When are Off-Label Indications and the Level of Evidence provided in a drug monograph?

Off-label drug information is included in Clinical Pharmacology when the data is found to be clinically relevant and of an acceptable quality for the given topic. Within Clinical Pharmacology, Level of Evidence documentation is provided for off-label indications within select therapeutic classes. In these cases, the Level of Evidence document is linked to the off-label indication and provides additional details summarizing the strength of recommendation, level of evidence rating, evidence summary, citations of evidence reviewed, and discussion. A recommendation may be for or against the use of a drug for a particular condition.

All evidence is reviewed and independently evaluated by at least two members of the Elsevier editorial team and/or review board. Elsevier uses a modified version of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Click herefor more information.