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Emergency contraception counseling: An opportunity for pharmacists
Research
Emergency contraception counseling: An opportunity for pharmacists Denise Ragland, Nalin Payakachat, Songthip Ounpraseuth, Adam Pate, Sara E. Harrod, and Rachel E. Ott
Received October 21, 2010, and in revised form February 15, 2011. Accepted for publication February 15, 2011.
Abstract Objective: To determine the impact of pharmacist counseling on patients’ knowledge of emergency contraception (EC). Design: Single-group, repeated-measures analysis. Setting: Academic medical center women’s clinic in Little Rock, AR, between January and July 2010. Participants: 116 women 18 years or older. Intervention: 10-minute education session provided by a pharmacist or trained student pharmacist. Main outcome measures: Change in participants’ test scores (range 0 [lowest possible] to 13 [highest possible]) at three assessment periods (pretest, posttest, and follow-up) using 12 knowledge questions. Results: 116 participants with a mean (±SD) age of 25 ± 5.9 years participated in this study. Mean knowledge scores were 5.3 ± 4.1 for the pretest and 10.7 ± 1.4 for the posttest (P < 0.001). The least-squares mean EC knowledge test score (adjusted for demographics) was 5.86 at pretest, 10.75 at posttest, and 10.75 at follow-up. A nonsignificant small change in scores from posttest to follow-up was detected after the Tukey-Kramer adjustment. A higher education level was associated with higher knowledge scores in this population. Conclusion: Brief pharmacist-driven counseling sessions provided in a clinic setting are feasible and have a positive impact on immediate EC knowledge and longterm knowledge retention. Keywords: Emergency contraception, patient knowledge, pregnancy, counseling (patient), patient satisfaction, attitudes. J Am Pharm Assoc. 2011;51:756–761. doi: 10.1331/JAPhA.2011.10157
Denise Ragland, PharmD, CDE, is Associate Professor; and Nalin Payakachat, PhD, is Assistant Professor, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock. Songthip Ounpraseuth, PhD, is Assistant Professor, College of Public Health, University of Arkansas for Medical Sciences, Little Rock. Adam Pate, PharmD, was a pharmacy practice resident, University Hospital of Arkansas, Little Rock, at the time this study was conducted; he is currently Assistant Professor, College of Pharmacy, University of Louisiana at Monroe. Sara E. Harrod is a student pharmacist, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock. Rachel E. Ott, BA, is Grants Director, Antenatal & Neonatal Guidelines, Education and Learning System, Center for Distance Health, and Rural Hospital Program, University of Arkansas for Medical Sciences, Little Rock. Correspondence: Denise Ragland, PharmD, CDE, College of Pharmacy, University of Arkansas for Medical Sciences, 4301 West Markham St., #522, Little Rock, AR 72205. Fax: 501-296-1168. E-mail: dragland@uams. edu Disclosure: The authors declare no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Previous presentation: American College of Clinical Pharmacy Annual Meeting, Austin, TX, October 16–20, 2010.
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n 2001, approximately one-half of all pregnancies in the United States were unintended.1 Possible reasons for these unintended pregnancies include failed contraception, nonadherence with contraception, lack of contraception use, or sexual assault.2 Another potential reason for unintended pregnancies may be a lack of knowledge about emergency contraception (EC). Levonorgestrel (Plan B—Teva) is a progestin-only EC product first approved by the Food and Drug Administration in 1999. In 2006, levonorgestrel was approved for nonprescription sales to individuals with a government-issued proof of age identification indicating 18 years or older. Despite this change, the unintended pregnancy rate for women in the United States was reported to be 41% in 2008.3 The minimum age for nonprescription EC users was further lowered to 17 years of age in July 2009.4 Although the use of EC will not eliminate unintended pregnancies, modifying the prescription-only status was an important step forward in increasing EC access.5 Unawareness and inaccurate knowledge of EC seem to be additional barriers to widespread EC use. These factors present a prime opportunity for pharmacist-provided EC counseling, thus equipping patients with the awareness necessary to administer self-care and make
At a Glance Synopsis: The emergency contraception (EC) knowledge scores of patients attending an academic medical center women’s clinic were assessed before, immediately after, and at least 1 month after a 10-minute education session by a pharmacist or student pharmacist. The least-squares mean EC knowledge test score (adjusted for demographics) was 5.86 at pretest, 10.75 at posttest, and 10.75 at follow-up (range 0–13). Higher education level was associated with higher knowledge scores among the study sample. The patients also were highly satisfied with the EC counseling and reported that the sessions helped them to better understand how EC works. Analysis: Although EC has been available for anyone 18 years or older since 2006, 30% of participants in this study reported no knowledge of EC prior to the counseling sessions, and many participants demonstrated inaccuracies in their knowledge. This study showed that a brief counseling session resulted in immediate improvement in participants’ EC knowledge and long-term retention of that knowledge. Given the high rate of unintended pregnancies in the United States and the findings of this study, it is important that women are aware of EC, how it works, how to use it, and how it can be obtained. Because EC is available without a prescription, pharmacists may miss valuable patient counseling opportunities. In the absence of the pharmacist counseling, flip charts or other visual aids can be used by nonmedical personnel who typically dispense EC.
