Healthcare Professional Survey of Prescription Drug Promotion

advertisement
DRAFT
Healthcare Professional Survey of Prescription Drug Promotion
Draft screener and Questionnaire
The following information must be present on the first page of the screener and the survey:
This research is authorized by Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)). Confidentiality is protected by 5 U.S.C. 552(a) and (b) and 21 CFR part 20.
OMB Control #0910-xxxx. Expires [date].]]
1
DRAFT
Introduction
The Department of Health and Human Services is conducting this study to understand health care
providers’ attitudes regarding issues affecting public health. Your responses, and those of your
colleagues nationwide, will provide valuable insight into matters affecting the medical
community. This survey will take approximately X minutes to complete and your responses will
be kept confidential.
The first few questions are about your time spent in patient care.
[NO. OF PATIENTS/WEEK]
Q1.
In the past 7 days, about how many patients did you see? If you are not sure, please
provide your best guess. _____
[PATIENT-INITIATED TOPICS]
Q2.
How frequently do your patients initiate discussions about each of the following topics?
[Randomize response options]
Never
Rarely Sometimes Often
a. Over the counter drugs
b. Herbal remedies or dietary
supplements
c. Generic drugs
d. Prescription drugs
e. Health and lifestyle changes
The next set of questions asks specifically about Direct-to-Consumer Advertising of prescription
drugs, also known as DTC advertising.
[FREQUENCY OF DTC CONVERSATIONS]
Q3. In the past 7 days, approximately how many of your patients have spoken with you about a
prescription drug they saw advertised on television, heard about on the radio, or read in
newspapers, magazines, or on the internet?
[fill in. Range from 0-100]
______%
[If answer to Q3 is 0%, skip Q4- to Q11 and Q13-Q17]
[ATTITUDES TOWARD PATIENT MENTION OF DTC]
Q4. Which of the following best represents your reaction when patients mention prescription
drugs they have seen advertised?
2
DRAFT
_____Very negative
_____Negative
_____Somewhat negative
_____Neither negative nor positive
_____Somewhat positive
_____Positive
_____Very positive
Q4a. What specifically made you choose that answer? (Open-ended)
_________________________________
[COUNTERBALANCE Q12 with series of questions from Q5-Q11.]
[PATIENT BEHAVIOR (prescription requests)]
Q5. When you discuss drugs patients have seen advertised do they typically…(Check all that
apply):
___Ask questions
___Request a prescription
___Request a sample
Q6. In the past 7 days, about how many patients have asked for a specific prescription drug by
name?
[fill in. Range from 0-1,000]
(______)
[If response to Q6 > 0, ask Q7-Q8]
[COUNTERBALANCE SET OF Q7-Q8 with Q9]
[PROVIDER PRESCRIBING BEHAVIOR]
Q7. Thinking about the patients that have requested a specific prescription drug by name in the
past 6 months, in what percentage of cases have you:
[fill in. Range from 0-100 for each; 4 items to equal 100%)
a. prescribed the specific drug requested:
_____%
b. prescribed another drug in the same drug class: _____%
c. prescribed another drug outside of the drug class:
_____%
d. prescribed no drug:
_____%
3
DRAFT
[PERCEIVED PRESSURE TO PRESCRIBE]
Q8. To what extent did you feel pressured to prescribe the requested drug in those cases?
Not at all pressured
Slightly pressured
Moderately pressured
Very pressured
Extremely pressured
Q9. When patients mention a drug they’ve seen advertised, how often do you feel obligated to
prescribe it?
____Never or rarely
____Sometimes
____Often
____Usually
[APPROPRIATENESS OF ADVERTISED DRUGS/PATIENT RECALL]
Q10. When a patient mentions a prescription drug he or she has seen advertised, to what extent are
the following true?
[randomize answer
options a through f
series—g1 and g2 are
A great
Not at all
A little
Somewhat
always asked together
deal
and in current order]
a. the drug is indicated for
the patient’s illness?
b. b. the drug is a good option
for the patient?
c. c. the patient recalls the name
of the drug correctly?
d. d. the patient recalls the
drug’s indication?
e. the patient recalls the
drug’s stated benefit?
f.the patient asks to be taken
off the advertised medicine?
