Study #9728: Plan B OTC Label Comprehension Study

 

[This is a medical officer addendum to the detailed review conducted by Dr. Karen Lechter, a social scientist in the Office of Drug Safety/HFD-410]

 

Report location:    Volume 31

 

Study date:            June 18, 2001 to July 18, 2001

 

Sponsors:              Women’s Capital Corporation

                              Family Health International (FHI)

                              (The sponsorship was transferred to the Barr Research in Nov, 03)

 

Investigators:         Family Health International (FHI), Research Triangle Park, NC

                              (study design and monitoring; data collection, management and analyses)

 

Study sites:            Eight malls in US:

Aurora, CO; Northridge, CA; Phoenix, AZ; Matteson, IL; Springfield, VA; San Antonio, TX; Deptford, NJ; and Pembroke Pines, FL

     

      Four Family Planning Clinics sites in US

      Boca Raton, FL; Chicago, IL; Los Angeles, CA; and San Antonio, TX

 

Study Drug:           Plan B package containing no tablets

 

 

Study Objectives:

 

To test if consumers can understand the proposed OTC Plan B label.

 

Subject Recruitment:

 

A total of 663 women were screened from 8 shopping malls and 4 family planning clinics cross the US (8 States); 656 were enrolled. The clinical sites were selected for enrollment of subjects that were minors so that parental consent was not necessary.

 

Communication objectives:

 

The following 11 communication objectives were tested. (The corresponding questionnaire follows each objective):

 

1.      Plan B is indicated for prevention of pregnancy after unprotected sex.

 

      Comprehension: correct or acceptable answers to at least 2 of the 4 questions.

 

Question

Comprehension Responses/Answers

Correct

Incorrect

Q7:  Without looking at the label, tell me what Plan B® is used for.

emergency contraception;

 

(Acceptable: contraception)

after sex (purpose unspecified); STI/HIV; emergency (sex not

mentioned); other; don’t know/refused

Q14:  A woman’s partner used a condom during sex with her but the condom broke.  The next morning, she used Plan B® to prevent pregnancy.  Was this a correct use of Plan B®?

correct

Incorrect; refused

Q16:  A woman with asthma had unprotected sex.  The next day, she took Plan B to prevent pregnancy.  Was this a correct use of Plan B®?

correct

Incorrect; refused

Q19:  A woman had unprotected sex 2 days ago and then used Plan B® to prevent pregnancy.  Was this a correct use of Plan B®?

correct

Incorrect; refused

 

2.      Plan B is intended as a back up method and should not be used for regular contraception.

 

      Comprehension: Correct answer to at least 3 (Q8 was not listed under this objective, but it appears it should be here) of the following 5 questions.

 

Question

Comprehension Responses/Answers

Correct

Incorrect

Q8:  Is Plan B® the same as ordinary birth control pills or is it different from ordinary birth control pills?

Different

Same; Refused

Q9:  According to the label, should Plan B® be used as regular birth control?

No

Yes; Refused

Q21:  A woman is planning to have sex tonight.  She usually uses condoms to prevent pregnancy.  This time she plans to use Plan B® instead because her husband complains about using condoms.  Is this a correct use of Plan B®?

Incorrect

Correct; Refused

Q22:  A woman used Plan B every day instead of her usual birth control pills.  Was this a correct use of Plan B®?

Incorrect

Correct; Refused

Q25:  A woman and her husband don’t like using condoms and the woman doesn’t want to take birth control pills.  They decide to use Plan B® as their main contraceptive method.  Is this a correct use of Plan B®?

Incorrect

Correct; Refused

 

 

3.      Plan B does not prevent sexually transmitted diseases or HIV/AIDS.

 

      Comprehension: correct answer to the following 2 questions

 

Question

Comprehension Responses/Answers

Correct

Incorrect

Q13:  A woman used Plan B® to be sure she doesn’t get any sexually transmitted diseases. Was this a correct use of Plan B®?

