Pharmacovigilance also continued to play an important role throughout a medicine’s entire life cycle in 2017. The safety profile is prepared before authorisation. Following authorisation, medicines are actively monitored during use in practice. Thus, there is an ongoing reassessment of the benefit-risk balance.
Public hearing for valproate
The Netherlands played a leading role in 2017 as reporter for the reassessment by the Pharmacovigilance Risk Assessment Committee PRAC of medicines with the active substance valproate.
These medicines were approved nationally in the European Union (EU) for the treatment of epilepsy, bipolar disorder and, in some countries, migraine.
Since 2014, measures apply for medicines that contain valproate for use by women and girls. There are risks for children when they have been exposed to valproate in the womb. The PRAC carried out a reassessment of the effectiveness of the measures as well as to consider whether further measures were necessary.
The PRAC organised a public hearing in order to include the experience in practice in the reassessment. 65 participants were present at this hearing, among whom 16 speakers. Patients, care providers, doctors, pharmacists and scientists shared their experiences with valproate. These, often very personal, experiences turned out to be very valuable in the reassessment.
The MEB consulted the expertise of the patient association and obtained important information in this manner about the experiences of patients and the proposed measures.
The results of the reassessment of valproate are expected in 2018.
Attention for reporting possible adverse reactions
The MEB and Netherlands Pharmacovigilance Centre Lareb participated in the European Adverse Events Week for the second time in November. Attention was also asked via Facebook, LinkedIn and Twitter for continuing to report possible adverse reactions to the Netherlands Pharmacovigilance Centre Lareb. These reports are an important source for the MEB when assessing the benefit-risk balance of medicines. The information on the MEB website about what happens with the reports and signals of adverse reactions has also been updated.
The updated system for the collection of suspected adverse reactions (ADRs), EudraVigilance, has been operational since November 2017. As a result, it has become easier to share reports of suspected adverse reactions between Member States and market authorisation holders. Furthermore, additional information such as photographs or scans can be attached to a report.
Activities of Pharmacovigilance
The MEB had an important share in the work of the PRAC in 2017. With the number of assigned PRAC reporterships, the Netherlands ranks among the top three in Europe. The Netherlands also plays an important role in the discussions of other assessments.
An overview of several key figures is provided below. This is not a complete reflection of all activities that fall under pharmacovigilance.
The Netherlands acted as a reporter once in 2017 for a reassessment initiated by the PRAC (Pharmacovigilance Risk Assessment Committee). The Netherlands was a reporter 14 times for new PRAC procedures. In addition, the MEB was involved many times as CMS in PRAC procedures.
|Lareb signals discussed during MEB meetings||14 (separate discussion since July 2015)||22||18|
|Implementation of additional risk minimisation measures||80||94||130|
|Netherlands Rapporteur PRAC procedures||11||17||13||14|
|Assessment of protocols for Post Approval Safety Studies (PASS)||18||29||34|
|Assessment of PSUR Single Assessment (PSUSA)||61||63||82|
|Lead Member State for monthly signal detection (number of substances)||52||61||90|
In 2017 trad het Nederland 1 keer op als rapporteur bij een door het geneesmiddelenbewakingscomité PRAC (Pharmacovigilance Risk Assessment Committee) geïnitieerde herbeoordeling. Nederland was 14 keer rapporteur voor nieuwe PRAC-procedures. Daarnaast was het CBG vele malen als CMS bij PRAC-procedures betrokken.
* Signaalmanagement: het gehele proces rondom de identificatie, beoordeling en uitwerking van nieuwe risico-informatie. Dit is inclusief aanbevelingen voor vervolgacties, zoals het aanpassen van de productinformatie en de communicatie.