Methodologic Advances in Evaluating Abuse Deterrent Opioid Analgesics: Physician and Pharmacist Surveys

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Methodological Advances in Evaluating Abuse-deterrent
Opioid Analgesics - Physician Survey
Thank you for taking the time to complete the survey. Your input will be valuable to us as we work to understand the
prescribing and dispensing of abuse-deterrent formulation opioid analgesics.
Please note that you can move between pages of the survey, and, if you are interrupted, can return to complete the
survey as long as you keep the window open.

You are invited to participate in a survey collecting information and opinions related to the prescribing and
dispensing of abuse-deterrent formulation opioid analgesics. This study is being conducted on behalf of the U.S. Food
and Drug Administration by researchers at the University of Kentucky Colleges of Pharmacy and Public Health.
You have been asked to participate in this survey because you are a licensed physician with the ability to prescribe
controlled substances in the state of Kentucky. If you voluntarily complete the survey, you will be one of
approximately 1,500 physicians to do so. The survey will take approximately 10 minutes to complete.
The survey asks about your prescribing of abuse-deterrent formulation opioid analgesics. The information generated
from this research will assist in our understanding of how these medications are being utilized in practice.
Your response to the survey is anonymous. Neither the researchers nor the licensure board will know who did, or did
not, respond to the survey. The research team will not attempt to trace responses back to individuals. There are no
known risks associated with disclosure of your opinions about the prescribing and dispensing of abuse-deterrent
formulations of opioid analgesics. Your information will be kept secure to the extent provided by law.
You may receive two additional email invitations to participate in this survey over the next two weeks. If you have
already responded, or elect not to respond to the survey, please ignore these additional emails.
Taking part in this research is completely voluntary. If you choose not to participate, there will be no penalty to you.
You are free to skip any question that you do not want to answer, and you can discontinue the survey at any time.
Although you will not personally benefit by completing the survey, the information that you provide may help us
understand how abuse-deterrent formulations might be used more effectively.
This study has been reviewed by the University of Kentucky Medical Institutional Review Board. If you have questions
about this study, you may call Patricia Freeman at 859-323-1381 or Svetla Slavova at 859-323-7873. If you have any
questions about your rights as a volunteer in this research, you may contact the staff in the Office of Research
Integrity at the University of Kentucky at 859-257-9428 or toll free at 1-866-400-9428.
Thank you for your time and we appreciate your consideration in completing this survey.
Patricia Freeman, PhD
Associate Professor
University of Kentucky College of Pharmacy
Svetla Slavova, PhD
Associate Professor
University of Kentucky College of Public Health

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OMB Control No.: 0910-0847
Expiration Date: 11/30/2020
Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, 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 0910-0847, and the expiration date is 11/30/2020. The time required
to complete this information collection is estimated to average 10 minutes per response,
including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information.
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.
This study is being conducted on behalf of the U.S. Food and Drug Administration by
researchers at the University of Kentucky Colleges of Pharmacy and Public Health.
Do you prescribe opioid analgesics in your practice?
Yes
No
Thank you for your willingness to participate. This survey focuses on the prescribing of opioid analgesics. We look
forward to your participation in future surveys.

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Section I. Questions about your perception of abuse-deterrent formulation opioids.
One of the ways that the U.S. Food and Drug Administration (FDA) has tried to address the opioid epidemic is by
approving opioid analgesic products that are designed to be harder to manipulate and abuse. These so-called 'abusedeterrent formulations' (e.g. OxyContin®, Embeda®, etc.) are intended to make certain types of abuse, such as
crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding.
Considering your experience prescribing opioid analgesics, how would you rate your familiarity with abuse-deterrent
formulation opioids?
Not familiar at all
Somewhat familiar
Familiar
Very familiar
Unsure

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Individuals who misuse/abuse prescription opioids do so using varied routes of administration.
In your professional opinion, how effective are abuse-deterrent formulation opioids in
mitigating abuse/misuse by each of these specific routes?
Not effective at
all

Somewhat
effective

Effective

Very effective

Unsure

Smoking
Snorting
Chewing or dissolving before
swallowing
Swallowing intact
Injection (intravenous,
intramuscular, or subcutaneous)

Please indicate the extent to which you agree or disagree with the following statement:
In my professional opinion, to gain and maintain FDA-approval, all opioid analgesics should meet FDA standards as
abuse-deterrent formulations.
Strongly disagree
Disagree
Agree
Strongly agree
Unsure
If you selected "Strongly agree," please elaborate.

