WC500185968

In follow-up to its discussion at the February 2015 meeting, the PRAC finalised the action plan for the
implementation of enhanced risk minimisation measures regarding the risk of osteonecrosis of the jaw
(ONJ) with bisphosphonates and denosumab. This included a proposal for key safety messages to be
reflected in the product information for these products, as well as for a patient reminder card. These
are currently being implemented for Aclasta (see 6.1.14. ) and will be considered during the upcoming
periodic reviews for all other bisphosphonates for intravenous use as well as for denosumab.
12.14. Interaction within the EU regulatory network
None
12.15. Contacts of the PRAC with external parties and interaction of the
EMA with interested parties
12.15.1. Guidelines of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH)
None
12.15.2. Others
12.15.2.1. International Society for Pharmacoepidemiology (ISPE)
Analysis of patient and healthcare professional input into EMA communications relating to the
oral contraceptives referral, following the symposium, October 2014
At the organisational matters teleconference held on 26 March 2015, the EMA Secretariat presented
feedback on the analysis of patient and healthcare professional input into the EMA communications
relating to the oral contraceptive referral presented at the International Society for
Pharmacoepidemiology at its conference in October 2014.
12.16. Others
Interaction with patients, consumers and organisations: revised framework
At the organisational matters teleconference held on 26 March 2015, the EMA Secretariat presented
the revised framework for interaction between the European Medicines Agency and patients and
consumers and their organisations, which was adopted by the EMA management board in December
2014. The aim of this revised framework was to clarify the objectives and consolidate the methodology
for such interactions. The PRAC welcomed this important progress and anticipated strengthening its
interactions with patients and consumers using the new framework.
13. Any other business
13.1. Medication errors
Risk minimisation strategy for medication errors with high strength/fixed combination insulins
As a follow-up to the discussion at the February 2015 PRAC, the EMA Secretariat presented revised
draft guidance and a revised draft EMA safety communication for patients and HCPs on the risk
minimisation strategy for medication errors with high strength/fixed combination insulins taking into
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 60/89