Understanding the Benefits and Risks of Pharmaceuticals Workshop Summary (2007) / Chapter Skim
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To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30–31, 2006.
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As panelists considered how to construct a systematic, consistent, and transparent approach to benefit–risk analysis, discussion focused on whether and how such a framework should be quantitatively based. Creating a quantitative system has many challenges, including the following: • Quantitatively capturing a complex drug benefit–risk profile; • Quantitatively characterizing drug benefit–risk for individuals because of variation among patients in terms of both physiology and preferences; • Updating benefit–risk assessments with new information through the drug life cycle; • Addressing the inherent uncertainty in benefit–risk measurement; • Resolving disagreement about the role that cost should play in benefit–risk calculations; • Addressing the cost of adopting a quantitative framework and its potential adverse effect on innovation; and • Effectively presenting and communicating quantitative information (see more below)
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Most of this discussion focused on the challenges involved in physician-topatient communication, with major challenges including the following: • Widespread inability, even among well-educated patients, to interpret quantitative information provided about drug benefits and risks; • Differences in how physicians and patients understand and respond to risk; • Barriers that make it difficult for physicians to communicate with their patients; and • Lack of confidence among physicians in their ability to effectively convey quantitative information, compounded by the reality that many physicians themselves are not as well informed as they should be about the benefits and risks of drugs. Discussion of how to improve communication included a review of recent research on labeling and several calls for the need to better understand the potential usefulness of new ways to visually represent benefit–risk data.
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Many participants suggested that patient education regarding understanding pharmaceutical benefit and risk concepts was paramount, thus they should be more involved with the decision-making process. There was substantial debate on the FDA's responsibility for guiding decision making.
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Additional suggestions included developing a fact sheet to help educate the public about the benefits and risks of drugs, planning follow-up meetings to focus on specific issues, encouraging patient and community physician involvement in future discussions, incorporating costs in the discussion of benefit–risk analysis, and instituting citizen councils to involve the public in decisions made by the FDA regarding drug benefits
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• Avoid assigning blame among the various stakeholders involved in benefit–risk assessment because it damages the public trust. • Consider instituting citizen councils, as the United Kingdom's National Institute for Clinical Excellence did when faced with a similar crisis in public trust.
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