Pharmacist prescribing of hormonal contraceptives: Results of the Direct Access study

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Pharmacist prescribing of hormonal contraceptives: Results of the Direct Access study Jacqueline S. Gardner, Leslie Miller, Donald F. Downing, Stephanie Le, David Blough, and Solmaz Shotorbani

Received November 1, 2007, and in revised form January 27, 2008. Accepted for publication January 27, 2008.

Abstract

Objective: To describe implementation of a collaborative drug therapy protocol to screen and counsel women for safe use of hormonal contraceptives prescribed by community pharmacists. Design: Community-based intervention study. Setting: Metropolitan Seattle, Wash., from June 2003 to December 2005. Participants: 26 community pharmacists and 214 women enrollees. Intervention: Pharmacists identified women at risk of unintended pregnancy and offered to evaluate them to determine whether they could safely use oral contraceptives, contraceptive patches, or the contraceptive vaginal ring. Interested women selfadministered medical and contraceptive history questionnaires. Pharmacists measured weight and blood pressure and prescribed hormonal contraceptives according to the protocol guidelines. Study interviewers followed up with women via telephone at 1, 6, and 12 months. Main outcome measures: Effectiveness of pharmacist interventions was measured by continuation of hormonal methods by women. Feasibility was determined by measuring acceptability and sustainability. Acceptability was measured by interviewing women and pharmacists. Sustainability was measured by evidence of willingness to pay for the services. Results: 195 women (91%) were prescribed hormonal contraceptives by participating pharmacists. A self-administered screening tool and physical measurement of weight and blood pressure enabled pharmacists to evaluate women for safe use of contraceptives. Most women (87%) were experienced users of hormonal contraceptives. More than 80% of women paid for the pharmacists’ services out of pocket. After 12 months, 70% of women responding to an interview reported continuing use of hormonal contraceptives. Women reported that they would want to obtain a gynecologic exam within 3-year intervals while taking hormonal contraceptives. Both women and pharmacists were satisfied with the experience. Nearly all respondents expressed willingness to continue to see pharmacist prescribers and to receive other services from them. Conclusion: Community pharmacists can efficiently screen women for safe use of hormonal contraceptives and select appropriate products. Women and pharmacists were satisfied with the services, and women were willing to pay for them. Keywords: Collaborative practice, contraceptives, prescribers, research. J Am Pharm Assoc. 2008;48:212–221. doi: 10.1331/JAPhA.2008.07138

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Jacqueline S. Gardner, PhD, is Professor of Pharmacy, School of Pharmacy, University of Washington, Seattle. Leslie Miller, MD, is Clinical Associate Professor of Obstetrics and Gynecology, University of Washington, Seattle. Donald F. Downing, BPharm, is Clinical Associate Professor of Pharmacy, School of Pharmacy, University of Washington, Seattle. Stephanie Le, BPharm, is Clinical Coordinator, Fred Meyer Pharmacies, Seattle. David K. Blough, PhD, is Research Associate Professor, School of Pharmacy, University of Washington, Seattle. Solmaz Shotorbani, MPH, is Country Program Manager, International Training and Education Center on HIV (I-TECH), University of Washington, Seattle. Correspondence: Jacqueline S. Gardner, Professor of Pharmacy, School of Pharmacy, University of Washington, Box 357630, Seattle, WA 98195. Fax: 206-543-3835. E-mail: [email protected] Disclosure: The authors declare no conflicts of interests or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Acknowledgments: To the participating pharmacists and pharmacy technicians from Bartell Drugs and Fred Meyer Pharmacies, to the many thoughtful colleagues who served on the Direct Access Advisory Committee, to Elizabeth James, PharmD, for analyses and poster presentation, to the interviewers and focus group facilitators, and to Monte Carlow for innovative data management services. Funding: By the National Institute of Child Health and Human Development (grant 1RO1HD42427-01). Previous presentations: Podium or poster presentations of preliminary findings of the Direct Access study were made at the American Pharmacists Association Annual Meeting and Exposition, Seattle, March 30, 2004, and Orlando, Fla., April 3, 2005, and at the Annual Meeting of the Association of Reproductive Health Professionals, Washington, D.C., September 9, 2004, Tampa Bay, Fla., September 8, 2005, and La Jolla, Calif., September 18, 2006.

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hen oral contraceptives were approved by the Food and Drug Administration (FDA) for prescription sale in the early 1960s, the practice decision was made to combine the prescribing process with screening for gynecologic cancer.1 Decades of experience with “the pill,” particularly as hormonal dosages were decreased incrementally, established oral contraceptives as generally safe to use.2,3 This information, combined with revised recommendations for the frequency of cervical cancer screening that lengthened the interval between Papanicolaou smears for healthy women,4 led to the recommendation by many national and international family-planning providers and advocates that the prescription of hormonal contraceptives be “unbundled” from well-woman care.1 Along with this

At a Glance Synopsis: After being trained and entering into collaborative drug therapy agreements, 26 community pharmacists in the Seattle metropolitan area safely prescribed hormonal contraceptives to 195 women. Participants completed a self-screening tool, enabling pharmacists to efficiently screen candidates, provide consultation, and document encounters. Hormonal contraception continuation rates were 92.6% (162 of 175) at 1-month interview, 80.3% (121 of 153) at 6-month interview, and 70.0% (89 of 127) at 12-month interview. The data suggest that women are willing to accept pharmacists as prescribers of contraceptives and are willing to pay for their services. Participants appreciated the convenience related to pharmacist accessibility, and 97.7% (171 of 175) reported being satisfied or very satisfied with the experience. Accessibility to hormonal contraceptives through pharmacist prescribers did not appear to prevent women from seeking regular gynecologic care from other providers. Analysis: Patient apprehension impeded discussions of ongoing contraceptive choices that pharmacists attempted with women presenting for emergency contraceptives. Future studies should address appropriate counseling behaviors by pharmacists in this difficult situation, especially since this group of women frequently needs more information in this regard. U.K. pharmacists are authorized to prescribe oral contraceptives directly to women 16 years of age or older. As the U.S. Food and Drug Administration continues to analyze the implications of a pharmacy-access or behind-the-counter category of drugs, low-dose oral contraceptives will invariably enter into the debate, and the role of pharmacists as “learned intermediaries” in improving safe access to medications available only through prescription will be a major consideration.

