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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 -
Current Drug Safety 2024Pharmacovigilance is important for generating accurate safety of herbal medications information. The present methods were designed for synthetic medications and will... (Review)
Review
Pharmacovigilance is important for generating accurate safety of herbal medications information. The present methods were designed for synthetic medications and will need to be modified to account for the unique characteristics of medicinal plants. The objective of pharmacovigilance is to identify, measure, and explain adverse effects or other potential drug-related issues associated with herbal, traditional, and complementary therapies, as well as to avoid them. Required data for pharmcovigilance of herbal drugs and formulation were obtained from electronic sources (google scholar, PubMed, Scopus, Web of Science), several textbooks. The keywords used to search for various journal publishers such as Willey Online Library, Springer, Wolters Kluwer and Elsevier were closely monitored. This review article covers all the relevant information on issues and challenges in pharmacovigilance of formulation covering Herbal drugs.
Topics: Humans; Pharmacovigilance; Plants, Medicinal; Drug-Related Side Effects and Adverse Reactions
PubMed: 36757041
DOI: 10.2174/1574886318666230209110922 -
Clinical Therapeutics Feb 2023
Topics: Humans; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions; Drug Interactions; Adverse Drug Reaction Reporting Systems
PubMed: 36641261
DOI: 10.1016/j.clinthera.2022.12.005 -
Therapie Apr 2016
Topics: Adverse Drug Reaction Reporting Systems; Humans; Periodicals as Topic; Pharmacovigilance
PubMed: 27080828
DOI: 10.1016/j.therap.2016.02.019 -
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 -
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 -
European Journal of Clinical... Sep 2019Engagement of patients and healthcare professionals is increasingly considered as fundamental to pharmacovigilance and risk minimisation activities. Few empirical... (Review)
Review
BACKGROUND
Engagement of patients and healthcare professionals is increasingly considered as fundamental to pharmacovigilance and risk minimisation activities. Few empirical studies of engagement exist and a lack of explicit conceptualisations impedes effective measurement, research and the development of evidence-based engagement interventions.
AIMS
This article (1) develops a widely applicable conceptualisation, (2) considers various methodological challenges to researching engagement, proposing some solutions, and (3) outlines a basis for converting the conceptualisation into specific measures and indicators of engagement among stakeholders.
METHOD
We synthesise social science work on risk governance and public understandings of science with insights from studies in the pharmacovigilance field.
FINDINGS
This leads us to define engagement as an ongoing process of knowledge exchange among stakeholders, with the adoption of this knowledge as the outcome which may feed back into engagement processes over time. We conceptualise this process via three dimensions; breadth, depth and texture. In addressing challenges to capturing each dimension, we emphasise the importance of combining survey approaches with qualitative studies and secondary data on medicines use, prescribing, adverse reaction reporting and health outcomes. A framework for evaluating engagement intervention processes and outcomes is proposed. Alongside measuring engagement via breadth and depth, we highlight the need to research the engagement process through attentiveness to texture-what engagement feels like, what it means to people, and how this shapes motivations based on values, emotions, trust and rationales.
CONCLUSION
Capturing all three dimensions of engagement is vital to develop valid understandings of what works and why, thus informing engagement interventions of patients and healthcare professionals to given regulatory pharmacovigilance scenarios.
Topics: Drug-Related Side Effects and Adverse Reactions; Health Personnel; Humans; Legislation, Drug; Pharmacovigilance; Stakeholder Participation
PubMed: 31240364
DOI: 10.1007/s00228-019-02705-1 -
The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs).Drug Safety Dec 2023
Topics: Humans; Developing Countries; Pharmacovigilance
PubMed: 37874450
DOI: 10.1007/s40264-023-01363-8 -
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