Journal of the American Pharmacists Association
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informed decisions to help prevent unintended pregnancies. Previous studies have shown that misinformation and lack of knowledge regarding EC is common among patients. Schwarz et al.6 surveyed 446 women in two urgent care clinics in California. Of the patients surveyed, only 49% knew that using EC would have no adverse effect on future fertility and 27% thought EC was somewhat or very unsafe. A survey of 158 women in an urban emergency department showed that one-third of those surveyed were either unaware of EC or uncertain about its effectiveness.7 A similar study of 761 women in an urban emergency department found that more than 70% of surveyed women did not understand the concept of EC.8 This environment of misinformation and lack of knowledge regarding EC may prevent women from effectively using EC and result in unintended pregnancies. Moreover, such an environment may support pharmacist-provided counseling to equip patients with the knowledge necessary to use medication essential to promoting self-care. In a preliminary study conducted at the University of Arkansas for Medical Sciences (UAMS) University Women’s Clinic (UWC) in 2005, 64% of 276 women surveyed were not aware of EC (Schmidt A, Hopkins D, Hong SH, unpublished observations, 2005). The American College of Obstetricians and Gynecologists endorses health professionals working to increase patient EC knowledge, awareness, and access as high priorities in reducing the incidence of unintended pregnancies.9 Unintended pregnancy is a major health care issue in the United States, which could be prevented by safer sex practices or EC use.10–13 Medical expenses for unintended pregnancies total approximately $5 billion per year in the United States according to the 2002 National Survey of Family Growth.14 In 2002, the last statistic reported, 50% of pregnancies in Arkansas were unintended.15 Also, in 2002, Medicaid paid for 48% of all prenatal care in Arkansas.15 In contrast to the statewide rate, 86% of UWC pregnant patients surveyed between 2006 and 2008 reported that their pregnancies were unintended.16 The study also found that 55% of 269 surveyed women were unaware of EC. After a brief counseling session, 61% of those women reported their willingness to use or to consider using EC in the future. Improving patient knowledge of EC has great potential to decrease the prevalence of unintended pregnancies along with the physical, emotional, and financial burdens associated with this condition. Considering that the majority of these participants were low income (83%), pharmacist-provided EC education may benefit socioeconomically disadvantaged patients who are unaware of its availability. In addition, approximately 90% of the patients receiving prenatal care at this clinic receive Arkansas Medicaid funding. Consequently, even a slight decrease in the number of unintended pregnancies in this patient population has great potential to reduce the associated challenges to the patient and her family, as well as statewide health care costs. The preliminary findings at UWC provided the groundwork for the current study. Although the previous surveys asked patients if they were aware of EC, the accuracy of the patient-reported knowledge was not assessed.
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Objective This study sought to measure the impact of pharmacist counseling on patient knowledge of EC (both immediate improvement and long-term retention)—an act that may empower a patient to use new awareness to make decisions elemental to the management of her health.
Methods This study was a single-group, repeated-measures analysis of a convenience sample of participants 18 years or older receiving care at UWC between January and July 2010. The goal was to compare EC knowledge scores at three assessment periods: before (pretest) and immediately after (posttest) providing EC counseling, as well as a follow-up at least 1 month later. Attitudes and satisfaction of the participants toward the counseling also were assessed. This study was approved by the UAMS Institutional Review Board. Assessment instrument The survey instrument was designed by the investigators. Four UAMS College of Pharmacy faculty members and one non–UAMS College of Pharmacy faculty member reviewed the instrument for content validity and readability. The final survey was modified based on the reviewers’ comments and was tested on eight student pharmacists. The self-administered 12-question survey was used as an assessment instrument to determine participants’ EC knowledge. It included multiple choice and true/false questions regarding the mechanism of EC, adverse effects, efficacy, administration, and availability (Flesch-Kincaid readability level 5.7). The knowledge scores range from 0 (the lowest possible score) to 13 (the highest possible score). Eleven questions are worth 1 point and one question is worth 2 points (adverse effects of EC). In the pretest survey, we added one question to determine the participant’s intent to become pregnant. Additional information regarding participants’ demographics (age, race, household income, obstetrical history, and education level) also was collected at the time of the pretest survey (Appendix 1 in the electronic version of this article, available online at www.japha.org). The posttest survey has the same 12 EC knowledge questions and four additional items regarding participants’ attitudes and satisfaction toward the counseling session (online Appendix 2). These four items were measured using a four-point Likert-type scale (1, strongly disagree, to 4, strongly agree; Flesch-Kincaid Readability level 6.9). The follow-up survey intended to evaluate long-term retention of information provided at the counseling session. It has only the 12 EC knowledge questions. The follow-up survey was administered by a trained student pharmacist via phone calls to the patients at least 1 month after the counseling. Process and intervention Research staff recruited participants from the clinic waiting room and provided informed consent in a private office between January and May 2010. Participants received a $10 gift card as incentive to participate in the study. Verbal consent was obtained before the pretest survey was administered. To en758 • JAPhA • 51 : 6 • N ov / D e c 2011
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sure instruction consistency, researchers used a flip chart as a visual aid during the counseling session. The education information included the definition of EC, how it works, adverse effects, proper administration, effectiveness, availability, facts and myths, and a list of other methods of contraception. The posttest survey was administered immediately after the counseling session. The participant had an opportunity to discuss the survey items and to ask any questions pertaining to EC or other methods of contraception before completing the posttest survey. If participants desired, they were provided with printed information on EC and other forms of contraception. Participants also were asked if they were willing to be contacted for a voluntary follow-up phone survey. The total process (obtaining a verbal consent, pretest, counseling session, and posttest) took approximately 30 minutes during the course of a routine clinic visit with individual patients. Data analysis Immediate improvement in participants’ EC knowledge scores (pre- and posttest) was tested by the one-sample paired t test. The linear trend in mean EC knowledge scores during the three assessment periods was evaluated using a repeated-measures analysis of variance (ANOVA) as a function of age, race, education level, income level, counselor (pharmacist or trained student pharmacist), and assessment periods. A spatial power law covariance structure was used, given that the EC knowledge scores for the follow-up assessment period were obtained on unequal time intervals. This allows the correlations among individual’s EC knowledge scores to decline as a function of time elapsed.17 Following significance of main effects, the TukeyKramer post hoc test was used to determine whether statistical significance occurred. Participants’ attitudes and satisfaction toward the counseling were descriptively reported. The Mann-Whitney U test (nonparametric independent t test) was used to examine whether counselor type (pharmacist or student pharmacist) affected the attitude and satisfaction scores. All statistical analyses were performed using SAS version 9.2 (SAS Institute, Cary, NC), with P values <0.05 considered statistically significant.
