Circular of the General Office of the National Health Commission on Strengthening the Control of Narcotic Drugs and Psychotropic Drugs of Category I in Medical Institutions
Circular of the General Office of the National Health Commission on Strengthening the Control of Narcotic Drugs and Psychotropic Drugs of Category I in Medical Institutions
Circular of the General Office of the National Health Commission on Strengthening the Control of Narcotic Drugs and Psychotropic Drugs of Category I in Medical Institutions
Guo Wei Ban Yi Fa [2020] No.13
September 11, 2020
The health commissions of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps,
The following working requirements are hereby put forward, in order to strengthen the control of narcotic drugs and psychotropic drugs of category I in medical institutions (hereinafter referred to as "narcotic drugs and psychotropic drugs") in medical institutions, ensure reasonable clinical demand, and strictly prevent narcotic drugs and psychotropic drugs from flowing into illegal channels,
I. Attaching Great Importance to the Control of Narcotic Drugs and Psychotropic Drugs
Narcotic drugs and psychotropic drugs are drugs subject to special control in accordance with laws and regulations in our country. Narcotic drugs and psychotropic drugs have obvious duality. On the one hand, they have a strong analgesic and sedative effects, and are essential drugs for clinical diagnosis and treatment; on the other hand, irregular continuous use of narcotic drugs and psychotropic drugs is prone to induce dependence and addiction. If narcotic drugs and psychotropic drugs flow into illegal channels, they will cause serious social harm and even crimes. Health administrative departments at all levels and medical institutions shall attach great importance to the control of narcotic drugs and psychotropic drugs in the clinical application, carefully sort out potential vulnerabilities that may exist, and formulate and improve specific measures for further strengthening the control of narcotic drugs and psychotropic drugs, to meet clinical demand, and also to prevent narcotic drugs and psychotropic drugs from flowing into illegal channels from medical institutions.
II. Improving the Management System for Narcotic Drugs and Psychotropic Drugs in Medical Institutions
Medical institutions are the liable subject for the control of narcotic drugs and psychotropic drugs in the clinical application. The principal of a medical institution shall perform the duties of the first person responsible for the control of narcotic drugs and psychotropic drugs in the institution. Personnel involved in the control and use of narcotic drugs and psychotropic drugs must carefully study and implement the Drug Administration Law of the People's Republic of China, the Regulations on the Control of Narcotic Drugs and Psychotropic Drugs, the Measures for the Administration of Prescriptions, and the Provisions on the Control of Narcotic Drugs and Psychotropic Drugs of Category I in Medical Institutions, to clarify the duties of the administration department of narcotic drugs and psychotropic drugs and relevant persons at various positions, and comprehensively strengthen the procurement, storage, deployment, use and safety control of narcotic drugs and psychotropic drugs. For the anesthesiology department, operating rooms and other departments that use a lot of narcotic drugs and psychotropic drugs and involve relatively more use control links, it is necessary to focus on strengthening management of them, set up a special working group with the head of the department as the first person responsible, and strengthen the daily control of narcotic drugs and psychotropic drugs. Through various measures, a management model that regulates links management through systems and promotes system implementation by performing duties shall be formed.
