Abstract
Background Information about drug withdrawals may not reach patients in a timely manner, and this could result in adverse events. Increasingly, the public turns to consumer health websites for health information, but such sites may not update their content for days or weeks following important events like Food and Drug Administration (FDA) drug withdrawal actions. There is no recognized standard for how quickly consumer health websites should respond to such events, and reports addressing this issue are lacking.Objective The objective of this study was to develop and implement an approach to enhance the efficiency with which a consumer health website (NetWellness.org) responds to FDA drug withdrawal actions.Methods Evaluation of the current approach used by NetWellness staff to update content affected by FDA action revealed a slow process driven by the goal of performing thorough and comprehensive review and editing. To achieve our desired goal of accurately updating affected content within 24 hours of FDA action, we developed a strategy that included rapid updating of affected Web pages with warning boxes and hyperlinks to the information about the withdrawal. With the next FDA withdrawal event, that of valdecoxib (Bextra) on April 7, 2005, we applied this new approach, observed the time and resource requirements, and monitored the rate at which consumers viewed the updated information to gauge its potential impact.Results Application of the new approach allowed one person to modify the affected Web pages in less than 1 hour and within 18 hours of the FDA announcement. Using the old strategy, response to a similar event, the withdrawal of rofecoxib (Vioxx) 6 months earlier, had taken over 3 weeks and the efforts of several personnel. Updated valdecoxib content received 188 hits within the first month and 4285 hits within 1 year.Conclusions Rapid updating of a consumer health website's content in response to an FDA drug withdrawal event was easily accomplished by applying the approach described. This allowed consumers to view accurate information regarding the withdrawn drug much sooner than would otherwise have been the case. Given that consumers increasingly turn to websites for their health information, adoption of a rapid response standard for important health events like FDA drug withdrawals should be considered by the consumer health informatics community.
Highlights
Despite the extensive evaluation process before a drug is approved for use by the US Food and Drug Administration (FDA), some drugs are occasionally found to have unanticipated significant adverse effects after their release
The process relied on the vigilance of NetWellness personnel to monitor relevant information sources, such as news items, in order to discover that such FDA actions had occurred, leaving open the possibility that such a process may not even be initiated for some time after an FDA action
On April 7, 2005, citing health concerns, the FDA issued an announcement that sales of another coxib medication, valdecoxib, were to cease immediately [17]
Summary
Despite the extensive evaluation process before a drug is approved for use by the US Food and Drug Administration (FDA), some drugs are occasionally found to have unanticipated significant adverse effects after their release In such cases, drugs may be withdrawn from the market after having been in wide use, sometimes for years. The public turns to consumer health websites for health information, but such sites may not update their content for days or weeks following important events like Food and Drug Administration (FDA) drug withdrawal actions. Conclusions: Rapid updating of a consumer health website's content in response to an FDA drug withdrawal event was accomplished by applying the approach described. This allowed consumers to view accurate information regarding the withdrawn drug much sooner than would otherwise have been the case. Given that consumers increasingly turn to websites for their health information, adoption of a rapid response standard for important health events like FDA drug withdrawals should be considered by the consumer health informatics community
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