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Pharmacist-prescribed hormonal contraception: A review of the current landscape
SCIENCE AND PRACTICE Journal of the American Pharmacists Association 59 (2019) 633e641
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COMMENTARY
Pharmacist-prescribed hormonal contraception: A review of the current landscape Casey R. Tak*, Laura T. Kessler, Mollie Ashe Scott, Karen M. Gunning a r t i c l e i n f o
a b s t r a c t
Article history: Received 27 February 2019 Accepted 21 May 2019 Available online 9 July 2019
Objective: The objective of this article is to review the current supply-side, demand-side, and regulatory landscape of pharmacist-prescribed hormonal contraception (HC) in the United States. Summary: Pharmacists appear to be supportive of pharmacist-prescribed HC. However, support does not necessarily indicate likelihood to implement the practice, even when reimbursement mechanisms exist. The likelihood of implementation can be increased with education and training of HC prescribing. Previous investigations suggest that women broadly support accessing contraception within a pharmacy. Expanded access, where available, can improve rates of use and adherence. Women at higher risk for unintended pregnancy, such as younger women and women without health insurance, are likely to use the pharmacy to procure HC. Despite a willingness to pay for HC consultations with pharmacists, costs can remain a significant barrier for many women. Conclusions: Expanding access to HC through pharmacist-prescriptive authority could help curb the rates of unintended pregnancy in the United States. Pharmacists are well positioned for such a role; however, significant barriers for pharmacists and patients remain. Examination of current implementation methods will assist policy makers in overcoming these barriers. © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
The Centers for Disease Control and Prevention has recognized the advent of contraception as one of the most important health technology advances in the twentieth century.1 Contraception has enabled women and couples to have more control over family planning, resulting in improvements in health outcomes and the social and economic standing of women.1 Despite the effectiveness of modern contraception in preventing pregnancy, unintended pregnancy rates remain high. Data from the National Survey for Family Growth suggest that approximately 51% of all pregnancies in the United States are unintended.2 Among women age 20 to 24 years, 64% of pregnancies are unintended2; these include pregnancies that are wanted
Disclosure: The authors declare no conflicts of interest or financial interests in any product or service mentioned in this article. * Correspondence: Casey R. Tak, PhD, MPH, Assistant Professor, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, One University Heights, Karpen Hall 143, Asheville, NC 28804. E-mail address: [email protected] (C.R. Tak). ORCID Casey Tak: https://orcid.org/0000-0002-1203-1782.
but mistimed and pregnancies that are unwanted. Unintended pregnancies are associated with a number of demographic factors, including younger age (e.g., < 25 years), marital status, lower levels of income, lower levels of educational attainment, non-white race or ethnicity, and no religious affiliation.2 Women with unintended pregnancies are less likely to seek early prenatal care, have more exposure to cigarette smoke, and are less likely to breastfeed postpartum.3 Unwanted pregnancies are associated with infants of low birthweight.4 Of all the unintended pregnancies in the United States, approximately 40% will end in abortion.2 The use of hormonal contraception offers a number of health benefits in addition to family planning. Menstrual benefits include decreases in dysmenorrhea, heavy menstrual bleeding, anemia, and cyclic mood problems. Hormonal contraception reduces the risk of ectopic pregnancy and symptomatic pelvic inflammatory disease.5 Furthermore, hormonal contraception use has been associated with protection against certain cancers.5 Adolescent females may be prescribed HC to treat and prevent acne.5 The high rates of unintended pregnancy suggest that barriers to contraception exist. Research has shown that many women face barriers associated with time off, child care, and
https://doi.org/10.1016/j.japh.2019.05.015 1544-3191/© 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
SCIENCE AND PRACTICE C.R. Tak et al. / Journal of the American Pharmacists Association 59 (2019) 633e641
Summary Key Points Supply-side landscape Background: Unintended pregnancy rates remain high in the United States, suggesting that barriers to contraception exist. Pharmacist-prescribed hormonal contraception has begun to be implemented across certain U.S. states. An increasing amount of evidence is being generated regarding the effect that pharmacist-prescribed hormonal contraception can have on access. Findings: At least 10 U.S. states have authorized pharmacists to prescribe hormonal contraception, with varying regulations. Pharmacists are generally supportive of greater involvement in furnishing hormonal contraception. Patients at high risk of unintended pregnancy are likely to want to use the pharmacy to procure hormonal contraception.
transportation, thus creating difficulty for women to visit their provider and obtain a prescription order for contraception.6 The American College of Obstetrics and Gynecology has identified barriers such as poor awareness of means to procure contraception, prohibitive cost-sharing, and issues with availability.7,8 Expanding access to contraception, particularly for those demographic groups that are at high risk of unintended pregnancy, may help to curb the high rates of unintended pregnancy. Increased pharmacy access has been identified as an avenue for improving uptake of contraception.9,10 As of 2016, 2 states, California and Oregon, began allowing pharmacists to prescribe self-administered methods of hormonal contraception (HC) approved by the U.S. Food and Drug Administration. Since then, other states have passed similar legislation and still others are considering the same.11 Expanding access within pharmacies to HC could improve access and rates of use, particularly among women for whom unintended pregnancy is a greater risk. Researchers have generated a growing amount of evidence regarding the implementation and potential effect that these laws can have on access to contraception and the subsequent health outcomes. Although emergency contraception is available over the counter, HC requires a prescription from a primary care provider or a pharmacist, depending on the state. The purpose of this review was to summarize the literature related to the implementation of pharmacist-prescribed HC legislation, including the attitudes and perceptions of pharmacists and patients, the potential impact on HC uptake, and possible barriers relevant parties may encounter. We also discuss the current landscape of pharmacist-prescribed HC legislation. A review of the historical perspective on emergency contraception is beyond the scope of this review.
