Florence Van Hunsel

Netherlands Pharmacovigilance Centre Lareb

Purpose: The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. Method: All signals from 2010 until 2015 were...

IntroductionPatient reporting of adverse drug reactions (ADRs) to spontaneous reporting systems can make a valuable contribution to pharmacovigilance. However, the implementation and promotion of patient reporting systems (PRSs) differ worldwide. Objective The objective of the study was to describe attitudes toward PRSs, and progress toward impleme...

Introduction: Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. Objective: The aim was to determine to what extent patients report relevant clinical information...

The World Health Organization (WHO) defines Pharmacovigilance as "the science and activities related to the detection, assessment and prevention of adverse effects or any other possible drug-related problems". In the Netherlands Lareb is responsible for maintaining the national spontaneous reporting system of registered drugs. Both healthcare profe...

Background/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...

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 P...

Background: 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 CO...

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,...

Patient involvement has become increasingly important in pharmacovigilance in recent years. There should be an active and collaborative interaction between patients and other stakeholders. Decision making should be guided by patients’ contributions as partners, recognising their unique perspective, experiences, values, and expertise. In pharmacovig...

Opioids are the strongest analgesics available and are crucial in the treatment of acute and chronic pain. The line between these critical medications and how they are used beyond standard therapeutics in cases such as abuse, misuse, and medication errors needs to be understood, as it affects their safety, efficacy, and manner of use. The aim of th...

The safety profile of COVID-19 vaccines in immunocompromised patients has not been comprehensively evaluated. To measure the frequency of patient-reported adverse drug reactions (ADRs) related to the first/second/booster dose of COVID-19 vaccine in immunocompromised subject versus matched cohort. As a secondary objective, the time course, evaluated...

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. Through the use of natural language processing, diff...

Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and results are generally poorly reported in published articles and existing guidelines do not capture the specific features of disproportionality ana...

In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk of incorrect conclusions when data are not placed in the correc...

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 revie...

Objective: 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. Milk levels of occasional triptan use have s...

In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the patient-reported adverse drug reactions (ADRs) following the first COVI...

Introduction:Menstrual disorders are commonly reported after COVID-19 vaccination and heavy menstrual bleeding was added to the product information of the COVID-19 vaccines of Moderna and Pfizer. The aim of this review, using a systematic search, is to provide an overview of available literature on the risk of menstrual disorders after COVID-19 vac...

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 T...

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...

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...

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 cours...

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. This study aimed to characterize t...

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 manifestatio...

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 th...

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...

To assess the risk of exposure to a medicinal product during pregnancy in an individual case report, the necessary information should be present, complete and clearly described. Previously designed grading tools were not developed for pregnancy pharmacovigilance data. This study aims to identify the elements that are necessary to assess of the qual...

Aims During the COVID‐19 vaccination campaigns, the number of reports of menstrual abnormalities increased rapidly. Here, we describe the nature and potential risk factors associated with menstrual abnormalities based on spontaneously reporting data as well as data from a prospective cohort event monitoring (CEM) study as these are poorly studied....

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 se...

Introduction: COVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccinees. Methods: A prospective cohort event monito...

Background: The large-scale COVID-19 vaccination campaigns in 2021 and 2022 led to a rapid increase in numbers of received adverse event reports in spontaneous reporting systems. As background incidences of naturally occurring medical events became increasingly relevant for causality assessment of potential associations with the vaccines, a novel...

This paper reports the presence of undeclared drugs in the herbal slimming supplement Sulami®. The four cases of the adverse drug reactions related to Sulami® were reported to the Dutch Pharmacovigilance Centre (Lareb) or the Dutch Poisons Information Centre (DPIC). The analysis of all four collected samples revealed adulteration with sibutramine a...

Aim Reactivation of the scar resulting from intradermal injection of bacillus Calmette‐Guérin (BCG) is a common specific reaction in Kawasaki's disease. It has also sporadically been associated with viral infections, multisystem inflammatory syndrome in children, influenza vaccination and mRNA COVID‐19 vaccination. In this case series, characterist...

Objective: To improve a previously developed prediction model that could assist in the triage of individual case safety reports using the addition of features designed from free text fields using natural language processing. Methods: Structured features and natural language processing (NLP) features were used to train a bagging classifier model. NL...

Background Albeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce. This prospective cohort study aimed to assess differences in the incidence and course of reporte...

Tea tree (Melaleuca alternifolia) essential oil is widely used as an antiseptic. It mainly consists of monoterpenes with terpinen-4-ol as the major constituent. The aim of this study was to review literature on safety data about tea tree oil and to assess its safety by investigating 159 cases of adverse reactions possibly caused by the oil, reporte...

