DSRCS REVIEW
NDA#: 21-045
Drug: Plan B (levonorgestrel) Tablets
Sponsor: Women's Capital Corporation
Study: Plan B Over-the-Counter Label Comprehension Study Final Report. Study Number 9728
Study Report Date:
Reviewer: Karen Lechter, J.D., Ph.D.
Reviewing Div: HFD-410
Review Completed:
Executive Summary
In a label comprehension study of the labeling on the outside and inside of the package, study participants demonstrated good understanding of some concepts and low understanding of a few concepts. Results for other concepts were inconclusive due to the wording of some of the questions and the sponsor's scoring system for open-ended questions. Despite some shortcomings in the questionnaire and some scores that were lower than desirable, the Division of Surveillance, Research, and Communication Support (DSRCS) believes that labeling changes are likely to result in acceptable levels of comprehension. Results of the Actual Use Study should weigh more heavily in evaluating the labeling.
Concepts that received relatively high comprehension scores are the following:
· Plan B is for contraception.
· Plan B does not protect against STD's, including HIV/AIDS.
· Do not take the product while pregnant; Plan B cannot end a pregnancy.
· Do not use Plan B if you are allergic to its ingredients.
· Nausea and vomiting are side effects.
Concepts with moderate levels of understanding include the following:
· Take the first tablet within 3 days of intercourse.
· Get medical help if severe abdominal pain develops.
Concepts that may not be clearly understood or for which the data are inconclusive are the following:
· Plan B is not for regular use for contraception.
· Take the first tablet as soon as possible after intercourse.
· Take the second tablet 12 hours after the first one.
· Do not use Plan B if you have unexplained vaginal bleeding
· Use Plan B after intercourse.
· Plan B can be used even if the woman has medical conditions not mentioned on the label. (Asthma was mentioned in the question.)
As a result of these findings, DSRCS believes that comprehension of the critical messages is adequate or would be adequate after changes to the labeling. Therefore, DSRCS has the following recommendations based on the study:
· Strengthen the following messages:
o Not for regular use (sponsor has bolded this)
o Timing of first dose
o Timing of second dose (sponsor has bolded this)
o If severe abdominal pain develops, seek immediate medical care
o Do no use if unexplained vaginal bleeding (if kept in the labeling)
· State on the label if there is a window of time for the second tablet, rather than just the 12 hour time already given.
In addition, DSRCS has a recommendation to help women time the second dose appropriately:
· Have a place on the label for the woman to write the time she took the first pill and the time she should take the second pill.
Inclusion of a package insert might be helpful for consumers.
REVIEW
The purpose of this study was to evaluate comprehension of a prototype OTC package label for Plan B emergency contraceptive pills.
The study tested 11 Communication Objectives important for safe and effective use of the product:
Methodology
Participants
Participants were 663 females, age 12-50 years old. Sample size was based on using a 95% confidence interval of +5 percentage points, conservatively assuming the proportion of correct responses would be 50%. Based on these requirements, a minimum sample size was 385. To ensure adequate demographic representation and a sufficient number of low literacy women for subset analyses, the target sample was increased to 575. In actuality, data for 656 participants were reported.
Distribution by age was as follows:
|
|
% |
|
12-16 |
12 |
|
17-25 |
54 |
|
26-50 |
34 |
Black and Hispanic women were overrepresented with respect to the general population as follows:
|
Race |
Study population % |
General population % |
|
Black |
24 |
12 |
|
Hispanic |
24 |
13 |
|
White |
49 |
75 |
More than ¾ of participants were sexually experienced. Most of them had had unprotected intercourse despite a desire not to become pregnant. More than half of participants who had used oral contraceptive pills reported having missed taking pills, and 40% of those who had used condoms had had a condom break. At least 82% of the sexually experienced participants had had either a pregnancy scare or sex not adequately protected by contraception. Only 32 of the sexually experienced participants had ever used emergency contraceptive pills.
Literacy levels among those age 18 or older who had not completed college were as follows:
|
Literacy Level |
% (n=395) |
|
3rd grade or less |
<1 |
|
4th-6th grade |
4 |
|
7th-8th grade |
31 |
|
High school |
64 |
|
Missing |
<1 |
The highest level of school completed was as follows:
|
Highest grade completed |
% (n=656) |
|
6th grade or less |
1 |
|
7th or 8th grade |
4 |
|
9th-11th grade |
23 |
|
High school or GED |
30 |
|
Vocational/technical school |
3 |
|
Less than 4 years of college |
18 |
|
College |
16 |
|
Graduate school |
6 |
|
Refused/missing |
<1 |
Procedure
Interviews were conducted in shopping malls and family
planning clinics in eight
Before the interviews began, participants who were age 18 or older who had not completed college were tested for literacy level using the Rapid Estimate of Adult Literacy in Medicine (REALM) test.
For the main questionnaire, participants were asked to look at the outside of the Plan B package as if they were thinking about whether to purchase the product. The interviewer then removed the package while the participant answered the first question. The participant was permitted to look at the outside of the package while answering five additional questions. Participants were then told to open the package and review the contents as if they were about to use the product. Participants could refer to the package as well as the contents for the remaining questions.
The only information on the front outside of the package was the name of the product, the statement "Emergency Contraception," and the number and strength of the tablets. On the back was the Drug Facts format containing the most important information about the indication, warnings, directions, and ingredients. The back also included storage and manufacturing information. Additional information that reinforced the Drug Facts information was on the inside of the package.
At the end of the main questionnaire, participants were given a questionnaire asking information about their sexual activities.
Comments: The sponsor did not give the REALM literacy
test to women who had graduated college or to participants younger than 18
years. It would have been better to test
everyone, to make their study experience similar and to test literacy at all
education levels, as all of these women represented potential product
users. The sponsor noted that even at
the level of some college education, there were some who tested as low
literate.
In correspondence with
the agency (Serial No. 110), the sponsor explained its decision not to test the
younger participants for two reasons:
(1) the REALM is designed for adults, and (2) the sponsor assumed that
women under the age of 18 would not be well-educated. The college graduates were not tested because
the sponsor assumed that college graduates would have at least a 9th
grade literacy level. In hindsight, the
sponsor notes that this assumption may not have been correct. The sponsor also pointed out that about 25%
of the entire study population was either poorly educated or tested in the
lower literacy group on the REALM.