Incorrect

Correct; refused

Q27:  According to the label, does Plan B protect against HIV (the virus that causes AIDS) and other sexually transmitted diseases?

No

Yes; refused

 

4.      The first pill should be taken as soon as possible after intercourse.

 

      Comprehension: correct or acceptable answer to at least 2 of the 4 questions

 

Question

Comprehension Responses/Answers

Correct

Acceptable

Incorrect

Q10:  After unprotected sex, when is the best time to take the first tablet?

as soon as possible and within 72 hours or 3 days

within 72 hours or 3 days; as soon as possible

72 hours or 3 days; other; don’t know/refused

Q29:  How many days does the label say is the longest after sex a woman should wait before taking the first Plan B® tablet?

3 days or

72 hours

 

any other answer; refused

Q19:  A woman had unprotected sex 2 days ago and then used Plan B® to prevent pregnancy.  Was this a correct use of Plan B®?

Correct

 

Incorrect; refused

Q20:  A woman had unprotected sex a week ago and then used Plan B to prevent pregnancy.  Was this a correct use of Plan B®?

Incorrect

 

Correct; refused

  

 

5.      The first pill should be taken within 72 hours after intercourse.

 

      Comprehension: correct or acceptable answer to either of the following questions.

 

Question

Comprehension Responses/Answers

Correct

Acceptable

Incorrect

Q10:  After unprotected sex, when is the best time to take the first tablet?

as soon as possible and within 72 hours or 3 days 

within 72 hours or 3 days;

as soon as possible

72 hours or 3 days; other; don’t know or refused

Q26:  Will Plan B® be more effective if a woman takes it 1 day after unprotected sex or if she takes it 2 days after unprotected sex?

1 day

 

both the same; 2 days; refused

  

6.      The second pill should be taken 12 hours after the first.

 

      Comprehension: correct or acceptable answer to the following question 30 (Q23 was not listed under this objective by the sponsor).

 

Question

Comprehension Responses/Answers

Correct

Acceptable

Incorrect

Q23:  A woman took both Plan B® tablets at the same time.  Was this a correct use of Plan B®?

Incorrect

 

Correct; Refused

Q30:  When should a woman take the 2nd Plan B® tablet?

12 hours after the first tablet

other but mentioned 12 hours; the next morning

other; don’t know/refused

 

7.      Plan B should not be used by women who are already pregnant (because it will not be effective).

 

      Comprehension: correct answer to either of questions 11 and 17

 

Question

Comprehension Responses/Answers

Correct

Incorrect

Q11:  Suppose I told you a woman who is 2 months pregnant used Plan B®.  Would you say she used Plan B® correctly or incorrectly?  

Incorrectly

 

Correctly; refused

Q12:  Why? (following Q11)

because she was already pregnant, it won’t work, it’s too late

other reason; don’t know or refused

Q17:  A woman has missed her period.  She did a home pregnancy test and it was positive.  She then used Plan B® because she didn’t want to be pregnant.  Was this a correct use of Plan B®?

Incorrect

Correct; Refused

 

8.      Plan B should not be used by women with unexplained vaginal bleeding

 

      Comprehension: correct answer to the following question

 

Question

Comprehension Responses/Answers

Correct

Incorrect

Q15:  A woman had unusual vaginal bleeding during the past week.  She had unprotected sex and then she took Plan B® to prevent pregnancy.  Was this a correct use of Plan B®?

Incorrect

Correct; Refused

 

9.      Plan B should not be used by women with allergy to any ingredient in the product.

 

Comprehension: correct answer to the following question

 

Question

Comprehension Responses/Answers

Correct

Incorrect

Q18:  A woman knows she is allergic to an ingredient in Plan B®.  She used Plan B® because she noticed that her partner’s condom broke during sex with her.  Was this a correct use of

Plan B®?

