Throughout the country, pharmacists play an important role in health care. In addition to filling prescriptions, they often serve as sources of information about a variety of health issues, monitor a patient's overall use of medications and offer referrals to other health care providers.
In some states, pharmacists are able to perform additional prescriptive activities under protocol or collaborative drug therapy agreements. A pharmacist and a prescriber, such as a physician or nurse practitioner, voluntarily enter into a collaborative agreement, under which the pharmacist receives the authority to write prescriptions based on a set of prescribing protocols.
Collaborative drug therapy agreements for emergency contraception, for example, would allow pharmacists to prescribe this therapy directly to women, either in response to an immediate need or in advance of need. Given the time-sensitive nature of emergency contraception—it must be initiated within 72 hours of unprotected intercourse—this prescribing arrangement has the potential to greatly improve its accessibility, and thereby contribute to increased use of emergency contraceptive pills.
From a client's perspective, obtaining emergency contraception from a pharmacist offers several advantages. Specifically, pharmacies have convenient business hours and locations. For many women, especially young women who do not have a regular health care provider, availability through a pharmacy is a way to avoid the long wait often experienced by clients, especially new ones, when they attempt to schedule a doctor's appointment.
This article describes preliminary results from an innovative project to expand access to emergency contraceptive pills by promoting collaboration between pharmacists and independent prescribers in the provision of emergency contraception. The effort was undertaken to enhance women's awareness and use of emergency contraception by utilizing pharmacists to increase its availability. We also discuss the impact that their expanded role is having on access to emergency contraception, and thereby the potential impact of the program on rates of unintended pregnancy.
The degree of authority to write prescriptions delegated to pharmacists varies by state, depending upon the legislation governing pharmacy practice and its interpretation. Generally, however, collaborative agreements allow pharmacists to prescribe and dispense certain drug therapies directly to clients. Currently, 22 states allow pharmacists to prescribe directly or adjust medications through collaborative agreements, which have worked well for immunizations and management of drug therapy for pain relief, as well as for other therapies.
The scope of collaborative agreements can be wide or relatively circumscribed. In some states, regulations limit pharmacists' authority to a specific formulary of drugs that can be dispensed by the pharmacist directly, according to state-authorized protocols. In other states, pharmacists have the right to prescribe a wide range of medications, as long as they have developed collaborative agreements with licensed prescribers that include a specific prescribing protocol for each medication. These protocols are used as the basis for delegating prescriptive authority, and are generally submitted to and reviewed by the State Board of Pharmacy. Once an agreement for a particular therapy is established, the pharmacist can use the agreement to prescribe that therapy to any patient who has a need for it and who meets the screening criteria outlined in the protocol.
Health outcomes are improved when pharmacists are actively involved in patient care, according to studies conducted within the past 30 years.1 Furthermore, a 1993 survey of prescribers and pharmacists in Washington State demonstrated a high level of satisfaction with collaborative drug therapy agreements among those who have experience with them.2
Responses to a small survey of 26 emergency contraceptive pill prescribers in four states indicate that most of them believe that collaborative agreements for emergency contraception yield numerous benefits.3 For example, 85% of respondents think that the greatest advantage is improved patient access to emergency contraception. Some 65% think such provision has the potential to decrease health care costs through the use of less-expensive providers. Further cooperation between prescribers and pharmacists (62%), improved patient compliance with therapeutic objectives (54%) and fewer emergency calls to the prescriber (46%) were among the advantages they also noted. Prescriber support for this approach is further evidenced by a recent Washington State Medical Association resolution endorsing the project.
Pharmacists also recognize the benefit of entering into collaborative drug therapy agreements for emergency contraception. Carrying out the activities of the agreement involves the pharmacist in a more patient-focused practice, and provides increased responsibility for patient care. For example, the elements of emergency contraception services—counseling about the benefits of regular contraception and referring women to providers of more comprehensive reproductive health care—allow pharmacists to assume a key role in health care service delivery.
The Washington State Project
When Washington enacted legislation allowing licensed pharmacists to participate in collaborative drug therapy agreements, it was one of the first states to do so. There is no statutory authority to limit the pharmacists' prescriptive authority to any particular class of drugs or location of practice.
