Attachment C_Questionnaire_Buprenorphine_August 1 2024

Attachment C

Exploring Barriers to Buprenorphine Access for Opioid Use Disorder

Questionnaire

OMB Control Number 0910-0695

Expiration Date: 8/31/2027

Paperwork Reduction Act Statement: The Paperwork Reduction Act of 1995 provides that an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0695. The time required to complete this information collection is estimated to average 10 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

The survey we are conducting is on behalf of the U.S. Food and Drug Administration (FDA).

[Programing Instructions in Blue]

Please respond to the following questions related to Opioid Use Disorder (OUD) and the use of buprenorphine-containing products and other medications for opioid use disorder (MOUD), to treat OUD.

Your participation / nonparticipation is completely voluntary, and your responses will not have an effect on your eligibility for receipt of any FDA services. In instances where respondent identity is needed (e.g., for follow-up of non-respondents), this information collection fully complies with all aspects of the Privacy Act and data will be kept private to the fullest extent allowed by law.

Buprenorphine Practice

1. Indicate which of the following apply to your professional experience:

(Do not randomize)

		1 Yes	2 No	3 Don’t Know
1a.	My employer has policies about buprenorphine prescribing to which I must adhere.	1	2	3
1b.	I have patients with OUD in my practice.	1	2	3
1c.	I currently have patients with OUD for whom I prescribe buprenorphine.	1	2	3
1d.	I have prescribed buprenorphine to treat OUD via telemedicine.	1	2	3
1e.	I have prescribed buprenorphine for OUD in the past but no longer actively prescribe it.	1	2	3
1f.	I have patients in my practice who are treated for OUD by another provider.	1	2	3
1g.	Prior to removal of the waiver requirement, I had a DATA waiver (X waiver) to prescribe buprenorphine for OUD.	1	2	3
1h.	I refer patients to another provider for OUD treatment.	1	2	3
1i.	Patients with OUD should be treated only by addiction specialists.	1	2	3
1j.	I hold a certification in addiction medicine.	1	2	3

OUD/Buprenorphine KAB

2. To what extent do you agree or disagree with the following?

RANDOMIZE OPTIONS

		1 Strongly Disagree	2 Disagree	3 Somewhat Disagree	4 Neither Agree or Disagree (Neutral)	5 Somewhat Agree	6 Agree	7 Strongly Agree
2a.	OUD is a treatable disease.	1	2	3	4	5	6	7
2b.	OUD requires long-term treatment.	1	2	3	4	5	6	7
2c.	I would consider prescribing buprenorphine if I identified a patient with OUD in my practice.	1	2	3	4	5	6	7
2d.	Other OUD medications are safer than buprenorphine.	1	2	3	4	5	6	7
2e.	Other OUD medications have fewer side effects than buprenorphine.	1	2	3	4	5	6	7
2f.	Other OUD medications are more effective than buprenorphine.	1	2	3	4	5	6	7
2g.	Prescribing buprenorphine for OUD attracts an ‘undesirable’ patient population.	1	2	3	4	5	6	7
2h.	I am confident in my ability to treat patients with OUD.	1	2	3	4	5	6	7
2i.	Buprenorphine treatment for OUD is substituting one drug for another.	1	2	3	4	5	6	7
2j.	Buprenorphine prescribed for OUD is likely to be diverted (used by someone other than the patient for whom it was prescribed).	1	2	3	4	5	6	7

Buprenorphine prescribing barriers

3. To what extent do you agree or disagree you have been hesitant to prescribe buprenorphine for OUD because of the following

RANDOMIZE OPTIONS

		1 Strongly Disagree	2 Disagree	3 Somewhat Disagree	4 Neither Agree or Disagree (Neutral)	5 Somewhat Agree	6 Agree	7 Strongly Agree
3a.	Non-drug modalities are more effective to treat OUD.	1	2	3	4	5	6	7
3b.	The complexity of treating patients with OUD.	1	2	3	4	5	6	7
3c.	Concerns about federal oversight.	1	2	3	4	5	6	7
3d.	The induction process.	1	2	3	4	5	6	7
3e.	Patients do not want to be on buprenorphine long term.	1	2	3	4	5	6	7
3f.	Patients with OUD will not use buprenorphine as prescribed.	1	2	3	4	5	6	7
3g.	State-level requirements.	1	2	3	4	5	6	7
3h.	Patients have given me negative feedback about buprenorphine.	1	2	3	4	5	6	7
3i.	Training and legal requirements are continually changing.	1	2	3	4	5	6	7
3j.	I am not comfortable initiating buprenorphine in an outpatient setting.	1	2	3	4	5	6	7

Buprenorphine prescribing barriers

4. To what extent do you agree or disagree the following would make you more likely to prescribe buprenorphine for OUD.

RANDOMIZE OPTIONS

	“I would be more likely to prescribe if…”	1 Strongly Disagree	2 Disagree	3 Somewhat Disagree	4 Neither Agree or Disagree (Neutral)	5 Somewhat Agree	6 Agree	7 Strongly Agree
4a.	I received additional education or training on how to use buprenorphine to treat OUD.	1	2	3	4	5	6	7
4b.	I had the resources (time/staff) required.	1	2	3	4	5	6	7
4c.	More flexible formulations were available to fit patients’ needs.	1	2	3	4	5	6	7
4d.	I knew that eventually patients would be able to discontinue buprenorphine.	1	2	3	4	5	6	7
4e.	I knew pharmacies would fill prescriptions.	1	2	3	4	5	6	7
4f.	I knew patients could afford it.	1	2	3	4	5	6	7
4g.	I knew I would be reimbursed.	1	2	3	4	5	6	7
4h.	Patients were engaged in concomitant psychosocial treatment.	1	2	3	4	5	6	7
4i.	I did not have to comply with special training and legal requirements (e.g., MATE Act).	1	2	3	4	5	6	7
4j.	I did not have to comply with mandated frequency of visits with patients.	1	2	3	4	5	6	7

Telemedicine

5. To what extent do you agree or disagree with the following?

(Do not randomize)

		1 Strongly Disagree	2 Disagree	3 Somewhat Disagree	4 Neither Agree or Disagree (Neutral)	5 Somewhat Agree	6 Agree	7 Strongly Agree
5a.	Telemedicine reduces stigma prescribers experience when prescribing buprenorphine to treat OUD.	1	2	3	4	5	6	7
5b.	Prescribing buprenorphine via telemedicine results in reimbursement challenges.	1	2	3	4	5	6	7
5c.	Telemedicine reduces stigma patients experience when seeking care for OUD.	1	2	3	4	5	6	7
5d.	Telemedicine makes buprenorphine treatment more accessible to patients with OUD.	1	2	3	4	5	6	7
5e.	Patients cannot access a coordinated OUD treatment plan via telemedicine.	1	2	3	4	5	6	7
5f.	Telehealth prescribers of buprenorphine do not effectively communicate with the rest of a patient’s care team.	1	2	3	4	5	6	7
5g.	Overall, telehealth is a useful tool for practitioners to treat patients with buprenorphine.	1	2	3	4	5	6	7

Open Ended

5. We understand treating patients with OUD is complex, and a provider’s reasons for choosing whether and how to do so depend on many factors. Please tell us more about why you do or do not prescribe buprenorphine for OUD.