first
In order to standardize prescription management, improve prescription quality, promote rational drug use and ensure medical safety, these measures are formulated in accordance with the Medical Practitioners Law, Drug Administration Law, Regulations on the Administration of Medical Institutions, Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs and other relevant laws and regulations.
second
The term "prescription" as mentioned in the present Measures refers to the medical documents issued by registered medical practitioners and assistant medical practitioners (hereinafter referred to as doctors) for patients in their diagnosis and treatment activities, which are reviewed, deployed and checked by pharmaceutical professional and technical personnel (hereinafter referred to as pharmacists) who have obtained the qualifications for pharmaceutical professional and technical positions, and serve as the patient's medication certificate. Prescriptions include medical institution ward medication orders.
These Measures are applicable to medical institutions and their personnel related to prescription, dispensing and storage.
essay
The Ministry of Health is responsible for the supervision and management of prescription, dispensing and storage.
The local health administrative departments at or above the county level shall be responsible for the supervision and management of prescription, dispensing and storage within their respective administrative areas.
Article 4
Doctors should follow the principles of safety, effectiveness and economy when prescribing Yamatonokusushi.
Prescription drugs should be sold, formulated and used by doctors.
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Chapter II General Principles of Prescription Management
Article 5
Prescription standards (Annex 1) are uniformly stipulated by the Ministry of Health, and prescription formats are uniformly formulated by the health administrative departments of all provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as provincial health administrative departments), and prescriptions are printed by medical institutions according to the prescribed standards and formats.
Article 6
Prescription writing should abide by the following rules:
(a) the patient's general situation and clinical diagnosis are clearly and completely filled in, and are consistent with the medical records.
(two) each prescription is limited to one patient.
(3) The handwriting is clear and shall not be altered; If it is necessary to modify, it should be signed at the modification place and indicate the date of modification.
(4) A standardized Chinese name shall be used for the name of a drug; if there is no Chinese name, a standardized English name may be used; Yamatonokusushi, a medical institution or physician, shall not compile abbreviations or use codes by himself; The name, dosage, specification, usage and dosage of drugs should be accurate and standardized, and the usage of drugs can be written in standardized Chinese, English, Latin or abbreviations, but vague words such as "following doctor's advice" and "for personal use" should not be used.
(five) the patient's age should fill in the full age, the date and month age of the newborn and baby, and indicate the weight when necessary.
(six) western medicine and Chinese patent medicine can be prescribed separately, or a prescription, Chinese herbal pieces should be prescribed separately.
(seven) prescription of western medicine and Chinese patent medicine, each drug should be listed in a new line, each prescription shall not exceed 5 drugs.
(eight) the prescription of Chinese herbal pieces shall be written in the order of "monarch, minister, assistant and envoy"; The special requirements for dispensing and decocting drugs are indicated in the upper right of the drugs, and brackets are added, such as wrapping cloth, frying first, dropping later, etc. Where there are special requirements for the origin and processing of the decoction pieces, it shall be indicated before the name of the drug.
(9) The usage and dosage of drugs shall conform to the conventional usage and dosage specified in the drug instructions. In case of overdose under special circumstances, the reasons shall be indicated and re-signed.
(ten) except in special circumstances, the clinical diagnosis should be indicated.
(eleven) draw a diagonal line in the blank after the prescription is issued, indicating that the prescription is finished.
(12) The signature style and special seal of the prescriber shall be consistent with the sample style kept by the hospital pharmacy department for future reference, and shall not be changed at will, otherwise it shall be re-registered.
Article 7
Dosage and quantity of drugs are written in Arabic numerals. Dose should use legal dosage units: weight is in grams (g), milligrams (mg), micrograms (μg) and nanograms (ng); Capacity units are liters (L) and milliliters (mL); International unit (IU), unit (u); The unit of Chinese herbal pieces is gram (g).
Tablets, pills, capsules and granules are used as tablets, pills, granules and bags respectively; The solution is in rods and bottles; Ointment and cream are in the form of sticks and boxes; Injections are in sticks and bottles, and the content should be indicated; Chinese herbal pieces take dosage as the unit.
