Patient participation in pharmacovigilance

Patiëntenparticipatie is van grote waarde voor de bewaking van de veiligheid van geneesmiddelen (farmacovigilantie). Leàn Rolfes concludeert in haar proefschrift dat meldingen van patiënten bijdragen aan het tijdig vinden van nieuwe bijwerkingen. De kwaliteit van de informatie die zij geven over de bijwerkingen die zij ervaren is goed. Bovendien geven patiënten informatie over in de invloed van bijwerkingen op hun dagelijkse leven. Voor een optimale bewaking van de veiligheid van geneesmiddelen zouden zorgverleners en patiënten gestimuleerd moeten worden om bijwerkingen te melden. Bijwerkingen die patiënten en zorgverleners opmerken in de dagelijkse praktijk, kunnen zij melden. In ons land kan dat bij het Bijwerkingencentrum Lareb. Meldingen van bijwerkingen worden door Bijwerkingencentrum Lareb geanalyseerd. Dit zorgt voor nieuwe kennis over bijwerkingen, die eerder niet of onvoldoende bekend was. Kennis die cruciaal is voor zorgverleners en patiënten bij de keuze voor een geneesmiddel, het mogelijk voorkomen en tijdig herkennen van bijwerkingen. Het proefschrift van Leàn Rolfes gaat over de impact van patiëntenparticipatie aan farmacovigilantie. Patiënten zijn degenen die bijwerkingen ervaren. Zij kunnen daarom een goede beschrijving geven van de bijwerkingen die zij ervaren. Toch was participatie van patiënten in de farmacovigilantie niet altijd vanzelfsprekend. Vanaf het begin van de 21e eeuw zijn steeds meer landen meldingen van patiënten gaan accepteren. Dit proefschrift focust zich op het type en de kwaliteit van informatie die patiënten melden. Daarnaast wordt ingegaan op de vraag of patiëntmeldingen bijdragen aan het tijdig herkennen van veiligheidsrisico’s van geneesmiddelen. Ook is aandacht voor de manier waarop een bijwerkingencentrum informatie aan patiënten terug kan geven wanneer zij een bijwerking hebben gemeld. Leàn Rolfes deed haar onderzoek bij Bijwerkingencentrum Lareb in combinatie met een aanstelling als parttime externe PhD-student aan het Groningen Research Institute of Pharmacy (GRIP) van de Rijksuniversiteit van Groningen

Electronic Health Record-Triggered Research Infrastructure Combining Real-world Electronic Health Record Data and Patient-Reported Outcomes to Detect Benefits, Risks, and Impact of Medication:Development Study

BACKGROUND: Real-world data from electronic health records (EHRs) represent a wealth of information for studying the benefits and risks of medical treatment. However, they are limited in scope and should be complemented by information from the patient perspective. OBJECTIVE: The aim of this study is to develop an innovative research infrastructure that combines information from EHRs with patient experiences reported in questionnaires to monitor the risks and benefits of medical treatment. METHODS: We focused on the treatment of overactive bladder (OAB) in general practice as a use case. To develop the Benefit, Risk, and Impact of Medication Monitor (BRIMM) infrastructure, we first performed a requirement analysis. BRIMM’s starting point is routinely recorded general practice EHR data that are sent to the Dutch Nivel Primary Care Database weekly. Patients with OAB were flagged weekly on the basis of diagnoses and prescriptions. They were invited subsequently for participation by their general practitioner (GP), via a trusted third party. Patients received a series of questionnaires on disease status, pharmacological and nonpharmacological treatments, adverse drug reactions, drug adherence, and quality of life. The questionnaires and a dedicated feedback portal were developed in collaboration with a patient association for pelvic-related diseases, Bekkenbodem4All. Participating patients and GPs received feedback. An expert meeting was organized to assess the strengths, weaknesses, opportunities, and threats of the new research infrastructure. RESULTS: The BRIMM infrastructure was developed and implemented. In the Nivel Primary Care Database, 2933 patients with OAB from 27 general practices were flagged. GPs selected 1636 (55.78%) patients who were eligible for the study, of whom 295 (18.0% of eligible patients) completed the first questionnaire. A total of 288 (97.6%) patients consented to the linkage of their questionnaire data with their EHR data. According to experts, the strengths of the infrastructure were the linkage of patient-reported outcomes with EHR data, comparison of pharmacological and nonpharmacological treatments, flexibility of the infrastructure, and low registration burden for GPs. Methodological weaknesses, such as susceptibility to bias, patient selection, and low participation rates among GPs and patients, were seen as weaknesses and threats. Opportunities represent usefulness for policy makers and health professionals, conditional approval of medication, data linkage to other data sources, and feedback to patients. CONCLUSIONS: The BRIMM research infrastructure has the potential to assess the benefits and safety of (medical) treatment in real-life situations using a unique combination of EHRs and patient-reported outcomes. As patient involvement is an important aspect of the treatment process, generating knowledge from clinical and patient perspectives is valuable for health care providers, patients, and policy makers. The developed methodology can easily be applied to other treatments and health problems

