(251) Evaluation of Medication Electronic Monitoring Systems (MEMS®) in Adherence Measurement in the real world setting

Background: RECOVER is an ongoing multi-site (n=8) post-marketing study of clinical outcomes in people with Cystic Fibrosis (CF) who are prescribed Elexacaftor/Tezacaftor/Ivacaftor in Ireland and the United Kingdom. Previous studies of CF treatments have shown suboptimal adherence. Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor in real world settings may not match that which is seen under controlled trial conditions. MEMS® is an objective measure of adherence that uses a computer chip embedded in the medication bottle cap to record every occurrence of cap removal. MEMS® are being used as one of three methods to measure real-world adherence as part of the RECOVER study. Although recognised as the ‘gold standard’ adherence software for clinical trials and academic research, participant withdrawal from RECOVER MEMS® sub-study has been noted.

Methods: Adherence to Elexacaftor/Tezacaftor/Ivacaftor is being prospectively investigated using MEMS® in a subset of RECOVER study participants 12 years and over (12+) during a 12-month period. Participants are invite to participate on enrolment. They collect their dedicated MEMS® medication bottles from their community pharmacist monthly [one for Elexacaftor/Tezacaftor/Ivacaftor and one for Ivacaftor(pm)]. Data are extracted from the MEMS® caps at routine clinic visits. Where participants withdraw from the MEMS study, they were invited to complete a feedback form capturing reasons for discontinuation and perceived limitations associated with MEMS® caps.

Results: Initially 80% of target MEMS recruitment (n=32) was achieved. Only 15 participants (47%) remained at the end of the 12-month study period. Interim MEMS® data (n=9) extracted and collated at this point indicated adherence rates of 81.6% for Elexacaftor/Tezacaftor/Ivacaftor and 79.8% for Ivacaftor, and overall adherence of 80.7% (see image 1). Data collection is ongoing for this 12+ cohort with additional 12-month data extraction and analysis due to be collected in Q2 of this year. Feedback forms were completed by 14 of the 17 study dropouts. 7/14 (50%) found it harder to track their medication use, 6/14 (43%) found it harder to remember to take their medication, 5/14 (36%) felt more likely to skip their medication, 5/14 (36%) reported finding it harder to remember when to request a new prescription and 2/14 (14%) reported the packaging more difficult to use.

Conclusions: Although MEMS® is considered the gold standard for measuring adherence, this study highlights the barriers to continued participation in this cohort of people taking Elexacaftor/Tezacaftor/Ivacaftor. This insight led to the development of an updated information leaflet for the next phase of the RECOVER study (6-11 years). MEMS® recruitment for this cohort is currently in the early phases. Additional data will be available for presentation at the conference.

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