I. Importance of Adverse Drug Reaction Reporting
Adverse drug reaction refers to the harmful reactions unrelated to the purpose of medication that occur in the process of preventing, diagnosing, treating diseases or regulating physiological functions of medicines in the course of normal usage and dosage. These adverse reactions may cause harm to the patient's health or even endanger life. Therefore, timely and accurate reporting of adverse drug reactions is essential to ensure the safety of patients' medication.
Two, the implementation of the regular reporting system at each level
According to the provisions of the adverse drug reaction reporting system, drug manufacturers and operators and medical institutions should first carry out internal assessment and treatment to ensure the safety of patients after discovering adverse drug reactions. Then, in accordance with the prescribed procedures and requirements, the adverse reaction information should be reported to the local drug supervision and management departments at each level. These departments will summarize, analyze and evaluate the reported information so that necessary measures can be taken in a timely manner to prevent the recurrence of similar adverse reactions.
During the process of cascading reports, drug supervision and management departments at all levels should strengthen the review and gatekeeping of the reported information to ensure the authenticity and accuracy of the information. At the same time, an information ****sharing mechanism should also be established to strengthen communication and collaboration between departments in order to better respond to adverse drug reaction events.
Third, the provisions of the report shall not be reported at different levels
In order to ensure the efficiency and accuracy of the transmission of information on adverse drug reactions, the system stipulates that the report shall not be reported at different levels. This means that drug manufacturers, business enterprises and medical institutions in the discovery of adverse drug reactions, must be reported in accordance with the prescribed levels and procedures, and shall not skip the intermediate links directly to the higher level of drug supervision and management departments. This provision helps to avoid omissions and misunderstandings in the transmission of information, and ensures the completeness and accuracy of the information.
In summary:
The implementation of a level-by-level periodic reporting system for adverse drug reactions is to safeguard the safety of patients' medication. Drug manufacturers and operators at all levels and medical institutions should strictly abide by this system and report adverse drug reactions in accordance with the prescribed procedures and requirements. At the same time, the drug supervision and management departments should also strengthen the examination and checking of the reported information to ensure the authenticity and accuracy of the information. Through *** with the same efforts, we can better respond to adverse drug reaction events and protect the safety of patients' medication.
Legal basis:
"Chinese People's **** and the State Drug Administration Law"
Article 70 stipulates:
Drug production, management enterprises and medical institutions should find that may be related to the use of medication, serious adverse reactions, must be promptly reported to the local people's government drug supervision and management department and the health administrative department. Specific measures shall be formulated by the drug supervision and management department of the State Council in conjunction with the health administrative department of the State Council.
Adverse Drug Reaction Reporting and Monitoring Measures
Article 14 provides:
Drug manufacturers and operators and medical institutions shall designate full-time (part-time) personnel to be responsible for the reporting and monitoring of adverse drug reactions in their organizations.
Article 16 provides:
Drug manufacturers, business enterprises and medical institutions shall report through the national adverse drug reaction monitoring system when they are informed of or discover adverse reactions that may be related to the use of medicines; if they don't have the conditions for online reporting, they shall report to the county-level drug supervision and management departments where they are located by means of paper or electronic statements, and the county-level drug supervision and management departments shall report on behalf of them online.
Reporting
The content of the report should be true, complete and accurate.