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Related Concept Videos

Pharmacovigilance01:19

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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According to obedience research, we may harm others under the forceful pressures of an authority figure (Milgram, 1974). How about if the inappropriate orders were delivered with less force? The increasing interdependence between nurses and physicians compelled Hofling and his colleagues to explore nurses’ reactions to a potentially harmful medical request made by the perceived authority figure, the doctor (Hofling, Brotzman, Dalrymple, Graves, & Pierce, 1966). In this situation,...
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The placebo effect occurs when people's expectations or beliefs influence or determine their experience in a given situation. In other words, simply expecting something to happen can actually make it happen.
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Related Experiment Video

Updated: Jul 2, 2025

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Prescriber perceptions of boxed warnings: A qualitative study.

Rachel N Ingersoll1, Elise T Bui1, Blair Coleman2

  • 1Fors Marsh, Health Communication Research, Arlington, Virginia, USA.

Pharmacoepidemiology and Drug Safety
|February 28, 2024
PubMed
Summary

Boxed warnings (BWs) are one factor influencing prescriber decisions, with context and patient perception playing key roles. Risk information from BWs is viewed differently based on the specific drug and condition treated.

Keywords:
boxed warningsdrug safetylabelingqualitative research

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Area of Science:

  • Pharmacovigilance
  • Clinical Decision-Making
  • Health Communication

Background:

  • Boxed warnings (BWs) are FDA-mandated risk communication tools.
  • Understanding prescriber integration of BWs into clinical practice is crucial.

Purpose of the Study:

  • To investigate how boxed warning (BW) information influences prescriber treatment decisions.
  • To explore prescriber communication strategies regarding BWs with patients.

Main Methods:

  • In-depth interviews with 52 primary care providers and specialists.
  • Participants reviewed prescribing scenarios involving vulvovaginal atrophy (VVA) treatment and chronic hepatitis C virus (HCV) treatment.
  • Interviews assessed treatment decision-making, reactions to prescribing information, and perceptions of BWs.

Main Results:

  • BWs are one of multiple factors influencing treatment decisions, alongside clinical factors specific to the condition.
  • Perceptions of BWs varied; the direct-acting antiviral (DAA) BW for HCV was generally viewed positively, while the estrogen vaginal insert BW for VVA was perceived by some as overstating risk.
  • Providers considered how patients might interpret BW information.

Conclusions:

  • The influence of BWs on clinical practice is context-dependent.
  • Prescribers integrate BW information alongside other clinical and patient-specific factors.
  • Patient perception of BWs is a significant consideration for healthcare providers.