OBJECTIVE

2

To construct a clinical inapplicability evaluation system for the instructions of oral Chinese patent medicines containing toxic decoction pieces， so as to provide references for the revision and improvement of such drug instructions and the formulation of instructions for new drugs.

METHODS

2

The initial indicator framework was determined based on policy documents and literature related to instruction registration and revision. Two rounds of Delphi consultation were conducted among 25 experts to refine and optimize the indicator system. The analytic hierarchy process was employed to construct judgment matrices and obtain indicator weights. The comprehensive weights were converted into a 100-point scale to evaluate 11 instructions of oral Chinese patent medicines containing toxic decoction pieces from the medical institution of the research team.

RESULTS

2

The average questionnaire recovery rate of the two rounds of consultation was 96%. The expert authority coefficients were 0.87 and 0.88， respectively， and the Kendall’s

W

was statistically significant （

P

＜0.001）. The final evaluation system comprised 4 first-level indicators （defect of toxicity identification， defect of dosage information， defect of risk warning， and defect of information guidance） and 24 second-level indicators （e.g.， failure to label toxic decoction pieces in 【warnings】， failure to indicate all decoction piece compositions， absence of medication course specifications， etc.）. The total scores of the 11 oral Chinese patent medicine instructions ranged from 15.50 to 50.87 points. The main clinical inapplicability issues included the absence of medication course specifications and the failure to provide warnings in items such as 【precautions】 for decoction pieces involving the “eighteen incompatibilities and nineteen mutual antagonisms”.

CONCLUSIONS

2

The constructed indicator system can meet the requirements for evaluating the clinical inapplicability of instructions for oral Chinese patent medicines containing toxic decoction pieces. All evaluated instructions exhibited certain clinical applicability defects. Pharmaceutical manufacturers should revise the instructions in accordance with policy requirements and clinical needs.