Risk minimisation activities associated with Risk Management Plans Evaluating effectiveness of risk minimisation activities Dr Jane Cook Branch Head Post-market Surveillance Branch Monitoring and Compliance Division, TGA ARCS Scientific Congress 2015 6 May 2015
What are risk minimisation activities? • Initiatives that attempt to positively influence patients or health care professional behaviours, and through these changes lead to improved patient outcomes • Focuses on minimising harms • Need to plan the level of change or achievement of outcome indicators that the intervention was successful. • A protocol for how the evaluation will occur needs to be developed and this should specify the metrics and thresholds by which the programme success will be measured and audited • Should be supplied with the Risk Management Plan (RMP) Risk minimisation activities associated with 1 Risk Management Plans
Types of risk minimisation activities Focus on: • Risk prevention – identifying those at particular risk through testing and not prescribing, adjusting dose etc. • Risk mitigation – usually relies on monitoring during therapy to identify increase risk and allow intervention • Neither preventable or able to be mitigated – may be acceptable depending on risk-benefit profile Risk minimisation activities associated with 2 Risk Management Plans
Tool selection Will depend on the following factors: • Level of risk • Objectives of the risk minimisation activity • The target or targets of the activity • The characteristics of the prescribers (generalists versus specialists) • Characteristic of potential patients – vulnerability access • Potential variability in standards of care across regions – activity may already be embedded as part of patient selection A comprehensive strategy may require a range of interventions Risk minimisation activities associated with 3 Risk Management Plans
Types of risk minimisation activities • Communication: - DHCP letters/information - Prescribing dispensing guidelines - Patient brochures, alert cards - Education • Restricted access: - Registration programmes for patients - Certification programmes for prescribers/dispensers - Limited pack size, repeats, dosage forms - Dispensing linked to test confirmation - Certain types of prescribers - Limited to patient specific group – limited pharmacogenomic profile • Controlled regulatory framework - scheduling Risk minimisation activities associated with 4 Risk Management Plans
Risk Minimisation Programme • You have identified the risks to be mitigated • Selected the tools (activities) to be used in the programme • You now need to ensure the activities will meet their objectives and be successful in mitigating the identified risks • You now need to develop an evaluation framework or proto Risk minimisation activities associated with 5 Risk Management Plans
Areas to consider when developing a framework Area Description Reason for and description of the interventions and tools and their objectives Structure Key aspects, including any comparison, and duration and measures of success Design Those to address adequacy of the content Process Those to assess adequacy of coverage, utilisation and maintenance indicators Knowledge and awareness, attitudes, actual behaviours – depend on nature of activity Outcome Those related to patient outcomes such as avoidance of C/I drugs, morbidity or mortality indicators measures How measure of performance will be undertaken against pre-identified measures of Analyses success When will data be collected What type of analyses will be performed Risk minimisation activities associated with 6 Risk Management Plans
Programme evaluation • Need to measure effectiveness of overall programme as well as each individual component • Indicators selected to evaluate the performance of the programme need to be: – relevant – well-defined – sensitive – reliable – evidence-based – objective – tailored to the programme Risk minimisation activities associated with 7 Risk Management Plans
Evaluation • Comprehensive evaluation of overall effectiveness should involve measuring performance in several aspects or domains • One methodology is the RE-AIM framework: – Reach – Efficacy/effectiveness – Adoption – Implementation – Maintenance Risk minimisation activities associated with 8 Risk Management Plans
RE-AIM Dimensions Definition Reach Number and representativeness of participants selected for inclusion in evaluation the protocol Efficacy/effectiveness What are the changes expected – behavioural, patient outcome have these any negative consequences? Adoption Number and representativeness of those that agree to participate – do these continue to be representative – bias? Implementation The degree to which the intervention has been delivered as intended (could also consider cost) Maintenance The extent to which the intervention has been delivered overtime as intended Risk minimisation activities associated with 9 Risk Management Plans
How did the intervention succeed in the ‘real world’ • Implementation fidelity • Poor design or poor implementation? • Good outcomes could they be better? Risk minimisation activities associated with 10 Risk Management Plans
Evaluating implementation fidelity Area Description Examples of assessment methods Exposure Were all aspects delivered to Survey, review administrative records of delivery of the target recipients? elements to participants. Samples need to be representative Content Was what delivered the same Focus groups as originally designed? Was the interpretation of the materials as expected? I.e. was messaging ‘fit for purpose’? Frequency Was it delivered consistently at Stakeholder survey, patient clinical reviews, drug utilisation the frequency in the initial study activities plan? Duration Was it delivered consistently Sampling as above 11 throughout the activity period
Evaluating effectiveness of the risk minimisation programme • Selecting appropriate outcome indicators – Specific – Measurable – Time-bound • Consistent with overall aim of the risk minimisation programme • Meaningful targets from both clinical and public health perspective • Precisely defined – hepatotoxicity versus liver failure vs hepatitis, contraindication • Will influence sample size • Consideration of surrogate or composite endpoints Risk minimisation activities associated with 12 Risk Management Plans
Characteristics of suitable outcome measures Characteristic Description Preventable or mitigatable Specific Clearly defined and requires little judgement Easy to diagnose/detect Easy to identify and confirm Rich in information Consider periodic rather than one off sampling Responsive Is sensitive the proposed activity Reliable Precise, reproducible, unlikely to be variable on repeated measures Internally validity Linked to use External validity Generalizable to general population Clinical relevance Likely to influence treatment choices Practical Easily implementable and low cost 13
Designs • Comparator – can be difficult where has been required as part of registration • Staggered roll out • Before and after comparison if available • Trend analysis through interrupted time series (periodic sampling) and use of other existing databases e.g. health claims data • Should confirm persistence and maintenance of the programme impact over time Risk minimisation activities associated with 14 Risk Management Plans
Other considerations • When would evaluation cease? • When could the risk minimisation activity cease? Risk minimisation activities associated with 15 Risk Management Plans
Summary • Life-cycle approach • Evaluation of the parts and the whole of the risk minimisation programme • Should be simple, pragmatic and user friendly to prevent undue clinician and patient workload • Measures should be clearly defined, easy to use, reproducible and practical • Risk management programme should aim to in the real world ensure that ‘the right prescriber provides the right medicine to the right patient, at the right dose and right time’ Risk minimisation activities associated with 16 Risk Management Plans
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