Twenty-eight aged 17 or younger had not gotten past 8th grade
in school, and 139 who were tested were in the lower literate category.
As only the 393 women
age 18 or older who had not graduated from college were categorized by literacy
level, we do not have results by literacy level for the entire sample. We do not know what effect, if any, this fact
had on the results of the analyses by literacy groups. However, because the
results suggest a literacy effect for almost all of the communication
objectives, we should proceed as if literacy has an effect on almost everything
tested, and try to improve those aspects of the label for which the lower
literate group seemed to have particular problems.
Questionnaires
Questions included multiple choice and open-ended questions. The latter are questions for which choices are not provided by the questioner. Many questions presented a hypothetical scenario and asked participants if Plan B use would be correct to use in the situation.
Comment: Scenario-type questions require more
cognitive processing than more direct questions about information on the
labeling because scenario questions require participants to apply the information.
Main Questionnaire
Question 7 was the first question asked about the product. It was asked after only the outside of the package had been read and after the package was removed. Therefore, this response was based on recall. Questions 8-12 were asked with only the outer carton available for reference. For the remaining questions, participants could open the carton and inspect the contents before responding.
At the end of the questioning about the labeling, participants were asked for demographic information and took a self-administered test ("Confidential Information Questionnaire") about sexual and contraceptive history.
Comments: The scenario
questions asked, in essence, if the hypothetical person was using the product
correctly or not. Many questions were of
the yes/no or correct/incorrect variety.
Such questions have a 50% chance of a correct response by chance. It would have been better to follow all of
these questions with a probe asking participants why they answered as they
did. We therefore do not know if
participants answered correctly by chance or because they knew the information.
Personal information
questions about marital status and income did not seem useful to ask for
comprehension purposes.
Confidential
Information Questionnaire
This questionnaire asked about the participants' experience with sex and birth control. Results were used to further analyze responses to the main questionnaire by categorizing participants according to their responses to these questions.
Comment: The question "Have you ever had sex?" (Q. 1) would have benefited from providing a definition for "sex." Without such a definition, we must assume participants knew it meant sexual intercourse, but we cannot be sure. Q. 6 asked if the participant had ever used birth control pills and had missed taking two or more from one pack. The results were used to conclude that participants responding affirmatively to this question might have experienced anxiety about the possibility of being pregnant. Q. 10 asked if the woman had ever used emergency contraceptive pills. It would have been best to exclude these women from the study, as their experience, possibly with Plan B, might have raised their scores artificially. However, the results showed that there were only 32 in this group, and thus, they may have had little influence on the overall results. An analysis by the sponsor showed no effect of this prior experience on understanding the Communication Objectives. However, the small size of this group may be responsible for the lack of apparent effect. Thus, we cannot conclude that women with prior experience with emergency contraception would not understand the information better than others.
Results by
Communication Objective
Results for the total sample were provided for each question. In addition, results for each Communication Objective were provided based on the following characteristics: literacy level, age, race, ethnicity, interview location, type of site (mall or clinic), income, education, previous sexual experience, sexual experience in the past three months, experience with pregnancy scare (condom break, missed pills, unprotected intercourse, worry about unwanted pregnancy), and experience using emergency contraceptive pills. Literacy level and location of the interview had an effect on most responses. Literacy level affected nine of the Communication Objectives. Location affected all of them. Other characteristics had far fewer effects. Any significant findings based on particular characteristics are mentioned in the appropriate sections that follow. The sponsor did not make adjustments for multiple confidence interval estimations.
The sponsor determined whether Communication Objectives had been met by participants based on formulas that differed among the Communication Objectives. For some objectives, correct responses to only half of the questions under that Communication Objective were deemed sufficient to indicate understanding of that Communication Objective. For others, 75% or 100% of the questions needed to be correct to satisfy the sponsor's criteria for successful understanding.
Based on the sponsor’s scoring method for Communication Objectives, more than 85% of participants understood seven of the 11 Communication Objectives, if both acceptable and correct answers were counted. Ninety-three percent (93%) understood that Plan B is indicated for prevention of pregnancy after unprotected sex (Objective 1), 94% understood it does not prevent HIV or AIDS (Objective 3), and almost all (98%) understood that it should not be used by pregnant women (Objective 7). Less than 80% understood two objectives: 67% understood Objective 2 (Plan B is intended as a back up method and should not be used for regular contraception), and 75% understood objective 8 (Plan B should not be used by women with unexplained vaginal bleeding.). The results by Communication Objective appear in Table 1.
Table 1. Results by Communication Objective.
|
Communication Objective |
% Understanding* (N=656) |
|
1. Plan B is indicated for prevention of pregnancy after unprotected sex |
90/93** |
|
2. Plan B is intended as a back up method and should not be used for regular contraception |
67 |
|
3. Plan B does not prevent sexually transmitted diseases or HIV/AIDS |
94 |
|
4. The first pill should be taken within 72 hours after intercourse |
85 |
|
5. The first pill should be taken as soon as possible after intercourse |
82 |
|
4. or 5. The first pill should be taken within 72 hours or as soon as possible after intercourse. |
97 |
|
6. The second pill should be taken 12 hours after the first |
69/85† |
|
7. Plan B should not be used by women who are already pregnant |
98 |
|
8. Plan B should not be used by women with unexplained vaginal bleeding |
75 |
|
9. Plan B should not be used by women with allergy to any ingredient in the product |
91 |
|
10. Side effects of Plan B include nausea and vomiting |
89 |
|
11. If severe abdominal pain develops, the user should seek medical care immediately |
81 |
*Based
on sponsor's criteria of 50%-100% correct on questions relevant to each
Communication Objective.
**First number based on
correct responses for Q. 7 (Sponsor’s interpretation). Second number based on correct/acceptable
responses for Q. 7 (Sponsor’s interpretation).
†
First number based on correct responses for Q. 30. Second number based on correct/acceptable
responses for Q. 30. (Sponsor’s interpretation.)
More than 80% of lower literate women were able to understand eight of the 11 objectives. Women aged 16 years or younger were less likely than older women to understand many of the objectives, but the differences were not statistically significant in most cases, and more than 80% of the younger women understood seven objectives.
Comment: In correspondence with the Agency (facsimile
dated
In some instances,
these criteria made it easier to reach the objective by using correct responses
for less than all of the questions in an objective. Because there may be disagreement as to what
criteria would be appropriate for each Communication Objective, this review
will examine results of questions individually, as well as results by
Communication Objective.
