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Regulations
2015年02月03日
Concerning the procedures for the control of drug maintenance treatment work for notification
The 2015-01-09 national health and population and family planning commission of the People's Republic of China
The CDC is sent [2014] 2014
Provinces, autonomous regions and municipalities directly under the central government health and family planning commission, public security bureaus, food and drug supervision bureau, the xinjiang production and construction corps, food and drug supervision bureau, health bureau, the public security bureau
For the implementation of the drug laws of the People's Republic of China, the HIV/AIDS prevention and control regulations, regulations on the drug, and "the central committee of the communist party of China, the state council on strengthening anti-drug work opinion", further standardize drug maintenance treatment work, the national health and family planning commission, the ministry of public security, state food and drug supervision bureau jointly established the procedures for the control of drug maintenance treatment work for (which can be downloaded from the national health and family planning commission website www.nhfpc.gov.cn). The way has been under the state council AIDS working committee deliberated and adopted at the second plenary session, hereby printed and distributed to you, please comply with them.
National health and family planning commission of the ministry of public security
State food and drug supervision administration
On December 31, 2014
Procedures for the control of drug maintenance treatment work for
The first chapter the general
Article 1 with a view to reduce caused by abuse of opioids diseases such as HIV/AIDS spread and illegal and criminal behavior, consolidate the detoxification effect, standardize the detoxification drug maintenance treatment work, according to the drug laws of the People's Republic of China, the law of the People's Republic of China on the prevention and control of infectious diseases, the professional medical practitioners law of the People's Republic of China, regulations on the drug, the HIV/AIDS prevention and control ordinance, the "regulations on the administration of medical institutions" and the "regulations on the administration of narcotic drugs and psychotropic drugs" and other relevant laws and regulations and these measures.
Referred to in article 2 hereof detoxification drug maintenance therapy (hereinafter referred to as maintenance treatment), refers to the qualified medical institutions, choose appropriate drugs to long-term maintenance treatment of opioid addicts, in order to reduce their dependence on opioids, promote physical rehabilitation rehabilitation medical activities.
Detoxification drug maintenance treatment institutions "as mentioned in the present measures (hereinafter referred to as maintenance treatment agencies), is approved by the provincial family planning administrative department of public health, medical institutions engaged in the work of detoxification drug maintenance treatment.
Article 3 the maintenance treatment work is an important part of the prevention and control of AIDS and the drug control work, must adhere to the principle of public welfare, for the purpose of profit-making.
Maintenance treatment work shall be incorporated in the people's governments at various levels for AIDS and drug control work plans, implements the unified leadership of government, relevant departments of the individual, the working mechanism of social participation.
Article 4 in maintenance treatment work have made significant achievements and units and individuals that make outstanding contributions in accordance with the relevant provisions of the state to give recognition and reward.
The second chapter organization management
Article 5 the state health and family planning commission jointly with the ministry of public security, state food and drug supervision administration organization and coordination, monitoring and evaluation and supervision and management of maintenance treatment work throughout the country.
National health and family planning commission, in accordance with the requirements of the national AIDS prevention and control work and provincial family planning administrative department of public health report of maintenance treatment work plan, determine the provinces (autonomous regions and municipalities) task.
Article 6 provincial family planning administrative department of health under the state council in conjunction with the public security, food and drug supervision departments at the same level for the jurisdiction of maintenance treatment work planning, organization and coordination, monitoring and evaluation, etc.
Provincial family planning administrative department of health is responsible for the jurisdiction maintenance treatment of examination and approval, organization maintenance treatment institution of professional personnel training, and supervision and management and technical guidance to maintenance treatment work.
The provincial public security organs shall be responsible for the jurisdiction treatment personnel information registration work.
Provincial food and drug regulatory departments shall be responsible for maintenance treatment drug dispensing unit within the districts of audit and determine, supervision and administration of the maintenance treatment drug preparation and supply, the treatment of drug abuse monitoring work.
Article 7, divided into districts, municipal family planning administrative department of public health at the county level jointly with the public security organs at the same level, food and drug regulatory departments establish joint meeting mechanism, talk things over solve the problems existing in the maintenance treatment work.
, divided into districts, municipal family planning administrative department of public health at the county level is responsible for the maintenance treatment institutions maintenance treatment in drug use and the relevant supervision and administration of medical activities.
, divided into districts, municipal public security organs at the county level shall be responsible for the processing in accordance with the maintenance treatment of illegal and criminal behavior.
