Electronic Theses and Dissertations

Title

Effects of Off-Label Prescribing on Patient Decision Making

Author

Douglas Paul

Date of Award

2012

Document Type

Dissertation

Degree Name

Ph.D. in Pharmaceutical Sciences

First Advisor

Noel Wilkin

Second Advisor

Brian Reisetter

Third Advisor

Doug Vorhies

Abstract

Objectives: Despite the common use of off-label prescribing in the US, no research has been conducted to understand the impact of off-label prescribing on patient decision making. This study sought to measure the impact on trust in physicians, intentions of involvement in the decision making, beliefs about the drug, and initial compliance intentions in elderly and nonelderly populations. Methods. This study was designed to assess the effects of off-label prescribing using a 2 × 2 × 2 design. Using an online panel, 830 consumers were surveyed, 409 elderly and 421 nonelderly, using 8 different scenarios based on disease criticality, off-label use norms, and the FDA approval status of the drug for the disease for which it was prescribed. The effect on trust in the physician, intentions of involvement in decision making, beliefs about the drug, and initial compliance intentions were assessed. Results. Off-label prescribing decreased trust in the physician, increased intentions of involvement in medical decision making, and lowered positive beliefs about the drug. There was a greater loss in physician trust when receiving an off-label prescription in a less critical disease state than when receiving an off-label prescription in a more critical disease state. The data revealed a significant loss in positive beliefs about the drug when receiving an off-label prescription compared to on-label drug in the less critical disease state. Respondents judged the physician-provided information about the drug as relevant/reliable, and this led to the creation of positive beliefs about the drug as well as initial compliance intentions. The elderly appeared slightly more trusting of physicians and positive in their beliefs about drugs and possessed higher intentions of initial compliance. Conclusions. Off-label prescribing can lead to deleterious effects on patients' health, including lower compliance, lower trust in the physician, and lower beliefs in the drug. Differences exist between the elderly and the nonelderly that may call for different interventions. As shown in previous research, judgments of the relevance/reliability of the information appear to filter which information is used to form beliefs about the drug and affect initial compliance intentions. This work revealed a rich area for future research.

Concentration/Emphasis

Pharmaceutics

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