Active monitoring of adverse reactions of capecitabine-induced hand-foot syndrome based on the hospital information system

doi:10.19803/j.1672-8629.20220007

Abstract

Abstract: Objective To explore active monitoring methods of capecitabine-induced hand-foot syndrome. Methods Retrospective risk signal mining was performed on patients who had been hospitalized in Beijing Hospital and taken capecitabine between October 1, 2020 and September 30, 2021 using the PASS ADR. Manual causality evaluation and screening were performed on suspected cases of capecitabine-induced hand-foot syndrome, and the clinical characteristics, therapeutic drugs, treatments and outcomes of the positive cases of capecitabine-induced hand-foot syndrome were analyzed. Results A total of 257 inpatients were treated with capecitabine in the course of monitoring, 35 of whom had risk signals of hand-foot syndrome detected through PASS ADR. Through manual screening and causality evaluation, 14 patients with capecitabine-related drug-induced hand-foot syndrome were finally obtained. The incidence of capecitabine-induced hand-foot syndrome was 5.45%, and the correct rate of identification by the active monitoring system was 40.0%. Conclusion Active monitoring can effectively improve the sensitivity of ADR monitoring and early detection of mild adverse reactions.

Key words: capecitabine, hand-foot syndrome, active monitoring, risk signal, adverse drug reaction, medical institution information system

CLC Number:

ZHENG Yujing, ZHAO Zinan, JIN Pengfei, ZHAO Fei, HU Xin, ZHANG Yatong. Active monitoring of adverse reactions of capecitabine-induced hand-foot syndrome based on the hospital information system[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 441-443.

References

[1] SCHELLENS JHM.Capecitabine[J]. The Oncologist, 2007, 12(2): 152-155.
[2] MIKHAIL SE, SUN JF, MARSHALL JL.Safety of capecitabine: a review[J]. Expert Opinion on Drug Safety, 2010, 9(5): 831-841.
[3] WANG D.Active surveillance of adverse drug reaction and its development trend[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2015, 12(10): 600-602.
[4] TAN XQ, GUO LJ, KONG FF, et al.Actively discover adverse drug reactions with the help of hospital electronic information system[J].Journal of Pharmaceutical Practice, 2010, 5: 381-382.
[5] BUSTO NC, SELLERS EM, SANDOR P, et al.A method for estimating the probability of adverse drug reactions[J]. Clin Pharmacol Ther, 1981, 30(2): 239-245.
[6] LAZAROU J, POMERANZ BH, COREY PN.Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies[J]. JAMA, 1998, 279(15): 1200-1205.
[7] DAVIES EC, GREEN CF, TAYLOR S, et al.Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes[J]. PLoS One, 2009, 4(2): e4439.
[8] GREENER M.Understanding adverse drug reactions: an overview[J]. Nurse Prescribing, 2014, 12(4): 189-195.
[9] BAI HH, NIE XJ, XIA L, et al.Effect evaluation of adverse drug reactions monitoring based on Chinese hospital pharmacovigilance system[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(10): 1136-1139.
[10] WANG D, SHEN L.The method of active monitoring of adverse drug reaction and its application in my country[J]. Chinese Journal of Drug Evaluation, 2012,29(1): 85-87.
[11] GUO DH,YU CX.Expert consensus on automated surveillance and evaluation of clinical medication risk based on hospital information system data[J]. Chinese Journal of Drug Application and Monitoring, 2021, 18(5): 277-287.
[12] DAI HJ, SU CH, WU CS.Adverse drug event and medication extraction in electronic health records via a cascading architecture with different sequence labeling models and word embeddings[J]. J Am Med Inform Assoc, 2020, 27(1): 47-55.
[13] ELIF A, YUCEL KT, EKİNCİOGLU AB, et al. Capecitabine induced hand-foot syndrome: a systematic review of case reports[J]. Clinical and Experimental Health Sciences, 2019, 9(2): 178-191.
[14] NIKOLAOU V, SYRIGOS K, SAIF MW.Incidence and implications of chemotherapy related hand-foot syndrome[J]. Expert Opinion on Drug Safety, 2016, 15(12): 1625-1633.
[15] HUANG XZ, CHEN Y, CHEN WJ, et al.Clinical evidence of prevention strategies for capecitabine-induced hand-foot syndrome[J]. International Journal of Cancer, 2018, 142(12): 2567-2577.
[16] HOU YF, SONG HB, LIU HL, et al.Practice and discussion on active surveillance by China hospital pharmacovigilance system[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(4): 212-214.