1 post marketing plan earl sands, m.d. vice president and chief medical officer us research and...
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Post Marketing PlanPost Marketing PlanPost Marketing PlanPost Marketing Plan
Earl Sands, M.D.
Vice President and Chief Medical Officer US Research and Development
Solvay Pharmaceuticals
Earl Sands, M.D.
Vice President and Chief Medical Officer US Research and Development
Solvay Pharmaceuticals
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Post Marketing Plan AgendaPost Marketing Plan AgendaPost Marketing Plan AgendaPost Marketing Plan Agenda
RiskMAP
PULZIUM® Observational Study – “POST”
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RiskMAP DevelopmentRiskMAP DevelopmentRiskMAP DevelopmentRiskMAP Development
Inclusion of multiple stakeholders in US and EU– Physicians, nurses and pharmacists
Pretesting via user panels in US and EU– Iterative process; revisions made based on feedback
Objective: to provide the optimal benefit/risk balance for tedisamil by ensuring product use consistent with prescribing information– Minimizing risks– Preserving benefits
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RiskMAP ObjectivesRiskMAP ObjectivesRiskMAP ObjectivesRiskMAP Objectives
Align usage with the label
Appropriate clinical setting (ECG monitoring and staff training)
Appropriate patient selection
Correct dose and administration
Monitoring for a minimum of 2 hrs from the start of infusion and until QTc becomes normal
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Risks to be MinimizedRisks to be MinimizedRisks to be MinimizedRisks to be Minimized
As with all antiarrhythmic drugs, tedisamil use has risks
– Torsade de Pointes – Bradycardia– Hypotension
These risks can be minimized by addressing the potential contributory factors/causes:– Miscalculation/misadministration of dose
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RiskMAP ToolsRiskMAP ToolsRiskMAP ToolsRiskMAP ToolsLabeling
– Comprehensive, first line of risk communication– Gender-specific, detailed height and weight-based dosing chart
Targeted education and outreach– A number of tools will be used in educating physicians and HCPs,
which also have a reminder function and are therefore listed in the section below
– HCP website
Reminder systems– Physician checklist– Infusion bag stickers – Arrhythmia diagnostic guide– QTc guide– Dose guide and calculator– Administration and monitoring guide
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Selected RiskMAP ToolsSelected RiskMAP ToolsSelected RiskMAP ToolsSelected RiskMAP Tools
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Gender-specific Dosing ChartsGender-specific Dosing ChartsGender-specific Dosing ChartsGender-specific Dosing Charts
Separate charts for males and females, which provide dose volume based on weight and height
Height
Wei
ght
Height
Wei
ght
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Outline of the Two-Bag RegimenOutline of the Two-Bag RegimenOutline of the Two-Bag RegimenOutline of the Two-Bag Regimen
Pump
3 - way - cock
Infusion:
Step1: Infuse Bag 1 at 10 ml / min over 10 min
Step 2: Infuse Bag 1 at 5 ml / min over 20 min
Bag 2
100 ml20 min
Bag 1
100 ml10 min
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Multiplicity of RiskMAP ToolsMultiplicity of RiskMAP ToolsMultiplicity of RiskMAP ToolsMultiplicity of RiskMAP ToolsRisk Minimizing Tool
Risk
Physician
checklist
Infusion bag sticker
Arrhythmia
diagnostic guide
Dose guide
QTc guide
HCP admin &
monitoring guide
HCP websit
e
Torsade de Pointes
Ventricular tachycardia and bradycardia
Miscalculation of dose by weight, height or gender
Impaired electrolyte conditions, e.g. diarrhea
Drug-drug interactions and CYP2D6 inhibition
Use in severely renally-impaired patients
Hypertension and hypotension
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Post Marketing PlanPost Marketing PlanPost Marketing PlanPost Marketing Plan
Earl Sands, M.D.
Vice President and Chief Medical Officer US Research and Development
Solvay Pharmaceuticals
Earl Sands, M.D.