III. Enhancing All Links and the Whole Process of Management of Narcotic Drugs and Psychotropic Drugs
Health administrative departments at all levels shall strengthen the management of the prescription and use of narcotic drugs and psychotropic drugs, encourage areas where conditions permit to realize intra-regional prescription information networking, focus on the prescription dosage and frequency of narcotic drugs and psychotropic drugs, and avoid that the same patient obtains narcotic drugs and psychotropic drugs repeatedly from multiple medical institutions, or from the outpatient department and the inpatient department of the same medical institution. Medical institutions shall fully implement the various requirements on the control of narcotic drugs and psychotropic drugs, and further strengthen all links and the whole process of the management. They shall, in light of the needs of clinical diagnosis and treatment, purchase narcotic drugs and psychotropic drugs with suitable packaging and specifications to reduce residual medicine liquid. Outpatient and emergency pharmacies, inpatient pharmacies, wards, operating rooms, endoscopy rooms and other key departments having base quotas for narcotic drugs and psychotropic drugs shall use double-lock safes or intelligent dispensing cabinet of narcotic drugs and psychotropic drugs for storage. The storage area shall be equipped with anti-theft facilities and security monitoring systems. It is necessary to strengthen the safety precautions for medicines in the operating room, and install video monitoring devices to monitor such behaviors as taking medicines and recycling medicines. In principle, the period for keeping relevant surveillance videos shall not be less than 180 days. The use and recycle management of narcotic drugs and psychotropic drugs shall ensure the daily closing and consistence between drugs and their account books. For chronic patients who suffer from cancer pain and need long-term outpatient use of narcotic drugs and psychotropic drugs, the disease evaluation and prescription made at the time of picking up drugs every time shall be recorded in detail through the informatization means or establishment of clinic medical records and other ways.
IV. Standardizing the Prescription Authority and Use and Operation Management of Narcotic Drugs and Psychotropic Drugs
Physicians and pharmacists shall, in accordance with the relevant regulations, obtain the corresponding right to prescribe or the qualification for dispensing narcotic drugs and psychotropic drugs, after they have received trainings on the use of and standardized management of narcotic drugs and psychotropic drugs organized by medical institutions and have passed the relevant examination. Medical institutions shall further refine and improve the specific operating procedures and standard requirements for the use of narcotic drugs and psychotropic drugs in the whole process. Especially for key departments, it is necessary to strictly implement the whole-process two-person operation system to change the current situation where an anesthesiologist operates narcotic drugs and psychotropic drugs alone. The prescription, use and control of narcotic drugs and psychotropic drugs must not be conducted by the same person. In principle, anesthesiologists do not participate in the control of narcotic drugs and psychotropic drugs. It is encouraged to gradually include pharmacists in the management team of narcotic drugs and psychotropic drugs of key departments such as wards and operating rooms, to carry out the review of medical advice and prescription comment on narcotic drugs and psychotropic drugs, and participate in the verification of the management and use of narcotic drugs and psychotropic drugs and the dual signatures by two persons. The persons participating in the dual signatures shall not be fixed for a long time. Medical institutions shall formulate administrative measures for the rotation of persons related to the dual signatures, and specify the rotation cycle. For the injection that has not been used up and the remaining liquid medicine in the analgesic pump, two persons among doctors, pharmacists or nurses will pour them into the sewer or dispose them under video surveillance, and make records one by one.
V. Meeting the Reasonable Clinical Demand for Narcotic Drugs and Psychotropic Drugs
Medical institutions shall, according to their respective clinical medication needs, purchase narcotic drugs and psychotropic drugs as required, and maintain reasonable inventory thereof. Doctors with the right to prescribe narcotic drugs and psychotropic drugs shall use narcotic drugs and psychotropic drugs rationally according to clinical diagnosis and treatment standards, guiding principles for clinical application of narcotic drugs and psychotropic drugs, and drug instructions. They shall evaluate the pain of patients, and select the corresponding drugs according to the principle of three-step analgesia therapy, before prescribing narcotic drugs and psychotropic drugs for pain patients. It is necessary to strengthen the standardized treatment of cancer pain, acute pain and moderate and severe pain, rationally use narcotic drugs and psychotropic drugs, to improve the life quality of patients, and to avoid that excessive control of narcotic drugs and psychotropic drugs affect the rational drug use needs of patients. Medical institutions shall organize special comments on prescriptions of narcotic drugs and psychotropic drugs and admission orders, and intervene in a timely and effective manner according to the results of the comments. The pharmaceutical department shall monitor the use of narcotic drugs and psychotropic drugs in its own institution. For the abnormal increase in the usage amount of narcotic drugs and psychotropic drugs, it shall immediately report the situation to the management institution of narcotic drugs and psychotropic drugs of this institution, analyze the reasons and put forward management suggestions.