The Impact of Experiencing Adverse Drug Reactions on the Patient's Quality of Life:A Retrospective Cross-Sectional Study in the Netherlands

INTRODUCTION: There is little information as to what extent adverse drug reactions (ADRs) influence patients' health-related quality of life (HR-QOL). From a pharmacovigilance perspective, capturing and making the best use of this information remains a challenge. The Netherlands Pharmacovigilance Centre Lareb received about 1800 reports after the packaging of the drug Thyrax(®) (levothyroxine; Aspen Pharma Trading Limited, Dublin, Ireland) changed from a brown glass bottle to a blister package in the Netherlands. OBJECTIVE: The objective of this study was to explore the impact of ADRs on HR-QOL in patients who reported a possible ADR to Lareb in relation to the change in the packaging of the drug Thyrax(®). A secondary objective was to explore factors correlated with change in HR-QOL. METHODS: Patients who reported an ADR in relation to the Thyrax(®) packaging change were included in this study. A web-based adapted version of the COOP/WONCA questionnaire was sent to explore the HR-QOL before versus during the ADR, expressed on a 5-point scale from no impact (1) to high impact (5). Multivariable linear regression analysis was used to identify factors correlated with change in HR-QOL. RESULTS: Overall, 1167 patients returned the questionnaire (71.2 % response rate). The difference in HR-QOL was -0.8 for physical, -1.2 for mental, -1.4 for daily activities, -1.3 for social, and -1.3 for overall health status (p < 0.001 for each domain). Age, sex, educational level of the patient, and absence from work due to an ADR were correlated with at least one domain, while severity of the ADR was found to be correlated with all domains of HR-QOL. CONCLUSION: Patients who reported possible ADRs after the Thyrax(®) packaging change experienced a significant decrease in HR-QOL. This impact was highest for the domains 'daily activities', 'overall health status', and 'mental health' and lowest for 'physical fitness'

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database:A Retrospective Comparison of Time to Reporting Between Patients and Healthcare Professionals in a Global Database

OBJECTIVE: To explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug-adverse drug reaction (ADR) associations which led to drug safety signals. DESIGN: This was a retrospective comparison of time to reporting selected drug-ADR associations which led to drug safety signals between patients and healthcare professionals. SETTING: ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase. Reports were selected based on drug-ADR associations of actual drug safety signals. MAIN OUTCOME MEASURES: Primary outcome was the difference in time to reporting between patients and HCPs. The date of the first report for each individual signal was used as time zero. The difference in time between the date of the reports and time zero was calculated. Statistical differences in timing were analysed on the corresponding survival curves using a Mann-Whitney U test. RESULTS: In total 2822 reports were included, of which 52.7% were patient reports, with a median of 25% for all included signals. For all signals, median time to signal detection was 10.4 years. Overall, HCPs reported earlier than patients: median 7.0 vs 8.3 years (p <0.001). CONCLUSIONS: Patients contributed a large proportion of reports on drug-ADR pairs that eventually became signals. HCPs reported 1.3 year earlier than patients. These findings strengthen the evidence on the value of patient reporting in signal detection, and highlight an opportunity to encourage patients to report suspected ADRs even earlier in the future