Jinan City, the use of drugs in medical institutions management measures

Article 1 In order to strengthen the supervision and management of the use of medicines in medical institutions, to ensure the quality of medicines, to ensure the safety and effectiveness of people's medicines, according to the "People's Republic of China *** and the State Drug Administration Law" and other relevant laws and regulations, combined with the actual situation in the city, the formulation of these measures. Article 2 Where in the administrative area of the city engaged in social medical services at all levels and types (including institutions, troops, enterprises, institutions, social organizations) and their branches of medical institutions, medical collaboration consortiums and individual practitioners (hereinafter referred to as medical institutions) in the use of medicines in the medical business are applicable to this approach. Article III city, county (city) health administrative department in charge of the jurisdiction of the use of drugs in medical institutions supervision and management. Article IV of the medical institutions in the use of drugs in the medical business must have the following conditions:

(a) hold a "medical institutions registration certificate" or "medical institutions license";

(b) with the medical business with pharmacy titles of pharmacy technicians or by the municipal (including municipal) above the health administrative department of the pharmacy technical assessment from the staff of the drug:

(3) with the medical business in line with the provisions of the medicine cabinet, pharmacy and storage, dispensing, processing and concocting medicines necessary equipment and measuring instruments;

(4) have a sound and perfect procurement, storage, use of drugs regulations. Article V of the counties (cities) medical institutions to use the application of drugs by the county (city) health administrative department for approval; the district medical institutions to use the application of drugs by the district health administrative department for approval after the initial examination of the municipal health administrative department. Medical institutions approved and receive a "license to use drugs," before the use of drugs in medical practice. Article VI of the medical institutions of the "drug license" by the city, county (city) health administrative department once a year. Without the "drug license", is not allowed to use drugs in medical practice. Article VII of the medical institutions employed by the departed, retired and leave without pay pharmacy technicians must be examined by the municipal health administrative department, to receive "from the drug qualification certificate", before engaging in pharmacy technology. Article VIII of the medical institutions in direct contact with the drugs of the personnel, must be a yearly health checkup. Personnel suffering from infectious diseases or other diseases that may contaminate medicines shall not engage in direct contact with medicines. Article 9 Medical institutions should purchase medicines from the national pharmaceutical supply units at all levels as the main channel of purchase, and it is strictly prohibited to purchase medicines from the units without the "Drug Business Enterprise License" and from private drug dealers. It is strictly forbidden to purchase medicines without approval numbers, registered trademarks or brand names, and it is strictly forbidden to purchase counterfeit or substandard medicines. Article 10 The pharmacy of the medical institutions should be fully closed and isolated, must be hygienic and clean, the positioning of the drugs placed, marked conspicuously, and shall not be mixed with veterinary drugs, sanitation pesticides, rodenticides, disinfectants, chemical reagents and other non-drugs. Article XI of the medical institutions must receive "preparation license", and according to the clinical needs of the preparation. Medical institutions should be prepared in accordance with the provisions of the preparation of quality inspection, qualified, with a doctor's prescription for use, and shall not be sold in the market.

No "preparation license" of the medical unit shall not process their own preparations, formulations with special therapeutic effects, confirmed by the municipal health administrative department, designated by the conditions of the pharmaceutical institutions to process on behalf of the qualified test can only be used in the clinic. Article XII of the medical institutions should be regular inventory of drugs, inspection, to prevent backlogs, precipitation and discoloration, labeling fuzzy, expired, deterioration and expiration of drugs, should immediately stop using. Article 13 Medical institutions shall rationalize the use of medicines in medical practice, shall not prescribe large prescriptions, shall not sell medicines to non-attending patients, shall not distribute non-pharmaceuticals, and shall not operate or disguise the operation of medicines in the name of medical treatment. Article XIV medical institutions using narcotic drugs, psychotropic drugs, toxic drugs and radioactive drugs, shall be strictly in accordance with the relevant state regulations on the management and use of special drugs. Article XV of medical institutions without approval shall not carry out intravenous infusion business. Article XVI of the medical institutions in the medical business in the use of drugs should be in accordance with the price department approved the project and standard charges, is strictly prohibited to set up unauthorized charges, increase charges. Article XVII of the medical institutions to use the prescription, diagnosis and treatment orders, medical records, reports, registers, etc. should be properly preserved for three years, the preservation of the expiration of the need to destroy, must be reported to the competent health administrative department for approval. Article 18 of the violation of the provisions of the medical institutions, the health administrative department shall give criticism and education, warning or the following penalties:

(a) distribution, use of counterfeit drugs, confiscation of all counterfeit drugs and illegal income, the batch of counterfeit drugs posing as the price of the genuine article of a fine of less than five times, and the responsible leaders and directly responsible personnel shall be sentenced to a fine of more than 300 yuan of less than two thousand yuan;

p>(b) the distribution and use of inferior drugs, confiscate all inferior drugs and illegal income, impose a fine of up to three times the price of the batch of inferior drugs equivalent to the genuine product, and the leaders and persons directly responsible may be fined less than one thousand yuan respectively;

(c) the sale of non-pharmaceuticals under the name of medical treatment or disguised as the sale of non-pharmaceuticals, confiscate all the non-pharmaceuticals and the illegal income, and impose a fine of up to three times the value of the non-pharmaceuticals;

(d) without the Preparation License to prepare preparations, confiscate all preparations and illegal income, and impose a fine of up to five times the price of the preparations prepared, the leaders responsible and directly responsible persons were fined more than 500 yuan and less than 5,000 yuan;

Have the Preparation License but prepared preparations are not qualified for use in patients, impose a fine of more than 500 yuan and less than 5,000 yuan A fine of not less than five hundred yuan and not more than five thousand yuan, and the leaders and directly responsible persons shall be fined not less than fifty yuan and not more than three hundred yuan respectively;

Sale or disguised sale of prepared preparations shall be fined not less than five thousand yuan and not more than twenty thousand yuan;

(e) unauthorized use of drugs without a Preparation License shall be confiscated all the medicines and proceeds from the use of medicines, and be fined not more than five times the price of confiscated medicines;

(F) the employment of personnel who do not meet the conditions of the provisions of these Measures from the drug, ordered to make corrections, and impose a fine of up to three thousand yuan, and the leaders responsible for the fine of fifty dollars or more than three hundred dollars;

(G) violation of the provisions of Article 10 of these Measures, a fine of up to two thousand yuan.

Violation of these measures is serious, the health administrative department may order its suspension and rectification until the withdrawal of the "medication license", "preparation license", revocation of the "registration certificate of medical institutions" or "medical institutions license"; violation of criminal law, be held criminally responsible.