Use of non-specific immunoglobulins in Catalonia in three third-level hospitals: a descriptive analysis of a hospital-prescribed medication registry
BackgroundThe increasing use of non-specific immunoglobulins (NSIGs) and their current shortage show a need for NSIGs’ use prioritization. Data from a clinical perspective are necessary, mainly for pediatric patients.ObjectivesThe aim of the study was to assess the level of clinical evidence (LoE) o...
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Frontiers Media S.A.
2024-12-01
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| author | J. Riera-Arnau J. Riera-Arnau E. Ballarín R. Llop R. Llop E. Montané E. Montané P. Hereu P. Hereu G. Vancells N. Padullés-Zamora N. Padullés-Zamora A. M. Barriocanal G. Cardona-Peitx C. Casasnovas C. Casasnovas J. B. Montoro M. Nuñez E. Santacana Juncosa E. Santacana Juncosa A. Selva-O’Callaghan X. Solanich X. Solanich X. Solanich M. Sabaté Gallego M. Sabaté Gallego |
| author_facet | J. Riera-Arnau J. Riera-Arnau E. Ballarín R. Llop R. Llop E. Montané E. Montané P. Hereu P. Hereu G. Vancells N. Padullés-Zamora N. Padullés-Zamora A. M. Barriocanal G. Cardona-Peitx C. Casasnovas C. Casasnovas J. B. Montoro M. Nuñez E. Santacana Juncosa E. Santacana Juncosa A. Selva-O’Callaghan X. Solanich X. Solanich X. Solanich M. Sabaté Gallego M. Sabaté Gallego |
| author_sort | J. Riera-Arnau |
| collection | DOAJ |
| description | BackgroundThe increasing use of non-specific immunoglobulins (NSIGs) and their current shortage show a need for NSIGs’ use prioritization. Data from a clinical perspective are necessary, mainly for pediatric patients.ObjectivesThe aim of the study was to assess the level of clinical evidence (LoE) of the indications that NSIGs are used for, the reasons for discontinuation, and the costs invested.MethodsA retrospective multicentric study was conducted on NSIG incident users between September 2019 and December 2021 retrieved from the Registry of Patients and Treatments (RPT) from Catalonia (Spain). LoE was categorized as A) authorized indications, B) unauthorized with scientific support, C) unauthorized without support, and D) unknown (UNK), following local and the United Kingdom’s guidelines as a sensitivity analysis. We also estimated overall spending and costs per patient visit.ResultsA total of 400 patients were included (17.3% pediatric), with a mean follow-up of 122.1/person-years for adults. The most frequent indications were nervous system and blood diseases. Almost all pediatric patients (56; 81.2%) were treated under A-level indications, as for 217 (65.6%) adults. In the sensitivity analysis, the A-level usage rate decreased to one-third and the B-level usage rate increased by 2–3 times. Furthermore, 37.8% (151) of individuals discontinued. This was predominantly due to remission or no response. The total costs were 868,462.6€/year, with median spending per visit amounting to 1,500€ for adults and 700€ for pediatric patients.ConclusionNSIGs are used in clinical practice mainly for approved indications; however, non-approved indications are still an important issue. This could represent a significant economic burden on the healthcare system, focusing on the pediatric population and those at risk for discontinuation with alternative therapeutic options. |
| format | Article |
| id | doaj-art-4c7585f2997e4b1d9e8aff4b9e2a741d |
| institution | OA Journals |
| issn | 1663-9812 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Frontiers Media S.A. |
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| spelling | doaj-art-4c7585f2997e4b1d9e8aff4b9e2a741d2025-08-20T02:35:46ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122024-12-011510.3389/fphar.2024.14206821420682Use of non-specific immunoglobulins in Catalonia in three third-level hospitals: a descriptive analysis of a hospital-prescribed medication registryJ. Riera-Arnau0J. Riera-Arnau1E. Ballarín2R. Llop3R. Llop4E. Montané5E. Montané6P. Hereu7P. Hereu8G. Vancells9N. Padullés-Zamora10N. Padullés-Zamora11A. M. Barriocanal12G. Cardona-Peitx13C. Casasnovas14C. Casasnovas15J. B. Montoro16M. Nuñez17E. Santacana Juncosa18E. Santacana Juncosa19A. Selva-O’Callaghan20X. Solanich21X. Solanich22X. Solanich23M. Sabaté Gallego24M. Sabaté Gallego25Department of Clinical Pharmacology, Vall d’Hebron Hospital Universitari, Vall Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona (UAB), Barcelona, SpainDepartment of Clinical Pharmacology, Vall d’Hebron Hospital Universitari, Vall Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Clinical Pharmacology, Hospital Universitari de Bellvitge, Bellvitge Hospital Campus, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, SpainPatology and Experimental Therapeutics Department, Universitat de Barcelona (UB), Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona (UAB), Barcelona, SpainDepartment of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol, Germans Trias i Pujol Hospital Campus, Barcelona, SpainDepartment of Clinical Pharmacology, Hospital Universitari de Bellvitge, Bellvitge Hospital Campus, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, SpainPatology and Experimental Therapeutics Department, Universitat de Barcelona (UB), Barcelona, SpainPharmacy Service, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainPharmacy Service, Hospital Universitari de Bellvitge, Bellvitge