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change in the standard of prescribing practice for contraceptives came opportunities for new nontraditional prescribers. Since 1979, Washington state’s pharmacy practice act has authorized pharmacists to enter into collaborative drug therapy agreements that give them dependent prescribing authority.5 Washington pharmacists use this authority extensively for managing chronic medications, including anticoagulation, and providing vaccines and emergency contraceptives (ECs). Because community pharmacists in Washington established themselves as primary providers of EC beginning in 1998,6 the logical next step seemed to be increasing access to ongoing contraceptives at the EC visit. In considering whether pharmacists might be logical providers of hormonal contraceptives, several issues surfaced. First was patient safety: Could a pharmacy-based service ensure the same quality of screening for safe use that other providers might achieve? The second issue was whether pharmacists would be sufficiently accessible to provide the ongoing support to enable women to continue hormonal contraceptive methods and to provide that support at least as well as other providers. A study by Frost et al.7 reported a continuation rate of 50% at 12 months for women who had used hormonal contraceptives at baseline. Could pharmacist prescribers meet that continuation rate? A basic consideration was whether women would accept pharmacists as providers of hormonal contraceptives. The predominant reason consumers give for adopting pharmacist-provided services is convenience.6,8 It was impossible to anticipate whether convenience would be an important factor to patients when the service they sought had traditionally been provided by medical specialty providers and clinics. Finally, even if the issues discussed above were not barriers, could the elements of a contraceptive provider service be integrated into a busy community pharmacy practice without overburdening the existing workload, and would pharmacists want to perform the service? To address these questions, a National Institute of Child Health and Human Development–funded study, Improving Contraceptive Practice and Delivery through Community Pharmacy (called the Direct Access study locally), was launched. A network of eight chain pharmacies was established to conduct the study. An expert committee made up of pharmacists, other family-planning providers, public health officials, pharmacy regulators, and women’s health advocates was formed to advise investigators with respect to the basic questions of safety, accessibility, and acceptability for all parties. The committee met quarterly at first and then annually throughout the study; it reviewed plans, forms, and preliminary results and often suggested modifications.

Objectives The objectives of the Direct Access study were to evaluate (1) the impact of pharmacist-prescribed contraceptive care on hormonal contraception initiation and continuation rates; (2) the effectiveness of self-screening by women as a tool for selecw w w. p h a r m a c i s t . c o m

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tion of appropriate candidates to receive hormonal contraception provided by pharmacists; (3) the feasibility of pharmacist hormonal contraceptive screening, provision, and management in community pharmacies; and (4) the acceptability to users of hormonal contraceptive initiation and management by community pharmacists.

Methods Pharmacist recruitment into the research network

The managers of two regional pharmacy chains agreed to collaborate. Pharmacies were prioritized for inclusion according to the number of prescriptions for ECs written by pharmacists at each location in the previous year. A letter explaining the study objectives and procedures was sent to each pharmacist at the top five sites in each organization. Pharmacists were asked if they would participate in the study to recruit participants, prescribe hormonal contraceptives, and conduct documentation and data collection. Because pharmacists were collaborators in the research and not study enrollees, they were not required to undergo consent procedures. Pharmacists were not paid to participate. Pharmacist and technician training

The study protocol established World Health Organization level 1 criteria for patient safety as the standard for pharmacist prescribing.3 The standard recommends that only healthy women for whom contraceptive benefits clearly outweighed any identified risks would be eligible to receive a prescription from pharmacists. The standard was adopted for patient safety and to prevent time-consuming screening procedures that might render community pharmacy–based prescribing impracticable. The study physician investigator (Dr. Miller) signed all collaborative agreements (see Appendix 1 in the electronic version of this article, available online at www.japha.org). Twelve hours of continuing education were provided to participating pharmacists in reproductive physiology and contraceptive therapeutics to bring them up to date with prescribing considerations for study-specific contraceptive methods and to familiarize them with local resources for referrals for further care, as needed. Existing training materials for providers in the Public Health Seattle King County Family Planning Clinics were adapted for pharmacist use. Pharmacy technicians at each site were also invited to assist with recruiting, obtaining consent, and collecting and transferring data. Technicians who agreed received 4 hours of training in the informed consent process. In some cases, pharmacy technicians were also taught to measure and record blood pressure. Enrollment flow diagrams for easy reference were provided to pharmacists on laminated cards (online Appendices 2 and 3)

investigators set the lower age limit at 18 years to avoid delays that might be caused by a need to educate University of Washington Human Subjects Review Committee members about the legitimacy of pharmacists prescribing contraceptives to minors. Study inclusion criteria included absence of personal or family history of conditions that would preclude or compromise safe use of combined hormonal contraceptives, blood pressure less than 140/90 mm Hg, weight less than 200 pounds, and no suspected pregnancy. Women also had to agree to be interviewed by telephone up to four times and to continue to use the same pharmacy or one of the eight pharmacies in the network for 1 year. Women who did not meet these criteria were offered a referral to a family-planning clinic for more extensive evaluation of risk factors and contraceptive selection. Women were also asked to pay for their contraceptive coverage or to provide insurance information for billing because the study did not provide free contraceptives. Fees for screening and prescribing services were generally $25. If women were unable to pay for the products or service, they received a referral to an authorized provider of the Washington State Medicaid waiver program “Take Charge” or to a subsidized family clinic. Recruitment began June 30, 2003, and terminated December 31, 2004. Pharmacists recruited directly from among women to whom they were prescribing ECs. Women also were self-referred or learned of the study from posters, shelf-talkers, and brochures in the local pharmacies; from local or national news coverage of the study; or from ads placed in print media in neighborhoods surrounding the pharmacies. Determining the total number of potentially eligible women patronizing collaborating pharmacies during the study period was not possible. Several mechanisms were proposed for obtaining such an estimate, but none was feasible for daily practice. Consequently, this article reports information only on women who chose to enroll and cannot address characteristics of those who did not. Other than age, no information was collected from individual enrollees about sociodemographic characteristics. Analyses of the areas served by the collaborating pharmacies in conjunction with the funding application showed that the “catchment” areas of the pharmacies had distributions of ethnic and socioeconomic characteristics that were similar to those in the population of King County, Wash. Women found to be ineligible for any reason (n = 19) were invited to participate and complete study interviews; however, they could not receive prescribed hormonal contraception from pharmacists. The original intent was to use the data provided by these women for comparison with eligible participants, but recruitment was not systematic and waned over time. Consequently, the data provided by these women are included only in the description of their baseline characteristics.

