■: The Technical Specifications for Dispensing Commonly Used Chinese Patent Medicines in Clinical Emergency and Critical Care focus on key dispensing procedures in the administration of injections, including drug dispensing and medication guidance, prescription review and evaluation, and medication monitoring, aiming to provide a reference for the rational use and risk prevention of traditional Chinese medicine (TCM) injections in clinical emergency and critical care settings. Objective: Technical Specifications for Dispensing Commonly Used Chinese Patent Medicines in Clinical Emergency and Critical Care, Part 2: Injections (T/CACM 1378.2–2022), hereinafter referred to as the Specifications, is one component of a series of standards, following Part 1: General Rules (T/CACM 1378.1–2022). These standards were jointly issued by the China Association of Chinese Medicine and developed under the leadership of the TCM Dispensing Standardization Research Center of Beijing University of Chinese Medicine. TCM injections represent a significant advancement in TCM routes of administration and have played a unique role in the treatment of clinical emergencies and critical illnesses. However, several issues remain in their clinical application. In particular, the lack of clear, standardized guidance for pharmacists during the dispensing process leads to operational difficulties and uncertainties, which may pose potential risks to patient medication safety. Therefore, there is an urgent need to establish systematic dispensing specifications to provide a clear basis for pharmacists’ practice and to ensure the provision of more efficient and safer pharmaceutical services. This study aims to interpret the development process and core content of the Specifications, clarify the responsibilities of pharmacists, improve the quality of pharmaceutical services, and ensure the safety and efficacy of TCM injections in clinical practice. Methods: The drafting group for the Specifications systematically identified key issues in the dispensing process of TCM injections in clinical emergency and critical care using multiple research approaches, including literature review, analysis of regulatory documents, panel discussions, questionnaires, and expert consultations. With reference to national laws and regulations, industry guidelines, standards, expert consensus statements, and relevant domestic and international standards, and in consideration of the current practices in medical institutions as well as expert opinions, the identified issues were categorized, summarized, and analyzed. Through expert consensus, the key technical components of the dispensing process were determined to include drug dispensing and medication guidance, prescription evaluation, prescription review, and medication monitoring. A total of 33 external experts (non-drafting members) were invited to provide feedback on the draft group standard. The drafting group systematically compiled and analyzed the feedback, which primarily focused on requirements for pharmacists’ qualifications in dispensing roles, drug dispensing and medication guidance, and medication monitoring. Based on this process, 15 key issues were incorporated, and the draft standard was revised and refined accordingly. Conclusions: TCM injections play an essential role in pharmaceutical dispensing in clinical emergency and critical care settings; however, several issues persist in current dispensing practices. Therefore, there is an urgent need to develop a scientifically grounded set of technical specifications for dispensing commonly used TCM injections in these settings. The establishment of these Specifications addresses existing gaps in the field of TCM injection dispensing for emergency and critical care, supplements relevant standards, and provides pharmacists with clear and standardized guidance for practice. It also promotes the standardization and regulation of dispensing procedures, facilitates the rational use of TCM injections in clinical practice, and ensures their safety and effectiveness. Furthermore, the development of a standardized dispensing system for TCM injections in emergency and critical care, under the guidance of TCM theory, expands and refines the scope of dispensing practice. It serves as an important enhancement to existing pharmaceutical services and contributes to better alignment with the international development of pharmaceutical care.
Wen et al. (Mon,) studied this question.