Incorrect

Correct; Refused

 

10.   Side effects of Plan B® include nausea and vomiting.

 

Comprehension: correct answer to questions 32 and 34, or name nausea and vomiting to question 37, or yes to questions 32-36.

 

Question

Comprehension Responses/Answers

Correct

Incorrect

Q32:  Can nausea be a side effect of Plan B®?  

Yes

No; Refused

Q33:  Can trouble breathing be a side effect of Plan B®?

No

Yes; Refused

Q34:  Can vomiting be a side effect of Plan B®?

Yes

No; Refused

Q35:  Can fever be a side effect of Plan B ?  

No

Yes; Refused

Q36:  Are there any other possible side effects that I haven’t mentioned?

Yes

No; Refused

Q37:  Please name one of these other possible side effects.  

named a condition listed on package

did not name condition listed on package; refused

 

 

11.   If severe abdominal pain develops, the user should seek medical care immediately.

 

Comprehension: correct answer to the following question

 

Question

Comprehension Responses/Answers

Correct

Incorrect

Q31:  According to the label, if a woman gets severe stomach pain after using Plan B, what should she do?  

See/call a doctor (time not mentioned); see/call a doctor immediately

See/call a doctor but not immediately; stop using it; call number on box; other; don’t know/refused

 

12.   Outcome after taking Plan B

 

Comprehension: correct or acceptable answer to the following question

 

Question

Comprehension Responses/Answers

Correct

Acceptable

Incorrect

Q28:  After a woman takes Plan B®, when should she expect her next period?   Should she expect it immediately, at about the normal time, 1 week late, or never?

at about the normal time

1 week late

immediately; never; refused

 

 

RESULTS

 

Subject Demographics

 

Age and Race: The median age of 656 subjects was 21 years (12-50 years) and approximately 11% of them (76 of 656) were ages 12-16 (Table 2). Half of the participants were Caucasians and about 23% were Hispanic.

 

 

Table 2. Demographics of 656 Eligible Subjects

 

Demographic Characteristics

Number

%

Age (years)

 

 

12-16

76

11.6

17-25

355

54.1

26-50

225

34.3

Race

 

 

White

324

49.4

Black

155

23.6

Asian or Pacific Islander

30

4.6

American Indian or Alaska native

6

0.9

Other

115

17.5

Refused/missing

26

4.0

Ethnicity

 

 

Hispanic

154

23.5

non Hispanic

500

76.2

Refused/missing

2

0.3

Income

 

 

0-$15,000

57

8.7

$15,001-$25,000

63

9.6

$25,001-$35,000

101

15.4

$35,001-$45,000

111

16.9

$45,001 or more

159

24.2

did not know

139

21.2

refused/missing

26

4.0

Marital status

 

 

single

487

74.2

married

143

21.8

divorced

17

2.6

widowed

8

1.2

refused/missing

1

0.2

Data were adapted from the sponsor’s Table 2 (pa16, vol 31)

Education and Literacy: Approximately 27% of subjects (178 of 656) had educational levels less than high school (Table 3). About 30% of subjects (139 of 395) ≥ 18 years of age who had not completed college were at a literacy level of ≤ 8th grade.

 

Sexual activity and Contraception: About 79% (474 of 599 who responded) of subjects were sexually experienced; 71% of subjects (314 of 440 who responded) had a history of unprotected intercourse with concern about an unwanted pregnancy at some time in the past; 89% (410 of 460) of subjects used a condom.

 

Previous EC experience: Six percent (32 of 473 who responded) had previously used emergency contraceptive pills.