4
DRAFT
g1.the patient recalls the
drug’s side effects and risks?
g2. The patient does not
recall the drug’s side effects
and risks, but asks about
them?
[PROVIDER BEHAVIOR]
Q11. As a result of discussion about advertised prescription drugs, how often have you:
[randomize answer
Never
Rarely
Sometimes
Often
Always
options]
a. Provided a brochure
for that drug
b. Directed your
patients to a website
for that drug
c. Provided a sample
of that drug
d. Written a
prescription for that
drug
e. Written a
prescription for
another drug
f. Recommended nonprescription treatment
such as OTC
medicines
g. Recommended
dietary supplements
h. Recommended
health and lifestyle
changes
[HELPFULNESS OF DTC]
Q12. Please complete this sentence. I believe that DTC advertising is, in general, …:
_____Very beneficial to my patients
_____Beneficial to my patients
_____Somewhat beneficial to my patients
_____Neither beneficial nor harmful to my patients
5
DRAFT
_____Somewhat harmful to my patients
_____Harmful to my patients
_____Very harmful to my patients
[EFFECTS OF DTC ON QUALITY OF CARE & INFORMED DECISION MAKING]
Q13. How much do you agree or disagree with the following statements?
My patients’ exposure to DTC advertising for prescription drugs…
[randomize answer
options]
Completely
disagree
Disagree
Somewhat
disagree
Neither
agree nor
disagree
Somewhat
agree
Agree
Completely
agree
a. makes it easier for
me to communicate
with my patients
1
2
3
4
5
6
7
b. helps them to
make more informed
decisions about
prescription
medications.
c. allows me to have
a conversation with
patients that I might
not have otherwise
had.
d. helps them ask
questions about
treatment therapies
e. reminds them to
ask questions about
side effects
f. reminds them to
ask questions about
product benefits
g. helps them share
in decisions about
their treatment
1
2
3
4
5
6
7
1
2
3
4
5
6
7
1
2
3
4
5
6
7
1
2
3
4
5
6
7
1
2
3
4
5
6
7
1
2
3
4
5
6
7
6
DRAFT
[KNOWLEDGE/AWARENESS/CONFUSION]
Q14. Next, you’ll see some potential effects DTC advertising might have on your patients’
knowledge and understanding of prescription drugs. Please indicate how often exposure to
DTC advertising has caused each of the following for your patients: never, rarely, sometimes,
often or always.
Thinking about the past 12 months, to what extent do you believe that DTC advertising for
prescription drugs:
Not
A
Some A
[randomize answer options]
at all
little
-what great
deal
a. Caused your patients to become aware of possible
treatments
1
2
3
4
b. Confused your patients about the risk-benefit trade-off
of prescription drugs
1
2
3
4
c. Caused your patients to become knowledgeable about the
effectiveness of the drugs
1
2
3
4
d. Caused your patients to become knowledgeable about
potential drug side effects
1
2
3
4
e. Caused your patients to think drugs work better than
they actually do
1
2
3
4
f. Caused your patients to become more aware about their 1
disease state
2
3
4
g. Gave patients a better understanding of the risk-benefit
trade off of prescription drugs
1
2
3
4
h. Caused your patients to think prescription drugs are
riskier than they really are
i. Increased compliance with drugs patients are already
on
1
2
3
4
1
2
3
4
7
DRAFT
[COUNTERBALANCE Q15 and Q17]
[ATTITUDES]
Q15. Next, you’ll see some potential effects DTC advertising might have on your patients’
attitudes or concerns about prescription drugs. Please indicate the extent to which you believe
exposure to DTC advertising has caused each of the following for your patients: not at all, a little,
somewhat or a great deal.
In the past 12 months, how often has exposure to DTC advertising for prescription drugs:
Not at all
A little
SomeA great
[randomize answer options]
what
deal
a. Caused your patients to be more
involved in their health care
1
2
3
4
b. Caused your patients to want
advertised prescription drugs rather than
other recommended treatments
1
2
3
4
c. Created unnecessary anxieties about
potential diseases
1
2
3
4
d. Caused your patients to doubt the
value of the drugs they see advertised
1
2
3
4
[PATIENT-PROVIDER RELATIONSHIP]
Q16. Next, you’ll see some potential effects DTC advertising might have on your conversations
or relationships with your patients. Please indicate to what extent to which you believe that
DTC advertising has caused each of the following for your patients: not at all, a little, somewhat
or a great deal.
