18 risk management

7/28/2019 18 Risk Management

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Decision making: managing

risk

Summary of an ISoP workshop,Berlin, 2004
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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


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General overview

Define risk, or potential for a risk for aproduct

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


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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
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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 theproduct


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What kind of decision?

Amending SPC requires: Prescriber-useful information

Good communication practice

Follow up

Avoiding regulatory control may requirecomparative effectiveness-riskassessment


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Decision theory

Context Anticipation

Definition Simplification

Investigation

Data & information

Summation

Communication /Action

Follow up

Impact

Revision


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Anticipating risks

Pro-activity Continuity Science based evaluation in

addition to spontaneousreports Multidisciplinary Consider costs & resources

Feasability & opportunity MAH image Win-win.


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Anticipating risks

Risk management plan started in early clinicaldevelopment 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


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Anticipating risks

Conditional approval based on riskmanagement 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


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Anticipating risks

Need for definitions of terms andcriteria relating to risk management andplanning etc.

Legal issues of compliance Co-responsibility Who decides protocols?

Use diversity Transparency, ethical and dataprotection issues


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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


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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


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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
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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


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Players may havecompeting interestsin communication

even if public healthis a common aim

Personnel skills Independent

Cope with divergentaims

Cope with uncertainty Communication and

action
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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


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What to communicate Rare but important

Frequent, relevant

Important negative info.

Serious quality problems

Information on imminent products


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To whom MAH and RA H Ps Patient organisations Public Social security Analysts & stock

exchange?

By whom Must be competent

communicator Familiar with issues


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Wide range of issues possible Difficult to predict response

Prepare for rapid and intensecommunication

HPs before public!

Communicating uncertainty

Dialogue in Pharmacovigilance


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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


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A hierarchy of evidence basedmedicine in pharmacovigilance Signal

Hypothesis

Controlled studies

Get to stronger evidence Information

Knowledge detection

UMC and IMS [email protected]

Wisdom YOU
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