Adverse reaction knowledge
1. What is a drug adverse event?
Answer: According to the relevant technical guidelines of the Coordination Committee on Technical Requirements for Human Drug Registration (ICH E2D), Adverse Drug Event (ADE) refers to any adverse medical event that occurs when a patient uses a drug, and may not necessarily have a causal relationship with this treatment. An adverse event can be any sign (such as abnormal laboratory results), symptom, or disease that is time related to the use of the drug and unrelated to the purpose of the medication, regardless of whether it has a causal relationship with the drug.
2. What is an adverse drug reaction?
Answer: According to the "Management Measures for Reporting and Monitoring of Adverse Drug Reactions" (Order No. 81 of the Ministry of Health), Adverse Drug Reactions (ADRs) refer to harmful reactions of qualified drugs that occur under normal usage and dosage and are unrelated to the purpose of the medication.
3. How to view adverse drug reactions? How to objectively understand the relationship between adverse reactions and drug quality?
Answer: Adverse drug reactions are inherent properties of drugs, and any drug may cause adverse reactions. Qualified drugs may also cause adverse reactions, and adverse reactions cannot be confused with drug quality issues. Whether there are any issues with the quality of drugs should be based on the inspection results to see if they meet the statutory quality standards.
In short, adverse drug reactions are a common and highly harmful phenomenon that requires sufficient attention and attention under the premise of rational drug use. To prevent adverse drug reactions, in addition to following medical advice for rational medication, it is also necessary to be careful not to arbitrarily change the dosage and usage of the drug, especially not to mix it with other drugs. Once adverse drug reactions occur, seek medical attention as soon as possible and implement corresponding treatment methods, such as stopping medication, reducing dosage, and changing medication.