Objective  To summarize the current research status and cutting-edge trends of the off-label drug use in China, with a view to providing reference for researchers in this field.

Methods  CNKI and SinoMed databases were searched to collect research of the off-label drug use in China, and used Microsoft Excel 2021, the R software Bibliometric, and VOSviewer 1.6.18 to visualize the time and trend of publication, province, issuing authors and units, journals, keywords, and topic evolution of the included studies.

Results  1 475 papers were included in the research. A total of 2 808 authors from 31 provinces, cities and regions had conducted relevant studies on over-the-counter medication, with an overall increasing trend in the number of publications. Among them, Guangdong province published the most studies related to this field, the Straits Pharmacy Journal and China Pharmacy published the most studies in this field. Proprietary Chinese medicines, antimicrobials, antitumor drugs, and other drugs were the research hotspots. In addition, the patients in pediatrics, outpatient emergency, obstetrics and gynecology, psychiatry and other departments as a special sick population, the clinical use of medication exists in the overspecification situation was also a future research trend.

Conclusion  At present, research in this field focuses more on OLDU for special populations, special diseases, special drugs, etc. In the future, researchers should conduct evidence-based evaluation of drugs on the basis of more high-quality evidence in order to seek the best evidence for guiding the clinical use of medication. At the same time, drug administration and medical institutions should also develop standardized management policies and systems to promote the rational and safe use of medication in healthcare institutions.

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