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Pediatric post-marketing safety systems in North America: assessment of the current status.
Pharmacoepidemiol Drug Saf. 2015 Aug; 24(8):785-92.PD

Abstract

PURPOSE

It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use.

METHODS

We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety.

RESULTS

Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples.

CONCLUSIONS

Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics.

Authors+Show Affiliations

Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.Office of Pharmacovigilance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.Duke Clinical Research Institute, Duke School of Medicine, Durham, NC, USA.Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.Duke Clinical Research Institute, Duke School of Medicine, Durham, NC, USA.Office of Pharmacovigilance and Epidemiology, US Food and Drug Administration, Silver Spring, MD, USA.Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26098297

Citation

McMahon, Ann W., et al. "Pediatric Post-marketing Safety Systems in North America: Assessment of the Current Status." Pharmacoepidemiology and Drug Safety, vol. 24, no. 8, 2015, pp. 785-92.
McMahon AW, Wharton GT, Bonnel R, et al. Pediatric post-marketing safety systems in North America: assessment of the current status. Pharmacoepidemiol Drug Saf. 2015;24(8):785-92.
McMahon, A. W., Wharton, G. T., Bonnel, R., DeCelle, M., Swank, K., Testoni, D., Cope, J. U., Smith, P. B., Wu, E., & Murphy, M. D. (2015). Pediatric post-marketing safety systems in North America: assessment of the current status. Pharmacoepidemiology and Drug Safety, 24(8), 785-92. https://doi.org/10.1002/pds.3813
McMahon AW, et al. Pediatric Post-marketing Safety Systems in North America: Assessment of the Current Status. Pharmacoepidemiol Drug Saf. 2015;24(8):785-92. PubMed PMID: 26098297.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pediatric post-marketing safety systems in North America: assessment of the current status. AU - McMahon,Ann W, AU - Wharton,Gerold T, AU - Bonnel,Renan, AU - DeCelle,Mary, AU - Swank,Kimberley, AU - Testoni,Daniela, AU - Cope,Judith U, AU - Smith,Phillip Brian, AU - Wu,Eileen, AU - Murphy,Mary Dianne, Y1 - 2015/06/22/ PY - 2015/01/22/received PY - 2015/05/06/revised PY - 2015/05/11/accepted PY - 2015/6/23/entrez PY - 2015/6/23/pubmed PY - 2016/5/5/medline KW - FDA KW - Pediatrix KW - active surveillance KW - adalimumab KW - adverse events KW - cilastatin KW - drug safety KW - electronic medical record KW - etanercept KW - imipenem KW - infliximab KW - meropenem KW - octreotide KW - passive surveillance KW - pharmacoepidemiology KW - retrospective chart review SP - 785 EP - 92 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 24 IS - 8 N2 - PURPOSE: It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. METHODS: We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. RESULTS: Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. CONCLUSIONS: Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/26098297/Pediatric_post_marketing_safety_systems_in_North_America:_assessment_of_the_current_status_ L2 - https://doi.org/10.1002/pds.3813 DB - PRIME DP - Unbound Medicine ER -