Department of Psychological Medicine, Otago Medical School - Dunedin Campus, University of Otago, 464 Cumberland St, Dunedin, 9016, New Zealand.
Department of Psychological Medicine, University of Auckland, Auckland City Hospital, 2 Park Road, Grafton, Auckland, 1142, New Zealand.
Res Social Adm Pharm. 2021 Jul;17(7):1288-1299. doi: 10.1016/j.sapharm.2020.09.014. Epub 2020 Sep 28.
Generic medicines have been associated with less perceived efficacy and more side effects compared to brand name drugs. Educational interventions to improve individuals' negative perceptions of generic medicines show contradictory effects.
This study investigated whether an interventional video that informs about the approval process of releasing medicines has better effects on outcomes related to perceptions and effectiveness of generic medicines in participants with headaches, in comparison with another interventional video that addresses bioequivalence between brand name and generic drugs or a control video.
Participants with frequent tension headaches were randomized to one of three groups (one of two interventional videos or the control video). One of the interventional videos explained the process of approval of generic medicines (n = 34), the other one explained the bioequivalence between brand name and generic drugs (n = 35). The control video informed participants about the epidemiology and etiology of headaches (n = 34). After watching the video, participants treated their next two consecutive episodes of headache with a brand name and a generic analgesic in randomized order.
Self-report measures of understanding and perceptions of and preference for medicines, pain severity and side effects.
Linear mixed models showed that both interventional videos improved participants' understanding of generic medicines. The generic drug approval process video enhanced the perceived effectiveness, safety and quality of generic drugs. The bioequivalence video positively influenced the preference for generic drugs. The brand name and generic drug were equally effective in relieving pain in participants who watched either the generic drug approval process or the bioequivalence video.
Information about both, approving a switch from brand name medicines to generic counterparts and bioequivalence, can be important and should be addressed in future educational interventions.
与品牌名药物相比,仿制药的疗效往往被认为较差,副作用更多。旨在改善个体对仿制药负面看法的教育干预措施显示出矛盾的效果。
本研究旨在调查与另一个介绍品牌名药物和仿制药之间生物等效性的干预视频相比,告知药品放行审批过程的干预视频是否对与参与者对仿制药的看法和疗效相关的结果具有更好的影响,该研究纳入的参与者患有频繁的紧张性头痛。
将患有频繁紧张性头痛的参与者随机分为三组(两个干预视频之一或对照组视频)。一个干预视频解释了仿制药的审批过程(n=34),另一个干预视频解释了品牌名药物和仿制药之间的生物等效性(n=35)。对照组视频告知参与者头痛的流行病学和病因(n=34)。观看视频后,参与者以随机顺序用品牌名和仿制药镇痛药治疗接下来的两个连续头痛发作。
对药物的理解、看法和偏好、疼痛严重程度和副作用的自我报告措施。
线性混合模型显示,两个干预视频均提高了参与者对仿制药的理解。仿制药审批过程视频增强了对仿制药的有效性、安全性和质量的感知。生物等效性视频对仿制药的偏好产生了积极影响。观看仿制药审批过程或生物等效性视频的参与者中,品牌名和仿制药在缓解疼痛方面同样有效。
有关批准从品牌名药物转换为仿制药以及生物等效性的信息可能很重要,应在未来的教育干预中加以解决。