Objective:
1)	To understand the pharmaceutical industry stakeholders’ perspective to meet the legal obligation of global risk management plan (RMP) commitments including implementation and tracking.
2)	To identify the root cause of non-compliance of RMP commitments and related solutions
Method:
To understand the challenges faced by industry for RMP commitments, three-way analysis of MHRA GPvP metrics 2017-18, author’s experiences and stakeholders’ perspectives through anonymous survey was undertaken using online SurveyMonkey® application.
Results: Three-way analyses revealed critical lack in adherence to RMP commitments [failure in additional risk minimisation measures (aRMMs) implementation and effectiveness assessment, specific data monitoring in lieu of a Post Authorisation Safety Studies (PASS) and targeted follow-up of events] and lack of robust process (including aRMM tracking, outreach to target audience, lack of awareness and resource crunch) for RMP implementation at Marketing Authorisation Holders’ end. Challenges like aRMM translation and version management during national approval (36%); distribution, stakeholders training and budget during implementation of aRMMs (40%); and higher chances of manual miss due to use of excel based tracking tools (55%) were identified from survey results of 38 respondents comprehend author’s experiences and GPvP metrics. Effectiveness assessment included post-marketing incidence and reporting rates, and drug utilisation studies. Possible challenges in RMP commitments implementation and tracking require collaborative approach.

Conclusion: Maintenance of products with complex risk management systems is always a challenge and such systems are under the scanner of the inspectors. Analyses revealed that ARMM education, local market alliance and multi-faceted IT tools can be supportive aid to ensure that legal obligations are met and risk to the patients are adequately communicated and mitigated. Multi-prong solutions would increase visibility of measures reaching target and achieve the objective of risk reduction.

Stakeholders’ perspective in implementation of additional risk minimisation measures: Reflection on challenges & solutions