VI.
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Guo Wei Ban Yi Fa [2020] No.13
September 11, 2020
The health commissions of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps,
The following working requirements are hereby put forward, in order to strengthen the control of narcotic drugs and psychotropic drugs of category I in medical institutions (hereinafter referred to as "narcotic drugs and psychotropic drugs") in medical institutions, ensure reasonable clinical demand, and strictly prevent narcotic drugs and psychotropic drugs from flowing into illegal channels,
I. Attaching Great Importance to the Control of Narcotic Drugs and Psychotropic Drugs
Narcotic drugs and psychotropic drugs are drugs subject to special control in accordance with laws and regulations in our country. Narcotic drugs and psychotropic drugs have obvious duality. On the one hand, they have a strong analgesic and sedative effects, and are essential drugs for clinical diagnosis and treatment; on the other hand, irregular continuous use of narcotic drugs and psychotropic drugs is prone to induce dependence and addiction. If narcotic drugs and psychotropic drugs flow into illegal channels, they will cause serious social harm and even crimes. Health administrative departments at all levels and medical institutions shall attach great importance to the control of narcotic drugs and psychotropic drugs in the clinical application, carefully sort out potential vulnerabilities that may exist, and formulate and improve specific measures for further strengthening the control of narcotic drugs and psychotropic drugs, to meet clinical demand, and also to prevent narcotic drugs and psychotropic drugs from flowing into illegal channels from medical institutions.
II. Improving the Management System for Narcotic Drugs and Psychotropic Drugs in Medical Institutions
Medical institutions are the liable subject for the control of narcotic drugs and psychotropic drugs in the clinical application. The principal of a medical institution shall perform the duties of the first person responsible for the control of narcotic drugs and psychotropic drugs in the institution. Personnel involved in the control and use of narcotic drugs and psychotropic drugs must carefully study and implement the Drug Administration Law of the People's Republic of China, the Regulations on the Control of Narcotic Drugs and Psychotropic Drugs, the Measures for the Administration of Prescriptions, and the Provisions on the Control of Narcotic Drugs and Psychotropic Drugs of Category I in Medical Institutions, to clarify the duties of the administration department of narcotic drugs and psychotropic drugs and relevant persons at various positions, and comprehensively strengthen the procurement, storage, deployment, use and safety control of narcotic drugs and psychotropic drugs. For the anesthesiology department, operating rooms and other departments that use a lot of narcotic drugs and psychotropic drugs and involve relatively more use control links, it is necessary to focus on strengthening management of them, set up a special working group with the head of the department as the first person responsible, and strengthen the daily control of narcotic drugs and psychotropic drugs. Through various measures, a management model that regulates links management through systems and promotes system implementation by performing duties shall be formed.
III. Enhancing All Links and the Whole Process of Management of Narcotic Drugs and Psychotropic Drugs
Health administrative departments at all levels shall strengthen the management of the prescription and use of narcotic drugs and psychotropic drugs, encourage areas where conditions permit to realize intra-regional prescription information networking, focus on the prescription dosage and frequency of narcotic drugs and psychotropic drugs, and avoid that the same patient obtains narcotic drugs and psychotropic drugs repeatedly from multiple medical institutions, or from the outpatient department and the inpatient department of the same medical institution. Medical institutions shall fully implement the various requirements on the control of narcotic drugs and psychotropic drugs, and further strengthen all links and the whole process of the management. They shall, in light of the needs of clinical diagnosis and treatment, purchase narcotic drugs and psychotropic drugs with suitable packaging and specifications to reduce residual medicine liquid. Outpatient and emergency pharmacies, inpatient pharmacies, wards, operating rooms, endoscopy rooms and other key departments having base quotas for narcotic drugs and psychotropic drugs shall use double-lock safes or intelligent dispensing cabinet of narcotic drugs and psychotropic drugs for storage. The storage area shall be equipped with anti-theft facilities and security monitoring systems. It is necessary to strengthen the safety precautions for medicines in the operating room, and install video monitoring devices to monitor such behaviors as taking medicines and recycling medicines. In principle, the period for keeping relevant surveillance videos shall not be less than 180 days. The use and recycle management of narcotic drugs and psychotropic drugs shall ensure the daily closing and consistence between drugs and their account books. For chronic patients who suffer from cancer pain and need long-term outpatient use of narcotic drugs and psychotropic drugs, the disease evaluation and prescription made at the time of picking up drugs every time shall be recorded in detail through the informatization means or establishment of clinic medical records and other ways.