Recruitment of study participants

Eligible women were 18 to 44 years of age and in need of contraception. Although sexually active women of any age are legally able to obtain medical services in Washington, the study 214 • JAPhA • 4 8 : 2 • M a r /A p r 2 0 0 8

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Self-screening and enrollment

A simple screening tool developed for international use9 was adapted for self-administration (online Appendix 4). The quesJournal of the American Pharmacists Association

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tionnaire, which consisted of 20 yes/no questions, was validated during the study as concurring with the screening performed by other family-planning providers.10 Women could answer the questions at their own pace to determine whether they were likely to be able to use hormonal contraceptives safely and, if so, when they might start therapy. Presentation of this screening form at the pharmacy started the study process, including the informed consent procedures, measurement of weight and blood pressure, and completion of an additional self-administered birth control history form. These data were reviewed and interpreted by the pharmacist to determine whether any contraindications to prescribing were present or whether pregnancy was suspected. If any doubt existed regarding whether a woman was pregnant, she was asked to buy and administer a urine pregnancy test before the pharmacist would prescribe hormonal contraception. If the woman and the pharmacist agreed that a hormonal contraception method offered by the study was appropriate, counseling about hormonal contraception use and effects and review of the corresponding FDA-approved patient information was completed. Each woman was prescribed only 3 months of contraception and was instructed to return in 3 months for additional blood pressure and weight measurements to ensure safe use for the remainder of the year. Data collection forms supported this flow of activity and included pharmacist intervention documentation forms for the initial visit and for the revisit at 3 months, as well as for any unscheduled visits or telephone contacts throughout the study. Follow-up interviews

Computer-assisted telephone interviews of participants were conducted by nonpharmacist study personnel at 1, 6, and 12 months after study enrollment. Five attempts to reach participants were made by interviewers within 7 days of the scheduled dates and, for those who missed an interview, no further contact was initiated by the study until the next scheduled interview. The focus of the telephone interviews was patient satisfaction with provider interactions, continuation of contraceptives and/ or reasons for discontinuation, and visits to pharmacists and/ or other providers for contraceptive or other care in the interval since last contact. Participants were paid $20 for each completed interview regardless of whether they received contraception from the pharmacist or continued on their study-prescribed method. Intervention participants who missed their scheduled 3-month visit were asked to complete a telephone interview to determine their continuation status and assess for adverse effects. Pharmacist satisfaction and feedback

Pharmacist satisfaction with the study procedures and the prescribing protocol was solicited through formal focus groups and informal conversations with study personnel. Structured focus groups were conducted to obtain feedback from participating pharmacists about their experiences and their recomJournal of the American Pharmacists Association

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mendations for implementing contraceptive prescribing in pharmacies on a broader scale. Discussion guides were developed with a consultant from the Program for Appropriate Technology in Health. All active Direct Access study pharmacists (i.e., those currently or recently enrolling participants) were invited to take part in the focus group discussions. Pharmacists who were unable to participate in the focus groups were invited to provide insight through in-depth telephone interviews. All focus groups were conducted at the University of Washington. A skilled and neutral moderator was hired to facilitate the discussion. Telephone interviews were conducted by the study research assistant from the study coordination center. All participants were given $30 for their time, and a light dinner was served at each focus group meeting. Overall, 15 of the 26 Direct Access pharmacists provided insights on the implementation of the study and the prescribing experience; 12 pharmacists participated in the focus groups and 3 in individual telephone interviews. Nine women and six men participated in feedback sessions. Compensation for pharmacists’ services

A third-party payer, Uniform Medical Plan (UMP), compensated pharmacists for their evaluation, counseling, and prescribing interventions. Using the services of Northwest Pharmaceutical Services, a pharmacy benefits management company, pharmacists could bill services online to UMP via dummy National Drug Codes that were mapped to service codes acceptable to UMP. UMP compensated pharmacies directly according to a fee schedule for each service code. UMP was the only third-party payer that compensated pharmacists for their service in prescribing hormonal contraceptives; however, other plans reimbursed for the contraceptives prescribed by the pharmacists according to plan agreements. Quality assurance

The study was approved by the University of Washington Human Subjects Committee. Quality-assurance procedures focused on several areas. The study physician (Dr. Miller) reviewed pharmacist documentation forms weekly for protocol violations. Regular summaries of critical quality-assurance variables were produced for review from the database. The principal investigator conducted periodic review of recorded telephone interviews for concordance of responses given by respondents with data entered in the computerized database by the interviewers. Interviews were recorded only after obtaining respondent permission and identifying that information documentation had been completed by the interviewer. Regular visits to participating pharmacy sites were made by the research study coordinator and by a coinvestigator (Mr. Downing) to continually monitor and update recruitment and consent procedures and to ensure that all site personnel were comfortable with and knowledgeable about the procedures. For serious adverse events reported during the study, reports were w w w. p h a r m a c i s t . c o m

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filed with both the University of Washington Human Subjects Committee and FDA MedWatch program. Participants were sent an information letter by study staff 1 month before the end of their enrollment period to remind them that their contraceptive prescriptions would expire 12 months after their initial enrollment date. They were provided a list of community family-planning clinics and encouraged to make appointments with prescribers for new contraceptive prescriptions. Because the study protocol authorized pharmacists to prescribe for only 1 year (13 cycles) of hormonal contraceptives, participants were not able to continue to receive prescriptions from study pharmacists.

Enrolled in Direct Access 214

Eligible (prescribed) 195 (91.2%)

Eligible—completed 1-month telephone interview 175 (89.7%)

Results Pharmacist prescribers

A total of 26 pharmacists from 8 sites were included in the training and the collaborative drug therapy agreements. While all collaborating pharmacists recruited at least one participant into the study, considerable variation existed in enrollment of women by site, with three high-volume pharmacies providing most of the study participants. These sites often had more pharmacists trained and working per shift. During the course of the study, one high-volume site transferred ownership to another chain and one low-volume site ended participation because all Direct Access–trained pharmacists discontinued employment there. Six pharmacies continued participation in the study. Characteristics of enrollees

In all, 214 women were recruited into the study (Figure 1). Overall, 10 (4.7%) women withdrew consent to participate and 49 (22.9%) were lost to follow-up. Of the 214 women enrolled in the study, 195 were eligible intervention participants and 19 were nonprescribed participants (Table 1). Nearly two-thirds (12 of 19) of the women deemed ineligible had measured blood pressure that fell above the threshold of 140/90 mm Hg, and more than 40% (8 of 19) exceeded the 200-pound body weight threshold (data not shown). Most eligible participants (87%) had used hormonal contraception before approaching the study pharmacists, and one-half reported using such contraceptive products at the time of enrollment in the study. One-half of the intervention and nearly two-thirds (63%) of nonprescribed participants reported being satisfied with their current method of birth control at the time of study enrollment. Of eligible women, 12% reported never having had a pelvic and breast examination, and of these, one-half were younger than 21 years of age. Of the eligible women who ever had examinations and gave dates for their last examinations, nearly all (168 of 171 [98.2%]) of the participants reported at study entry having had a pelvic examination within the previous 24 months. Slightly more than one-half (54.9%) of eligible enrollees reported having a regular physician or clinic for care, and 57.9% (113 of 195) provided insurance information.

