Analysis of Adverse Reactions Associated with the Use of -Containing Herbal Products.

Products from various parts of species are traditionally applied as a cardiotonic. In Europe and the USA, mainly Jacq. (Lindm.

Achieving patient engagement in pharmacovigilance: from high-income countries to lower and -middle-income countries with focus on Africa.

Introduction: Patient engagement in pharmacovigilance (PEP) has been shown to improve information on adverse drug reactions (ADRs), which may not be found in reports from healthcare professionals. This review shows that there is paucity of information on PEP in lower-middle-income countries (LMICs), particularly Africa. It provides insights into PEP in high-income countries (HICs) compared with Africa to help identify the disparities and system challenges in Africa.

Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study.

Conventional vaccines rarely cause severe allergic reactions. However, the rapid development and approval of COVID-19 vaccines left limited initial data on their adverse reactions, particularly in individuals with a history of allergy. The aim of this study was to assess and compare the safety profile of different doses and brands of COVID-19 vaccines in subjects with a history of allergy vs.

Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide.

Background And Objective: The use of herbal products globally is substantial, but varying definitions and regulatory frameworks have led to differences in their status as medicinal products and in approaches to monitoring their safety. This article explores the current landscape of herbal pharmacovigilance, drawing insights from interviews with global experts in the field, and offers recommendations for best practices to enhance the safety and benefit-to-harm balance of herbal products.

Methods: This study comprised semi-structured interviews with members of the International Society of Pharmacovigilance-Herbal and Traditional Medicines Special Interest Group and the Nutrivigilance Information Exchange Network, recruited using purposive sampling.

GP consultations for menstrual disorders after COVID-19 vaccination - A self-controlled cohort study based on routine healthcare data from the Netherlands.

Introduction: Several studies described that COVID-19 vaccinations can cause menstrual disorders. Our study aimed to describe whether this also resulted in more general practitioner (GP) consultations for menstrual disorders after COVID-19 vaccination, based on a large cohort study.

Methods: A retrospective self-controlled cohort study was performed including vaccinated women in 2021 aged 12-49 years from two large, representative GP databases in the Netherlands.

The Therapeutic Potential of Essential Oils in Managing Inflammatory Skin Conditions: A Scoping Review.

Conventional therapy is commonly used for the treatment of inflammatory skin conditions, but undesirable effects, such as erythema, dryness, skin thinning, and resistance to treatment, may cause poor patient compliance. Therefore, patients may seek complementary treatment with herbal plant products including essential oils (EOs). This scoping review aims to generate a broad overview of the EOs used to treat inflammatory skin conditions, namely, acne vulgaris, dermatitis and eczema, psoriasis, and rosacea, in a clinical setting.

An innovative method to strengthen evidence for potential drug safety signals using Electronic Health Records.

Reports from spontaneous reporting systems (SRS) are hypothesis generating. Additional evidence such as more reports is required to determine whether the generated drug-event associations are in fact safety signals. However, underreporting of adverse drug reactions (ADRs) delays signal detection.

Breastfeeding-Related Adverse Drug Reactions of Triptans: A Descriptive Analysis Using Four Pharmacovigilance Databases.

: Migraine attacks are common in women of reproductive age. Although attacks are often less severe and less frequent during pregnancy, they regularly reoccur shortly after delivery. When first-line analgesic treatment is insufficient, triptans may be used for acute treatment of migraine attacks.

Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study.

Introduction: During the COVID-19 pandemic, EMA set-up a large-scale cohort event monitoring (CEM) system to estimate incidence rates of patient-reported adverse drug reactions (ADRs) of different COVID-19 vaccines across the participating countries. This study aims to give an up to date and in-depth analysis of the frequency of patient-reported ADRs after the 1st, 2nd, and booster vaccination, to identify potential predictors in developing ADRs and to describe time-to-onset (TTO) and time-to-recovery (TTR) of ADRs.

Methods: A CEM study was rolled out in a period ranging from February 2021 to February 2023 across multiple European countries; The Netherlands, Belgium, France, the United Kingdom, Italy, Portugal, Romania, Slovakia and Spain.

Medication errors by caregivers in the homes of children discharged from a pediatric department in Ghana.

Background: Medication errors (MEs) by caregivers at home are a cause of morbidity and mortality, shortly after discharge from the hospital.

Objectives: The objective of this study was to determine the rate and types of MEs at the homes of children discharged from a hospital in Ghana and to explore the factors associated with these errors.

Design: This was a cross-sectional study of infants and children discharged from the hospital to review medication administration practices.