Thinking about the past 12 months, how often has DTC advertising for prescription drugs:
[Randomize order of items]
Not at all A
Somewhat A great
little
deal
a. Increased the likelihood that patients
1
2
3
4
with stigmatized medical conditions
(such as major depression) will discuss
their illness with you
b. Caused tension between you and your 1
2
3
4
patients
c. Caused your patients to question or
1
2
3
4
“second guess” your treatment
8
DRAFT
d. Caused you and your patients to have
better discussions about their health
1
2
3
4
[PATIENT BEHAVIOR]
Q17. Next, you’ll see some potential effects DTC advertising might have on your patients’
behavior regarding prescription drugs. Please indicate the extent to which you believe that
exposure to DTC advertising has caused each of the following for your patients: not at all, a little,
somewhat or a great deal.
In the past 12 months, how often has DTC advertising for prescription drugs:
[Randomize order of items]
Not at all A
Somewhat A great
little
deal
a. Caused your patients to refuse to take 1
2
3
4
prescription drugs because of the
side effects
b. Improved the likelihood that your
1
2
3
4
patients will use their medicines
properly
c. Caused your patients to adhere to
1
2
3
4
their treatment regimen
[COUPON BEHAVIOR]
Q18. Has a patient ever come to you with a coupon for an advertised prescription drug?
_____Yes [go to Q19; skip Q20]
_____No [skip Q19; go to Q20]
[PROVIDER ATTITUDES TOWARD DRUG COUPON]
Q19. How did you feel about being asked for a drug that has a coupon?
_____Very negative
_____Negative
_____Somewhat negative
_____Neither negative nor positive
_____Somewhat positive
_____Positive
_____Very positive
Q20. How would you feel about being asked for a drug that has a coupon?
_____Very negative
_____Negative
_____Somewhat negative
_____Neither negative nor positive
_____Somewhat positive
9
DRAFT
_____Positive
_____Very positive
Q21. Have you ever had a patient who refused to take or stopped taking a drug because of the side
effects they saw in advertising?
_____Yes
_____No
_____Cannot remember
[FREQUENCY OF DISCUSSION OF QUANTITATIVE SIDE EFFECT INFO]
Q22. How often do your patients ask for quantitative information about the side effects of
prescription drugs?
_____Never
_____Rarely
_____Sometimes
_____Often
_____Always
[AWARENESS OF BAD AD PROGRAM]
Q23. Have you heard of the Bad Ad program?
_____Yes
_____No
_____Don’t know/Not sure
[ATTITUDES TOWARD BAD AD PROGRAM]
Q24. FDA's "Bad Ad" Program is an outreach program to educate healthcare providers about the
role they can play in helping FDA make sure that prescription drug advertising and promotion is
truthful and not misleading. It is designed to help healthcare providers recognize misleading
prescription drug promotion and provide them with an easy way to report this activity to the
agency (via phone, 877-RX-DDMAC, or email, BadAd@fda.gov).
How do you feel about the FDA’s Bad Ad program?
_____Very useful
_____Moderately Useful
_____Slightly useful
_____Not at all useful
10
DRAFT
[PAST BEHAVIOR: Reporting]
Q25. Have you ever reported prescription drug advertising or promotion that you thought was
false or misleading to the FDA?
_____Yes
_____No
_____Don’t remember
[INTENTIONS TO REPORT BAD ADS]
Q26. How likely are you to report prescription drug advertising or promotion that you think is
false or misleading to FDA in the future?
_____Very unlikely [ask Q27]
_____Unlikely [ask Q27]
_____Somewhat unlikely [ask Q27]
_____Neither likely nor unlikely [skip to Q28]
_____Somewhat likely [skip to Q28]
_____Likely [skip to Q28]
_____Very likely [skip to Q28]
[BARRIERS TO REPORTING]
Q27. What is it about the BadAd program that makes you unlikely to report false or misleading
advertising to FDA? (open-ended)
[SELF-EFFICACY re: RECOGNIZING BAD ADS]
Q28. How sure are you that you can recognize misleading advertising or promotion about
prescription drugs?