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Nonpharmacist health care professionals’ perceptions and attitudes In the past few decades, pharmacists have begun to take an expanded role in patient care through such services as education, medication management, and other clinical pharmacy services. These roles rely heavily on a professional relationship with physicians and other providers to ensure harmonious patient care. For HC, pharmacists have been a centerpiece of access through dispensing the drugs to millions of women.12 Currently, in most states, women are required to first see their primary care provider (physician, physician assistant, or nurse practitioner) to obtain a prescription, which is then filled at the pharmacy. Granting prescriptive authority to pharmacists would be a shift to a role more often performed by physicians. Several studies have examined the attitudes of physicians and other primary care providers toward allowing pharmacists to prescribe HC. In Rafie et al.,6 the majority of respondents, comprising physicians and advanced practice clinicians, indicated that pharmacist-prescribed methods would increase access for women and might even improve adherence because of the ease of access to pharmacies for renewing a prescription.6 These findings are reinforced by a related study in which more than 60% of providers expressed confidence in the ability of pharmacists to identify contraindications for HC use and provide adequate education or counseling.13 Furthermore, compared with other models of pharmacy-based HC access, pharmacist prescribing has the highest support among health care providers (67%-74% vs over the counter [OTC; 17%-28%] and behind the counter [38%-45%]).13 Notwithstanding the benefits perceived from a pharmacistprescribed model, health care professionals have also expressed concerns. In a survey of health care providers in California, approximately 72% of advanced practice clinicians and physicians expressed concern that pharmacist-prescribed HC may decrease Papanicolaou, pelvic, breast, and sexually transmitted infection screening.13 Moreover, a majority of providers expressed concern regarding the pharmacist’s ability to manage adverse effects and to provide confidentiality.13 Most striking, 63% of providers expressed concern that too few pharmacists would participate in such a program.13 Pharmacists’ willingness to prescribe and dispense HC To understand the reality of pharmacist-prescribed HC, it is necessary to examine the willingness and likelihood of pharmacists to prescribe HC. Davidson et al.14 conducted a survey in Nevada of pharmacists’ willingness to dispense select medication, including oral contraception (OC), emergency contraception (EC), and medical abortifacients.14 Of the 35% who responded statewide, the majority of pharmacists were willing to dispense EC (85.0%), OC (98.3%), and medical abortifacients (72.4%) without moral objection; 7.5%, 1.2%, and 10.4% of pharmacists are willing to dispense EC, OC, and medical abortifacients with moral objection, respectively. Female pharmacists had significantly higher odds (2.08) of being willing to dispense at least one controversial (i.e., contraceptives, fertility medications, and medical abortifacients)
Table 1 Summary of statutes and regulation of pharmacist-prescribed hormonal contraception by state Statea
California
Oregon
Effective date or date of enactment or approval
Protocol approval body
January 1, 2014
Medical Board of California, Not stated California Pharmacists Association
January 1, 2016
Duration Prescription Education or Protocol between duration training summary provider visits
12 months
Yes
Yes
1. Self-screening tool to Self-administered identify patient risk hormonal factors (3 years) contraception with routes: a. Oral 2. Measure BP if b. Transdermal combined hormonal contraceptives 3. Ensure appropriate training in administration 4. Counseling 1. Health and history screening
Reimbursement Minors mandate
Statute or regulation
Yes
Yes
Self-administered hormonal contraceptives; emergency contraception drug therapy, Cal. Bus. & Prof. Code x 4052.3 (West) Title 16, California Code of Regulations x 1746.1
Not stated
Yes, with prior Rx Pharmacist may prescribe and dispense hormonal contraceptives; rules; insurance coverage
c. Vaginal
d. Depot Injection Self-administered hormonal contraception with routes: a. Oral 2. Pregnancy screening b. Transdermal 3. Medication screening
c. Vaginal
4. Blood pressure measurement
d. Depot injection
Or. Rev. Stat. Ann. x 689.683 (West)
5. Evaluate patient history and preference
Tennesseeb
April 27, 2016
Board of Pharmacy, Board of Not stated Medical Examiners, and Board of Osteopathic Examination
Not stated
Yes
6. Discuss strategy for treatment 7. Visit summary and notify provider 1. Self-screening risk assessment tool
Hormonal Yes contraceptive; self-administered drug or a transdermal patch approved by the FDA
Yes (if emancipated)
Tenn. Code Ann. x 63-10-219
Pharmacist-prescribed hormonal contraception
Oregon Medical Board, Not stated Oregon State Board of Nursing, and Oregon Health Authority, State Board of Pharmacy
12 months
Types authorized
2. Provide documentation about hormonal contraception provided to the patient
4. Provide the patient with contact information of a primary care practitioner 5. Dispense hormonal contraceptive (continued on next page)
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3. Provide a standardized factsheet about the contraception
Statea
Colorado
Effective date or date of enactment or approval
Protocol approval body
Duration Prescription Education or Protocol between duration training summary provider visits
Types authorized
Reimbursement Minors mandate
Statute or regulation
Adopted March 17, 2017a
Colorado State Board of Pharmacy
3 Years
1. Complete Colorado Self-Screening Risk Assessment Questionnaire
Hormonal contraception with routes: a. Oral
Not stated
Collaborative Pharmacy Practice
2. Follow Colorado standard procedures algorithm 3. Prescribe the contraceptive 4. Provide visit summary
b. Transdermal
12 months
Yes
No
3 Colo. Code Regs. x 719-1:17.00.00
6. Refer patient to social service agency, if appropriate 7. Ensure appropriate space requirements are met June 9, 2017
New Mexico Board of Pharmacy
Not stated
12 months
Yes
1. Screening questionnaire
All selfadministered hormonal contraception
Not stated
Yes (capable of becoming pregnant)
Section 61-11-6.A(1) NMSA 1978
2. Blood pressure
Pharmacist Prescriptive Authority
3. Provide contraception choices 4. Provide patient information and education 5. Patient must sign informed consent form
N.M. Admin. Code 16.19.26
6. Advise patient’s provider Hawaii
July 1, 2017 (Passed in 2017, Hawaii State Board of first special session) Pharmacy
Not required
12 months
Yes
1. Provide selfscreening questionnaire 2. Provide Rx for contraception 3. Refer patient to PCP
All FDA-approved self-administered contraceptives
Yes
Not stated
Contraceptive supplies; authority to prescribe and dispense; requirements Haw. Rev. Stat. Ann. x 461-11.6 (West) PharmacistsdPrescriptive AuthoritydContraceptive SuppliesdReimbursement, 2017 Hawaii Laws Act 67 (S.B. 513)
Self-administered hormonal contraception
Yes
Not stated
Definitions of health occupations.
