National Health Commission Office Medical Issuance [2019] No. 12

To the Health Commissions of all provinces, autonomous regions, municipalities directly under the central government, and the Xinjiang Production and Construction Corps:
　　To thoroughly implement the Outline of the “Healthy China 2030” Plan and the National Action Plan to Curb Bacterial Resistance (2016–2020), and to continuously strengthen the management of clinical antimicrobial use, ensure medical quality, and curb bacterial resistance, the following requirements are hereby set forth:
　　 I. Further optimize the management model for antimicrobial agents.
　　 (1) Formulate and implement technical specifications for the management of antimicrobial agents. All medical institutions shall, in accordance with the requirements of the Measures for the Clinical Application Management of Antimicrobial Agents, formulate systematic and operational technical specifications for antimicrobial management and ensure their rigorous implementation. They should adopt a scientifically grounded approach to the clinical management of antimicrobial agents and clearly define management objectives aimed at improving outcomes in infectious diseases and enhancing the quality of care. The principal leaders of medical institutions must earnestly fulfill their responsibilities as the primary persons accountable for antimicrobial management, lead their institution’s antimicrobial management task force, leverage the strengths of multidisciplinary teams, and carry out all related management tasks effectively.
　　 (2) Promote multidisciplinary diagnosis and treatment of infectious diseases. All medical institutions should prioritize strengthening interdisciplinary collaboration among critical care medicine, infectious diseases, clinical pharmacy, and clinical microbiology, with a particular focus on challenging infectious conditions. They should also reinforce hospital infection prevention and control measures to elevate the overall standard of diagnosis and treatment for infectious diseases. Furthermore, they should develop multidisciplinary diagnostic and therapeutic workflows and standardized operating procedures to enhance both the quality of care and operational efficiency.
　　 II. Striving to Enhance the Capacity for the Rational Use of Antimicrobial Agents
　　 (3) Conduct extensive training on antimicrobial knowledge. Health administrative departments at all levels and medical institutions shall establish standardized and rational training and assessment systems, develop training syllabi and plans, and provide relevant healthcare personnel with training and assessments on the standardized diagnosis and treatment of infectious diseases, the appropriate use of antimicrobial agents, and hospital infection prevention and control. Particular emphasis should be placed on strengthening physician training to enhance adherence to diagnostic and therapeutic guidelines and clinical pathways for infectious diseases. Only physicians who have completed institution‑provided training and passed the corresponding assessment may be granted the authority to prescribe antimicrobial agents. Prescription privileges shall not be conferred solely on the basis of a physician’s professional title.
　　 (4) Attach great importance to the development of relevant disciplines. By intensifying discipline development, we will strengthen the technical support system for the clinical management of antimicrobial use. It is essential to implement the requirements for establishing infectious disease departments in comprehensive hospitals at or above the secondary level, and by 2020, set up dedicated infectious disease wards or medical teams primarily focused on bacterial and fungal infections, thereby accelerating the enhancement of diagnostic and therapeutic capabilities in this field. We will also bolster the training and staffing of clinical pharmacists, transform the model of pharmaceutical services, and fully leverage their role in the diagnosis and treatment of infectious diseases. Furthermore, we will rigorously adhere to relevant health‑industry standards and expert consensus on the collection and submission of microbiological specimens, thereby improving the level of etiological diagnosis for bacterial and fungal infections. Finally, we will reinforce the workforce of hospital infection control personnel and elevate both the managerial and technical competencies in this area. Provincial health administrative departments are required to incorporate these requirements into hospital accreditation processes to ensure effective implementation.
　　 (5) Enhance the rational use of antimicrobial agents at the primary care level. Health administrative departments at all levels should, in conjunction with the tiered diagnosis and treatment system and the development of medical consortia, strengthen technical support for county hospitals and primary healthcare institutions. Through advanced training, paired assistance, remote consultations, and other measures, they should guide primary care personnel in mastering and implementing relevant clinical practice guidelines and clinical pathways, enhance their awareness of appropriate medication use, and promote standardized diagnosis and treatment of infectious diseases at the grassroots level.
　　 (6) Strengthen hospital infection prevention and control. Strictly implement basic measures for hospital infection prevention and control, enhance physicians’ adherence to hand hygiene, and ensure compliance with relevant operational protocols and technical standards. Prioritize infection prevention and control in key departments such as the ICU, respiratory units, and emergency departments, as well as in primary healthcare facilities, to reduce the incidence of central venous catheter‑related bloodstream infections, ventilator‑associated pneumonia, urinary tract infections associated with indwelling catheters, dialysis‑related infections, surgical site infections, post‑procedural pneumonia, and multidrug‑resistant infections. Strengthen surveillance and control of infections caused by carbapenem‑resistant Gram‑negative bacteria. By effectively implementing hospital infection prevention and control, we can curb the transmission of resistant pathogens, opportunistic pathogens, and other pathogenic microorganisms, thereby lowering the risk of hospital‑acquired infections and reducing the unnecessary use of antimicrobial agents.
　　 III. Strengthen Management of Key Links in the Use of Antimicrobial Agents
