Background/Purpose:

The introduction of biologics has significantly improved long-term outcome of immune-mediated inflammatory diseases. However, after discontinuation or switch of therapy, 26-49% of patients on subcutaneous biologics have unused injectors at home, leading to spillage of these costly drugs. When drug quality is ensured by proper storage within recommended temperature ranges (2˚C-8˚C), unused injectors could potentially be redistributed reducing spillage. The aim of this study was to assess the quality of home storage by evaluating the proportion of injectors stored within the recommended temperature range.

Methods:

All subcutaneous golimumab users at the Maastricht University Medical Centre+, irrespective of the indication, were asked to participate in this prospective study between April and October 2015. During 3 months, patients received golimumab in the original package provided in a sealed bag containing a validated temperature sensor connected to the internet. Patients were asked to store their medication as usual. Temperature was measured every 5 minutes. Deviations from the recommended range were defined as 1). > 30 minutes below 2˚C or above 8˚C and 2). any duration below 0˚C. After 3 months, patients filled out a questionnaire on their opinion about monitoring medication storage conditions at home and potential redistribution of unused injectors.

Results:

In total, 50 patients (46.3% male, mean age 52.3 ± 13.8 years) received 276 injectors with temperature sensors that generated 2,466,576 measurements. Figure 1 shows that 11.6% of the injectors were stored within the recommended temperature range. Of the remainder, 11.2% were stored more than 30 minutes below 0˚C and 19.6% were stored above 8°C for more than 48 hours. Of all patients, 95% would appreciate an alarm when the injector is not stored under the right conditions, and also 95% is willing to accept unused medication when product quality is ensured.  

Conclusion:

Only a minority of injectors was stored within the recommended temperature range. This hinders not only redistribution of unused biologics, but is also alarming regarding the effectiveness of the drug in these patients. We are currently investigating how to improve biologics’ home- and transport storage conditions and the criteria to be met for redistribution.