4. Provide record of contraception for PCP
District of Columbia
October 1, 2017
Board of Pharmacy, Board of Not stated Medicine, American Congress of Obstetricians and Gynecologists
12 months
Yes
5. Dispense contraception 1. Self-screening tool
2. Referral to patient’s PCP
D.C. Code Ann. x 3-1201.02
C.R. Tak et al. / Journal of the American Pharmacists Association 59 (2019) 633e641
5. Advise consultation with provider
New Mexico
SCIENCE AND PRACTICE
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Table 1 (continued )
Maryland
July 1, 2017; to be enacted January 1, 2019
The Board, in consultation Not stated with the State Board of Physicians, the State Board of Nursing, the Maryland Chapter of the American College of Obstetricians and Gynecologists, the Maryland Chapter of the American Academy of Pediatrics, the Maryland Pharmacists Association, the Maryland Affiliate of the American College of Nurse-Midwives, the Maryland Nurses Association, Planned Parenthood of Maryland, the Maryland Association of Chain Drug Stores, and other interested health professional associations and stakeholders
12 months
Yes
1. Self-screening tool
Contraceptive medications and self-administered contraceptive devices approved by the FDA
Not stated
Not stated
2. Patient assessment
Pharmacists prescribing and dispensing contraceptives
Md. Code Ann., Health Occ. x 12-511 (West)
Utah
Washington
May 8, 2018
1979
Board of Pharmacy and Physicians Licensing Board
Pharmacy Quality Assurance Commission
24 months
Not stated
Not stated
Not stated
Yes
Yes
1. Self-screening risk assessment questionnaire
Self-administered hormonal contraceptives approved by the FDA (oral hormonal contraceptive, hormonal vaginal ring, and a hormonal contraceptive patch)
2. Refer to provider, if appropriate 3. Patient education or counseling 1. Self-screening risk Contraceptive assessment tool patches, contraceptive rings, and oral contraceptives
6. Dispense the contraception
Abbreviations used: BP, blood pressure; Rx, prescription; FDA, U.S. Food and Drug Administration; PCP, primary care provider. a Other states have introduced pharmacist-prescribed hormonal contraception legislation that are not listed here (updated as of November 2018). b Not yet implemented.
No
Pharmacist Dispensing Authority Amendments
2018 Ut. SB 184
Yes
Yes (with prior Rx)
Pharmacist Prescriptive Authority Protocol
WAC 246-863-100 RCW 48.43.094
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2. Select contraceptive product 3. Refer patient to primary care practitioner 4. Provide written record to patient
Not stated
Pharmacist-prescribed hormonal contraception
3. Referral to patient’s primary care provider 4. Provide a visit summary 5. Document visit
SCIENCE AND PRACTICE C.R. Tak et al. / Journal of the American Pharmacists Association 59 (2019) 633e641
medication (with or without moral objection) compared with male pharmacists. Before implementation of the pharmacist-prescribed HC model in Oregon, Rodriguez et al.15 examined all practicing pharmacists’ knowledge and interest toward prescriptive authority. Under the assumption of payer reimbursement and educational training, pharmacists were overall interested in prescribing hormonal contraception (57%) and helping women to manage their hormonal contraception (54%); however, fewer (39.1%) expressed intent to actually prescribe hormonal contraception. This finding may be due to insufficient education on HC. Fewer than half indicated that they were knowledgeable of various forms of HC: combined pill (46.0%), patch (41.7%), ring (42.1%), and progestin-only pill (46.8%). The largest positive predictor of pharmacists planning to prescribe HC were willingness to dispense EC (odds ratio [OR], 2.23; 95% CI, 1.47-3.40); negative predictors included practicing in rural locations (OR, 0.58; 95% CI, 0.37-0.89) and being male (OR, 0.67; 95% CI, 0.42-1.00).
Impact of pharmacist-driven services The advanced practice role of the pharmacist has been supported by the National Governors’ Association, the Centers for Disease Control and Prevention, and the Patient Centered Primary Care Collaborative.16-18 Previous literature has described the health outcomes benefits of increased pharmacist involvement in patient care. For example, when some states began allowing pharmacists to administer vaccines without a patient-specific prescription order (either through prescriptive authority or broad protocols), vaccination rates increased.19,20 Several studies have examined the impact that pharmacist involvement can have on EC and OC. Raine et al.21 examined the effect of pharmacist-provided EC compared with advanced provision and clinic-provided EC.21 The results demonstrate that there was no significant difference between pharmacist-provided and clinic-provided EC for adverse events. This finding implies that although pharmacies do not provide a significant benefit over other means of accessing EC, it also does not provide any additional risk to patients. That is, pharmacist-provided EC appears to be as safe as other means of provision. In the Direct Access study conducted in Washington on the implementation of a collaborative drug therapy protocol for improved pharmacy access to contraception, pharmacists were involved in the identification of women who were at risk for unintended pregnancy and evaluated patients for safe use of OC, among other contraceptives.10 Of the 200 women who participated, 70% continued their use of OC after 1 year.10 This points to the role that greater access has to improved medication adherence. Expanding access could also improve uptake. Foster et al.22 examined the economic benefit that wider availability of OC in the pharmacy can have. Under the assumption that OC would be available without a prescription, the results indicate that with low out-of-pocket (OOP) payments, estimates on the proportion of OC users would increase 11%, from 31% to 42%. The majority of these would be from women who previously were using less effective forms of birth control; however, for increasing levels of cost, the proportion of women switching from less effective forms of birth control to OC decreases. To increase adoption of OC within the pharmacy, particularly for 638
those without insurance coverage, affordability needs to be considered. Although allowing patients to obtain OC directly from a pharmacy would improve access, it may be limited to areas where pharmacies are available, are willing, and have policies and procedures in place. For example, Rodriguez found that pharmacists in rural locations were less likely to be willing to prescribe OCs.15 However, urban-based patient may also face issues with access. Chisholm-Burns et al.23 examined dispar-vis drug pricing, ities that minority populations can face vis-a pharmacy services, and pharmacy access.23 The investigators’ findings indicate that poor pharmacy access and the likelihood of fewer pharmacy services are significantly greater in areas with predominantly minority populations.
