Smale Elisabeth M, van den Bemt Bart J F, Heerdink Eibert R, Desar Ingrid M E, Egberts Toine C G, Bekker Charlotte L
Department of Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Pharmacy, Sint Maartenskliniek, Ubbergen, the Netherlands.
JAMA Oncol. 2024 Jan 1;10(1):87-94. doi: 10.1001/jamaoncol.2023.4865.
New strategies targeting waste are required to improve financial and ecologic sustainability of expensive therapies, such as oral anticancer drugs, that frequently remain unused by patients. Redispensing unused oral anticancer drugs seems to be a promising strategy when drug quality is guaranteed.
To determine the waste reduction and net cost savings attained by redispensing oral anticancer drugs that go unused by patients compared with the standard practice of disposal.
DESIGN, SETTINGS, AND PARTICIPANTS: The ROAD study was a prospective single-group intervention conducted in the outpatient pharmacies of 4 hospitals in the Netherlands from February 1, 2021, to February 1, 2023, with 12-month follow-up of each patient. Patients with cancer and who had a prescription for an oral anticancer drug that could be stored at room temperature were included. Of 2426 eligible patients, 602 did not consent and 601 did not respond. Data analyses were performed from August 25, 2022, to April 19, 2023.
Participants received oral anticancer drugs for use at home in special packaging (ie, sealed packaging with time-temperature indicator), to be returned to the pharmacy should these remain unused. The pharmacy ensured quality of returned drugs based on authenticity, appearance, remaining shelf life and adequate storage temperature. Drugs fulfilling quality requirements were redispensed to other patients.
Total waste reduction and mean net annual cost savings per patient compared with the standard practice of disposal. Optimization of cost savings was explored by introducing variations in the quality assurance procedure and patient population. All analyses used the average exchange rate for 2021 €1 = US $1.18.
Of 1223 patients with cancer who consented, 1071 participated (median [IQR] age, 70 [62-75] years; 622 [58.1%] were male). In all, 171 patients (16.0%; 95% CI, 13.8%-18.3%) returned 335 unused oral anticancer drug packages. Of the returned drugs, 228 packages were redispensed, which reduced waste by 68.1% (95% CI, 67.7%-68.5%) compared with the standard practice (disposal). Redispensing unused oral anticancer drugs comprised 2.4% (95% CI, 2.2%-2.5%) of total drug costs, providing mean net annual cost savings of US $680 (95% CI, $524-$837) up to $1591 (95% CI, $1226-$2002) per participant.
The findings of this multicenter intervention study indicate that redispensing unused oral anticancer drugs is associated with waste reduction and cost savings, which in turn may improve the affordability and sustainability of cancer treatment.
World Health Organization International Clinical Trials Registry Platform Identifier: NL9208.
需要针对药物浪费制定新策略，以提高昂贵治疗方法（如口服抗癌药物）的财务和生态可持续性，这些药物患者常常未使用。在保证药品质量的情况下，重新调配未使用的口服抗癌药物似乎是一个有前景的策略。
确定与标准处置方法相比，重新调配患者未使用的口服抗癌药物可减少的浪费量及净成本节约情况。
设计、设置和参与者：ROAD研究是一项前瞻性单组干预研究，于2021年2月1日至2023年2月1日在荷兰4家医院的门诊药房进行，对每位患者进行12个月的随访。纳入患有癌症且有可在室温下储存的口服抗癌药物处方的患者。在2426名符合条件的患者中，602名不同意参与，601名未回复。数据分析于2022年8月25日至2023年4月19日进行。
参与者收到用于在家使用的特殊包装（即带有时间 - 温度指示器的密封包装）的口服抗癌药物，若未使用应归还药房。药房根据药品的真实性、外观、剩余保质期和适当储存温度确保归还药品的质量。符合质量要求的药品重新调配给其他患者。
与标准处置方法相比，每位患者减少的总浪费量和平均每年净成本节约情况。通过引入质量保证程序和患者群体的变化来探索成本节约的优化。所有分析使用2021年的平均汇率（1欧元 = 1.18美元）。
在1223名同意参与的癌症患者中，1071名参与（年龄中位数[四分位间距]为70[62 - 75]岁；622名[58.1%]为男性）。共有171名患者（16.0%；95%置信区间，13.8% - 18.3%）归还了335个未使用的口服抗癌药物包装。在归还的药物中，228个包装被重新调配，与标准做法（处置）相比，浪费减少了68.1%（95%置信区间，67.7% - 68.5%）。重新调配未使用的口服抗癌药物占药品总成本的2.4%（95%置信区间，2.2% - 2.5%），每位参与者平均每年净成本节约680美元（95%置信区间，524 - 837美元），最高可达1591美元（95%置信区间，1226 - 2002美元）。
这项多中心干预研究的结果表明，重新调配未使用的口服抗癌药物与减少浪费和节约成本相关，这反过来可能提高癌症治疗的可承受性和可持续性。
世界卫生组织国际临床试验注册平台标识符：NL9208
