Education Center for Clinical Pharmacy, Faculty of Pharmacy, Takasaki University of Health and Welfare, Takasaki, Gunma, Japan.
Department of Clinical Pharmacology and Therapeutics, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
Eur J Hosp Pharm. 2024 Oct 25;31(6):555-559. doi: 10.1136/ejhpharm-2022-003632.
Lenalidomide, a hazardous drug, has strict distribution controls. However, the risk of contamination with lenalidomide when patients take the drug has not been studied and the risk of drug exposure to people in the patient's living environment is unknown. Thus, we investigated the amount of lenalidomide that could be dispersed during the period between removal of the capsule and returning the used blister packages, and we considered the conditions under which lenalidomide could be dispersed and countermeasures.
The amount of lenalidomide contamination was measured on the outside of the unused blister packages returned by the patients, on the surface of the capsule, and on the inside of the package immediately after removal of the capsule. In addition, the amount of contamination was measured on the blister packages used by the patients and on the gloves worn by the pharmacists on receipt of the packages. Lenalidomide was analysed by liquid chromatography-tandem mass spectrometry.
Lenalidomide amounts on the outside of the unused blister packages returned by the three patients were <10, <10, and 26.8 ng/pack, those on the capsule surface immediately after removal from the packages were 297, 388, and 297 ng/capsule, and those on the inside of packages immediately after removal of all capsules were 143, 184, and 554 ng/pack, respectively. A median of 15.6 ng/pack lenalidomide was detected on the surface of packages used by the patients (n=18). The lenalidomide remaining in the packages immediately after capsule removal (200 ng/pack), except for the 15.6 ng/pack detected in the packages used by the patients, may have been dispersed in the patient's living environment (90% or more). The maximum amount of lenalidomide on the surface of the packages used by the patients was over 2500 ng/pack.
The amount of lenalidomide contamination per package was found to be at least 100 ng less after collection by the pharmacist than immediately after removal of the capsules. Therefore, it is recommended to clean the surrounding area and wash one's hands after taking the capsules.
来那度胺是一种危险药物，其分发受到严格控制。然而，患者服用该药时污染的风险尚未得到研究，患者生活环境中的人员接触药物的风险也不得而知。因此，我们调查了胶囊被取出和用过的泡罩包装被退回之间这段时间内可能分散的来那度胺量，并考虑了来那度胺可能分散的条件和应对措施。
测量了患者退回的未使用泡罩包装的外部、胶囊表面和胶囊取出后包装内部的来那度胺污染量。此外，还测量了患者使用的泡罩包装和药剂师在收到包装时戴的手套上的污染量。采用液相色谱-串联质谱法分析来那度胺。
三位患者退回的未使用泡罩包装外部的来那度胺量分别为<10、<10 和 26.8 ng/包，从包装中取出胶囊后立即测量胶囊表面的来那度胺量为 297、388 和 297 ng/胶囊，立即取出所有胶囊后的包装内部的来那度胺量分别为 143、184 和 554 ng/包。患者使用的包装表面检测到中位数为 15.6 ng/包的来那度胺（n=18）。胶囊取出后包装中残留的来那度胺（200 ng/包），除了患者使用的包装中检测到的 15.6 ng/包外，可能已在患者的生活环境中分散（90%或更多）。患者使用的包装表面上的来那度胺最大量超过 2500 ng/包。
与胶囊取出后立即相比，药剂师收集后每个包装的来那度胺污染量至少减少了 100 ng。因此，建议在服用胶囊后清洁周围环境并洗手。
