Oral Therapy Safety Compliance

Background: As therapy for multiple sclerosis becomes more complex, many treatments require close monitoring.  Monitoring is essential for patient safety.  This involves a concerted effort between prescribing physicians and patients.  There are many barriers including limited resources, costs in education, and costs in monitoring.  Failure to comply with monitoring protocols by either party can lead to serious, life threatening complications.

Objectives: Two of the more recently available therapies include Aubagio and Gilenya.  Aubagio requires blood monitoring every month for the first 6 months.  Gilenya, requires blood monitoring every 3 months and patients are required to have baseline and follow up eye exams.  The purpose of the monitoring is to evaluate for liver disease and, in the case of Gilenya, macular edema.

Methods: All patients at the MS Center of Atlanta who were prescribed Aubagio or Gilenya were educated on the benefits and risks of treatments, were given a written protocol, and were given required lab tests and eye exam prescriptions.  

We performed a retrospective chart review for the first 6 months of therapy.  For Aubagio, we will looked at the percentage of patients who complied with required monthly blood testing.  For Gilenya, we looked at the percentage of patients who complied with the blood testing at months 3 and 6 and the percentage who went for their 4 month follow-up eye exam.

Results:  Adherence to monitoring protocol will be presented with numerical data showing a concerning low adherence rate despite a rigid protocol and patient education.  For Gilenya, 81% of patients performed the required blood testing, but only 38% performed the required follow-up eye exam.  For Aubagio, only 42% of patients performed over half of the required blood tests whereas 58% performed 3 or less of the required 6 tests.

Conclusions: Patient adherence to moitoring protocols was poor.  As therapies become more effective, complex safety monitoring protocols also raise patient risk.