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:
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),
(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
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
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 | |