DSRCS would not
necessarily agree with the scoring of some of the "acceptable"
responses. Thus, scores for some
Communication Objectives may be lower under DSRCS's scoring.
Of the subgroups, DSRCS is most interested in results by literacy level. As noted earlier, the sponsor did not include all participants in the analyses of Communication Objectives based on literacy levels. Instead, only participants age 18 or older who had not completed college were included. Thus, because we do not have a complete comparison of the entire sample of the lower literate (reading level 8th grade or below) with those of a higher reading level, any conclusions we draw from the literacy analysis should be viewed with the understanding that the sample had limitations. Presumably, many of those below age 18 (at least 12%) would test as lower literate, because they had not completed high school. On the other hand, those who had graduated from college (22%) were more likely to be in the higher literacy group. Thus, we cannot be sure how well the literacy results reflect the range of potential product users.
Communication Objective 1: Plan B is indicated for prevention of
pregnancy after unprotected sex. (Q 7, 14, 16, 19) [Communication Objective satisfied if at least two answered correctly]
The first question in this set (Q. 7) was open-ended (not multiple choice). The other three were all of the yes/no variety, asking if the hypothetical situation described was a correct use of the product.. For these three questions, the correct response was that it was a correct use.
Q. 7 asked what Plan B is used for. The response was based on recall, as the carton was removed before the question was asked. Forty-five percent (45%) responded that the product is for contraception after sex. Thirty-nine percent (39%) stated only that it is for contraception. The sponsor counted both of these as acceptable responses. Therefore, a total of 84% provided correct or acceptable responses to this question under the sponsor's scoring system. For this question, the lower literate group scored 73%, compared with 87% for the higher literate group.
For this Communication Objective, there was a statistically significant difference between the adult (age 18 or older) lower literate (8th grade or lower) and those with a higher reading level. As noted earlier, participants under age 18 and college graduates were not included in this analysis. The results show that 84% of the adult lower literate met the sponsor's criterion for success on this objective, while 96% of the adult higher literate were successful. Table 2 summarizes the most common responses to Q.7.
Table 2. Responses to open-ended question about purpose of product (Q.7)
|
Response |
% Responding (N = 656) |
|
contraception after sex* |
45 |
|
contraception** |
39 |
|
after sex, purpose unspecified |
4 |
|
STI/HIV |
1 |
|
emergency (sex not mentioned) |
1 |
|
other |
4 |
|
don't know/refused |
6 |
*correct under sponsor’s
scoring
** acceptable
under sponsor's scoring
Comment: For Q. 7, it
is not clear that those who mentioned only that the product was for
contraception, and did not mention "after sex," truly understood the
full nature of the indication. It would
have been better if this question had probed for more responses by asking if
there was anything else the participant wanted to add. Therefore, the total
figure of acceptable responses for that question of 84% may be overstating the
level of understanding of the participants on this issue. On the other hand, it is likely that some,
perhaps many, of those who mentioned only contraception actually understood
that the product is used after sex, but failed to mention that detail. We should keep in mind that Q. 7 was answered
without participants being able to refer to the carton. For that reason, the relatively low totally
correct score (contraception after sex) for this item should not be cause for
concern, particularly when viewed in conjunction with other questions about
specific uses for the product.
Q. 14 was a scenario about a woman who wanted to use Plan B after a condom broke. Participants were asked if this was an appropriate use according to the package. Ninety-one percent (91%) responded correctly that it was an appropriate use. Eighty-one percent (81%) of the lower literate were correct, while 95% of the higher literate were correct.
Q. 16 stated that a woman with asthma had unprotected sex and took Plan B the next day to prevent pregnancy. Participants were asked if this was a correct use. Sixty-three percent (63%) responded correctly that it was an appropriate use.
Q. 19 asks about using the product two days after unprotected sex. Eighty-seven percent (87%) correctly stated that it was an appropriate use. For this question, 78% of the lower literate and 90% of the higher literate were correct.
Table 3 summarizes responses to the three scenario questions for these Communication Objectives for the total sample.
Table 3. Correct responses to scenario questions about the indication
|
Question |
% Correct (N = 656) |
|
14. condom broke |
91 |
|
16. asthma/unprotected sex |
63 |
|
19. unprotected sex 2 days ago |
87 |
The sponsor stated that 90% of participants met the criterion for understanding this Communication Objective. The criterion for success was to answer at least two of the four questions correctly or acceptably.
Comment: The relatively low rate of correct responses
for the question about the woman with asthma suggests that there may be a
tendency for participants to be confused if other medical conditions are
mentioned. This may be due to an
inclination to respond conservatively to the questions, so that when in doubt,
the participant would state that product should not be used. In correspondence with the Agency (Serial No.
110), the sponsor speculates that some women may not fully understand the term "asthma"
and some women may have been flustered by this question. Further study would be necessary to determine
what caused so many incorrect responses for the question mentioning asthma. Asking participants why they responded as
they did might have clarified the situation.
Overall, results for
this Communication Objective suggest the following:
·
About 90%
understand some specific situations in which it is appropriate to use the
product.
·
There is a
tendency to state, incorrectly, that certain medical conditions might
preclude use. However, incorrect
responses may be an artifact of the testing situation. Moderately high
proportions of participants were able to identify two situations under this
Communication Objective in which the product would be appropriate.
·
Many
participants did not clearly express the full indication for the product when
asked from memory without further prompting.
·
The
sponsor's criterion for success on this Communication Objective (two of the
four responses correct or acceptable) seems rather low. With a higher criterion for success, fewer
than 90% would have been considered to have answered correctly.
Communication
Objective 2: Plan B is intended as a
back-up method and should not be used for regular contraception. (Q. 9, 21,
22, 25) [Communication Objective
satisfied if at least three answered correctly]
For this series of questions, the three scenarios all depict inappropriate uses, and one question is direct. Q. 9 asks the direct question whether Plan B should be used as regular birth control. Eighty-five percent (85%) answered correctly. Only 71% of the lower literate were correct, while 93% of the higher literate were correct.