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Chapter III Acquisition of Limitation Rights
Article 8
Registered medical practitioners have obtained the corresponding prescription right at the practice place.
A prescription issued by a registered practicing assistant physician in a medical institution shall be valid only after the medical practitioner signs or affixes a special seal at the place where he practices.
Article 9
Registered practicing assistant doctors independently engage in general practice activities in medical institutions in townships, nationality townships, towns and villages, and can obtain corresponding prescription rights in registered practice places.
Article 10
Before prescribing, doctors should sign samples at registered medical institutions or put them on record with special signatures.
Article 11
Medical institutions shall, in accordance with the relevant provisions, train their medical practitioners in the knowledge and standardized management of narcotic drugs and psychotropic drugs. Medical practitioners have the right to prescribe narcotic drugs and psychotropic drugs of category I after passing the examination, and pharmacists are qualified to prepare narcotic drugs and psychotropic drugs of category I after passing the examination.
Doctors may prescribe narcotic drugs and psychotropic drugs of category I in this institution only after obtaining the right to prescribe, but they may not prescribe such drugs for themselves. Pharmacists can only prepare narcotic drugs and psychotropic drugs of category I in this institution after they have obtained the qualification of narcotic drugs and psychotropic drugs of category I.
Article 12
The prescription issued by the executive outside prison shall be examined by the medical practitioner who has the right to prescribe in the medical institution, and it shall be valid only after being signed or stamped with a special seal.
Article 13
Doctors receiving advanced studies are granted the corresponding prescription right after the actual situation of their professional working ability is confirmed by the medical institutions receiving advanced studies.
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Chapter IV Prescription Making
Article 14
Doctors should prescribe drugs according to the medical treatment, prevention, health care needs, indications, pharmacological effects, usage, dosage, contraindications, adverse reactions and precautions in the diagnosis and treatment specifications and drug instructions.
The prescriptions of toxic drugs and radioactive drugs for medical use shall strictly abide by the provisions of relevant laws, regulations and rules.
Article 15
Medical institutions shall formulate drug formularies according to their nature, functions and tasks.
Article 16
Medical institutions shall purchase drugs in accordance with the general name of drugs approved and published by the drug supervision and administration department. There shall be no more than two drugs with the same generic name, injection form and oral dosage form, and the prescription shall consist of 1 ~ 2 similar compound preparations. However, drugs with other dosage forms and dosage specifications need to be used for special diagnosis and treatment.
Article 17
When making prescriptions, doctors should use the generic names of drugs, the names of patented drugs with new active compounds and the names of compound preparations approved and published by the pharmaceutical supervisory and administrative departments.
Doctors should use the name approved by the provincial health administrative department and the drug supervision and administration department when prescribing hospital preparations.
Doctors can use the customary names of drugs published by the Ministry of Health to make prescriptions.
Article 18
The prescription is valid on the date of issuance. If it is necessary to extend the validity period under special circumstances, the prescriber shall indicate the validity period, but the longest validity period shall not exceed 3 days.
Article 19
Prescription shall generally not exceed 7 days; Emergency prescription shall generally not exceed 3 days; For some chronic diseases, senile diseases or special circumstances, the prescription dose may be appropriately extended, but the doctor should indicate the reasons.
Prescription doses of toxic drugs and radioactive drugs for medical use should be strictly implemented in accordance with relevant state regulations.
Article 20
Doctors should prescribe narcotic drugs and psychotropic drugs of Category I in accordance with the Guiding Principles for Clinical Application of Narcotic Drugs and Psychotropic Drugs formulated by the Ministry of Health.
Article 21
If patients with cancer pain and patients with moderate or severe chronic pain need to use narcotic drugs and psychotropic drugs of Category I for a long time, the first-time physician shall personally examine the patients, establish corresponding medical records and require them to sign informed consent.
Copies of the following materials shall be kept in the medical records:
(1) A diagnosis certificate issued by a hospital above Grade II;
(2) the patient's household registration book, ID card or other relevant valid identification documents;
(three) the identity certificate of the patient's agent.
