207 research outputs found
sj-docx-1-taw-10.1177_20420986231225850 – Supplemental material for Medication errors by caregivers in the homes of children discharged from a pediatric department in Ghana
No full textSupplemental material, sj-docx-1-taw-10.1177_20420986231225850 for Medication errors by caregivers in the homes of children discharged from a pediatric department in Ghana by George Tsey Sabblah, Florence van Hunsel, Katja Taxis, Mahama Duwiejua, Seth Kwaku Seaneke and Eugène van Puijenbroek in Therapeutic Advances in Drug Safety</p
Analysis of Adverse Reactions Associated with the Use of Crataegus-Containing Herbal Products
Get PDFBackground/Objectives: Products from various parts of Crataegus species are traditionally applied as a cardiotonic. In Europe and the USA, mainly Crataegus monogyna Jacq. (Lindm.) and Crataegus laevigata (Poir.) DC (synonym Crataegus oxyacantha L.) are used, but worldwide, other Crataegus species are also used. Phytotherapeutic preparations with a standardised content of flavonoids and/or oligomeric procyanidins are commercially available. The products are generally considered as safe and are at most associated with minor and atypical adverse reactions. The aim of this study was to critically assess the information about the safety of Crataegus-containing products in humans. Methods: A scoping review of the literature about adverse reactions associated with Crataegus-containing products was performed. Next, individual case safety reports (ICSRs) were assessed, which were included in VigiBase (the World Health Organisation’s global database of adverse event reports for medicines and vaccines) and in the database of the Netherlands Pharmacovigilance Centre Lareb. The findings are discussed in relation to the literature. Results: The scoping review yielded 23 clinical studies with single-herb and 14 with multi-herb preparations, from which only a few minor gastrointestinal and cardiac events had been reported. A total of 1527 reports from VigiBase, from 1970 to 2023, were analysed, as well as 13 reports from Lareb. The most frequently reported adverse reactions belonged to the system organ classes ‘gastrointestinal disorders’, ‘skin and subcutaneous tissue disorders’, ‘general disorders and administration site conditions’, ‘cardiac disorders’ or ‘nervous system disorders’. In 277 reports of VigiBase, a single-herb product was the only suspect for causing the adverse reaction(s). Of these, 12.6% were graded as serious. Conclusions: The results of our study provide deeper insight in the adverse reaction profile of Crataegus-containing products and should contribute to their safe application in the treatment of less severe forms of cardiac failure
Promotion of pharmacovigilance among patient organizations in Europe: a qualitative study
No full textUCR::Docencia::Salud::Facultad de Farmaci
Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation
No full textIntroduction: European drug regulations aim for a patient-centered approach, including involving patients in the pharmacovigilance (PV) systems. However many patient organizations have little experience on how they can participate in PV activities. Aim: The aim of this study was to understand patient organizations’ perceptions of PV, the barriers they face when implementing PV activities, and their interaction with other stakeholders and suggest methods for the stimulation of patient organizations as promoters of PV. Methods: A sequential qualitative method study was conducted and integrated with the quantitative study performed by Matos, Weits, and van Hunsel to complete a mixed method study. Results: The qualitative phase expands the understanding of the quantitative results from a previous study by broadening the knowledge on external barriers and internal barriers that patient organizations face when implementing PV activities. The strategies to stimulate patient-organization participation are the creation of more awareness campaigns, more research that creates awareness, education for patient organizations, communication of real PV examples, creation of a targeted PV system, creation of a PV communication network that provides feedback to patients, improvement of understanding of all stakeholders, and a more proactive approach from national competent authorities. Conclusion: Both study phases show congruent results regarding patients’ involvement and the activities patient organizations perform to promote drug safety. Patient organizations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement.</p
Promotion of pharmacovigilance among patient organizations in Europe: a qualitative study
No full textProyecto de graduación (licenciatura en farmacia)--Universidad de Costa Rica. Facultad de Farmacia, 2019UCR::Docencia::Salud::Facultad de Farmaci
Safety aspects of adaptogenic and immunomodulating natural products. Scoping review protocol
No full textThe objectives of this scoping review: 1. To identify key adaptogenic and immunomodulating natural products based on existing literature. 2. To identify the active compounds responsible for the adaptogenic and immunomodulatory effects. 3. To identify the mechanism of action of these active compounds. 4. To assess the safety profiles of adaptogenic and immunomodulating natural products through a scoping review of existing literature. 5. To analyse adverse reaction reports related to adaptogenic and immunomodulating natural products using data from VigiBase, the World Health Organization’s global database of individual case safety reports (ICSR) and from the Lareb database. 6. To identify possible interactions between adaptogenic and immunomodulating natural products and conventional medicine. 7. To identify limitations in the current knowledge surrounding the safety profiles of adaptogenic and immunomodulating natural products, and highlight areas that need further exploration The primary research question for this scoping review is: What are the safety profiles of adaptogenic and immunomodulating natural products? To address this, the following sub-research questions are explored: 1. Which natural products are assumed to have adaptogenic and/or immunomodulating properties in the literature? 2. What are the active compounds responsible for the adaptogenic and immunomodulatory effects of these natural products? 3. How do these active compounds exert their adaptogenic and immunomodulatory effects, in terms of mechanisms of action? 4. What is known about the safety of adaptogenic and immunomodulating natural products in humans, based on existing research? 5. What are the potential interactions between adaptogenic and immunomodulating natural products and conventional medications
Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation
No full textEuropean drug regulations aim for a patient-centered approach, including involving patients in the pharmacovigilance (PV) systems. However many patient organizations have little experience on how they can participate in PV activities.