If you selected "Strongly disagree," please
elaborate.

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Section II. Questions about your experience prescribing medications newly-approved by the
FDA and abuse-deterrent formulation opioid analgesics.
Which of these describes you well when it comes to prescribing medications newly approved by the FDA? (select all
that apply)
Usually prescribe new medications before others do
Prefer medications which have worked well for patients in the past
Like being able to share with colleagues about new medications I've prescribed
Like the variety of prescribing new medications
Feel more comfortable using familiar medications
Prefer to wait until I hear about colleagues' experiences with prescribing new medications
Other
If you selected 'Other,' please describe.

When making prescribing decisions regarding which opioid analgesic to prescribe, do you consider whether or not
the opioid is an abuse-deterrent formulation?
Yes
No

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To what extent do each of the following patient-specific factors influence your decision to
prescribe an abuse-deterrent formulation opioid over a non-abuse-deterrent opioid analgesic?
No influence

Little influence

Some influence

Patient demographics (e.g. age,
ethnicity)
Patient preference for a specific
opioid product
Concern for misuse/abuse by
patient or patient's family
member
Anticipated cost to patient
Risk of diversion by patient or
patient's family members
Total daily dosage of opioid
patient requires
Patient's risk stratification score
Patient's concomitant
medication use
Concern over patient switching
to illicit opioid
Which of the following risk-stratification tools do you most commonly utilize?
Opioid risk tool
Screener and Opioid Assessment for Patients with Pain - Version 1 (SOAPP-1)
Screener and Opioid Assessment for Patients with Pain - Revised (SOAPP-R)
Brief Risk Interview
Other
If you selected 'Other,' please provide the name of
the risk-stratification tool you most commonly
utilize.

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Great influence

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To what extent do each of the following non-patient-specific factors influence your decision to
prescribe an abuse-deterrent formulation opioid over a non-abuse deterrent opioid analgesic?
No influence

Little influence

Some influence

Past experience prescribing
abuse-deterrent formulations
System or government oversight
of prescribing patterns
Anecdotal prescribing
experience of colleagues
Third-party payer considerations
Effectiveness compared to
traditional formulations
Practice- or system-level policies
Information provided by sales
reps, medical liaisons, etc.
Innovative nature of
abuse-deterrence mechanisms
Potential public health impact of
reducing the supply of abusable
prescription opioids

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Great influence

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For each of the following abuse-deterrent formulation opioids, please indicate the frequency
with which you have prescribed them in your practice.
Never

Rarely (i.e. a few
times a year)

Occasionally
(i.e. monthly)

Frequently (i.e.
weekly)

Embeda® (morphine sulfate and
naltrexone hydrochloride
extended-release)
Hysingla® ER (hydrocodone
bitartrate extended-release)
MorphaBond® ER (morphine
sulfate extended-release)
Xtampza® ER (oxycodone
extended-release)
OxyContin® (oxycodone
hydrochloride extended-release)

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Very frequently
(i.e. daily)

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For the abuse-deterrent formulations that you have never prescribed, please indicate to what
extent the following factors generally influenced your decision NOT to prescribe these agents?
No influence

