R M Micó-Pérez1, C Payares-Herrera2, P I Palomo-Jiménez3, J Sánchez-Fierro4, C Avendaño-Solá2, J L Llisterri-Caro5. 1. Consultorio Fontanars dels Alforins, EAP Ontinyent, Valencia, España. Electronic address: rmicop@semergen.es. 2. Servicio de Farmacología Clínica, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, España. 3. Departamento Médico Sanofi-Aventis, Madrid, España. 4. Abogado especialista en derecho sanitario, Madrid, España. 5. Centro de Salud Ingeniero Joaquín Benlloch, Valencia, España.
Abstract
INTRODUCTION: The objective of this study was to evaluate the awareness and training needs on biosimilar drugs in Primary Care (PC) physicians. MATERIAL AND METHODS: Descriptive cross-sectional study based on an on-line questionnaire with a total of 34 multiple choice questions, published on the SEMERGEN website. The main Knowledge areas were: biosimilar definition; regulatory and legal framework; prescription, traceability, interchangeability and pharmacovigilance; availability of biosimilars in the PC setting, and the biosimilars contribution to sustainability. The software used for the analysis and data processing was the Barbwin 7.5. RESULTS: An analysis was performed on the responses from 701 questionnaires completed. There was a slight majority (57%) of women participants. The majority of participant worked in urban centres (60.91%). The definition of biosimilar was not known by 58% of those that responded, and 73% were unaware that the management of biosimilars and generics was not comparable. Most (84%) of those that responded were not aware that the studies required for the approval of biosimilars is different from reference biological medicines. Around two-thirds (66%) those that responded did not know of any biosimilars available in PC setting, and the 94% were also unaware of the Spanish legal framework for the management of biosimilar medicines. CONCLUSIONS: The current knowledge about biosimilars among PC physicians is low. The critical areas in need of further training include specific information on biosimilars currently available in PC setting, as well as key aspects regarding prescription, interchangeability and pharmacovigilance requirements. Six out of ten doctors do not know of any biosimilar used in PC in Spain.
INTRODUCTION: The objective of this study was to evaluate the awareness and training needs on biosimilar drugs in Primary Care (PC) physicians. MATERIAL AND METHODS: Descriptive cross-sectional study based on an on-line questionnaire with a total of 34 multiple choice questions, published on the SEMERGEN website. The main Knowledge areas were: biosimilar definition; regulatory and legal framework; prescription, traceability, interchangeability and pharmacovigilance; availability of biosimilars in the PC setting, and the biosimilars contribution to sustainability. The software used for the analysis and data processing was the Barbwin 7.5. RESULTS: An analysis was performed on the responses from 701 questionnaires completed. There was a slight majority (57%) of womenparticipants. The majority of participant worked in urban centres (60.91%). The definition of biosimilar was not known by 58% of those that responded, and 73% were unaware that the management of biosimilars and generics was not comparable. Most (84%) of those that responded were not aware that the studies required for the approval of biosimilars is different from reference biological medicines. Around two-thirds (66%) those that responded did not know of any biosimilars available in PC setting, and the 94% were also unaware of the Spanish legal framework for the management of biosimilar medicines. CONCLUSIONS: The current knowledge about biosimilars among PC physicians is low. The critical areas in need of further training include specific information on biosimilars currently available in PC setting, as well as key aspects regarding prescription, interchangeability and pharmacovigilance requirements. Six out of ten doctors do not know of any biosimilar used in PC in Spain.