Pharmacovigilance

Medicine product information changed 228 times as a result of new EU pharmacovigilance system

A strengthened EU-wide system to detect, assess and act on new or known adverse drug events has created a “new era for patient protection and transparency in patient safety,” according to an analysis of the system.…

EMA makes recommendations to reduce methotrexate dosing errors

Only doctors with expertise in using methotrexate-containing medicines should be able to prescribe them, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has recommended.…

EMA committee says cough medicines containing fenspiride should not be marketed

A European Medicines Agency committee has recommended that marketing authorisations for cough medicines containing fenspiride should be revoked, meaning they will no longer be marketed in the EU.…

Pharmaceutical companies vow to improve monitoring of medicine side effects

Pharmaceutical companies have agreed to work together on improved ways to identify and monitor adverse drug reactions.…

A day in the life of a head of pharmacovigilance

Deji Alli details a typical day as head of pharmacovigilance and Responsible Person for the largest clinical homecare provider in the UK.…

EMA committee maintains recommendation to suspend hydroxyethyl-starch solutions for infusion

The EMA’s Pharmacovigilance Risk Assessment Committee has confirmed its recommendation to suspend hydroxyethyl-starch solutions for infusion in the European Union.…

EMA committee starts review of methotrexate dosing errors

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has started a review of the risk of dosing errors with methotrexate medicines, which are used to treat cancers and various inflammatory conditions.…

EMA starts safety referral for prostate cancer drug

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has begun two new safety-related referrals…

MHRA launches social media campaign to promote Yellow Card reporting

The Medicines and Healthcare products Regulatory Agency has launched a social media campaign to promote the reporting of suspected side effects from over-the-counter medicines…

PGEU sets out best practice on pharmacovigilance and risk minimisation

The Pharmaceutical Group of the European Union has published a new Best Practice Paper on Pharmacovigilance and Risk Minimisation.…