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Developing, Pilot Testing

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Target key groups most likely to be able to minimize risk ... Market research data. Competitive products. Physician prescribing behavior ... – PowerPoint PPT presentation

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Title: Developing, Pilot Testing


1
Developing, Pilot Testing Evaluating RiskMAP
Interventions
  • Annette Stemhagen, DrPH, FISPE
  • Vice President
  • UBC Epidemiology Risk Management
  • The FDA Regulatory and Compliance Symposium
  • August 25, 2005

2
Risk Minimization (RiskMAP) Guidance
  • Goal minimize a products risks while
    preserving its benefits.
  • For the majority of products, routine risk
    minimization measures are sufficient
  • RiskMAP -- strategic safety program minimizing
    known risks of a product while preserving its
    benefits.
  • A RiskMAP uses tools to achieve goals.
  • Development and Use of Risk Minimization Action
    Plans (RiskMAPs)http//www.fda.gov/cder/guidance/
    6358fnl.htm

2
3
How to Design a Risk Minimization Program
  • Complete risk and benefit assessment
  • Define goals and objectives for risk minimization
    intervention
  • Identify appropriate tools
  • Conduct feasibility

3
4
Risk and Benefit Assessment
  • Quantify risks, if possible
  • High risk populations?
  • Specific doses?
  • Inappropriate use?
  • Off-label use?
  • Misuse or abuse?
  • Evaluate risk in context of benefit

4
5
Goals and Objectives for Risk Minimization
  • Ideal Goals
  • No deaths
  • No abuse
  • No pregnancies
  • No patients taking drug X also take Drug Y
  • Specify objectives
  • Inform all health care professionals
  • Inform all patients
  • Increase knowledge of appropriate use
  • Require pregnancy test before each prescription
    fill

5
6
RiskMAP Tool Selection
  • Maintain widest accessibility with least burden
    to health care system
  • Target key groups most likely to be able to
    minimize risk
  • Determine the feasibility of proposed approach

6
7
Categories of RiskMAP Tools
  • Targeted Education and Outreach
  • Increase appropriate knowledge and behaviors of
    stakeholders who have the capacity to prevent or
    mitigate risks
  • Reminder Systems
  • Systems that prompt, remind or guide in
    prescribing, dispensing, or using a product to
    minimize risk
  • Performance-Linked Access Systems
  • Link product access to laboratory testing or
    other documentation.

7
8
RiskMAP Tools
  • Targeted education and outreach
  • Health care provider letters
  • Training programs
  • Continuing education
  • Patient package inserts
  • Medication Guides
  • Promotional techniques

8
9
RiskMAP Tools
  • Reminder systems, processes or forms
  • Patient agreement or acknowledgement forms
  • Health care practitioner certification or
    attestation programs
  • Limited Rx amount or refills
  • Specialized packaging to enhance safety
  • Prescription stickers
  • Special prescription pads

9
10
RiskMAP Tools
  • Performance-linked access systems that guide
    prescribing, dispensing and use
  • Compulsory reminder systems
  • Certification of prescribers/dispensers
  • Documentation of safe-use conditions
  • blood tests for agranulocytosis
  • pregnancy tests

10
11
How Can You Determine if Your Approach Will
Succeed?
  • Feasibility assessments prior to designing
    intervention
  • Pilot testing prior to full implementation, if
    feasible
  • Ongoing evaluation over the life of the program

11
12
Initial Feasibility Assessments
  • Determine likelihood of success with
  • Stakeholders
  • Physicians
  • Pharmacists
  • Patients and caregivers
  • Wholesalers/distributors
  • Others
  • Program Design
  • Fit busy practice routine?
  • Represent actual clinical practice?
  • Need no extraordinary testing?
  • Requires minimal training?

12
13
Assessing Feasibility Using Existing Data
  • Medical chart review
  • Natural history of disease
  • Cross sectional surveys, e.g., NCHS
  • Registries
  • Large automated databases
  • Market research data
  • Competitive products
  • Physician prescribing behavior
  • ISS and ISE (particularly placebo groups)
  • Literature
  • Past experience

13
14
Ad Hoc Data Collection for Assessing Feasibility
  • Panel of experts
  • Focus groups
  • Stakeholder surveys
  • Health Care Providers
  • Patients
  • General population sample
  • Time and Motion studies

14
15
Ongoing Feasibility Throughout the Program
  • Conduct Failure Mode and Effects Analysis (FMEA)
  • Test your assumptions
  • How good were the data?
  • How good were the assumptions?
  • Projected vs. actual
  • Implement mid-course corrections

15
16
Pilot Test Tools
  • Qualitative and quantitative testing of
    educational materials
  • Health literacy
  • Comprehension
  • Randomized trial of educational programs
  • User acceptance testing of systems
  • Phased roll out of program to small group of
    physicians prior to widespread implementation
  • Registry
  • Large streamlined study

16
17
RiskMAP Evaluation
  • Continually assess modify
  • Use evidence based performance measures
  • At least two different approaches
  • Quantitative, representative, minimally biased
  • Measure health outcome goal
  • Surrogates
  • Process measures
  • KAB

17
18
Evaluation Strategies
  • Root Cause Analysis
  • Spontaneous AE report monitoring (Medication
    errors)
  • Record review
  • Stakeholder surveys
  • Knowledge, Attitude and Behavior
  • Program audits
  • System audit trail

18
19
Evaluation Strategies
  • Large automated database study
  • National surveys databases, e.g., DAWN, TESS
  • Market research data, e.g., IMS-Health
  • Registries
  • Product exposure registry
  • Pregnancy registry
  • Large streamlined study

19
20
What Works in Risk Minimization?
  • Really dont have enough history to know
  • Involves changing behaviors and/or
    systemseducation? marketing?
  • Limited/controlled distribution works
  • No blood, no drug
  • Attestation, testing, limiting access in other
    ways
  • Lotronex

20
21
What Doesnt Work in Risk Minimization?
  • Severe restriction of use via complex program
  • Dofetilide
  • Plenaxis
  • Unintended consequences
  • Unrealistic study size or expectations

21
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