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Eligible—completed 3-month revisit or telephone interview 174 (89.2%)

Eligible—completed 12-month telephone interview 127 (65.1%)

Figure 1. Number of participants enrolled in Direct Access, prescribed contraception, and followed up with at 1, 3, 6, and 12 months Women were asked why they chose to seek hormonal contraceptives from the pharmacists. More than 60% of eligible women reported that convenience was the primary motivator for their decision. Responses by women indicating that they did not currently have a physician and that they did not wish to have a pelvic examination in order to obtain birth control were perhaps related to convenience. More than 80% of eligible women paid for the screening and prescribing consultation out of pocket, and nearly one-half of participants who were prescribed contraceptives (90 of 195) paid for the product out of pocket. Ineligible women differed from eligible women predominantly with respect to health risk factors for safe use of hormonal contraceptives. Effectiveness of self-screening

Women enrollees and pharmacists agreed on the suitability of hormonal contraception. Six women did not express a preference among the offered hormonal contraceptive choices, but a majority of those who expressed a preference selected oral contraceptives (149 of 189 [78.8%]). Of the 44 women who chose

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Table 1. Characteristics of women who enrolled in the Direct Access study (n = 214) Characteristic

No. eligible women (%)

n 195 Age group (years) <20 18 (9.2) 20–24 67 (34.4) 25–29 49 (25.1) 30–34 36 (18.5) ≥35 24 (12.3) Women who reported having a regular physician 107 (54.9) Women who reported having had a pelvic examination within (months) Never 24 (12.3) <12 87 (44.6) 12–24 81 (41.5) >24 3 (1.5) Women who were recruited through EC consultation 14 (7.2) Women who paid out of pocket for contraceptive screening and consultation 160 (82.1) Women who were not charged by the pharmacist for screening and consultation 25 (12.8) Women who ever used hormonal birth control method before enrolling in the study 170 (87.2) Reason for contacting a pharmacist for hormonal contraceptiona Convenience (hours, location) 120 (61.5) Did not want pelvic examination in order to get birth control 58 (29.7)

No. ineligible women (%) 19 1 (5.3) 2 (10.5) 11 (58.0) 2 (10.5) 2 (10.5) 11 (58.0) 6 (31.6) 8 (42.1) 5 (26.3) 0 2 (10.5) 3 (15.8) 14 (73.7) 16 (84.2) 13 (68.4) 7 (36.8)

Abbreviation used: EC, emergency contraceptive. a

Multiple responses allowed.

the contraceptive patch, pharmacists found it appropriate for 36 (81.8%), and among 18 women initially choosing the vaginal ring, pharmacists determined it was appropriate for 17. Of the six women who did not express a preference upon enrollment, five received combined oral contraceptives and one received a contraceptive patch. An early learning curve was evident for pharmacists in their ability to interpret patients’ history and measurement data. In seven cases, pharmacists prescribed hormonal contraception despite protocol prohibitions: five cases involved elevated measured blood pressure at initial or 3-month visit, and two cases involved contraindicated concomitant medication use. In all cases, pharmacists were notified to discontinue or invalidate the prescriptions and, in all cases, they did. The women who received disallowed contraceptives typically were recent or current users of hormonal contraceptives for whom the study exclusion criteria had not been applied previously. During follow-up, one woman using the contraceptive patch reported a blood clot. She stopped using the patch immediately and obtained medical care. Over the course of telephone follow-up, 11 women reported having stopped their contraceptive either because they had become pregnant or were trying to become pregnant. A study was undertaken to validate the Direct Access selfJournal of the American Pharmacists Association

screening tool against nurse practitioner screening for contraceptive prescribing.10 Women were recruited from six public health family-planning clinics in the Seattle metropolitan area. A matching medical evaluation questionnaire was completed concurrently by each participant’s health care provider. Using provider evaluation as the gold standard against which self-reported medical history was compared, participant–provider agreement with point estimates and 95% confidence intervals (CIs) were calculated. Of 399 participant and provider pairs, participant– provider agreement was obtained for 392 participant pairs. The estimated proportion of the overall agreement was 96% (95% CI 0.92–0.98). Women were more likely to report severe headaches (12.4% versus 3.3%), possible pregnancy (7.3% versus 3.5%), and smoking (6.2% versus 2.1%) than providers but less likely to report smoking more than 15 cigarettes per day (2.6% versus 9.2%) and irregular menses (6.5% versus 9.9%). We concluded that, overall, a high proportion of the women in this validation study completed our medical history questionnaire in concordance with their health care providers’ same-day medical evaluation. Agreement on critical medical eligibility criteria such as hypertension was well above 90%. For criteria on which disagreement occurred, women were more likely to identify contraindications than their providers.

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The protocol called for prescribing pharmacists to provide information about the prescribed contraceptive methods, including when to begin using them and when to make referrals that the pharmacist considered in the patients’ best interest. In addition to required patient information, pharmacists reported providing study-designed written instruction sheets 85% of the time (166 of 195 patients). A total of 27 women (14%) were advised to delay starting their method until after taking a pregnancy test, and 86 were advised to use a backup method of contraception in their first week of use. Nearly one-third (32.3%) of women were advised to begin the method on the same day it was prescribed; 42% were advised to wait until the first day of their next menstrual period. During the initial visits, pharmacists did not document any referrals for sexual assault. They made 57 referrals for pelvic examinations and 6 for further medical evaluation. For these consultations, pharmacists reported spending an average of 23 minutes (range 10–35) per participant. These estimates are exclusive of the study-related consent procedures. During the course of the study period, 76 women (38.9%) were referred by pharmacists for other care.

were predominantly a mixture of adverse method effects and relationship changes. The distribution of those reasons at the 1-, 6-, and 12-month interviews were “side effects” reported by two, nine, and four women; pregnancy reported by one, three, and six women; and “not having sex” reported by zero, four, and four women, respectively. By the 12-month interview, seven women reported discontinuing because of cost of contraceptives. Because of the transfer of ownership of one site and some unreported name changes by study participants, prescription profiles were available for only 162 participants (83.1%) at the end of the study. From these, the date of the last hormonal contraceptive prescription filled at the Direct Access prescribing pharmacy was recorded. The average number of days between first Direct Access prescription and last hormonal contraceptive filled was 277 days (~9 months). On the assumption that one prescribed cycle may have been completed, we calculated continuation rates for those not documented using only the initial prescription date plus 28 days. At the end of the study, the average number of days between initial prescription by a pharmacist and 28 days beyond the last recorded hormonal contraception prescription was 262 days (~8.7 months).

