Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician Surveys on Experiences with REMS Programs
OMB Control Number: 0910-0847
Expiration Date: 12/31/2022
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National Survey of Physician Experiences with Ambrisentan
Thank you for agreeing to participate in this survey relating to your experiences prescribing ambrisentan. This research is being conducted by investigators at Brigham and Women’s Hospital / Harvard Medical School and is sponsored by the US Food and Drug Administration (FDA). If you have NOT prescribed ambrisentan in the last year, please email Sandra Applebaum, MS (sandra.applebaum@luminasllc.com) at Luminas, the survey administrator, and DO NOT proceed further.
Your participation in the survey is voluntary, and you may withdraw at any time. Your responses will be aggregated with other responses and analyzed in a de-identified manner. The survey methods have been approved by the Institutional Review Board at Brigham and Women’s Hospital and the FDA Research Involving Human Subjects Committee.
The survey should take approximately 20 minutes to complete. In addition to the $20 enclosed in this packet, following completion, you will be asked for your email address and emailed a $80 Amazon gift card as a token of appreciation. This survey is not connected in any way with a pharmaceutical manufacturer.
We appreciate your contribution to this important topic. Thank you in advance for your participation!
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Instructions for Completing the Survey
As a reminder, you can take the survey online if you prefer at the following link: [link].
Using a blue or black pen, place an “X”
in the box next to the appropriate response as shown:
.
If asked to provide a written response to a question, please PRINT legibly in the space provided.
If completing the paper questionnaire, please return it in the enclosed postage-paid envelope.
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Section A: Prescribing and Certification Requirements
We will start the survey by getting a better understanding of your experience with ambrisentan.
A1. Approximately when was the last time you prescribed ambrisentan?
month year
A2. Approximately how many of your patients have you prescribed ambrisentan to over the last 3 years?
1 1-10 patients
2 11-20 patients
3 21 or more patients
A3. Approximately how many women of reproductive potential have you prescribed ambrisentan to over the last 3 years?
1 1-5 patients
2 6-10 patients
3 11 or more patients
As you may know, ambrisentan is subject to a special FDA safety program. Before prescribing ambrisentan, physicians must go through a certification process administered by the manufacturer. The certification process typically involves such activities as reviewing certain materials, training, and filling out forms.
A4. Approximately how many years ago did you first complete the certification process for ambrisentan?
years ago
A5. How well do you recall the certification process that allowed you to begin to prescribe ambrisentan?
1 Very well
2 Moderately well
3 Slightly well
4 Not well at all
A6. Did the certification process for ambrisentan provide information on the following risks?
|
Yes |
No |
I don’t remember |
a. Birth defects (women of reproductive potential) |
1 |
2 |
3 |
b. Decreased hemoglobin count |
1 |
2 |
3 |
c. Decreased sperm count (men) |
1 |
2 |
3 |
d. Pulmonary edema |
1 |
2 |
3 |
e. Respiratory infections |
1 |
2 |
3 |
f. Stroke |
1 |
2 |
3 |
A7. When you start a patient on ambrisentan, how often do you discuss the following risks?
|
Never (0% of the time) |
Rarely (1%-5% of the time) |
Sometimes (6%-25% of the time) |
Often (26%-50% of the time) |
Most of the time (51%-75% of the time) |
Always/almost always (76% of the time or more) |
reproductive potential) |
1 |
2 |
3 |
4 |
5 |
6 |
|
1 |
2 |
3 |
4 |
5 |
6 |
c. Decreased sperm count (men) |
1 |
2 |
3 |
4 |
5 |
6 |
d. Pulmonary edema |
1 |
2 |
3 |
4 |
5 |
6 |
e. Respiratory infections |
1 |
2 |
3 |
4 |
5 |
6 |
f. Stroke |
1 |
2 |
3 |
4 |
5 |
6 |
A8. Using a scale from 1 (most) to 4 (least), please rank the following risks to patients receiving ambrisentan in order of their magnitude of concern to you.
1 Birth defects (women of reproductive potential)
2 Decreased sperm count (men)
3 Decreased hemoglobin count
4 Pulmonary edema
A9. Using a scale from 1 (most) to 5 (least), please rank the usefulness of the following sources of information in contributing to your understanding of the risks of ambrisentan.
1 Clinical decision support tools (e.g., UpToDate, MicroMedex, ePocrates)
2 Manufacturer sales representatives’ presentations or materials
3 Professional colleagues
4 Studies and other articles published in medical journals
5 The drug’s FDA-approved labeling
A10. At first, how frequently must the testing required for ambrisentan be performed?
If fewer than 10 weeks, please enter as 2 digits, e.g., 04.
