20 19 The high-frequency examination center of Pharmaceutical Affairs Management and Regulations for licensed pharmacists summarizes six moral requirements in the medical field.
First, the moral requirements in drug production.
1. Customer first, patient-centered.
2. Quality first, consciously abide by the norms.
3. Protect the environment and protect the health of drug producers.
4. Standardize packaging and publicize truthfully.
Second, the moral requirements in drug management
1. Be honest and trustworthy to ensure the quality of drugs.
2. Promotion according to law and integrity promotion.
3. Guide medication and provide pharmaceutical services.
Third, the moral requirements in hospital pharmacy work
1. Adjust carefully and explain patiently.
2. Keep improving and ensure quality.
3. Legal procurement and standardized medical care.
4. Safeguard the interests of patients and improve the quality of life.
Application and approval of imported medicinal materials
The applicant for importing medicinal materials shall be a pharmaceutical production enterprise or pharmaceutical trading enterprise that has obtained a Pharmaceutical Production License or a Pharmaceutical Trading License in China. Applications for importing medicinal materials include first-time applications for importing medicinal materials and non-first-time applications for importing medicinal materials. The first import application of medicinal materials includes the first import application of medicinal materials with legal standards and the first import application of medicinal materials without standards.
The State Food and Drug Administration of the United States conducts a formal review of the standardization and completeness of the application materials, and issues a notice of acceptance or rejection.
China Institute of Food and Drug Inspection completed the first quality standard review and sample inspection of imported medicinal materials, and submitted the inspection report and comments to the State Food and Drug Administration of the United States.
The State Food and Drug Administration of the United States shall conduct technical review and administrative review after receiving the inspection report and review opinions from China Food and Drug Inspection Institute. To meet the requirements, the "approval of imported medicinal materials" shall be issued; Do not meet the requirements, issued a "notice of examination opinions", and explain the reasons.
The application for non-first-time import of medicinal materials will not be reviewed by quality standards, but will be directly examined and approved by the State Food and Drug Administration.
20 19 requirements for drug mailing management in high-frequency test sites pharmaceutical affairs management and licensed pharmacist system ii
Requirements for mailing drugs:
For mailing narcotic drugs and psychotropic drugs, the sender shall submit a certificate of approval for mailing issued by the pharmaceutical supervisory and administrative department of the people's government of a province, autonomous region or municipality directly under the Central Government. Postal business institutions shall examine and keep the approved mailing vouchers; Postal institutions shall not accept and send mail without a transportation permit.
The competent postal departments of provinces, autonomous regions and municipalities directly under the Central Government shall designate postal institutions that meet the safety and security conditions to be responsible for receiving and sending narcotic drugs and psychotropic drugs. Postal business institutions shall inspect the narcotic drugs and psychotropic drugs received and sent according to law.
Specific measures for the administration of mailing narcotic drugs and psychotropic drugs shall be formulated by the drug supervision and administration department of the State Council in conjunction with the competent department of postal services of the State Council.
General provisions and prescription standards of prescription management
Prescription standards shall be uniformly stipulated by the Ministry of Health, and prescription formats shall be uniformly formulated by the health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as provincial health administrative departments), and prescriptions shall be printed by medical institutions in accordance with the prescribed standards and formats.
1. Prescription content
The preface includes the name of medical institution, fees, patient's name, gender, age, outpatient or inpatient medical record number, department or ward and bed number, clinical diagnosis, date of issuance, etc. Items with special requirements can be added.
The prescription of narcotic drugs and psychotropic drugs of category I shall also include the patient's identification number, the name of the agent and the identification number.
② Text: marked with Rp or R (abbreviation of Latin prescription "Please take it"), indicating the name, dosage form, specification, quantity, usage and dosage of the drug respectively.
③ Postscript: doctor's signature or special seal, drug amount, and pharmacist's signature or special seal for reviewing, preparing, checking and distributing drugs.
2. Prescription color
① The commonly used prescription printing paper is white.
② The emergency prescription printing paper is light yellow, and the words "emergency" are marked in the upper right corner.
③ Pediatric prescription printing paper is light green with "Pediatrics" in the upper right corner.
④ The paper for printing prescriptions of narcotic drugs and psychotropic drugs of category I is light red, and the words "Ma" are marked in the upper right corner.
⑤ The paper used for printing prescriptions of psychotropic drugs of category II is white, with "Jinger" marked in the upper right corner.
20 19 high-frequency test center of pharmaceutical affairs management and regulations for licensed pharmacists functions of the national drug supervision and administration department
According to the Provisions on the Main Responsibilities of the State Food and Drug Administration of the United States (Guo Ban Fa 2008 100), the State Food and Drug Administration (deputy ministerial level) is a national bureau managed by the Ministry of Health.