Provider contacts

Participant satisfaction

Some women reported contacting a health care provider for problems related to their contraceptive methods during the study period: 8 women at 1 month, 18 women at 6 months, and 7 women at 12 months. The study pharmacist was the provider contacted by all of the women in the first month, by more onethan half (11 of 18) of the women in the next 6 months, but by no women at the 12-month interview. At the 6-month interview, 31 of 153 respondents (20.2%) reported having visited a health care provider for pelvic or breast examinations or screening for sexually transmitted diseases in the previous 3 months; by the 12-month interview, 48 of 127 respondents (37.8%) reported having seen a health care provider. A total of 118 of 127 respondents (93%) to the 12-month interview reported that they would be comfortable continuing to receive hormonal contraceptives without a physical or pelvic examination for 3 years or less.

Participants were asked at the 1-month interview how satisfied they were with their experience in obtaining hormonal contraceptives. Of 175 respondents, 171 (97.7%) reported that they were satisfied or very satisfied with the experience, that they felt they could ask the pharmacist about their prescription or any other questions they may have (96.6%), and that they would recommend the pharmacist to a friend (97.1%). A total of 171 respondents to the 1-month interview reported that it was convenient or very convenient to obtain hormonal contraception from a pharmacist compared with another provider, such as a family-planning clinic. A total of 154 respondents (88%) to the 1-month interview and 121 of 127 respondents (95%) to the 12-month interview reported that they would be willing to receive other health services from pharmacists, such as pregnancy or self-administered Chlamydia-screening tests. At the 12-month interview, 96.8% (123 of 127) of respondents reported that they would feel comfortable continuing to receive prescriptions for hormonal contraceptives from the pharmacist after completion of the study.

Instructions and referrals by pharmacists

Continuation of hormonal contraceptives

Participants reported using hormonal contraceptives in the interval between contacts (visits, telephone interviews). Of respondents to the 1-month interview who answered the questions about contraceptive continuation, 162 of 175 respondents (92.6%) reported using hormonal contraceptives in the previous month. At 6 and 12 months, 121 of 153 (80.3%) and 89 of 127 (70.0%) respondents, respectively, reported using hormonal contraceptives. In the later interviews, not all of the hormonal contraceptives used were those that had been prescribed by study pharmacists; some prescriptions were the outcomes of referrals made by study pharmacists or women’s self-referrals for gynecologic care during the interval. Reported reasons for discontinuation of prescribed methods 218 • JAPhA • 4 8 : 2 • M a r /A p r 2 0 0 8

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Pharmacist satisfaction

All pharmacists reported feeling confident and comfortable initiating, counseling, and managing contraception but agreed that enrolling patients was “awkward the first time.” They all indicated receiving very positive feedback from patients and clients, except from those who were excluded by the protocol. The general belief of pharmacists was that the women served were very satisfied. Pharmacists felt that the protocol and data collection materials were easy to follow, helpful, and supportive of their decision making and documentation, although the burJournal of the American Pharmacists Association

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den of study requirements “scared some people away.” In particular, requiring a potential study participant to use the same pharmacy for the entire study year was considered a barrier, particularly for college-age women traveling between home and school. The duration of the study was also cited as a drawback in that word-of-mouth momentum for a new service requires sufficient time to see results and study enrollment had terminated before such momentum could occur. Many pharmacists wanted more flexibility in the protocol and specifically wanted to see the lower age limit reduced to 16 years. They also wanted to be able to use body mass index rather than measured weight as an inclusion criterion. Confusion was expressed about continuing contraceptive prescriptions for women who came to the pharmacy while using other medications that excluded them from the study protocol, and considerable confusion was noted regarding how reported “headaches” should be evaluated to ensure safe contraceptive use without unduly restricting access for women who had used the method without problems in the past. However, pharmacists did not want the protocol to allow prescribing for “riskier” patients because of medical liability concerns. Their motivation to participate was largely to go beyond their distributive activities by providing a needed service in the community using their cognitive abilities. Some pharmacists also mentioned being motivated by helping women have easier access to contraception. All expressed wanting to continue to provide contraception at the end of the study. The majority looked for active involvement of the collaborating prescriber as an information source, a “sounding board,” and backup support for their decisions. Pharmacists in the focus groups spent considerable time discussing which groups of women were and were not served by the study and, by extension, by the pharmacist prescribers. In general, the pharmacists agreed that women best served were experienced with contraception but without current physicians, were between prescribers and between prescriptions, were new to or passing through the area, and rated convenience as important. For uninsured women, cost was perceived as an advantage because pharmacist services were less costly than a physician visit. The pharmacists noted that very young women were an underserved group that was not served by the study protocol. Pharmacists also noted that low-income women were excluded from the study because the state Medicaid payer would not compensate pharmacists for prescribing contraception to their clients. In discussing the relationship of EC consultation to study recruitment, pharmacists expressed several insights. First, they noted that many, if not most, of the EC clients in their practices were younger than 18 years of age or Medicaid clients and, therefore, were excluded from the study. Second, they felt that because most EC services were paid out of pocket (see below section), a hormonal contraceptive consultation fee at the same visit was burdensome. Some pharmacists opined that women seeking EC from them did not want other services; they were Journal of the American Pharmacists Association

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focused on their need for EC. Some pharmacists indicated feeling awkward about raising the question of ongoing contraception with EC clients because they perceived EC clients as feeling anxious regarding their visit. Pharmacists appreciated the media attention that accompanied the initiation of the Direct Access study and felt that more marketing would be desirable, although they acknowledged the difficulty of maintaining this level of media attention in regular practice. Compensation of pharmacist prescribers