Results A total of 160 patients were randomly invited to participate in the study. Women were eligible to participate if they were aged 18 years or older, currently receiving care at UWC, could independently read and speak English, and were mentally competent. Of the 121 women who consented, 4 did not complete the survey because they were called back to the exam room by the nurse. One participant was excluded due to cognitive disability, resulting in a total sample size of 116. No items were missing in the EC knowledge responses. The mean (±SD) age of the participants was 25 ± 5.9 years. The majority of participants were currently pregnant (94%), and 65% characterized their pregnancies as unintended. Of participants, 43% had some college education or higher and 86% had an annual household income less than $20,000. Table 1 shows participants’ demographics/descriptors Journal of the American Pharmacists Association
Table 1. Patient demographics and mean emergency contraception knowledge scores Characteristic Age (years) ≤19 20–24 25–30 >30 Race White Nonwhite Educationa High school or less Some college or above Income ($)b ≤20, 000 >20,000 Knowledge scores (mean ± SD)c Pretest (n = 116) Posttest (n = 116) Follow-up (n = 53)
No. (%) 21 (18) 44 (38) 30 (26) 21 (18)
EC knowledge means score
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12
10.92
10
64 (57) 48 (43) 83 (86) 13 (14)
5.3 ± 4.1 10.7 ± 1.4 10.3 ± 1.6
Missing data for four participants. Missing data for 20 participants. c Unadjusted mean scores by assessment periods. a b
and unadjusted mean test score results for each of the three assessment periods. A total of 35 women (30%) reported no previous awareness of EC. Overall, the 116 participants had a pretest knowledge score of 5.3 ± 4.1 and a posttest knowledge score of 10.7 ± 1.4 (difference 5.36 ± 3.99). The result of the paired t test (pre- and posttest scores) implied that a significant mean increase in participants’ EC knowledge test score occurred following the brief pharmacist-driven counseling sessions (P < 0.001). Of the 116 participants, 101 agreed to participate in the follow-up survey, which was administered by a trained student pharmacist via phone call between May and July 2010. Nine participants (8.9%) refused to answer the follow-up survey when contacted by phone, nine (8.9%) did not respond after three contact attempts, and 30 (29.7%) could not be reached due to a nonworking number, wrong number, or lack of voicemail. Long-term knowledge retention of 53 participants (52.5%) was assessed anywhere between 1 to 5 months after the counseling (follow-up time 71.2 ± 32.5 days [range 31–152]). Results from the unequally spaced repeated-measures ANOVA revealed no interaction between assessment periods and race, income level, counselor, or age categories. However, the analysis indicated a statistically significant interaction among education level and the assessment period based on participants’ EC knowledge test scores (F2,119 = 4.28, P = 0.016) (Figure 1). After adjusting for other demographic characteristics, the mean EC test scores for the group with an education level of some college or above were greater than those with an educaJournal of the American Pharmacists Association
11.14 10.58
8
10.35
7.2
6 4.53
4 2 0
Pre-test
Post-test
High school or less
59 (51) 57 (49)
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Some college or above
Figure 1. Adjusted mean scores for emergency contraception knowledge for two different education levels according to assessment periods tion level of high school or less at the pretest period. However, both education level groups displayed a significant increase in test scores immediately following the counseling sessions. Also, a small change was observed in the adjusted mean scores between posttest and follow-up for both education levels. For the main effects, education level (P = 0.015), race (P = 0.031), and assessment period (P < 0.001) were statistically significant. When averaged over time, the adjusted mean EC knowledge test scores were higher for white compared with nonwhite participants. After adjusting for demographic characteristics, the least-squares mean EC knowledge test score was 5.86 at pretest, 10.75 at posttest, and 10.75 at follow-up. Significant differences among adjusted means test scores at posttest and follow-up were observed when compared with the pretest scores. However, no statistical difference was observed between posttest and follow-up mean scores following the TukeyKramer adjustment. Participants’ attitudes and satisfaction toward the counseling session are displayed in Table 2. All participants rated either 3 (agree) or 4 (strongly agree) on each statement. Only the statement “I feel that today’s pharmacist counseling helped me better understand EC use” showed significant differences in scores between the two types of counselor (pharmacist, 3.9 ± 0.3, trained student pharmacist, 3.7 ± 0.4; P = 0.024). Of participants, 84% strongly agreed and 16% agreed with the statement “I am satisfied with today’s pharmacist counseling.”
Discussion The current study demonstrated that a 10-minute EC counseling session resulted in immediate improvement in participants’ EC knowledge and long-term retention of that knowledge. Although EC has been available for anyone 18 years or older since 2006, 30% of participants in this study reported no knowledge of EC prior to the counseling sessions. In addition, many participants demonstrated that their knowledge of EC was inaccurate. Increased knowledge of EC may empower female patients to use new awareness to make decisions instrumental to their personal health care. Integrating brief pharmacist-driven EC counseling sessions into patients’ scheduled visits at this large academic center women’s clinic proved to be feasible and effective. The cliniwww. japh a. or g
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Table 2. Participants’ attitudes toward and satisfaction with emergency contraception counseling sessions
Questiona n I feel that today’s pharmacist counseling helped me better understand EC use. I feel that today’s pharmacist counseling will help me to use EC in the future if needed. I would recommend this pharmacist counseling to a friend or family member. I am satisfied with today’s pharmacist counseling.
