Managing and Communicating Risks
Since July 2012 all new medicinal products must now have a Risk Management Plan (RMP) which focuses on the assessment and minimisation of important risks associated with the medicine throughout its lifecycle. Some risks can be effectively managed by including warnings in the product information (Summary of Product Characteristics- SmPC and Patient Information Leaflet-PIL), the labelling of the product, its pack size or design or through the prescription status of the product (e.g. available through prescription-only). However, when necessary, additional measures can be taken in order to ensure that healthcare professionals and patients remain informed about specific risks and how to minimise them. Examples of such measures include writing directly to healthcare professionals (Direct Healthcare Professional communications-DHPCs), providing educational materials and tools for healthcare professionals and patients or recommending specific tests be carried out before the patient receives the medicine or during the time the patient is on the medicine in order to recognize a side effect at an early stage, lessen the side effect or avoid it altogether. The RMP may also include plans to gain more information about certain aspects of the safety of the medicine (post authorisation safety studies).
It is important that patients, consumers and healthcare professionals have access to good quality information on the benefits and risks of medicines. The SmPCs and PILs of medicines authorised in Ireland and within the EU are available here on the HPRA and EMA websites. European public assessment reports are available on the EMA website and HMA website. The agendas, highlights and minutes of PRAC are published on the EMA website on a monthly basis. Information on topics with major public health interest relating to the benefit-risk of specific medicines is also made available along with dedicated press releases or Q&A documents where appropriate. Product safety announcements and DHPCs are published regularly on the HPRA website.