More than four-fifths of women paid for the screening and prescribing consultation out of pocket (Table 1), and nearly onehalf of participants who were prescribed contraceptives (90 of 195) paid for the product out of pocket. Only one local third-party payer expressed willingness to compensate pharmacist prescribers for services to its beneficiaries, but this payer represented a large population of state employees and low-income employees who were not eligible for Medicaid. The compensation, which was separate from the covered product reimbursement, was the same as that paid by the insurer to other nonphysician prescribers, such as advanced registered nurse practitioners for assessing, evaluating, and prescribing contraceptives. An insurmountable technical barrier prevented the successful billing of this payer. Specifically, compensation for the services provided to enrollees of this payer was to be paid by the medical benefits administrators, but pharmacies were only able to directly bill the drug benefit administrators. A planned secondary billing route, via an independent pharmacy benefits manager willing to provide technical services for a small fee, was not successful. Therefore, although pharmacists were reimbursed for the contraceptive product, breakthroughs in the practice of pharmacists being compensated for their services did not occur.

Discussion In a previous analysis of data from the Direct Access study, we showed that women were able to self-select for safe use of appropriate hormonal contraception.10 Participating pharmacists found that, with the assistance of the self-screening tool, they were able to efficiently conduct needed screening, consultation, and documentation activities to safely prescribe hormonal contraceptives. They expressed satisfaction in doing so on several fronts. Some protocol violations occurred in the study in that pharmacists prescribed hormonal contraceptives for some women who should have been excluded for safety reasons. The protocol for Direct Access was conservative in that women who had uncomplicated medical histories were selected. We believe that this level of conservatism is warranted in pharmacy practice, especially when extensive diagnostic evaluation or probing into medical history is inappropriate and time consuming. Most cases of protocol violation occurred when women who should w w w. p h a r m a c i s t . c o m

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have been excluded by study protocol were not excluded because they were already using or had previously used hormonal contraceptives. The collaborating physician caught these violations, and the lesson going forward should be that a collaborating prescriber must be an active participant in the review of pharmacists’ prescribing decisions, particularly when a service is initiated. Our data support the willingness of women, particularly those who are experienced users of hormonal contraceptives, to accept pharmacist prescribers of contraceptives and to pay for their services. This is consistent with the findings of the national survey in which two-thirds of women surveyed indicated that they would use pharmacy access to hormonal contraceptives if it were available, and two-thirds of those respondents were women who already used hormonal contraceptives.11 The convenience feature of the services provided by Direct Access pharmacists was compromised unavoidably by the requisite study enrollment procedures, which required women to complete many forms and consents that would not be necessary in a usual care setting and to commit to remain a patient of a single pharmacy for 1 year. The study also attempted to determine whether women who initiated (or continued) hormonal contraceptives prescribed by pharmacists would be likely to continue therapy for 1 year. (The family-planning literature generally reports continuation rates at 1 year.) In one nationwide study, among the 56% of respondents who began the survey year using hormonal contraceptives, 50% were also using hormonal contraceptives at the end of the year.7 In our study, 70% of respondents (all of whom were hormonal contraceptive users at the beginning of the year) reported using hormonal contraceptives at 12 months of follow-up. However, only 65% of women who began the study responded to the 12-month interview, which makes the measured continuation rate unreliable. But the same reasons for contraceptive discontinuation and gaps in coverage (i.e., ambivalence about avoiding pregnancy, age 35–44 years, infrequent sexual intercourse, not being in a current relationship) are likely to apply to patients of pharmacists who provide contraception.12 Two other reasons for discontinuation—dissatisfaction with one’s contraceptive method and the belief that service providers were not available to answer method-related questions—were not supported by our data.12 Collaborators and investigators alike were surprised to find that women seeking ECs were reluctant to discuss ongoing contraceptive options at the same visit. Once this became apparent in our experience, other providers came forward with anecdotal reports of similar experiences. The reasons posited were that women did not want to think about ongoing contraception until they determined whether they were pregnant after taking ECs and that the anxiety about possible unintended pregnancy prevented them from engaging in dialogue that extended beyond the immediate situation. We suggest that future studies address this

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topic, as our study was not designed to capture the appropriate information. The study team was disappointed in not being able to bill directly for pharmacists’ services to the one third-party payer that agreed to pay for them. However, after the study terminated, a national initiative grew out of the provisions of the Medicare Part D drug benefit program that authorized payment for pharmacists’ nondispensing services. As a result, the capability for pharmacists to bill third-party payers directly via the medical benefits administrators is becoming established in every state. If pharmacists continue to provide contraceptive services, they will likely be able to bill payers for these and many other services. The high ratio of recent gynecologic examinations among Direct Access enrollees is directly related to the high proportion of women who are experienced contraceptive users. However, during the course of the study, nearly 40% of enrollees contacted a health care provider and most reported that they would not be comfortable continuing hormonal contraceptives without having a gynecologic examination within 3 years. This suggests that women are able to separate contraception-seeking behavior from gynecologic visits and that pharmacist prescribing of contraceptives would not result in women failing to seek evaluations for other needed preventive services. Indeed, women who are willing to pay for prescriptions are able to purchase them via the Internet without risk screening or medical requirements.13 These women may have “unbundled” contraception from preventive care for themselves. A strength of the study is that it was conducted in busy community chain pharmacies in an urban environment, and therefore the feasibility of establishing this service within other settings is more likely. While our pharmacy research “network” did not meet the Agency for Healthcare Research and Quality’s criteria for practice-based networks (www.ahrq.gov/research/pbrn/ pbrnfact.htm), pharmacists, technicians, and administrators of the six community pharmacies that completed the Direct Access study gained valuable experience in sponsored research. All of these pharmacies are now registered at the National Institutes of Health with Federal-Wide Assurances of policies relating to research involving human subjects. Each has assisted in responding to queries by the University of Washington Human Subjects Committee and has been helpful in educating members of that committee about pharmacists’ legal capabilities, professional roles and training, and practice experience. These pharmacies are prepared to review and potentially participate in other research protocols and may have a faster start-up time with future research compared with that experienced with Direct Access. The Direct Access study was undertaken to evaluate the feasibility of pharmacist prescribers of hormonal contraceptives. Whether pharmacists were capable of prescribing or legally authorized to prescribe were not research questions,

