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The state of dietary supplement adverse event reporting in the United States.
Pharmacoepidemiol Drug Saf. 2008 Oct; 17(10):962-70.PD

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.

Authors+Show Affiliations

USP Dietary Supplements Information Expert Committee, Rockville, MD 02118, USA. paula.gardiner@bmc.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

18613260

Citation

Gardiner, Paula, et al. "The State of Dietary Supplement Adverse Event Reporting in the United States." Pharmacoepidemiology and Drug Safety, vol. 17, no. 10, 2008, pp. 962-70.
Gardiner P, Sarma DN, Low Dog T, et al. The state of dietary supplement adverse event reporting in the United States. Pharmacoepidemiol Drug Saf. 2008;17(10):962-70.
Gardiner, P., Sarma, D. N., Low Dog, T., Barrett, M. L., Chavez, M. L., Ko, R., Mahady, G. B., Marles, R. J., Pellicore, L. S., & Giancaspro, G. I. (2008). The state of dietary supplement adverse event reporting in the United States. Pharmacoepidemiology and Drug Safety, 17(10), 962-70. https://doi.org/10.1002/pds.1627
Gardiner P, et al. The State of Dietary Supplement Adverse Event Reporting in the United States. Pharmacoepidemiol Drug Saf. 2008;17(10):962-70. PubMed PMID: 18613260.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The state of dietary supplement adverse event reporting in the United States. AU - Gardiner,Paula, AU - Sarma,Dandapantula N, AU - Low Dog,Tieraona, AU - Barrett,Marilyn L, AU - Chavez,Mary L, AU - Ko,Richard, AU - Mahady,Gail B, AU - Marles,Robin J, AU - Pellicore,Linda S, AU - Giancaspro,Gabriel I, PY - 2008/7/10/pubmed PY - 2009/5/5/medline PY - 2008/7/10/entrez SP - 962 EP - 70 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 17 IS - 10 N2 - 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. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/18613260/The_state_of_dietary_supplement_adverse_event_reporting_in_the_United_States_ L2 - https://doi.org/10.1002/pds.1627 DB - PRIME DP - Unbound Medicine ER -