IV. Standardizing the Prescription Authority and Use and Operation Management of Narcotic Drugs and Psychotropic Drugs
Physicians and pharmacists shall, in accordance with the relevant regulations, obtain the corresponding right to prescribe or the qualification for dispensing narcotic drugs and psychotropic drugs, after they have received trainings on the use of and standardized management of narcotic drugs and psychotropic drugs organized by medical institutions and have passed the relevant examination. Medical institutions shall further refine and improve the specific operating procedures and standard requirements for the use of narcotic drugs and psychotropic drugs in the whole process. Especially for key departments, it is necessary to strictly implement the whole-process two-person operation system to change the current situation where an anesthesiologist operates narcotic drugs and psychotropic drugs alone. The prescription, use and control of narcotic drugs and psychotropic drugs must not be conducted by the same person. In principle, anesthesiologists do not participate in the control of narcotic drugs and psychotropic drugs. It is encouraged to gradually include pharmacists in the management team of narcotic drugs and psychotropic drugs of key departments such as wards and operating rooms, to carry out the review of medical advice and prescription comment on narcotic drugs and psychotropic drugs, and participate in the verification of the management and use of narcotic drugs and psychotropic drugs and the dual signatures by two persons. The persons participating in the dual signatures shall not be fixed for a long time. Medical institutions shall formulate administrative measures for the rotation of persons related to the dual signatures, and specify the rotation cycle. For the injection that has not been used up and the remaining liquid medicine in the analgesic pump, two persons among doctors, pharmacists or nurses will pour them into the sewer or dispose them under video surveillance, and make records one by one.
V. Meeting the Reasonable Clinical Demand for Narcotic Drugs and Psychotropic Drugs
Medical institutions shall, according to their respective clinical medication needs, purchase narcotic drugs and psychotropic drugs as required, and maintain reasonable inventory thereof. Doctors with the right to prescribe narcotic drugs and psychotropic drugs shall use narcotic drugs and psychotropic drugs rationally according to clinical diagnosis and treatment standards, guiding principles for clinical application of narcotic drugs and psychotropic drugs, and drug instructions. They shall evaluate the pain of patients, and select the corresponding drugs according to the principle of three-step analgesia therapy, before prescribing narcotic drugs and psychotropic drugs for pain patients. It is necessary to strengthen the standardized treatment of cancer pain, acute pain and moderate and severe pain, rationally use narcotic drugs and psychotropic drugs, to improve the life quality of patients, and to avoid that excessive control of narcotic drugs and psychotropic drugs affect the rational drug use needs of patients. Medical institutions shall organize special comments on prescriptions of narcotic drugs and psychotropic drugs and admission orders, and intervene in a timely and effective manner according to the results of the comments. The pharmaceutical department shall monitor the use of narcotic drugs and psychotropic drugs in its own institution. For the abnormal increase in the usage amount of narcotic drugs and psychotropic drugs, it shall immediately report the situation to the management institution of narcotic drugs and psychotropic drugs of this institution, analyze the reasons and put forward management suggestions.
VI.
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