Examples of risk evaluation and mitigation strategy REMS experience

Disease Area Sample Product Type of Research Study Methodology
Antiviral Patients New Rx Medication REMS Assessment for measuring
understanding of the serious medication risks		 Web-Based and Call Supported Survey
Antiviral Patients Existing Rx Medication REMS Assessment for measuring
understanding of the serious medication risks		 Web-Based and Call Supported Survey
Antiviral Patients Existing Rx Medication REMS Assessment for measuring
understanding of the serious medication risks		 Web-Based and Call Supported Survey
Antiviral/Oncology Patients Existing Rx Medication REMS Assessment for measuring
understanding of the serious medication risks		 Web-Based and Call Supported Survey
Asthma Patients New Rx Medication REMS Assessment for measuring
understanding of the serious medication risks		 Web-Based and Call Supported Survey
Cardiovascular Patients and
Prescribers		 New Rx Medication REMS Assessment for measuring
understanding of medication risks,
appropriate use, and medication guide distribution compliance		 Web-Based and Call Supported Survey
Cardiovascular Patients Existing Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
CNS Patients and
Physicians		 New Rx Medication REMS Assessment for measuring
understanding of medication risks,
appropriate use, and medication guide distribution compliance		 Web-Based and Call Supported Survey
CNS Patients New Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
CNS Patients New Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Diabetes Patients New Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Diabetes Patients Existing Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Diabetes Patients Existing Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Diabetes Patients New Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Epilepsy Patients New Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Epilepsy Patients New Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Epilepsy Patients Existing Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Epilepsy Patients Existing Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Gastroenterology Patients New Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Gastroenterology Patients New Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Metabolic Patients New Rx Medication REMS Assessment for measuring
understanding of the serious medication risks		 Web-Based and Call Supported Survey
Oncology Patients New Rx Medication REMS Assessment for measuring
understanding of the serious medication risks		 Web-Based and Call Supported Survey
Pain Patients New Rx Medication REMS Assessment for measuring
understanding of the serious medication risks		 Web-Based and Call Supported Survey
Pain Patients and
Physicians		 New Rx Medication REMS Assessment for measuring
understanding of serious risks and
medication guide distribution compliance		 Web-Based and Call Supported Survey
Surgical/Other Patients and
Physicians		 New Rx Medication REMS Assessment for measuring
understanding of medication risks,
appropriate use, and medication guide distribution compliance		 Web-Based and Call Supported Survey
Transplantation Patients and
Prescribers		 New Rx Medication REMS Assessment for measuring
understanding of medication risks,
appropriate use, and medication guide distribution compliance		 Web-Based and Call Supported Survey
Transplantation Patients and
Prescribers		 Existing Rx Medications Elements to Assure Safe Use Program,
Shared REMS. REMS assessment design and
implementation for patients and health care
providers to measure REMS performance		 Web-Based and Call Supported Survey