Scores Mean ± SD Trained student Pharmacist pharmacist 62 54
Pb
3.9 ± 0.3
3.7 ± 0.4
0.02
3.7 ± 0.4
3.7 ± 0.5
0.69
3.8 ± 0.4 3.9 ± 0.3
3.8 ± 0.4 3.8 ± 0.4
0.41 0.41
Abbreviation used: EC, emergency contraception. a Responses for each statement range from 1 (strongly disagree) to 4 (strongly agree). b Mann-Whitney U test.
cal pharmacist at this site provides contraception counseling in addition to other services such as diabetes education, depression screenings, and drug recommendations in pregnancy and lactation. The wait time patients experienced in this busy practice setting provided researchers the perfect opportunity for the education sessions. Future longitudinal studies of unintended pregnancies rates in this sample population are needed to determine the long-term impact of EC counseling. Pharmacist-provided EC counseling may empower women to prevent their unintended pregnancies. Given the high rate of unintended pregnancies in the United States and the findings of this study, it is important that women are aware of EC, how it works, how to use it, and how it can be obtained. The tremendous need for patient education can be fulfilled by pharmacists, or pharmacy staff supervised by pharmacists, so that patients have the tools necessary to make informed decisions regarding the use of EC. Because of the nonprescription status of EC, pharmacists are in a prime position to increase the appropriate use of EC. Several studies have shown that pharmacists support an enhanced professional role in the provision of EC and the counseling that should be provided with EC.18–20 Because this study was conducted at an academic institution, trained student pharmacists were used to provide 47% of the education sessions. This gave the student pharmacists an opportunity to practice counseling, which proved to be just as effective as the counseling provided by pharmacists. No significant difference was observed between pharmacist and student pharmacist counseling according to the patients’ assessment of the statement “I feel that today’s pharmacist counseling will help me to use EC in the future if needed.” Although this study was conducted in a clinic setting, it can be easily adapted for use in a busy community pharmacy. Unfortunately, the nonprescription sale of EC means that it is often dispensed without counseling by pharmacists. Flip charts or other visual aids can be used by nonmedical personnel who typically dispense EC. Selling EC products without counseling is a missed opportunity to provide much needed patient education. 760 • JAPhA • 51 : 6 • N ov / D e c 2011
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Limitations This study included participants receiving care at one clinic site, which generally serves low-income women referred from throughout Arkansas. The results may not be generalizable to the general population.
Conclusion Despite a decade of availability, patients’ lack of awareness and misinformation regarding EC remains a barrier to its effective use. Women are not receiving adequate information about EC from health care providers, and pharmacists can help address this gap in patient education. This study demonstrates that pharmacists and student pharmacists can improve patient knowledge of EC during a 10-minute counseling session. Brief counseling sessions provided to patients in a clinic setting are not only feasible but also effective in improving both immediate improvement in patient EC knowledge and long-term retention of that knowledge. In addition, the patients were highly satisfied with the EC counseling, reported that the sessions helped them to better understand how EC works, and, most importantly, improved their knowledge of how to use EC should they require it in the future. References 1. Finer LB, Henshaw SK. Disparities in unintended pregnancy rates in 1994 and 2001. Perspect Sex Reprod Health. 2006;38:90–6. 2. Schwarz EB, Kavanaugh M, Erika D, et al. Interest in intrauterine contraception among seekers of emergency contraception and pregnancy testing. Obstet Gynecol. 2009;113:833–9. 3. Centers for Disease Control and Prevention. Pregnancy Risk Assessment Monitoring System (PRAMS): PRAMS and unintended pregnancy. Accessed at www.cdc.gov/PRAMS/UP.htm, August 10, 2009. 4. Food and Drug Administration. FDA approves Plan B One-Step emergency contraceptive; lowers age for obtaining two-dose Plan B emergency contraceptive without a prescription. Accessed at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM109775, September 28, 2009. Journal of the American Pharmacists Association
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5. Steinbrook R. Waiting for Plan B: the FDA and nonprescription use of emergency contraception. N Engl J Med. 2004;350:2327–9. 6. Schwarz EB, Reeves MF, Gerbert B, Gonzales R. Knowledge of and perceived access to emergency contraception at two urgent care clinics in California. Contraception. 2007;75:209–13. 7. Abbott J, Feldhaus KM, Houry D, Lowenstein SR. Emergency contraception: what do our patients know? Ann Emerg Med. 2004;43:376–81. 8. Merchant RC, Casadei K, Gee EM, et al. Patient’s emergency contraception comprehension, usage, and view of the emergency department role for emergency contraception. J Emerg Med. 2007;33:367–75.
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14. Chandra A, Martinez GM, Mosher WD, et al. Fertility, family planning, and reproductive health of U.S. women: data from the 2002 National Survey of Family Growth. Vital Health Stat. 2005;23(25):1–160. 15. Williams L, Morrow B, Shulman H, et al. PRAMS 2002 Surveillance Report. Atlanta, GA: Centers for Disease Control and Prevention; 2006. 16. Payakachat N, Ragland D, Houston, C. Impact of emergency contraception status on unintended pregnancy; observational data from a women’s health practice. Pharmacy Practice. 2010;8:173–8. 17. Little RC, Milliken GA, Stroup WW, et al. SAS for mixed models. 2nd ed. Cary, NC: SAS Institute; 2006.
9. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin no. 112: emergency contraception. Obstet Gynecol. 2010;115:1100–9.
18. Landau S, Besinque K, Chung F, et al. Pharmacist interest in and attitudes toward direct pharmacy access to hormonal contraception in the United States. J Am Pharm Assoc. 2009;49:43–50.
10. Kuroki LM, Allsworth JE, Redding CA, et al. Is a previous unplanned pregnancy a risk factor for a subsequent unplanned pregnancy? Am J Obstet Gynecol. 2008;199:517.e1–7.
19. Hopkins D, West D. Arkansas pharmacists’ perceptions towards emergency contraception and nonprescription Plan B. Pharmacy Practice. 2008;6:98–102.
11. Phipps MG, Matteson KA, Fernandez GE, et al. Characteristics of women who seek emergency contraception and family planning services. Am J Obstet Gynecol. 2008;199:111.e1–5.
20. El-Ibiary SY, Raine T, McIntosh J, et al. Pharmacy access to emergency contraception: perspectives of pharmacists at a chain pharmacy in San Francisco. J Am Pharm Assoc. 2007;47:702–10.
12. Trussell J, Ellertson C, Stewart F, et al. The role of emergency contraception. Am J Obstet Gynecol. 2004;190:S30–8. 13. Westhoff C. Emergency contraception. N Engl J Med. 2003;349:1830–5.
