Clinicians' and Patients' Involvement in Reporting Adverse Drug Reactions and Adherence to Treatment of Biological Drugs in Rheumatology, Dermatology, Gastroenterology

• Published in: Drug safety 2022-10, Vol.45 (10), p.1153-1154
• Main Authors: Sapigni, E, Ricciardelli, R, Ajolfi, C, Croce, S, Mogheiseh, N, Nikitina, V, Potenza, A M, Pasi, E, Viani, N, Rolli, M
• Format: Article
• Language: English
• Subjects: Arthritis; Biological products; Cards; Collaboration; Dermatology; Drugs; Effectiveness; Gastroenterology; Health care; Health services; Immunosuppressive agents; Inflammatory diseases; Intestine; Medical electronics; Medical equipment; Medicine; Patient compliance; Patients; Pharmacology; Pharmacovigilance; Psoriasis; Rheumatoid arthritis; Rheumatology; Side effects; Skin diseases; Switches; Systematic review
• ISSN: 0114-5916; 1179-1942

Introduction: Biological/biotechnological drugs play a key role in the treatment of immune-mediated inflammatory diseases, such as rheumatoid arthritis, chronic inflammatory diseases of the intestines and psoriasis. The involvement of clinicians and patients in the reporting of suspected adverse drug reactions (ADRs) is essential, and a more effective interaction aimed at the correct and safe use of medicines should be promoted. It is a regional Pharmacovigilance project funded by the Italian Medicines Agency. Objective: To promote the collection of ADRs to biological drugs used in rheumatology/dermatology/gastroenterology, through an active interaction with clinicians, paying attention to the reports' quality, lack of efficacy and therapeutic switches; to produce information cards that improve adherence to therapy, promote proper methods of home intake and reporting of ADRs. To encourage the use of biosimilar drugs in clinical practice. Methods: A multidisciplinary regional group composed by clinicians and pharmacists of Local Health Units and Hospital Trusts of Modena, Reggio-Emilia, Bologna, Ferrara, Romagna, Pharmacovigilance Regional Centre and Scientific secretary of the Regional Commission of the drug (CRF) was involved. They deepened the topic of the quality of ADRs' reports and shared methods of collection and analysis of ADRs. This collaboration led to definition of information cards regarding each medicinal product and its medical devices, which were developed for patients and distributed for its use in health practice. Results: During the period 02/01/2020-28/02/2022 a total of 232 reports were collected: 72.4% submitted online; 98.7% filled out by clinicians; 37.1% with at least one follow-up; 56.5% with outcome; 94.4% with de-rechallenge; 14,1% with lack of efficacy; 44% with therapeutic switches; > 90% use of biosimilars. The total of 51 patient information cards was produced, combining 25 cards related to active ingredients and 40 cards for medical devices. The contents included: methods of conservation; aspects to be addressed; expected behaviors in case of missed intake; side effects of clinical relevance. Conclusion: The discussion among healthcare professionals has allowed a dialogue on pharmacovigilance, with insights on reports of ineffectiveness and therapeutic switches. A multidisciplinary approach has allowed patients to identify clinical relevance of ADRs and correct use of these drugs. The collaboration between healthcare profess