Download:
pdf |
pdfPage 1 of 18
Methodological Advances in Evaluating Abuse-deterrent
Opioid Analgesics - Pharmacist 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 pharmacist with the ability to dispense
controlled substances in the state of Kentucky. If you voluntarily complete the survey, you will be one of
approximately 1,000 pharmacists to do so. The survey will take approximately 10 minutes to complete.
The survey asks about your stocking and dispensing 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 pharmacy 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 required 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 t he 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
10/10/2019 5:17pm
projectredcap.org
Page 2 of 18
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 dispense opioid analgesics in your practice?
Yes
No
Thank you for your willingness to participate. This survey focuses on the dispensing of opioid analgesics. We look
forward to your participation in future surveys.
10/10/2019 5:17pm
projectredcap.org
Page 3 of 18
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 dispensing opioid analgesics, how would you rate your familiarity with abuse-deterrent
formulation opioids?
Not familiar at all
Somewhat familiar
Familiar
Very familiar
Unsure
10/10/2019 5:17pm
projectredcap.org
Page 4 of 18
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 misuse/abuse 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.
10/10/2019 5:17pm
projectredcap.org
Page 5 of 18
Section II. Questions about your experience dispensing abuse-deterrent formulation opioid
analgesics.
When making dispensing decisions regarding opioid analgesic prescriptions, do you consider whether or not the
opioid is an abuse-deterrent formulation?
Yes
No
If you answered "Yes," please describe why you make
this consideration.
If you answered "No," please describe why you do not
make this consideration.
10/10/2019 5:17pm
projectredcap.org
Page 6 of 18
For each of the following abuse-deterrent formulation opioids, please indicate the frequency
with which you have dispensed them in your practice.
Not in stock,
Never
dispensed
In stock,
Never
dispensed
Rarely (i.e. a
few times a
year)
Occasionally
(i.e. monthly)
Frequently
(i.e. weekly)
Very
frequently
(i.e. daily)
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)
In general, for those not stocked and never dispensed, please indicate the primary reason(s) why they are not
stocked in your pharmacy. (select all that apply)
Too few prescriptions presented to the pharmacy
Inventory costs are too great
Lack of third-party payer coverage makes them unaffordable for most patients
Time/resources involved in securing third-party payment approval (e.g. prior authorization)
Other
If you selected 'Other,' please describe.
10/10/2019 5:17pm
projectredcap.org
Page 7 of 18
Considering your past dispensing experience, please indicate the frequency with which you
have taken the following actions?
Never
Rarely
Occasionally
Frequently
Very frequently
Substituted a generic
non-abuse-deterrent formulation
opioid when presented with a
prescription for an
abuse-deterrent formulation
opioid
Dispensed an abuse-deterrent
formulation opioid when
presented with a prescription
written generically (e.g.
dispensed MorphaBond® ER for
morphine sulfate ER)
Contacted a prescriber to
recommend an abuse-deterrent
formulation opioid for a patient
SPECIFICALLY because of its
abuse-deterrent properties
Declined to fill an
abuse-deterrent formulation
prescription because it was not
in stock
Asked patient with an
abuse-deterrent formulation
prescription not in stock to
return next day to pick up the
prescription
What circumstance(s) best describe(s) your reason(s) for substituting a generic non-abuse-deterrent formulation
opioid when presented with a prescription for an abuse-deterrent formulation opioid? (select all that apply)
Patient preferred / requested non-abuse-deterrent formulation
Only product stocked was non-abuse-deterrent formulation
Abuse-deterrent formulation opioid was not covered by patient insurance
Patient copay/coinsurance for the abuse-deterrent formulation was not affordable for the patient
Other
If you selected 'Other,' please describe.
What circumstance(s) best describe(s) your reason(s) for dispensing an abuse-deterrent formulation opioid when
presented with a generically-written prescription ? (select all that apply)
Patient's past medical history
General concern about potential misuse/abuse
Patient preferred / requested abuse-deterrent formulation
Only product stocked is abuse deterrent formulation
Reimbursement for abuse-deterrent formulation is more favorable
Other
10/10/2019 5:17pm
projectredcap.org
Page 8 of 18
If you selected 'Other,' please describe.
10/10/2019 5:17pm
projectredcap.org
Page 9 of 18
Section III. Questions about third-party payer requirements and reimbursement for
abuse-deterrent formulation opioids that you have dispensed.
For each of the following abuse-deterrent formulation opioids that you have in stock or have
dispensed, please indicate how often the claims you submit for reimbursement are rejected by
third-party payers.
Rarely
Occasionally
Almost always
I am unsure how
often claims are
rejected.
