Background Proper storage and controlled distribution of biological disease modifying antirheumatic drugs (bDMARDs) is essential to ensure drug quality. Deviations from the manufacturers' Summary of Product Characteristics (SmPC) recommended temperature range (2°C-8°C) at patients' home may lead to protein aggregation which has been associated with an increased immunogenicity and formation of antibodies. This could result in decreased clinical efficacy and increased risk of adverse drug reactions.
Objectives To evaluate whether patients' home storage temperatures for bDMARDs comply with SmPC recommended storage temperature range.
Methods This prospective observational follow-up study was conducted in eight Dutch outpatient pharmacies from December 2013 till January 2015. Consenting adult patients using bDMARDs (etanercept, adalimumab, golimumab, certolimumab pegol or abatacept) received their bDMARDs in the original package inserted in a sealbag containing a validated temperature logger. Patients were instructed to store their packages according to standard label instructions and to return the temperature logger(s) after use. Primary outcome was defined as the number of patients that stored their bDMARDs within the SmPC recommended temperature range without excursions longer than 48 hours below 2°C or above 8°C. Deviations from the SmPC recommended temperature range were further defined as 1) the frequency of episodes longer than 2 hours consecutive time below 0°C or above 25°C and 2) longest duration of a single episode below 0°C or above 25°C.
Results 338 patients (mean age 52.4 (SD 13.5), 54.4% female) received 1309 temperature loggers in total. 278 (82.2%) patients (mean age 52.9 (SD 13.4), 52.0% female) returned in total 756 temperature loggers (57.8%). The majority (95.7%) of the patients were treated with etanercept or adalimumab. 79 patients (28.5%) stored their bDMARD within the SmPC recommended temperature range without excursions longer than 48 hours below 2°C or above 8°C (Figure 1). 23.4% of the patients stored one or more bDMARD packages for more than 2 hours consecutive time below 0°C (per package – frequency: 4 times [IQR 1–14], median longest duration: 7.2 hours [IQR 4.3–21.3], maximum duration: 46 days). 1.8% of patients stored bDMARDs above 25°C for episodes longer than 2 hours consecutive time (per package – median frequency: 1 time [IQR 1–2], median longest duration: 10.9 hours [IQR 6.1–33.9], maximum duration: 16 days).
Conclusions The majority of patients do not store their bDMARDs within the SmPC recommended storage temperature range. To what extent moderate and extreme deviations in storage temperatures could affect product quality, influence efficacy and occurrence of side-effects of the bDMARDs needs further investigation.
Disclosure of Interest None declared