Specific legal provisions:
According to China's Drug Administration Law, drug trading enterprises should report serious adverse drug reactions to National Medical Products Administration within 24 hours.
This is to report the safety of drugs in time and ensure the health and safety of the public. Timely reporting of serious adverse reactions plays an important role in the monitoring and intervention measures of drug regulatory authorities to ensure that adverse reactions are evaluated, disposed and notified in time.
Punishment of adverse drug accidents:
1. Failing to establish a management system for reporting and monitoring adverse drug reactions in accordance with regulations, or failing to set up a special institution or equip full-time personnel to be responsible for reporting and monitoring adverse drug reactions in the unit.
2. Adverse drug reaction monitoring files have not been established and kept.
3. Failing to report, investigate, evaluate and deal with adverse drug reactions or group adverse events as required.
4. Failing to submit regular safety update report as required.
5. Failing to conduct key monitoring as required.
Symptoms of adverse drug reactions:
1, allergic reaction
Drug allergic reaction refers to the adverse reactions similar to allergic clinical symptoms caused by pharmaceutical preparations. Usually, patients show itchy skin, headache, fever and dyspnea, and in severe cases, anaphylactic shock may occur.
2. Toxicity of liver and kidney function
Because drugs need to be metabolized by liver and kidney, if the liver and kidney function are incomplete or the dosage is too large, it will lead to drug accumulation, liver cell destruction, transaminase increase, and even jaundice, and may also lead to toxic reactions such as renal tubular or glomerular lesions and chronic renal insufficiency;
3. Others
Because improper use of drugs will have an all-round impact on the body, some patients will also have symptoms such as drug eruption, drowsiness, drowsiness, fatigue, and serious adverse drug reactions may even lead to death.
Most drugs have some adverse reactions in clinic, so patients need to go to the general department of the hospital in time when there are indications for drugs. After improving vision examination, blood routine, urine routine, magnetic resonance imaging, etc., they should use drugs under the guidance of doctors to avoid irreversible damage to health caused by improper use of drugs.
The above data comes from Baidu Encyclopedia.