Contributions
Abstract: P1211
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Alemtuzumab is effective treatment for MS, but pathology monitoring for late adverse effects is difficult to implement. In the real world, patients may miss tests, and pathology reports might not be received or reviewed.
Aims: To improve the benefit:risk ratio of alemtuzumab for MS by: developing an efficient automated system to prompt and track patient pathology collection; provide customisable alerts for abnormalities in identified risks; an app based education module; and a systematic approach to pre-treatment screening.
Methods: Ten patients with active MS treated with alemtuzumab and followed for 2 years. Pathology monitoring by a networked pathology provider and hardcopy reports reviewed. Electronic results (=HL7) were also sent to project software (RiskMxTM), once operational. We developed electronic (email, SMS) alerts for abnormal results and patient reminders. Compliance, time to receipt, time to alerting, and clinical consequences of alerts were evaluated.
Results: The study successfully met the combined endpoint of design and implementation of the monitoring system, educational app and prescreening tool.
Once operational, there were 146 monthly pathology episodes of 151 expected, compliance 96.7%. All HL7 were received by RiskMx, 8 hardcopy reports were never received. Final receipt of HL7 = 1.10days post collection (dPC) +/-1.57(0-15), final receipt of hardcopy = 15.08 dPC +/-15.99(0-106), p< 0.001. Alerts when required were sent 0.87+/-0.45 dPC (0-2).
Three patients had 5 autoimmune conditions: 3 hyperthyroidism, 1 neutropenia, 1 ITP. All were alerted correctly by RiskMx prior to hardcopy receipt. The neurologist received and acknowledged the ITP alert (platelets=77, nadir12) while travelling internationally 2h:11m after HL7 release, the paper report and urgent fax was received 7 days later.
We made the RiskMx system available to Australia for use with alemtuzumab outside AMS3. To date, this application (BloodwatchTM) monitors >1000 patients, is used by 100% of prescribing neurologists and >99% of patients in Australia. From 4/2015 to end 1/2017, it processed 9777 monthly collections of 9908 expected, a compliance of 98.7% with the risk management program.
Conclusions: The RiskMx platform effectively supported risk management plan implementation, improved compliance with monitoring, and timely receipt of abnormalities, without requiring extra clinical staff. The largely automated service was delivered to a nation.
Disclosure:
Acknowledgments: The authors wish particularly to acknowledge the substantial intellectual contributions, study design inputs, procedural support over the course of the study and reviews by Richard Worrell, B. Pharm. Mr Worrell is an employee of Sanofi-Aventis Australia Pty Ltd. We also wish to acknowledge significant contributions to study design and implementation by Jamshed Ahmed. Dr Ahmed was an employee of Sanofi-Aventis Australia Pty Ltd.
Disclosures:
Sanofi-Aventis Australia Pty Ltd provided funding and product for this study. This company was not involved in the design, collection, analysis or interpretation of the study, but they were given the opportunity to review this abstract prior to submission. The decision to submit for publication was made by the authors independently.
S. Reddel has received payments for grant support from Biogen, CSL, Novartis and Sanofi-Genzyme, travel support from Merck, Sanofi-Genzyme and Teva, membership on advisory councils from Biogen, Merck, Sanofi-Genzyme and Teva, speaker's bureau from Biogen, Novartis, and Sanofi-Genzyme, and is a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
Michael Barnett has received institutional support for research, speaking and/or participation in advisory boards for Biogen, Merck, Novartis, Roche and Sanofi Genzyme. Dr Barnett is a research consultant at Medical Safety Systems and research director for the Sydney Neuroimaging Analysis Centre.
S. Riminton has received payments for grant support from Octapharma and CSL Bioplasma, travel support from Sanofi-Genzyme, membership on advisory councils from Merck, Sanofi-Genzyme, National Blood Authority of Australia and Baxter Healthcare, speaker's bureau from Sanofi-Genzyme, and Biogen, and is a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
T. Dugal has received travel support from Sanofi-Genzyme, and is a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
D. Gahan is a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
F. Fitzgerald is an employee of Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
K. Buzzard has received educational support from Sanofi-Genzyme, Teva and Biogen, speakers honorarium from Biogen, Novartis and Sanofi-Genzyme, and membership on advisory boards from Merck.
D. Erickson: nothing to disclose.
D. Wang is a director of Converged IT, a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
T. Ackland is a director of Converged IT, a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
R. Thompson is a director of Converged IT, a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
Abstract: P1211
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Alemtuzumab is effective treatment for MS, but pathology monitoring for late adverse effects is difficult to implement. In the real world, patients may miss tests, and pathology reports might not be received or reviewed.
