Kalindi Hapani1, Nipa Parikh2, Krystle Pianka2, Harshil Patel3. 1. APCER Life Sciences, 1601 & 1602, Mondeal Heights, Wing A, Iskcon Cross Rd, Ramdev Nagar, Ahmedabad, Gujarat, 380015, India. khapani@yahoo.co.in. 2. Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA. 3. APCER Life Sciences, 1601 & 1602, Mondeal Heights, Wing A, Iskcon Cross Rd, Ramdev Nagar, Ahmedabad, Gujarat, 380015, India.
Abstract
BACKGROUND: Most national competent authorities issue guidance on the dissemination and implementation of additional risk minimisation measures (aRMMs), like the European Medicines Agency. However, national competent authorities guidance includes additional regulatory requirements, the reasons for which are unclear. OBJECTIVES: The purpose of this study was to identify significant barriers to risk management implementation and methodological challenges encountered by local safety managers in the European Union and the UK owing to differences in country-specific regulations and regional national competent authorities guidance. METHODS: The European Medicines Agency and national competent authorities guidance for each of the aRMM programme's formative components were compared. A survey was conducted to ascertain the challenges encountered by local safety managers throughout the implementation phases and the responses analysed. RESULTS: Twenty-seven national guidance documents were compared with the European Medicines Agency's guidance, and it was observed that national competent authorities provide additional aRMM dissemination and implementation parameters for the format and layout of aRMM, translation requirements, guidance on aRMM content, submission requirements, monitoring parameters and aRMM update requirements, among others. The survey was completed by 11 out of 21 local safety managers (52.38%). Eight local safety managers rated submission of an implementation plan as the most challenging aspect. Multiple national competent authorities requests, frequent updates, and delayed approval impacted planning and implementation, resulting in modifications and delays. Moreover, the study discovered that managing frequent version updates of digital aRMMs was challenging, and most national competent authorities neglected the post-implementation phase activities. Further, most local safety managers followed both the local and global processes to maintain documentation of aRMM implementation. CONCLUSIONS: It was evident that the European Medicines Agency and national competent authorities empower marketing authorisation holders to implement and disseminate aRMM materials tailored to their local healthcare settings. However, this poses a challenge for marketing authorisation holders because of a lack of clarity in guidance in executing an aRMM programme and an added burden of complying with both European Medicines Agency and national competent authority requirements.
BACKGROUND: Most national competent authorities issue guidance on the dissemination and implementation of additional risk minimisation measures (aRMMs), like the European Medicines Agency. However, national competent authorities guidance includes additional regulatory requirements, the reasons for which are unclear. OBJECTIVES: The purpose of this study was to identify significant barriers to risk management implementation and methodological challenges encountered by local safety managers in the European Union and the UK owing to differences in country-specific regulations and regional national competent authorities guidance. METHODS: The European Medicines Agency and national competent authorities guidance for each of the aRMM programme's formative components were compared. A survey was conducted to ascertain the challenges encountered by local safety managers throughout the implementation phases and the responses analysed. RESULTS: Twenty-seven national guidance documents were compared with the European Medicines Agency's guidance, and it was observed that national competent authorities provide additional aRMM dissemination and implementation parameters for the format and layout of aRMM, translation requirements, guidance on aRMM content, submission requirements, monitoring parameters and aRMM update requirements, among others. The survey was completed by 11 out of 21 local safety managers (52.38%). Eight local safety managers rated submission of an implementation plan as the most challenging aspect. Multiple national competent authorities requests, frequent updates, and delayed approval impacted planning and implementation, resulting in modifications and delays. Moreover, the study discovered that managing frequent version updates of digital aRMMs was challenging, and most national competent authorities neglected the post-implementation phase activities. Further, most local safety managers followed both the local and global processes to maintain documentation of aRMM implementation. CONCLUSIONS: It was evident that the European Medicines Agency and national competent authorities empower marketing authorisation holders to implement and disseminate aRMM materials tailored to their local healthcare settings. However, this poses a challenge for marketing authorisation holders because of a lack of clarity in guidance in executing an aRMM programme and an added burden of complying with both European Medicines Agency and national competent authority requirements.
Authors: Giampiero Mazzaglia; Sabine M J Straus; Peter Arlett; Daniela da Silva; Heidi Janssen; June Raine; Enrica Alteri Journal: Drug Saf Date: 2018-02 Impact factor: 5.606