Legal considerations As indicated earlier, some pharmacists may be unwilling to dispense HC, particularly those who identify with certain religious affiliations. The federal government and many states have passed legislation to allow pharmacists and other health care professionals to legally object to providing certain services on the grounds of moral opposition, religious or otherwise. These laws were traditionally formed around the provision of abortion services but have since been interpreted to include other services. For example, conscience clauses that many states have adopted permit pharmacists to refuse to dispense contraception, some of which may have accommodation requirements (e.g., referral to another pharmacist). The Guttmacher Institute reports that, as of December 2017, 12 states have some type of conscience clause specifically allowing health care providers to refuse dispensing or prescribing contraception.24 The exact language and protections vary by state. All 12 states extend these protections to individual providers, and 6 states mention pharmacists specifically.24 Multiple legal events have led to the current landscape of conscientious objection. After Roe v Wade, the U.S. Congress passed the Church Amendment to allow health care professionals with religious or moral objections who receive federal funding to refuse to perform abortions and sterilizations.25 Furthermore, legislation such as the Religious Freedom Restoration Act (RFRA), has facilitated individuals to claim religious objections to providing health care services.26,27 Many states have followed suit with their own legislation to extend conscience clauses and religious objection at the state level.25 On the ground, these legal developments signify that health care providers, including pharmacists, are able to opt out of providing health care services constitutionally.27-29 Multiple professional organizations have also weighed in on conscientious objection, ranging from full support to no support.2,8,30,31, The American Pharmacist Association “recognizes the individual pharmacist’s right to exercise conscientious refusal.” The American College of Obstetricians and Gynecologists issued a statement emphasizing that “patient autonomy supersedes the healthcare provider’s moral objections.” Finally, the American Medical Association supports “legislation that requires referral to other pharmacies if a pharmacist objects to filling a legal prescription.” Although most pharmacists indicate a willingness to dispense forms of contraception, it is unknown how conscientious objection may impact those populations most at-risk of unintended pregnancy.
SCIENCE AND PRACTICE Pharmacist-prescribed hormonal contraception
Key takeaways Pharmacists tend to be generally supportive of pharmacistprescribed HC. This is especially pronounced in female pharmacists or who have no religious objections. However, this support does not necessarily mean that the pharmacist will indeed implement HC prescribing practices, even when reimbursement mechanisms exist; this may be due to lack of education, as a significant number of pharmacists reported relatively little expertise with HC. As states develop training and educational processes for contraception provision, it is likely that schools and colleges of pharmacy will adapt student training to meet these requirements. California law specifically states that a curriculum-based training program completed on or after 2014 in an accredited California school of pharmacy is equivalent to the training requirement.32 Expanded access, where available, can improve rates of use and adherence. Conscientious objection will likely not be a prohibitive factor for many patients. For example, in areas where many pharmacies are available or the option to defer to another pharmacist is available, the patient will likely experience little to no barrier. However, in rural regions and in areas where pharmacies are less available, such as some innercity areas, it is possible that refusal to prescribe will present a major obstacle.8 Although prescribing privileges are relatively new for pharmacists, the role of pharmacists in the United States has been constantly evolving.33 As has happened with vaccinations, it is likely that as more states and pharmacies implement pharmacist-prescribed HC and as barriers such as reimbursement are resolved, pharmacist prescribing will become part of regular practice. Demand-side landscape Support for pharmacist-prescribed contraception Several studies have been conducted examining women’s experience with procurement of contraception within a pharmacy, either through pharmacist-prescribed means or OTC. Grossman et al.34 found that 62.2% of women in the United States would support OTC OC.34 However, despite the broad support, fewer women indicated that they would actually use OTC OC (37.1%). Across demographic strata, younger women, women who indicated they had never been married, women in the South, women with private or no insurance, and current OC users were more likely to want use OTC OC. Similarly, Landau et al.35 surveyed a nationally representative sample of women in the United States to understand the readiness that women have to obtain EC and hormonal contraception in a pharmacy. Of the 811 respondents, greater than 60% of them support access to OC in a pharmacy, and greater than 70% of them would be “very likely” to use a pharmacy to procure contraception. Predictors of willingness to use a pharmacy for EC included women without insurance coverage, low-income women, women who identified as African American or Latina, women who had previously encountered EC barriers, and women who had previous experienced an unintended pregnancy. Furthermore, younger women (18-25 years old) indicated more often that they would be likely to use a pharmacy (74%) compared with
women who were 26-35 years old (68%) and 36-44 years old (63%). Concerns Prospective users of pharmacy-procured contraception have also expressed some concerns. In a report by Baum et al.,36 female consumers believed that greater access might yield some health risks by improper use and possible early initiation of sex. The potential for sustained OOP costs to women at high risk of unintended pregnancy also poses a major concern. Young people in particular have often encountered barriers with cost, including unawareness of health plan coverage or lack of insurance.37 These results are corroborated by Foster et al.,22 who found that OC uptake was directly related to OOP expenditures. Key takeaways It appears that women broadly support accessing contraception within a pharmacy. Regarding likelihood to use these services, women who are at higher risk for unintended pregnancy, such as younger women and women without health insurance, might be willing to use the pharmacy for HC procurement. Some of the perceived benefits as indicated by the studies include an increased sense of privacy and increased availability of HC. However, even with high levels of willingness, women expressed concerns with health risks. Evidence suggests that these concerns can be addressed, as studies have shown that pharmacists and women as patients can safely screen for HC