1. Formulate policies, plan and supervise the implementation of food safety supervision and management in the fields of drugs, medical devices, cosmetics and consumption, and participate in drafting relevant laws, regulations and departmental rules.
2 responsible for food hygiene license and food safety supervision and management in consumption.
3. Formulate and supervise the implementation of food safety management norms in the consumption field, carry out investigation and monitoring of food safety status in the consumption field, and release relevant information on food safety supervision in the consumption field.
4. Responsible for cosmetics hygiene license, hygiene supervision and management and cosmetics examination and approval.
5. To be responsible for the administrative supervision and technical supervision of drugs and medical devices, and to formulate quality management standards for the research, development, production, circulation and use of drugs and medical devices and supervise their implementation.
6. Be responsible for the registration, supervision and management of drugs and medical devices, formulate national standards for drugs and medical devices and supervise their implementation, organize the monitoring of adverse drug reactions and adverse events of medical devices, be responsible for the re-evaluation and elimination of drugs and medical devices, participate in the formulation of the national essential drug list, cooperate with relevant departments to implement the national essential drug system, and organize the implementation of the classified management system for prescription drugs and over-the-counter drugs.
7. Be responsible for formulating and organizing the implementation of the supervision and management norms of traditional Chinese medicine and ethnic medicine, formulating the quality standards of traditional Chinese medicine and ethnic medicine, organizing the formulation of the quality management norms of traditional Chinese medicine production, the local system of Chinese herbal pieces and supervising the implementation, and organizing the implementation of the variety protection system of traditional Chinese medicine.
8. Supervise and manage the quality and safety of drugs and medical devices, supervise and manage radioactive drugs, narcotic drugs, psychotropic drugs and psychotropic drugs, and release the quality and safety information of drugs and medical devices.
9. Organize to investigate and deal with illegal acts in the research and development, production, circulation and use of drugs, medical devices and cosmetics in the field of food safety and consumption.
10. Guide the supervision and management, emergency response, inspection and information construction of local food and drug-related aspects.
1 1. Formulate and improve the qualification access system for licensed pharmacists, and guide and supervise the registration of licensed pharmacists.
12. carry out international exchanges and cooperation related to food and drug supervision and management.
13. To undertake other tasks assigned by the State Council and the Ministry of Health.
20 19 pharmacist's high-frequency test site "pharmaceutical affairs management and regulations" 4 characteristics of drugs as special commodities
① Life relevance: Drugs are substances related to human life. This is the basic commodity characteristic of drugs.
② Quality: Only qualified products and unqualified products can be distinguished. Statutory national drug standards are the only basis for ensuring drug quality and distinguishing qualified and unqualified drugs.
(3) Public welfare: Drugs are commodities that prevent and treat diseases and safeguard people's health, and have the nature of social welfare. The social public welfare of drugs is also reflected in the government's pricing of drugs in the basic medical insurance drug list to ensure that people can buy high-quality and cheap drugs.
4 Strong professionalism: Another feature that distinguishes drugs from other commodities is strong professionalism.
⑤ Variety diversity: Variety is another difference between drugs and other commodities.
Nature and types of drug quality supervision and inspection
Drug supervision and inspection is different from production inspection and acceptance inspection in nature, and has the impartiality of third-party inspection, which represents the national inspection of the quality of drugs developed, produced, sold and used, and has higher authority than production or acceptance inspection; The inspection is carried out in accordance with national laws and regulations, and it has strong arbitration in law.
Type: random inspection, registration inspection, national inspection, entrusted inspection, import inspection and re-inspection.
1. Spot check is a drug inspection institution authorized by the drug supervision and administration department. According to the spot check plan of the drug supervision and administration department, the samples taken by the drug production, marketing and use units shall be inspected.
2. Registration inspection refers to the inspection when approving new drugs and copying existing national standard drug varieties, as well as the inspection required for approving imported drugs.
3. National inspection refers to the provisions of national laws or drug supervision departments that certain drugs must be inspected by designated government drug inspection agencies before they are sold. Pre-market inspection, compulsory inspection and batch inspection.
4. Entrusted inspection refers to the sample inspection involved by the administrative and judicial departments, and the drugs entrusted by pharmaceutical production enterprises, trading enterprises and medical institutions to the drug inspection institute because they do not have the inspection technology and inspection conditions belong to entrusted inspection and enterprise inspection.
5. Import inspection is the inspection of imported drugs. The state establishes port drug inspection offices to inspect imported drugs.
