1. A pharmaceutical affairs management and drug treatment committee has been set up in hospitals above the second level, which is composed of personnel in pharmacy, 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) Implement the relevant laws, regulations and rules on medical and health care and pharmaceutical affairs management;
(2) to promote the formulation and implementation of clinical diagnosis and treatment guidelines and guiding principles for clinical application of drugs related to drug treatment, monitor and evaluate the drug use in this institution, put forward intervention and improvement measures, and guide clinical rational drug use;
(three) to formulate the drug prescription set and the basic drug supply catalogue of this institution;
(four) to examine and formulate the rules and regulations of pharmaceutical affairs management and pharmaceutical work of this institution, and supervise the implementation;
(5) Analyze and evaluate the risks of drug use, adverse drug reactions and drug damage events, and provide suggestions and guidance;
(six) to educate and train medical personnel in the laws, regulations and rules of pharmaceutical affairs management and the knowledge of rational drug use;
(seven) to 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 newly purchased drugs, adjust drug varieties or supply enterprises, and declare hospital preparations applied by clinical departments of this institution;
(9) to publicize the knowledge of safe drug use to the public.
3. When setting up pharmacy department in tertiary hospitals, pharmacy department should be set up (secondary departments can be set up according to actual conditions); 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, deployment, adverse reaction monitoring, clinical medication and other specific responsibilities.
6. In the relevant records of medical institutions, what are the acceptance records, purchase records, purchase and sale records and sales vouchers? Preservation 1 year or more, but not less than 3 years; The retention period of drug purchase documents 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. For drug hospitals with large clinical dosage and high amount and produced by many enterprises, public bidding and procurement shall be adopted.
8. For exclusive and patented drug hospitals, the procurement method of price negotiation shall be adopted.
9. For drugs with small clinical dosage and low common price, the hospital directly purchases them online.
10. Fixed-point production is adopted for medicines in short supply.
1 1. Anesthesia, psychotropic drugs and free drugs for preventing infectious diseases are purchased by the hospital according to regulations.
12. The prescription includes preface, text and postscript.
13. Preface of prescription (patient information) includes: name of medical institution, patient's name, age, sex, 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 name of the agent and the ID number.
14. Prescription text (beginning with Rp or R, drug information) includes: drug name, dosage form, specification, quantity, usage and dosage.
15. Prescription postscript (signature and seal) includes: signature or special seal of doctor or dispensing pharmacist, dosage, audit, deployment, verification and personnel signature.
16. Prescription color: light green? Pediatrics, marked in the upper right corner? Pediatrics? ; Light yellow? Emergency, marked in the upper right corner? An emergency? ; Pink horse, marked in the upper right corner? Horses, and? ; White? Jingji, marked in the upper right corner? Jingji? .
17. Western medicine and 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, you can write it in a standardized English name.
20. Yamatonokusushi, a medical institution and physician, shall not compile abbreviations or use codes by himself in the prescription.
2 1. The usage of drugs in prescriptions can be written in standardized Chinese, English, Latin or abbreviated forms, but not? Follow the doctor's advice? 、? For personal use? Words like that.
22. Write the date and month age of the newborn and baby on the prescription, and indicate the weight if necessary.
23. Acquisition of prescription right: (1) Medical practitioners obtain it in medical institutions; (2) The assistant practicing physician is valid after being signed or sealed by the practicing physician, and the township can independently engage in general practice activities; (3) Probation period personnel are valid after being examined and signed by medical practitioners; (4) The refresher doctors are effective after filing.
24 medical practitioners or pharmacists have passed the training and examination of this medical institution and obtained the qualification for prescription or deployment of narcotic drugs and psychotropic drugs; Doctors are not allowed to prescribe this medicine for themselves.
25. Prescription limit: (1) Ordinary and refined prescriptions: each prescription does not exceed 7 days; (2) Emergency prescription: no more than 3 days dose (3) Anesthesia and essence I: ① Ordinary patients: 1 time (injection), 3 days dose (other dosage forms), 7 days dose (controlled and sustained release preparation); ② Pain patients: 3-day dose (injection), 7-day dose (other dosage forms) and 15-day dose (controlled and sustained release preparation); (4) Inpatients prescribe drugs daily, and the daily dosage of each prescription is1; (5) Special drugs: ① Pethidine is commonly used once (only for medical institutions); (2) the usual dosage of dihydroetorphine (used by medical institutions above the second level); ③ The daily dose of methylphenidate should not exceed 15.
26. Prescription audit includes legality audit, normative audit and suitability audit.
27. Basic requirements for prescription review: (1) Pharmacist is the first responsible person for prescription review. Prescriptions shall be checked by pharmacists or other pharmaceutical technicians who have obtained qualifications according to law, and drugs listed in prescriptions shall not be changed or replaced without authorization; (2) Refusing to prepare prescriptions with incompatibility or overdose; 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 to practice; (2) Whether the prescriber obtained the prescription right at the place of practice at the time of prescription; (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 traditional Chinese medicine prescriptions, and audit items: ① drugs requiring 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 administration and interaction; ④ Whether the dosage form and route of administration are appropriate; (five) 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 contraindications for medication; 8 Whether the administration speed of intravenous infusion is appropriate; (2) Chinese herbal pieces, review whether the poison hemp tablets are prescribed according to regulations.