use.10,38 The issue of cost remains to be explored. Although women appear to be willing to pay for HC consultations with pharmacists,10 it is unknown what their willingness-to-pay threshold might be or what reimbursement levels for these consults are; moreover, if the contraception itself remains cost-prohibitive, uptake might not improve significantly. Current legislation and implementation Currently, 7 states (California, Oregon, Colorado, Hawaii, Maryland, Utah, and Tennessee) and Washington, DC, have passed legislation to permit pharmacist-prescribed HC.11 New Mexico and Washington have had statutory authority since the 1970s for pharmacists to prescribe a wide array of medications under the regulation of statewide protocols approved the state board of pharmacy; this has recently included HC as well.11 Other states, including Illinois, Minnesota, Missouri, New Hampshire, and Iowa, are all considering legislation to promote or advance pharmacist-prescribed HC models.11 A number of similarities and differences exist among the states who have passed pharmacist-prescribed HC legislation. The types of contraception authorized are approved selfadministered HCs approved by U.S. Food and Drug Administration, including oral, transdermal, vaginal, and the depot injection. Not all states permit all forms of self-administered HC. For example, Colorado currently permits only oral and transdermal forms of HC, and Utah permits oral contraceptives, hormonal vaginal rings, and the hormonal contraceptive patch. All states require an educational or training component that pharmacists must undergo before prescribing. The states vary
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with respect to prescribing to minors. Two states, Colorado and Utah, require periodic visits (3 years and 2 years, respectively) to a primary care practitioner before receiving a pharmacistprescribed HC. Table 1 summarizes the statutes and regulations. In a telephone survey of pharmacies in California conducted 1 year after implementation of pharmacist-prescribed HC, Gomez39 found that approximately 11% of pharmacies have adopted this expanded practice. This rate of adoption was consistent across pharmacy type and rural versus urban settings.39 For pharmacies that administer pharmacist-prescribed HC, more than two thirds (68%) have established a fee requirement for the consultation, the majority of which charge $45 or more.39 The types of HC available include OC (78%), vaginal ring (40%), patch (38%), and depot medroxyprogesterone acetate (9%).39 A recent study conducted in California and Oregon examined characteristics associated with HC prescriptions written by pharmacists at a large supermarket chain.40 The findings suggest that the majority of women seeking pharmacistprescribed contraception are between the ages of 18 and 35 (81%), have insurance (74%), have seen their primary care provider within the prior year (89%), and have previously used HC (91%).40
and after legislative changes to facilitate pharmacist contraception provision. Pharmacies that have implemented HC prescriptions have begun to establish reimbursement fees for HC consultation. Several states have mandated reimbursement for these consults. In the case of California and Oregon, state legislatures have approved reimbursement for patients with Medicaid coverage; however, only Oregon has established mechanisms for private insurance reimbursement.39 Women have shown a willingness to pay for improved access to contraception.10 It is unknown whether this willingness to pay, particularly for those without insurance who are at risk of unintended pregnancy, is aligned with current consultation fees, such as those implemented in California. This factor is significant because unintended pregnancy rates are disproportionately higher among women who are unable to afford contraception.8 It remains to be seen what effect, if any, conscientious objection will have on implementation and uptake of pharmacistprescribed HC. States in which conscientious objection might be more prevalent need to consider appropriate means to ensure, as NeJaime and Siegel concluded, that these laws do not “undermine, rather than advance, pluralistic values.”41 States should understand the willingness of local pharmacists to prescribe HC in areas of high need and, if necessary, work to overcome barriers that arise.
Discussion The reduction of unintended pregnancies in the United States remains a goal outlined in the U.S. Department of Health and Human Services’ Healthy People 2020.2 Innovative methods to improve access to contraception, including the use of pharmacist-prescribed HC, have been explored in the literature. The current legislative landscape suggests that widespread adoption of pharmacist-prescribed HC authorization might be imminent: an ever-increasing number of states are looking to this model to improve contraception access. Expanded access to HC in the pharmacy generally has broad support from pharmacists and providers, and it appears to be of interest to patients. Pharmacists are a valued member of the health care team and are trained to provide medication therapy management and a number of wellness and prevention clinical services. Prescribing HC presents a novel opportunity for pharmacists to expand their clinical services portfolio and become more engaged in the delivery of patient care. Pharmacist-prescribed HC will likely improve the availability of HC; however, early adopters need to recognize there remain barriers to overcome. The low uptake by pharmacies suggests that the operationalization presents a significant obstacle. Despite general support for HC prescriptive authority, pharmacists have expressed reservation to adoption because of increased workflow burdens. Educational and other regulatory requirements, such as patient screening and provider referrals, could pose additional difficulties with implementation. Another concern is poor accessibility in populations hindered by prohibitive cost-sharing requirements. It remains to be determined whether pharmacist-prescribed HC will improve access in low-income or uninsured populations who face barriers to access. As such, it is important for policy makers and community advocates to understand the impact that any potential legislation would have on their community and work to develop targeted solutions. It is key to recognize barriers in order to address them systematically, both before 640
Conclusion As health care providers collaborate on goals for their patients, such as contraception access, and develop effective means at delivering those goals, optimal health outcomes are more likely to result.42 Expanding access to HC through pharmacist-prescriptive authority, therefore, may help to curb the rates of unintended pregnancy in the United States. Despite the barriers that pharmacist-prescribed HC might face and the ambiguity of its implementation, it appears that pharmacists are well positioned for such a role. As the practice of pharmacist-prescribed HC continues to spread to other states and becomes routine, the lessons learned from the current laboratories will serve as a guide for policy makers to inform improved access and patient care.
