REMS Assessment for measuring knowledge and understanding of medication risks, appropriate use, and medication guide distribution compliance
Web-Based and Call Supported Survey
Cardiovascular
Prescribers
New Indication
of Existing Rx Medication
REMS Assessment for measuring knowledge and understanding of medication risks, appropriate use, and medication guide distribution compliance
Web-Based and Call Supported Survey
CNS
Patients and Physicians
New Rx Medication
REMS Assessment for measuring knowledge and understanding of medication risks, appropriate use, and medication guide distribution compliance
Web-Based and Call Supported Survey
Gastroenterology
Patients
New Rx Medication
REMS Assessment for measuring knowledge and understanding of medication risks, appropriate use, and medication guide distribution compliance
Web-Based and Call Supported Survey
Metabolic
Patients and Physicians
New Rx Medication
REMS Assessment for measuring knowledge and understanding of medication risks, appropriate use, and medication guide distribution compliance
Web-Based and Call Supported Survey
Surgical/Other
Patients and Physicians
New Rx Medication
REMS Assessment for measuring knowledge and 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
Examples of Other Pharmaceutical Risk Management Experience:
Disease Area
Sample
Product
Type of Research Study
Methodology
Allergy
Patients and Parent Caregivers
Injectable Drug/Device combination
Observational study
pre-market assessment of usability and attitudes towards a new drug delivery device
One-on-one interviews
Asthma
Patients and Parent Caregivers
Inhaled Drug/Device combination
Observational study and
pre-market assessment on proable use patterns and attitudes towards new inhaler technology
Web-based Survey
Dermatology
Patients
Injectable Aesthetic
Observational study and
pre-testing of a patient package insert for readability and comprehension
One-on-one interviews
Diabetes
Patients
Injectable Drug/Device combination
Observational periapprovalstudy on product usability and comprehension of patient
package insert
One-on-one interviews
Epilepsy
Patients and Parent Caregivers
Rectally administered Drug/Device combination
Observational periapproval study on product usability and comprehension of patient package insert
One-on-one interviews
Pharmacists
Rectally administered Drug/Device combination
Observational periapproval study on dose preparation and understanding of intructional materials
One-on-one interviews
Patients and Parent Caregivers
Rectally administered Drug/Device combination
Phase IV Patient Registry to measure pharmacy dispensing performance and patient understanding
Survey
Gastro-esophageal
Reflux (GERD)
Patients
Orally administered Drug capsule
Pre-Market Product Evaluation for new oral GERD medication including swallow test
