Abstract:

Objective To investigate the selection of lowest grade of injury in compensation of adverse drug reactions (ADR) for responsible parties, and analyse the characteristics. Methods The selection of lowest grade of injury in compensation of ADR and the amount of compensation for injury higher than grade 7 were investigated among responsible parties of pharmaceutical manufacturers (260 units), government departments (115 units) and medical institutions(125 units) by questionnaire survey, and comparisons were made among these three parties. Results A total of 480 questionnaires were recovered, with the recovery rate of 96.0%. There were 467 effective questionnaires, and the effective rate was 93.4%. Most units (n=81, 17.34%) chose grade 7 as the lowest grade in compensation, and 5 units (1.07%) only compensated for death of ADR. More severe injury led to larger amount of compensation, and the largest amount of compensation for death was 300 thousand RMB yuan. The willingness of compensation significantly increased in all parties when the severity of injury increased from grade 4 to grade 3. However, there were disparities among parties in compensation for slight injury. There were significant differences in the distributions of lowest grade of injury in compensation among three parties (P<0.05). Conclusion Responsible parties for ADR may provide compensation for the injured, and the amount of compensation may vary according to the severity of injury. There exist disparities in the lowest grade of injury in compensation among different parties. All parties lay emphasis on the severely injured rather than the slightly injured.

Key words: adverse drug reaction, injury, compensation characteristics