Aim
The aim of this study was to understand patient organizations’ perceptions of PV, the barriers they face when implementing PV activities, and their interaction with other stakeholders and suggest methods for the stimulation of patient organizations as promoters of PV.
Methods
A sequential qualitative method study was conducted and integrated with the quantitative study performed by Matos, Weits, and van Hunsel to complete a mixed method study.
Results
The qualitative phase expands the understanding of the quantitative results from a previous study by broadening the knowledge on external barriers and internal barriers that patient organizations face when implementing PV activities. The strategies to stimulate patient-organization participation are the creation of more awareness campaigns, more research that creates awareness, education for patient organizations, communication of real PV examples, creation of a targeted PV system, creation of a PV communication network that provides feedback to patients, improvement of understanding of all stakeholders, and a more proactive approach from national competent authorities.
Conclusion
Both study phases show congruent results regarding patients’ involvement and the activities patient organizations perform to promote drug safety. Patient organizations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement.UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR
The contribution of direct patient reporting to pharmacovigilance
No full textSummary
Phannacovigilance is defined by the World Health Organization (WHO) as the science and activities relating to the detectioll, assessment. understanding and prevention of adverse elrects or any other possible drug-related problems. Spontaneous reporting is one of the cornerstones of pharmocovigilance. It entails a system whereby case reports of adverse drug events are voluntarily submitted to the national phannacovigilance centre. One of the aims of a spontaneous reporting system is the detection of signals. indicating a possible association between a suspected drug and a reported adwrse drug reaction (ADR). The success or failure of any spontaneous reporting system depends on the active participation of reporters. Healthcare professionals have been the major providers of case reports of suspected ADRs throughout the history of phannacovigilance. although more schemes for reporting by patients have been initiated in the recent years. There has been discussion if the nature of patients' reports diners from healthcare professionals' reports. making them less valuable to spontaneous reporting systems. Lack of experience with patient reporting in real lite was one of the main drawbacks in this debate.
In the Netherlands. the Netherlands Phannacovigilance Centre Lareb is the organization which maintains the spontaneous reporting system for adverse drug reactions. Lareb collects and analyzes reports of ADRs with the main goal to find new and previously unknown adverse drug reactions. Lareb accepts ADR reports from healthcare professionals like physicians and (hospital) phannacist. Since April 2003. patients have also been able to report possible adverse drug reactions directly to the pharmacovigilance centre. The number of reports from patients has been increasing ever since. from less than 173 reports in 2003 (4% of the total number of reports) to 1545 reports in 2010 (almost 16% of the total number of reports). Besides the challenge to discern \hat has been found in practice of all the possible objectives that came up in the academic debate around the value of patient reporting. the substantial growth in the number of reports from patients emphasizes the need to evaluate the patient reporting scheme in the Netherlands and to compare our experiences with other countries. The objective of this thesis is to evaluate the contribution of patient reporting of adverse drug reactions to pharmacovigilance.
First year results of using a new prediction model-based algorithm for computer-assisted database screening of adverse drug reactions in the Netherlands
No full text- …
