Safety monitoring of the newer disease modifying therapies in multiple sclerosis patients in Mater Dei hospital

Abstract

Patients with highly active Multiple Sclerosis can be started on the newer pharmaceutical agents, Dimethyl Fumarate or Fingolimod. Safety monitoring recommended includes regular blood analysis and also ophthalmic tests and MRI scans in the case of Fingolimod. The aim of this audit is to verify whether timely investigations are being taken, checked and results documented in a database and whether the appropriate action is being taken should safety become a concern. Method: An Excel document shared by all four Neurology consultants documents the patients’ personal details, any baseline investigations or other recommended tests taken and the blood results taken at regular intervals. This data was analysed for accuracy by keeping it up to date. The products’ SPC recommendations were used as guidelines and the time-frame modified locally. Results: After analyzing all the blood tests taken while on Dimethyl fumarate, 39% of patients took their regular blood tests on time; 31% were not taken on time and 30% had no blood tests taken at all. On the other hand, only 59% of patients on Fingolimod took their blood tests on time. 82% of the blood results were documented in their Excel document. A repeat MRI scan 6 months after starting Fingolimod showed that only 53% took it on time. Conclusion: Using an Excel document was a trial to try and ensure compliance with these recommendations. However, this audit clearly documents that it is not enough to follow patients on a regular basis, highlighting the need for a specialist nurse to monitor such patients.