Q. 21 presents a scenario in which a woman's husband complains about using condoms and asks if it is correct to use Plan B in this situation. The correct response is that it is not an appropriate use. Only 47% correctly responded here. The sponsor suggests this may be due to the fact that some of the questions used to define this objective “may have required excessively strict or unrealistic interpretation of the concept of ‘emergency’ contraception." The intent of Q. 21 was that the woman should find another contraceptive method or refuse to have sex when her husband refuses to use condoms. The sponsor stated that this choice might be improbable in the minds of many women, who may have assumed unprotected sex was inevitable and therefore using Plan B would be appropriate. The sponsor will bold the label text “Plan B should not be used in place of regular contraception” to emphasize this point. The lower literate scored 37% for this question, while the higher literate scored 53%.
Q. 22 is a scenario about someone who inappropriately uses Plan B daily instead of usual birth control. Ninety-one percent (91%) were correct on this question. The lower literate scored 76%; the higher literate scored 95%.
Q. 25 is about a couple that wants to use Plan B as the main contraceptive method. Only 68% answered this one correctly. The lower literate scored 50%; the higher literate scored 78%.
The sponsor concluded that the Communication Objective was met by a participant if three of the four questions were answered correctly. Sixty-seven percent (67%) of participants met this criterion. There was a statistically significant difference between the lower and higher literacy participants for this Communication Objective. Forty-six percent (46%) of the adult lower literate met the criterion for success, while 78% of the adult higher literate were successful. Table 4 presents the results for these four questions for the total sample.
Table 4. Correct responses to scenario questions about Using Plan B for regular contraception
|
Question |
% Correct (N = 656) |
|
9. Direct question about use for regular birth control |
85 |
|
21. Husband complains about condoms |
47 |
|
22. Use Plan B daily instead of usual birth control |
91 |
|
25. Couple uses Plan B as main contraceptive method |
68 |
Comment: Results for these questions would have been
easier to interpret if each question had been followed by another question
asking why the woman responded as she did.
We do not know if correct responses were correct for the right reasons,
or if the incorrect ones were incorrect due to misunderstanding or for some
other reason.
In response to the
direct question about use for regular contraception, a respectable proportion
of participants (85%) answered correctly.
However, far fewer were correct about use if one's partner does not want
to use protection. The scenario for that
question (Q.21) stated that ”This time she plans to
use plan B.” The implication could be
that this is a one-time event. Thus, it may not be unreasonable for the women
to believe that Plan B is appropriate.
Therefore, the relatively low results of this question (Q.21) should not
be counted heavily.
However, there does
not seem to be a clear rationale for the relatively low scores (68%) for the
scenario about using Plan B as the main contraceptive method (Q.25), despite
the fact that many more (85%) were correct in saying the product should not be
used for regular birth control (Q.9), and a high proportion (92%) answered
correctly for a different scenario (Q. 22) that the product should not be used
daily instead of usual birth control. In correspondence with the Agency (Serial
No. 110), the sponsor suggests that Q. 25 required "more extended thought
processes" than the other questions, which may have contributed to the
lower correct response rate.
Even using the
sponsor's criterion for achieving the Communication Objective (3/4 correct), a
relatively low number of participants (67%) seemed to understand clearly and
consistently that the product is not to be used as the main form of
contraception. Even fewer lower literate
participants seemed to understand this concept.
The conflicting
results for questions under this Communication Objective suggest that the
message that this product is not for regular use should be strengthened on the
label.
Communication
Objective 3: Plan B does not prevent sexually transmitted diseases
or HIV/AIDS. (Q. 13 and 27) [Communication Objective satisfied if both
answered correctly.]
The two questions in this group include a scenario question and a direct question. Responses to both of these questions should be that Plan B does not protect against STD's. Q. 13 is a scenario about a woman using Plan B to avoid STD's. Ninety-six percent (96%) answered correctly. Among the lower literate, 88% were correct, while among the higher literate, 99% were correct. Q. 27 is a direct question asking if Plan B protects against HIV and other STD's. Ninety-eight percent (98%) answered this correctly.
For this Communication Objective, there was a statistically significant difference between the lower literate and higher literate. Eighty-four percent (84%) of the adult lower literate met the sponsor's criterion for success for this question, while 99% of the adult higher literate were successful. Table 4. summarizes these results for the total sample.
Table 5. Correct responses to questions about use for STD's
|
Question |
% Correct (N = 656) |
|
13. scenario about use to avoid STD's |
96 |
|
27. direct question about protection against HIV and other STD's |
98 |
Comment: Participants understood at high rates that
Plan B cannot protect against STD's.
Although the lower literate scored lower than the higher literate,
scores for the lower literate were not very low.
Communication
Objective 4: The first pill should be taken within 72 hours after intercourse. (Q.
10, 29, 19, 20) [Communication Objective
satisfied if at least two answered correctly: 10 (if response mentions 72 hours
or 3 days), 29, (19 and 20)]
Q. 10 asks what the best time is to take the first pill. If the participant has not already said both "within 3 days" and "as soon as possible," Q. 10 also includes a second part that asks if the label says anything more specific. The correct answer is "as soon as possible and within 72 hours or three days." Twenty-three percent (23%) gave this response. Acceptable responses were the following: "within 72 hours or three days" (31%), or "as soon as possible" (26%). Thus, a total of 80% had correct or acceptable responses. An additional 10% said "72 hours or 3 days." These responses were not scored as correct because they did not indicate that was the maximum time.
Q. 29 asks how many days is the longest after sex that a woman should wait before taking the first pill. Ninety-one percent (91%) correctly responded 72 hours. Eighty-four percent (84%) of the lower literate and 95% of the higher literate were correct on this question.
Q. 19 applies also to the first Communication Objective, discussed earlier. Eighty-seven percent (87%) correctly said it was correct to use Plan B if the woman had unprotected sex two days earlier.
Q. 20 asks about use if unprotected sex was a week ago. Ninety-five percent (95%) correctly stated that this was an incorrect use.
The sponsor scored this objective as having been met if participants answered at least two of the four questions correctly. Eighty-five percent (85%) met this criterion. There was a statistically significant difference between the literacy groups in attaining the criterion for success for this Communication Objective. Seventy-one percent (71%) of the adult lower literate and 90% of the adult higher literate met the criterion. Table 6 presents the results for this Communication Objective for the full sample.