At the county level, the food and drug supervision department is responsible for maintaining the level of district-constituted municipalities treatment of drug preparation of daily supervision and inspection, supplies, etc.
Article 8 the maintenance treatment for eligible to apply for maintenance treatment personnel to provide a comprehensive intervention treatment, and services in accordance with the specification, and in accordance with the provisions, laboratory testing, information management, etc.
Maintenance treatment institutions should work with the community rehabilitation and community rehabilitation institutions cooperate with each other, for executing community rehabilitation, community rehabilitation treatment personnel, carry out the necessary social psychological intervention, etc.
The third chapter agency personnel
Article 9 of the provincial family planning administrative department of health under the state council in conjunction with the public security organs at the same level, food and drug regulators, according to the existing opiates addicts within their respective jurisdiction distribution and demand, combined with the existing medical and health resources distribution within their respective jurisdictions, planning the number and layout of maintenance treatment institutions, and can be adjusted according to the changing conditions.
Article 10 a medical institution intends to carry out the work of maintenance treatment, shall submit to practice registration authority, the written application materials by the written materials submitted to the family planning administrative department of public health at the provincial level for approval. The family planning administrative department of public health at the provincial level shall, according to the jurisdiction of maintenance treatment work plans, and other relevant provisions of these measures to review, since 20 working days from the date of acceptance of application, make a decision on approval or disapproval of the approval, and inform the applicant in writing. Before approval, shall solicit opinions from the public security organs at the same level and the food and drug regulatory authorities.
Approved to carry out the maintenance treatment work of medical institutions, should be after the approval of the provincial family planning administrative department of public health, in a timely manner to the public security organs at the same level for the record. Family planning administrative department of public health at the provincial level shall transfer the relevant information about the public security organ at the same level, food and drug regulatory authorities. Provincial family planning, public security, health, food and drug regulatory departments shall put level administrative departments for the record.
Article 11 the maintenance treatment mechanism, location, the name of the principal changes, such as shall, in accordance with the "regulations on the administration of medical institutions and its implementing rules and other relevant provisions of the registration of change, and to the provincial health administrative departments of family planning and the public security organs at the same level for the record.
Article 12 the application carry out the work of maintenance treatment institution shall meet the following conditions:
(a) of the "practice license of medical institution";
(2) of the purchase and use for psychotropic drugs of category I must achieve narcotic drugs and signature card (hereinafter referred to as the signature card);
(3) has adapted to maintenance treatment work of medical practitioners, nurses and other professional and technical personnel and security personnel;
(4) in conformity with the relevant technical specifications of the maintenance treatment of rules.
With drug treatment service's application for medical institutions to carry out the maintenance treatment of qualifications, shall be governed by the provisions of article 10 of the present measures.
Article 13 the physician engaged in the work of maintenance treatment shall meet the following conditions:
(a) has the qualifications of medical practitioners and registered "physicians practicing certificate";
(2) for maintenance treatment by the regulation related training;
(3) the use of narcotic drugs and the psychotropic drugs of category I physician stupefacient and ChuFangQuan psychotropic drugs of category I shall obtain;
(4) other conditions prescribed by the family planning administrative department of public health at the provincial level.
Article 14 the nurses working in the field of maintenance treatment shall meet the following conditions:
(a) a nurse qualification and certified the nurse practice certificate;
(2) according to the rules for maintenance treatment work related training;
(3) other conditions prescribed by the family planning administrative department of public health at the provincial level.
Article 15 pharmacists work in the maintenance treatment shall meet the following conditions:
(a) with medicine over primary professional qualification;
(2) according to the rules for maintenance treatment work related training;
(3) other conditions prescribed by the family planning administrative department of public health at the provincial level.
Article 16 according to the actual situation of maintenance treatment institutions, may establish medicine extension points, and by the family planning administrative department of public health at the provincial level in accordance with the requirements prescribed in paragraph 1 of article 12 hereof for approval. Maintenance treatment agencies responsible for the daily management of medicine extension point.
Article 17 the maintenance treatment institutions in the treatment of workers in accordance with the relevant information confidential. Except in the case where the laws and regulations, without the consent of the applicant or his guardian, maintenance treatment agencies to any unit or individual shall not provide relevant information for the treatment of workers.
Chapter iv drug management
Article 18 drug maintenance treatment used for methadone hydrochloride oral solution (specification: 1 mg/ml, 5000 ml/bottle).
