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

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.