Table 6. Correct/acceptable responses to questions about taking the tablet within 72 hours after intercourse
|
Question |
% Correct/acceptable (N = 656) |
|
10. Best time to take first tablet |
80 |
|
29. The longest one should wait before first tablet |
91 |
|
19. Use 2 days after unprotected sex |
87 |
|
20. Use 1 week after unprotected sex |
95 |
Comment: If we deem as acceptable for Q. 10 those 10%
of responses that mentioned 72 hours or three days, but did not indicate that
was the maximum time, then the correct/acceptable score for Q. 10 would be
90%. It is likely that many in this 10%
group had the correct understanding, but were sloppy in expressing it. Overall, the results for this Communication
Objective suggest moderately high understanding of the timing of the first
tablet. However, to be sure that more lower literate women understand this issue, the timing
of the first tablet should be emphasized if possible.
Communication Objective 5: The first pill should be taken as soon as possible after intercourse. (Q.10, 26) [Communication Objective satisfied if either answered correctly, where response to Q. 10 mentions as soon as possible]
As noted earlier, Q. 10 asked the best time to take the first tablet. Twenty-three percent (23%) scored correctly (as soon as possible and within 72 hours or 3 days). A total of 57% scored acceptably (either within 72 hours or 3 days, or as soon as possible, without providing a time frame). Acceptable responses included 26% who said as soon as possible. Therefore, for Q. 10, 80% scored correctly or acceptably. Q. 26 asks if Plan B will be more effective if taken one day after unprotected sex or two days after unprotected sex. Seventy-one percent (71%) correctly said one day. Sixteen percent (16%) said both were the same, and 12% incorrectly said two days. Among the lower literate, 64% were correct, compared with 75% of the higher literate.
The sponsor counted people as responding correctly for this Communication Objective if for Q. 10 they mentioned "as soon as possible" or answered correctly to Q. 26. Eighty-two percent (82%) met this criterion. For this Communication Objective, there were no significant differences between the adult lower literate and higher literate participants. Table 7 presents these results.
Table 7. Correct/acceptable responses about timing of the first tablet
|
Question |
% Correct/acceptable (N = 656) |
|
10. Best time to take first tablet |
80 |
|
26. Better to take at 1 days or two? |
71 |
Comment: The moderate overall correct response rate
for Q. 10, and the even lower rate among the lower literate, combined with the
somewhat lower overall correct response rate for Q. 26 make it advisable to
strengthen the labeling for this issue. Approximately 1/3 seem not to have
understood the message about using the product as soon as possible, although
there seems to be good understanding, based on other questions, that it should
be taken within three days of unprotected intercourse.
Communication Objective 6: The second pill should be taken 12 hours after the first (Q. 30)
Q. 30 asks directly when a woman should take the second tablet. Sixty-nine percent (69%) correctly said 12 hours after the first tablet. The sponsor counted as acceptable those who mentioned 12 hours but said something other than the full correct response. Seventeen percent (17%) responded in this way. An additional person (<1%) gave the response of the next morning, which the sponsor counted as acceptable. Thus, 87% answered correctly or acceptably under the sponsor's scoring system. For this question, there was a statistically significant difference among the literacy groups, with 82% of the adult lower literate and 93% of the higher literate responding correctly or acceptably. Table 8 presents these results for the full sample.
Table 8. Responses about when to take the second tablet (Q. 30)
|
Response |
% Responding (N=656) |
|
12 hours after first tablet* |
69 |
|
12 hours (but did not give full response)* |
17 |
|
the next morning* |
<1 |
|
other |
12 |
*Scored
as correct or acceptable by sponsor
Comment: It is not clear whether those mentioning 12
hours but not saying “12 hours after the first tablet” truly understood the
concept. It is possible that some of
them did not, but it is also likely that many of them did. In correspondence with the Agency (facsimile
of
Based on only the
completely correct responses, only 69% conveyed clear understanding of when to
take the second pill. Because it is
possible a number of those participants who were scored as acceptable for this
question did not truly understand, the timing of the second pill should be
emphasized in the materials. We
recommend also that the label state what to do if the dose is not taken at
exactly 12 hours. If possible, the label
should indicate if there is a window of time in which the second dose can be
taken.
To assist women in determining exactly when to take the second tablet,
we suggest there be a space on the package for the woman to fill in with the
time when she took the first tablet and the time when she should take the
second tablet.
Q. 23 was not specifically associated with this Communication Objective. However, it is related to the timing of the second dose. Q. 23 asked if it was correct for a woman to take both tablets at the same time. Ninety-six percent (96%) answered correctly that it was not correct.
Comment: A more detailed scenario providing the
reasons why the woman might have taken both at the same time would have been
more realistic and perhaps would have provided a better question to test this
concept.
Communication
Objective 7: Plan B should not be used by women who are already pregnant (because it
would not be effective). (Q. 11 or Q. 17) [Communication objective met if either answered correctly.]
Q. 11 asks whether a woman who is two months pregnant should use Plan B. Ninety-two percent (92%) correctly responded. Q. 17 asks if it was correct for a pregnant woman to use Plan B because she didn't want to become pregnant. Eighty-nine percent (89%) answered this question correctly. Ninety-eight percent (98%) answered at least one of these correctly, which was the sponsor's criterion for having understood the concept. While scores for both literacy groups were high, there was a statistically significant difference between them. The adult lower literate scored 95% on this criterion for success, while the adult higher literate scored 99%.
Q. 12 was not associated with a specific Communication Objective by the sponsor. It is a follow-up to Q. 11, which asked if a woman who is two months pregnant should use Plan B. Q. 12 asks for the reason behind the response to Q. 11. Ninety-four percent (94%) responded correctly that she was already pregnant, the product won't work, or it is too late to use it. Table 9 presents the results for questions related to this Communication Objective.
Table 9. Correct/acceptable responses about use by
pregnant women
|
Question |
% Correct/Acceptable (N=656) |
|
11. Use by woman 2 months pregnant |
92 |
|
12. Reason for response to Q. 11 |
94 |
|
17. Use if have positive pregnancy test |
89 |
Comment: As stated in the protocol, one aspect of
this Communication Objective was that the product is not effective in pregnant
women. This issue was not specifically
tested, but it did surface in responses to Q. 12. It appears that a relatively high proportion
of participants understood that the product is not appropriate during
pregnancy. Responses to Q. 12 suggest
that the reasoning for responses to Q. 11 is appropriate.
