Florence van Hunsel

Adverse Drug Reaction Reporting by Patients in the Netherlands Three Years of Experience

AbstractBackground: There has been discussion about the acceptance of adverse drug reactions (ADRs) reported by patients to spontaneous reporting systems. Lack of experience with patient reporting in real life was one of the main drawbacks in this debate. This study covers 3 years of experience with patient reporting in daily practice. We compared patient reports with reports from healthcare professionals. Although patients have the opportunity to report ADRs in several countries, little is published in the literature about the contribution that patient reports have in practice. To our knowledge, this paper is the first to describe long-term experiences with patient reporting as part of a spontaneous reporting system. Methods: The number of reports received, age and sex of the reporters, characteristics of the most frequently reported drugs and characteristics of the ADRs (most frequently reported ADRs, seriousness, outcome) in a 3-year period (April 2004–April 2007) were compared between patient reports and reports from healthcare professionals. Findings: During this 3-year period, the Netherlands Pharmacovigilance Centre Lareb received 2522 reports directly from patients, concerning 5401 ADRs. In the same period, healthcare professionals submitted 10 635 reports, concerning 16 722 ADRs. Differences were found in the categories of seriousness and outcome of the reported ADRs between patients and healthcare professionals. Conversely, similarities between patient reports and reports from healthcare professionals were found in age, sex, most frequently reported ADRs and most frequently reported drugs. Interpretation: Our study highlights clearly that valuable differences between ADR reports from patients and reports from healthcare professionals exist. Differences in interpretation by patients and healthcare professionals may cause the observed disparities in seriousness and outcome of reported ADRs. However, the similarities between patient reports and reports from healthcare professionals in most frequently reported ADRs and most frequently reported drugs are striking. After 3 years of experience with patient reporting, we conclude that patient reporting in spontaneous reporting systems is feasible and that it contributes significantly to a reliable pharmacovigilance.

Experiences with Adverse Drug Reaction Reporting by Patients An 11-Country Survey

AbstractBackground: Patients are important stakeholders in pharmacovigilance; however, little formal evaluation has been undertaken of existing patient reporting schemes within and outside Europe. If patient reporting is to be recognized as beneficial for pharmacovigilance and further optimized, methodology and best practice must be internationally shared and promoted. Objective: This study aims to review the methods of patient reporting of adverse drug reactions (ADRs) in 11 countries worldwide and to compare different aspects of their experiences. Methods: A survey based on telephone interviews, e-mail discussions and field visits of existing practices in consumer and patient reporting of ADRs was performed in the second half of 2010. Results: The start dates of the patient reporting schemes vary from 1964 (Australia) to 2010 (Norway). The number of patient reports per country varies widely. Most countries would ideally spend more resources on making the public aware of the possibility that patients can report ADRs.

Motives for reporting adverse drug reactions by patient-reporters in the Netherlands

AimThe aim of this study was to quantify the reasons and opinions of patients who reported adverse drug reactions (ADRs) in the Netherlands to a pharmacovigilance centre.MethodA web-based questionnaire was sent to 1370 patients who had previously reported an ADR to a pharmacovigilance centre. The data were analysed using descriptive statistics, χ2 tests and Spearman’s correlation coefficients.ResultsThe response rate was 76.5% after one reminder. The main reasons for patients to report ADRs were to share their experiences (89% agreed or strongly agreed), the severity of the reaction (86% agreed or strongly agreed to the statement), worries about their own situation (63.2% agreed or strongly agreed) and the fact the ADR was not mentioned in the patient information leaflet (57.6% agreed or strongly agreed). Of the patient-responders, 93.8% shared the opinion that reporting an ADR can prevent harm to other people, 97.9% believed that reporting contributes to research and knowledge, 90.7% stated that they felt responsible for reporting an ADR and 92.5% stated that they will report a possible ADR once again in the future.ConclusionThe main motives for patients to report their ADRs to a pharmacovigilance centre were the severity of the ADR and their need to share experiences. The high level of response to the questionnaire shows that patients are involved when it comes to ADRs and that they are also willing to share their motivations for and opinions about the reporting of ADRs with a pharmacovigilance centre.

ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems

Consumer reporting of adverse drug reactions (ADRs) has existed in several countries for decades, but throughout Europe the role of consumers as a source of information on ADRs has not been fully accepted until recently. In Europe, The Netherlands and Sweden were among the first countries to implement consumer reporting well before it was mandated by law throughout the EU. Consumer reporting is an integral part of the spontaneous reporting systems in both The Netherlands and Sweden, with yearly numbers of reports constantly increasing. Consumer reporting forms and handling procedures are essentially the same as for healthcare professional reporting; the message in the reports, not the type of messenger, is what is of importance. Studies have established the significant contribution of consumer reporting to ADR signal detection. Combining all reports regardless of reporter type is recommended since it yields the largest critical mass of reports for signal detection. Examples of signals where consumer reports have been of crucial importance for signal detection are electric shock-like sensations associated with the use of duloxetine, and persistent sexual dysfunction after discontinuation of selective serotonin reuptake inhibitors. An example of consumer reporting significantly strengthening a detected signal is Pandemrix® (influenza H1N1 vaccine)-induced narcolepsy. Raising public awareness of ADR reporting is important, but time- and resource-consuming. The minimum effort taken should be to passively inform consumers, e.g. via stakeholders’ homepages and via drug product information leaflets. Another possibility of reaching out to this target group could be through co-operation with other (non-government) organizations. Information from consumer reports may give a new perspective on ADRs via the consumers’ unfiltered experiences. Consumers’ views may change the way the benefit–harm balance of drugs is perceived and assessed today, and, being the ultimate users of drugs, consumers could have a relevant influence in the regulatory decision-making processes for drugs. All stakeholders in pharmacovigilance should embrace this new valuable source of information.

Adverse drug reaction reports of patients and healthcare professionals—differences in reported information†

This study aims to explore the differences in reported information between adverse drug reaction (ADR) reports of patient and healthcare professionals (HCPs), and, in addition, to explore possible correlation between the reported elements of information.

Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring.

BACKGROUND When adjuvant vaccines against the pandemic influenza A (H1N1) virus became available after an accelerated registration process, safety issues dominated the public debate. As part of the immunisation campaign, the Dutch government installed an active monitoring of possible adverse events following immunisation (AEFIs). As part of the monitoring we conducted an anonymous prospective cohort study to identify and quantify the occurrence of AEFIs related to pandemic vaccination among the population immunised in general practice. METHOD Adults aged 60 years and older or persons with a risk-elevating medical condition recommended for vaccination in general practice were eligible for participation. After receipt of the first pandemic vaccine the administrator handed over an information flyer of the web-based monitoring program. The patient could sign up for study participation online. Within one week, three weeks and three months after the first immunisation questions were asked about demographics and health, immunisations, injections site reactions and labeled reactions as well as other possible new AEFIs. RESULTS In all, 3569 participants filled in the first questionnaire. Corresponding figures for the second and third questionnaires were 3395 (95.1%) and 3162 (88.6%). Mean age was 58 years (SD 15) and 50.1% was female. Main indication was 60 years or older followed by presence of pulmonary or cardiovascular disease. Of all participants, 1311 (37%) reported an AEFI. Unexpected serious reactions were not reported nor were there signals of possible new AEFIs. The occurrence of an AEFI was determined by gender, age and type of co-morbidity. CONCLUSION The web-based intensive monitoring system among patients immunised in general practice revealed AEFIs due to pandemic vaccination in one-third of participants. There were no unexpected serious adverse events in this population. This advanced methodology can be further developed to monitor real-time use and AEFIs of vaccines.

Important information regarding reporting of adverse drug reactions: a qualitative study

To give an overview of the views of different types of reporters (patients and healthcare professionals (HCPs)) and assessors of adverse drug reactions (ADRs) on what they consider important information regarding an ADR report.

The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

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.

Response to the validity and reliability of a signal impact assessment tool: statistical issue to avoid misinterpretation

We thank Sabour and Ghassemi for their suggestions on our paper. Sensitivity, specificity, positive predictive value, and negative predictive value are often used to test validity of diagnostic tools. In these cases, you have a dichotomous outcome; for instance, disease versus no disease. In our study, the Signal Impact Assessment Tool (SIAT) prioritizes signals into one out of four categories: strong or moderate signal strength and similarly health impact. Sensitivity and specificity can indeed be calculated when signal strength and health impact are explored separately. For example, sensitivity and specificity for the weight adjusted tool phase 2 are 57% and 50% for the signal strength and 60% and 87% for the health impact. Because signal strength and health impact of signals are closely related, it was a well-considered choice to use Cohen’s Kappa. Because the outcome of the SIAT is not a dichotomous outcome, another measure, expressing the coherence of the findings, was preferred. As not mentioned in the paper, we did indeed use a weighted kappa because of the prioritization in the SIAT categories. In the management and decision-making on drug safety signals in pharmacovigilance, the signal strength and its health impact are abstract concepts, expressed as judgement by a panel of experts in that moment of time, taking into account the information available at that specific time. Each expert brings their own experiences and motivations. As described in the paper, this tool will not replace the experts’ opinion, but it can be used as an aid in the process of signal selection. In this respect, we do not share the concern of Sabour and Ghassemi that misdiagnosis and mismanagement may occur.

The validity and reliability of a signal impact assessment tool

The Netherlands Pharmacovigilance Centre Lareb uses an operating Signal Impact Assessment Tool (SIAT) as aid in signal selection. SIAT prioritized signals into one of four categories: strong/moderate signal strength and similarly health impact. Although the SIAT has been used for many years, validity and reliability was never explored.