Hospital Campus, Barcelona, SpainPharmacotherapy, Pharmacogenetics and Pharmaceutical Technology Group, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, SpainFundació d’Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP), Barcelona, Spain0Pharmacy Service, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain1Neuromuscular Unit, Neurology Department, Bellvitge University Hospital, Barcelona, Spain2Neurometabolic Diseases Group, Bellvitge Biomedical Research Institute (IDIBELL) and CIBERER, Barcelona, SpainPharmacy Service, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol, Germans Trias i Pujol Hospital Campus, Barcelona, SpainPharmacy Service, Hospital Universitari de Bellvitge, Bellvitge Hospital Campus, Barcelona, SpainPharmacotherapy, Pharmacogenetics and Pharmaceutical Technology Group, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain3Internal Medicine Department, Autoimmune Systemic Diseases Unit, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain4Internal Medicine Department, Hospital Universitari de Bellvitge, Barcelona, Spain5Systemic Diseases and Aging Group, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain6Faculty of Medicine and Health Sciences, Universitat de Barcelona, Barcelona, SpainDepartment of Clinical Pharmacology, Vall d’Hebron Hospital Universitari, Vall Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona (UAB), Barcelona, SpainBackgroundThe increasing use of non-specific immunoglobulins (NSIGs) and their current shortage show a need for NSIGs’ use prioritization. Data from a clinical perspective are necessary, mainly for pediatric patients.ObjectivesThe aim of the study was to assess the level of clinical evidence (LoE) of the indications that NSIGs are used for, the reasons for discontinuation, and the costs invested.MethodsA retrospective multicentric study was conducted on NSIG incident users between September 2019 and December 2021 retrieved from the Registry of Patients and Treatments (RPT) from Catalonia (Spain). LoE was categorized as A) authorized indications, B) unauthorized with scientific support, C) unauthorized without support, and D) unknown (UNK), following local and the United Kingdom’s guidelines as a sensitivity analysis. We also estimated overall spending and costs per patient visit.ResultsA total of 400 patients were included (17.3% pediatric), with a mean follow-up of 122.1/person-years for adults. The most frequent indications were nervous system and blood diseases. Almost all pediatric patients (56; 81.2%) were treated under A-level indications, as for 217 (65.6%) adults. In the sensitivity analysis, the A-level usage rate decreased to one-third and the B-level usage rate increased by 2–3 times. Furthermore, 37.8% (151) of individuals discontinued. This was predominantly due to remission or no response. The total costs were 868,462.6€/year, with median spending per visit amounting to 1,500€ for adults and 700€ for pediatric patients.ConclusionNSIGs are used in clinical practice mainly for approved indications; however, non-approved indications are still an important issue. This could represent a significant economic burden on the healthcare system, focusing on the pediatric population and those at risk for discontinuation with alternative therapeutic options.https://www.frontiersin.org/articles/10.3389/fphar.2024.1420682/fullnon-specific human immunoglobulinsdrug utilizationpatient safetyhospital registrydiscontinuationcosts |
| spellingShingle | J. Riera-Arnau J. Riera-Arnau E. Ballarín R. Llop R. Llop E. Montané E. Montané P. Hereu P. Hereu G. Vancells N. Padullés-Zamora N. Padullés-Zamora A. M. Barriocanal G. Cardona-Peitx C. Casasnovas C. Casasnovas J. B. Montoro M. Nuñez E. Santacana Juncosa E. Santacana Juncosa A. Selva-O’Callaghan X. Solanich X. Solanich X. Solanich M. Sabaté Gallego M. Sabaté Gallego Use of non-specific immunoglobulins in Catalonia in three third-level hospitals: a descriptive analysis of a hospital-prescribed medication registry Frontiers in Pharmacology non-specific human immunoglobulins drug utilization patient safety hospital registry discontinuation costs |
| title | Use of non-specific immunoglobulins in Catalonia in three third-level hospitals: a descriptive analysis of a hospital-prescribed medication registry |
| title_full | Use of non-specific immunoglobulins in Catalonia in three third-level hospitals: a descriptive analysis of a hospital-prescribed medication registry |
| title_fullStr | Use of non-specific immunoglobulins in Catalonia in three third-level hospitals: a descriptive analysis of a hospital-prescribed medication registry |
| title_full_unstemmed | Use of non-specific immunoglobulins in Catalonia in three third-level hospitals: a descriptive analysis of a hospital-prescribed medication registry |
| title_short | Use of non-specific immunoglobulins in Catalonia in three third-level hospitals: a descriptive analysis of a hospital-prescribed medication registry |
| title_sort | use of non specific immunoglobulins in catalonia in three third level hospitals a descriptive analysis of a hospital prescribed medication registry |
| topic | non-specific human immunoglobulins drug utilization patient safety hospital registry discontinuation costs |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2024.1420682/full |
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