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Emergency contraception counseling: An opportunity for pharmacists Denise Ragland, Nalin Payakachat, Songthip Ounpraseuth, Adam Pate, Sara E. Harrod, and Rachel E. Ott
Received October 21, 2010, and in revised form February 15, 2011. Accepted for publication February 15, 2011.
Abstract Objective: To determine the impact of pharmacist counseling on patients’ knowledge of emergency contraception (EC). Design: Single-group, repeated-measures analysis. Setting: Academic medical center women’s clinic in Little Rock, AR, between January and July 2010. Participants: 116 women 18 years or older. Intervention: 10-minute education session provided by a pharmacist or trained student pharmacist. Main outcome measures: Change in participants’ test scores (range 0 [lowest possible] to 13 [highest possible]) at three assessment periods (pretest, posttest, and follow-up) using 12 knowledge questions. Results: 116 participants with a mean (±SD) age of 25 ± 5.9 years participated in this study. Mean knowledge scores were 5.3 ± 4.1 for the pretest and 10.7 ± 1.4 for the posttest (P < 0.001). The least-squares mean EC knowledge test score (adjusted for demographics) was 5.86 at pretest, 10.75 at posttest, and 10.75 at follow-up. A nonsignificant small change in scores from posttest to follow-up was detected after the Tukey-Kramer adjustment. A higher education level was associated with higher knowledge scores in this population. Conclusion: Brief pharmacist-driven counseling sessions provided in a clinic setting are feasible and have a positive impact on immediate EC knowledge and longterm knowledge retention. Keywords: Emergency contraception, patient knowledge, pregnancy, counseling (patient), patient satisfaction, attitudes. J Am Pharm Assoc. 2011;51:756–761. doi: 10.1331/JAPhA.2011.10157
Denise Ragland, PharmD, CDE, is Associate Professor; and Nalin Payakachat, PhD, is Assistant Professor, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock. Songthip Ounpraseuth, PhD, is Assistant Professor, College of Public Health, University of Arkansas for Medical Sciences, Little Rock. Adam Pate, PharmD, was a pharmacy practice resident, University Hospital of Arkansas, Little Rock, at the time this study was conducted; he is currently Assistant Professor, College of Pharmacy, University of Louisiana at Monroe. Sara E. Harrod is a student pharmacist, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock. Rachel E. Ott, BA, is Grants Director, Antenatal & Neonatal Guidelines, Education and Learning System, Center for Distance Health, and Rural Hospital Program, University of Arkansas for Medical Sciences, Little Rock. Correspondence: Denise Ragland, PharmD, CDE, College of Pharmacy, University of Arkansas for Medical Sciences, 4301 West Markham St., #522, Little Rock, AR 72205. Fax: 501-296-1168. E-mail: dragland@uams. edu Disclosure: The authors declare no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Previous presentation: American College of Clinical Pharmacy Annual Meeting, Austin, TX, October 16–20, 2010.
756 • JAPhA • 51 : 6 • N ov / D e c 2011
www.j aph a. or g
Journal of the American Pharmacists Association
emergency contraception counseling
I
n 2001, approximately one-half of all pregnancies in the United States were unintended.1 Possible reasons for these unintended pregnancies include failed contraception, nonadherence with contraception, lack of contraception use, or sexual assault.2 Another potential reason for unintended pregnancies may be a lack of knowledge about emergency contraception (EC). Levonorgestrel (Plan B—Teva) is a progestin-only EC product first approved by the Food and Drug Administration in 1999. In 2006, levonorgestrel was approved for nonprescription sales to individuals with a government-issued proof of age identification indicating 18 years or older. Despite this change, the unintended pregnancy rate for women in the United States was reported to be 41% in 2008.3 The minimum age for nonprescription EC users was further lowered to 17 years of age in July 2009.4 Although the use of EC will not eliminate unintended pregnancies, modifying the prescription-only status was an important step forward in increasing EC access.5 Unawareness and inaccurate knowledge of EC seem to be additional barriers to widespread EC use. These factors present a prime opportunity for pharmacist-provided EC counseling, thus equipping patients with the awareness necessary to administer self-care and make
At a Glance Synopsis: The emergency contraception (EC) knowledge scores of patients attending an academic medical center women’s clinic were assessed before, immediately after, and at least 1 month after a 10-minute education session by a pharmacist or student pharmacist. The least-squares mean EC knowledge test score (adjusted for demographics) was 5.86 at pretest, 10.75 at posttest, and 10.75 at follow-up (range 0–13). Higher education level was associated with higher knowledge scores among the study sample. The patients also were highly satisfied with the EC counseling and reported that the sessions helped them to better understand how EC works. Analysis: Although EC has been available for anyone 18 years or older since 2006, 30% of participants in this study reported no knowledge of EC prior to the counseling sessions, and many participants demonstrated inaccuracies in their knowledge. This study showed that a brief counseling session resulted in immediate improvement in participants’ EC knowledge and long-term retention of that knowledge. Given the high rate of unintended pregnancies in the United States and the findings of this study, it is important that women are aware of EC, how it works, how to use it, and how it can be obtained. Because EC is available without a prescription, pharmacists may miss valuable patient counseling opportunities. In the absence of the pharmacist counseling, flip charts or other visual aids can be used by nonmedical personnel who typically dispense EC.
