JMIR Publications

ABSTRACT

Background:

Commercialized since 2019, (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 hospital pharmacy 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 PASO DOBLE DEMI 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 patient satisfaction with their treatment whether they choose dispensation from a community pharmacy, or retained dispensation from the hospital pharmacy.

Methods:

The methodology is based on the 4-level Kirkpatrick’s evaluation model ; the immediate reaction of community pharmacists following training (Reaction), the knowledge acquisition (Learning), the professional practice (Behavior), and the patients’ satisfaction related to the treatment whether this is dispensed from a hospital or community pharmacy (Results).

Results:

Considering that single outcome measures cannot adequately reflect the complexity of this new organization, the Kirkpatrick’s evaluation model provides a four distinct outcomes ; the immediate reaction after the HEMOPHAR training program, the level of knowledge acquisition after the HEMOPHAR training program, the impact of training on professional practice and the patients satisfaction regarding access to emicizumab.

Conclusions:

The elaboration of the PASO DOBLE DEMI protocol has already a positive impact with the commitment of all health professionals, physicians, hospital and community pharmacists, as well as the patient community. The results will be transmitted to the French authorities and will make it possible, if necessary, to propose this access model to other rare diseases. Clinical Trial: ClinicalTrials.gov NCT05449197 related to the evaluation of Reaction, Learning and Behavior, and NCT05450640 related to the evaluation of Results.