Article 22
Except for patients with cancer pain and patients with moderate and severe chronic pain who need to use narcotic drugs and psychotropic drugs of category I for a long time, narcotic drug injections are only used in medical institutions.
Article 23
Narcotic injection used by outpatient (emergency) patients, each prescription is a common dose; Controlled-release and sustained-release preparations, each prescription shall not exceed 7 days; For other dosage forms, each prescription shall not exceed 3 days.
Psychotropic drug injections of category I, each prescription is a common dose; Controlled-release and sustained-release preparations, each prescription shall not exceed 7 days; For other dosage forms, each prescription shall not exceed 3 days. When methylphenidate is used to treat ADHD in children, each prescription should not exceed the daily dose of 15.
Psychotropic drugs of category II shall generally not exceed the dose of 7 days per prescription; For patients with chronic diseases or some special circumstances, the prescribed dose can be appropriately extended, and the doctor should explain the reasons.
Article 24
For outpatients with cancer pain (emergency) and patients with moderate and severe chronic pain, each prescription shall not exceed 3 doses per day; Controlled-release preparation, each prescription shall not exceed 15 daily dose; For other dosage forms, each prescription shall not exceed 7 days.
Article 25
Inpatients' prescriptions for narcotic drugs and psychotropic drugs of category I are issued daily, and the daily dosage of each prescription is 1.
Article 26
For narcotic drugs that need special control, the prescription of dihydroetorphine hydrochloride is a common dose, which is limited to hospitals above the second level; The prescription of pethidine hydrochloride is a common dose, which is only used in medical institutions.
Article 27
Medical institutions should require cancer patients and patients with moderate and severe chronic pain who have used narcotic drugs and psychotropic drugs of category I for a long time to make a follow-up visit every three months.
Article 28
When doctors use computers to draw up and transmit commonly used prescriptions, they should also print out paper prescriptions in the same format as handwritten prescriptions. The printed paper prescription is valid after being signed or sealed. When pharmacists distribute drugs, they should check the printed paper prescriptions and distribute them to drugs after they are correct, and keep the printed paper prescriptions and computer-transmitted prescriptions for future reference.
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Chapter V Prescription Adjustment
Article 29
Only those who have obtained the qualifications for professional and technical positions in pharmacy can engage in prescription dispensing.
Article 30
Pharmacists have obtained the qualification of prescription dispensing in licensed medical institutions. The pharmacist's signature or special signature pattern shall be kept in this institution for future reference.
Article 31
Personnel with professional and technical post qualifications above pharmacists are responsible for prescription review, evaluation, verification, drug distribution and guidance on safe drug use; Pharmacists are engaged in prescription preparation.
Article 32
Pharmacists should fill the medicine according to the doctor's prescription, but not without the doctor's prescription.
Article 33
Pharmacists should adjust prescription drugs according to the operating rules: carefully examine prescriptions, accurately allocate drugs, correctly write medicine bags or paste labels, and indicate patients' names, drug names, usage and dosage, and packaging; When delivering drugs to patients, the medication should be explained and guided according to the drug instructions or prescriptions, including the usage, dosage and precautions of each drug.
Article 34
Pharmacists should carefully check whether the preface, text and postscript of the prescription are clear and complete, and confirm the legality of the prescription.
Article 35
Pharmacists should review the suitability of prescription drugs, including:
(1) For drugs that must undergo skin test, whether the prescription indicates the allergy test and result judgment;
(2) Consistency between prescription medication and clinical diagnosis;
(3) the correctness of dosage and usage;
(four) the rationality of the choice of dosage form and route of administration;
(five) whether there is a phenomenon of repeated administration;
(6) Whether there are potential clinical drug interactions and incompatibility;
(seven) other inappropriate drugs.
Article 36
After reviewing the prescription, the pharmacist should inform the prescriber and ask him to confirm or reissue the prescription if he thinks that the drug is improper.
Pharmacists who find serious irrational drug use or drug use errors shall refuse to adjust, inform the prescriber in time, and record and report in accordance with relevant regulations.
