Abstract:
PURPOSE:The Dietary Supplements Information Expert Committee (DSI-EC; the Committee) of the United States Pharmacopeial Convention (USP) reviews safety profiles of dietary supplements before development of USP-National Formulary (USP-NF) quality monographs. Because the veracity of dietary supplement adverse event reports (DS AERs) directly affects DSI-EC safety reviews, the Committee reviewed the current status of DS AER reporting in the US. METHODS:DSI-EC reviewed PubMed searches, information from the US Food and Drug Administration's (FDA) MedWatch program, the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers (AAPCC), and reports from US and other agencies. DSI-EC analyzed this information to identify key factors that affect the quality of DS AERs. RESULTS:The overall incidence of DS AERs appears generally to be low. However, the primary reporting portal (FDA MedWatch) receives fewer AERs than do poison control centers (PCCs), and limited coordination exists among national and international surveillance programs for evaluating signals that may indicate potential public health risks. Both inadequate and poor-quality reporting of DS AERs are major limitations of DS safety monitoring in the US. CONCLUSIONS:Based on its assessments, the Committee advances recommendations to improve the quality of reporting, monitoring, and assessing DS AERs. These include (1) enhanced data collection approaches, (2) improved coordination of AER surveillance programs, (3) strengthening of educational programs for public and health care sectors, and (4) conduct of research concerning the safety of DS. If taken, these approaches are expected to improve the health and well-being of DS users.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Gardiner P,Sarma DN,Low Dog T,Barrett ML,Chavez ML,Ko R,Mahady GB,Marles RJ,Pellicore LS,Giancaspro GIdoi
10.1002/pds.1627subject
Has Abstractpub_date
2008-10-01 00:00:00pages
962-70issue
10eissn
1053-8569issn
1099-1557journal_volume
17pub_type
杂志文章,评审abstract:PURPOSE:We sought to determine the incidence and risks for severe thrombocytopenia (platelets < 50,000/μL) in United States Veteran patients treated with pegylated interferon (PEG-IFN) plus ribavirin for hepatitis C virus-positive (HCV) chronic liver disease (CLD). METHODS:Using a retrospective, observational cohort s...
journal_title:Pharmacoepidemiology and drug safety
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doi:10.1002/pds.1832
更新日期:2010-04-01 00:00:00
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pub_type: 撤回出版物
doi:
更新日期:2013-02-01 00:00:00
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更新日期:2011-03-01 00:00:00
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更新日期:2007-12-01 00:00:00
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更新日期:2016-12-01 00:00:00
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更新日期:2019-02-01 00:00:00
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更新日期:2005-09-01 00:00:00
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更新日期:2017-12-01 00:00:00
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更新日期:2018-03-01 00:00:00