Over-the-Counter (OTC) Drugs

Evaluation of Proposed Over-the-Counter (OTC)
Label Format Comprehension (Study A)

SUMMARY: In the Federal Register of February 27, 1997 (62 CFR 9024), the Food and Drug Administration (FDA) issued a proposed rule intended to enable consumers to better read and understand OTC drug product labeling and to more effectively apply the information in the labeling to safe and effective use of such products. As part of that rulemaking proceeding, the agency has collected data under a study entitled "Evaluation of Proposed Over-the-Counter (OTC) Label Format Comprehension," also known as "Study A". In Study A (Evaluation of Proposed OTC Label Format Comprehension), consumers were invited to view examples of OTC label designs. Respondents were asked questions designed to measure knowledge and attitudes about OTC drug products, as well as decisions about proper use of the products. The agency is now seeking comments on the data developed under Study A, including the participants’ responses on the comprehension elements measured for the specific label designs viewed. This document announces the availability of the data and frequency tabulations that summarize the Study A data, and reopens the comment period for the OTC rulemaking proceeding for 45 days to allow an opportunity to comment on these materials.

REQUEST FOR COMMENTS: Interested persons may, on or before March 31, 1998, submit written comments on STUDY A to the Dockets Management Branch (HFA-305), ATTN: STUDY A: OTC Drug Labeling Data Collection, Food and Drug Administration, 12420 Parklawn Dr., Room 1-23, Rockville, MD 20857. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with docket number 96N-0420 and labeled "ATTN: STUDY A: OTC Drug Labeling Data Collection."

TABLE OF CONTENTS

Variable Frequencies

Demographic Information

1. Interview Site
2. In the last month, have you participated in a study about drug labeling at this mall?
3. Respondent Age
4. Need Glasses to Read
5. Respondent Gender
6. Type of Questionnaire
7. Marital Status
8. Education
9. Profession
10. Health Rating
11. How often have you purchased an over-the-counter cough/cold drug in the past six months?
12. How often have you purchased an over-the-counter pain reliever drug in the past six months?
13. How often have you purchased an over-the-counter sunscreen in the past six months?
14. Are you being treated for any of these medical conditions?
15. Total Family Income
16. Ethnicity
    

Literacy Measure

FAT, FLU, PILL, DOSE, EYE, STRESS, SMEAR, NOTIFY, GALLBLADDER, CALORIES, DEPRESSION, MISCARRIAGE, PREGNANCY, ARTHRITIS, HEPATITIS, ANTIBIOTICS, INGREDIENT, TEMPORARY, EXCEED, INHALE, NAUSEA, EXCESSIVE, PHARMACIST, RELIEF, HEARTBURN, EFFECTIVENESS, DROWSINESS, PROLONGED, INHIBIT, PLACEBO, LIQUID, MUSCLE, DIAGNOSIS,POTASSIUM, ANEMIA, OBESITY, OSTEOPOROSIS, SYMPTOM, THALIDOMIDE, CONGESTION, CHRONIC, SINUSITIS