Changes in Local and Systemic Adverse Effects following Primary and Booster Immunisation against COVID-19 in an Observational Cohort of Dutch Healthcare Workers Vaccinated with BNT162b2 (Comirnaty).

In healthcare workers (HCWs) and in the general population, fear of adverse effects is among the main reasons behind COVID-19 vaccine hesitancy. We present data on self-reported adverse effects from a large cohort of HCWs who underwent primary (N = 470) and booster (N = 990) mRNA vaccination against SARS-CoV-2. We described general patterns in, and predictors of self-reported adverse effect profiles.

The International Working Group on New Developments in Pharmacovigilance: Advancing Methods and Communication in Pharmacovigilance.

Purpose: In 2019, the International Working Group (IWG), focusing on New Developments in Pharmacovigilance, was established. This group is coordinated by the Drug Safety Research Unit in the United Kingdom, and the mission of the IWG is to progress pharmacovigilance methodologies and promote the safe and effective use of medicines and vaccines, thereby further protecting patients. Novel therapeutics are continuously being developed to alleviate medical conditions, but with advancing technologies, innovative pharmacovigilance methodologies need to be developed to effectively monitor the use and safety of these products.

Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project.

Background: To assess the causal relationship between a medicinal product and a reported event, relevant information needs to be present. Information elements for assessing cases of exposure to medicinal products during pregnancy were predefined and used in a new tool to assess the quality of information. However, the extent in which the presence or absence of these predefined information elements is associated with the overall clinical quality of these cases, as evaluated by pharmacovigilance experts, remains uncertain.

The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands.

Introduction: The annual reformulation of the seasonal influenza vaccine results in fluctuating frequencies and severity of adverse effects following immunization (AEFIs), which stresses the importance of pharmacovigilance. Also, sex-related factors are known to influence the development of AEFIs. This study aims to describe the difference in incidence and course (i.

Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database.

Introduction: Opioids are commonly used as analgesics; however, like any medicine, they can produce adverse drug reactions (ADRs), including nausea, constipation, dependence, and respiratory depression, that result in harmful and fatal events. Therefore, it is essential to monitor the safety of these drugs in clinical practice.

Objective: This study aimed to characterize the safety profile of opioids by conducting a descriptive study based on a spontaneous reporting system (SRS) for ADRs in The Netherlands, focusing on abuse, misuse, medication errors, and differences between sexes.

The role of co-morbidities in the development of an AEFI after COVID-19 vaccination in a large prospective cohort with patient-reported outcomes in the Netherlands.

Background: The effect of a preexisting comorbidity on the occurrence of adverse events after immunization (AEFIs) has been studied poorly. In this longitudinal cohort study, we assess the association between co-morbidities and the occurrence of AEFIs after COVID-19 vaccination. Also, we described the occurrence of flare-ups and their manifestation after COVID-19 vaccination in people with rheumatic diseases.

Analysis of Safety Concerns on Herbal Products with Assumed Phytoestrogenic Activity.

Phytoestrogens (PEs) are plant-based compounds that can interact with estrogen receptors and are mainly used to treat menopausal complaints. However, the safety of products with assumed phytoestrogenic activity is not fully understood. This study aimed to identify plant species with assumed phytoestrogenic activity, review existing literature on their use and safety, and critically evaluate adverse reaction (AR) reports of single-herb, multi-herb, and mixed-multiple products, as submitted to the Netherlands Pharmacovigilance Centre Lareb and to VigiBase of the World Health Organization (WHO).

Adverse reactions following MPox (monkeypox) vaccination: An overview from the Dutch and global adverse event reporting systems.

Aims: The spreading of MPox (monkeypox) virus led to a vaccination campaign in the Netherlands for individuals at high risk of infection. This overview elucidates the characteristics of the reported adverse events following immunization (AEFI) following active immunization against monkeypox and thereby provides insight on the safety profile in daily practice.

Methods: Data were collected from the spontaneous reporting system of the Netherlands Pharmacovigilance Centre Lareb.

Spontaneously reported adverse events following COVID-19 basic and booster immunizations in the Netherlands.

Introduction: The rapid roll-out of novel COVID-19 vaccines made near real-time post-marketing safety surveillance essential to identify rare and long-term adverse events following immunization (AEFIs). In light of the ongoing booster vaccination campaigns, it is key to monitor changes in observed safety patterns post-vaccination. The effect of sequential COVID-19 vaccinations, as well as heterologous vaccination sequences, on the observed post-vaccination safety pattern, remains largely unknown.