TY - JOUR
T1 - The majority of patients do not store their biologic disease-modifying antirheumatic drugs within the recommended temperature range
AU - Vlieland, Nicolaas D
AU - Gardarsdottir, Helga
AU - Bouvy, Marcel L
AU - Egberts, Toine C G
AU - van den Bemt, Bart J F
AU - Vlieland, ND
N1 - © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: [email protected].
PY - 2016/4
Y1 - 2016/4
N2 - OBJECTIVE: To monitor whether biologic DMARD (bDMARD) home storage temperatures comply with the manufacturers' Summary of Product Characteristics (SmPC) recommendations.METHODS: This observational study included consenting adult patients from eight Dutch pharmacies who received their bDMARDs with 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 proportion of patients that stored their bDMARDs within the SmPC recommended temperature range. In addition, the proportion of patients storing bDMARDs below 0°C or above 25 °C for longer than two consecutive hours was estimated.RESULTS: A total of 255 (87.0%) patients (mean age 53.2 (s.d.; 13.1) years, 51.4% female) returned their temperature logger(s) to the pharmacy. Of these, 17 patients (6.7%) stored their bDMARD within the recommended temperature range. The proportion of the patients that stored their bDMARD for more than 2 h consecutive time below 0°C or above 25°C was respectively 24.3% (median duration: 3.7 h (IQR 2.2 h; range 2.0-1,097.1 h) and 2.0% (median duration: 11.8 h (IQR 44.3 h; range 2.0-381.9 h).CONCLUSION: The majority of patients do not store their bDMARDs within the SmPC-recommended temperature range.
AB - OBJECTIVE: To monitor whether biologic DMARD (bDMARD) home storage temperatures comply with the manufacturers' Summary of Product Characteristics (SmPC) recommendations.METHODS: This observational study included consenting adult patients from eight Dutch pharmacies who received their bDMARDs with 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 proportion of patients that stored their bDMARDs within the SmPC recommended temperature range. In addition, the proportion of patients storing bDMARDs below 0°C or above 25 °C for longer than two consecutive hours was estimated.RESULTS: A total of 255 (87.0%) patients (mean age 53.2 (s.d.; 13.1) years, 51.4% female) returned their temperature logger(s) to the pharmacy. Of these, 17 patients (6.7%) stored their bDMARD within the recommended temperature range. The proportion of the patients that stored their bDMARD for more than 2 h consecutive time below 0°C or above 25°C was respectively 24.3% (median duration: 3.7 h (IQR 2.2 h; range 2.0-1,097.1 h) and 2.0% (median duration: 11.8 h (IQR 44.3 h; range 2.0-381.9 h).CONCLUSION: The majority of patients do not store their bDMARDs within the SmPC-recommended temperature range.
KW - biologic DMARDs
KW - rheumatoid arthritis
KW - anti-TNF
KW - epidemiology
U2 - 10.1093/rheumatology/kev394
DO - 10.1093/rheumatology/kev394
M3 - Article
C2 - 26672907
SN - 1462-0324
VL - 55
SP - 704
EP - 709
JO - Rheumatology (Oxford, England)
JF - Rheumatology (Oxford, England)
IS - 4
ER -