药品不良反应自发报告系统

Spontaneous Reporting Systems (SRS) form the foundation of passive surveillance in pharmacovigilance. The core principle is the unsolicited reporting of suspected adverse 事件 by individuals, primarily healthcare providers but increasingly patients themselves. The UK’s Yellow Card Scheme, launched in 1964, is one of the earliest and most well-known examples. In the United States, the FDA Adverse Event Reporting System (FAERS) serves a similar function.

The primary strength of SRS is its broad scope. It can collect data on all drugs and all patients for an indefinite period, making it an invaluable tool for identifying safety issues that are too rare to be detected in the relatively small and controlled environment of pre-approval clinical trials. These systems are particularly effective at detecting ‘Type B’ (bizarre) adverse reactions, which are not related to the drug’s known pharmacological action.

However, SRS has significant limitations. The most critical is under-reporting; it is estimated that only a small fraction of all ADRs are ever reported. The data quality can be inconsistent, often lacking detailed clinical information. Furthermore, because there is no systematic data collection, it is impossible to calculate the incidence rate of an ADR, as the total number of patients exposed to the drug (the denominator) is unknown. Reports are also subject to various 偏见, such as notoriety of a drug leading to increased reporting (stimulated reporting). Despite these weaknesses, SRS remains an indispensable, cost-effective method for generating safety signals that can then be investigated using more rigorous epidemiological studies.