直销患者药房药学服务工作模式初探:以卡瑞利珠单抗相关甲状腺功能减退为例

Preliminary study on the work model of pharmacy services in direct to patient sale pharmacy:taking camrelizumab‑related hypothyroidism as an example

目的以卡瑞利珠单抗致甲状腺功能减退(甲减)的院外管理为例,初步评估直销患者(DTP)药房药学服务的效果。方法收集2019年7月1日至2021年7月31日于合肥高济苏祥特药专业药房旗下3家门店购买并接受卡瑞利珠单抗治疗患者的电子药历,记录患者的病史信息和DTP药房药师进行的药学服务数据。对卡瑞利珠单抗相关甲减的发生情况,干预措施和转归,以及患者对药物干预的依从性进行描述性分析。结果共有489例患者纳入分析,男性341例,女性148例;年龄(61±12)岁,范围18~75岁;肺癌129例、食管癌112例、肝癌60例、鼻咽癌8例,淋巴瘤4例,其他肿瘤(超适应证)176例。卡瑞利珠单抗的中位治疗时间为4个月,范围1~24个月;单药治疗者129例,联合化疗者156例,联合靶向药物治疗97例,联合化疗和靶向药物治疗83例,联合化疗和放疗4例,其他治疗方案不明者20例。共16例患者发生甲减,发生率3.3%(16/489),其中6例为DTP药房药师主动识别。16例甲减均经Naranjo因果关系评价法判定为与卡瑞利珠单抗相关;严重程度为2级者15例,1级者1例。1例1级甲减患者未予医学干预,因疾病进展停用卡瑞利珠单抗,甲减好转。发生2级甲减的15例患者均接受左甲状腺素钠治疗,用药1周时评估,依从性良好3例,一般8例,差5例。药师根据影响依从性的主要条目给予不同干预。截至本研究结束,15例2级甲减患者中,4例甲状腺功能恢复正常(其中1例因心律失常停用左甲状腺素钠后恢复正常),2例好转,9例持续异常。结论DTP药房药师开展院外药学服务有助于保障患者治疗依从性和安全用药。

Objective To evaluate the effectiveness of pharmaceutical services of direct to patients(DTP)sale pharmacy,taking the out⁃hospital pharmacy service of hypothyroidism caused by camreli⁃zumab as an example.Methods The electronic drug records of patients who received camrelizumab(the medicine was purchased from 3 stores under the Gaoji Suxiang Specialty Pharmacy in Hefei from July 1,2019 to July 31,2021)were collected and their medical history information and pharmacy service data provided by DTP pharmacists were recorded.The occurrence,intervention measures,and outcomes of camrelizumab⁃related hypothyroidism,as well as the patient′s compliance to the intervention were analyzed descriptively.Results A total of 489 patients were entered in the analysis,including 341 males and 148 females,aged(61±12)years with an range from 18 to 75 years.The drug was used for lung cancer in 129 patients,esopha⁃geal cancer in 112 patients,liver cancer in 60 patients,nasopharyngeal carcinoma in 8 patients,lymphoma in 4 patients,and other tumors beyond indications in 176 patients.The median treatment time of camrelizumab in these patients was 4 months,ranging from 1 to 24 months.Camrelizumab was used in monotherapy in 129 patients,in combination with chemotherapy in 156 patients,in combination with targeted drugs in 97 patients,in combination with both chemotherapy and targeted drugs in 83 patients,and in combination with both chemotherapy and radiotherapy in 4 patients;the additional treatment plans were unknown in 20 patients.Among the 489 patients,16 patients experienced hypothyroidism,with an incidence of 3.3%,of which 6 were actively identified by pharmacists in DTP pharmacy.All 16 cases of hypothyroidism were judged to be associated with camrelizumab by the Naranjo causality evaluation method,and the severity was grade 2 in 15 cases and grade 1 in 1 case.The patient with grade 1 hypothyroidism did not receive medical intervention;camrelizumab was stopped due to disease progression,which resulted in an improvement in hypothyroidism.All 15 patients with grade 2 hypothyroidism received treatment with levothyroxine sodium.In the following 1 week,patient compliance was good,average,and poor in 3,8,and 5 cases,respectively.Pharmacists provided corresponding interventions based on the main items that affected patient compliance.As of the end of this study,among the 15 patients with grade 2 hypothyroidism,the thyroid function turned normal in 4 patients(including 1 who stopped levothyroxine sodium due to arrhythmia),was improved in 2 patients,and had persistent condition in 9 patients.Conclusion Out⁃hospital pharmaceutical services provided by pharmacists in DTP pharmacy helps to ensure patient compliance and safe medication.