Programma d’intervento educativo per la promozione dell’aderenza terapeutica, controllo della patologia e funzione polmonare nei pazienti asmatici nel setting della farmacia di comunità

The present PhD project, which originated in collaboration with the Italian Society of Clinical Pharmacy (SIFAC), aimed to develop and test the effect of an educational intervention delivered by pharmacists on adherence to treatment, disease control and lung function in patients with asthma. The thesis reports a) the data of the study aimed at evaluating the effectiveness of the educational intervention program and b) the results of the validation process of the Italian version of the Test of Adherence to Inhalers (TAI test). a) The lack of therapeutic adherence represents one of the most important and relevant problems in clinical practice, especially in the treatment of chronic diseases. It is estimated that more than 50% of asthmatic patients do not take the prescribed medication as indicated by the physician: most of these subjects use inhalation therapy incorrectly or abandon it because they do not feel the need. Besides, understanding the indications and posology of the therapy plays a fundamental role in adhering to the therapy. Patients who do not fully understand the indications, perceive the therapy as less effective and safe. In addition to that, despite the indisputable positive effects of the education and training on the correct use of the medical device in chronic inhalation therapy, more than one in four patients do not receive instructions on the use of prescribed inhalers. Given the above, and since numerous studies have highlighted the crucial role of pharmacists in promoting therapeutic adherence in the management of respiratory diseases, this research project intended to evaluate the effectiveness of an educational intervention program, conducted by clinical pharmacists, guided by patient profiling using cognitive questionnaires and analytical tools. Overall, 34 Italian community pharmacies participated in the multicentric, prospective comparative study (intervention group: 23 pharmacies; control group: 11 pharmacies) and 242 subjects were enrolled (167 in the intervention group, 75 in the control group). Adherence to inhalation therapy (TAI test), asthma control (Asthma Control Test, ACT) and lung function (% FEV1 and% PEF ideal) were assessed in the enrolled subjects, at time zero and again after 2 months. The educational intervention at baseline was based on TAI results and administered by specifically trained pharmacists. Significant improvement in TAI score, ACT and lung function parameters (p-value <0.001) was detected between time zero and the follow-up visit in patients belonging to the intervention group. Patients with ACT ≥20 at time zero maintained greater proportion of disease control in the intervention group than in the control arm (95% vs 79.5%, p = 0.004). From the results obtained, it was possible to verify that the administration of targeted educational interventions guided by the results of the TAI questionnaire, conducted by trained clinical pharmacists, can help improve adherence to inhalation therapy and promote asthma control. b) Several approaches are available to assess the level of adherence. The TAI Test (Test of Adherence to Inhalers), is the only tailored tool which is able to evaluate the adherence to inhalers in patients with asthma. The questionnaire has been originally developed in Spain. To date, the Italian version of the TAI Test questionnaire has not been validated yet. Through the data of my PhD research project, it has been possible to describe the psychometric properties of the Italian version of the TAI test in terms of validity and reliability. The validation process involved more than 80 patients in two different rounds: at baseline and after two months. At each visit, patients were administered the Italian version of TAI. The results of our study confirm that the Italian version of the TAI is a valid and reliable tool to identify and monitor non-adherence.