 

Table 3. Education and Literacy

 

Education (highest level completed)

No of subjects

% of 656

6th grade or less

4

0.6

7th or 8th grade

26

4.0

9th-11th grade

148

22.6

high school or GED

199

30.3

vocational/technical school

18

2.7

less than 4 years college

117

17.8

college

105

16.0

graduate school

37

5.6

refused/missing

2

0.3

 

 

 

Literacy level*

Subjects age ≥ 18 not completed college, n=395

No of subjects

% of 395

3rd grade or less

1

0.3

4th-6th grade

17

4.3

7th-8th grade

121

30.6

high school

254

64.3

missing

2

0.5

*Assessed using Rapid Estimate of Adult Literacy in Medicine (Davis TC, Long SW, Jackson RH, et al. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med 1993;25:391-5.)

 

 

 

 

 

Comprehension of Communication Objectives

 

Comprehension rates for each communication objective are summarized in Table 4, which corresponds to the following parameters evaluating marketability of OTC drug:

 

Indication: Ninety-three percent of subjects understood that Plan B® is indicated for prevention of pregnancy after unprotected sex (objective 1).

 

Warning:

 

1.     Pregnancy: 98% of subjects understood that Plan B should not be used by pregnant women; (objective #7)

2.     Unexplained vaginal bleeding: 75% of subjects understood that Plan B should not be used by women with unexplained vaginal bleeding; (objective #8)

3.     Allergy: 91% of subjects understood that Plan B should not be used by women with allergy to any ingredient in the product. (objective #9)

 

Regular contraception: Sixty-seven percent of subjects understood that Plan B is intended as a back up method and should not be used for regular contraception (objective #2).

 

HIV and other STDs: Ninety-four percent of subjects understood that Plan B does not protect against HIV or any other sexually transmitted disease (objective #3).

 

Direction for Use: Ninety-seven percent of subjects understood that the first pill should be taken within 72 hours or as soon as possible after intercourse (objective #4/5). Sixty-nine percent of subjects understood that the second pill should be taken 12 hours after the first (objective #6).

 

Adverse Events: Eight-nine percent of subjects understood that side effects of Plan B include nausea and vomiting (objective #10). Two irrelevant side-effects, “fever” and “trouble breathing,” were included in the questionnaires; 80% and 83% of subjects, respectively, responded that “fever” and “trouble breathing” were not side effects of Plan B. However, if subjects responded that both relevant and irrelevant AEs were side-effects of Plan B, the responses were considered as correct. Therefore, the true comprehension on “nausea” and “vomiting” would be less than 89%.

 

Management of serious complication: Eight-one percent of subjects understood that if severe abdominal pain develops, the user should seek medical care immediately (objective #11).

 

Table 4. Comprehension of each communication objectives

(% of enrolled subjects)

 

Communication Objectives

Response

95% Confidence Interval

1

Plan B® is indicated for prevention of pregnancy after unprotected sex †

Correct

90

0.87 - 0.92

Acceptable*

93

0.91 - 0.95

2

Plan B® is intended as a back up method and should not be used for regular contraception.

67

0.64 - 0.71

3

Plan B® does not prevent sexually transmitted diseases or HIV/AIDS.

94

0.92 - 0.96

4

The first pill should be taken within 72 hours after intercourse.

85

0.82 - 0.88

5

The first pill should be taken as soon as possible after intercourse.

82

0.79 - 0.85

4/5

The first pill should be taken within 72 hours or ASAP after intercourse

97

0.96 - 0.98

6

The second pill should be taken 12 hours after the first.

Correct

69

0.65 - 0.72

Acceptable*

85

0.83 - 0.88

7

Plan B® should not be used by women who are already pregnant

98

0.97 - 0.99

8

Plan B® should not be used by women with unexplained vaginal bleeding

75

0.72 - 0.79

9

Plan B® should not be used by women with allergy to any ingredient in the product

91

0.88 - 0.93

10

Side effects of Plan B® include nausea and vomiting.

89

0.87 - 0.91

11

If severe abdominal pain develops, the user should seek medical care immediately.

81

0.78 - 0.84

Data were extracted from the sponsor’s Table 8 (p30, vol 31).

* The acceptable responses included “correct” responses.

