Programs
Risk Series
Research Issues
Identifying Risk. What are the best practices for finding and quantifying therapeutics risk from existing systems (e.g. FDA Adverse Event Reporting System (AERS))? How should dissimilar findings, extreme values and unique cases be taken into account?
Interpreting Signals. What are the conflicts between results from analyses of structured studies, spontaneous reports and large, structured databases? How should they be reconciled? Can such studies substitute for large clinical trials? What are the characteristics of database analyses and clinical trials that provide the best information about the balance of risk and benefit?
Acceptable Risk. What factors influence the level of risk that is acceptable to health care practitioners and patients? What factors influence the way health care practitioners and patients interpret benefit and risk probabilities?
Knowledge Base. How knowledgeable are health care practitioners about the balance of benefit and risk of therapeutics that they administer, distribute, monitor and prescribe to patients? How knowledgeable are patients about the risk associated with their medication? How knowledgeable are patients about others (and their roles) in the risk communication process?
Information Sharing. What are the most effective methods of informing health care practitioners about the balance of benefit and risk of therapeutics? What are the most effective methods of informing patients about therapeutics risk in the context of known benefits? What are the most effective methods of informing administrative health system decision makers about the balance of risk and benefit of therapeutics?
Effective Communications. What are the effects of the media, professional organizations, and other information sources in prescribing decisions and patients' use of medications? How can the media and professional organizations more effectively communicate to health care practitioners and patients?
Impact of Current Methods. What (positive and negative) effects have current methods of communicating risk information had on health care practitioners? (e.g. product label, CME)?
Decision Factors. What factors (e.g. technology, practice setting) increase the likelihood that health care practitioners take into account benefit and risk information when prescribing medications and following patients? What factors (e.g. level of education) increase the likelihood that patients take into account benefit and risk information when making decisions about their medical care?
Program Criteria. What are the characteristics of a risk management program that should be in place for all therapeutics? What are the criteria for requiring or strongly encouraging a risk management program that goes beyond the basal level?
Multidisciplinary Approaches. How can multidisciplinary approaches to risk communication be developed and tested, particularly those involving nurses, other non-physician providers and pharmacists?
Measuring Effectiveness. What is the effectiveness of each individual element of a risk management program? Which risk management tools work best in which situations? What are the parameters of a successful risk management program and what indicators of success should be used?
Privacy Concerns. What is the impact of privacy legislation on the ability to conduct risk management programs? How do different implementation strategies in response to privacy legislation affect the ability to improve prescribing and adherence in alignment with the balance of benefit and risk?