Guidance Documents for Off-Label Drug Use Management for Chinese Health Care Institutions: A Scoping Review

Area of Science:

• Pharmacology
• Health Policy
• Regulatory Science

Background:

• Off-label drug use (OLDU) is prevalent in Chinese healthcare institutions.
• Numerous guidance documents exist to manage OLDU, but their consistency and comprehensiveness are unclear.
• A review is needed to compare these documents and identify management gaps.

Purpose of the Study:

• To conduct a scoping review of guidance documents for OLDU management in Chinese healthcare.
• To compare existing recommendations across various OLDU management aspects.
• To identify deficiencies and areas for improvement in current OLDU guidelines.

Main Methods:

• Searched multiple databases (PubMed, EMbase, Chinese databases) and official websites for OLDU guidance documents.
• Included 16 documents: 12 expert consensuses, 2 practice guidelines, 2 group standards.
• Extracted and compared practices related to management systems, organizational structure, prerequisites, approval, evidence evaluation, and informed consent.

Main Results:

• Only six documents specified requirements for management systems.
• Few documents clearly defined supervisory authority and responsibilities for OLDU management.
• Significant disparities were found in approval processes, evidence-based evaluation, and informed consent recommendations.
• A minority of documents addressed training, assessments, and adverse reaction monitoring for OLDU.

Conclusions:

• Existing OLDU guidance documents in China exhibit considerable variation and lack emphasis on critical management aspects.
• There is a need for unified national guidelines to standardize off-label drug use management.
• Health administrative authorities should promote the development of comprehensive, consistent national standards.