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Health issues risk-benefit assessments

Many patients with type 2 diabetes and therefore with multiple health issues may be able to handle changes only one step at a time. The long-term therapeutic action plan will, however, require multiple steps but the plan needs to be gradually developed by the physician and the patient together based upon individualized risk assessment, digestible evidence-based information, empathetic motivation and realistic tradeoffs related to benefits and potential undesired effects of the intervention. [Pg.159]

Risk assessment is a multi-step process to relate the association of exposure to a chemical or physical agent with adverse outcome. Initially the focus was human health but now it has broadened to include wider environmental and ecological concerns. Risk management is a more overtly political process directed at determining an action based on relevant public and environmental health goals, cost, societal issues, and other related or even unrelated issues. An important part of risk management is balancing the risks, costs, and benefits - never an easy task. [Pg.240]

Whenever a product and its medical claim are promoted, there must be provision for the recipient of the information to obtain additional comprehensive information about the product. Advertising in print must be accompanied by the brief summary of risks. The FDA permits print advertising directed at the consumer to be accompanied by a consumer-directed brief summary, which can be in the form of a Q A. If a product is promoted directly to the consumer through a television commercial, then provision must be made to assure that the consumer can obtain substantial additional information needed to assess the benefits and risks of the product. Under an FDA guidance issued in August 1999, this requirement can be met through four mechanisms an 800 number that the consumer can call to ask that the information be mailed or read referral to an internet site information in an advertisement in a current issue of a magazine or materials that can be obtained from a health care provider. ... [Pg.60]

The systematic application of policies, practices, and resources to the assessment and control of risk affecting human health and safety and the environment, which is also combined with economic, political, legal, and ethical considerations to make decisions. Hazard, risk, and cost-benefit analysis are used to support development of risk reduction options, program objectives, and prioritization of issues and resources. Risk Management Plan (RMP)... [Pg.250]


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