Safety communication channels

Depending on the severity of new safety issues, different channels of communication can be considered. These include but are not limited to:

1. Direct communication to healthcare professionals (DHPC) by the MAH or the competent authorities (see section 6 on DHPC)

2. Documents in lay language (e.g. the use of a questions and answers format) to help patients and the general public to understand the scientific evidence and regulatory actions relating to the safety concern

3. Press communication that includes press releases and press briefings. This is intended primarily for journalists. Journalists are an important way to reach a wider audience. However, in cases where there is a direct communication to healthcare professionals as well, the healthcare professionals should ideally receive it before or around the same time of the press communication

4. Websites of competent health authorities and MAHs where easily accessible and understandable information can be found. The EMA web portal ( contains information on all medicines authorised in the EU and links to the national medicines web portals (see section EudraVigilance in lesson 2)

5. Other web-based communications like the more rapid communication channels of social media

6. Bulletins and newsletters provided by competent authorities

7. Inter-authority communication like ‘the line-to-take’ which are documents prepared by the authorities to assist their own staff in responding to external enquiries or communicating on specific safety issues

8. Systems put in place by the MAHs or the competent authorities to respond to enquiries from individual members of the public

9. Scientific journals and professional bodies’ publications

The process of communication can be established globally (FDA, EMA) but also locally. For example, some clinics and hospitals have schools dedicated for patients. These schools have specific objectives, such as getting patients’ opinion and feedback on an established way of treating a disease.

Some tools and channels may be used in the context of risk management; in addition to the product information, other communication tools can be used to disseminate information about the product. These are considered as additional risk minimisation measures and may include patient alert cards or educational materials (see also lesson 3 Risk management).