背景:自2019年商业化以来,emicizumab(Hemlibra)仅在法国医院药房使用,用于预防有或没有抑制剂的血友病A。自2021年6月15日起,患者可以在医院和社区药房之间进行选择。护理途径的这些变化对患者具有重要的组织后果,他们的亲戚,和卫生专业人员。社区药剂师有两个培训计划:国家血友病参考中心提出的“HEMOPHAR”培训计划和销售产品的实验室提出的罗氏培训计划。
目的:PASODOBLEDEMI研究旨在评估在分配emicizumab的情况下,向社区药剂师提供的培训计划的直接影响。并评估患者对其治疗的满意度,无论他们选择从社区药房分配还是从医院药房保留分配。
方法:我们基于4级Kirkpatrick评估模型设计了一项横断面研究:社区药剂师在培训后的即时反应(反应),在培训(学习)期间获得的知识,社区药剂师在分配产品期间的专业实践(行为),以及患者对治疗的满意度,无论是从医院还是从社区药房分发(结果)。
结果:考虑到单一结果指标不能充分反映这个新组织的复杂性,Kirkpatrick评估模型提供了4种不同的结果:HEMOPHAR训练计划后的即时反应,在HEMOPHAR培训计划后获得的知识水平,培训对专业实践的影响,和患者对emicizumab的满意度。我们为柯克帕特里克评估模型的4个级别中的每个级别开发了专门的问卷。所有参与分配emicizumab的社区药剂师,无论他们是否遵循HEMOPHAR或罗氏培训计划,有资格列入。所有重度血友病A患者均符合条件,无论使用抑制剂,年龄,用emicizumab治疗,以及他们是否选择从社区药房分配或从医院药房保留分配。
结论:在法国社区药房为A型血友病患者配药emicizumab的新组织必须伴随着最佳的安全性和质量条件,因为在罕见出血性疾病的管理中存在严重和紧急出血情况的风险。PASODOBLEDEMI协议的制定已经对所有卫生专业人员的承诺产生了积极影响,医师,医院和社区药剂师,和病人社区。结果将在法国当局之间传播,并将使,如有必要,提出了其他罕见疾病的获取模式。
背景:ClinicalTrials.govNCT05449197,https://clinicaltrials.gov/ct2/show/NCT05449197?term=NCT05449197;ClinicalTrials.govNCT05450640,https://ct2/show/NCT450term=CT640
未经批准:DERR1-10.2196/43091。
BACKGROUND: Commercialized since 2019, emicizumab (Hemlibra) was available only in French hospital pharmacies for prophylaxis of hemophilia A with or without inhibitors. Since June 15, 2021, patients can choose between a hospital and community pharmacy. These changes in the care pathway have important organizational consequences for patients, their relatives, and health professionals. Two training programs are available for community pharmacists: the \"HEMOPHAR\" training program proposed by the national reference center for hemophilia and the Roche training program proposed by the laboratory that markets the product.
OBJECTIVE: The PASODOBLEDEMI study aims to evaluate the direct impact of the training programs provided to community pharmacists in the context of the dispensing of emicizumab, and to evaluate patients\' satisfaction with their treatment whether they choose dispensation from a community pharmacy or retained dispensation from the hospital pharmacy.
METHODS: We designed a cross-sectional study based on the 4-level
Kirkpatrick evaluation model: the immediate reaction of community pharmacists following training (Reaction), the knowledge acquired during the training (Learning), the professional practice of community pharmacists during dispensing of the product (Behavior), and patients\' satisfaction related to the treatment whether it is dispensed from a hospital or from a community pharmacy (Results).
RESULTS: Considering that single outcome measures cannot adequately reflect the complexity of this new organization, the
Kirkpatrick evaluation model provides 4 distinct outcomes: the immediate reaction after the HEMOPHAR training program, the level of knowledge acquired after the HEMOPHAR training program, the impact of training on professional practice, and patient satisfaction with access to emicizumab. We developed specialized questionnaires for each of the 4 levels of the
Kirkpatrick evaluation model. All community pharmacists involved in dispensing emicizumab, whether they have followed the HEMOPHAR or the Roche training program or neither, were eligible for inclusion. All patients with severe hemophilia A were eligible, irrespective of inhibitor use, age, treatment with emicizumab, and whether they chose dispensation from a community pharmacy or retained dispensation from a hospital pharmacy.
CONCLUSIONS: The new organization for dispensing emicizumab to patients with hemophilia A in French community pharmacies must be accompanied by optimal safety and quality conditions due to the risk of serious and urgent bleeding situations in the management of rare bleeding diseases. The elaboration of the PASODOBLEDEMI protocol has already a positive impact with the commitment of all health professionals, physicians, hospital and community pharmacists, and the patient community. The results will be disseminated among the French authorities and will enable, if necessary, proposing this access model to other rare diseases.
BACKGROUND: ClinicalTrials.gov NCT05449197, https://clinicaltrials.gov/ct2/show/NCT05449197?term=NCT05449197; ClinicalTrials.gov NCT05450640, https://clinicaltrials.gov/ct2/show/NCT05450640?term=NCT05450640.
UNASSIGNED: DERR1-10.2196/43091.