6. Re-inspection refers to the fact that drug sampling inspectors have objections to the inspection results of drug inspection institutions, and can apply for re-inspection to the original drug inspection institution or the drug inspection institution set up or determined by the drug supervision and administration department at the next higher level within the prescribed time limit. You can also apply for re-inspection directly to the drug inspection agency set up or determined by the drug supervision and administration department of the State Council. Re-inspection is to ensure the authenticity and accuracy of drug test results and protect the legitimate rights and interests of the parties.
20 19 statistical investigation and management of five drugs in high-frequency test sites for pharmaceutical affairs management-management norms for licensed pharmacists
Article 14 The statistical agency of China Food and Drug Administration shall formulate statistical standards such as the meaning, calculation method, classification, statistical coding and other statistical survey indicators related to food and drug supervision and management throughout the country.
Fifteenth food and drug supervision and management departments at all levels shall organize the statistical investigation of food and drug supervision and management according to law.
China Food and Drug Administration is responsible for uniformly formulating the statistical investigation items of national food and drug supervision and management and reporting them to the National Bureau of Statistics for filing or examination and approval.
Local food and drug supervision and management departments at all levels shall be responsible for uniformly formulating statistical investigation items of food and drug supervision and management in their respective administrative areas and reporting them to the statistical agencies of the people's governments at the same level for examination and approval or filing.
Article 16 The internal organs and directly affiliated units of food and drug supervision and administration departments at all levels shall apply for statistical investigation items according to the needs of their work, with sufficient reasons, clear purpose, data use scope, consistent with the functions of their own departments, clear division of labor with statistical investigation institutions of their own departments, mutual coordination and no overlapping.
The internal organs of food and drug supervision and management departments at all levels and their subordinate units shall formulate their own statistical investigation plans when conducting statistical investigations (including one-time investigations, regular investigations, general surveys, etc.). ), after being reported to the department statistical agency for examination and approval, it shall be organized and implemented by the internal organization or subordinate unit. After the investigation is completed, the relevant statistical data and reports shall be filed with the statistical agencies of the department in a timely manner.
Subject and scope of adverse drug reaction report
Statutory reporting subjects: pharmaceutical production enterprises (including overseas pharmaceutical production enterprises importing drugs), commercial enterprises and medical institutions are the statutory reporting subjects of China's adverse drug reaction reporting system.
The scope of ADR reports in China is: domestic drugs during the monitoring period of new drugs or imported drugs approved for import for the first time in five years, and all ADR reports are made; Other domestic drugs and imported drugs allowed to be imported for more than 5 years for the first time reported new serious adverse reactions.
20 19 national drug policy and essential drugs, the high-frequency test site of pharmaceutical affairs management and regulations for licensed pharmacists
(1) objectives and contents of the national drug policy:
① Rational drug use.
(2) Ensure the provision of safe, effective and high-quality drugs to the public.
③ Availability of essential drugs.
Contents of national drug policy:
Essential drugs, reasonable prices, financial support, supply system, quality assurance and rational drug use.
(2) Formulating the selection principles and purposes of the list of essential drugs.
Selection principle: clinical necessity, safety and effectiveness, reasonable price, convenient use, and equal emphasis on Chinese and western medicine.
National essential drugs: refers to drugs that can meet the people's priority medical care needs and have a limited number after careful screening according to certain selection principles.
The purpose of formulating the list of essential drugs: The purpose of formulating the national essential drugs policy is to strengthen the scientific management and macro-control of drug research, production, management, use and supervision, rationally allocate resources, and ensure public health requirements. Make the essential drug policy give full play to its due functions: ① to protect the health of the whole people; ② Standardize and rationally use drugs; ② Promoting the reform of medical insurance system; ④ Correctly guide drug research and development.
Food for special medical use
Nutrition categories are divided into three categories:
Total nutrition formula food: formula food for special medical use that can be used as a single nutrition source to meet the nutritional needs of the target population;
Specific total nutrition formula food: formula food for special medical use that can be used as a single nutrition source to meet the nutritional needs of the target population under specific diseases or medical conditions;
Non-total nutrition formula food: formula food that can meet part of the nutritional needs of the target population and is not suitable for special medical use as a single nutritional source.
Classification of routes of administration:
Enteral nutrition is a nutritional support way to provide nutrients and other nutrients needed for metabolism through gastrointestinal tract. It depends on the length of time, mental state and gastrointestinal function. There are two ways of enteral nutrition: oral and catheter infusion.
Parenteral nutrition: intravenous diet (including central vein and peripheral vein nutrition).