EMA releases risk minimisation checklist
Key issue is better targeting summaries of product characteristics and packaging leaflets to their audience
The European Medicines Agency (EMA) has released a checklist of reform proposals that it thinks could minimise the risks involved in taking and administering medicines. The advice was culled from a workshop staged by the European Union (EU) agency in September 2015.
One key issue raised was better targeting summaries of product characteristics and packaging leaflets to their audience, taking account of the likely level of their health and medicines knowledge. It said that pharmaceutical firms could maybe liaise better with patient organisations to improve the drafting of such messages. Indeed, said the EMA report, good collaboration with healthcare professionals and patient groups is critical and they should be involved early on in designing such materials. Better training could help here – especially in helping health professionals liaise with regulators, as well as patients.
Regulators need to work with pharmaceutical firms and health professionals so that 'more is…done to create an atmosphere of risk awareness without undermining trust', so that users have 'critical trust' regarding taking medicines, rather than 'blind trust on the one hand and no trust on the other'.
Meanwhile, the industry needs to look beyond relying on hard copy communications to using the Internet, including social media, to improve messaging effectiveness, 'making sure that the correct communication tool is chosen in each situation and the message adapted to each audience'.
And a more systematic approach is needed to monitor the effectiveness of risk minimisation measures at different levels, developing criteria for when and how deeply to assess their effectiveness, considering the importance of medicines to public health and the feasibility of risk minimisation strategies.