Background and importance The problem of severe asthma refractory to treatment has been addressed in clinical practice guidelines but there is still a notable percentage of patients poorly controlled, under treated and with inadequate follow-up. The pharmacy service (PS) of a third level hospital proposed a pharmaceutical care programme (PCP) to dispense omalizumab in prefilled syringes for self-administration in hospital and subsequently the patient would self-administer at home.
Aim and objectives To evaluate the effectiveness and safety of treatment with omalizumab after implementation of a PCP for asthmatic patients treated with omalizumab in January 2019.
Material and methods In this observational retrospective study, all patients treated with omalizumab in our hospital and who had started the PCP were included. The primary endpoint was the degree of effectiveness and safety of omalizumab in patients with the new protocol. The effectiveness indicators used to compare the study periods were: the number of exacerbations due to asthma, asthma control test for people over 12 years of age (ACT12 score) and clinical status assessment of asthma by a doctor (reduction in forced expiratory volume in 1 s (FEV1)). Exacerbation was defined as an increase in symptomatology that required systemic corticosteroid recovery treatment. Secondary endpoints included adherence to treatment and treatment modifications.
Results A total of 28 patients were evaluated, 50% women, with a mean age of 24 years (8–56), and an average treatment duration with omalizumab of 29 months (1–66). Since the introduction of the PCP, 18% of patients suffered exacerbations (1–4) with an average ACT12 score of 11: 40% of patients showed an improvement in FEV1 and no patient reported a reaction at the injection site. Adherence to omalizumab was 96% but adherence to the basic treatment was only good in 45% of patients and was 0% in four patients.
Conclusion and relevance Implementation of the PCP allowed follow-up of efficacy and safety of omalizumab treatment.
References and/or acknowledgements 1. European public assessment report of omalizumab (https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf).
I would like to express my great appreciation to the staff of the service.
No conflict of interest.