References 1. Centers for Disease Control and Prevention. Achievements in public health, 1900-1999: family planning. JAMA. 2000;283(3):326e327, 331. 2. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. New Engl J Med. 2016;374(9):843e852. 3. Lindberg L, Maddow-Zimet I, Kost K, Lincoln AJM, Journal CH. Pregnancy intentions and maternal and child health: an analysis of longitudinal data in Oklahoma. Matern Child Health. 2015;19(5):1087e1096. 4. Kost K, Lindberg LJD. Pregnancy intentions, maternal behaviors, and infant health: investigating relationships with new measures and propensity score analysis. 2015;52(1):83e111. 5. Hatcher RA, Nelson AL, Trussell J, et al. Contraceptive Technology. 21st ed. New York, NY: Ayer Company Publishers; 2018. 6. Rafie S, Haycock M, Rafie S, Yen S, Harper CC. Direct pharmacy access to hormonal contraception: California physician and advanced practice clinician views. Contraception. 2012;86(6):687e693. 7. ACOG Committee Opinion Number 542: access to emergency contraception. Obstet Gynecol. 2012;120(5):1250e1253. 8. ACOG Committee opinion no. 615: access to contraception. Obstet Gynecol. 2015;125(1):250e255. 9. Peters LM, DiPietro Mager NA. Pharmacists’ provision of contraception: established and emerging roles. Inov Pharm. 2016;7(3).
SCIENCE AND PRACTICE Pharmacist-prescribed hormonal contraception
10. Gardner JS, Downing DF, Blough D, Miller L, Le S, Shotorbani S. Pharmacist prescribing of hormonal contraceptives: results of the Direct Access study. J Am Pharm Assoc. 2008;48(2):212e226. 11. NASPA. Pharmacists Authorized to Prescribe Birth Control in More States. 2017. Available at: https://naspa.us/2017/05/pharmacists-authorizedprescribe-birth-control-states/. Accessed December 15, 2017. 12. Gallagher RM, Gallagher HC. Improving the working relationship between doctors and pharmacists: is inter-professional education the answer? Adv Health Sci Educ Theory Pract. 2012;17(2):247e257. 13. Rafie S, Kelly S, Gray EK, Wong M, Gibbs S, Harper CC. Provider opinions regarding expanding access to hormonal contraception in pharmacies. Womens Health Issues. 2016;26(2):153e160. 14. Davidson LA, Pettis CT, Joiner AJ, Cook DM, Klugman CM. Religion and conscientious objection: A survey of pharmacists’ willingness to dispense medications. Soc Sci Med. 2010;71(1):161e165. 15. Rodriguez MI, McConnell KJ, Swartz J, Edelman AB. Pharmacist prescription of hormonal contraception in Oregon: Baseline knowledge and interest in provision. J Am Pharm Assoc. 2016;56(5):521e526. 16. Centers for Disease Control and Prevention. Advancing Team-Based Care Through Collaborative Practice Agreements: A Resource and Implementation Guide for Adding Pharmacists to the Care Team. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2017. 17. Patient-Centered Primary Care Collaborative. The Patient Centered Medical Home: Integrating Comprehensive Medication Management to Optimize Patient Outcomes. Washington, DC. 2012. 18. Isasi F, Krofah E. The Expanding Role of Pharmacists in a Transformed Health Care System. Washington, DC: National Governors Association Center for Best Practices; 2015. 19. Steyer TE, Ragucci KR, Pearson WS, Mainous 3rd AG. The role of pharmacists in the delivery of influenza vaccinations. Vaccine. 2004;22(8):1001e1006. 20. Tak CR, Gunning K, Kim J, et al. The effect of a prescription order requirement for pharmacist-administered vaccination on herpes zoster vaccination rates. Vaccine. 2019;37(4):631e636. 21. Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA. 2005;293(1):54e62. 22. Foster DG, Biggs MA, Phillips KA, Grindlay K, Grossman D. Potential public sector cost-savings from over-the-counter access to oral contraceptives. Contraception. 2015;91(5):373e379. 23. Chisholm-Burns MA, Spivey CA, Gatwood J, Wiss A, Hohmeier K, Erickson SR. Evaluation of racial and socioeconomic disparities in medication pricing and pharmacy access and services. Am J Health Syst Pharm. 2017;74(10):653e668. 24. Guttmacher. Refusing to provide health services. 2017. Available at: https:// www.guttmacher.org/state-policy/explore/refusing-provide-health-services. Accessed December 15, 2017. 25. Stahl RY, Emanuel EJ. Physicians, not conscriptsdconscientious objection in health care. New Engl J Med. 2017;376(14):1380e1385. 26. Chaganti S. Why the Religious Freedom Restoration Act provides a defense in suits by private plaintiffs. Virginia Law Rev. 2013;99:343e374. 27. Topliff ML. Validity, construction, and application of Religious Freedom Restoration Act. (42 USCS xx 2000bb et seq), 135 A.L.R. FED, 121, 144-48. 1996. 28. Murray M, Luker K. Cases on Reproductive Rights and Justice. St. Paul, MN: Foundation Press; 2015.