Methadone hydrochloride oral solution of active pharmaceutical ingredients supply planning program, according to the actual situation proposed by maintenance treatment drug dispensing unit demand plan, approved by the state food and drug supervision bureau after execution.
Article 19 the determine the maintenance treatment of drug dispensing units shall, in accordance with the national drug standards methadone hydrochloride oral solution, and distribution to maintenance treatment agencies.
Article 20 the maintenance treatment institutions shall be by signature card from the province (area, city) to determine the maintenance treatment of drug dispensing unit purchases methadone hydrochloride oral solution. Across the province to buy, need to quote the relevant provincial food and drug regulatory authorities for the record.
Maintenance treatment institutions allocate and scattered drugs used by the container and the tools shall be disinfected regularly or replaced, drugs to prevent pollution.
Article 21 maintenance treatment drug transport, use and storage management must strictly implement of the "drugadministration law of the People's Republic of China" and the "regulations on the administration of narcotic drugs and psychotropic drugs" rules.
The fifth chapter maintenance treatment
Article 22, aged 18 or above with full capacity for civil conduct in opioid addicts, can according to the principle of voluntary application to participate in the maintenance treatment. Under the age of 18 of opioid addicts, invalid shall adopt other measures for rehabilitation and, written consent from the guardian can apply for to participate in the maintenance treatment.
Contraindications to have treatment, temporary not accept maintenance treatment. Contraindications to cure, can apply for to participate in the maintenance treatment.
Article 23 the application for maintenance treatment of personnel shall be to maintain treatment institutions provide the following information:
(a) personal id photocopy;
(2) of drugs through written materials;
(3) the relevant medical examination report.
After receiving the applicant submit qualified maintenance treatment institutions within five working days, inform the applicant in writing if treatment can attend, and report the results of audits to maintenance treatment mechanism to the local public security organ for the record.
Article 24 personnel shall apply for the treatment promises to strictly abide by the maintenance treatment institution during the period of treatment each rules and regulations, maintain treatment institutions to carry out regular inspection of infectious diseases and drug detection, treatment and sign a voluntary agreement.
Article 25 the treatment personnel of maintenance treatment institution shall set up medical records, and will treat information in a timely manner in accordance with provisions to maintenance treatment mechanism to the local public security organs register put on record.
Article 26 the eligible for maintenance treatment of community rehabilitation, community rehabilitation, classics countryside (town), streets, community rehabilitation, community rehabilitation work studies agree that can apply to the maintenance treatment institutions to participate in the maintenance treatment.
Article 27 the maintenance treatment institutions except to provide maintenance therapy for the treatment, still need to carry out the following work:
(a) to carry out the drug control and prevention and control of AIDS propaganda of laws and regulations,
(2) to carry out the prevention and treatment of infectious diseases such as AIDS and hepatitis c, syphilis and drug knowledge propaganda;
(3) to provide psychological counseling, psychological rehabilitation treatments and behavior and so on work;
(4) to carry out HIV/AIDS, hepatitis c, syphilis and drug testing;
(5) assist the related department for the treatment of HIV antibody positive personnel follow-up, treatment and referral;
(6) assist the food and drug regulators in treatment of drug abuse monitoring work.
Article 28 maintenance treatment institutions should work with local community rehabilitation, community rehabilitation agencies and drug rehabilitation sites set up the mechanism of cohesion, strengthen information communication and exchanges.
Community rehabilitation, community rehabilitation agencies, forced isolation rehab and drug rehabilitation workplace ought to carry out drug treatment and rehabilitation measures are personnel to carry out the policies and the publicity and education of knowledge, maintenance treatment, for those willing to participate in the maintenance treatment, should help them with maintenance treatment organizations do a good job in information communication.
Article 29 maintain institutions find personnel depigmentation treatment, it shall timely report to the local public security organ; Found that is executing community rehabilitation, community rehabilitation personnel depigmentation, shall communicate relevant community rehabilitation, community rehabilitation work at the same time.
Article 30. Because of census register seat or change the latter, not in the original maintenance treatment agencies to accept treatment, treatment of staff should report to the original maintenance treatment institution, the original maintenance treatment institution is responsible for the referral for the treatment of personnel work, to continue to maintain treatment services in different places.
Executing community rehabilitation, community rehabilitation measures, shall, in conjunction with the community rehabilitation, community rehabilitation work institutions deal with relevant formalities.