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informed decisions to help prevent unintended pregnancies. Previous studies have shown that misinformation and lack of knowledge regarding EC is common among patients. Schwarz et al.6 surveyed 446 women in two urgent care clinics in California. Of the patients surveyed, only 49% knew that using EC would have no adverse effect on future fertility and 27% thought EC was somewhat or very unsafe. A survey of 158 women in an urban emergency department showed that one-third of those surveyed were either unaware of EC or uncertain about its effectiveness.7 A similar study of 761 women in an urban emergency department found that more than 70% of surveyed women did not understand the concept of EC.8 This environment of misinformation and lack of knowledge regarding EC may prevent women from effectively using EC and result in unintended pregnancies. Moreover, such an environment may support pharmacist-provided counseling to equip patients with the knowledge necessary to use medication essential to promoting self-care. In a preliminary study conducted at the University of Arkansas for Medical Sciences (UAMS) University Women’s Clinic (UWC) in 2005, 64% of 276 women surveyed were not aware of EC (Schmidt A, Hopkins D, Hong SH, unpublished observations, 2005). The American College of Obstetricians and Gynecologists endorses health professionals working to increase patient EC knowledge, awareness, and access as high priorities in reducing the incidence of unintended pregnancies.9 Unintended pregnancy is a major health care issue in the United States, which could be prevented by safer sex practices or EC use.10–13 Medical expenses for unintended pregnancies total approximately $5 billion per year in the United States according to the 2002 National Survey of Family Growth.14 In 2002, the last statistic reported, 50% of pregnancies in Arkansas were unintended.15 Also, in 2002, Medicaid paid for 48% of all prenatal care in Arkansas.15 In contrast to the statewide rate, 86% of UWC pregnant patients surveyed between 2006 and 2008 reported that their pregnancies were unintended.16 The study also found that 55% of 269 surveyed women were unaware of EC. After a brief counseling session, 61% of those women reported their willingness to use or to consider using EC in the future. Improving patient knowledge of EC has great potential to decrease the prevalence of unintended pregnancies along with the physical, emotional, and financial burdens associated with this condition. Considering that the majority of these participants were low income (83%), pharmacist-provided EC education may benefit socioeconomically disadvantaged patients who are unaware of its availability. In addition, approximately 90% of the patients receiving prenatal care at this clinic receive Arkansas Medicaid funding. Consequently, even a slight decrease in the number of unintended pregnancies in this patient population has great potential to reduce the associated challenges to the patient and her family, as well as statewide health care costs. The preliminary findings at UWC provided the groundwork for the current study. Although the previous surveys asked patients if they were aware of EC, the accuracy of the patient-reported knowledge was not assessed.
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Objective This study sought to measure the impact of pharmacist counseling on patient knowledge of EC (both immediate improvement and long-term retention)—an act that may empower a patient to use new awareness to make decisions elemental to the management of her health.
Methods This study was a single-group, repeated-measures analysis of a convenience sample of participants 18 years or older receiving care at UWC between January and July 2010. The goal was to compare EC knowledge scores at three assessment periods: before (pretest) and immediately after (posttest) providing EC counseling, as well as a follow-up at least 1 month later. Attitudes and satisfaction of the participants toward the counseling also were assessed. This study was approved by the UAMS Institutional Review Board. Assessment instrument The survey instrument was designed by the investigators. Four UAMS College of Pharmacy faculty members and one non–UAMS College of Pharmacy faculty member reviewed the instrument for content validity and readability. The final survey was modified based on the reviewers’ comments and was tested on eight student pharmacists. The self-administered 12-question survey was used as an assessment instrument to determine participants’ EC knowledge. It included multiple choice and true/false questions regarding the mechanism of EC, adverse effects, efficacy, administration, and availability (Flesch-Kincaid readability level 5.7). The knowledge scores range from 0 (the lowest possible score) to 13 (the highest possible score). Eleven questions are worth 1 point and one question is worth 2 points (adverse effects of EC). In the pretest survey, we added one question to determine the participant’s intent to become pregnant. Additional information regarding participants’ demographics (age, race, household income, obstetrical history, and education level) also was collected at the time of the pretest survey (Appendix 1 in the electronic version of this article, available online at www.japha.org). The posttest survey has the same 12 EC knowledge questions and four additional items regarding participants’ attitudes and satisfaction toward the counseling session (online Appendix 2). These four items were measured using a four-point Likert-type scale (1, strongly disagree, to 4, strongly agree; Flesch-Kincaid Readability level 6.9). The follow-up survey intended to evaluate long-term retention of information provided at the counseling session. It has only the 12 EC knowledge questions. The follow-up survey was administered by a trained student pharmacist via phone calls to the patients at least 1 month after the counseling. Process and intervention Research staff recruited participants from the clinic waiting room and provided informed consent in a private office between January and May 2010. Participants received a $10 gift card as incentive to participate in the study. Verbal consent was obtained before the pretest survey was administered. To en758 • JAPhA • 51 : 6 • N ov / D e c 2011
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sure instruction consistency, researchers used a flip chart as a visual aid during the counseling session. The education information included the definition of EC, how it works, adverse effects, proper administration, effectiveness, availability, facts and myths, and a list of other methods of contraception. The posttest survey was administered immediately after the counseling session. The participant had an opportunity to discuss the survey items and to ask any questions pertaining to EC or other methods of contraception before completing the posttest survey. If participants desired, they were provided with printed information on EC and other forms of contraception. Participants also were asked if they were willing to be contacted for a voluntary follow-up phone survey. The total process (obtaining a verbal consent, pretest, counseling session, and posttest) took approximately 30 minutes during the course of a routine clinic visit with individual patients. Data analysis Immediate improvement in participants’ EC knowledge scores (pre- and posttest) was tested by the one-sample paired t test. The linear trend in mean EC knowledge scores during the three assessment periods was evaluated using a repeated-measures analysis of variance (ANOVA) as a function of age, race, education level, income level, counselor (pharmacist or trained student pharmacist), and assessment periods. A spatial power law covariance structure was used, given that the EC knowledge scores for the follow-up assessment period were obtained on unequal time intervals. This allows the correlations among individual’s EC knowledge scores to decline as a function of time elapsed.17 Following significance of main effects, the TukeyKramer post hoc test was used to determine whether statistical significance occurred. Participants’ attitudes and satisfaction toward the counseling were descriptively reported. The Mann-Whitney U test (nonparametric independent t test) was used to examine whether counselor type (pharmacist or student pharmacist) affected the attitude and satisfaction scores. All statistical analyses were performed using SAS version 9.2 (SAS Institute, Cary, NC), with P values <0.05 considered statistically significant.
