Pediatrics
December 2015, VOLUME 136 / ISSUE 6
http://pediatrics.aappublications.org/content/136/6?current-issue=y

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Characteristics of Physicians Who Dismiss Families for Refusing Vaccines
Sean T. O’Leary, Mandy A. Allison, Allison Fisher, Lori Crane, Brenda Beaty, Laura Hurley, Michaela Brtnikova, Andrea Jimenez-Zambrano, Shannon Stokley, Allison Kempe
Abstract
BACKGROUND AND OBJECTIVES: Physicians dismissing families who refuse vaccines from their practices is controversial. We assessed the following among pediatricians (Peds) and family physicians (FPs): (1) reported prevalence of parental refusal of 1 or more vaccines in the infant series; (2) physician response to refusal; and (3) the association between often/always dismissing families and provider/practice characteristics and state exemption laws.
METHODS: Nationally representative survey conducted June to October 2012. A multivariable analysis assessed association of often/always dismissing families with physician/practice characteristics, state philosophical exemption policy, and degree of difficulty obtaining nonmedical exemptions.
RESULTS: The response rate was 66% (534/815). Overall, 83% of physicians reported that in a typical month, ≥1% of parents refused 1 or more infant vaccines, and 20% reported that >5% of parents refused. Fifty-one percent reported always/often requiring parents to sign a form if they refused (Peds 64%, FP 29%, P < .0001); 21% of Peds and 4% of FPs reported always/often dismissing families if they refused ≥1 vaccine. Peds only were further analyzed because few FPs dismissed families. Peds who dismissed families were more likely to be in private practice (adjusted odds ratio [aOR] 4.90, 95% confidence interval [CI] 1.40–17.19), from the South (aOR 4.07, 95% CI 1.08–15.31), and reside in a state without a philosophical exemption law (aOR 3.70, 95% CI 1.74–7.85).
CONCLUSIONS: Almost all physicians encounter parents who refuse infant vaccines. One-fifth of Peds report dismissing families who refuse, but there is substantial variation in this practice. Given the frequency of dismissal, the impact of this practice on vaccine refusers and on pediatric practices should be studied.

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FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007–2013
Judith U. Cope, Geoffrey L. Rosenthal, Pamela Weinel, Amy Odegaard, Dianne M. Murphy
Abstract
BACKGROUND AND OBJECTIVES: In 2002, Congress mandated that the US Food and Drug Administration (FDA) monitor postmarketing pediatric adverse events and present safety reports to the FDA’s Pediatric Advisory Committee (PAC). These safety reviews play a critical role in the postmarketing surveillance and identification of pediatric safety issues. This article follows a previous review ending in 2007 and summarizes 6 years of recent pediatric safety reporting, recommendations by the PAC, and actions by the FDA, including labeling changes.
METHODS: An analysis of the FDA’s PAC safety reviews performed from November 2007 through September 2013 was conducted. PAC recommendations for subsequent labeling changes, future studies, or other safety issues were reviewed.
RESULTS: There were 6930 serious adverse event reports in 181 reviews. These findings resulted in 33 (18%) recommended labeling changes, and 21 (64%) of these changes were adopted. For 10 products, information was added to the Warning and Precautions section of the label. The PAC also discussed or recommended additional studies for certain products.
CONCLUSIONS: This article highlights the importance of the FDA’s ongoing pediatric postmarketing safety reviews of regulated products, advice from the PAC, and FDA actions in the best interest of pediatric patients. This mandated process facilitates detection of safety concerns that may not be identified in prelicensure clinical trials. It continues to identify critical safety concerns, including unlabeled adverse events, frequent off-label use, product misuse, and secondary exposures in children.