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