Results A total of 160 patients were randomly invited to participate in the study. Women were eligible to participate if they were aged 18 years or older, currently receiving care at UWC, could independently read and speak English, and were mentally competent. Of the 121 women who consented, 4 did not complete the survey because they were called back to the exam room by the nurse. One participant was excluded due to cognitive disability, resulting in a total sample size of 116. No items were missing in the EC knowledge responses. The mean (±SD) age of the participants was 25 ± 5.9 years. The majority of participants were currently pregnant (94%), and 65% characterized their pregnancies as unintended. Of participants, 43% had some college education or higher and 86% had an annual household income less than $20,000. Table 1 shows participants’ demographics/descriptors Journal of the American Pharmacists Association
Table 1. Patient demographics and mean emergency contraception knowledge scores Characteristic Age (years) ≤19 20–24 25–30 >30 Race White Nonwhite Educationa High school or less Some college or above Income ($)b ≤20, 000 >20,000 Knowledge scores (mean ± SD)c Pretest (n = 116) Posttest (n = 116) Follow-up (n = 53)
No. (%) 21 (18) 44 (38) 30 (26) 21 (18)
EC knowledge means score
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12
10.92
10
64 (57) 48 (43) 83 (86) 13 (14)
5.3 ± 4.1 10.7 ± 1.4 10.3 ± 1.6
Missing data for four participants. Missing data for 20 participants. c Unadjusted mean scores by assessment periods. a b
and unadjusted mean test score results for each of the three assessment periods. A total of 35 women (30%) reported no previous awareness of EC. Overall, the 116 participants had a pretest knowledge score of 5.3 ± 4.1 and a posttest knowledge score of 10.7 ± 1.4 (difference 5.36 ± 3.99). The result of the paired t test (pre- and posttest scores) implied that a significant mean increase in participants’ EC knowledge test score occurred following the brief pharmacist-driven counseling sessions (P < 0.001). Of the 116 participants, 101 agreed to participate in the follow-up survey, which was administered by a trained student pharmacist via phone call between May and July 2010. Nine participants (8.9%) refused to answer the follow-up survey when contacted by phone, nine (8.9%) did not respond after three contact attempts, and 30 (29.7%) could not be reached due to a nonworking number, wrong number, or lack of voicemail. Long-term knowledge retention of 53 participants (52.5%) was assessed anywhere between 1 to 5 months after the counseling (follow-up time 71.2 ± 32.5 days [range 31–152]). Results from the unequally spaced repeated-measures ANOVA revealed no interaction between assessment periods and race, income level, counselor, or age categories. However, the analysis indicated a statistically significant interaction among education level and the assessment period based on participants’ EC knowledge test scores (F2,119 = 4.28, P = 0.016) (Figure 1). After adjusting for other demographic characteristics, the mean EC test scores for the group with an education level of some college or above were greater than those with an educaJournal of the American Pharmacists Association
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8
10.35
7.2
6 4.53
4 2 0
Pre-test
Post-test
High school or less
59 (51) 57 (49)
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Some college or above
Figure 1. Adjusted mean scores for emergency contraception knowledge for two different education levels according to assessment periods tion level of high school or less at the pretest period. However, both education level groups displayed a significant increase in test scores immediately following the counseling sessions. Also, a small change was observed in the adjusted mean scores between posttest and follow-up for both education levels. For the main effects, education level (P = 0.015), race (P = 0.031), and assessment period (P < 0.001) were statistically significant. When averaged over time, the adjusted mean EC knowledge test scores were higher for white compared with nonwhite participants. After adjusting for demographic characteristics, the least-squares mean EC knowledge test score was 5.86 at pretest, 10.75 at posttest, and 10.75 at follow-up. Significant differences among adjusted means test scores at posttest and follow-up were observed when compared with the pretest scores. However, no statistical difference was observed between posttest and follow-up mean scores following the TukeyKramer adjustment. Participants’ attitudes and satisfaction toward the counseling session are displayed in Table 2. All participants rated either 3 (agree) or 4 (strongly agree) on each statement. Only the statement “I feel that today’s pharmacist counseling helped me better understand EC use” showed significant differences in scores between the two types of counselor (pharmacist, 3.9 ± 0.3, trained student pharmacist, 3.7 ± 0.4; P = 0.024). Of participants, 84% strongly agreed and 16% agreed with the statement “I am satisfied with today’s pharmacist counseling.”
Discussion The current study demonstrated that a 10-minute EC counseling session resulted in immediate improvement in participants’ EC knowledge and long-term retention of that knowledge. Although EC has been available for anyone 18 years or older since 2006, 30% of participants in this study reported no knowledge of EC prior to the counseling sessions. In addition, many participants demonstrated that their knowledge of EC was inaccurate. Increased knowledge of EC may empower female patients to use new awareness to make decisions instrumental to their personal health care. Integrating brief pharmacist-driven EC counseling sessions into patients’ scheduled visits at this large academic center women’s clinic proved to be feasible and effective. The cliniwww. japh a. or g
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Table 2. Participants’ attitudes toward and satisfaction with emergency contraception counseling sessions
Questiona n I feel that today’s pharmacist counseling helped me better understand EC use. I feel that today’s pharmacist counseling will help me to use EC in the future if needed. I would recommend this pharmacist counseling to a friend or family member. I am satisfied with today’s pharmacist counseling.