Vice President and Chief Medical Officer US Research and Development
Solvay Pharmaceuticals
12
Post Marketing Plan AgendaPost Marketing Plan AgendaPost Marketing Plan AgendaPost Marketing Plan Agenda
RiskMAP
PULZIUM® Observational Study – “POST”
13
RiskMAP DevelopmentRiskMAP DevelopmentRiskMAP DevelopmentRiskMAP Development
Inclusion of multiple stakeholders in US and EU– Physicians, nurses and pharmacists
Pretesting via user panels in US and EU– Iterative process; revisions made based on feedback
Objective: to provide the optimal benefit/risk balance for tedisamil by ensuring product use consistent with prescribing information– Minimizing risks– Preserving benefits
14
RiskMAP ObjectivesRiskMAP ObjectivesRiskMAP ObjectivesRiskMAP Objectives
Align usage with the label
Appropriate clinical setting (ECG monitoring and staff training)
Appropriate patient selection
Correct dose and administration
Monitoring for a minimum of 2 hrs from the start of infusion and until QTc becomes normal
15
Risks to be MinimizedRisks to be MinimizedRisks to be MinimizedRisks to be Minimized
As with all antiarrhythmic drugs, tedisamil use has risks
– Torsade de Pointes – Bradycardia– Hypotension
These risks can be minimized by addressing the potential contributory factors/causes:– Miscalculation/misadministration of dose
16
RiskMAP ToolsRiskMAP ToolsRiskMAP ToolsRiskMAP ToolsLabeling
– Comprehensive, first line of risk communication– Gender-specific, detailed height and weight-based dosing chart
Targeted education and outreach– A number of tools will be used in educating physicians and HCPs,
which also have a reminder function and are therefore listed in the section below
– HCP website
Reminder systems– Physician checklist– Infusion bag stickers – Arrhythmia diagnostic guide– QTc guide– Dose guide and calculator– Administration and monitoring guide
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Selected RiskMAP ToolsSelected RiskMAP ToolsSelected RiskMAP ToolsSelected RiskMAP Tools
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Gender-specific Dosing ChartsGender-specific Dosing ChartsGender-specific Dosing ChartsGender-specific Dosing Charts
Separate charts for males and females, which provide dose volume based on weight and height
Height
Wei
ght
Height
Wei
ght
19
Outline of the Two-Bag RegimenOutline of the Two-Bag RegimenOutline of the Two-Bag RegimenOutline of the Two-Bag Regimen
Pump
3 - way - cock
Infusion:
Step1: Infuse Bag 1 at 10 ml / min over 10 min
Step 2: Infuse Bag 1 at 5 ml / min over 20 min
Bag 2
100 ml20 min
Bag 1
100 ml10 min
20
Multiplicity of RiskMAP ToolsMultiplicity of RiskMAP ToolsMultiplicity of RiskMAP ToolsMultiplicity of RiskMAP ToolsRisk Minimizing Tool
Risk
Physician
checklist
Infusion bag sticker
Arrhythmia
diagnostic guide
Dose guide
QTc guide
HCP admin &
monitoring guide
HCP websit
e
Torsade de Pointes
Ventricular tachycardia and bradycardia
Miscalculation of dose by weight, height or gender
Impaired electrolyte conditions, e.g. diarrhea
Drug-drug interactions and CYP2D6 inhibition
Use in severely renally-impaired patients
Hypertension and hypotension
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PULZIUMPULZIUM®® Observational Study – “POST” Observational Study – “POST”PULZIUMPULZIUM®® Observational Study – “POST” Observational Study – “POST”
A prospective observational study – 1200 - 2000 patients – demographic, prescribing and adverse event data – 120 geographically diverse sites
The aim of the study would be to generate real-world benefit/risk data on tedisamil – detailed, real-time safety data – evaluating safety and efficacy in ethnic minorities, i.e.
African-Americans, Hispanics, etc. – evaluating the success of the RiskMAP as a whole
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PULZIUMPULZIUM®® Observational Study Observational StudyPULZIUMPULZIUM®® Observational Study Observational Study
The study would be under the auspices of an independent DSMB
Data evaluated quarterly and every 300 treated patients
Periodic and real-time updates to FDA as necessary to meet the new REMS criteria*
*Source: Title II FDA Revitalization Act. Subtitle A – Risk Evaluation and Mitigation Strategy(from http://help.senate.gov/minpress/2007_04_18 accessed on 9-12-07
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Post Marketing Plan ConclusionsPost Marketing Plan ConclusionsPost Marketing Plan ConclusionsPost Marketing Plan ConclusionsTargeted interventions to address known risks
Key objective – aligning usage with label
Proactive, comprehensive program–Built-in redundancy to improve effectiveness
Consistent with existing clinical practice
Sponsor is committed to evaluation and program revision, as needed
Robust observational study to reinforce a positive benefit/risk profile