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)
Considering your past experience, when a claim submitted for an abuse-deterrent formulation opioid was rejected,
which of the following actions have you taken? (select all that apply)
Contacted the third-party payer and/or prescriber to request a prior authorization
Asked the patient to contact the third-party payer and/or prescriber to request a prior authorization
Substituted a generic non-abuse-deterrent formulation
Contacted the prescriber to request a new e-script for a different product
Asked the patient to contact the prescriber to get a new script for a different product
Allowed patient to pay cash or use copay/discount card
Other
I have never submitted a claim for an abuse-deterrent formulation that was rejected by the payer
If you selected 'Other' please describe.
Considering your past experience dispensing abuse-deterrent formulation opioids, how often has high cost-sharing
(i.e. copayment or coinsurance) resulted in a patient being unable or unwilling to obtain the abuse-deterrent
formulation?
Never
Rarely
Occasionally
Frequently
Very frequently
10/10/2019 5:17pm
projectredcap.org
Page 10 of 18
Considering your past experience dispensing abuse-deterrent formulation opioids, which of the following types of
third-party payer claims are most often rejected or subject to high cost-sharing such that the patient does not
receive the prescribed abuse-deterrent formulation opioid?
Medicare
Medicaid
Commercial
TRICARE
Unsure
These issues appear to be similar among third-party payers
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 not support this legislation.
Please elaborate as to why you would support this legislation.
10/10/2019 5:17pm
projectredcap.org
Page 11 of 18
Section IV. 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
10/10/2019 5:17pm
projectredcap.org
Page 12 of 18
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
10/10/2019 5:17pm
projectredcap.org
Unsure
Page 13 of 18
Section V. Questions about calculating days' supply for controlled substances.
The calculation of days' supply for controlled substance prescriptions is not standardized and may vary based upon
pharmacist interpretation and clinical judgment. This section seeks to better understand how pharmacists determine
days' supply and the factors that might influence days' supply calculations.
You are presented with the following prescription:
Hydrocodone/Acetaminophen 5 mg/325 mg
1-2 tabs Q 4-6H PRN breakthrough pain
#360
What days' supply would you enter for this
prescription?
Please explain the rationale you used to determine the days' supply to enter for this prescription.
You are presented with the following prescription:
Morphine sulfate 10 mg/5 mL
2 tsp Q6H PRN breakthrough pain
#280 mL
What days' supply would you enter for this
prescription?
When determining the days' supply of a controlled substance prescription, which of the following factors do you
consider? (check all that apply)
Likelihood that patient misuses/abuses the prescription
Patient fill history patterns
If the prescription is written on a scheduled or on an 'as needed' basis
Concomitant use of other controlled substances
Familiarity with practitioner's prescribing patterns
Third-party payer restrictions on days' supply
Schedule of the prescription (C-II to C-V)
Instructions from the prescriber regarding intended duration of the prescription
System or government oversight of dispensing patterns
Other
I calculate days' supply without considering any of these factors
If you selected 'Other,' please describe.
In your professional opinion, accurate days' supply calculations is/are important to: (check all that apply)
Satisfy 3rd party payer requirements
Satisfy DEA regulations and KY Board of Pharmacy Rules
Ensure accurate assessment of doctor shopping behavior in KASPER
Ensure accurate calculation of morphine milligram equivalents in KASPER
Determine when medication is due to be filled/refilled
Support safe medication use for patients
10/10/2019 5:17pm
projectredcap.org
Page 14 of 18
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.
What is your terminal degree?
BS Pharmacy
PharmD
Which of the following best characterizes your primary practice setting?
Community pharmacy - chain/supermarket/mass merchandiser
Community pharmacy - independent
Health-system outpatient pharmacy
Long-term care pharmacy
Mail order or specialty pharmacy
Hospital inpatient pharmacy
Other
If you selected 'Other,' please describe.
Please indicate your total number of years in practice.
<5
5-15
16-25
26-35
> 35
10/10/2019 5:17pm
projectredcap.org
Page 15 of 18
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
10/1L0e/2t0c1h9e5r :17pm
projectredcap.org
Page 16 of 18
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
On average, how many total prescriptions (opioid and non-opioid) are dispensed daily from your primary practice
site?
< 150
150-249
250-349
350-450
> 450
Unsure
Page 17 of 18
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
10/10/2019 5:17pm
projectredcap.org
Page 18 of 18
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.
10/10/2019 5:17pm
projectredcap.org
| File Type | application/pdf |
| Author | Brown, John R. |
| File Modified | 2019-11-01 |
| File Created | 2019-10-17 |