ObjectiveTo analyze the issues and risks associated with the policy of temporary import of urgently needed clinical drugs and offer optimized suggestions for this domain in our country. MethodsThe focus group interview method and in-depth interview method were employed, and 34 individuals related to the temporary import of urgently needed clinical drugs were selected for the interviews. Based on the results of the review of domestic and international policies for the temporary import of urgently needed clinical drugs and the conclusions drawn from the interviews, a questionnaire was formulated. The Delphi expert consultation method was utilized to select 14 experts from various relevant fields, and questionnaires were distributed and collected by mail for objective presentation. Through an expert consensus meeting, the final suggestions were formed. ResultsInitially, 20 suggestions were proposed for each stage of the temporary import of urgently needed clinical drugs. After expert consultation, 32 questionnaires were retrieved (a response rate of 91%), and all were valid (a validity rate of 100%). Through discussions at the expert consensus meeting, 17 policy suggestions were ultimately formed. ConclusionIt is recommended that the National Health Commission, in collaboration with the National Medical Products Administration and the customs, conduct in-depth discussions and refine the specific implementation measures for the temporary import of urgently needed clinical drugs to guarantee the safety, efficacy, and timeliness of clinical drug use.
ObjectiveThis study aimed to characterize the adverse reactions related to medication errors (MEs) in pediatric population reported in the US Food and Drug Administration Adverse Event Reporting System (FAERS), and to identify the signals for different drug MEs. MethodsData from pediatric MEs reports in the FAERS from January 1, 2004, to December 1, 2022, were collected. MEs reports were categorized by patient age groups, MEs, and anatomical therapeutic chemical classification system. Disproportionality analyses were performed. ResultsA total of 16 515 MEs reports were retrieved. Psychostimulants and immunosuppressants were the most frequently reported drugs. Administration errors (72.4%) were most frequent, followed by prescription errors (7.1%) and storage errors (3.9%). In infants (1 year), ibuprofen and paracetamol were the most frequently reported, and MEs signals were found for dose and administration errors. In children (2-11 years), methylphenidate and somatropin recombinant were the most frequently reported, and MEs signals were found for dose omission and prescription errors. In adolescents (12-18 years), somatropin recombinant and adalimumab were the most frequently reported, and MEs signals were found for dose errors. ConclusionThis study systematically analyzed pediatric MEs reported in the FAERS database, identifying age-specific high-risk drugs and common error types, and noting that some high-frequency reports may be influenced by reporting mechanisms. Combined with domestic monitoring data and clinical practice experience, the findings highlight the need for age-targeted prescription review, pharmacist involvement, and medication education to reduce pediatric MEs and improve medication safety.