Article 37
Pharmacists must make "four checks and ten pairs" when dispensing prescriptions: investigator, subject, name and age; Check drugs, drug names, dosage forms, specifications and quantities; Look up the contraindications of compatibility and discuss the characteristics, usage and dosage of drugs; Check the rationality of clinical diagnosis medication.
Article 38
After dispensing, the pharmacist shall sign or affix a special seal to the prescription.
Article 39
Pharmacists shall compile the numbers of narcotic drugs and psychotropic drugs of category I daily.
Article 40
Pharmacists may not adjust prescriptions that are not standardized or whose legality cannot be judged.
Article 41
Medical institutions shall inform patients of the relevant information of similar drugs in the basic drug supply catalogue of their own institutions.
Article 42
Except narcotic drugs, psychotropic drugs, toxic drugs for medical use and pediatric prescriptions, medical institutions shall not restrict outpatients from purchasing drugs from pharmaceutical retail enterprises by prescription.
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Chapter VI Supervision and Administration
Article 43
Medical institutions should strengthen the management of prescription, dispensing and storage of their own institutions.
Article 44
Medical institutions shall establish a prescription review system, fill in a prescription evaluation form (Annex 2), implement dynamic prescription monitoring and abnormal early warning, register and notify unreasonable prescriptions, and timely intervene irrational drug use.
Article 45
Medical institutions should give warnings to doctors who have prescribed prescriptions for more than three times without justifiable reasons, and limit their prescription rights; After the prescription right is restricted, if there are still more than two consecutive abnormal prescriptions without justifiable reasons, the prescription right shall be revoked.
Article 46
In any of the following circumstances, the medical institution to which the doctor belongs shall cancel the prescription right:
(a) was ordered to suspend practice;
(two) during the training period, the examination failed to leave the post;
(3) The practice certificate has been cancelled or revoked;
(four) not in accordance with the provisions of the prescription, causing serious consequences;
(five) do not use drugs in accordance with the provisions, causing serious consequences;
(6) Seeking personal gain by prescription.
Article 47
Persons who have not obtained the right to prescribe and doctors whose right to prescribe has been revoked shall not prescribe. Doctors who have not obtained the qualification to prescribe narcotic drugs and psychotropic drugs of category I shall not prescribe narcotic drugs and psychotropic drugs of category I.
Article 48
Except for the needs of treatment, doctors may not prescribe narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs.
Article 49
Personnel who have not obtained the qualifications for professional and technical positions in pharmacy shall not engage in prescription dispensing.
Article 50
Medical institutions that allocate prescription drugs shall properly keep prescriptions. The storage period of common prescriptions, emergency prescriptions and pediatric prescriptions is 1 year, the storage period of toxic drugs for medical use and psychotropic drugs of category II is 2 years, and the storage period of narcotic drugs and psychotropic drugs of category I is 3 years.
After the expiration of the prescription storage period, it can be destroyed only after it is approved and registered by the main person in charge of the medical institution.
Article 51
Medical institutions shall, according to the prescriptions of narcotic drugs and psychotropic drugs, register their dosage in special account books according to the varieties and specifications of narcotic drugs and psychotropic drugs, including the date of administration, the name of patients, the number of drugs used, etc. The special volume shall be kept for 3 years.
Article 52
Local health administrative departments at or above the county level shall regularly supervise and inspect the prescription management of medical institutions within their respective administrative areas.
In the process of supervision and management of medical institutions, the health administrative departments at or above the county level shall order medical institutions to cancel the prescription right of doctors if they find that doctors have the circumstances stipulated in Article 46 of these Measures.
Article 53
The staff of the administrative department of health shall show their certificates when supervising and inspecting the prescription management of medical institutions according to law; The medical institution under inspection shall cooperate, truthfully reflect the situation and provide necessary information, and shall not refuse, obstruct or conceal it.
