PENTHROX-SURVEY
Research type
Research Study
Full title
Evaluation of the effectiveness of Penthrox® (methoxyflurane) educational tools adopted as additional risk minimisation measures: Healthcare Professional and Patient Survey
IRAS ID
198904
Contact name
Maggie Oh
Contact email
Sponsor organisation
Medical Developments International Limited
Clinicaltrials.gov Identifier
ID13035, ENCePP
Duration of Study in the UK
0 years, 8 months, 6 days
Research summary
Evaluating the effectiveness of risk minimisation interventions is a regulatory requirement imposed to marketing authorisation holders by the pharmacovigilance legislation of 2010. Such an evaluation is particularly important when risk minimisation measures are introduced in addition to those applied routinely (labelling, SmPC, prescription status, etc.). This is the case with Penthrox®, since the UK Medicines and Healthcare products Regulatory Agency (MHRA) imposed an educational programme targeting both HCPs and patients as a condition for its marketing authorisation. Additional Risk Minimisation Measures (aRMM) have been developed ad hoc in the form of educational tools to increase awareness about the safety profile of the product and to ensure its safe and effective use.
The proposed study is intended to assess the effectiveness of the Penthrox® aRMM in terms of awareness of the educational materials, usage, readability, knowledge and understanding of the messages, impact on behavioural implementation of key safety messages and determinants for non-adherence.The results of this survey will complement data from a twin PASS assessing safety outcome(s).
The study will be conducted in UK A&E units where administration of Penthrox® started after its authorisation early in 2016. To ensure a comprehensive range of situations in which to evaluate the effectiveness of Penthrox® aRMMs, Health Care Professionals (HCPs) will be enrolled from emergency room and from ambulance crew. Similarly, patients who were administered Penthrox® in ambulance or in A&E will be enrolled.
REC name
London - South East Research Ethics Committee
REC reference
16/LO/1038
Date of REC Opinion
8 Jun 2016
REC opinion
Favourable Opinion