Evidence map›Paper›PMID 34364803›Full record

ArticleResearch in social & administrative pharmacy : RSAP2022

Physicians' use of and preferences for FDA-approved prescribing information.

Helen W Sullivan, Claudia Squire, Kathryn J Aikin, Janice Tzeng, Kate Ferriola-Bruckenstein, Eric Brodsky, Ann Marie Trentacosti, Mihaela Johnson

Abstract read
In one paragraph

Article in Research in social & administrative pharmacy : RSAP, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Perceptions and Preferences for Defining Biosimilar Products in Prescription Drug Promotion.Journal of the American Board of Family Medicine : JABFM · 2025
    Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Helen W SullivanUS Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Helen.Sullivan@fda.hhs.gov.
Claudia SquireRTI International, Research Triangle Park, NC, USA.
Kathryn J AikinUS Food and Drug Administration, Silver Spring, MD, USA.
Janice TzengRTI International, Research Triangle Park, NC, USA.
Kate Ferriola-BruckensteinRTI International, Research Triangle Park, NC, USA.
Eric BrodskyUS Food and Drug Administration, Silver Spring, MD, USA.
Ann Marie TrentacostiUS Food and Drug Administration, Silver Spring, MD, USA.
Mihaela JohnsonRTI International, Research Triangle Park, NC, USA.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

backgroundThe Prescribing Information (PI) is the US Food and Drug Administration (FDA)'s primary tool for communicating a summary of the essential scientific information needed for the safe and effective use of a prescription drug to healthcare providers.[1] One challenge with this type of communication is balancing the need to be thorough with the need to be concise.

objectivesThis study aimed to explore physicians' preferences for and understanding of specific content and formatting in the PI. This study also explored physicians' use of and perceptions of the PI.

methodsSeventy semi-structured qualitative interviews were conducted with primary care physicians (n = 35) and physicians from a wide range of specialties (n = 35) using web conferencing technology. Using fictitious PI examples, the guide assessed physicians' interpretation of language and preferences for how certain information is organized and communicated in select sections of the PI. The interview guide also included questions about the resources physicians use to find information about prescription drugs, when and how physicians access the PI, and their perceptions of the PI.

resultsThe findings suggest that of the content and formatting items surveyed, physicians had the greatest preference for: (1) uniformly specifying the age group for which the drug is indicated in the INDICATIONS AND USAGE section, even for medical conditions that are highly associated with only one particular age group (e.g., adult patients), and (2) uniformly including administration information in relation to food (e.g., "with or without food") in the DOSAGE AND ADMINISTRATION section for drugs with oral dosing. The findings also suggest that including a long list of interacting drug examples in the DRUG INTERACTIONS section may be misinterpreted to be a comprehensive list.

conclusionThis qualitative research suggests physicians may prefer more clarity in some sections of the PI.

Indexed as

PhysiciansPrescription DrugsAdultHumansPractice Patterns, Physicians'Qualitative ResearchSurveys and QuestionnairesPrescription DrugsCommunicationLabelingPerceptionsPhysicianPreferencesPrescribing information

Identifiers

PMID34364803
PMCPMC8803992

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.