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P083���A model to guide designing Risk-Proportionate Risk Minimisation and Vigilance Programs

On behalf of the ISoP SIG Rmin Asia

J. C. Delumeau (presenter), Y. Moride, H. Le Louët

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Disclaimer: The views and opinions expressed in the presented slides are those of the individual presenter and should not be attributed to the Organizers of this meeting  

Receiving a salary from Bayer South East Asia Pte. Ltd. Not owning any share or any stock option of any company supplying health care products or providing service to the health care industry.

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ISoP SiG Rmin Asia Members

Based in Asia: §  Dr Chen Wen Wen (Taiwan) §  Ms Wimon Suwankesawong (Thailand) §  Dr Nguyen Hoag Anh (Viet Nam) §  Ms Siti Asfija Abdoella (Indonesia) §  Dr Cheap Thon Vuthy (Cambodia) §  Dr Choki Dorji (Bhutan) §  Ms Noraisyah Modh Sani (Malaysia) §  Dr Jiang Su Jin (Korea) §  Pr Yogendra Kumar Gupta (India) §  and Dr J.C Delumeau (Singapore) Coordinator

§  Additional persons who have agreed upon contributing to the Delphi study are welcome to join the SiG Rmin Asia.

§  Initiated the creation of the group

Based outside Asia §  Pr Hervé Le Louët (France) Chairperson §  Pr Yola Moride (Canada) Methodologist §  Dr Peter Pitts (USA)

ISoP SiG Risk Minimisation Methods for Asian Countries | Agra October 2016

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SiG Risk Minimisation Methods for Asian Countries���To address needs

q  Need for a method to map the risk of specific products with the stringency of RMIs, in consideration of the capability of the health care system.

q  Need for workable RMIs suitable for diverse Asian countries to be applied in a risk proportionate manner

q  Need for affordable solutions applicable for products non longer promoted

Ø  Take advantage from e-medicine technologies to develop novel solutions to support RMIs.

ISoP SiG Risk Minimisation Methods for Asian Countries | Agra October 2016

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SiG Risk Minimisation Methods for Asian Countries���Following-up on CIOMS IX

q  The CIOMS IX Working Group emphasized the need for adapting risk minimisation strategies and tools proportionally to the risk associated to the product and to the characteristics of the health care system, but did not actually develop a method for it.

ISoP SiG Risk Minimisation Methods for Asian Countries | Agra October 2016

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Determinants of risk proportionality

q  Research Question: What are the components and determinants of risk proportionality applicable to Risk Minimisation Interventions (RMI) in a large array of Asian countries?

q RMIs will be categorised according to:

§  Level 0 RMI: No RMI beyond the label (Summary of Product Characteristics)

§  Level 1 RMI | Low stringency e.g. RMIs, consisting usually of basic patient and/or physician communication tools

§  Level 2 RMI | Medium stringency e.g. RMIs, consisting in more advances education, training, patient and/or physician communication tools

§  Level 3 RMI | High stringency e.g., restricted distribution in the hospital setting, mandatory laboratory testing, etc..

ISoP SiG Risk Minimisation Methods for Asian Countries | September 2016

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Risk Minimisation & Vigilance Programs

q  Level 1 RMVP to include one Level 1 RMI

q  Level 2 RMVP to include one Level 2 RMI

q  Level 3 RMVP to include one Level 3 RMI

ISoP SiG Risk Minimisation Methods for Asian Countries | Agra October 2016

AD: Additional data collection

EP Enforce Patient Education

EM: Enforce HCP Education

AE: Structured ICSR Collection

AR: Product Access

restriction

Risk-proportionate decision making

PH Public Health

interventions

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Overview of the RMVP concept

§  Simple

§  Modular

§  Versatile

§  Risk-proportionate

§  Capable of evolving

To meet the needs of

§  Health Authorities

§  License Holders

ISoP SiG Risk Minimisation Methods for Asian Countries | Agra October 2016

AD: Additional data collection

EP Enforce Patient Education

EM: Enforce HCP Education

AE: Structured ICSR Collection

AR: Product Access

restriction

Risk-proportionate decision making

PH Public Health

interventions

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Mapping Product Risk to different levels of RMI

q Responding to the question with a Delphi approach

§  To collect the experience necessary for developing a framework to guide decisions regarding the assessment of risk proportionality

§  In order to determine the RMIs to be applied taking into account the characteristics of the healthcare system of a large array of Asian countries

q Geographic scope: South-East Asian (ASEAN), South-Asian and North-East Asian countries.

