Evaluating the Impact of Package Inserts on Vaccine Prescribing Habits of Obstetricians/Gynecologists for Pregnant Women in the United States Público
Saini, Jannat (Spring 2019)
Abstract
Abstract
Background:
In the United States, gaps exist between the overlap of national guidelines’ maternal vaccination recommendations and the indications listed in Food and Drug Association (FDA) package inserts for those vaccinations. Certain vaccines, while strongly recommended by national and international bodies, were classified as Category B drugs (‘animal studies failed to find fetal risk, inadequate studies in pregnant women’). Recently, the FDA amended the Pregnancy Category rule of package inserts with the Pregnancy and Lactation Labeling Rule (PLLR). Effectively communicated recommendations from obstetricians/gynecologists are important in improving the awareness and uptake of maternal vaccination, however, there is insufficient general understanding of vaccine recommendations and labeling among providers.
Objectives:
To examine the extent to which providers utilize package inserts to make maternal vaccine recommendations, and compare how different vaccine package insert statements and labeling affect their perceptions regarding safety and effectiveness of vaccines during pregnancy.
Methods:
A cross-sectional survey was mailed to a random sample of 800 American College of Obstetricians and Gynecologists (ACOG) Fellows in the United States in March 2019. The survey evaluated providers’ attitudes about vaccine inserts and asked whether they’d recommend a vaccine following sample package insert statements with both Pregnancy Categories and the Pregnancy Lactation and Labeling Rule.
Results:
Currently, 303 of 762 surveys mailed have been received (Response Rate = 39.8%). The majority (90.7%) of providers recommended and/or administered maternal vaccination, with very few respondents (7.0%) reading package inserts for information regarding it. After reading sample insert statements, Pregnancy Lactation and Labeling Rule (47%) complying inserts were not as highly recommended as Pregnancy Category inserts (88%). Thematic analyses of free text responses showed provider doubt in vaccine manufacturers and inserts.
Conclusions:
Our study suggests providers do not actively consider package inserts in maternal vaccination decision-making. Providers were more likely to prefer using the old Pregnancy Categories rule instead of PLLR. Although there is value in providing more data, improved communication style may be needed in inserts. Collaborative efforts are necessary to update inserts with recent clinical practices for pregnancy and reduce the apprehensiveness around package inserts to generate safer and more cognizant recommendations for pregnant women.
Table of Contents
Table of Contents
Chapter I. Background and Literature Review............1
Chapter II. Manuscript...............................................16
Introduction..................................................16
Materials and Methods..................................18
Results...........................................................21
Discussion.....................................................26
Appendices....................................................30
Chapter III. Public Health Implications......................44
References..................................................................46
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