Little influence

Some influence

Great influence

Generally prescribe generic
medications over brand-name
medications
Lack of familiarity with the
product(s)
Patient preference for a
non-abuse deterrent formulation
Lack of third-party coverage or
high copays makes them
unaffordable for most patients
Concern that patients will switch
to illicit alternative (e.g. heroin)
Skepticism that abuse-deterrent
properties will prevent addiction
or overdose
Concern that the
abuse-deterrent formulation
may provide inadequate
analgesia
Patients to whom I prescribe
opioid analgesics are at low risk
for misuse/abuse
Evidence-based guidelines do
not list abuse-deterrent
formulations as preferred over
non-abuse deterrent
formulations
In general, please indicate the primary reason you have prescribed OxyContin®.
It is an extended-release opioid product covered by most third-party payers
It is an abuse-deterrent formulation
It is an appropriate extended release regimen for patients who have been on oxycodone immediate-release
It has been an effective treatment for previous patients
Patient was started on OxyContin by another provider and appears to benefitting from it

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Section III. Communication with patients and pharmacists regarding abuse deterrent
formulation opioids.
To your recollection, have any of your patients ever specifically requested to receive an abuse-deterrent opioid
formulation instead of a non-abuse-deterrent opioid formulation?
Yes
No
What circumstances best describe the reason(s) a patient specifically requested an abuse-deterrent formulation
opioid instead of a non-abuse-deterrent opioid? (select all that apply)
Past medical history
Concern about misuse/abuse potential of non-abuse-deterrent formulations by others
Belief that abuse-deterrent formulations were safer than non-ADFs
Other
If you selected 'Other,' please describe.

To your recollection, has a patient to whom you prescribed an abuse-deterrent formulation opioid ever specifically
requested to switch to a non-abuse-deterrent formulation?
Yes
No
Please describe the reason(s) the patient requested
to switch to a non-abuse-deterrent formulation opioid.
To your recollection, have you ever been contacted by a pharmacist who recommended an abuse-deterrent
formulation opioid for a patient SPECIFICALLY because of its abuse-deterrent properties?
Yes
No
To your recollection, have you ever been contacted by a pharmacist to request substitution of a non-abuse-deterrent
formulation opioid for an abuse-deterrent formulation opioid? (e.g. MorphaBond® ER to MS Contin)?
Yes
No
What circumstance(s) best describe(s) the reason(s) a pharmacist contacted you to request substitution of a
non-abuse-deterrent formulation opioid for an abuse-deterrent formulation opioid? (select all that apply)
Abuse-deterrent formulation was out of stock
Cost to patient was lower for non-abuse-deterrent formulation
Patient preferred / requested a non-abuse-deterrent formulation
Claim to third-party payer for abuse-deterrent formulation was rejected
Other
If you selected 'Other,' please describe.

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Did you approve the pharmacist's request to substitute a non-abuse-deterrent formulation opioid?
Yes
No

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Section IV. Questions about third party payer requirements for abuse deterrent formulation
opioids.
For each of the following abuse-deterrent formulation opioids that you have prescribed,
please indicate how often prescriptions are subject to additional requirements from
third-party payers (e.g. prior authorization).
Rarely

Occasionally

Almost always

I am unsure how
often prescriptions
are subject to
additional
requirements.

Embeda® (morphine sulfate and
naltrexone hydrochloride
extended-release)
Hysingla® ER (hydrocodone
bitartrate extended-release)
MorphaBond® ER (morphine
sulfate extended-release)
OxyContin® (oxycodone
hydrochloride extended-release)
Xtampza® ER (oxycodone
extended-release)
At this time, would you support state legislation mandating third-party payer coverage of abuse-deterrent
formulation opioids?
Yes
No
Please elaborate as to why you would support this
legislation.
Please elaborate as to why you would not support this
legislation.

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Section V. Questions about your perception of opioid misuse/abuse.
Please indicate to what extent you agree or disagree with the following statements.
Strongly
disagree

Disagree

Agree

Strongly agree

Unsure

The misuse/abuse of prescription
opioids is a problem in my
community.
The misuse/abuse of prescription
opioids is a problem among
patients at my practice.

I am confident in my ability to
identify a patient who is
misusing/abusing prescription
opioids.

