1. What is ‘safety communication’?
What is ‘safety communication’?
Communicating safety information to patients, carers and healthcare professionals as the main target audiences is a public health responsibility. Moreover, it is essential for achieving the objectives of pharmacovigilance in terms of promoting the rational, safe and effective use of medicines, preventing harm from adverse reactions (ADRs) and contributing to the protection of patients’ and public health.
Safety communication is a broad term covering different types of information on medicines, including required information contained in the product information (i.e. the Summary of Product Characteristics (SmPC). Package of Leaflet (PL) and the labelling of the packaging) and public assessment reports. Safety communication concerns authorised medicines and tend to relate to major safety issues: withdrawal or suspension of a medicine from the market, new contraindications or warnings, restriction of use or product defects leading to safety concerns.
Safety communications are provided by marketing
authorisation holders (MAHs) and health authorities (HAs).
Safety communications are provided by marketing authorisation holders (MAHs) and health authorities (HAs).
Although some principles apply to all types of safety communication, the term ‘Safety communication’ in this lesson is used to indicate the communication of ‘important new safety information’, which means new information about a previously known or unknown risk of a medicine which has or could have an impact on a medicine’s -benefit risk balance and its condition of use.
Safety communication aims at:
- providing timely, evidence-based information on the safe and effective use of medicines;
- facilitating changes to healthcare practices (including self-medication practices) where necessary;
- changing attitudes and behaviours in relation to the use of medicines;
- supporting risk minimisation behaviour;
- helping to prevent future adverse reactions or medical errors;
- promoting dissemination of important safety information by patients, consumer and healthcare professional organisations.
Safety communication provides:
- knowledge from previous experience that was reported and analysed (To note: One safety finding communicated properly and in a timely manner to the Health Authorities (HA) and resulting in the appropriate actions can prevent ADRs);
- information about the appropriate clinical management of patient treatment;
- advice to patients on how to take a medicine - or what to do in case of adverse reactions – which can increase confidence and reduce concerns.
Communication of important new safety information on medicinal products should take into account the views and expectations of concerned parties, including patients and healthcare professionals, with consideration given to relevant legislation.
The EMA in collaboration with the EU member states produced the ‘Guideline on good pharmacovigilance Practices (GVP) Module XV – Safety communication’ which provides guidance to marketing authorisation holders (MAH), competent authorities in Member States (NCA) and the European Medicines Agency (EMA) on how to communicate and coordinate safety information concerning medicinal products authorised in the EU. This guideline is the main document on which the subsequent sections are based.
 EMA Guideline on good pharmacovigilance practices (GVP) Module XV – Safety communication. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/WC500137666.pdf