目的 在真实世界中比较国家组织集中带量采购(以下简称“带量采购”)政策实施后,抗高血压药的仿制品种替换对患者处方依从性的影响。方法 采用回顾性队列研究,筛选“带量采购”实施前,连续处方氨氯地平、氯沙坦、厄贝沙坦和厄贝沙坦氢氯噻嗪4种药物中≥1种、且“带量采购”实施后继续处方上述同通用名药物的患者,根据在“带量采购”实施后是否替换为仿制品种分为仿制替换组和非仿制替换组,仿制替换组根据替换仿制品种后是否再次替换为原研品种分为二次替换组和非二次替换组,比较进行仿制品种替换和仿制替换后进行二次替换对患者处方依从性、剂量调整等结局的影响,并探究其他影响患者处方依从性的因素。结果 氯沙坦替换为仿制品种的患者构成比显著高于其他药物,氨氯地平进行仿制替换后再次替换回原研药品患者的构成比高于氯沙坦,氯沙坦非仿制替换组中断治疗率高于仿制替换组,4种药品的仿制替换组剂量调整率均高于非仿制替换组。年龄和本地居住是患者进行仿制品种替换的影响因素,本地居住、年龄≥65岁和固定科室就诊是患者替换为仿制品种后再次替换为原研品种的影响因素。结论 “带量采购”政策实施后,既往处方抗高血压药原研品种的患者替换为仿制品种,对处方依从性无显著影响,但可能影响医师处方时的剂量选择。年龄、居住地和是否固定科室就诊可能影响患者抗高血压药的品种选择,值得临床关注。
Abstract
OBJECTIVE To compare the effect of generic variety replacement of antihypertensive drugs on prescription compliance after the implementation of the national organization centralized procurement policy in the real world. METHODS A retrospective cohort study was conducted to select patients who were continuously prescribed amlodipine, losartan, irbesartan and irbesartan hydrochlorothiazide before the implementation of dose procurement, and continued to prescribe the above drugs with the same generic name after the implementation of dose procurement, and were divided into generic replacement group and non-generic replacement group according to whether they were replaced with generic varieties after the implementation of dose procurement. The generic replacement group was divided into the secondary replacement group and the non-secondary replacement group according to whether the generic varieties were replaced with the original varieties again. The effects of generic varieties replacement and secondary replacement after generic varieties replacement on outcomes such as prescription compliance and dose adjustment were compared, and other factors affecting patients′ prescription compliance were explored. RESULTS The composition ratio of patients replaced with generic losartan was significantly higher than that of other drugs, the composition ratio of patients replaced with original drug again after generic replacement of amlodipine was higher than that of losartan, the interruption rate of treatment in non-generic replacement group was higher than that in generic replacement group, and the dose adjustment rate in generic replacement group of 4 drugs was higher than that in non-generic replacement group. Age and local residence were influencing factors for generic variety replacement, while local residence, age ≥65 years old, and visit to fixed department were influencing factors for patients replaced by generic varieties and then replaced by original varieties. CONCLUSIONS After the implementation of the national centralized drug procurement policy, patients who had previously prescribed original antihypertensive drugs were replaced by generic drugs, which had no significant effect on prescription compliance, but might affect the choice of dosage when prescribing by physicians. Age, residence and fixed department may affect the selection of antihypertensive drugs, which is worthy of clinical attention.
关键词
抗高血压药 /
带量采购 /
仿制药 /
品种替换 /
处方依从性
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Key words
antihypertensive drug /
national centralized drug procurement /
generic drug /
variety replacement /
prescription compliance
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中图分类号：
R95
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参考文献
[1] Revision Committee of Guidelines on Hypertension Prevention and Treatment, Hypertension Alliance (China) Cardiovascular Branch of Chinese Medical Association, Hypertension Professional Committee of Chinese Medical Doctor Association, et al. 2018 Chinese guidelines for the management of hypertension[J]. Chin J Cardiovasc Med (中国心血管杂志), 2019, 24(1):24-56.