Communication Objective 8: Plan B should not be used by women with unexplained vaginal bleeding. (Q. 15)
Q. 15 is a scenario about a woman who had unusual vaginal bleeding during the week and who took Plan B to prevent pregnancy after unprotected sex. Participants were asked if this was a correct use of Plan B. Seventy-six percent (76%) answered correctly. Again, there was a statistically significant difference between the literacy groups. The adult lower literate scored 69%, while the adult higher literate scored 82%.
Comment: Clearly, this concept was not highly
understood. If it is kept in the
labeling, it should be emphasized further, either by bolding or by explaining
its importance, or both.
Communication
Objective 9: Plan B should not be used by women with allergy to any ingredient in
the product. (Q. 18)
Q. 18 is a scenario about a woman allergic to an ingredient in Plan B who used it because she noticed that her partner's condom broke during sex. When asked if this was a correct use of Plan B, 91% answered properly that it was an incorrect use. The differences between literacy groups were statistically significant. The adult lower literate scored 82%, while the higher literate scored 96%.
Communication Objective 10: Side effects of Plan B include nausea and vomiting. (Q. 32-37) [Communication Objective satisfied if correct on Q. 32 and Q. 34, or nausea/vomiting mentioned in answer to Q. 37. Scored as not meeting Objective if she answered "yes" to all of Q. 32-36.]
Q. 32-35 ask if different symptoms can be side effects of Plan B (32-nausea; 33-trouble breathing; 34-vomiting; 35-fever). Q. 36 asks if there are any other possible side effects, and Q. 37 asks participants to name one of the possible side effects.
The sponsor considered participants as having understood the Communication Objective if they answered Q. 32 and Q. 34 correctly or if nausea and vomiting were mentioned in answer to Q. 37, unless all of Q. 32-36 were answered "yes." Based on these criteria, 89% understood this Communication Objective. For this Communication Objective, there were statistically significant literacy differences. The adult lower literate scored 84%, while the adult higher literate scored 96%. For Q. 37, 81% of the lower literate were correct and 93% of the higher literate were correct.
When those who said there were other possible side effects were asked to name one additional side effect, 87% provided a correct response. Table 10 presents the results for this set of questions.
Table 10. Correct responses to side effects questions.
|
Question |
% Correct (N = 656) |
|
32. nausea a side effect? |
99 |
|
33. trouble breathing a side effect? |
83 |
|
34. vomiting a side effect? |
96 |
|
35. fever a side effect? |
80 |
|
36. other possible side effects? |
94 |
|
37. name one other side effect |
87 |
Comment: These results
show that participants generally understand the side effects of vomiting and
nausea. However, there is a slight
tendency to say that everything is a side effect, as evidenced by incorrect
scores of about 15-20%
for the questions about symptoms that are not real side
effects. Such a tendency may have
slightly elevated the scores for the nausea and vomiting items. The question asking for another side effect
does not seem to contribute much to our understanding of participants'
knowledge of the full range of side effects.
However, there were no Communication Objectives addressing specific side
effects other than nausea and vomiting
Communication Objective 11: If severe abdominal pain develops, the user should seek medical care immediately. (Q. 31)
The question for this Communication Objective presented a scenario asking what a woman should do if she gets severe stomach pain after using Plan B. Seventy percent (70%) said to see or call a doctor, with no time frame mentioned. Eleven percent (11%) said to see or call a doctor immediately. Four percent (4%) said to see a doctor, but not immediately, and 10% said to stop using the product. The sponsor scored as correct responses to see or call a doctor immediately or to see a doctor with the time not mentioned. On that basis, 81% responded acceptably. There were no differences between literacy groups. Table 11 presents the results.
Table. 11. Responses about what to do for severe abdominal pain (Q. 31)
|
Response |
% Responding (N=656) |
|
See/call a doctor (time not specified)* |
70 |
|
See/call a doctor immediately* |
11 |
|
See/call a doctor, not immediately |
4 |
|
Stop using |
10 |
|
Other |
1 |
|
call number on box |
<1 |
*Scored
as correct or acceptable.
Comment: Based on these results, it is not clear that
participants understand that they should get immediate medical help for severe
abdominal pain. However, as the sponsor
suggests, perhaps in real life, it is likely that women who experience this
pain would seek medical help quickly.
The sponsor should consider emphasizing this message.
Additional Results
Some questions were not associated by the sponsor with particular Communication Objectives. Q. 8 asks if Plan B is the same or different from ordinary birth control pills. Eighty two percent (82%) answered correctly. For this question, 73% of the lower literate and 87% of the higher literate answered correctly.
Comment: Unfortunately, the questionnaire did not ask
how this product is different, to enable us to further understand the
responses.
Q. 24 was eliminated by the sponsor. It asked "A woman stopped taking her
birth control pills a week ago and then she had sex with no other birth control
method. She then used Plan B to prevent
pregnancy. Was this a correct use of
Plan B?" The sponsor said the
question was "excluded from the analysis because it was recognized to have
been ambiguous after the survey was concluded." No additional explanation was provided.
Comment: We do not know why the sponsor dropped this
question, yet retained Q. 21, which also may have been ambiguous. A better explanation of the criteria used to
drop a question would have been helpful here.
Q. 28 was a multiple choice question that asked when a woman should expect her next period after taking Plan B. The correct response, at about the normal time, was given by 79% of participants. The sponsor considered the response of one week later as acceptable because the label said "…your next period should come at the normal time, or a few days early or late. If your period is more than one week late, you may be pregnant." An additional 10% gave the acceptable response, making a total of 89% correct or acceptable. Five percent (5%) said she should expect her period immediately, and about 1% said she never should expect it. Table 12 shows these results.
Table 12. Responses to when to expect the next period (Q. 28)
|
Response |
% Responding (N = 656) |
|
About normal time* |
79 |
|
1 week late* |
10 |
|
immediately |
5 |
|
refused |
5 |
|
never |
1 |
*Correct
or acceptable
Comment: These results suggest a fairly good
understanding of the effect of the medication on women's menstruation. The choice of
"never" seemed unlikely to be correct on its face, and should
have been replaced with another choice.
Results by demographic characteristics
Age. Using the sponsor’s criteria for demonstrating comprehension of each Communication Objective, age made a statistically significant (p<.05) difference for four of the objectives. Table 13 presents those differences.
