In 2016, pharmacovigilance continued to play an important role throughout a medicine’s entire life cycle. The safety profile is prepared before authorisation. Following authorisation, medicines are actively monitored during use in practice. In so doing, there is an ongoing reassessment of the benefit-risk balance.

Knowledge exchange and training

Because the 2012 pharmacovigilance legislation is extensive and complex, the European Commission set up the Strengthening the Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action project (2013-2016). The aim of this programme is to share knowledge between Member States. After identifying problems and possible solutions, materials were developed to tackle the common problems.

Best Practice Guides, e-learning modules, checklists, toolkits and training courses were put in place. 2016 was the last year of SCOPE, and training courses and workshops were held on the basis of these materials. The information will be integrated in the training programme of the MEB and will become part of the EUNTC (European Network for Training Center) at EU level. The MEB coordinated the section on signal management and played an important role in the workshops on risk communication and the training courses on the lifecycle of pharmacovigilance. Signal management covers the entire process covering the identification, assessment and processing of new risk information. This includes recommendations for follow-up action, such as revising product information and communication.

Signals from the Netherlands to Europe

In the Netherlands, healthcare providers and patients report suspected adverse reactions and medication errors to the Netherlands Pharmacovigilance Centre Lareb and the Patient Safety Portal.

The MEB discusses the signals reported by Lareb and, if necessary, submits them to the European pharmacovigilance committee PRAC or another Member State that acts as a Rapporteur. In this way, the Netherlands’ practical experience contributes to the identification of risks associated with the use of medicines in Europe.

The Patient Safety Portal / Central Medication Incidents Registration (PvP/CMR) is the national reporting centre for medication errors. The PvP and the MEB entered into a collaboration in 2016. This means that the PvP conducts further analysis on medication errors and informs the MEB on this periodically.

Assessment of adverse effects of salbutamol

Between October 2014 and July 2016, Lareb received 63 reports about the Sandoz salbutamol inhaler. It only concerns the type of inhaler available on the Dutch market since autumn 2014. The product was reported to be less effective. Many complaints concerned children, and even involved hospitalisation. The MEB carried out investigations into the product in 2016. After consulting the European network, it was found that in the 11 countries in which the inhaler is used, only Germany experienced a short peak of notifications in 2010. The batches of inhalers available on the Dutch market were not found to have any quality issues.

Extra examination of the dossier did not reveal anything out of the ordinary. It was also found that the reported number of hospitalisations of children did not deviate from the expected pattern. The large-scale switch (approx. 350,000 patients) to this type of inhaler in a short period of time may be a significant factor in the complaints. It is not uncommon for patients to encounter problems when they start using new respiratory medicines.

The MEB consulted with pharmacists and patients on the situation that arose. The severity of the problems was emphasised during these consultations. Having weighed the advantages and disadvantages, the MEB came to the conclusion that the Sandoz salbutamol inhaler could remain on the market.

Below you find an overview of several important figures. This is not a complete reflection of all activities falling under pharmacovigilance.

Appendix C: Important risk information about medicinal products issued to doctors and pharmacists (DHPCs) in 2016

Important risk information about medicines issued to doctors and pharmacists (DHPCs)

Important risk information about medicines issued to doctors and pharmacists (DHPCs)
Source table as .csv (53 bytes)

National activities/assessments

National activities/assessments
Lareb signals discussed during MEB meetings14 (separate discussion since July 2015)22
Implementation of additional risk minimisation measures8094
Source table as .csv (164 bytes)

European activities/procedures (NL = rapporteur)

European activities/procedures (NL = rapporteur)
Assessment of protocols for Post Approval Safety Studies (PASS)1829
Assessment of PSUR Single Assessment (PSUSA)6163
Signal management*1811
Lead Member State for monthly signal detection (number of substances)5261

* Signal management: the entire process covering the identification, assessment and processing of new risk information.

Source table as .csv (238 bytes)