[2] SICRAS-MAINAR A, SáNCHEZ-áLVAREZ L, NAVARRO-ARTIEDA R, et al. Treatment persistence and adherence and their consequences on patient outcomes of generic versus brand-name statins routinely used to treat high cholesterol levels in Spain: a retrospective cost-consequences analysis[J]. Lipids Health Dis, 2018, 17(1):277.
[3] DEGLI ESPOSTI L, SANGIORGI D, BUDA S, et al. Therapy discontinuation or substitution in patients with cardiovascular disease, switching among different products of the same off-patent active substance: a ‘real-world’ retrospective cohort study[J]. BMJ Open, 2016, 6(11):e012003.
[4] HEDEGAARD U, KJELDSEN L J, POTTEGÄRD A, et al. Improving medication adherence in patients with hypertension: a randomized trial[J]. Am J Med, 2015, 128(12):1351-1361.
[5] VIPREY M, XUE Y, ROUSSEAU A, et al. Adherence with brand versus generic bisphosphonates among osteoporosis patients: a new-user cohort study in the French National Healthcare Insurance database[J]. Sci Rep, 2020, 10(1):7446.
[6] MISHUK A U, CHEN L, LI C, et al. Patient factors associated with oral generic olanzapine initiation and substitution among Medicaid beneficiaries: a new user cohort study[J]. Curr Med Res Opin, 2021, 37(4):655-664.
[7] Circular of The General Office of the State Council on Printing and distributing the Pilot Program for the Centralized Procurement and Use of Drugs organized by the State(国务院办公厅关于印发国家组织药品集中采购和使用试点方案的通知)[EB/OL]. (2019-01-17)[2022-11-28]. http://www.gov.cn/zhengce/content/2019-01/17/content_5358604.htm.
[8] TRUSELL H, SUNDELL K A. Effects of generic substitution on refill adherence to statin therapy: a nationwide population-based study[J]. BMC Health Serv Res, 2014, 14:626.
[9] HANSEN R A, QIAN J, BERG R, et al. Comparison of generic-to-brand switchback rates between generic and authorized generic drugs[J]. Pharmacotherapy, 2017, 37(4):429-437
[10] RODRIGUEZ F, MARON D J, KNOWLES J W, et al. Association of statin adherence with mortality in patients with atherosclerotic cardiovascular disease[J]. JAMA Cardiol, 2019, 4(3):206-213.
[11] HUANG T, BAI L, WUSHOUER H, et al. Clinical outcome and medical cost of originator and generic antihypertensive drugs: a population-based study in Yinzhou, China[J]. Front Pharmacol, 2022, 13:757398.
[12] ZHANG S Y, TAO L Y, YANG Y Y, et al. Evaluation of blood pressure lowering effect by generic and brand-name antihypertensive drugs treatment: a multicenter prospective study in China[J]. Chin Med J (Engl Ed) (中华医学杂志英文版), 2021, 134(3):292-301.
[13] QU J, ZUO W, TOOK R L, et al. A nationwide survey exploring physicians′ and pharmacists′ knowledge, awareness and perceptions regarding generic medicines in China[J]. BMC Health Serv Res, 2022, 22(1):1069.
[14] LI C, CHEN L, HUO N, et al. Generic escitalopram initiation and substitution among medicare beneficiaries: a new user cohort study[J]. PLoS One, 2020, 15(4):e0232226.
[15] UDE M, SCHUESSEL K, QUINZLER R, et al. Generic switch after ramipril patent expiry is not associated with decreased pharmacy refill compliance: a retrospective study using the DAPI database[J]. J Hypertens, 2011, 29(9):1837-1845.
[16] HUO N, CHEN L, ULLAH MISHUK A, et al. Generic levothyroxine initiation and substitution among Medicare and Medicaid populations: a new user cohort study[J]. Endocrine, 2020, 68(2):336-348.
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基金
国家自然科学基金面上项目资助(81974183);中央高水平医院临床科研业务费资助(2022-PUMCH-B-060);中国药学会-施维雅青年医院药学创新资助项目(CPA-B04-ZC-2023-001)
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