IntroductionDue to the COVID-19 vaccination campaign, national pharmacovigilance (PV) centres had to deal with high volumes of Individual Case Safety Reports (ICSRs) that needed to be processed and assessed in a short time span. This necessitated the development of a dedicated system to enable near real-time vaccine safety monitoring at the Dutch P...

Background: The number of Individual Case Safety Reports (ICSRs) in pharmacovigilance databases are rapidly increasing world-wide. The majority of ICSRs at the Netherlands Pharmacovigilance Centre Lareb is reviewed manually to identify potential signal triggering reports (PSTR) or ICSRs which need further clinical assessment for other reasons. Obj...

Reactivation of the scar resulting from intracutaneous injection of Bacillus Calmette-Guérin (BCG) is a common specific reaction in Kawasaki’s Disease. It has also sporadically been associated with viral infections, Multisystem Inflammatory Syndrome in Children, influenza vaccination and mRNA COVID-19 vaccination. Since the start of the COVID-19 va...

IntroductionInvolving 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, pat...

Background: Intranasal corticosteroids are one of the cornerstone treatment options for allergic rhinitis and chronic sinusitis complaints. Safety information in the summary of product characteristics may not be representative for observations in daily clinical practice. The Netherlands Pharmacovigilance Center (Lareb) collects post-marketing safe...

Background: Adverse drug reaction (ADR) reports in pharmacovigilance databases often contain coded information and large amounts of unstructured or semi-structured information in plain text format. The unstructured format and sheer volume of these data often render them neglected. Structural topic modelling (STM) represents a potentially insightfu...

Introduction: The inclusion of herbal medicinal products and herbal supplements in pharmacovigilance systems is important because a systematic approach of collecting and analyzing adverse drug reactions related to these products will help practitioners, patients, and regulators to gain more knowledge and prevent harm. Objective: We aimed to cate...

The Dutch Pharmacovigilance Centre Lareb receives an increasing number of reports on products that fall within the grey area of non-registered health-enhancing products, including supplements. Currently, there is no structural vigilance approach to handling these spontaneous reports of suspected adverse events. This explorative study identified whe...

Introduction: Sexual dysfunction (SD) is a problem that can affect any phase of the sexual response cycle (such as sexual desire, arousal and orgasm) and individuals of any age. SD can be caused by physical reasons, such as medical conditions, alcoholism or drug abuse; psychological factors, such as stress and anxiety; and different medicines, suc...

Introduction: The rapid rollout of coronavirus disease 2019 (COVID-19) vaccines for a large proportion of the population necessitates a strong emphasis on safety. Complementary to the existing spontaneous reporting system, The Netherlands Pharmacovigilance Centre Lareb conducted patient-reported cohort event monitoring (CEM). Objective: The prim...

Background: A large number of herbal preparations are offered on the internet. Some of these may contain substances not listed on the label. When these are illegal "regular" drugs, this can lead to serious side effects. Case description: In January 2021, The Netherlands Pharmacovigilance Centre Lareb received 4 reports of side effects after usin...

Background Reviewing the epidemiological profile of medication errors (MEs) reported by African countries and the systems put in place to report such errors is crucial because reporting plays an important role in improving patient safety. The objectives of this study were to characterize the profile of spontaneously reported MEs submitted by Africa...

Genetic defects in interleukin-12/23/17 immunity are known to cause Staphylococcus aureus and herpesvirus skin infections. This study analysed spontaneous safety reports from the WHO Pharmacovigilance Center of bacterial skin or herpesvirus infections associated with secukinumab, ustekinumab and tumour necrosis factor-α inhibitors. Associations fou...

Genetic defects in interleukin-12/23/17 immunity are known to cause Staphylococcus aureus and herpesvirus skin infections. This study analysed spontaneous safety reports from the WHO Pharmacovigilance Center of bacterial skin or herpesvirus infections associated with secukinumab, ustekinumab and tumour necrosis factor-α inhibitors. Associations fou...

Objectives To explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands. Design A web-based prospective cohort design using patient reported outcomes (PROs). Setting Any person who has been vaccinated with any brand of COVID-19 vaccine in the Dutch COVID immunization...

IntroductionVortioxetine, a multimodal serotonergic drug, is widely used as treatment for major depressive disorder. Although on the market since late 2013, the data of the relative safety of vortioxetine, especially compared to selective serotonin reuptake inhibitors, are still scarce.Objective The aim of this study was to explore the adverse even...

VigiBase is the World Health Organization global database of individual case safety reports (ICSRs), reports of suspected adverse drug reactions to medicines. VigiBase is maintained by the Uppsala Monitoring Centre, an independent centre for drug safety and scientific research. By June 2020, VigiBase contained over 21 million de-duplicated ICSRs, s...

Many pharmacovigilance centres worldwide receive spontaneous reports for herbal medicines (including unapproved/unlicensed products) in addition to reports for conventional medicines. Reports involving herbal medicines are stored in pharmacovigilance databases that are mainly developed for storing, coding, assessing, analysing and transferring data...

