title: The majority of patients do not store their biologic disease-modifying antirheumatic drugs within the recommended temperature range.
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).
  
  
  CONCLUSIONS
  The majority of patients do not store their bDMARDs within the SmPC-recommended temperature range.
authors.affiliation: Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht.
authors.forename: Nicolaas D
authors.initials: ND
authors.lastname: Vlieland
authors.affiliation: 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.
authors.forename: Helga
authors.initials: H
authors.lastname: Gardarsdottir
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht.
authors.forename: Marcel L
authors.initials: ML
authors.lastname: Bouvy
authors.affiliation: 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.
authors.forename: Toine C G
authors.initials: TC
authors.lastname: Egberts
authors.affiliation: Department of Pharmacy, Sint Maartenskliniek and Department of Pharmacy, Radboud Medical Center, Nijmegen, The Netherlands b.vandenBemt@maartenskliniek.nl.
authors.forename: Bart J F
authors.initials: BJ
authors.lastname: van den Bemt
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000592:standards* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000523:psychology; D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use; D004356:Drug Storage / Q000379:methods / Q000592:standards*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D013696:Temperature; D013997:Time Factors; D016903:Drug Monitoring
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products
keywords: anti-TNF; biologic DMARDs; epidemiology; rheumatoid arthritis