What is the current definition of adverse drug reactions in China

Adverse drug reactions refer to unrelated or unexpected harmful reactions that occur under the normal usage and dosage of qualified drugs.

Adverse drug reactions refer to reactions that are harmful rather than expected and have a causal relationship with the use of the drug during the normal application of the drug at a prescribed dose.

The three elements that trigger an adverse drug reaction are as follows:

1) Adverse drug reactions include drugs, adverse reactions, and adverse drug reactions.

Drugs are the means or tools of the disease, and they are also the factors that cause adverse reactions.

Adverse reactions are pathological phenomena of the body. It can be caused by a disease or by a drug.

Adverse drug reactions are pathophysiological changes in the body caused by medication, including functional and organic changes.

2) There are three elements in the occurrence of adverse reactions, namely drugs, organisms, and diseases.

Adverse reactions can occur only when drugs are used in humans.

The body's complex internal environment and individual differences make drugs have a "diverse" effect.

Diseases can alter the body's effects on drugs and the effects of drugs on the body.

Classification of adverse reactions to drugs.

1. Harmful to the human body. For example, atropine is used to relieve gastrointestinal spasms that cause dry mouth.

2. Toxic reactions. Such as insomnia, tinnitus, anemia, liver damage, etc.

3. Allergic reactions.

4. Three-way effect. Teratogenic, mutagenic, carcinogenic, etc.

5. After-effects.

6. Secondary reactions.

Unrelated or harmful reactions to the purpose of the drug under normal usage and dosage of the qualified drug. The elements should be "qualified drugs", "normal usage and dosage", and "irrelevant or harmful to the purpose of use".

First, the nature is different.

1. Adverse drug reactions refer to harmful reactions that occur under the normal usage and dosage of qualified drugs that are unrelated to the purpose of the drug.

2. Adverse drug events (ADE): The World Health Organization defines adverse events as adverse feelings, which refers to any unfortunate medical and health events that occur in the process of drug **, and this kind of event does not necessarily have a causal relationship with drug **.

Second, the classification is different.

1. Adverse reactions of drugs.

1) Type A adverse reactions.

It is due to the enhancement of the pharmacological effect of the drug. It is characterized by the fact that it can be **, related to the conventional pharmacological effect, the occurrence of the reaction is dose-related, the symptoms are reduced or disappeared quickly after stopping or reducing the dose, the incidence is high (>1%), and the mortality rate is low.

2) Type B adverse reactions.

It is an abnormal reaction that is completely unrelated to the normal pharmacological effect of the drug. It is characterized by general difficulty**, cannot be found by conventional toxicological screening, low incidence (<1% =, high mortality.

3) Type C adverse reactions.

Some adverse reactions are difficult to simply classify type A or type B, and some scholars have proposed that they are type C adverse reactions. Type C adverse reactions are characterized by high incidence, complex or incomplete drug history, non-specific (referring to drugs), no clear time relationship, and long incubation period.

2. Adverse drug events: drug standard defects, drug quality problems, adverse drug reactions, medication errors and drug abuse.

Adverse drug events (

ADE): The World Health Organization defines adverse events as adverse feelings, which refers to any unfortunate health event that occurs in the course of a drug**, and such an event does not necessarily have a causal relationship with the drug**. From the perspective of drugs**, we can get the definition of adverse drug events, which refers to the physical damage associated with the drug.

Adverse drug events consist of two elements:

The first is that the occurrence of adverse events is caused by the marketed drugs, and the second is that the results produced are harmful to the human body. Measures for the Administration of Adverse Drug Reaction Reporting and Monitoring (Decree No. 81 of the Ministry of Health).

2011-05-04.

Publish. Chapter VIII. Attach. Rule.

Article 63.

The meaning of the following terms in these Measures:

1) Adverse drug reactions refer to harmful reactions that occur under the normal usage and dosage of qualified drugs that are unrelated to the purpose of medication.

2) Adverse drug reaction reporting and monitoring refers to the process of discovery, reporting, evaluation and control of adverse drug reactions.

3) Serious adverse drug reaction refers to the reaction caused by the use of drugs in one of the following conditions:

1.resulting in death;

2.life-threatening;

3.Carcinogenic, teratogenic, birth defects;

4.results in significant or permanent disability or impairment of organ function;

5.resulting in hospitalization or prolonged hospital stay;

6.Resulting in other important medical events, such as not being carried out** may be subject to the conditions listed above.

4) New adverse drug reactions refer to adverse reactions that are not specified in the drug instructions. If it has been described in the instructions, but the nature, extent, consequences or frequency of adverse reactions are inconsistent with the description in the instructions or more serious, they shall be treated as new adverse drug reactions.

5) Adverse events of drug groups refer to incidents that cause damage or threat to the health or life safety of a certain number of people in a relatively concentrated time and area during the use of the same drug, and need to be dealt with urgently.

Same drug: refers to the same drug name, the same dosage form, and the same specification produced by the same manufacturer.

6) Key drug monitoring refers to drug safety monitoring activities carried out in order to further understand the clinical use of drugs and the occurrence of adverse reactions, and to study the characteristics, severity and incidence of adverse reactions.

Adverse drug events include: adverse drug reactions, drug quality problems, drug dispensing, and use errors.

Thanks to Mr. Anti-Teacher's reply, the scope of adverse drug events is far greater than that of adverse drug reactions.

Answer]: A Adverse drug reaction refers to the unrelated or unexpected harmful reaction of the qualified drug under the normal usage and dosage of the drug.

The state implements a reporting system for adverse drug reactions. Pharmaceutical production and trading enterprises and medical institutions must constantly inspect the quality, efficacy and response of the drugs produced, operated and used by their units. If serious adverse reactions that may be related to drug use are found, they must be reported to the local provincial, autonomous region, and municipal people's drug regulatory departments and health administrative departments in a timely manner.

For drugs that have been confirmed to have serious adverse reactions, the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may take emergency control measures to stop production, sales and use, and shall organize appraisal within five days, and make an administrative decision in accordance with the law within 15 days from the date of the appraisal conclusion.

Legal basisArticle 3 of the Administrative Measures for the Reporting and Monitoring of Adverse Drug Reactions.

The state implements a reporting system for adverse drug reactions. Drug manufacturers (including overseas pharmaceutical manufacturers of imported drugs), drug dealers, and medical institutions shall report adverse drug reactions found in accordance with regulations.

Article 4 The State Drug Administration is in charge of the reporting and monitoring of the national drug dishonorable and good reactions, and the local drug regulatory departments at all levels are in charge of the reporting and monitoring of adverse drug reactions within their respective administrative areas. Health administrative departments at all levels are responsible for the management of medical institutions within their respective administrative areas related to the implementation of the adverse drug reaction reporting system. Local drug regulatory departments at all levels shall establish and improve adverse drug reaction monitoring institutions, which shall be responsible for the reporting of adverse drug reactions and the technical work of monitoring nuclear deficiency within their respective administrative regions.

Article 5 The State encourages citizens, legal persons and other organizations to report adverse drug reactions.