High-risk drugs include cytotoxic chemotherapy drugs, high-concentration electrolyte preparations, muscle relaxants and so on. The list of high-risk drugs in hospitals should be updated synchronously with the relevant national regulations.
High-risk drugs management system is to promote the rational use of this drug and reduce adverse reactions. The management system is as follows:
1, high-risk drugs refers to drugs that have obvious and rapid pharmacological effects and are easy to cause harm to human body, including high-concentration electrolyte preparations, insulin preparations, muscle relaxants, cytotoxic drugs and vasoactive drugs. For details, please refer to the Catalogue of High-risk Drugs;
2. Regularly update the list of high-risk drugs, fully demonstrate the newly introduced high-risk drugs, and inform the clinic of drug information in time after introduction to promote rational clinical application;
3. On the basis of meeting the requirements of fragrance storage in the drug instructions, the storage places of high-risk drugs should be relatively concentrated, so as to avoid mixing with other drugs as much as possible;
4, high-risk drugs medicine rack should be eye-catching, set up red and white labels to remind medical staff;
5. High-risk drugs should be used in strict accordance with the instructions, and unconventional use should be checked again. When the electronic system displays high-risk drugs, it is displayed with yellow background and bold characters to play a warning role;
6. When using high-risk drugs, strictly implement the principle of 5R, and check the patient's name, bed number, drug name, drug dosage and route of administration. For patients who use high-risk drugs, it is necessary to strengthen monitoring, and once abnormal conditions are found, communicate with the attending doctor immediately and treat them in time;
7, high-risk drug dispensing and clinical use double review system, to ensure the accuracy of dispensing and use;
8, each department should strengthen the validity management of high-risk drugs, keep FIFO, to ensure safety and effectiveness. The pharmacy department counts every quarter, and the ward nurse station counts every day;
9. In principle, the nursing workstation does not store high-risk drugs (except rescue drugs). If necessary, it must be stored separately in a fixed place. The storage place shall be marked with eye-catching label paper, and the storage shall be limited, and the standby situation shall be checked regularly (quarterly);
10, all departments should strengthen the maintenance of high-risk drugs, strictly control the storage conditions of drugs, and store them in strict accordance with the storage conditions listed in the drug instructions approved by the state.
legal ground
People's Republic of China (PRC) Drug Administration Law
Article 30 The holder of a drug marketing license refers to an enterprise or a drug development institution that has obtained a Drug Registration Certificate.
The holder of drug marketing license shall be responsible for non-clinical research, clinical trials, production and marketing, post-marketing research, adverse reaction monitoring, reporting and handling of drugs in accordance with the provisions of this Law. Other units and individuals engaged in drug research, production, sale, storage, transportation and use shall bear corresponding responsibilities according to law. The legal representative and principal responsible person of the drug marketing license holder shall be fully responsible for the drug quality. Article 32 The holder of a drug marketing license may produce drugs by himself or entrust a drug production enterprise to produce drugs.
If the holder of the drug marketing license produces drugs on his own, he shall obtain a drug production license in accordance with the provisions of this law; Where production is entrusted, it shall be entrusted to a qualified pharmaceutical production enterprise for production. The holder of the drug marketing license and the entrusted production enterprise shall sign an entrustment agreement and a quality agreement, and strictly fulfill the obligations stipulated in the agreement.
The drug supervision and administration department of the State Council shall formulate the guidelines for the quality agreement of drug consigned production, and guide and supervise the holders of drug marketing licenses and consigned production enterprises to fulfill their obligations of drug quality assurance.
Shall not entrust the production of blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use and pharmaceutical precursor chemicals; However, unless otherwise provided by the drug supervision and administration department of the State Council.