Esther Artime1, Irene Shui2, Ignacio Mendez3, Stephanie Tcherny-Lessenot4, Pierre D'Arbigny5, Noelia Alfaro6, Nawab Qizilbash7. 1. Pharmacoepidemiology, Oxon Epidemiology SL, Madrid, Spain. 2. Epidemiology and Benefit-risk Evaluation, Sanofi, Bridgewater, Township, NJ, USA. 3. Epidemiology, Oxon Epidemiology SL, Madrid, Spain. 4. Global Pharmacovigilance and Epidemiology, Sanofi, Paris, France. 5. Risk Management unit, Global Pharmacovigilance, Sanofi, Paris, France. 6. Qualitative Research, Oxon Epidemiology SL, Madrid, Spain. 7. London School of Hygiene and Tropical Medicine, Epidemiology, Oxon Epidemiology SL, London, UK.
Abstract
BACKGROUND: The alglucosidase alfa (Myozyme®) Safety Information Packet ("previous SIP") was updated to improve readability and content ("updated SIP"). We compared the previous and updated SIPs. METHODS: A two-wave pre-post multicountry survey was conducted among health care professionals (HCPs) who prescribed or monitored patients on alglucosidase alfa in the largest European Union ("EU5") countries and Poland. Wave (W) 2 started 15 months after completion of W1 and the implementation of the updated SIP. Changes between the waves were analysed. RESULTS: Forty-six HCPs (34 physicians/12 nurses) participated in W1 and 52 in W2 (42 physicians/10 nurses); 22 participated in both waves. Nonsignificant differences were observed between waves 1 and 2 for awareness (75.6% in W1 and 82.4% in W2) and receipt (77.7% in W1 and 74.5% in W2) of the SIP, reading (88.6% in W1 and 89.5% in W2) and usage (88.2% in W1 and 89.5% in W2) among receivers of the SIP, or the overall knowledge about immunological testing (61.1% in W1 vs 55.1% in W2). Frequency of performance of immunological testing was significantly higher in W2 than in W1 (50.3% vs 34.4%; P = .024) with a tendency for increases in the appropriate performance of all types of testing in W2. CONCLUSIONS: Both versions of the SIP showed relatively high awareness, receipt, reading, and usage, with an overall trend for most measures to improve numerically in W2. The updated SIP did not require further changes.
BACKGROUND: The alglucosidase alfa (Myozyme®) Safety Information Packet ("previous SIP") was updated to improve readability and content ("updated SIP"). We compared the previous and updated SIPs. METHODS: A two-wave pre-post multicountry survey was conducted among health care professionals (HCPs) who prescribed or monitored patients on alglucosidase alfa in the largest European Union ("EU5") countries and Poland. Wave (W) 2 started 15 months after completion of W1 and the implementation of the updated SIP. Changes between the waves were analysed. RESULTS: Forty-six HCPs (34 physicians/12 nurses) participated in W1 and 52 in W2 (42 physicians/10 nurses); 22 participated in both waves. Nonsignificant differences were observed between waves 1 and 2 for awareness (75.6% in W1 and 82.4% in W2) and receipt (77.7% in W1 and 74.5% in W2) of the SIP, reading (88.6% in W1 and 89.5% in W2) and usage (88.2% in W1 and 89.5% in W2) among receivers of the SIP, or the overall knowledge about immunological testing (61.1% in W1 vs 55.1% in W2). Frequency of performance of immunological testing was significantly higher in W2 than in W1 (50.3% vs 34.4%; P = .024) with a tendency for increases in the appropriate performance of all types of testing in W2. CONCLUSIONS: Both versions of the SIP showed relatively high awareness, receipt, reading, and usage, with an overall trend for most measures to improve numerically in W2. The updated SIP did not require further changes.
Authors: Hina Patel; Thanh G N Ton; Jessica Davies; Simon Fear; Carolin Block; Kunihiko Tanaka; Danny Gonzalez; Roger Mutter; Noelia Alfaro-Oliver; Ignacio Mendez; Nawab Qizilbash Journal: Pharmaceut Med Date: 2021-12-07