22 Licensed Pharmacist Examination "Regulations": 58 Summary of Pharmaceutical Affairs Management in Medical Institutions
1. A pharmaceutical affairs management and pharmacotherapy committee was established in hospitals above the second level, and its personnel consisted of pharmaceutical, clinical medicine, nursing, infection management and administrative posts with senior titles. The organization is an internal advisory body, not an administrative department or a permanent institution.
2. The responsibilities of the Pharmaceutical Affairs Management Committee of medical institutions include:
(1) Implementing relevant laws, regulations and rules on medical and health care and pharmaceutical affairs management;
(2) Promote the formulation and implementation of clinical diagnosis and treatment guidelines related to drug therapy and guiding principles for clinical application of drugs, monitor and evaluate the drug use in this institution, propose intervention and improvement measures, and guide clinical rational drug use;
(3) Formulating the drug formulary and the basic drug supply catalogue of this institution;
(4) To examine and formulate the rules and regulations on pharmaceutical affairs management and pharmaceutical work of this institution, and supervise their implementation;
(5) Analyze and evaluate drug use risks, adverse drug reactions and drug damage events, and provide advice and guidance;
(6) Educate and train medical staff on laws, regulations, rules and regulations on pharmaceutical affairs management and knowledge of rational drug use;
(7) Supervise and guide the clinical use and standardized management of narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs;
(8) Establish a drug selection system, review the newly purchased drugs, adjust drug varieties or supply enterprises and declare hospital preparations applied by clinical departments of this institution;
(9) Publicize the knowledge of safe drug use to the public.
3. When setting up the pharmacy department, the tertiary hospital should set up the pharmacy department (the secondary department can be set up according to the actual situation); Second-level hospitals set up pharmacy departments; Other medical institutions set up pharmacies.
4. The person in charge of the pharmacy department of a hospital above the second level requires a senior professional title plus a bachelor's degree in pharmacy or clinical pharmacy; Other medical institutions require pharmacists to have professional titles and college degrees.
5. Hospital pharmacists are mainly responsible for prescription review, preparation, adverse reaction monitoring, clinical medication and other specific duties.
6. among the relevant records of medical institutions, what are the acceptance records, purchase records, purchase and sale records and sales vouchers? Save it for more than 1 year, but not less than 3 years; The retention period of bills for purchasing drugs shall not be less than 3 years; Copies of documents related to the first drug purchase shall be kept for not less than 5 years.
7. Hospitals with large clinical dosage and high amount of money and produced by many enterprises purchase drugs by public bidding.
8. The exclusive and patented pharmaceutical hospitals adopt the procurement method of price negotiation.
9. For drugs with small clinical dosage and commonly used low prices, hospitals directly purchase them online.
1. Fixed-point production is adopted for medicines in short supply.
11. Free drugs for anesthesia, psychotropic drugs and prevention of infectious diseases are purchased by hospitals according to regulations.
12. Prescription includes preface, text and postscript.
13. Prescription Preface (patient information) includes: name of medical institution, patient's name, age, gender, outpatient or inpatient medical record number, department or ward, bed number and clinical diagnosis. The prescription of narcotic drugs and refined drugs also includes the patient's ID number, the agent's name and ID number.
14. Prescription text (beginning with Rp or R, drug information) includes: drug name, dosage form, specification, quantity, usage and dosage.
15. Postscript (signature and seal) of prescription includes: signature or special seal of doctor or pharmacist, drug amount, audit, preparation, check and signature of personnel.
16. Prescription color: light green? Pediatrics, marked in the upper right corner? Pediatrics? ; Light yellow? Emergency, marked in the upper right corner? Emergency? ; Pale red Ma and Jing Yi, marked in the upper right corner? Ma, Jing Yi? ; White? Jingji, marked in the upper right corner? Jingji? .
17. Western medicine and traditional Chinese medicine can be prescribed together or separately, and each prescription shall not exceed 5 drugs.
18. Chinese herbal pieces must be prescribed separately.
19. The names of drugs in prescriptions should be written in standardized Chinese names. If there is no Chinese name, it can be written in standardized English names.
2. Medical institutions, doctors and pharmacists in prescriptions are not allowed to compile their own abbreviated names or use codes.
21. The usage of drugs in a prescription can be written in standard Chinese, English, Latin or abbreviations, but there must be no? Follow the doctor's advice? 、? For personal use? Words such as.
22. Write the date, month age and weight of newborns and infants in the prescription if necessary.
23. Acquisition of prescription right: (1) Medical practitioners obtain it in medical institutions where they practice; (2) The assistant practicing physician is valid after being signed or sealed by the practicing physician, and villages and towns can independently engage in general practice activities; (3) It is valid after the probation period personnel are examined and signed by the medical practitioners; (4) The refresher doctors are effective after filing.
