Cedeño Erica, Cruz Ambar, Cortés Joaris, Melin Kyle, Roman Luis, Gonzalez Angel, Duconge Jorge, Santiago Darlene
Department of Pharmacy Practice, School of Pharmacy, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.
Department of Chemistry, Rio Piedras Campus, University of Puerto Rico, San Juan, Puerto Rico.
Patient Prefer Adherence. 2022 Jan 11;16:69-78. doi: 10.2147/PPA.S336155. eCollection 2022.
Differences in the suppression of withdrawal symptoms have been observed in opioid-use-disorder (OUD) patients who were switched from Suboxone (the brand name of buprenorphine/naloxone sublingual films) to either 1 of 2 generic versions. These descriptive observations evidence the need to further assess the use of these generics and its impact on the adherence to and outcomes of OUD treatments. The objective of this case series was to describe patient and provider experiences, perceptions, and preferences when said patients were abruptly switched from Suboxone to one of the generic versions manufactured by Sandoz or Alvogen.
A retrospective chart review of 24 Suboxone-maintained OUD patients from a single clinic who were forced to switch to a generic was performed to collect withdrawal and craving symptoms that occurred after the switch, as well as toxicology results and changes in dose (documented by the provider).
The medical records of 9 (37.5%) of the 24 patients showed that they were suffering from withdrawal symptoms and/or cravings, had had their doses adjusted, and/or had had a positive urine toxicology screen. All 9 subjects communicated a preference for the brand formulation over that of either of the generic versions; few expressed a preference for one generic formulation over the other. None of patients were able to switch back to the brand formulation, nor were any of them able to choose the generic that worked best for them. Insomnia, muscle pain, and gooseflesh skin were the most common withdrawal symptoms reported by the patients using the generics. Better outcomes were observed in patients who received a buprenorphine dose increase (2 mg) to suppress the withdrawal symptoms experienced while using the generics.
Our study serves as a reference to prescribers regarding approaches (eg, a small dose adjustment) that may potentially encourage OUD treatment adherence and even improve outcomes in patients who appear to be decompensating after the brand-to-generic switch.
在从舒倍生（丁丙诺啡/纳洛酮舌下膜片的商品名）换用两种仿制药之一的阿片类物质使用障碍（OUD）患者中，观察到了戒断症状抑制方面的差异。这些描述性观察结果表明，有必要进一步评估这些仿制药的使用情况及其对OUD治疗依从性和疗效的影响。本病例系列的目的是描述患者和医疗服务提供者在患者突然从舒倍生换用山德士或奥维根生产的仿制药之一时的经历、看法和偏好。
对来自单一诊所的24名使用舒倍生维持治疗的OUD患者进行回顾性病历审查，这些患者被迫换用仿制药，以收集换药后出现的戒断和渴求症状，以及毒理学结果和剂量变化（由医疗服务提供者记录）。
24名患者中有9名（37.5%）的病历显示，他们出现了戒断症状和/或渴求，剂量进行了调整，和/或尿液毒理学筛查呈阳性。所有9名受试者都表示更喜欢品牌制剂而非任何一种仿制药；很少有人表示更喜欢一种仿制药制剂而非另一种。没有患者能够换回品牌制剂，也没有人能够选择最适合自己的仿制药。失眠、肌肉疼痛和鸡皮疙瘩是使用仿制药的患者报告的最常见戒断症状。在接受丁丙诺啡剂量增加（2毫克）以抑制使用仿制药时出现的戒断症状的患者中，观察到了更好的疗效。
我们的研究为开处方者提供了参考，涉及可能有助于鼓励OUD治疗依从性，甚至改善在从品牌药换用仿制药后似乎出现失代偿的患者疗效的方法（例如小剂量调整）。