Table 13. Statistically significant differences for Communication Objectives by age
|
Communication
Objective |
Age 12-15 Correct/ acceptable (%) (n=76) |
Age 17-25 Correct/ acceptable (%) (n=355) |
Age 26-50 Correct/ acceptable (%) (n=255) |
Total Correct/ acceptable (%) (n=656) |
|
1. Plan B indicated for prevention of pregnancy after unprotected sex* |
86 |
93 |
95 |
93 |
|
3. Plan B does not prevent sexually transmitted diseases or HIV/AIDS |
93 |
96 |
92 |
94 |
|
6. Second pill should be taken 12 hours after the first** |
77 |
90 |
82 |
86 |
|
10. Side effects include nausea and vomiting |
90 |
93 |
84 |
89 |
*includes
correct and acceptable responses for Q. 7
**includes
correct and acceptable responses for Q. 30
Comment: We should keep in mind that there were no adjustments for multiple comparisons. Therefore, some of these apparently statistically significant differences might have occurred by chance. For 3/4 of these Communication Objectives, the youngest age group scored lowest. For 3/4 of the objectives, the oldest age group scored lower than the middle group. Thus, there is no clear linear effect of age on increasing or decreasing comprehension. It is possible that there is a quadratic relationship, with the youngest and oldest understanding less than those in the mid-range. It is likely that because of the varying age ranges for the three age categories, particularly the very wide (26-50) range for the oldest group, some age-related differences were not detected. Even with these differences, the youngest group (Age 12-15) did not score extremely low.
Race. For three of the Communication Objectives, race made a statistically significant difference. Table 14 presents these results. There was not a consistent trend for any particular racial group to do better than others. In two of the thee objectives, whites did better than blacks. However, in another, blacks did better than whites and the "other" group.
Table 14. Statistically significant differences for Communication Objectives by race
|
Communication
Objective |
White % Correct/ Acceptable |
Black % Correct/ Acceptable |
Other % Correct/ Acceptable |
Total % Correct/ Acceptable |
|
2. Plan B is intended as a back up method and should not be used for regular contraception |
75 |
57 |
61 |
67 |
|
8. Plan B should not be used by women with unexplained vaginal bleeding |
77 |
68 |
79 |
75 |
|
11. If severe abdominal pain develops, the user should seek medical care immediately |
79 |
88 |
81 |
81 |
Literacy. Literacy level had a statistically significant effect on nine of the 11 Communication Objectives. Table 15 presents the Communication Objectives that showed these differences.
Table 15. Statistically significant differences for Communication Objectives by literacy level.
|
Communication
Objective |
Lower Literate % Correct/Acceptable (N=139) |
Higher Literate % Correct/Acceptable (N=254) |
Total (N=393) |
|
1. 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 |
|
6. 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 |
84 |
96 |
92 |
*Includes
correct and acceptable responses for Q. 7.
**Includes
correct and acceptable responses for Q. 30.
In addition to literacy differences by Communication Objective, there were many instances of differences between the literacy groups for the individual questions. Differences between the groups for correct and acceptable responses varied from 1 percentage point to 28 percentage points, with a mean of 11 points. In all cases, the lower literate group scored lower than the higher literate group. The sponsor did not report which of these differences may have been statistically significant. Responses for the two literacy groups are reported in Table 16.
Table 16. Correct/acceptable results for questions by literacy groups.
|
Question |
Lower Literate % Correct/Acceptable (N=139) |
Higher Literate % Correct/Acceptable (N=254) |
|
7. Tell what Plan B is used for |
73 |
87 |
|
8. Different from ordinary birth control? |
73 |
87 |
|
9. Should Plan B be used as regular birth control? |
71 |
93 |
|
10. Best time to take 1st tablet |
21/75* |
26/83* |
|
11. Use if 2 months pregnant |
88 |
93 |
|
13. Correct to use to avoid STD's? |
88 |
99 |
|
14. Use after condom broke |
81 |
95 |
|
15. Use if unusual vaginal bleeding |
69 |
82 |
|
16. Use if have asthma |
61 |
66 |
|
17. Use if positive pregnancy test |
84 |
92 |
|
18. Use if allergic and condom broke |
82 |
96 |
|
19. Use 2 days after sex |
78 |
90 |
|
20. Use after 1 week |
88 |
96 |
|
21. Husband complains about condoms; woman wants to use Plan B |
37 |
54 |
|
22. Use Plan B every day instead of usual birth control pills |
76 |
95 |
|
23. Take both tablets together |
89 |
98 |
|
25. Couple wants to use Plan B as main contraceptive method |
50 |
78 |
|
26. Is plan B more effective 1 day or 2 days after sex? |
64 |
75 |
|
27. Protection against STD's |
94 |
100 |
|
28. When expect next period |
65/84* |
85/91* |
|
29. What is longest woman can wait to take first tablet? |
84 |
95 |
|
30. When take second tablet? |
64/82* |
77/93* |
|
31. What do if severe stomach pain? |
7 |
10 |
|
32. Nausea a side effect? |
96 |
100 |
|
33. Trouble breathing a side effect? |
78 |
88 |
|
34. Vomiting a side effect? |
97 |
98 |
|
35. Fever a side effect? |
77 |
82 |
|
36. Other side effects not mentioned? |
91 |
95 |
|
37. Name other side effects not mentioned in previous questions |
81 |
93 |
*First
number correct; second number correct plus acceptable by sponsor's scoring
Comment: Literacy
level had a definite effect on the results of the study. For most Communication Objectives and for
most questions, there were substantial differences in scores between the two
literacy groups. Comprehension among the
lower literate was particularly low for Communication Objective 2, concerning
use of Plan B as a back up method and not for regular contraception. These results suggest that any strengthening
of the messages in the labeling might increase comprehension among the lower
literate, but particular attention should be paid to messages about not using
the product for regular contraception and not using it if there is unexplained
vaginal bleeding, as the lower literate scores were the worst for these two concepts.
We should keep in mind
that the only participants included in the literacy analyses were those who
were age 18 or older who had not graduated from college. Therefore, all college graduates were
eliminated, as were teen-agers.