Scores Mean ± SD Trained student Pharmacist pharmacist 62 54
Pb
3.9 ± 0.3
3.7 ± 0.4
0.02
3.7 ± 0.4
3.7 ± 0.5
0.69
3.8 ± 0.4 3.9 ± 0.3
3.8 ± 0.4 3.8 ± 0.4
0.41 0.41
Abbreviation used: EC, emergency contraception. a Responses for each statement range from 1 (strongly disagree) to 4 (strongly agree). b Mann-Whitney U test.
cal pharmacist at this site provides contraception counseling in addition to other services such as diabetes education, depression screenings, and drug recommendations in pregnancy and lactation. The wait time patients experienced in this busy practice setting provided researchers the perfect opportunity for the education sessions. Future longitudinal studies of unintended pregnancies rates in this sample population are needed to determine the long-term impact of EC counseling. Pharmacist-provided EC counseling may empower women to prevent their unintended pregnancies. Given the high rate of unintended pregnancies in the United States and the findings of this study, it is important that women are aware of EC, how it works, how to use it, and how it can be obtained. The tremendous need for patient education can be fulfilled by pharmacists, or pharmacy staff supervised by pharmacists, so that patients have the tools necessary to make informed decisions regarding the use of EC. Because of the nonprescription status of EC, pharmacists are in a prime position to increase the appropriate use of EC. Several studies have shown that pharmacists support an enhanced professional role in the provision of EC and the counseling that should be provided with EC.18–20 Because this study was conducted at an academic institution, trained student pharmacists were used to provide 47% of the education sessions. This gave the student pharmacists an opportunity to practice counseling, which proved to be just as effective as the counseling provided by pharmacists. No significant difference was observed between pharmacist and student pharmacist counseling according to the patients’ assessment of the statement “I feel that today’s pharmacist counseling will help me to use EC in the future if needed.” Although this study was conducted in a clinic setting, it can be easily adapted for use in a busy community pharmacy. Unfortunately, the nonprescription sale of EC means that it is often dispensed without counseling by pharmacists. Flip charts or other visual aids can be used by nonmedical personnel who typically dispense EC. Selling EC products without counseling is a missed opportunity to provide much needed patient education. 760 • JAPhA • 51 : 6 • N ov / D e c 2011
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Limitations This study included participants receiving care at one clinic site, which generally serves low-income women referred from throughout Arkansas. The results may not be generalizable to the general population.
Conclusion Despite a decade of availability, patients’ lack of awareness and misinformation regarding EC remains a barrier to its effective use. Women are not receiving adequate information about EC from health care providers, and pharmacists can help address this gap in patient education. This study demonstrates that pharmacists and student pharmacists can improve patient knowledge of EC during a 10-minute counseling session. Brief counseling sessions provided to patients in a clinic setting are not only feasible but also effective in improving both immediate improvement in patient EC knowledge and long-term retention of that knowledge. In addition, the patients were highly satisfied with the EC counseling, reported that the sessions helped them to better understand how EC works, and, most importantly, improved their knowledge of how to use EC should they require it in the future. References 1. Finer LB, Henshaw SK. Disparities in unintended pregnancy rates in 1994 and 2001. Perspect Sex Reprod Health. 2006;38:90–6. 2. Schwarz EB, Kavanaugh M, Erika D, et al. Interest in intrauterine contraception among seekers of emergency contraception and pregnancy testing. Obstet Gynecol. 2009;113:833–9. 3. Centers for Disease Control and Prevention. Pregnancy Risk Assessment Monitoring System (PRAMS): PRAMS and unintended pregnancy. Accessed at www.cdc.gov/PRAMS/UP.htm, August 10, 2009. 4. Food and Drug Administration. FDA approves Plan B One-Step emergency contraceptive; lowers age for obtaining two-dose Plan B emergency contraceptive without a prescription. Accessed at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM109775, September 28, 2009. Journal of the American Pharmacists Association
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5. Steinbrook R. Waiting for Plan B: the FDA and nonprescription use of emergency contraception. N Engl J Med. 2004;350:2327–9. 6. Schwarz EB, Reeves MF, Gerbert B, Gonzales R. Knowledge of and perceived access to emergency contraception at two urgent care clinics in California. Contraception. 2007;75:209–13. 7. Abbott J, Feldhaus KM, Houry D, Lowenstein SR. Emergency contraception: what do our patients know? Ann Emerg Med. 2004;43:376–81. 8. Merchant RC, Casadei K, Gee EM, et al. Patient’s emergency contraception comprehension, usage, and view of the emergency department role for emergency contraception. J Emerg Med. 2007;33:367–75.
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14. Chandra A, Martinez GM, Mosher WD, et al. Fertility, family planning, and reproductive health of U.S. women: data from the 2002 National Survey of Family Growth. Vital Health Stat. 2005;23(25):1–160. 15. Williams L, Morrow B, Shulman H, et al. PRAMS 2002 Surveillance Report. Atlanta, GA: Centers for Disease Control and Prevention; 2006. 16. Payakachat N, Ragland D, Houston, C. Impact of emergency contraception status on unintended pregnancy; observational data from a women’s health practice. Pharmacy Practice. 2010;8:173–8. 17. Little RC, Milliken GA, Stroup WW, et al. SAS for mixed models. 2nd ed. Cary, NC: SAS Institute; 2006.
9. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin no. 112: emergency contraception. Obstet Gynecol. 2010;115:1100–9.
18. Landau S, Besinque K, Chung F, et al. Pharmacist interest in and attitudes toward direct pharmacy access to hormonal contraception in the United States. J Am Pharm Assoc. 2009;49:43–50.
10. Kuroki LM, Allsworth JE, Redding CA, et al. Is a previous unplanned pregnancy a risk factor for a subsequent unplanned pregnancy? Am J Obstet Gynecol. 2008;199:517.e1–7.
19. Hopkins D, West D. Arkansas pharmacists’ perceptions towards emergency contraception and nonprescription Plan B. Pharmacy Practice. 2008;6:98–102.
11. Phipps MG, Matteson KA, Fernandez GE, et al. Characteristics of women who seek emergency contraception and family planning services. Am J Obstet Gynecol. 2008;199:111.e1–5.
20. El-Ibiary SY, Raine T, McIntosh J, et al. Pharmacy access to emergency contraception: perspectives of pharmacists at a chain pharmacy in San Francisco. J Am Pharm Assoc. 2007;47:702–10.
12. Trussell J, Ellertson C, Stewart F, et al. The role of emergency contraception. Am J Obstet Gynecol. 2004;190:S30–8. 13. Westhoff C. Emergency contraception. N Engl J Med. 2003;349:1830–5.
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