Background : Sexual dysfunction is highly prevalent worldwide. A specific form is persistent sexual dysfunction after SSRI withdrawal. We conducted a systematic literature review in order to characterize factors related to post SSRI sexual dysfunction (PSSD) and analyzed spontaneous reports of persistent sexual dysfunction reported to the Netherlan...

Background Biologics directed against the T-helper (Th)-17 pathway have been approved for several inflammatory diseases. Interleukin (IL)-17 is involved in anti-Candida host defense, and clinical trials suggested increased candidiasis incidence during IL-17 inhibitor therapy. We describe the worldwide epidemiology of candidiasis during Th17 inhibit...

Introduction Drug use is inherently related to both beneficial effects on health as well as the occurrence of risks. The beneficial effects may be related to efficacy, the treatment range of a product, or even to user-friendliness of a product. However, in addition to the occurrence of adverse drug reactions, a drug can also have an unexpected bene...

Due to the high intensity of the COVID‐19 vaccination campaigns and heightened attention for safety issues, the number of spontaneous reports has surged. In the Netherlands, pharmacovigilance centre Lareb has received more than 100 000 reports on adverse events following immunization (AEFI) associated with Covid‐19 vaccination. It is tempting to in...

Background: Stuttering is a well-known condition that affects mainly children. Often, they recover as they get older. However, a drug-induced form of stuttering may occur at any age. The aim of the present study was to detect drugs that have been associated with stuttering and discuss the mechanisms involved. Method: A descriptive study based on re...

Haaruitval (alopecia) en textuurveranderingen van het haar, waardoor het gaat krullen, zijn bijwerkingen van retinoïden. Hoewel haartextuurveranderingen medisch gezien geen ernstige bijwerkingen zijn, worden ze door patiënten wel als vervelend ervaren, waardoor ze mogelijk van invloed zijn op de therapietrouw. Bij Lareb zijn haartextuurveranderinge...

Objectives The number of reports on products that fall within the grey area of non-registered health-enhancing products, including supplements and herbal extracts, received by the Dutch pharmacovigilance centre Lareb is increasingly yearly. Currently, such spontaneous reports of suspected adverse events are dealt with on a case-by-case basis in var...

Background Janus kinase (JAK) inhibitors are effective small molecular drugs for rheumatoid arthritis (RA) and other immune mediated inflammatory diseases (IMIDs). JAK inhibitors exert their immunosuppressive effects by suppressing the action of JAK, an intracellular tyrosine. Although infections are the most reported side effects, potential glucos...

Purpose The aim of the study is to characterise safety signals based on the Dutch spontaneous reporting system (SRS) and to investigate the association between signal characteristics and Product Information (PI) update stratified by approval type: centrally authorised products (CAPs) versus nationally and decentralized authorised products (NAPs)....

IntroductionThe impact of pharmacovigilance activities on public health remains under-investigated, and measuring the impact on health of pharmacovigilance activities for a specific safety signal is challenging.Objective To gain more insight into the methodological challenges and the data required, we assessed the impact of pharmacovigilance on pub...

Serious concerns are expressed on the safe use of red yeast rice (RYR) supplements. The aim of the present study was to analyse cases received by Lareb on RYR‐related adverse health events. These cases were analysed for the number of reports, number of adverse drug reactions (ADRs), causality, seriousness of the reaction, latency‐period, age and se...

Objectives: . To describe the cumulative incidences of adverse drug reactions (ADRs) associated with disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients from real-world data (RWD), using the DREAM-RA registry, and to compare these with incidence frequencies mentioned in the Summary of Product Characteristics (SmPC...

Introduction 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 th...

Objective: The aim was to assess the perception of risk for developing adverse drug reaction (ADRs) and knowledge, attitudes and opinions regarding pharmacovigilance in diabetic patients, and to investigate the effect of being a member of a patient organisation for diabetes on these factors, in comparison with other patients. Methods: A cross-sect...

Xylometazoline is geregistreerd voor de behandeling van een verstopte neus, al dan niet in combinatie met ipratropium. Na paracetamol is xylometazoline het best verkochte middel dat vrij verkrijgbaar is in de apotheek en bij de drogist. Bijwerkingencentrum Lareb krijgt geregeld meldingen binnen van patiënten met een lang-QT-syndroom die hartritmest...

The article "Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands", written by Linda Härmark, Gerda Weits, Rietje Meijer, Federica Santoro, G. Niklas Norén, Florence van Hunsel, was originally published electronically on 16 May 2020 without open access.

Aims Medication safety requires urgent attention in hospital pharmacy. This study evaluated the medication‐related problems/errors as reported to the Dutch medication incident registry and disseminated for information to pharmacists. Through analysis by an expert panel we aimed to better understand which problems could have been mitigated by the dr...