 

Comprehension rates among subjects with different Demographics

 

Ages (Table 5): Significantly fewer subjects ages 12-16 understood objectives #1A, #2, #4 and #6 compared with those ages ≥ 17 years.

 

Education and Literacy (Tables 6a & b): Lower comprehension rates on correct self-selection (related to objectives 1A, 2, 3 and 4) of Plan B were found in subjects who did not complete high school, as compared to those who completed high school. Subjects at age 18 or older with ≤ 8th grade literacy scored significantly lower on objectives related to self-selection/deselection and correct use. Only 46% of the low literacy group understood that Plan B was not intended for routine contraception.

 

Study Sites (Table 7): Approximately 89% of subjects (583 of 656) were recruited from family planning clinics and the rest, 11% (73 of 656) from shopping malls in the original sNDA submission. However, in the sponsor’s response (October 30, 2003) to the Agency’ request on comparing the demographics of subjects between both locations, the proportion of the subjects recruited from both location was transposed; the sponsor claimed that 89% subjects were from the malls and 11% from the clinics.

 

Overall comprehension on the proposed OTC label was comparable between the clinics and the malls, except that the subjects in shopping malls demonstrated significantly less understanding of side-effects based on the original sNDA submission. However, when subjects were stratified based on demographics provided in the new submission (assuming that the transposed locations were correct), the following subgroups of subjects from the clinics had lower comprehension on some communication objectives such as such as “used as a back-up but not for regular contraception”: age 12-16, low income (≤ $15,000/yr), low education (< HS), and no prior EC experience. The comprehension rate on “not for regular contraception” in subjects age 12-16 was 20% in the clinics and 61% in mall.

 

 

 

 

 

Table 5. Comprehension rate of communication objectives in different age groups

(% of enrolled subjects)

 

Communication Objectives

Age (years)

Total

N=656

12-16

n=76

17-25

n=355

26-50

n=255

1A†

Plan B® is indicated for prevention of pregnancy after unprotected sex.

86#

93

95

93

2

Plan B® is intended as a back up method and should not be used for regular contraception.

57

67

71

67

3

Plan B® does not prevent sexually transmitted diseases or HIV/AIDS.

93#

96

92

94

4

The first pill should be taken within 72 hours after intercourse.

77

86

87

85

5

The first pill should be taken as soon as possible after intercourse.

84

83

81

82

4/5

4 or 5 The first pill should be taken within 72 hours or ASAP after intercourse.

94

97

98

97

6A‡

The second pill should be taken 12 hours after the first. ‡

77*

90

82

86

7

Plan B® should not be used by women who are already pregnant.

97

99

97

98

8

Plan B® should not be used by women with unexplained vaginal bleeding.

72

77

74

75

9

Plan B® should not be used by women with allergy to any ingredient in the product.

90

91

91

91

10

Side effects of Plan B® include nausea and vomiting.

90*

93

84

89

11

If severe abdominal pain develops, the user should seek medical care immediately

81

84

77

81

Data were extracted from the sponsor’s Table 9 (p30).

* P < 0.01 and # P < 0.05

† using acceptable definition for Q7; ‡ using acceptable definition for Q30.

 

Table 6a. Comprehension rates on communication objective at different education levels

(% of enrolled subjects)

 

Communication Objectives

Education

Total

n=654

< HS

n=178

≥ HS

n=476

1A†

Plan B® is indicated for prevention of pregnancy after unprotected sex.

86*

96

93

2

Plan B® is intended as a back up method and should not be used for regular contraception.

55*

72

67

3

Plan B® does not prevent sexually transmitted diseases or HIV/AIDS.

90#

96

94

4

The first pill should be taken within 72 hours after intercourse.

77*

89

85

5

The first pill should be taken as soon as possible after intercourse.

85

81

82

4/5

The first pill should be taken within 72 hours or ASAP after intercourse

97

97

97

6A‡

The second pill should be taken 12 hours after the first.