In your professional opinion, which of the following routes of administration is used most commonly by individuals
who misuse/abuse opioid medications?
Smoking
Snorting
Chewing or dissolving before swallowing
Swallowing intact
Injection (intravenous, intramuscular, or subcutaneous)
Unsure

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In your professional opinion, how effective are the following strategies in mitigating the
misuse/abuse of prescription opioids?
Not effective at
all

Somewhat
effective

Effective

Very effective

Checking the prescription drug
monitoring program (KASPER)
Pharmacist-driven pill counts
Abuse-deterrent formulation
opioids
Urine drug screening
Prescriber-driven pill counts
Payer restriction programs to a
single pharmacy and/or single
prescriber (e.g. lock-in program)
Prescribing (days' supply) limits

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Unsure

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Section VI. Questions about you and your practice.
What is your gender?
Male
Female
Prefer not to answer
Prefer to self-describe
If you selected 'Prefer to self-describe,' you may do
so here.
Please indicate your total number of years in practice following completion of residency training.
Currently in residency training
<5
5 -15
16 - 25
26 - 35
> 35
Which of the following best describes your primary specialty?
Addiction medicine
Anesthesiology
Cardiovascular disease
Critical care medicine or Pulmonary disease
Emergency medicine
Family medicine
Gastroenterology
General surgery
Hematology & Oncology
Internal medicine
Neurology or Neurological surgery
Obstetrics & Gynecology
Ophthalmology
Orthopedic surgery
Otolaryngology
Pain medicine
Pediatrics or Neonatal-Perinatal medicine
Plastic surgery
Psychiatry
Radiology & Diagnostic radiology
Urology
Other
If you selected 'Other,' please describe.

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In which county is your primary practice site located (i.e. the site where you spend the most time each week)?
Adair
Allen
Anderson
Ballard
Barren
Bath
Bell
Boone
Bourbon
Boyd
Boyle
Bracken
Breathitt
Breckinridge
Bullitt
Butler
Caldwell
Calloway
Campbell
Carlisle
Carroll
Carter
Casey
Christian
Clark
Clay
Clinton
Crittenden
Cumberland
Daviess
Edmonson
Elliott
Estill
Fayette
Fleming
Floyd
Franklin
Fulton
Gallatin
Garrard
Grant
Graves
Grayson
Green
Greenup
Hancock
Hardin
Harlan
Harrison
Hart
Henderson
Henry
Hickman
Hopkins
Jackson
Jefferson
Jessamine
Johnson
Kenton
Knott
Knox
LaRue
Laurel
Lawrence
Lee
Leslie
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Lewis
Lincoln
Livingston
Logan
Lyon
McCracken
McCreary
McLean
Madison
Magoffin
Marion
Marshall
Martin
Mason
Meade
Menifee
Mercer
Metcalfe
Monroe
Montgomery
Morgan
Muhlenberg
Nelson
Nicholas
Ohio
Oldham
Owen
Owsley
Pendleton
Perry
Pike
Powell
Pulaski
Robertson
Rockcastle
Rowan
Russell
Scott
Shelby
Simpson
Spencer
Taylor
Todd
Trigg
Trimble
Union
Warren
Washington
Wayne
Webster
Whitley
Wolfe
Woodford

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Which of the following best characterizes your primary practice setting?
Solo practice
Small private group practice (5 or less practitioners)
Large private group practice (6 or more practitioners)
Academic practice
Emergency department
Hospital-based clinic
Hospital inpatient
Managed care organization
VA health-system or another governmental agency
Other
If you selected 'Other,' please describe.

On average, across all practice sites (primary
practice and other practice) how many patients do
you see each week?

< 25
25-49
50-74
75-100
> 100

To your recollection, have you ever completed continuing education that discussed the use of abuse-deterrent
formulation opioids as a means of promoting safe opioid use?
Yes
No

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Section VII. Opportunity to provide additional thoughts on survey topics.
Please share any additional thoughts you have about
abuse-deterrent formulation opioids and opioid
misuse/abuse.

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