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 department, 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.
ObjectiveTo compare the recommended medicines from malignancy guidelines/consensuses with essential medicines from the 2023 World Health Organization Model List of Essential Medicines (WHO-EML) and the 2018 National Essential Medicine List (NEML) in differences and similarities. MethodsTen guideline databases/association websites including Guidelines International Network, and the American Cancer Society, etc. were systematically searched until July 2023. The latest guidelines/consensuses for ten malignant tumors were screened, including lung cancer, liver cancer, stomach cancer, and other cancers. Recommended medicines were extracted from guidelines/consensuses and compared with WHO and Chinese essential medicines. ResultsA total of 163 guidelines/consensuses were included, extracting 244 recommended medicines, 12 categories, mainly antineoplastic and immunomodulating agents (190 medicines, 10 subcategories). For the 244 recommended medicines, 29.92% (73/244) were included in WHO-EML and 23.36% (57/244) were included in NEML, among which 45 medicines were included both in WHO-EML and NEML, 27 in WHO-EML only, 11 in NEML only, and 161 in neither. ConclusionThe number of recommended medicines in WHO-EML/NEML for ten malignancies is low, and the number in NEML is even much lower than that in WHO-EML. When adjusting medicines for malignant tumors in NEML, reference can be made to specific guidelines/consensuses and WHO-EML to ensure timely inclusion of applicable medicines and strengthen the role of essential medicines in meeting basic medical needs and rational use.