Legal analysis: drugs, consumables purchase and sale of inventory management system
In order to standardize the management of clinic pharmacy, to ensure the safety and effectiveness of medication, according to the "Regulations on the Management of Medical Institutions" and "Chinese People's Republic of China *** and the State Drug Administration Law" and other laws and regulations to formulate this system.
I. Drugs referred to in this system refers to the items that have obtained the State Drug Certification Number. Including Western medicine, proprietary Chinese medicine and Chinese medicine tablets. Consumables refers to a disposable medical and health supplies, sterilization products.
Second, the purchase of audit management: the purchase of drugs, consumables should be to ensure quality as a prerequisite, from the legally qualified drug production, drug wholesale enterprises to purchase drugs, strict audit of the supply unit, the purchase of drugs and the qualifications of sales staff, the establishment of the supply unit file.
Three, acceptance management: the establishment and implementation of incoming inspection and acceptance system, acceptance of personnel should be checked batch by batch of drugs packaging, specifications, labels, instructions, certificates of conformity and other identification; does not meet the prescribed requirements, shall not be imported. The establishment of a true and complete purchase and acceptance records of medicines, tickets, accounts, things in line. Purchase and acceptance records saved to more than the expiration date of the drug 1 year, but not less than 3 years.
Four, storage management: at room temperature (temperature of 0-30C), cool (temperature not higher than 20C), cold (temperature of 2-10C) under the conditions of storage of medicines, relative humidity is stored between 45-75%. Special requirements for the storage of drugs should be in accordance with the drug instructions or packaging labeled conditions and the relevant provisions of the storage, temperature and humidity to do a good job of monitoring and management, temperature and humidity beyond the prescribed range, should be promptly regulated and recorded.
Fifth, the use of management: must be based on the store's licensed physician issued a prescription or medical advice. Drugs, consumables
Supplies should follow the distribution of "first produced first out", "near-expiry first out" and the principle of distribution by lot number. The removal is
No bare hands directly touching the drugs, should make a detailed record, kept for at least one year. After completing the prescription mixing
dispensing, the prescription must be properly stored in accordance with the relevant provisions.
Legal basis: "The People's Republic of China *** and the State Drug Administration Law"
Article 3 The management of medicines shall be centered on people's health, adhere to the principles of risk management, full control and social *** governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of medicines, and safeguard the safety, efficacy and accessibility of medicines.
Article 12 The state establishes and improves the drug traceability system. The drug supervision and management department under the state council shall formulate unified standards and specifications for drug traceability, promote drug traceability information sharing, and realize drug traceability.
The State establishes a pharmacovigilance system to monitor, identify, evaluate and control adverse drug reactions and other harmful reactions related to the use of medicines.
Article 34 A holder of a listed drug license may sell the drugs for which it has obtained a certificate of drug registration on its own, or it may entrust the sale to a drug business enterprise. If the holder of a listed drug license engages in retailing of drugs, it shall obtain a drug business license.
The holder of a listed drug license to sell drugs, shall have the conditions set forth in Article 52 of this Law; commissioned sales, should be entrusted to meet the conditions of the drug business enterprises. Drug marketing license holder and entrusted business enterprises should sign a commissioning agreement, and strictly fulfill the obligations agreed upon.