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as the legal authority is within the Washington State Pharmacy Practice Act. In considering future research, we recommend that this service be incorporated into other models of pharmacy practice than chain pharmacies. Whether younger women, particularly EC seekers, would use pharmacist-prescribed, ongoing hormonal contraceptives is an area of particular interest. Also, we are interested to see whether health plans become more accustomed to pharmacists being compensated for nondistributive functions and, as a result, pharmacist-prescribed contraceptives emerge as a covered benefit. Finally, more than research, we encourage pharmacists to provide this service and charge for it. Since the Direct Access study was completed, pharmacists in the United Kingdom have been authorized to prescribe oral contraceptives directly to women 16 years of age or older.14 As FDA revisits the question of a pharmacist-only or behind-thecounter category of drugs in the United States,15 the role of pharmacists as “learned intermediaries” in improving safe access to pharmaceutical products currently available only through prescription will be a major consideration. Inevitably, one of the products considered for the pharmacy-access, or behind-thecounter, category of drugs will be low-dose oral contraceptives. Based on our data, we consider pharmacists the logical providers of behind-the-counter hormonal contraceptives if a scheme to compensate them is included in the regulation.

Limitations The generalizability of our findings was limited because we were unable to compare the number of women eligible to enroll in the study with the number who actually enrolled. Also, we were unable to study the willingness to seek hormonal contraception in pharmacies by uninsured women younger than 18 years of age. A further limitation is that only 65% of women who enrolled in the study completed the 12-month telephone interview.

Conclusion Although the Direct Access study was small, we believe that it met its objectives. It demonstrated pharmacists’ ability to evaluate healthy women and safely prescribe hormonal contraceptives. Women who received prescriptions from pharmacists reported 1-year method continuation rates comparable with those reported in recent family planning literature. Women appreciated the convenience of pharmacist accessibility and demonstrated this through their willingness to pay for the service and their expressed willingness to continue to see phar-

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macist prescribers. We expect that the practice of pharmacists prescribing hormonal contraceptives will expand in Washington and will be introduced in other states, particularly those in which pharmacists already prescribe ECs. The barrier of compensation for pharmacist services, particularly for low-income women, may be partially addressed by state Medicaid, state Medicaid family-planning waiver programs, or other payers as new Medicare Part D policies expand familiarity with pharmacist services as compensable. References

1. Stewart FH, Harper CC, Ellertson CE, et al. Clinical breast and pelvic examination requirements for hormonal contraception: current practice vs evidence. JAMA. 2001;285:2232–9. 2. Trussell J, Stewart F, Potts M, et al. Should oral contraceptives be available without prescription? Am J Public Health. 1993;83:1094–9. 3. World Health Organization. Improving access to quality care in family planning: medical eligibility criteria for contraceptive use. Geneva: World Health Organization; 2000 [WHO/ RHR/00.02]. 4. American College of Obstetricians and Gynecologists. ACOG practice bulletin: cervical cytology screening: number 45, August 2003. Int J Gynaecol Obstet. 2003;83:237–47. 5. Fuller TS, Christensen DB, Williams DH. Satisfaction with prescriptive authority protocols. J Am Pharm Assoc. 1996;NS36:739–45. 6. Gardner JS, Hutchings J, Fuller TS, Downing D. Increasing access to emergency contraception through community pharmacies: lessons from Washington State. Fam Plan Perspect. 2001;33:172–5. 7. Frost JJ, Singh S, Finer LB. U.S. women’s one-year contraceptive use patterns, 2004. Perspect Sex Reprod Health. 2007;39:48–55. 8. Grabenstein JD, Guess HA, Hartzema AG, et al. Effect of vaccination by community pharmacists among adult prescription recipients. Med Care. 2001;39:340–8. 9. Family Health International. Reproductive health publications and materials. Accessed at www.fhi.org/en/RH/Pubs/index. htm, June 7, 2007. 10. Shotorbani S, Miller L, Blough DK, Gardner J. Agreement between women’s and providers’ assessment of hormonal contraceptive risk factors. Contraception. 2006;73:501–6. 11. Landau SC, Tapias MP, McGhee BT. Birth control within reach: a national survey on women’s attitudes toward and interest in pharmacy access to hormonal contraception. Contraception. 2006;74:463–70. 12. Frost JJ, Singh S, Finer LB. Factors associated with contraceptive use and nonuse, United States, 2004. Perspect Sex Reprod Health. 2007;39:90–9. 13. Memmel LM, Miller L, Gardner J. Over-the-internet availability of hormonal contraceptives regardless of risk factors. Contraception. 2006;73:372–5. 14. Boseley S. Women to be able to get pill on demand at local pharmacy. The Guardian. December 13, 2007. 15. U.S. Department of Health and Human Services. Behind the counter availability of certain drugs: public meeting. Fed Regist. 2007;72:56769–70 [docket no. 2007N-0356].

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Appendix 1. Sample hormonal contraception collaborative agreement As a licensed health care provider authorized to prescribe medications in the State of Washington, I authorize ___________employed at The _________ Pharmacy to prescribe hormonal contraception according to the protocol that follows. The protocol provides written guidelines for initiating drug therapy in accordance with the laws (RCW 18.64.011) and regulations (WAC 246-863-100) of the State of Washington. Purpose To provide medically eligible women with access to hormonal contraception from Washington State _______________(Pharmacy) pharmacists, to ensure that patients receive adequate information to successfully continue therapy for up to 12 months, and to assist patients in appropriate follow-up care, including referral to community healthcare providers. Procedure When a woman requests hormonal contraception at this pharmacy, she and her pharmacist will assess the patient’s eligibility for hormonal contraception by completing and evaluating the patient’s answers to questions on the self-administered questionnaire (Appendix A). The patient’s blood pressure and weight will be checked by the pharmacist and if the patient’s blood pressure is >140 / 90, her Body Mass Index (BMI) >30, or fails to qualify using other eligibility criteria as elicited by the self-administered questionnaire the patient will be deemed ineligible for pharmacist-provided hormonal contraception. All patient responses to the questionnaires must be clearly consistent and confirm the use of hormonal contraception to be deemed safe. If the patient is eligible for hormonal contraception according to the screening criteria, the pharmacist and patient will discuss therapeutic options, procedures for contraceptive initiation, and the ongoing management of hormonal contraception. Hormonal Contraception Product Selection: The pharmacist will only prescribe products that are FDA approved for hormonal contraception. Along with the medication, patients will be provided with the FDA-approved patient information (package insert) with each hormonal product. The information discussed with the patient will address dosing, potential side effects, and the signs and symptoms of rare adverse events such as thrombosis (headache, leg swelling, chest or abdominal pain, or visual changes). Information regarding the initiation and regular effective use of the method will also be given. No “off-label” use of hormonal contraceptives will be authorized by this collaborative agreement. Pharmacists will start patients who choose an oral contraceptive with a preference to the lowest estrogen content possible and to monophasic over multi-phasic formulations. Patients currently taking a hormonal contraceptive when they present to the pharmacy and patients who have taken hormonal contraceptives within the prior 6 months without complication and who desire to continue or re-start on the same contraceptive brand may continue with current and recently used (within past 6 months) products if medically eligible, and if the pharmacist and patient mutually agree to their use. Therapeutic management: Once a patient commences with hormonal contraception she and her pharmacist will maintain a therapeutic relationship in order to manage medication adherence, to identify and resolve drug therapy problems, and to change or possibly terminate contraceptive care. Stopping Prescription: The pharmacist will stop the patient’s hormonal contraceptive and refer the patient to see a physician or other family planning provider if the patient experiences new or persistent side effects or complaints. Additionally, patients will be referred if the pharmacist identifies any other barriers to use of new or on-going contraceptives.