State regulations require the Board of Pharmacy to review all collaborative agreements. A complete prescribing protocol, cosigned by a practitioner licensed to prescribe (such as a physician, nurse practitioner, advanced registered nurse practitioner, clinical nurse specialist or nurse midwife) and a pharmacist, must be reviewed by the State Board. The protocol must describe the types of diseases, the drugs or drug categories involved and the plan, procedures or decision criteria to be used by the pharmacist. The protocol also must specify the method by which decisions will be documented, and include a plan for periodic feedback and review of the pharmacist's prescriptive activities by the authorizing practitioner.
In July 1997, a group of Washington organizations began an innovative effort to make emergency contraception more widely available to women in the Puget Sound region, using pharmacist collaborative agreements. The two-year demonstration project, funded by the David and Lucile Packard Foundation, is managed by the Program for Appropriate Technology in Health (PATH), working in partnership with the Washington State Board of Pharmacy, Washington State Pharmacists Association, University of Washington Department of Pharmacy and Elgin/DDB, a public relations firm that has worked with the Reproductive Health Technologies Project. The key components of the project include educating pharmacists about emergency contraception, helping them link up with prescribers, informing women about the availability of emergency contraception and evaluating the impact of the project.
The project conducts training sessions to educate pharmacists about all aspects of emergency contraception provision under prescriptive protocols. More than 500 pharmacists (representing approximately one-quarter of the practicing pharmacists in the Puget Sound region) have participated in training sessions to date, and ongoing training is planned throughout the project period to meet demand. Increasingly, the training sessions are being attended by physicians and nursing professionals in addition to pharmacists.
Topics covered during training include therapeutic and dispensing information; patient care issues, including the need for sensitive counseling, procedures for informed consent and service delivery to minors; information on collaborative agreements; referral to reproductive health services, including family planning clinics; insurance reimbursement issues; and public relations. Participating pharmacists seem pleased with the information they receive at training sessions and endorse increasing women's access to emergency contraception. Pharmacists from outside the project area have shown considerable interest in the program as well.
Facilitating Prescriptive Protocols
Following training, project staff help link participating pharmacists with sponsoring prescribers to develop collaborative agreements for emergency contraception. As awareness of the project initiative spreads, pharmacists are increasing their collaborative agreements for emergency contraception prescriptions with clinicians with whom they regularly interact.
The protocols specify the conditions under which the treatment can be provided; for instance, they cover provision of emergency contraceptive pills both in advance of need as well as after unprotected intercourse. Protocols also provide a mechanism for regular interaction and feedback between the pharmacist and prescriber sponsor. The protocols are submitted to the Washington State Board of Pharmacy for review and activation. By August 1998, 117 such protocols had been filed.
Project staff also have worked to encourage chain drugstores to participate in the project. So far, four major chains in the area are participating, and three have sponsored training sessions for their pharmacists.
Women must be informed of the availability of emergency contraception through local pharmacies if they are to make use of such services. Paid print and radio advertisements have been used to advise women that pharmacists are now prescribing emergency contraception and to link them to a national telephone hotline and website for emergency contraception (operated by the Reproductive Health Technologies Project). The national emergency contraception hotline (1-888-NOT-2-LATE) lists both pharmacies and clinics in Washington State where women can obtain emergency contraceptive pills. This contact information also is provided on the emergency contraception website (http://opr.princeton.edu/ec/).
In addition, a press conference was held on February 25, 1998, the one-year anniversary of the U.S. Food and Drug Administration's publication of a statement in the Federal Register endorsing the use of emergency contraception, to announce the official launch of services. The availability of the new service received considerable news coverage, both locally and nationally.
Evaluating Program Impact
The project evaluation will assess the impact that pharmacists' prescribing of emergency contraceptive pills is having on women's access to emergency contraception and on unintended pregnancies and abortions in the Puget Sound region. All women who receive emergency contraception through pharmacies are being asked to complete an anonymous written survey related to their experience with obtaining emergency contraception directly from a pharmacist. Any changes in the incidence of unintended pregnancy will be estimated based on the number of women served through project sites.
In addition, both pharmacists' and sponsoring prescribers' perceptions of and experiences with supplying emergency contraception through this mechanism will be assessed. Results from the evaluation will be used to refine and guide further efforts in Washington, as well as the work of those in other states interested in replicating this approach.
The preliminary response to the project has been overwhelmingly positive. In the four months following the project's launch, the hotline received 4,934 calls from Washington State, an average of 1,160 per month. Prior to the launch, the hotline had averaged 110 calls per month for the state. Over the same period, area pharmacists at 111 participating pharmacies wrote and filled 2,765 prescriptions for emergency contraception. Furthermore, prior to the project's launch, one major chain reported filling an average of one prescription for emergency contraception per week. Since the project's launch, that number has increased to 61 per week.
