tried to address these issues by incorporating causal inference paradigms. Our literature search revealed that most existing data sources and tasks for pharmacovigilance were not designed for causal inference. Additionally, pharmacovigilance was lagging in adopting machine learning-causal inference integrated models. We highlight several currently trending directions or gaps to integrate causal inference with machine learning in pharmacovigilance research. Finally, our literature search revealed that the adoption of causal paradigms can mitigate known issues with machine learning models. We foresee that the pharmacovigilance domain can benefit from the progress in the machine learning field.
Topics: Causality; Drug-Related Side Effects and Adverse Reactions; Humans; Machine Learning; Models, Theoretical; Pharmacovigilance
PubMed: 35579811
DOI: 10.1007/s40264-022-01155-6 -
BMJ Open Sep 2023The slow progress of pharmacovigilance (PV) in low-income and middle-income countries (LMIC) raises questions about core challenges on the growth of PV, and the... (Review)
Review
OBJECTIVES
The slow progress of pharmacovigilance (PV) in low-income and middle-income countries (LMIC) raises questions about core challenges on the growth of PV, and the appropriateness of strategies used so far to develop PV. Therefore, this scoping review aims to describe strategies and interventions to strengthen PV in LMIC and to propose recommendations for future investments in PV capacity building.
INCLUSION CRITERIA
Publications included were primary studies, articles, policy and guideline papers, describing interventions to strengthen PV in LMIC.
METHODS
The review was conducted following the Joanna Briggs Institute (JBI) guidelines on conducting scoping reviews. Literature searches were performed in MEDLINE, EMBASE, Web of Science, PDQ-evidence, CINAHL and other relevant websites from January 1990 to January 2021. Two reviewers independently screened titles, abstracts and full texts. One reviewer performed data extraction and descriptive analysis, which were reviewed by two other reviewers.
RESULTS
10 922 unique titles were screened and 152 were eligible for full text review. Of these, 57 and an additional 13 reports from grey literature fulfilled eligibility criteria for inclusion in the review. These were grouped into two categories: (1) Interventions aimed at increasing PV knowledge and adverse drug reactions (ADR) reporting (45 papers), primarily education of healthcare professionals (HCP), alone or in combination with other interventions such as mobile and electronic reporting and (2) Interventions aimed at strengthening various components of the national PV system (25 papers), describing strategies or mixed interventions implemented at the national level, targeting different components of the national PV system.
CONCLUSIONS
Results of this review suggest that educating HCP on ADR reporting is the most common approach to build PV capacity in LMIC. Though important, education alone is insufficient and should ideally be organised within the holistic framework of strengthening national PV systems, with a focus on also building capacity for advanced activities such as signal detection.
Topics: Humans; Developing Countries; Pharmacovigilance; Educational Status; Academies and Institutes; Capacity Building; Drug-Related Side Effects and Adverse Reactions
PubMed: 37709326
DOI: 10.1136/bmjopen-2022-071079 -
Therapie 2024Antibiotics are drugs widely used all around the world. Central nervous system adverse drug reactions (CNS ADRs) are mostly under-suspected with antibiotics....
Antibiotics are drugs widely used all around the world. Central nervous system adverse drug reactions (CNS ADRs) are mostly under-suspected with antibiotics. Nevertheless, these ADRs could lead to severe complications such as encephalopathy. To illustrate the clinical patterns of these off-target ADRs, we here present data from pharmacovigilance system, through different populations and points of view (worldwide, French population, vulnerable population and individual). These data could help clinicians to better know about CNS ADRs with antibiotics, to better identify risk factors and vulnerable patients and to highlight the importance to set up the right diagnostic explorations in the best timing to avoid complications. Clinicians should request a pharmacological opinion from pharmacologist (biologists and pharmacovigilance clinicians) in front of vulnerable population before or during antibiotics. Pharmacovigilance advice could help clinicians in the diagnosis and the management of an ADR. Therapeutic drug monitoring is particularly contributive to adjust doses of antibiotics administered in vulnerable patients. Pharmacovigilance advice and TDM are essential to perform personalized medicine, and contribute to the proper use of drugs.
Topics: Humans; Anti-Bacterial Agents; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Health Personnel; Pharmacovigilance
PubMed: 37957055
DOI: 10.1016/j.therap.2023.09.008 -
Therapie Apr 2020The French-style organization in the field of rare diseases allows a close contact between reference centres and regional pharmacovigilance centres thanks to their... (Review)
Review
The French-style organization in the field of rare diseases allows a close contact between reference centres and regional pharmacovigilance centres thanks to their implementation within the French university hospital. This collaboration leads to highlight more and more drug-induced rare diseases. Through several historical examples (eosinophilia-myalgia syndrome due to L-tryptophan, type 1 narcolepsy with H1N1 pandemic influenza vaccine, capillary leak syndrome, acquired von Willebrand syndrome), it remains clear that pharmacovigilance is the cornerstone of the alert system. Clinicians from the rare disease reference centres can easily report adverse drug reactions (ADRs) to pharmacologists from their regional pharmacovigilance centre. Through experience, collaboration between countries, large database, and sometimes pharmacoepidemiological studies, an alert can then be raised. This collaboration underlines also similarities between the two disciplines, through the frequency of ADRs and diseases, the difficulty of the diagnosis in front of scarce data, and through the unusual worsening symptoms. Patients and associations of patients play also a proactive role as research partners at different steps, to quantify and qualify symptoms and ADRs, and also to develop orphan drugs. These several collaborations are a precious tool to improve patients' outcomes. These close contacts between the different actors are important to make earlier diagnosis of rare diseases and severe ADRs. Rare disease does not have to mean overlooked diseases.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; France; Humans; Pharmacoepidemiology; Pharmacovigilance; Rare Diseases
PubMed: 32113688
DOI: 10.1016/j.therap.2020.02.012