Frequencies for Cough/Cold Questionnaire Items

Type: Divided Attention

1. Label Version
2. Time spent reading food label (seconds)
3. Time spent reading drug label (seconds)
4. You should stop using this product if stomach pain occurs.
5. A person using this drug should take no more than 10 softgels in a 24-hour period.
6. This product relieves nasal congestion due to the common cold.
7. This product relieves persistent cough from smoking.
8. People with heart disease should ask a doctor before taking this product.
9. This product can be taken with drugs used to treat depression.
10. This product can be given to children 8 years of age.
11. A person taking this drug for asthma should ask a doctor before use.
12. You may continue to use this product if cough is accompanied by fever or a persistent headache.
13. This product can be given to children under age 6.
14. You should stop using this product if you get a rash.
15. A person using this drug should not exceed 4 doses in 24 hours.
16. If stomach pain occurs while taking this product, you can continue to use this product as soon as the pain improves.
17. Women should not take this product during the last 5 months of pregnancy.
18. People with liver disease should not take this product unless directed by a physician.
19. People using a prescription medicine to treat a mental condition should not take this product.
20. A person with a persistent cough from smoking should ask a doctor before use.
21. Women should avoid taking this drug during the first 4 months of pregnancy.
22. A person with a cough that lasts from emphysema cannot use this product.
23. A person taking a drug for the treatment of asthma cannot use this product.
24. At what temperature should this drug be stored?
25. Time answering Q3a (seconds)
26. What is the maximum number of days you can take this drug?
27. Think about another person who is taking this drug and has stomach pain. Should this person:
28. Time answering Q3c (seconds).
29. When would you take your next dose (time).
30. When would you take your next dose (hours later).
31. Think about another person who is considering taking this drug but has breathing problems. Should this person:
32. Time answering Q3e (seconds).
33. Imagine you have a child, age 13. How many softgels can you give the child in one dose?
34. What about a person who has just learned she is pregnant and is considering taking this product. Should she:
35. Time answering Q3g (seconds).
36. What about a person who is considering taking this product but is having nervousness and difficulty sleeping? Should this person:
37. Time answering Q3h (seconds).
38. How willing would someone be to read the label?
39. How useful is the label in helping someone decide whether or not to use the drug?
40. How much do you like the format or layout of the label?
41. How easy is it to find information on the label?
42. How difficult is it to see each of the words printed on the label?
43. How difficult was it to read the label?
44. How important would it be for someone to read all the information on the label?
45. How confusing is the format or layout of the label?
46. How well organized is the format or layout of the label?
47. How easy to understand is the information in the label?
48. How easy would it be for someone with poor eyesight to read the words printed on the label?
49. Important
50. Relevant
51. Means a lot to me
52. Valuable
53. Exciting
54. Appealing
55. Fascinating
56. Involving
57. Interesting
58. Needed
59. Recognize any adverse (bad) reactions.
60. Follow the directions for taking the correct dose.
61. Know which drugs interact with this one.
62. Remember the warnings.
63. Know when to stop taking the drug.
64. Know what conditions are treated by this drug.
65. Identify the correct dosage for a child.
66. Tell the difference between a minor side effect and a major reaction.
67. Identify who should not take this drug.
68. Know when you should ask a doctor or health professional if side effects occur.
69. Overall, how safe would you say this drug is?
70. Overall, how effective would you say this drug is?
71. How would you rate the amount of information in the drug label?
72. How would you say the important information in the drug label stood out?
73. When you first read the label, would you say your attention was focused just on the drug information label:
74. Overall, how useful was the presentation [of the information in the label]?
75. How would you rate the label [for reading]?
76. How easy was it to find the important information in the label?
77. Overall, how much did you trust the information in the label?
78. Overall, how believable was the information in the label?

Type: Focused Attention

1. Label Version
2. Time spent reading food label (seconds)
3. Time spent reading drug label (seconds)
4. You should stop using this product if stomach pain occurs.
5. A person using this drug should take no more than 10 softgels in a 24-hour period.
6. This product relieves nasal congestion due to the common cold.
7. This product relieves persistent cough from smoking.
8. People with heart disease should ask a doctor before taking this product.
9. This product can be taken with drugs used to treat depression.
10. This product can be given to children 8 years of age.
11. A person taking this drug for asthma should ask a doctor before use.
12. You may continue to use this product if cough is accompanied by fever or a persistent headache.
13. This product can be given to children under age 6.
14. You should stop using this product if you get a rash.
15. A person using this drug should not exceed 4 doses in 24 hours.
16. If stomach pain occurs while taking this product, you can continue to use this product as soon as the pain improves.
17. Women should not take this product during the last 5 months of pregnancy.
18. People with liver disease should not take this product unless directed by a physician.
19. People using a prescription medicine to treat a mental condition should not take this product.
20. A person with a persistent cough from smoking should ask a doctor before use.
21. Women should avoid taking this drug during the first 4 months of pregnancy.
22. A person with a cough that lasts from emphysema cannot use this product.
23. A person taking a drug for the treatment of asthma cannot use this product.
24. At what temperature should this drug be stored?
25. Time answering Q3a (seconds).
26. What is the maximum number of days you can take this drug?
27. Think about another person who is taking this drug and has stomach pain. Should this person:
28. Time answering Q3c (seconds).
29. When would you take your next dose (time).
30. When would you take your next dose (hours later).
31. Think about another person who is considering taking this drug but has breathing problems. Should this person:
32. Time answering Q3e (seconds).
33. Imagine you have a child, age 13. How many softgels can you give the child in one dose?
34. What about a person who has just learned she is pregnant and is considering taking this product. Should she:
35. Time answering Q3g (seconds).
36. What about a person who is considering taking this product but is having nervousness and difficulty sleeping? Should this person:
37. Time answering Q3h (seconds).
38. How willing would someone be to read the label?
39. How useful is the label in helping someone decide whether or not to use the drug?
40. How much do you like the format or layout of the label?
41. How easy is it to find information on the label?
42. How difficult is it to see each of the words printed on the label?
43. How difficult was it to read the label?
44. How important would it be for someone to read all the information on the label?
45. How confusing is the format or layout of the label?
46. How well organized is the format or layout of the label?
47. How easy to understand is the information in the label?
48. How easy would it be for someone with poor eyesight to read the words printed on the label?
49. Important
50. Relevant
51. Means a lot to me
52. Valuable
53. Exciting
54. Appealing
55. Fascinating
56. Involving
57. Interesting
58. Needed
59. Recognize any adverse (bad) reactions.
60. Follow the directions for taking the correct dose.
61. Know which drugs interact with this one.
62. Remember the warnings.
63. Know when to stop taking the drug.
64. Know what conditions are treated by this drug.
65. Identify the correct dosage for a child.
66. Tell the difference between a minor side effect and a major reaction.
67. Identify who should not take this drug.
68. Know when you should ask a doctor or health professional if side effects occur.
69. Overall, how safe would you say this drug is?
70. Overall, how effective would you say this drug is?
71. How would you rate the amount of information in the drug label?
72. How would you say the important information in the drug label stood out?
73. When you first read the label, would you say your attention was focused just on the drug information label:
74. Overall, how useful was the presentation [of the information in the label]?
75. How would you rate the label [for reading]?
76. How easy was it to find the important information in the label?
77. Overall, how much did you trust the information in the label?
78. Overall, how believable was the information in the label?