Every weeks
A11. Please indicate to what extent you agree or disagree with the following statements.
|
Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
process, while other drugs I prescribe for my patients with pulmonary arterial hypertension do not have a certification process. |
1 |
2 |
3 |
4 |
5 |
|
1 |
2 |
3 |
4 |
5 |
|
1 |
2 |
3 |
4 |
5 |
d. The educational materials provided as part of the certification process should include information about any clinically important risk of ambrisentan. |
1 |
2 |
3 |
4 |
5 |
e. The educational materials provided as part of the certification process should include information about how well ambrisentan is expected to work. |
1 |
2 |
3 |
4 |
5 |
f. The certification process effectively explained the testing required of patients receiving ambrisentan. |
1 |
2 |
3 |
4 |
5 |
|
1 |
2 |
3 |
4 |
5 |
h. Physicians should be required to repeat the certification process each year while they are active prescribers of ambrisentan. |
1 |
2 |
3 |
4 |
5 |
i. Physicians should be compensated for having to complete the certification process for ambrisentan. |
1 |
2 |
3 |
4 |
5 |
Section B: Patient Initiation and Monitoring
As you may know, prior to and while taking ambrisentan, patients are also required to follow certain “safe use requirements”.
B1. To receive an initial prescription for ambrisentan, patients must do the following:
|
Yes |
No |
Not sure |
a. Get a liver function test |
1 |
2 |
3 |
b. Get a pregnancy test (women of reproductive potential) |
1 |
2 |
3 |
c. Get a urinalysis |
1 |
2 |
3 |
|
1 |
2 |
3 |
B2. When you prescribe ambrisentan, how long, on average, do you or someone on your team spend explaining to patients the safe use requirements related to the drug?
1 We do not discuss safe use requirements with my patients.
2 5 minutes or less
3 6-10 minutes
4 11-15 minutes
5 More than 15 minutes
B3. Who on your clinical team is primarily responsible for helping patients complete administrative paperwork or enrollment forms involved with the safe use requirements?
1 I am
2 A nurse practitioner or registered nurse
3 A physician assistant
4 Other (Please specify: __________________________________)
5 No one
B4. Do your patients receive from you or your team any other materials describing the risks of taking ambrisentan?
1 Yes
2 No GO TO B6.
B5. What materials do you or your team provide describing the risks or harms of ambrisentan? Please check all that apply.
1 Published articles or stories
2 Links to manufacturer website
3 Links to any non-manufacturer websites
4 Pamphlets or brochures produced by the manufacturer
5 Pamphlets or brochures produced by you or your institution
6 Other materials (Please specify: __________________________________)
B6. After learning about the safe use requirements for ambrisentan, how often do your patients seek another treatment option instead?
1 Never (0% of the time)
2 Rarely (1%-5% of the time)
3 Sometimes (6%-25% of the time)
4 Often (26%-50% of the time)
5 Most of the time (51%-75% of the time)
6 Always/almost always (76% of the time or more)
B7. In your estimation, how frequently do your patients follow the testing schedule that is part of the safe use requirements?
1 Never (0% of the time)
2 Rarely (1%-5% of the time)
3 Sometimes (6%-25% of the time)
4 Often (26%-50% of the time)
5 Most of the time (51%-75% of the time)
6 Always/almost always (76% of the time or more)
B8. Please indicate to what extent you agree or disagree with the following statements.
|
Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
a. The testing requirement is clinically necessary for safe use of ambrisentan. |
1 |
2 |
3 |
4 |
5 |
b. The paperwork involved with the safe use requirements facilitates discussion about ambrisentan between patients and me or my team. |
1 |
2 |
3 |
4 |
5 |
c. The safe use requirements are burdensome for most patients. |
1 |
2 |
3 |
4 |
5 |
|
1 |
2 |
3 |
4 |
5 |
|
1 |
2 |
3 |
4 |
5 |
|
1 |
2 |
3 |
4 |
5 |
Section C: Overall Experiences and Perceptions and Reforms
C1. Please rate how easy or hard it is to complete the following tasks related to prescribing ambrisentan.
|
Very easy |
Somewhat easy |
Neither easy nor hard |
Somewhat hard |
Very hard |
a. The physician certification process |
1 |
2 |
3 |
4 |
5 |
b. The patient enrollment process |
1 |
2 |
3 |
4 |
5 |
c. Testing patients |
1 |
2 |
3 |
4 |
5 |
d. Reporting testing findings |
1 |
2 |
3 |
4 |
5 |
C2. How willing would you be to prescribe ambrisentan if it was not subject to…?
|
Very willing |
Somewhat willing |
Neither willing nor unwilling |
Somewhat unwilling |
Very unwilling |
a. Physician certification requirements |
1 |
2 |
3 |
4 |
5 |
b. Patient safe use requirements |
1 |
2 |
3 |
4 |
5 |
C3. How often are patients needing ambrisentan referred to you by other physicians in your specialty because they are not certified to prescribe it?