30. Four checks and ten pairs: (1) Investigator: subject, name, age; (2) Check drugs: check the name, dosage form, specification and quantity of drugs; (3) Check the incompatibility: the nature, usage and dosage of the drug; (4) Check the rationality of medication: it is used for clinical diagnosis.
3 1. The shelf life of general, emergency and pediatric prescriptions is 1 year; The shelf life of toxic drugs and psychotropic drugs of category II is 2 years; The prescriptions 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. Special volumes for narcotic drugs and psychotropic drugs shall be kept for 3 years.
33. Preparations of medical institutions refer to fixed prescription preparations prepared and used by medical institutions 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 pharmacy department prepares by itself; ⑤ Qualified in quality inspection.
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 five years, and medical institutions shall apply for renewal of the license six months before the expiration of the validity period.
37. Changes in the Pharmaceutical Preparation License for Medical Institutions can be divided into permitted items and registered items. 38. Changes in licensing matters: changes in the person in charge of the preparation room, the address of the preparation and the scope of the preparation.
39. Change of registered items: change of name, category, legal representative and registered address of medical institution.
40. The procedure for changing the licensing matters is to propose the change to the original issuing authority 30 days in advance, and make a decision within 15 days.
4 1. Supplementary application for preparations in medical institutions: When the preparation process, prescription, preparation place and entrusted preparation unit change, supplementary application shall be made.
42. Non-declared varieties of preparations in medical institutions include: (1) existing varieties 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; (six) varieties containing active ingredients that have not been approved by National Medical Products Administration; (seven) other preparations that do not meet the relevant provisions of the state.
43. For narcotic drugs and psychotropic drugs that are not available in the market for clinical needs, if a medical institution holding the seal card of the Preparation License for Medical Institutions needs to prepare preparations, it shall be approved by the local provincial drug supervision and administration department.
44. The validity period of the preparation registration documents of medical institutions is 3 years. If it is necessary to continue the preparation after the expiration of the validity period, the applicant shall apply for re-registration in accordance with the original preparation application procedure 3 months before the expiration of the validity period; Approval number: X drug series H)Z(+4-digit year number +4-digit serial number.
45. Preparations from general medical institutions are only used in hospitals. In case of disaster, epidemic, emergency or clinical emergency, when there is no supply in the market, it 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 National Medical Products Administration.
46. The person in charge of the preparation room and the 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 the 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 viral infections.
48. Clinical application principles of antibacterial drugs: safe, effective and economical.
49. Unrestricted use refers to antibacterial drugs that have been proved to be safe and effective in clinical application, have little effect on bacterial resistance, and have relatively low prices; Physicians with junior titles who prevent, limit and slightly infect should report their clinical application once a year.
50. Restricted use refers to antibacterial drugs that have been proved to be safe and effective in clinical application, have a great impact on bacterial resistance, or are relatively expensive; Intermediate title physician, complicated severe infection, report clinical application once every six months;
5 1. Special use level 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 effectiveness and safety; Expensive antibacterial drugs; Doctors with senior titles shall not be used for outpatient service or consultation, and report the clinical application once every six months.
52. According to the catalogue of antibacterial drugs formulated by the provincial health administrative department, formulate the catalogue of this institution; It shall be adjusted once every two years, with a minimum of 1 year, and shall be reported to the health administrative department that issued the License for Medical Institutions 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 basic drugs.
54. Antimicrobial drug selection and introduction system: (1) The application report for the selection of medical institutions and the new introduction of antimicrobial drugs shall be submitted by the clinical department, and the opinions of the pharmaceutical department shall be reviewed by the antimicrobial drug management working group; (2) More than two-thirds of the members of the Working Group on Antimicrobial Drug Management agree to review, and they 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 Drug Therapy Committee.
55. Antimicrobial drug discontinuation and replacement system: (1) The discontinuation plan 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 Drug Treatment Committee for the record, and the replacement plan shall be implemented after being discussed and approved by the Pharmaceutical Administration and Drug Treatment Committee; (2) In principle, the varieties or specifications of antibacterial drugs that have been discontinued or replaced cannot re-enter the supply catalogue of antibacterial drugs in this institution within 12 months.
56. If the leapfrog use of antibacterial drugs is involved, the relevant procedures for the leapfrog use of antibacterial drugs shall be completed within 24 hours; The prescription dose of super antibacterial drugs shall not exceed 1 day.
57 village clinics, clinics and community health service stations shall be approved by the health administrative department at the county level to carry out intravenous infusion of antibacterial drugs.
58. Antimicrobial drug resistance rate and measures: (1) Inform the medical staff of this institution of the early warning information for the antimicrobial drugs with the resistance rate of the main target bacteria exceeding 30%; (2) Antibacterials with a drug resistance rate of over 40% should be used with caution; (3) Antibacterials with drug resistance rate greater than 50% should be selected according to the results of drug sensitivity test; (4) Antibacterials with drug resistance rate over 75% should be stopped.
The above is the Regulation of 2020 Licensed Pharmacist Examination brought by Bian Xiao, a summary of 58 pharmaceutical affairs management in medical institutions. In addition, Bian Xiao also compiled the exam outline for licensed pharmacists in 2020, high-frequency test sites over the years, analysis of real questions over the years and other reference materials. Welcome to consult and study on this platform in time!
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