Frequencies for Pain Reliever Questionnaire Items

Type: Divided Attention

1. Label Version
2. Time spent reading food label (seconds)
3. Time spent reading drug label (seconds)
4. You should stop using this product if stomach pain occurs.
5. A person using this drug should not exceed 10 tablets in a 24-hour period.
6. This product does not reduce fever.
7. This product treats minor aches and pains associated with headache.
8. People taking medications for high blood pressure should ask a doctor before taking this product.
9. People allergic to other pain relievers can take this product.
10. This product can be given to children 14 years of age.
11. People who consume more than 3 alcohol-containing drinks per day should ask a doctor for advice before use.
12. You should consult a physician before using this product if the area that hurts is red and swollen.
13. This product can be given to children over age 16.
14. You can take up to 4 tablets in 6 hours if the pain is severe.
15. A person using this drug should not take more than 6 tablets in 24 hours.
16. If stomach pain occurs while taking this product, you can continue to use this product as soon as the pain improves.
17. People with stomach ulcers can use this product.
18. People with liver disease should not take this product unless directed by a physician.
19. A person who is allergic to aspirin should not use this product.
20. This product may cause selling and redness in the painful area.
21. This product may make ulcers worse.
22. You should not take this product within 24 hours of consuming alcohol.
23. A person using this product should take 2 tablets every 6 hours while symptoms persist.
24. At what temperature should this drug be stored?
25. Time answering Q3a (seconds).
26. What is the maximum number of days you can take this drug?
27. Think about another person who is taking this drug and has stomach pain. Should this person:
28. Time answering Q3c (seconds).
29. Imagine you have a child, age 15. How many tablets can you give the child in one dose?
30. Think about a person who is considering taking this product but is allergic to aspirin. Should this person:
31. Time answering Q3e (seconds).
32. When would you take your next dose (time).
33. When would you take your next dose (hours later).
34. Think about another person who is has an ulcer and is considering taking this product? Should this person:
35. Time answering Q3g (seconds).
36. What about a person who is considering taking this product but is under a doctor's care for high blood pressure? Should this person:
37. Time answering Q3h (seconds).
38. How willing would someone be to read the label?
39. How useful is the label in helping someone decide whether or not to use the drug?
40. How much do you like the format or layout of the label?
41. How easy is it to find information on the label?
42. How difficult is it to see each of the words printed on the label?
43. How difficult was it to read the label?
44. How important would it be for someone to read all the information on the label?
45. How confusing is the format or layout of the label?
46. How well organized is the format or layout of the label?
47. How easy to understand is the information in the label?
48. How easy would it be for someone with poor eyesight to read the words printed on the label?
49. Important
50. Relevant
51. Means a lot to me
52. Valuable
53. Exciting
54. Appealing
55. Fascinating
56. Involving
57. Interesting
58. Needed
59. Recognize any adverse (bad) reactions.
60. Know which drugs interact with this one.
61. Remember the warnings.
62. Know when to stop taking the drug.
63. Know what conditions are treated by this drug.
64. Identify the correct dosage for a child.
65. Tell the difference between a minor side effect and a major reaction.
66. Identify who should not take this drug.
67. Know when you should ask a doctor or health professional if side effects occur.
68. Would you say the amount of information contained in the drug label was:
69. How would you rate the amount of information in the drug label?
70. How would you say the important information in the drug label stood out?
71. Would you say the important information in the drug label stood out:
72. When you first read the label, would you say your attention was focused just on the drug information label:
73. Overall, how useful was the presentation [of the information in the label]?
74. How would you rate the label [for reading]?
75. How easy was it to find the important information in the label?
76. Overall, how much did you trust the information in the label?
77. Overall, how believable was the information in the label?