Article 31 during treatment of personnel in the maintenance treatment appeared in violation of the provisions of treatment, drug relapse, seriously affect the normal work order maintenance treatment institutions or was detained for illegal and criminal behavior and cannot continue to accept treatment, such as maintenance treatment institutions shall terminate its treatment, timely report to the local public security organs.
Terminated the healer application again to take part in the maintenance treatment, maintenance treatment institutions shall conduct audit strictly, to carry out medical assessment, and determine whether to accept the applicant according to the results of the audit and assessment to re-enter the maintenance treatment. Maintenance treatment institutions audit results shall be timely reported to the local public security organ for the record.
The sixth chapter supervision and management
Article 32 the state health and family planning commission, the ministry of public security and state food and drug supervision administration organization on a regular basis to carry out the supervision and management of the maintenance treatment work throughout the country, supervision and examination assessment work.
Article 33 the local family planning administrative department of health at or above the county level the supervision and inspection of the main contents include:
(a) maintenance treatment institutions and their staff qualifications;
(2) of narcotic drugs and the use of psychotropic drugs of category I qualification;
(3) the responsibilities to carry out the situation of maintenance treatment institutions;
(4) maintenance treatment institution staff training;
(5) maintenance therapy and drug use, storage, destruction and safety management.
Article 34 the local public security organ at or above the county level shall supervise and inspect the main contents include:
(a) the maintenance of public order situation of maintenance treatment institutions;
(2) treatment of personnel information registration and filing;
(3) the treatment of treatment in accordance with the law personnel illegal and criminal behavior.
Article 35 the local food and drug supervision departments at or above the county level shall supervise and inspect the main contents include:
(a) maintenance therapy drug preparation and quality control;
(2) to maintain the supply of drugs;
(3) maintenance therapy drug dispensing unit safety management of the drug.
Article 36 maintenance treatment institution shall formulate the internal supervision and management system, and the staff perform their duties of supervision and management.
Article 37 the maintenance treatment institution and staff should consciously accept the supervision of the society and citizens. The family planning administrative departments for public health shall, in conjunction with the public security organs and the timely processing of the food and drug regulator reporting ACTS of violation of the individual or organization in violation of these measures.
Article 38 for maintenance treatment shall comply with the relevant state laws, regulations and rules, perform maintenance treatment related technical specification. Maintenance treatment work in violation of the provisions of these measures, the family planning administrative department of public health, public security organs and the food and drug supervision departments will be in accordance with the relevant state laws and regulations for processing.
Chapter 7 safeguards
Article 39 maintenance treatment agencies provide maintenance treatment services prices to perform local provincial family planning, human resources, health, social security and other departments of the relevant provisions. Maintenance treatment institutions charge treatment personnel of diagnosis and treatment by the regulation, can be used to maintain the configuration of the drugs, transport, distribution and maintenance treatment agencies daily operation, personnel training, to extend the medicine management expenditure.
Article 40 the conform to the planning is needed to set up a maintenance treatment institution equipment purchase and other necessary working funds into the fiscal budget at the same level, be properly supported by the central government.
Article 41 the maintenance treatment institutions may, according to local economic development, is really necessary for therapist give a medical treatment and the economic difficulties, maintain care assistance such as free treatment.
Article 42 in the maintenance treatment institutions shall staff for infectious diseases such as HIV/AIDS occupational exposure protection training, and take effective protective measures.
Maintenance treatment to HIV occupational exposure in the work, in accordance with the relevant provisions of prevention measures after exposure.
The eighth chapter bylaws
Article 43 the maintenance treatment need to use other drugs, by the national health and family planning commission jointly with the ministry of public security and state food and drug supervision administration and published.
Article 44 local family planning administrative department of health at or above the county level shall, in a period of 6 months from the date of enforcement of this way, in accordance with the measures to carry out the work of maintenance therapy have institutions within its jurisdiction for the review. In conformity with the provisions, be approved by the provincial family planning administrative department of public health for its treatment institutions, at the same time to inform the public security organs at the same level. Shall be ordered to make rectification within a time limit to is not in conformity with the provisions, and the rectification after the expiry of the review. Still not qualified, revoke the qualifications to carry out the maintenance treatment institutions, and notify the public security organ at the same level.
Article 45 the measures apply only to maintenance treatment work, other drug treatment services for interim measures for the procedures for the control of medical services (health medical ZhengFa [2010] no. 2).
Article 46 in the present measures shall enter into force as of February 1, 2015. The abuse of opioid addicts community drug maintenance treatment program (who CDC hair [2006] no. 256) shall be repealed simultaneously.