Investigation and Analysis of Medication Warning Information Annotation for Patients with Liver Insufficiency in Package Inserts

OBJECTIVE To provide reference for the regulation of medication warning information for patients with liver insufficiency by investigating the warning information for patients with liver dysfunction in package inserts of 415 varieties. METHODS The medication information for patients with liver insufficiency in Mcdex was sorted out. All the drugs are recorded in Hepatox and Livertox with hepatotoxicity. Statistical analysis was applied on the labeling of medication warning information in patients with liver dysfunction. RESULTS 26.26% of the drugs, 18.03% of their package inserts had no medication warning information on patients with liver insufficiency. 53.92% of the drugs had different warning information from different manufacturers. Thirteen of them had differences in warning information between domestic manufacturers and imported manufacturers. Only 17.65% of the drugs had dose adjustment information for patients with liver insufficiency, while 5 of them had different information on the dose adjustment from different manufacturers. CONCLUSION Pharmaceutical manufacturers shall undertake the responsibility of revising and improving the drug instructions on their own initiative. In clinical, clinicians and pharmacists shall strengthen pharmaceutical monitoring for patients with liver dysfunction and attach importance of drug information collection to promote the improvement of the drug instructions.