_____Very unsure
_____Unsure
_____Somewhat unsure
_____Neither unsure nor sure
_____Somewhat sure
_____Sure
_____Very sure
[TRAINING ABOUT DTC]
Q29. Did you receive any formal training regarding pharmaceutical marketing during your
professional training?
11
DRAFT
_____Yes
_____No
_____Don’t remember
[ATTITUDES TOWARD TRAINING re: DTC]
Q30. How useful do you think it would be for new healthcare professionals to receive formal
training regarding pharmaceutical marketing for prescription drugs?
_____Not at all useful
_____Slightly useful
_____Moderately useful
_____Very useful
_____Extremely useful
[SOCIAL MEDIA MEMBERSHIP/PARTICIPATION]
Q31. Are you a member of any social media sites restricted to healthcare professionals (e.g.,
Sermo)?
_____Yes
_____No [skip to Q37a]
Q32. Please list the site or sites of which you are a member: ____________________
Q33. How often do you use these sites for the following activities: ?
[Randomize order of items]
Never
a. Posting information
b. Responding to others’ posts
c. Moderating discussions
d. Reading posts and information
e. Browsing the site
1
1
1
1
1
Rarely Sometimes Often
2
2
2
2
2
3
3
3
3
3
Always
4
4
4
4
4
5
5
5
5
5
Q34. Do you participate in these sites to….
[Randomize order of items; “other” always goes last]
a. Seek colleague opinions
b. Provide advice to others
c. Experience camaraderie
d. To post of read about patient issues
e. To post or read about healthcare insurance provider issues
12
Yes
No
DRAFT
f. To post or read about office management issues
g. To post or read about issues with pharmaceutical
representatives
h. Other
[If yes to Q34h, please prompt respondent:
Please specify________________ (open-ended)]
Q35. In the past 30 days, how often did you comment about pharmaceutical issues (e.g.,
treatments, prescription drug options, sales representatives) on these sites?
_____Never
_____Rarely
_____Sometimes
_____Often
_____All the time
Q36. In the past 30 days, how often did you read others’ comments about pharmaceutical issues
(e.g., treatments, prescription drug options, sales representatives) on these sites?
_____Never
_____Rarely
_____Sometimes
_____Often
_____All the time
[INFORMATION SEEKING SOURCES]
Q37a. Please select all of the following sources that you use for information about new
prescription drugs. [select all that apply; randomize response options, except for “other” which
will be last]
_____Pharmaceutical representatives
_____Pharmaceutical company webpages
_____Physical package label
_____Package insert
_____Medical journals
_____Colleagues
_____Medical Apps (e.g., Epocrates)
_____Search engines (e.g., Google, Yahoo!)
_____Other [for cognitive testing only, then any additional options will be added]
Q37b. Please select which of the following sources for information about new prescription drugs
you use most frequently [choose one; only show the options that were selected in Q37a].
13
DRAFT
_____Pharmaceutical representatives
_____Pharmaceutical company webpages
_____Physical package label
_____Package insert
_____Medical journals
_____Colleagues
_____Medical Apps (e.g., Epocrates)
_____Search engines (e.g., Google, Yahoo!)
_____Other [for cognitive testing only, then any additional options will be added]
[DEMOGRAPHICS]
Q38. Are you part of any of the following health-care arrangements? (check all that apply)
____A solo practice
____A small group practice or partnership
____A multispecialty group practice
____A health maintenance organization or HMO
____A preferred provider list or network of physicians
____None of the above
Q39. Does your practice allow:
_____unlimited access for pharmaceutical sales representatives
_____somewhat limited access for pharmaceutical sales representatives
_____substantially restricted access for pharmaceutical sales representatives
_____no access for pharmaceutical sales representatives
Q40. How many prescriptions do you write in a week?
Q41. In what year were you born? _________
Q42. How many years have you been practicing medicine? _____
Q43. Where did you receive your medical training?
___In the United States
___In a U.S. Territory (e.g. Puerto Rico, Guam, U.S. Virgin Islands)
___Outside the United States or its territories
Q44. Gender:
___Male
___Female
14
DRAFT
Q45. Are you Hispanic or Latino?
� No
� Yes
Q46. What is your race? You may select one or more races.
� American Indian or Alaska Native
� Asian
� Black or African American
� Native Hawaiian or other Pacific Islander
� White
� Some Other Race
15
Download