Adverse Drug Reaction Monitoring and research progress Administration and the Ministry of Health jointly issued a management approach, reflecting the inherent laws of the pharmaceutical industry which are inseparable. This is an important symbol of national attention to the public's safe and effective medication, as well as guidance by scientific laws in drug development research and circulation. China's Adverse Drug Reaction Monitoring (ADRM), aims to strengthen supervision, management, and scientific evaluation of the safety of marketed drugs for the protection of the public's safe and effective medication, and to guide the rational use of medicines. ADRM is one of the most basic methods in the descriptive study of Pharmacoepidemiology. Through the introduction of the adverse drug reaction reporting system, it obtains information about drug safety. Early signals of problems on ADRM information can be scientifically analyzed and conclusions drawn, forming the basis of drug-induced disease (DID) etiology hypotheses, another state drug re-evaluation (reevaluation), and promoting clinical rational drug use.
The implementation includes the following elements:
5.1 Management System and Reporting Body: China’s State Drug Administration and the provincial Drug Administrations are responsible for national and regional ADRM work. The state encourages and protects units and individuals reporting ADRs. Regulations specify that the main body of operation and use of pharmaceutical production units are ADR reporting units.
5.2 Reporting Procedures and Requirements: Countries implement step-by-step periodic ADR reporting systems. Serious or rare ADRs must be reported immediately; when necessary, they can leapfrog to report. Drugs listed within five years are considered national key monitoring drugs, and all suspected adverse reactions should be reported. Drugs listed for more than five years mainly report serious, rare, or new adverse reactions caused by drugs. Countries emphasize that medical prevention and health care institutions discovering serious, uncommon, or new ADR cases should report within 15 days to local ADR professional organizations after initial treatment.
5.3 Evaluation of Information and Feedback: Countries stipulate that national ADRM agencies timely verify, analyze, and evaluate serious, rare, or new ADRs, promptly reporting to the State Drug Administration and the Ministry of Health. The State Drug Administration occasionally informs about ADRM and releases drug re-evaluation results.
6 Correct Understanding of Bias in ADR Implementation to Promote Healthy Development of the Pharmaceutical Industry: There are real difficulties in ADRM implementation, with some misunderstanding and prejudice regarding ADRs. For instance, some consider ADRs as medical malpractice, fearing to face them as inevitable occurrences, associating them with drug quality issues, not Taiwan grid products, thus intending to cover them up. Others believe ADRs are individual differences unrelated to drugs, not attaching importance to them. Therefore, during ADRM implementation, it should be emphasized that ADRs are one of the attributes of drugs. Knowledge of ADRs, restricted by the level of medical research, implementing ADRM will deepen comprehensive understanding of pharmaceutical properties and raise the level of pharmaceutical research, promoting clinical unit medication management, and serving as an important measure to protect the public's safe and effective medication.