Evidence map›Paper›PMID 37975085›Full record

ArticleJournal of diabetes and metabolic disorders2023

Off-label prescription: developing a guideline and validating an instrument to measure physicians' and clinical pharmacists' knowledge and attitudes toward off-label medication use.

Pooneh Salari, Bagher Larijani, Farzaneh Zahedi, Mahshad Noroozi

Abstract read
In one paragraph

Article in Journal of diabetes and metabolic disorders, 2023. 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

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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. Article
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

4 authors.

Pooneh SalariPresent Address: Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.ORCID 0000-0001-5595-0087
Bagher LarijaniPresent Address: Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.ORCID 0000-0001-5386-7597
Farzaneh ZahediEndocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
Mahshad NorooziDepartment of Medical Ethics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.ORCID 0000-0002-1476-6408

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Off-label medications have been challenging in healthcare systems, and their significance is emphasized throughout pandemics. The study was designed to develop an ethics guideline for prescribing off-label medications and also aimed to develop a valid instrument for evaluating physicians' and clinical pharmacists' knowledge and attitudes regarding off-label medication use. Methods: In 2021, the two-phase study was done. A gap analysis study and a review of relevant guidelines and peer-reviewed papers were conducted in the first phase. There were three hybrid expert panel discussions with nine specialists until a consensus was reached. In the second phase, a questionnaire was developed to assess physicians' and pharmacists' knowledge and attitudes toward off-label prescribing medications. An expert panel of nine ethicists, physicians, and pharmacists determined the face and content validity. To evaluate the reliability and construct validity of the instrument, 201 physicians and clinical pharmacists participated. Results: This guideline provides 24 recommendations classified into seven themes to assist clinicians, pharmacists, and policymakers in managing off-label medication use. The preliminary questionnaire contained 72 items. Items were removed if their I-CVI and CVR were less than 0.79 and 0.78, respectively. The S-CVI/Average ratio was 0.937. The Cronbach α was 0.848. Ten factors were identified through exploratory factor analysis. These ten factors comprised 64.652% of the variance. There was no significant difference between general physicians, specialist physicians, and clinical pharmacists in one-way ANOVA [F = 0.584, P = 0.559]. Conclusion: We developed an ethical guideline for off-label medication use that can integrate ethical principles into related practice. Moreover, our valid and reliable questionnaire can evaluate the ethical adherence of physicians and pharmacists to scientific and ethical challenges of off-label medications in the country, especially during pandemics. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01288-0.

Indexed as

Ethical guidelineKAP studyOff-labelPandemicsPharmacy ethicsPhysician

Identifiers

PMID37975085
PMCPMC10638311

What OpenQuestion holds

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Registered trials

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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.