Decision making: managing risk Summary of an ISoP workshop, Berlin, 2004.
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Transcript of Decision making: managing risk Summary of an ISoP workshop, Berlin, 2004.
Decision making: managing risk
Summary of an ISoP workshop, Berlin, 2004
ICH E2E
• Risk Management Plan – When a new drug is launched, what do
you need to do to find out about, and minimise, risks
– Also for new, major risks
New Regulatory approach!
General overview
• Define risk, or potential for a risk for a product
• What type of decision is needed • Best data and information for the job• Patient safety and preventability
– Expansion of pharmacovigilance
• Communication is a major area of consideration
Eliminating risk (not possible!)
• Risk specification • Risk plan
– Milestones
• Risk minimisation • Start early and
continue • High potency, high
risk products – Tripartite involvement:
• Prescriber• Dispenser • Patient
What kind of decision?
• To communicate a new risk • To add information which will aid
prescribers in: – Avoiding risk – The early diagnosis of harm – The management of harm that has
occurred
• To alter the overall availability of the product
What kind of decision?
• Amending SPC requires:– Prescriber-useful information – Good communication practice – Follow up
• Avoiding regulatory control may require comparative effectiveness-risk assessment
Decision theory
• Context – Anticipation
• Definition – Simplification – Investigation– Data & information – Summation
• Communication /Action • Follow up• Impact • Revision
Anticipating risks
• Pro-activity • Continuity • Science based evaluation in
addition to spontaneous reports
• Multidisciplinary • Consider costs & resources
– Feasability & opportunity – MAH image– Win-win.
Anticipating risks
• Risk management plan started in early clinical development – Pre-clinical data – Class effects – Natural history of indication & co-morbidity
• Consider reasons for extra safety studies (Predict ‘real life’)– Need for multiple methods – Need for better data sources– Risk groups e.g. children, pregnancy, elderly – Anticipate off label use: paediatrics– Special drugs
• Orphan drugs, NCEs
Anticipating risks
• Conditional approval based on risk management plan – Should not lead to poorer pre-marketing
standards
• Management of studies? – Joint MAH & RA ?– Academia and professional bodies
• Funding – Public? – Joint?
• Periodic refreshing of plan
Anticipating risks
• Need for definitions of terms and criteria relating to risk management and planning etc.
• Legal issues of compliance– Co-responsibility – Who decides protocols?
• Use diversity
• Transparency, ethical and data protection issues
Investigating emerging risks
• Multidimensional challenge • Factors effecting tool
– Life cycle (rarity of event; extent of use) – Complexity of ADR (terminology issues,
definitions, diagnosis v. signs and symptoms )
• Requirements for data source
• Signal – Consolidation – Confirmation (time constraint) – Choose best tool (described) – Effectiveness-risk communication – Impact
Investigating emerging risks
• What to focus on and communicate– ‘Useful to clinician ‘ – What will affect patients’ choice
• Preventability. • ADR diagnosis • ADR management• change in effectiveness
– Interactions/additive/negative effects– Seriousness and severity issues – Quality of information – Clarity of clinical/epidemiological situation
Warning and communication of risk
• SPC– Use of PSUR – Legal v. Communication– Which section of SPC
• Contra indication, warning – When changed? – Design ?
• ‘Dear Health Professional‘ communication – Web – Design – Repeated
• Media • Bulletins
Warning and communication of risk
• Considerable legal framework and guidelines – Governs what happens between players
• Particularly reporting • Accuracy of information
• Timing important• Start early? • Limitation on communicating between industry and
HPs and public
• Communication within company • Structure and responsibility (personal!)
• ‘Communications’ v. ‘advertising’– Responsibility of journals
Warning and communication of risk
• Players may have competing interests in communication even if public health is a common aim
• Personnel skills – Independent – Cope with divergent
aims – Cope with uncertainty
• Communication and action
Warning and communication of risk
• Media – Dramatic news a priority – Internet
• No control • When to communicate
– Pro-activity • Know media • Call for vigilance • During effectiveness/risk
evaluation – Crisis (out of control, reactive)
• Rapid response is different • Provoked by third party
communication
Warning and communication of risk
• What to communicate – Rare but important – Frequent, relevant – Important negative info.– Serious quality problems – Information on imminent products
Warning and communication of risk
• To whom – MAH and RA – H Ps – Patient organisations – Public – Social security – Analysts & stock
exchange? • By whom
– Must be competent communicator
– Familiar with issues
Warning and communication of risk
• Wide range of issues possible – Difficult to predict response – Prepare for rapid and intense
communication – HPs before public! – Communicating uncertainty
• ‘Dialogue in Pharmacovigilance’
Warning and communication of risk
• Outcomes – Follow up?
• Questionnaires – General
• Count responses? – Need more information on
outcomes – Better public education– Less paternalism
• Better view of us!• Openness
– Constructive law & media interaction
Warning and communication of risk
• A hierarchy of evidence based medicine in pharmacovigilance – Signal – Hypothesis – Controlled studies
• Get to stronger evidence – Information – Knowledge detection
• UMC and IMS– [email protected]
– Wisdom • YOU