If there is a concern that the patient may be at risk for or could have contracted a sexually transmitted disease through unprotected sex, and/or if the patient indicates that she has been sexually assaulted the pharmacist will initiate appropriate referral. Documentation and quality assurance: Each prescription authorized by the pharmacist will be documented in a patient profile as required by law. The self-administered questionnaire will be used to inform the profile and will be retained at the pharmacy as a patient record for reference by the pharmacist in managing the patient On a quarterly basis, the authorizing prescriber and the pharmacist will perform a quality assurance review of the prescribing decisions with respect to appropriateness of method selected. The prescriptive authority is granted for a period of two years from the date of approval, unless rescinded in writing earlier by either the authorizing prescriber or the pharmacist. Signatures Authorizing Prescriber ____________________________

License# License Date

Authorized Pharmacist _____________________________License #_______________ Date

Appendix 2. Direct Access enrollment flow chart Initial eligibility criteria  Women 18–45, able to get pregnant  May be recruited into the study as EC client, walk-in, shelf talkers

***For technicians***

• •

For EC clients, read verbal consent Provide the woman with a screening brochure and ask her to complete this form first • Inquire about insurance and ability to pay for services.

Participant is not eligible to receive birth control from the study pharmacy, if (consult with pharmacist): • She says yes to questions 1–3 in the screening brochure • Has a blood pressure ≥140/90 • Weighs ≥200 pounds • Cannot pay for the services/product

If still interested and eligible, provide the woman with: 1. A written consent form (white copy) and 2. Birth control history form (ask her to wait for the pharmacist)

•

Participant should: 1. Read & sign the consent form before proceeding 2. Complete the birth control history form

•

Invite her to participate in the study control group. Comparators should: 1. Read & sign the consent form 2. Complete the screening brochure 3. Fill out birth control history form 4. Receive blood pressure & weight assessment, $15 in-store gift card and a pink copy of the consent form 5. Pharmacist will complete an Initial Documentation Form Refer client to family planning clinic for birth control care/Take Charge

***For Pharmacists Only***

Pharmacist should: 1. 2. 3.



Review consent form, screening brochure and birth control history form Complete the initial documentation form Obtain blood pressure & weight measurement

If no contraindication to method, intervention participant will receive: o 3 cycles of hormonal contraceptive products o Pink copy of the consent form o $15 gift card o Patient handout on the pill, the patch, or the ring o Package insert o 3-month revisit appointment card o Other information pharmacist deems necessary

•

Blood pressure is ≥140/90

•

Weight is ≥200 pounds

Green = Proceed with enrollment Yellow = Proceed with Caution Red = Stop! Read directions before proceeding

ABSOLUTE CONTRAINDICATIONS REFERENCE SHEET 1. Absolute contraindications to any hormonal method of birth control in the Direct Access Study. Do not prescribe any methods if: a. Age < 18 or >45 b. Cannot get pregnant c. Breast cancer d. Pregnancy or no regular monthly periods or undiagnosed vaginal bleeding e. Liver disease or jaundice f. Pills for tuberculosis, fungal infections, seizures or if any other chronic medications verify whether OCP use is contraindicated g. Measured weight greater than 200 pounds h. Blood pressure reading equal to or greater than 140/90 i.

Allergy to any of the components in the method prescribed, i.e. iodine in pills for tinting/coloring

2. Additional absolute contraindications to any combined method (containing estrogen) of birth control in the Direct Access Study. Do not prescribe estrogen if: a. Smoking greater than 15 cigarettes per day or any smoking for women ≥35 years old b. Migraines and headaches as described in the brochure c. Breastfeeding a baby under 6 months of age d. A pregnancy of more than 5-6 months (24 weeks gestation) ending less than 4 weeks prior because of the risk of blood clots e. Hypertension, even if controlled by antihypertensive medication f. Diabetes mellitus g. Gallbladder disease h. History of stroke, blood clots, MI or other heart disease i.

Family history of blood clots (as described in the brochure)

j.

Wheelchair bound

k. Planning to have surgery in the next 4 weeks l.

Been told by medical professional not to take hormones

m. Report of a chronic medical condition not listed on the screening form but is listed in the text or in the package labeling (may have to consult MD)

METHOD START INSTRUCTIONS It is important to document your directions to the client regarding when to start and if a back up method is needed. If the woman gets pregnant you must be able to show by documentation that you gave her proper advice. There are basically three start options: 1. Ongoing prescription- Continue with an ongoing prescription according to her existing schedule with no interruption in use (except the normal hormone free week for menses per the package insert). No back up is needed unless switching formulations. 2. Per package labeling- Begin a method according to the package instructions with the menses and usually within 1-5 days of the first day of bleeding and always by the 7th day (this would be a Sunday start as well). Usually, unless a day 1 start, a back up method is advised for the first 7 days of use. 3. Anytime- Begin anytime regardless of the last period (as long as she had a period in the past month and there is no indication of pregnancy). This is called a “same day start”. It is prudent to ask the woman to get a pregnancy test if she has had unprotected sex in the prior two weeks. If she has had unprotected sex in the prior 5 days, provision of ECP is a good idea. She will need 7 days of back up as well. It takes 7 days of daily progestin exposure to change the cervical mucus and for the methods to become effective. Women should never go longer than 7 days without a progestin to maintain their protection.