Research Strategies for Assessing Adverse Events Associated with Vaccines A Workshop Summary (1994) / Chapter Skim
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CASE REPORTS AND PASSIVE SURVEILLANCE
CASE REPORTS AND PASSIVE SURVEILLANCE
Pages 2-9
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The workshop participants included academic researchers, members of vaccine safety advocacy groups, vaccine manufacturers, health care providers, representatives of federal research and regulatory agencies, and IOM staff. A list of participants is included at the end of this summary.
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Letters are sent to about 240,000 health care providers every 6 to 9 months explaining what they are required to report and emphasizing that a temporal relation to vaccination is the criterion for reporting an adverse event. There are plans to increase educational efforts aimed at physicians.
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A significant factor in the success of passive surveillance systems is whether the information about the reaction is complete and accurate. This is probably best achieved if a health care professional reports the reaction or verifies information received from a nonhealth care professional.
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As a passive surveillance system, VAERS suffers problems of both underreporting and overreporting. Although health care professionals are required to report some adverse events, specifically, those that are covered by the no-fault component of the Vaccine Injury Compensation Program, there are no provisions for enforcement.
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Reporting and analysis of summary statistics require careful consideration of and explanations for these factors. Signal Detection and Hypothesis Generation Passive surveillance systems can be used to establish patterns of adverse event reporting and to monitor changes in those patterns as vaccines change (different lots, different formulations, different antigens)
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More rigorous, well-established epidemiologic and statistical methods could be applied to passive reporting systems, and PHS representatives indicated that some such methods are under development. For example, in the fall of 1993, a joint meeting of FDA and CDC investigators looked at clusters of adverse events, particularly deaths associated with specific vaccine lots.
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Some shortcomings of passive surveillance systems are common to other strategies for evaluating adverse events; for example, no data-gathering system, including LLDBs, can easily assess causation when multiple vaccines are administered simultaneously. As another example, because of the emphasis on events temporally associated with vaccination, events that occur long after vaccination may not be detected.
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That is, physicians or other health care providers sometimes fail to report an event after vaccination because they do not believe that the event is related to vaccination. This tacit decision to report only well-established adverse consequences of vaccines means that the previously unrecognized effects of vaccines would continue to go unnoticed.
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