Marin J de Jong1,2, Marieke J Pierik1,2, Andy Peters1, Mark Roemers3, Veronique Hilhorst4, Astrid van Tubergen5,6. 1. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, The Netherlands. 2. NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands. 3. AntTail, Utrecht, The Netherlands. 4. Department of Clinical Pharmacy & Toxicology, Maastricht University Medical Center+, Maastricht, The Netherlands. 5. Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center+, Maastricht, The Netherlands. 6. CAPHRI - School for Public Health and Primary Care, Maastricht University Medical Center+, Maastricht, The Netherlands.
Abstract
BACKGROUND AND AIM: Biologicals are potent drugs for immune-mediated inflammatory diseases. After discontinuation or switch of therapy, many patients have unused biological injectors left. This study aimed to evaluate potential redistribution of unused injectors to prevent spillage of these costly drugs by assessing (i) the quality of transport and home storage through the proportion of injectors stored within the recommended temperature range (2-8 °C) and (ii) acceptance of redistribution by patients. METHODS: All golimumab users, irrespective of the indication, at Maastricht University Medical Center were eligible for inclusion. Patients received golimumab in a sealed bag containing a validated temperature sensor, measuring temperature every 5 min. Patients were asked to store their medication as usual. Deviations from the recommended range were defined as any duration below 0 °C and > 30 min below 2 °C or above 8 °C. After 3 months, patients completed a questionnaire on their opinion towards potential redistribution of unused biologicals. RESULTS: Fifty patients (42.0% male, mean age 53.2 ± 14.3 years) received 276 injectors. The mean storage time was 30.9 ± 33.1 days. Only 11.6% of the injectors were stored within the recommended temperature range. In addition, 11.2% were stored > 30 min below 0 °C and 33.2% were stored > 1 week above 8 °C. Of all patients, 95% would accept redistributed medication when product quality is ensured. CONCLUSIONS: During transport and home storage, only one in eight biological injectors was stored within the recommended temperature range. This hinders redistribution of unused injectors but also raises concern regarding drug effectiveness in immune-mediated inflammatory disease patients.
BACKGROUND AND AIM: Biologicals are potent drugs for immune-mediated inflammatory diseases. After discontinuation or switch of therapy, many patients have unused biological injectors left. This study aimed to evaluate potential redistribution of unused injectors to prevent spillage of these costly drugs by assessing (i) the quality of transport and home storage through the proportion of injectors stored within the recommended temperature range (2-8 °C) and (ii) acceptance of redistribution by patients. METHODS: All golimumab users, irrespective of the indication, at Maastricht University Medical Center were eligible for inclusion. Patients received golimumab in a sealed bag containing a validated temperature sensor, measuring temperature every 5 min. Patients were asked to store their medication as usual. Deviations from the recommended range were defined as any duration below 0 °C and > 30 min below 2 °C or above 8 °C. After 3 months, patients completed a questionnaire on their opinion towards potential redistribution of unused biologicals. RESULTS: Fifty patients (42.0% male, mean age 53.2 ± 14.3 years) received 276 injectors. The mean storage time was 30.9 ± 33.1 days. Only 11.6% of the injectors were stored within the recommended temperature range. In addition, 11.2% were stored > 30 min below 0 °C and 33.2% were stored > 1 week above 8 °C. Of all patients, 95% would accept redistributed medication when product quality is ensured. CONCLUSIONS: During transport and home storage, only one in eight biological injectors was stored within the recommended temperature range. This hinders redistribution of unused injectors but also raises concern regarding drug effectiveness in immune-mediated inflammatory diseasepatients.
Authors: Fernando do Pazo-Oubiña; Bartomeu Alorda-Ladaria; Ana Gomez-Lobon; Bàrbara Boyeras-Vallespir; María Margalida Santandreu-Estelrich; Clara Martorell-Puigserver; María Gomez-Zamora; Pere Ventayol-Bosch; Olga Delgado-Sanchez Journal: Sci Rep Date: 2021-03-16 Impact factor: 4.379