In addition, preliminary feedback from women suggests that the service is meeting their need for convenient access to emergency contraception and quality service. In the first two months of the project, 129 women (roughly 11% of those who obtained emergency contraceptive pills prescribed by a pharmacist) completed and mailed in the survey. Almost all were aged 18-35.
The respondents ranked their interaction with the pharmacist very high on such issues as the degree of respect shown by the pharmacist to the client, the presentation of information in a way that was comprehensible and the amount of time available for the client to ask questions. The women elected to go to the pharmacy for emergency contraception because it was convenient, and the majority said they would tell other women about this option. More than half said that if they had been unable to receive emergency contraception through a pharmacy, they would have waited to see if they became pregnant (42%) or didn't know what they would have done (16%).
A sampling of representative comments from the user survey highlights women's satisfaction with the pharmacy service and the critical role emergency contraception can play in preventing pregnancy and abortion:
"If this were available 10 years ago, I could have avoided an abortion. [I'm] old enough to know better, but life is not perfect or fair. I do have a plan for regular birth control pills to start with next period (not soon enough!)."
"Glad this was available, failure of birth control was frightening, even at 40. Thank you for this service."
"I am a 41-year-old professional with two small children and was dismayed to have this unprotected intercourse (we use fertility awareness and condoms). Thank goodness for this option and very timely and convenient given my daily obligations. Thank you."
"Having emergency contraception available at pharmacies is very convenient and a lot less humiliating."
"Thankful it was available, though [the therapy was] not very enjoyable. I've decided to go on the pill."
"I'm so grateful that this drug is available. I don't think I could emotionally handle an abortion and am not ready for kids."
The Potential Impact
Can increasing access to emergency contraception make a difference in the incidence of unintended pregnancy? We can estimate the number of unintended pregnancies and abortions prevented through the program by using the number of prescriptions filled in the first four months of the program in Washington State (2,765). The risk of pregnancy after an unprotected act of intercourse depends upon when in the cycle intercourse occurs, and can range from 8% to 30%. Assuming that the pregnancy risk is 10% and that emergency contraceptives are effective 75% of the time,4 emergency contraception prescriptions written and filled by pharmacists theoretically have prevented 207 unintended pregnancies (2,765 x .10 x .75). In Washington, approximately half of unintended pregnancies end in abortion; therefore, in four months the program may have prevented as many as 103 abortions.
The program's impact will grow as collaborative agreements for emergency contraception become more widely established throughout the state. In addition, the impact of such agreements will be influenced by the availability of a dedicated emergency contraception product in the United States. Recently, one such product was approved for marketing,* and at least one more is expected within the next year. The availability of dedicated products that can be marketed specifically for emergency contraception will increase awareness about the method among women and may lead to increased demand through all service delivery channels, including pharmacies. The first dedicated product is available by prescription only, and pharmacists will be able to dispense it under existing collaborative agreements.
Expanding collaborative agreements to other states has the potential to have a great impact on emergency contraceptive use. At least six, and possibly up to 14, other states currently have legislation that is favorable to establishing prescriptive practice agreements, and other states are pursuing changes in legislation that would allow pharmacists to provide emergency contraceptive pills and other drugs under protocol.
The project group in Washington State has been contacted by both pharmacy and family planning groups in other states that are interested in replicating the project. As was the case in Washington State, establishing emergency contraception collaborative agreements will initially require a high level of coordination among pharmacists, prescribers and family planning advocates.
While not a panacea, emergency contraception is a unique and important addition to the array of available contraceptive options. Women have a right to convenient access to this safe and relatively effective contraceptive method. The Washington experience demonstrates that pharmacists can play an important role in making this method more readily available to women who need it, and thereby contribute to reduced rates of unintended pregnancy.
Although a number of physicians and pharmacists in Washington State were skeptical about how the program would be accepted, its success to date is noteworthy. Applying a similar approach in other states that currently allow pharmacists to perform wider prescriptive activities would likely yield similar results. In those states where pharmacists are not allowed to prescribe under collaborative agreement protocols, family planning advocates and others can help pave the way to easier emergency contraceptive access by working with pharmacists to gain emergency contraception prescribing privileges.