29. Lund CC. Religious liberty after Gonzales: a look at state RFRAs. South Dakota Law Review. 2010;55:466. 30. Actions of the 2017 APhA House of Delegates. J Am Pharm Assoc. 2017;57(4):442e452. 31. American Medical Association. House of Delegates. H 120.947. Preserving patients’ ability to have legally valid prescriptions filled. House of Delegates Resolutions, Sub. Res. 6, A-05. Available at: http://www.ama-assn. org/apps/pf_new/pf_online?f_n¼resultLink&doc¼policyfiles/HnE/H-120. 947.HTM&s_t¼Hþ120.947&catg¼AMA/HnE&catg¼AMA/BnGnC&catg¼ AMA/DIR&&nth¼1&&st_p¼0&nth¼1&. Accessed June 19, 2019. 32. California State Board of Pharmacy. Self-administered hormonal contraception protocol for pharmacists. 2016. Available at: https://www. pharmacy.ca.gov/publications/hormonal_contraception_protocol_rphs.pdf. Accessed May 9, 2019. 33. Higby GJ. American pharmacy in the twentieth century. Am J Health System Pharm. 1997;54(16):1805e1815. 34. Grossman D, Grindlay K, Li R, Potter JE, Trussell J, Blanchard K. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception. 2013;88(4):544e552. 35. 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(6):463e470. 36. Baum S, Burns B, Davis L, et al. Perspectives among a diverse sample of women on the possibility of obtaining oral contraceptives over the counter: a qualitative study. Womens Health Issues. 2016;26(2):147e152. 37. Bessett D, Prager J, Havard J, Murphy DJ, Agenor M, Foster AM. Barriers to contraceptive access after health care reform: experiences of young adults in Massachusetts. Womens Health Issues. 2015;25(2):91e96. 38. Shotorbani S, Miller L, Blough DK, Gardner J. Agreement between women's and providers' assessment of hormonal contraceptive risk factors. Contraception. 2006;73(5):501e506. 39. Gomez A. Availability of pharmacist-prescribed contraception in California, 2017. JAMA. 2017;318(22):2253e2254. 40. Lu S, Rafie S, Hamper J, Strauss R, Kroon L. Characterizing pharmacistprescribed hormonal contraception services and users in California and Oregon pharmacies. Contraception. 2019;99(4):239e243. 41. Nejaime D, Siegel RB. Conscience wars: complicity-based conscience claims in religion and politics. Yale Law J. 2014-2015;124:2516. 42. Reeves S, Pelone F, Harrison R, Goldman J, Zwarenstein M. Interprofessional collaboration to improve professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2017;6:CD000072. Casey R. Tak, PhD, MPH, Assistant Professor, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill; and UNC Health Sciences at MAHEC, Asheville, NC Laura T. Kessler, JSD, LLM, JD, Professor, College of Law, University of Utah, Salt Lake City, UT Mollie Ashe Scott, PharmD, BCACP, CPP, FASHP, Clinical Associate Professor, Division of Practice Advancement and Clinical Education, Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC; and UNC Health Sciences at MAHEC, Asheville, NC Karen M Gunning, PharmD, BCACP, BCPS, FCCP, Professor (Clinical), Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT
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Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
COMMENTARY
Pharmacist-prescribed hormonal contraception: A review of the current landscape Casey R. Tak*, Laura T. Kessler, Mollie Ashe Scott, Karen M. Gunning a r t i c l e i n f o
a b s t r a c t
Article history: Received 27 February 2019 Accepted 21 May 2019 Available online 9 July 2019
Objective: The objective of this article is to review the current supply-side, demand-side, and regulatory landscape of pharmacist-prescribed hormonal contraception (HC) in the United States. Summary: Pharmacists appear to be supportive of pharmacist-prescribed HC. However, support does not necessarily indicate likelihood to implement the practice, even when reimbursement mechanisms exist. The likelihood of implementation can be increased with education and training of HC prescribing. Previous investigations suggest that women broadly support accessing contraception within a pharmacy. Expanded access, where available, can improve rates of use and adherence. Women at higher risk for unintended pregnancy, such as younger women and women without health insurance, are likely to use the pharmacy to procure HC. Despite a willingness to pay for HC consultations with pharmacists, costs can remain a significant barrier for many women. Conclusions: Expanding access to HC through pharmacist-prescriptive authority could help curb the rates of unintended pregnancy in the United States. Pharmacists are well positioned for such a role; however, significant barriers for pharmacists and patients remain. Examination of current implementation methods will assist policy makers in overcoming these barriers. © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
The Centers for Disease Control and Prevention has recognized the advent of contraception as one of the most important health technology advances in the twentieth century.1 Contraception has enabled women and couples to have more control over family planning, resulting in improvements in health outcomes and the social and economic standing of women.1 Despite the effectiveness of modern contraception in preventing pregnancy, unintended pregnancy rates remain high. Data from the National Survey for Family Growth suggest that approximately 51% of all pregnancies in the United States are unintended.2 Among women age 20 to 24 years, 64% of pregnancies are unintended2; these include pregnancies that are wanted
Disclosure: The authors declare no conflicts of interest or financial interests in any product or service mentioned in this article. * Correspondence: Casey R. Tak, PhD, MPH, Assistant Professor, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, One University Heights, Karpen Hall 143, Asheville, NC 28804. E-mail address: [email protected] (C.R. Tak). ORCID Casey Tak: https://orcid.org/0000-0002-1203-1782.