24. A medical practitioner or pharmacist is qualified to prescribe or dispense narcotic and psychotropic drugs after passing the training and examination in this medical institution; Doctors are not allowed to prescribe such drugs for themselves.
25. Prescription limit: (1) General and refined prescriptions: each prescription does not exceed 7 daily dosage; (2) Emergency prescription: no more than 3 daily dosage (3) Anesthesia and Essence I: ① Ordinary patients: once (injection), 3 daily dosage (other dosage forms) and 7 daily dosage (controlled and sustained release preparation); ② Pain patients: 3 daily dosage (injection), 7 daily dosage (other dosage forms) and 15 daily dosage (controlled and sustained release preparation); (4) Inpatients will be prescribed daily, and the daily dosage of each prescription is 1; (5) Special drugs: ① Pethidine is commonly used at one time (only used in medical institutions); (2) the usual dosage of dihydroetorphine (used in medical institutions above the second level); ③ The daily dosage of methylphenidate should not exceed 15.
26. Prescription review includes legality review, normative review and suitability review.
27. Basic requirements for prescription review: (1) Pharmacists are the first person responsible for prescription review. Pharmacists or other pharmaceutical technicians who have been qualified according to law should check prescriptions, and the drugs listed in prescriptions should not be changed or substituted without authorization; (2) The prescription with incompatibility or overdose shall be refused to be prepared; When necessary, it can be prepared only after being corrected or re-signed by the prescriber.
28. The prescription legality review includes: (1) whether the prescription issuer has obtained the qualification of a doctor and registered for practice; (2) Whether the prescriber obtained the prescription right at the place of practice when prescribing; (3) Whether the prescriptions of narcotic drugs, psychotropic drugs of category I, toxic drugs for medical use, radioactive drugs, antibacterial drugs and other drugs are prescribed by doctors with corresponding prescription rights.
29. Prescription suitability audit includes: (1) Western medicine and Chinese traditional medicine prescriptions, and audit items: (1) drugs that must undergo skin test, whether the prescriber indicates the allergy test and the judgment of the results; ② Whether the prescription medication is consistent with the diagnosis; (3) whether there is repeated drug administration and interaction; ④ Whether the dosage form and route of administration are suitable; (5) the correctness of dosage and usage, and whether the total amount of a single prescription meets the requirements; ⑥ Whether there are compatibility taboos; ⑦ Whether there are any contraindications to medication; ⑧ Whether the drug administration speed of intravenous infusion is appropriate; (2) Chinese herbal pieces, review whether the fine pieces of poison hemp are prescribed according to regulations.
3. Four checks and ten pairs: (1) Investigator: subject, name and age; (2) Check drugs: check the drug name, dosage form, specification and quantity; (3) Check the incompatibility: the drug properties, usage and dosage; (4) Check the rationality of medication: for clinical diagnosis.
31. The storage period of general, emergency and pediatric prescriptions is 1 year; The storage period of prescriptions for toxic drugs and psychotropic drugs of category II is 2 years; The prescription of narcotic drugs and psychotropic drugs of category I shall be kept for 3 years; Retail pharmacy prescriptions must be kept for more than 2 years for future reference.
32. The special books of narcotic drugs and psychotropic drugs shall be kept for 3 years.
33. Preparations of medical institutions are fixed prescription preparations prepared by medical institutions for their own use upon approval according to the clinical needs of their own units. Preparations prepared by medical institutions should be varieties that are not available in the market.
34. Preparations in medical institutions have the following characteristics: ① Double-certificate management; ② Hospital-based self-use; (3) variety filling; ④ Self-preparation in pharmacy department; ⑤ The quality inspection is qualified.
35. Preparations of medical institutions must be examined and approved by the local provincial health administrative department; Approved by the provincial drug administration, qualified, issued a "medical institution preparation license".
36. The validity period of the Pharmaceutical Preparation License for Medical Institutions is 5 years, and the medical institution shall apply for renewal six months before the expiration of the license.
37. Changes in the Pharmaceutical Preparation License for Medical Institutions can be divided into changes in licensing items and changes in registered items. 38. Change of licensing items: change of the person in charge of the preparation room, preparation address and preparation scope.
39. Changes in registered items: changes in the name, category, legal representative and registered address of medical institutions.
4. The procedure for changing the licensing matters is to submit the change to the original issuing authority 3 days in advance, and make a decision within 15 days.
41. Supplementary application for preparations of medical institutions: Supplementary application shall be made when the process, prescription, preparation place and entrusted preparation unit of preparations are changed.
42. Non-declarable varieties of pharmaceutical preparations in medical institutions include: (1) varieties already available in the market; (2) toxic drugs and radioactive drugs for medical use; (3) A compound preparation consisting of traditional Chinese medicine and chemical medicine; (4) traditional Chinese medicine injection; (5) Biological products other than allergens; (6) Varieties containing active ingredients that have not been approved by the State Drug Administration; (7) other preparations that do not meet the relevant provisions of the state.
