Nicolaas D Vlieland1, Helga Gardarsdottir2, Marcel L Bouvy3, Toine C G Egberts2, Bart J F van den Bemt4. 1. Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht. 2. Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht. 3. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht. 4. Department of Pharmacy, Sint Maartenskliniek and Department of Pharmacy, Radboud Medical Center, Nijmegen, The Netherlands b.vandenBemt@maartenskliniek.nl.
Abstract
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.
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.
Authors: N D Vlieland; M R Nejadnik; H Gardarsdottir; S Romeijn; A S Sediq; M L Bouvy; A C G Egberts; B J F van den Bemt; W Jiskoot Journal: Pharm Res Date: 2018-02-05 Impact factor: 4.200
Authors: Nicolaas D Vlieland; Bart J F van den Bemt; Charlotte L Bekker; Marcel L Bouvy; Toine C G Egberts; Helga Gardarsdottir Journal: Drugs Aging Date: 2018-03 Impact factor: 3.923
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
Authors: Rosanne W Meijboom; Helga Gardarsdottir; Matthijs L Becker; Mark C H de Groot; Kris L L Movig; Johan Kuijvenhoven; Toine C G Egberts; Hubert G M Leufkens; Thijs J Giezen Journal: Pharmacol Res Perspect Date: 2021-08