Salari Pooneh, Larijani Bagher, Zahedi Farzaneh, Noroozi Mahshad
Present Address: Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
J Diabetes Metab Disord. 2023 Sep 2;22(2):1599-1608. doi: 10.1007/s40200-023-01288-0. eCollection 2023 Dec.
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.
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.
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].
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.
The online version contains supplementary material available at 10.1007/s40200-023-01288-0.
在医疗保健系统中，超说明书用药一直是个难题，在大流行期间其重要性尤为凸显。本研究旨在制定超说明书用药处方的伦理准则，同时开发一种有效工具，以评估医生和临床药师对超说明书用药的知识和态度。
2021年开展了这项两阶段研究。第一阶段进行了差距分析研究，并对相关指南和同行评审论文进行了综述。与九位专家进行了三次混合专家小组讨论，直至达成共识。第二阶段，设计了一份问卷，以评估医生和药师对超说明书用药处方的知识和态度。由九位伦理学家、医生和药师组成的专家小组确定了表面效度和内容效度。为评估该工具的信度和结构效度，201名医生和临床药师参与其中。
本准则提供了24条建议，分为七个主题，以协助临床医生、药师和政策制定者管理超说明书用药。初步问卷包含72个项目。如果项目的I-CVI和CVR分别小于0.79和0.78，则将其删除。S-CVI/Average比率为0.937。Cronbach α系数为0.848。通过探索性因素分析确定了十个因素。这十个因素占方差的64.652%。在单因素方差分析中，普通医生、专科医生和临床药师之间无显著差异[F = 0.584，P = 0.559]。
我们制定了超说明书用药的伦理准则，可将伦理原则融入相关实践。此外，我们有效且可靠的问卷能够评估医生和药师在该国，尤其是在大流行期间，对超说明书用药的科学和伦理挑战的伦理遵循情况。
在线版本包含可在10.1007/s40200-023-01288-0获取的补充材料。