Aims: To improve the benefit:risk ratio of alemtuzumab for MS by: developing an efficient automated system to prompt and track patient pathology collection; provide customisable alerts for abnormalities in identified risks; an app based education module; and a systematic approach to pre-treatment screening.
Methods: Ten patients with active MS treated with alemtuzumab and followed for 2 years. Pathology monitoring by a networked pathology provider and hardcopy reports reviewed. Electronic results (=HL7) were also sent to project software (RiskMxTM), once operational. We developed electronic (email, SMS) alerts for abnormal results and patient reminders. Compliance, time to receipt, time to alerting, and clinical consequences of alerts were evaluated.
Results: The study successfully met the combined endpoint of design and implementation of the monitoring system, educational app and prescreening tool.
Once operational, there were 146 monthly pathology episodes of 151 expected, compliance 96.7%. All HL7 were received by RiskMx, 8 hardcopy reports were never received. Final receipt of HL7 = 1.10days post collection (dPC) +/-1.57(0-15), final receipt of hardcopy = 15.08 dPC +/-15.99(0-106), p< 0.001. Alerts when required were sent 0.87+/-0.45 dPC (0-2).
Three patients had 5 autoimmune conditions: 3 hyperthyroidism, 1 neutropenia, 1 ITP. All were alerted correctly by RiskMx prior to hardcopy receipt. The neurologist received and acknowledged the ITP alert (platelets=77, nadir12) while travelling internationally 2h:11m after HL7 release, the paper report and urgent fax was received 7 days later.
We made the RiskMx system available to Australia for use with alemtuzumab outside AMS3. To date, this application (BloodwatchTM) monitors >1000 patients, is used by 100% of prescribing neurologists and >99% of patients in Australia. From 4/2015 to end 1/2017, it processed 9777 monthly collections of 9908 expected, a compliance of 98.7% with the risk management program.
Conclusions: The RiskMx platform effectively supported risk management plan implementation, improved compliance with monitoring, and timely receipt of abnormalities, without requiring extra clinical staff. The largely automated service was delivered to a nation.
Disclosure:
Acknowledgments: The authors wish particularly to acknowledge the substantial intellectual contributions, study design inputs, procedural support over the course of the study and reviews by Richard Worrell, B. Pharm. Mr Worrell is an employee of Sanofi-Aventis Australia Pty Ltd. We also wish to acknowledge significant contributions to study design and implementation by Jamshed Ahmed. Dr Ahmed was an employee of Sanofi-Aventis Australia Pty Ltd.
Disclosures:
Sanofi-Aventis Australia Pty Ltd provided funding and product for this study. This company was not involved in the design, collection, analysis or interpretation of the study, but they were given the opportunity to review this abstract prior to submission. The decision to submit for publication was made by the authors independently.
S. Reddel has received payments for grant support from Biogen, CSL, Novartis and Sanofi-Genzyme, travel support from Merck, Sanofi-Genzyme and Teva, membership on advisory councils from Biogen, Merck, Sanofi-Genzyme and Teva, speaker's bureau from Biogen, Novartis, and Sanofi-Genzyme, and is a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
Michael Barnett has received institutional support for research, speaking and/or participation in advisory boards for Biogen, Merck, Novartis, Roche and Sanofi Genzyme. Dr Barnett is a research consultant at Medical Safety Systems and research director for the Sydney Neuroimaging Analysis Centre.
S. Riminton has received payments for grant support from Octapharma and CSL Bioplasma, travel support from Sanofi-Genzyme, membership on advisory councils from Merck, Sanofi-Genzyme, National Blood Authority of Australia and Baxter Healthcare, speaker's bureau from Sanofi-Genzyme, and Biogen, and is a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
T. Dugal has received travel support from Sanofi-Genzyme, and is a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
D. Gahan is a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
F. Fitzgerald is an employee of Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
K. Buzzard has received educational support from Sanofi-Genzyme, Teva and Biogen, speakers honorarium from Biogen, Novartis and Sanofi-Genzyme, and membership on advisory boards from Merck.
D. Erickson: nothing to disclose.
D. Wang is a director of Converged IT, a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
T. Ackland is a director of Converged IT, a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.
R. Thompson is a director of Converged IT, a shareholder in Medical Safety Systems P/L Australia, owner of the RiskMx™ system.