Technological process with cochrane library of reasonability assessment of off-label uses of drugs found in comments on prescription / 中国药学杂志

ABSTRACT

OBJECTIVE: Off-label uses of drugs incur much debate, which is often encountered when doing prescription comment. The reasonability assessment of off-label uses is the key problem and requires solution urgently. This paper attempts to set up a normative evaluation process of off-label uses in routine prescription comment. METHODS: The off-label uses gathered in 2014 prescription comment were used for example. The off-label uses were searched in the Cochrane Library, and the results such as CDSR (Cochrane Database of Systematic Review), DARE (Database of Abstracts of Reviews of Effectiveness), RCT (Random Clinical Controlled Trial) and CCT (Clinical Controlled Trial) were screened according the criterion and analyzed. RESULTS: Eight Off-label uses were found with prescription comment. The edaravone for head injury, L-ornithine-L-aspartate for rise of hepatic transaminase, progesterone for urinary calculi and levocarnitine for myocardium protection were no evidence found in Cochrane Library, and were treated as irrationality. According to results of CDSR and DARE the edaravone for brain hemorrhage, and levocarnitine for cancer fatigue were not supported, but thymalfasin for cancer were supported. After assessing risk of bias with Cochrane tool, only under special circumstances can alprostadil for pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) be evaluated as conformation with evidence-based medicine. CONCLUSION: Assessment of reasonability for Off-label uses according to evaluation process using Cochrane Library can improve medication reasonability and safety, and increase the knowledge and competence of drug administration.