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Objective To explore the trend of antitumor drugs by comparing and analyzing the novel antitumor drugs of China and US, in order to provide a basis for the selection of antitumor drugs. Methods US Food and Drug Administration and China National Medical Products Administration databases were searched, and the drug name, marketing time, indication and other information were collected(as of April 30, 2021). The proportion of listed drugs in China were calculated. Results As of April 30, 2021, there were 122 novel antitumor drugs marketed in the US, covering 14 disease types. Among them, 41.80% (51/122) were marketedin China. The proportion of monoclonal drugs was the highest(46.15%), followed by the small molecule targeted drugs (44.58%), and antibody-drug conjugate (15.38%). The number of novel antitumor drugs increased significantly(70.59%, 36/51) since 2015, and the proportion of listed drug in China from 2015 to 2021 was 50.70%(36/71), while that from 2010 to 2014 was only 19.35%(6/31). China has imported novel antitumor drugs covering 13 disease types. The average proportion of imported novel antitumor drugs for the top 5 tumors in China was 62.15%. A total of 14 novel antitumor drugs have been independently developed in China, including 7 monoclonal drugs and 7 small molecule targeted drugs, accounting for 21.54% (14/65) of the available novel antitumor drugs in China. Among them, 11 drugs (78.57%, 11/14) have been listed since 2015. The indications of novel antitumor drugs independently developed in China cover 8 disease types (57.14%, 8/14). Conclusions There are still gaps between China and US in terms of novel antitumor drugs, but these drugs can basically meet the clinical needs in China. Since 2015, China has made progress in accelerating approval and independent innovation. We should consider the safety, effectiveness, economic and clinical necessity of the listed and unlisted drugs, so as to provide a basis for drug selection in the future.

Objective To design a safety management system for antitumor drugs, which can intercept or warn the overdose of medical orders from the prescription source, and ensure the safety of clinical application of antitumor drugs. Methods The threshold of interception and warning strategy of 88 kinds of antitumor drugs were developed, and the safety management system of antitumor drugs was established to intercept or warn the overdose orders. The interception and warning data from January 2021 to June 2021 in the safety management system of antitumor drugs were extracted and analyzed. Results A total of 665 medical orders were intercepted or warned by the safety management system of antitumor drugs, and the majority of the intercepted or warned drugs were oral tablets(74.29%). The intercepted orders were 642 (96.54%), and the warned orders were 23(3.46%). Among the intercepted medical orders, frequency error (64.22%) has the highest proportion, followed by route error (11.73%) and dose error (9.92%). A total of 564 medical orders were intercepted, involving 28 kinds of antitumor drugs. Methotrexate tablets ranked first in overdose quantity, with an average of seven times. Pemetrexed ranked first in overdose multiples, with an average overdose of 1000 times. 78 medical orders were intercepted for over pathway, involving 5 kinds of antitumor drugs. Conclusion The safety management system of antitumor drugs can eliminate the error of overdose in prescription and guarantee the safety of antitumor drugs.

Objective The aim of this study is to investigate the clinical use of 17 antineoplastic drugs passing national medical insurance negotiation in Peking Union Medical College Hospital before and after the implementation of national policies about promoting the inclusion of antineoplastic drugs in health insurance, and to provide reference for the optimization and adjustment of hospital formulary. Methods The prescription data of 17 antineoplastic drugs of outpatients and inpatients in our hospital from December 1, 2017 to November 30, 2019(December 1, 2017 to November 30, 2018 for the year 2018, December 1, 2018 to November 30, 2019 for the year 2019) were collected. The basic information of patients, the usage amount and cost, defined daily doses (DDDs), and defined daily cost (DDC) were analyzed. Results A total of 6881 patients used the 17 antineoplastic drugs in 2019. Among them, there were 4713(68.5%) outpatients and 2168(31.5%) inpatients. The proportions of the cost of 17 antineoplastic drugs to that of all antineoplastic drugs and all formulary drugs in our hospital were 16.3% and 3.8%, respectively. The 17 antineoplastic drugs were mainly used for thorax, hematologic, and urologic malignancies. The top three antineoplastic drugs in terms of cost were osimertinib, octreotide acetate microspheres and crizotinib, with good synchronization between drug cost and DDDs. The top three drugs in terms of DDC were vemurafenib, cetuximab and ibrutinib. The total cost and prescription of the six drugs that had already been included in the formulary of our hospital before the implementation of the policy increased by 78.2% and 89.8%, respectively in 2019 compared with those in 2018, and the proportions of the cost of six antineoplastic drugs to that of all antineoplastic drugs and all formulary drugs in the hospital increased by 54.4% and 78.6%, respectively. After the implementation of national policies, the quantity and cost of osimertinib increased significantly, and the drugs increased in quantity but decreased in cost were cetuximab, axitinib, and sunitinib in sequence. Both the quantity and the cost of pegaspargase decreased significantly. Conclusions The national health insurance negotiation policy promoted the use of 17 antineoplastic drugs in the hospital and improved the accessibility of these drugs to patients significantly. At the same time, the total cost of the involved drugs had a sharp rise. It is necessary to strengthen the monitoring and dynamic evaluation of the clinical application of related drugs, so as to promote rational drug use while meeting patients' needs.