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Chapter VII Legal Liability
Article 54
If a medical institution is under any of the following circumstances, the health administrative department at or above the county level shall, in accordance with the provisions of Article 48 of the Regulations on the Administration of Medical Institutions, order it to make corrections within a time limit and may impose a fine of not more than 5,000 yuan; If the circumstances are serious, the Practice License of Medical Institution shall be revoked:
(1) using the prescription of a person who has not obtained the prescription right or a doctor whose prescription right has been revoked;
(2) prescribing narcotic drugs and psychotropic drugs of category I by using a doctor who has not obtained the qualification for prescribing narcotic drugs and psychotropic drugs of category I;
(three) the use of personnel who have not obtained the qualifications of pharmaceutical professional and technical positions to engage in prescription dispensing work.
Article 55
Medical institutions fail to keep prescriptions of narcotic drugs and psychotropic drugs in accordance with the provisions, or fail to register special account books in accordance with the provisions. According to the provisions of Article 72 of the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs, the municipal health administrative department with districts shall order it to make corrections within a time limit and give it a warning; If no correction is made within the time limit, a fine of more than 5,000 yuan 1 10,000 yuan shall be imposed; If the circumstances are serious, its signature card shall be revoked; The directly responsible person in charge and other directly responsible personnel shall be punished by demotion, dismissal and expulsion according to law.
Article 56
Doctors in any of the following circumstances shall be punished by the health administrative department at or above the county level in accordance with the provisions of Article 73 of the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs:
(1) Doctors who have not obtained the qualification for prescribing narcotic drugs and psychotropic drugs of category I prescribe narcotic drugs and psychotropic drugs of category I without authorization;
(2) Doctors who hold prescriptions for narcotic drugs and psychotropic drugs of category I fail to prescribe narcotic drugs and psychotropic drugs of category I in accordance with regulations, or use narcotic drugs and psychotropic drugs of category I in accordance with the Guiding Principles for Clinical Application of Narcotic Drugs and Psychotropic Drugs formulated by the Ministry of Health;
(three) the pharmacist fails to adjust the prescription of narcotic drugs and psychotropic drugs according to the regulations.
Article 57
Under any of the following circumstances, the administrative department of health at or above the county level shall, in accordance with the provisions of Article 37 of the Law on Medical Practitioners, give a warning or order it to suspend its practice for more than six months but less than one year; If the circumstances are serious, his practice certificate shall be revoked:
(1) Prescribing drugs without obtaining the prescription right or after the prescription right is cancelled;
(two) failing to prescribe drugs in accordance with the provisions of these measures;
(three) in violation of other provisions of these measures.
Article 58
Pharmacists fail to adjust prescription drugs in accordance with the regulations, and if the circumstances are serious, the health administrative department at or above the county level shall order it to make corrections and give a warning, informed criticism; And disciplinary action shall be given by the medical institution or its superior unit.
Article 59
Where the local health administrative department at or above the county level fails to perform its supervisory duties in accordance with the provisions of these Measures, the health administrative department at a higher level shall order it to make corrections.
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Chapter VIII Supplementary Provisions
Article 60
According to the Regulations on the Management of Rural Doctors' Practice, rural doctors prescribe drugs within the scope of the list of essential drugs for rural doctors formulated by the provincial health administrative department.
Article 61
The term "pharmaceutical professional and technical personnel" as mentioned in these Measures refers to the personnel who have obtained the qualifications for pharmaceutical professional and technical positions in accordance with the Trial Regulations of the Ministry of Health, including chief pharmacists, deputy chief pharmacists, competent pharmacists, pharmacists and pharmacists.
Article 62
The term "medical institutions" as mentioned in these Measures refers to medical institutions such as hospitals, community health service centers (stations), maternal and child health centers, hospitals, sanatoriums, outpatient departments, clinics, clinics (stations), emergency centers (stations), specialized disease prevention hospitals (stations) and sanatoriums (stations) approved and registered in accordance with the Regulations on the Administration of Medical Institutions.
Article 63
These Measures shall come into force as of May 6, 2007. "Prescription Management Measures (Trial)" (No.269 [2004] of Wei Fa) and "Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs" (No.436 [2005] of Wei Fa) shall be abolished at the same time.