1 A lot
2 Sometimes
3 Never
Please indicate to what extent you agree or disagree with the following statements:
C4. Overall, the positives of the …
|
Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
outweigh the negatives. |
1 |
2 |
3 |
4 |
5 |
outweigh the negatives. |
1 |
2 |
3 |
4 |
5 |
Section D: Pandemic Impact
D1. Did you prescribe ambrisentan prior to the start of the COVID-19 pandemic in March 2020?
1 Yes
2 No
D2. IF YOU ANSWERD NO TO D1, SKIP TO D3. IF YOU ANSWERED YES TO D1, please rate how much easier or harder it was to complete the following tasks related to prescribing ambrisentan during vs. before the pandemic.
|
Much easier |
Somewhat easier |
Neither easier nor harder |
Somewhat harder |
Much harder |
a. The patient enrollment process |
1 |
2 |
3 |
4 |
5 |
b. Testing patients |
1 |
2 |
3 |
4 |
5 |
c. Reporting testing findings |
1 |
2 |
3 |
4 |
5 |
D3. Were you aware of the pandemic policy related to required testing under special FDA drug safety programs?
1 Yes
2 No
In March 2020, the FDA announced it would permit drug manufacturers and health care providers to make accommodations for laboratory tests required under the drug safety programs during the COVID-19 pandemic, such as allowing patients to take home pregnancy tests instead of using a blood test.
D4. Did the manufacturers of ambrisentan change the drug’s pregnancy testing requirements in response to the pandemic?
1 Yes
2 No
3 I don’t know
D5. Did you change pregnancy testing requirements for your patients taking ambrisentan in response to the pandemic (independent of the drug manufacturers)?
1 Yes (If yes, describe briefly: _________)
2 No
Section E: Demographics
E1. What gender do you identify as…? Mark only one.
1 Male
2 Female
3 Prefer not to answer
E2. Which of the following best describes your race? Mark one or more.
1 American Indian or Alaska Native
2 Asian
3 Black or African-American
4 Native Hawaiian or Other Pacific Islander
5 White
6 Prefer not to answer
E3. Are you of Hispanic, Latino, or Spanish origin?
1 Yes
2 No
E4. What year did you graduate from medical school?
E5. Which of the following best describes your specialty? You may select up to 2.
1 Allergy/Immunology
2 Anesthesiology
3 Cardiology
4 Dermatology
5 Endocrinology
6 Emergency Medicine
7 Family/General Practice
8 Geriatrics
9 Internal Medicine
10 Medical Genetics
11 Neurological Surgery
12 Nephrology
13 Neurology
14 Obstetrics/Gynecology
15 Oncology
16 Ophthalmology
17 Orthopedics
18 Otolaryngology
19 Pathology
20 Pediatrics
21 Physical Medicine and Rehab
22 Plastic Surgery
23 Preventive Medicine
24 Psychology
25 Pulmonology
26 Radiology
27 Rheumatology
28 Sleep medicine
29 Surgery
30 Urology
31 Other (Please specify: ___________)
E6. In what ZIP code is your practice located?
E7. In what clinical settings do you prescribe ambrisentan? You may select more than one.
1 Outpatient clinic (solo practice)
2 Outpatient clinic (group practice)
3 Community hospital (non-military/VA)
4 Academic hospital (non-military/VA)
5 Military or VA hospital
6 Other (Please specify: __________________________________)
E8. What percentage of your professional time is spent in direct patient care?
percent
E9. Have you received any of the following from Gilead, the brand-name manufacturer of ambrisentan, over the past three years? Please select all that apply.
1 Speaker fees
2 Payment for membership on an advisory board
3 Research grants
4 Other benefits (Please specify: __________________________________)
E10. Please provide your email address to receive your gift card: ______________
THANK YOU FOR TAKING THE TIME TO COMPLETE THIS SURVEY. PLEASE RETURN YOUR COMPLETED
QUESTIONNAIRE IN THE ENCLOSED ENVELOPE OR MAIL IT TO:
Adapt, Inc.
Physician Survey
5610 Rowland Road
Suite 160
Minnetonka, MN 55343
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Sarpatwari, Ameet,Ph.D.,J.D. |
File Modified | 0000-00-00 |
File Created | 2022-05-23 |