This is a non-interventional post-authorization safety study (PASS) employing a cross sectional design to evaluate the effectiveness of the additional risk minimization measures (aRMMs) for REBLOZYL. A survey will be used to measure the knowledge and comprehension of the REBLOZYL aRMMs among European Economic Area (EEA) based healthcare professionals (HCPs). The PASS will be conducted among HCPs in a representative sample of EEA countries where REBLOZYL is commercially available, potentially including Austria, Germany, Italy, Norway, Sweden, the Netherlands, Poland, and Spain. Additional EEA countries may be included, as needed, based on commercial availability and reimbursement status.
Study Type
OBSERVATIONAL
Enrollment
187
Local Institutions
Vienna, Austria
Local Institutions
Brussels, Belgium
Local Institutions
Berlin, Germany
Local Institutions
Rome, Italy
Knowledge that although there are no data from the use of REBLOZYL in pregnant women, studies in animals exposed to REBLOZYL have shown reproductive toxicity and embryo-fetal toxicity
Calculated as the percentage of healthcare professionals (HCPs) who answer "True" to question 1A
Time frame: Up to 3 months
Knowledge that women of childbearing potential (WCBP) who become pregnant during treatment with REBLOZYL should not continue REBLOZYL treatment even if they receive appropriate monitoring
Calculated as the percentage of HCPs who answer "False" to question 1B
Time frame: Up to 3 months
Knowledge that HCPs must counsel WCBP of the potential teratogenic risk of REBLOZYL
Calculated as the percentage of HCPs who answer "True" to question 1C
Time frame: Up to 3 months
Knowledge that for WCBP who become pregnant during treatment with REBLOZYL, the pregnancy outcome should be evaluated
Calculated as the percentage of HCPs who answer "False" to question 1D
Time frame: Up to 3 months
Knowledge that the use of REBLOZYL is contraindicated during pregnancy and in WCBP who are not using at least 1 highly effective method of contraception
Calculated as the percentage of HCPs who answer "True" to question 1E
Time frame: Up to 3 months
Knowledge of what information about contraception methods should be provided when counselling WCBP
Calculated as the percentage of HCPs who answer "WCBP should use at least 1 highly effective method of contraception during treatment with REBLOZYL and for at least 3 months after stopping treatment" to question 2
Time frame: Up to 3 months
Knowledge of how many pregnancy tests should be performed for WCBP before they start treatment with REBLOZYL
Calculated as the percentage of HCPs who answer "A single pregnancy test must be performed and medically verified before starting treatment with REBLOZYL" to question 3
Time frame: Up to 3 months
Knowledge of the frequency pregnancy tests should be repeated for WCBP who are receiving treatment with REBLOZYL
Calculated as the percentage of HCPs who answer "At suitable intervals and medically verified as negative" to question 4
Time frame: Up to 3 months
Knowledge that WCBP should be informed to report a pregnancy that occurs during treatment with REBLOZYL and should receive counselling if they become pregnant
Calculated as the percentage of HCPs who answer "True" to question 5
Time frame: Up to 3 months
Knowledge of how long after stopping treatment with REBLOZYL should WCBP be informed to report a pregnancy that occurs and should they receive counselling if they become pregnant
Calculated as the percentage of HCPs who answer "Pregnancies that occur within 3 months after stopping REBLOZYL should be reported and participants should receive counselling" to question 6
Time frame: Up to 3 months
Always providing WCBP with the REBLOZYL Patient Card
Calculated as the percentage of HCPs who answer "Yes, always" to providing the REBLOZYL Patient Card to WCBP (question 10-A). The denominator for this variable is the n who answer question 10 (not the n who answer 10-A)
Time frame: Up to 3 months
Composite knowledge for all 5 items in the core question set
A composite endpoint calculated as the percentage of HCPs who answer: None of questions 1E, 2, 3, 4, and 10-A correctly; 1 of questions 1E, 2, 3, 4, and 10-A correctly; 2 of questions 1E, 2, 3, 4, and 10-A correctly; 3 of questions 1E, 2, 3, 4, and 10-A correctly; 4 of questions 1E, 2, 3, 4, and 10-A correctly; All 5 of questions 1E, 2, 3, 4, and 10-A correctly
Time frame: Up to 3 months
Awareness of the HCP Checklist
Calculated as the percentage of HCPs who answer "Yes" to question 7
Time frame: Up to 3 months
Read/reviewed the HCP Checklist
Calculated as the percentage of HCPs who answer "Yes, all of it" or "Yes, some of it" to question 8
Time frame: Up to 3 months
Use of the HCP Checklist prior to initiating treatment
Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9A
Time frame: Up to 3 months
Use of the HCP Checklist at each subsequent administration
Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9B
Time frame: Up to 3 months
Use of the HCP Checklist for at least 3 months after stopping treatment
Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9C
Time frame: Up to 3 months
Primary source from which HCPs learned about the appropriate indication, contraindications and precautions for use, and potential risks for REBLOZYL
Calculated as the percentage of HCPs who tick each source in question 11 (for example, percentage of HCPs that ticked the REBLOZYL summary of product characteristics (SmPC), etc.)
Time frame: Up to 3 months
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