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Drug Safety Oct 2021
Topics: Egypt; Humans; Pharmacovigilance
PubMed: 34424491
DOI: 10.1007/s40264-021-01112-9 -
Annales de Dermatologie Et de... Sep 2023
Topics: Humans; Pharmacovigilance; Dermatology; Anti-Bacterial Agents; Drug Eruptions; Referral and Consultation; Acute Generalized Exanthematous Pustulosis; Exanthema
PubMed: 36496263
DOI: 10.1016/j.annder.2022.08.011 -
Journal of Pharmacy & Pharmaceutical... 2022Epitomizing one of the rapidly maturing segments of pharmaceutical industry, biologics gestalt has severely implicated treatment algorithms of many life-threatening... (Review)
Review
Epitomizing one of the rapidly maturing segments of pharmaceutical industry, biologics gestalt has severely implicated treatment algorithms of many life-threatening diseases especially in oncology, immunology, diabetes, and irresistible infections through integration of biologics in the clinical practice guidelines. As of 2021, the impact is expected to gain resilience as more patents on new biological drugs (such as Erbitux, Avastin, Orencis) are going off. Growing acceptance, trusting on stringent risk-benefits assessment, cost-effectiveness, and potential for return on investment, drive the global market of biosimilars is expected to remain steadfast in the following years; hence knowing about regulatory requirements for approval, opportunities, and barriers to biosimilars uptake in the biggest markets of USA, European Union, Canada, and Asia-Pacific (India and Pakistan) is warranted for development of effective biosimilars marketing strategies. This article reviews the biosimilars development from the beginning (historic) to the end (development & marketing approval perspectives) and then tries to present a clear picture on areas that are still uncertain concerning the biosimilars landscape especially the biologics effect on immunogenicity, the provocative issue of interchangeability, and extrapolation of indications.
Topics: Biosimilar Pharmaceuticals; Canada; Drug Industry; India; Pharmacovigilance
PubMed: 35439428
DOI: 10.18433/jpps32433 -
The Lancet. HIV Sep 2023
Topics: Pregnancy; Female; Humans; Pharmacovigilance; HIV Infections; Pregnancy Complications; Drug-Related Side Effects and Adverse Reactions
PubMed: 37506722
DOI: 10.1016/S2352-3018(23)00146-7 -
Clinical Pharmacology and Therapeutics Oct 2023
Topics: Humans; Pharmacovigilance; Adverse Drug Reaction Reporting Systems; Databases, Factual
PubMed: 37259792
DOI: 10.1002/cpt.2950 -
Drug Safety Jul 2024
Topics: Pharmacovigilance; Humans; Adverse Drug Reaction Reporting Systems; Peer Review; Drug-Related Side Effects and Adverse Reactions
PubMed: 38498258
DOI: 10.1007/s40264-024-01419-3 -
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 -
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 -
Drug Safety Oct 2022Involving patients in decision making adds value in the context of pharmacovigilance (PV). This added value goes beyond participation in spontaneous reporting systems... (Review)
Review
INTRODUCTION
Involving patients in decision making adds value in the context of pharmacovigilance (PV). This added value goes beyond participation in spontaneous reporting systems for adverse drug reactions. However, there is a gap between allowing patients to report and actual patient involvement. Views regarding best practices from regulators, patient organizations and pharmaceutical companies could help increase and improve patient involvement in PV.
OBJECTIVE
The aim of this study was to investigate the factors contributing to best practices for patient involvement in PV and to develop a definition of patient involvement based on a qualitative multistakeholder study across Europe.
METHODS
A literature review was conducted to map the field of study and obtain insights for the elaboration of an interview guide. Subsequently, patient representatives, members of the pharmaceutical industry and regulators were invited to participate in interviews. These interviews were analyzed using NVIVO software and employing reflective thematic analysis.
RESULTS
A total of 20 interviews were conducted with representatives at both the national and European levels. The best practices identified were engagement from the start, face-to-face communication, a full circle of feedback, same-level partners, structured involvement and guidelines, establishing common goals, patient education and empowerment, and developing trust and balance. These activities can be implemented via deep collaboration among stakeholders. A definition of patient involvement was constructed in accordance with the input of all stakeholder groups, which reflects the involvement of all types of patients at all levels of the decision-making process.
CONCLUSION
In this study, we developed a definition for patient involvement based on qualitative interviews. The factors contributing to best practices for patient involvement were mentioned across stakeholder groups and aimed to stimulate patient involvement in PV. Patients are eager to become equal partners and to engage effortlessly in the same manner as other stakeholders.
Topics: Europe; Humans; Patient Participation; Pharmaceutical Preparations; Pharmacovigilance; Qualitative Research
PubMed: 36008634
DOI: 10.1007/s40264-022-01222-y -
Therapie 2021According to French guidelines on good pharmacovigilance practices, a pharmacovigilance survey is an assessment of the available drug safety data. It is requested by the...
INTRODUCTION
According to French guidelines on good pharmacovigilance practices, a pharmacovigilance survey is an assessment of the available drug safety data. It is requested by the French national agency for medicines and health products safety (ANSM). The objective is to validate a signal, to characterize it, or to provide strengthened monitoring of a drug.
MATERIAL AND METHODS
All the available data were retrieved by ANSM/Regional Pharmacovigilance Centers (RPC) and assessed by a nominate RPC which provides a report for discussion during the monthly Committee between ANSM and the Regional Pharmacovigilance Network (RPN). A descriptive analysis of the minutes available on the ANSM website between 2016 and 2018 has been done: objective, data sources, duration of the survey, number of suspected adverse drug reactions, nature of the drugs and of the signals and recommendations for actions.
RESULTS
Between 2016 and 2018, a total of 115 surveys were discussed concerning 135 drugs, mainly from the nervous system according to the anatomic therapeutic chemical classification (n=31, 27%). They involved a whole pharmacological class for 18 ones. The main objective of the 115 surveys was to provide a strenghtened monitoring for some drugs (72%) or to validate one or more than one signal (28%). Result from surveys allowed to detect one or several new potential safety signals in 63 ones (55%), an off-label-use in 12 (10%) or to characterize some others signals in all the studies. The Committee recommended one or several actions by survey: 67 prolongations (58%) of the survey and regulatory or investigatory actions which included 43 European actions (37%), 37 label changes (32%), 30 national communications (26%) and 29 additional monitoring (25%).
DISCUSSION/CONCLUSION
The current process allows a collegiate, clinical and pharmacological discussion with integration of the regulatory framework. A significant number of new signals are detected and/or validated. This efficient tool which is unique in Europe and is allowed by the decentralized pharmacovigilance which leads to a great reactivity of decision-making. It has to be reassessed and to be adapted continuously to the new challenges of the growing multiplication of signals.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Europe; Humans; Pharmacovigilance
PubMed: 32553501
DOI: 10.1016/j.therap.2020.05.011