　　 (7) Strengthen the substantive development of specialized file management. Based on clinical monitoring, continue to implement dedicated record‑keeping for carbapenem antibiotics and tigecycline, while strengthening their internal management. This dedicated record‑keeping should encompass all stages, including prescription issuance, prescription review, clinical use, and prescription evaluation. Strict adherence to the “Expert Consensus on the Clinical Use of Carbapenem Antibiotics,” the “Detailed Rules for the Clinical Evaluation of Carbapenem Antibiotics,” and the “Detailed Rules for the Clinical Evaluation of Tigecycline” is required to curb the rapid rise in carbapenem resistance. Healthcare institutions are encouraged to place high‑priority monitoring on antimicrobial agents—such as enzyme inhibitor–containing combination preparations—with elevated resistance rates, incorporating them into the dedicated record‑keeping system.
　　 (8) Reasonably adjust the antimicrobial drug formulary. Medical institutions shall implement a system for the selection and evaluation of antimicrobial drug formularies, comprehensively assessing the adoption of new drugs and emerging technologies to ensure that formulary adjustments are scientifically sound and appropriately dynamic. The formulary revision cycle shall, in principle, be two years, with a minimum of one year, to prevent unwarranted, frequent changes to the list of covered agents. The formulary must meet the clinical needs for the diagnosis and treatment of infectious diseases, and any off‑formulary or externally sourced medications used in violation of regulations must be strictly prohibited. Furthermore, based on actual clinical practice, timely formulary updates should be initiated to remove from the list those agents characterized by high resistance rates, frequent adverse reactions, insufficient evidence‑based support, or prominent patterns of inappropriate use, thereby avoiding prolonged neglect of formulary revisions.
　　 (9) Reduce prophylactic use and inappropriate intravenous infusions. Continue to strengthen the management of perioperative prophylactic antimicrobial use for Class I and Class II surgical incisions, and reverse the overreliance on antimicrobials for preventing surgical site infections. In regions where outpatient intravenous antimicrobial administration is restricted, particular attention should be paid to emergency‑room intravenous antimicrobial use, with emphasis on the principle that “oral administration is preferred over intramuscular injection, and intramuscular injection is preferred over intravenous infusion.” Localities should, based on antimicrobial use surveillance data, implement targeted measures to reduce inappropriate prophylactic use and unnecessary intravenous antimicrobial administration.
　 　IV. Enhancing the Management of Antimicrobial Agents
　　 (10) Strengthen information-based management. All medical institutions shall integrate the implementation of electronic health records and embed all requirements for the clinical management of antimicrobial agents into their hospital information systems. Leveraging information technology, they should enforce provisions such as physicians’ prescribing privileges for antimicrobials, pharmacists’ qualifications for prescription review, evaluation of prescriptions for critically restricted‑use antimicrobials, and dynamic assessment and early warning mechanisms. By harnessing the positive role of digital tools in diagnostic support and clinical decision‑making, they should progressively achieve scientific, refined, automated, intelligent, and personalized management of antimicrobial agents.
　　 (11) Conduct phased effectiveness assessments. All localities and medical institutions shall regularly organize and conduct phased evaluations of the effectiveness of clinical antimicrobial stewardship. In addition to indicators of antimicrobial use and bacterial resistance control, assessments of antimicrobial stewardship should also comprehensively consider relevant outcome measures, such as the cure rate and attributable mortality for infectious diseases, the incidence of hospital-acquired infections, the incidence of adverse drug events, and the incidence of Clostridioides difficile infection. Particular emphasis should be placed on evaluating the appropriateness of initial antimicrobial therapy in patients with sepsis—including septicemia—and septic shock.
　　 (12) Conduct thorough clinical monitoring. All medical institutions shall, in accordance with the requirements, submit surveillance data to the Clinical Use Monitoring Network for Antimicrobial Agents and the Bacterial Resistance Surveillance Network, ensuring data quality. Health administrative departments at all levels are encouraged to expand the scope of surveillance, with particular attention to medication use among vulnerable populations such as children, the elderly, and pregnant and postpartum women, and to place great emphasis on the evaluation and application of surveillance findings. At the same time, proactive hospital‑acquired infection surveillance and prospective assessments should be conducted to promptly identify and mitigate infection risks. Strengthened surveillance of hospital‑acquired infections in key areas and critical processes within healthcare facilities is essential; monitoring indicators should be scientifically and appropriately defined to timely detect operational weaknesses and guide effective infection prevention and control measures.
　　 V. Conduct science popularization and public education activities
　　Health administrative departments at all levels and medical institutions should strengthen guidance on the rational use of medications for patients, thoroughly publicize common misconceptions about antimicrobial use and the harms of inappropriate prescribing; correct patients’ improper self‑treatment practices, and, while exercising caution in antimicrobial use, ensure that medications are administered as prescribed, at the full recommended dose, and for the full prescribed course. A regular outreach mechanism for promoting the rational use of antimicrobials should be established, with awareness‑raising activities conducted annually during the third week of November in coordination with the World Health Organization. Public education on the rational use of antimicrobials should be integrated into community‑based and grassroots cultural initiatives, leveraging public media, new media, and other channels to provide accurate information and reporting, thereby scientifically disseminating knowledge about appropriate antimicrobial use.
 

                       General Office of the National Health Commission

March 29, 2019

Source: National Health Commission of the People’s Republic of China