Adverse Drug Event Reporting The Roles of Consumers and Health-Care Professionals: Workshop Summary (2007) / Chapter Skim
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4 Consumer Involvement in Reporting Adverse Events
4 Consumer Involvement in Reporting Adverse Events
Pages 26-33
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From page 26... ...
Zoledromic acid had been approved for use in the prevention of bone mineral loss in a variety of specific clinical settings when administered by a 15-minute infusion; there was no warning about potential kidney toxicity in the label, but experience suggested that this could exist if proper infusion approaches were not used. The IMF helped advise patients about safe use of the medication based on clinical experience and the problem diminished.
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From page 27... ...
Consumer Involvement In the Current medWatCh system MedWatch captures only a fraction of the adverse events that occur, leaving the total burden unknown. Alison Rein of the National Consumers League concluded that this is due, in part, to a lack of meaningful consumer engagement in this process and the fact that reporting mechanisms are divorced from routine practice.
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From page 28... ...
, or in almost any relevant care delivery setting Encourages physician completion of Encourages consumer completion of form; form; no separate form for consumers separate, user-friendly form for consumer use Does not actively seek reporting of Seeks reports of events related to OTC events related to OTC medications, medications, vitamins, and herbal vitamins, and herbal supplements supplements Collects fewer fields; insufficient for Collects more and better data desired analyses NOTE: OTC = over-the-counter. SOURCE: Rachel Behrman, workshop presentation.
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From page 29... ...
Lipman reported that adverse events are estimated to occur in as many as 20 percent of patients taking medications, totaling more than 4 million events per year. Many adverse events are not life threatening, but they may cause serious physical or mental distress.
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However, there is a paradigm shift in the way drug safety is considered after approval: drugs are assumed safe once approved. Drug companies have limited incentives to conduct postmarketing safety studies because evidence against a product would necessitate labeling changes or even withdrawal from the market.
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From page 31... ...
Dr. Lipman recommended that mechanisms for the delivery of educational content could consist of point-of-sale drug information leaflets, consumer representatives or FDA advisory panels, and a clinical trials registry system that reports both positive and negative results of
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3-2 drug studies. Marketing success stories of change driven by consumer reports may boost consumer confidence in the regulatory and safety surveillance system.
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The first is the formation of a drug safety oversight board with its own regulatory power, comprising consumer representatives and scientists with no industry ties or involvement in the approval process. Second, a clinical trials registry should be established and monitored.
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