84

86

86

7

Plan B® should not be used by women who are already pregnant.

97

98

98

8

Plan B® should not be used by women with unexplained vaginal bleeding.

75

75

75

9

Plan B® should not be used by women with allergy to any ingredient in the product.

88

92

91

10

Side effects of Plan B® include nausea and vomiting. (P=0.0075)

88

90

89

11

If severe abdominal pain develops, the user should seek medical care immediately.

84

80

81

Data were extracted from the sponsor’s Table 15 (p37).

† using acceptable definition for Q7; ‡ using acceptable definition for Q30.

* P < 0.01 and # p < 0.05

< HS: did not complete high school; ≥ HS: completed high school

Table 6b. Comprehension rates on communication objective at different literacy levels

(% of enrolled subjects)

 

Communication Objectives

Literacy Level

Total

n=393

≤ 8th

n=139

HS

n=254

1A†

Plan B® is indicated for prevention of pregnancy after unprotected sex.

84*

96

92

2

Plan B® is intended as a back up method and should not be used for regular contraception.

46*

78

67

3

Plan B® does not prevent sexually transmitted diseases or HIV/AIDS.

84*

99

93

4

The first pill should be taken within 72 hours after intercourse.

71*

90

83

5

The first pill should be taken as soon as possible after intercourse.

84

83

83

4/5

The first pill should be taken within 72 hours or ASAP after intercourse

95

98

97

6A‡

The second pill should be taken 12 hours after the first.

82*

92

89

7

Plan B® should not be used by women who are already pregnant.

95*

99

98

8

Plan B® should not be used by women with unexplained vaginal bleeding.

69*

81

77

9

Plan B® should not be used by women with allergy to any ingredient in the product.

82*

95

90

10

Side effects of Plan B® include nausea and vomiting. (P=0.0075)

84*

96

92

11

If severe abdominal pain develops, the user should seek medical care immediately.

81

83

82

Data were extracted from the sponsor’s Table 16 (p38).

† using acceptable definition for Q7; ‡ using acceptable definition for Q30.

* P < 0.01

< 8th: 8th grade or less assessed with REALM test; HS: completed high school

Table 7. Comprehension rates in subjects recruited from Shopping Mall and Clinics

(% of enrolled subjects)

 

Communication Objectives

Study Sites#

Total

n=656

Mall

n=583

Clinic

n=73

1A†

Plan B® is indicated for prevention of pregnancy after unprotected sex.

93

93

93

2

Plan B® is intended as a back up method and should not be used for regular contraception.

68

61

67

3

Plan B® does not prevent sexually transmitted diseases or HIV/AIDS.

94

97

94

4

The first pill should be taken within 72 hours after intercourse.

85

87

85

5

The first pill should be taken as soon as possible after intercourse.

83

79

82

4/5

The first pill should be taken within 72 hours or ASAP after intercourse

97

98

97

6A‡

The second pill should be taken 12 hours after the first.

85

90

86

7

Plan B® should not be used by women who are already pregnant.

98

98

98

8

Plan B® should not be used by women with unexplained vaginal bleeding.

75

76

75

9

Plan B® should not be used by women with allergy to any ingredient in the product.

91

93

91

10

Side effects of Plan B® include nausea and vomiting.

88*

98

89

11

If severe abdominal pain develops, the user should seek medical care immediately.

81

83

81

Data were extracted from the sponsor’s Table 13 (p35).

* P < 0.01 (by Chi-square test).

† using acceptable definition for Q7; ‡ using acceptable definition for Q30.

# The proportion of subjects from clinics and malls is updated from the sponsor’s re-submission dated on October 30, 2003. In the original submission (April 2003), 583 subjects were recruited from clinic sites and 73 from shopping malls; the sponsor claimed this was transposed.