43. For narcotic drugs and psychotropic drugs that are clinically needed but not available in the market, if a medical institution with a seal card of a medical institution preparation license needs to prepare preparations, it shall be approved by the local provincial drug administration.
44. The validity period of the preparation registration documents of medical institutions is 3 years. If the preparation needs to be continued after the expiration of the validity period, the applicant shall apply for re-registration according to the original application preparation procedure 3 months before the expiration of the validity period; Approval number: X pharmaceutical system word H)Z(+4-digit year number +4-digit serial number.
45. Generally, the preparations of medical institutions are only used in hospitals. When there is a disaster, epidemic, emergency or urgent clinical need and there is no supply in the market, they can be adjusted and used within the prescribed time limit, quantity and scope; Intra-provincial transfers must be approved by the provincial drug administration, and inter-provincial transfers must be approved by the State Drug Administration.
46. The person in charge of the preparation room and drug testing room of a medical institution shall be an on-the-job pharmaceutical professional of the unit, and the person in charge of the preparation room and drug testing room shall not concurrently serve each other.
47. Antibacterials are suitable for bacteria, chlamydia, mycoplasma, rickettsia, spirochetes and fungi, but not for tuberculosis, parasitic diseases and various virus infections.
48. Clinical application principles of antibacterial drugs: safe, effective and economical.
49. Unrestricted use level refers to antibacterial drugs that are proved to be safe and effective in clinical application, have little impact on bacterial drug resistance, and have relatively low prices; Physicians with junior professional titles, who prevent, localize and mildly infect, report the clinical application once a year.
5. Restricted use level refers to antibacterial drugs that are proved to be safe and effective in clinical application, have a great impact on bacterial drug resistance, or have a relatively high price; Physicians with intermediate titles, complicated and severe infections, report the clinical application once every six months;
51. Special use grade refers to antibacterial drugs that have obvious or serious adverse reactions and should not be used at will; It is necessary to strictly control its use to prevent bacteria from producing drug-resistant antibacterial drugs too quickly; Antibacterials with less clinical data on efficacy and safety; Expensive antibacterial drugs; Physicians with senior titles shall not be used in outpatient service or after consultation, and report the clinical application once every six months.
52. Make the catalogue of this institution according to the catalogue of antibacterial drugs made by the provincial health administrative department; Adjusted once every 2 years, with a minimum of 1 year, and reported to the health administrative department that issued the License of Medical Institution for the record within 15 days after the catalogue adjustment.
53. In the list of antibacterial drugs, primary medical and health institutions can only choose the varieties of essential drugs.
54. Antimicrobial drug selection and introduction system: (1) The selection and new introduction of antimicrobial drugs by medical institutions shall be reviewed by the working group on antimicrobial drug management after the application report is submitted by the clinical department and put forward by the pharmaceutical department; (2) More than two-thirds of the members of the Working Group on Antimicrobial Drug Management agreed to review it, and it can only be included in the procurement and supply catalogue after being reviewed and approved by more than two-thirds of the members of the Pharmaceutical Administration and Pharmacotherapy Committee.
55. Antimicrobial drug return and replacement system: (1) The return proposal shall be implemented after being approved by more than half of the members of the Working Group on Antimicrobial Drug Management, and reported to the Pharmaceutical Administration and Pharmacotherapeutics Committee for the record, and the replacement proposal shall be implemented after being discussed and approved by the Pharmaceutical Administration and Pharmacotherapeutics Committee; (2) In principle, the varieties or specifications of antibacterial drugs that have been retired or replaced cannot re-enter the supply catalogue of antibacterial drugs in this institution within 12 months.
56. In case of leapfrog use of antibacterial drugs, the procedures related to leapfrog use of antibacterial drugs shall be completed within 24 hours; The prescription amount of special grade antibacterial drugs should not exceed 1 day's dosage.
57. Village health centers, clinics and community health service stations shall be approved by the health administrative department at the county level to carry out intravenous infusion activities with antibacterial drugs.
58. Antibacterial drug resistance rate and measures: (1) For antibacterial drugs with a drug resistance rate of more than 3% of the main target bacteria, the early warning information shall be notified to the medical staff of this institution in time; (2) Antibacterials with a drug resistance rate of more than 4% of the main target bacteria should be used with caution; (3) Antimicrobials with a drug resistance rate of more than 5% of the main target bacteria should be selected according to the results of drug sensitivity test; (4) Antimicrobial drugs whose drug resistance rate exceeds 75% should be suspended.
The above is a summary of the Regulations of the Licensed Pharmacist Examination in 22: 58 pharmaceutical affairs management in medical institutions. In addition, Xiaobian has also compiled preparation materials such as the outline of the Licensed Pharmacist Examination in 22, high-frequency test sites over the years, and analysis of real questions over the years. Welcome to check and learn on this platform in time!
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