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Delphi methodology

q  The Delphi method is a practical and structured approach of anonymous debating to generate discussion and converge toward group consensus.

q  This method was shown to have scientific value for leading to an agreed set of recommendations.

q  Respondents (Delphi Expert Panel) take part anonymously in sequential questionnaires that constitute different rounds, and each round is refined based on feedback from the previous version.

q  After each round, the group responses are synthesised into themes, which are fed back to the panelists who can reconsider their views based on the report of the group views.

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Applying a two-phase Delphi approach

q  Identify factors and circumstances that guide assessing risk proportionality and predict the level (H/M/L) of RMIs required in regions with the most extensive experience in risk management.

Ø  Pre-Delphi consultation: 10 Experts, EU, USA, Canada, Australia

q  Using those factors as starting point, reach consensus on a structured framework e.g. criteria and scoring system to assess risk proportionality guide selecting RMVP/RMI of suitable stringency.

Ø  Delphi Study: Expert panel >25 Respondent from Asian countries

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Phase-1: Pre-Delphi consultation

q Data collection §  Individual semi-structured in-depth interviews will be conducted and

recorded, lasting 30-60 minutes, either face-to-face or teleconference.

§  From those consultations, key questions driving the decisional algorithm for the assessment of risk proportionality will be established, as well as the key circumstances most likely to lead to Medium and High RMIs.

§  Resulting from the interviews, a list of criteria informing on risk proportionality will be developed to constitute the basis for the first Round of question in Phase 2 of the DELPHI study.

q Data analysis §  Qualitative analysis of the information provided during interviews. §  Emerging themes will be identified through a review of the sessions, until

saturation of themes is reached.

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q Delphi Expert Panel

§  PV professionals distributed across countries belonging to the Association of South -East Asian Nations (ASEAN), East-Asian and South-Asian countries.

§  3 groups of PV professionals involved in therapeutic risk minimisation:

o  Regulatory Authorities |Decision-makers,

o  HCPs | End-users of RMIs,

o  PV Professionals from Licence Holders | Responsible for recommending, designing, implementing and evaluating RMIs.

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Phase-2: Delphi Study

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Phase-2: Modified Delphi Questionnaire

q Data collection §  Three rounds of Delphi survey are anticipated to reach consensus.

§  The criteria identified during Pre-Delphi will be submitted to panelists for review and rank-ordering.

§  Panelists will be expected to comment on their ranking, and may add their own criteria, especially those related to the particularities of the healthcare system and population.

§  Responses to each round will be synthesised and analysed for grouping by the Steering Committee of the study Delphi. Grouped criteria will then be converted into a structured questionnaire and fed back to the panelists.

§  The questionnaires for all Delphi rounds will be designed using the online survey program SurveyMonkey®. Each survey round will be online for up to 4 weeks, with reminders sent weekly.

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q Data analysis §  Answers to the different rounds of questionnaire will be analysed using

descriptive statistics.

§  A sum of at least 70% of the experts that either totally agree or agree will be considered agreement. The same method will apply for disagreements.

§  Answers and comments will be presented both quantitatively (distribution and sum of the agreement and disagreement per question) and qualitatively (argumentation and comments of the panelists).

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Phase-2: Modified Delphi Questionnaire

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Ethics and Steering Committee

q Ethics §  All answers provided by interviewees (Phase 1) and panelists (Phase 2) will

remain strictly confidential. §  All feedback reports will be anonymous. All participants will need to sign an

informed consent prior to participation. §  Protocol for study will be submitted to the Scientific Board / Academic Ethics

Committee

q Steering Committee §  To prepare, supervise and monitor all Delphi rounds §  Will not take part as panel members. §  Chairperson (Principle Investigator): Prof. Yola Moride (Montreal) §  Members (Co-Investigators), Dr. J. Christophe Delumeau (Singapore),

Dr. Sarah Frise (Toronto), Prof. Hervé Le Louët (Paris), Academic from the University where the protocol will be submitted.

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Thank you for your attention

ISoP SiG Risk Minimisation Methods for Asian Countries October 2016