Twenty-two percent (22%) of the full sample had graduated college, and
more than 12% were under age 18. (The
sponsor reported age ranges of 12-16, 17-25, and 26-50. Therefore, we do not know exactly how many
were below age 18.) As a result of this
analysis of fewer than the full sample, the literacy results may be atypical,
as only adults who had not graduated from college were included. Because college graduates were excluded, it
is possible that the higher literacy group had lower literacy than a typical
higher literate group taken from the population as a whole, and differences
between the literacy groups may therefore be minimized. However, balancing that possibility is the
possibility that participants under age 18 would lower the literacy level of
the lower literate group, again widening the differences between the
groups.
It would have been
better to include all participants in the literacy analyses to get a better
picture of how literacy would affect the full range of potential product
users. Nevertheless, the results do show
that literacy had an effect on almost every Communication Objective, making it
apparent that lower literate women may have more trouble in understanding the
labeling than higher literate women.
Previous sexual experience. There were no statistically significant differences based on whether or not the participants had had sexual experience.
Experience using emergency contraceptive pills. There were not statistically significant differences based on pervious use of emergency contraception.
Comment: As there were only 32 in this group, we should not conclude that they would not answer differently than other women if there had been a larger sample.
Location of interview. There were statistically significant differences based on geographic interview location for all of the Communication Objectives.
Comment: This result is not surprising, as locations
are chosen to add variety to the socioeconomic and demographic characteristics
of participants.
Other demographic and location effects. Race had an effect on three Communication Objectives, and ethnicity on two. Income affected three Communication Objectives and education affected four. Previous sexual experience had no effect, and experience with a pregnancy scare and sex within the past three months affected only one Communication Objective, as did site (mall vs. clinic).
Comment: These differences were too few to lead to
conclusions that there were systematic effects of these participant
characteristics.
Discussion and
Conclusions
Based on the sponsor’s assessment, two Communication Objectives were understood by less than 80% of the sample. One was that Plan B is intended as a back up method and should not be used for regular contraception. The sponsor attributes this as possibly due to the wording of the questions. However, to help communicate this message, the sponsor will bold the text “Plan B should not be used in place of regular contraception.” The other Communication Objective that was understood by less than 80% stated that the product should not be used by women with unexplained vaginal bleeding. The sponsor does not believe this contraindication is appropriate and has stated that it will seek to remove it from the label.
Based on the sponsor's analyses of Communication Objectives, two objectives were understood by 80% and 85% of participants. One was that the first pill should be taken as soon as possible after intercourse and the other one was about what to do if severe abdominal pain develops. The sponsor states that the timing of the first pill should not be viewed in isolation, as the product is still highly effective if use is delayed up to 72 hours. Almost all (97%) understood the product should be used within 72 hours, or as soon as possible after sex. The sponsor believes that failing to demonstrate understanding of what to do if there is severe abdominal pain is not of “extreme clinical concern,” because women “do not need written instructions to know that they should see a doctor if severe pain develops.” The sponsor plans to bold “as soon as possible” and “a serious medical problem (describing ectopic pregnancy) in the next version of the labeling.
Comment: DSRCS does
not agree with the sponsor's scoring of some responses as acceptable. Further, some of the Communication
Objectives could be satisfied if fewer than 100% of the questions in the
objective were answered correctly. Thus, the sponsor's overall conclusions
about the level of comprehension based on Communication Objectives are probably
higher than those of DSRCS.
However, DSRCS
believes that comprehension of critical messages was generally adequate or
could be improved by label changes.
Misunderstandings about regular use would be affected by the cost of the
product and would not present public health issues.
The following summarizes DSRCS's findings for each Communication Objective:
1. Participants tended to understand that the product is for contraception. However, it was not clear if it was on the top of their mind that the product is for use after sex. As the question asked for information from memory and participants who gave partial responses were not probed for further information, it is possible that many participants may have known that the product was for use after sex but did not express that fact.
Participants understood a variety of situations in which to use the product, but there was a tendency to say that it should not be used if one has other medical conditions. This tendency may have been an artifact of the questioning situation.
2. There were inconsistent responses about use for regular contraception. These conflicting results may be due to weaknesses in the questionnaire rather than to lack of comprehension.
3. There is a high level of understanding that Plan B does not protect against STD's, including HIV/AIDS.
4. There is moderate to high understanding of when to take the first tablet. About 90% understood that users should wait no more than 3 days.
5. The fact that the first pill should be taken as soon as possible after intercourse was not understood at high levels. Of the two questions in this Communication Objective, one scored 80% and the other 71%.
6. The fact that the second tablet should be taken 12 hours after the first was not highly understood, or the results are ambiguous.
7. A fairly high majority understood not to take the product while pregnant and that the product could not end a pregnancy.
8. There was relatively low understanding (76%) not to use the product if there is unexplained vaginal bleeding. The sponsor stated that it plans to request that this information be removed from the label.
9. There is fairly high understanding not to use the product by persons allergic to its ingredients.
10. There is high understanding of nausea and vomiting as side effects.
11. There is moderate (81%) understanding that one must get medical help if severe abdominal pain develops. The sponsor states that women “do not need written instructions to know they should see a doctor if severe pain develops.”
This study suggests that there may be some lack of clarity about some issues. Failure to attain high scores for some questions may be due to actual knowledge deficits or to shortcomings of the questionnaire. As we cannot be sure of the source of the lower scores, we recommend stressing the messages that did not score in the high ranges. Messages in the labeling that may not have been communicated at the highest levels include the following:
· Do not use for regular contraception
· Use after intercourse
· Timing of doses
· Do not use if experiencing unexplained vaginal bleeding
· Get medical help for severe abdominal pain
Based on the results of this study, the sponsor has recognized some of the shortcomings of the label and stated that it planned to bold certain information in the label in an effort to communicate that information more effectively.
Results of this study and the ensuing changes to the label to emphasize information that had not been understood at very high levels should be viewed in conjunction with the Actual Use Study. That study provides insight as to whether the revised labeling was sufficient to enable women in the use trial to use the product appropriately.
Recommendations
Based on these results, DSRCS has the following recommendations for changes to the label that had been used in this study:
· Strengthen the following messages:
o Not for regular use (sponsor has bolded this)
o Timing of first dose
o Timing of second dose (sponsor has bolded this)
o If severe abdominal pain develops, seek immediate medical care
o Do no use if unexplained vaginal bleeding (if kept in the labeling)
· State if there is a window of time for the second tablet, rather than just the 12 hour time.
In addition, DSRCS has a recommendation to help women time the second dose appropriately:
· Have a place on the label for the woman to write the time she took the first pill and the time she should take the second pill.