SUMMARY

 

1.     Subjects: A total of 656 subjects (663 were screened) ages 12-50 were enrolled in the study; approximately 12% of subjects were age 12-16; 30% of subjects at age ≥ 18 who did not complete college were at a literacy level ≤ 8th grade. About 79% of subjects were sexually experienced and 6% had previous EC use experience.

 

2.     Comprehension of Indication: Ninety-three percent of subjects could correctly understand that Plan B is to be used “after unprotected sex”.

 

3.     Comprehension on Warning: Most subjects (91-98%) could understand the warnings (pregnancy and allergy) and that Plan B does not protect against the AIDS/STDs. However, only 67% of subjects could understand that Plan B is not for use as a regular contraceptive; and 75% of subjects were aware of the contraindication “unexplained vaginal bleeding”.

 

4.     Comprehension on correct use: Ninety-seven percent of subjects understood to take the first pill before 72 hours or as soon as possible after intercourse. However, only 69% of subjects understood the need to take the second pill at 12 hours after the first pill.

 

5.     Adverse events: Over 80% of subjects could understand side effects of Plan B.

 

6.     Ages: Lower comprehension rates were seem on the communication objectives #1A, #2, #4 and #6 in subjects ages 12-16 and on #1A, #2, #3 and #4 in subjects with lower literacy and less than a high school education.

 

7.     Education levels: Lower comprehension rates on the communication objectives #1A, #2, #3 and #4 in subjects with lower literacy and less than high school education.

 

8.     Shopping Malls and Clinics: Overall comprehension rates on the communication objectives were comparable between the 2 types of locations, except for the lower comprehension of the possible adverse events demonstrated by participants from the malls. However, among demographic cohorts, there were trends of lower comprehension on some elements in the proposed OTC label in the clinic sites compared to the malls, particularly among subjects ages 12-16, those with less education, and those with low literacy.

 

9.     STDs or HIV/AIDS: Ninety-four percent of subjects understood that Plan B does not prevent STDs or HIV/AIDS. However, the comprehension was less among the younger (12-16 years old) and lower literacy participants.

 

COMMENTS

 

  1. Approximately 20% of subjects did not understand the potential seriousness of severe abdominal pain that may occur after using Plan B. This issue (related to ectopic pregnancy) will be addressed in the global safety update review by HFD-580.

 

  1. Approximately 25% of subjects did not recognize that “unexplained vaginal bleeding” was a contraindication. The language may be too vague. The sponsor stated that there is no evidence to support this contraindication claim and proposed to remove it from the label. This issue will be addressed in the global safety update review by HFD-580.

 

  1. Sexually transmitted diseases other than HIV/AIDS were not mentioned in the questionnaires.

 

  1. The proportion of subjects from the clinics and the malls in the study was unclear because the sponsor reported them differently. In the original submission the sponsor reported that 89% of subjects were recruited from the clinics and 11% were from the malls. However, upon resubmission of this data, the sponsor rectified this error and stated that 89% of subjects were from the malls.

 

 

CONCLUSION

 

1.     Overall, the majority of subjects could understand the proposed OTC label with regard to the indication for Plan B, and could recognize common and severe adverse events.

 

2.     Subjects ages 12-16 and those with less education or low literacy were less apt to comprehend the indication and the directions for use.

 

3.     A package insert is recommended to improve comprehension of concepts of “emergency” and “routine” contraception in populations with lower literacy and those ages 12-16.

 

4.     The proposed changes on the OTC label from the sponsor: bolding the phrase “a serious medical problem” and removing “Unexplained (or unusual) vaginal bleeding”. Acceptability of this label will be determined by the AU study results.

 

5.     The majority of study subjects were recruited from a mall setting. This would probably more closely represent the general population than those subjects recruited in the actual use study and would help to evaluate the generalizability of label comprehension.

APPENDIX:

 

The Proposed OTC label used for the Label Comprehension Study

 

 

 


Plan B Label used for the Label Comprehension Study