Adverse drug reaction (ADR) reporting relies on HCPs and patients reporting these events in order to make medications safe. However, the MHRA is still finding that ADRs are being under reported. A recent survey by the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action Project, led by the MHRA, has found that in many countries there is a paucity of educational resources on ADR reporting. To this end, the Joint Action project set up an e-module to educate HCPs in reporting of ADRs. On completion of the module, HCPs will be awarded one credit from the European Accreditation Council for Continuing Medical Education (EACCME), equivalent to one hour’s continuing professional development (CPD) or continuing medical education (CME). A spokesperson from the MHRA said “Being vigilant not only in the prompt identification and reporting of suspected ADRs is important, but so is staying up-to-date with the latest safety information”. The e-module is a continuation of the MHRA’s EU-wide campaign to raise awareness of the importance of ADR reporting, which took place in November 2016 and involved 21 competent authorities. The MHRA have noted that it has already been implemented by a number of competent authorities including Croatia, Ireland, Italy, Latvia, Lithuania and Romania.

The numbers:

The MHRA has seen an annual rise in ADR reporting, with 42,000 ADRs reported in 2016 via the Yellow Card Scheme. This figure is the highest to date and the MHRA database now holds more than 820,000 records.

In a statement published on 16 June 2017, Mick Foy, group manager of the MHRA’s vigilance Risk Management of Medicines division said “We’ve created this e-learning module to help doctors so they can have confidence that their reports are making a difference……. doctors are critical to this as their position on the front line of care means they are often the first to recognise an adverse drug reaction”.