Type: Focused Attention

1. Label Version
2. Time spent reading food label (seconds)
3. Time spent reading drug label (seconds)
4. You should stop using this product if stomach pain occurs.
5. A person using this drug should not exceed 10 tablets in a 24-hour period.
6. This product does not reduce fever.
7. This product treats minor aches and pains associated with headache.
8. People taking medications for high blood pressure should ask a doctor before taking this product.
9. People allergic to other pain relievers can take this product.
10. This product can be given to children 14 years of age.
11. People who consume more than 3 alcohol-containing drinks per day should ask a doctor for advice before use.
12. You should consult a physician before using this product if the area that hurts is red and swollen.
13. This product can be given to children over age 16.
14. You can take up to 4 tablets in 6 hours if the pain is severe.
15. A person using this drug should not take more than 6 tablets in 24 hours.
16. If stomach pain occurs while taking this product, you can continue to use this product as soon as the pain improves.
17. People with stomach ulcers can use this product.
18. People with liver disease should not take this product unless directed by a physician.
19. A person who is allergic to aspirin should not use this product.
20. This product may cause swelling and redness in the painful area.
21. This product may make ulcers worse.
22. You should not take this product within 24 hours of consuming alcohol.
23. A person using this product should take 2 tablets every 6 hours while symptoms persist.
24. At what temperature should this drug be stored?
25. Time answering Q3a (seconds).
26. What is the maximum number of days you can take this drug?
27. Think about another person who is taking this drug and has stomach pain. Should this person:
28. Time answering Q3c (seconds).
29. Imagine you have a child, age 15. How many tablets can you give the child in one dose?
30. Think about a person who is considering taking this product but is allergic to aspirin. Should this person:
31. Time answering Q3e (seconds).
32. When would you take your next dose (time).
33. When would you take your next dose (hours later).
34. Think about another person who is has an ulcer and is considering taking this product? Should this person:
35. Time answering Q3g (seconds).
36. What about a person who is considering taking this product but is under a doctor's care for high blood pressure? Should this person:
37. Time answering Q3h (seconds).
38. How willing would someone be to read the label?
39. How useful is the label in helping someone decide whether or not to use the drug?
40. How much do you like the format or layout of the label?
41. How easy is it to find information on the label?
42. How difficult is it to see each of the words printed on the label?
43. How difficult was it to read the label?
44. How important would it be for someone to read all the information on the label?
45. How confusing is the format or layout of the label?
46. How well organized is the format or layout of the label?
47. How easy to understand is the information in the label?
48. How easy would it be for someone with poor eyesight to read the words printed on the label?
49. Important
50. Relevant
51. Means a lot to me
52. Valuable
53. Exciting
54. Appealing
55. Fascinating
56. Involving
57. Interesting
58. Needed
59. Recognize any adverse (bad) reactions.
60. Follow the directions for taking the correct dose.
61. Know which drugs interact with this one.
62. Remember the warnings.
63. Know when to stop taking the drug.
64. Know what conditions are treated by this drug.
65. Identify the correct dosage for a child.
66. Tell the difference between a minor side effect and a major reaction.
67. Identify who should not take this drug.
68. Know when you should ask a doctor or health professional if side effects occur.
69. Would you say the amount of information contained in the drug label was:
70. How would you rate the amount of information in the drug label?
71. How would you say the important information in the drug label stood out?
72. Would you say the important information in the drug label stood out:
73. When you first read the label, would you say your attention was focused just on the drug information label:
74. Overall, how useful was the presentation [of the information in the label]?
75. How would you rate the label [for reading]?
76. How easy was it to find the important information in the label?
77. Overall, how much did you trust the information in the label?
78. Overall, how believable was the information in the label?

Appendix

Screener

Cough/Cold Divided Attention Questionnaire

Pain Reliever Focused Attention Questionnaire

Cough/Cold Label Versions

Pain Reliever Label Versions