Exploring conditions for redistribution of anti‐tumor necrosis factors to reduce spillage: A study on the quality of anti‐tumor necrosis factor home storage

• Published in: Journal of gastroenterology and hepatology Vol. 33; no. 2; pp. 426 - 430
• Main Authors: Jong, Marin J, Pierik, Marieke J, Peters, Andy, Roemers, Mark, Hilhorst, Veronique, Tubergen, Astrid
• Format: Journal Article
• Language: English
• Published: Australia Wiley Subscription Services, Inc 01.02.2018
• Subjects: Adult; Aged; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - economics; anti‐TNF therapy; Drug Packaging; Drug screening; Drug Storage - methods; Drug Substitution; Drug Utilization - economics; Drug Utilization - statistics & numerical data; Female; Home Care Services; Humans; immune‐mediated inflammatory diseases; Immunosuppressive agents; Inflammatory diseases; Injections; Male; Middle Aged; Quality Control; spillage; Surveys and Questionnaires; Temperature; Temperature effects; Time Factors; treatment effectiveness; Tumor Necrosis Factor-alpha - antagonists & inhibitors; anti-TNF therapy; spillage; immune-mediated inflammatory diseases; treatment effectiveness
• ISSN: 0815-9319; 1440-1746
• DOI: 10.1111/jgh.13920

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.