but mistimed and pregnancies that are unwanted. Unintended pregnancies are associated with a number of demographic factors, including younger age (e.g., < 25 years), marital status, lower levels of income, lower levels of educational attainment, non-white race or ethnicity, and no religious affiliation.2 Women with unintended pregnancies are less likely to seek early prenatal care, have more exposure to cigarette smoke, and are less likely to breastfeed postpartum.3 Unwanted pregnancies are associated with infants of low birthweight.4 Of all the unintended pregnancies in the United States, approximately 40% will end in abortion.2 The use of hormonal contraception offers a number of health benefits in addition to family planning. Menstrual benefits include decreases in dysmenorrhea, heavy menstrual bleeding, anemia, and cyclic mood problems. Hormonal contraception reduces the risk of ectopic pregnancy and symptomatic pelvic inflammatory disease.5 Furthermore, hormonal contraception use has been associated with protection against certain cancers.5 Adolescent females may be prescribed HC to treat and prevent acne.5 The high rates of unintended pregnancy suggest that barriers to contraception exist. Research has shown that many women face barriers associated with time off, child care, and
https://doi.org/10.1016/j.japh.2019.05.015 1544-3191/© 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
SCIENCE AND PRACTICE C.R. Tak et al. / Journal of the American Pharmacists Association 59 (2019) 633e641
Summary Key Points Supply-side landscape Background: Unintended pregnancy rates remain high in the United States, suggesting that barriers to contraception exist. Pharmacist-prescribed hormonal contraception has begun to be implemented across certain U.S. states. An increasing amount of evidence is being generated regarding the effect that pharmacist-prescribed hormonal contraception can have on access. Findings: At least 10 U.S. states have authorized pharmacists to prescribe hormonal contraception, with varying regulations. Pharmacists are generally supportive of greater involvement in furnishing hormonal contraception. Patients at high risk of unintended pregnancy are likely to want to use the pharmacy to procure hormonal contraception.
transportation, thus creating difficulty for women to visit their provider and obtain a prescription order for contraception.6 The American College of Obstetrics and Gynecology has identified barriers such as poor awareness of means to procure contraception, prohibitive cost-sharing, and issues with availability.7,8 Expanding access to contraception, particularly for those demographic groups that are at high risk of unintended pregnancy, may help to curb the high rates of unintended pregnancy. Increased pharmacy access has been identified as an avenue for improving uptake of contraception.9,10 As of 2016, 2 states, California and Oregon, began allowing pharmacists to prescribe self-administered methods of hormonal contraception (HC) approved by the U.S. Food and Drug Administration. Since then, other states have passed similar legislation and still others are considering the same.11 Expanding access within pharmacies to HC could improve access and rates of use, particularly among women for whom unintended pregnancy is a greater risk. Researchers have generated a growing amount of evidence regarding the implementation and potential effect that these laws can have on access to contraception and the subsequent health outcomes. Although emergency contraception is available over the counter, HC requires a prescription from a primary care provider or a pharmacist, depending on the state. The purpose of this review was to summarize the literature related to the implementation of pharmacist-prescribed HC legislation, including the attitudes and perceptions of pharmacists and patients, the potential impact on HC uptake, and possible barriers relevant parties may encounter. We also discuss the current landscape of pharmacist-prescribed HC legislation. A review of the historical perspective on emergency contraception is beyond the scope of this review.
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Nonpharmacist health care professionals’ perceptions and attitudes In the past few decades, pharmacists have begun to take an expanded role in patient care through such services as education, medication management, and other clinical pharmacy services. These roles rely heavily on a professional relationship with physicians and other providers to ensure harmonious patient care. For HC, pharmacists have been a centerpiece of access through dispensing the drugs to millions of women.12 Currently, in most states, women are required to first see their primary care provider (physician, physician assistant, or nurse practitioner) to obtain a prescription, which is then filled at the pharmacy. Granting prescriptive authority to pharmacists would be a shift to a role more often performed by physicians. Several studies have examined the attitudes of physicians and other primary care providers toward allowing pharmacists to prescribe HC. In Rafie et al.,6 the majority of respondents, comprising physicians and advanced practice clinicians, indicated that pharmacist-prescribed methods would increase access for women and might even improve adherence because of the ease of access to pharmacies for renewing a prescription.6 These findings are reinforced by a related study in which more than 60% of providers expressed confidence in the ability of pharmacists to identify contraindications for HC use and provide adequate education or counseling.13 Furthermore, compared with other models of pharmacy-based HC access, pharmacist prescribing has the highest support among health care providers (67%-74% vs over the counter [OTC; 17%-28%] and behind the counter [38%-45%]).13 Notwithstanding the benefits perceived from a pharmacistprescribed model, health care professionals have also expressed concerns. In a survey of health care providers in California, approximately 72% of advanced practice clinicians and physicians expressed concern that pharmacist-prescribed HC may decrease Papanicolaou, pelvic, breast, and sexually transmitted infection screening.13 Moreover, a majority of providers expressed concern regarding the pharmacist’s ability to manage adverse effects and to provide confidentiality.13 Most striking, 63% of providers expressed concern that too few pharmacists would participate in such a program.13 Pharmacists’ willingness to prescribe and dispense HC To understand the reality of pharmacist-prescribed HC, it is necessary to examine the willingness and likelihood of pharmacists to prescribe HC. Davidson et al.14 conducted a survey in Nevada of pharmacists’ willingness to dispense select medication, including oral contraception (OC), emergency contraception (EC), and medical abortifacients.14 Of the 35% who responded statewide, the majority of pharmacists were willing to dispense EC (85.0%), OC (98.3%), and medical abortifacients (72.4%) without moral objection; 7.5%, 1.2%, and 10.4% of pharmacists are willing to dispense EC, OC, and medical abortifacients with moral objection, respectively. Female pharmacists had significantly higher odds (2.08) of being willing to dispense at least one controversial (i.e., contraceptives, fertility medications, and medical abortifacients)
Table 1 Summary of statutes and regulation of pharmacist-prescribed hormonal contraception by state Statea
California
Oregon
Effective date or date of enactment or approval
Protocol approval body
January 1, 2014
Medical Board of California, Not stated California Pharmacists Association
January 1, 2016
Duration Prescription Education or Protocol between duration training summary provider visits
12 months
Yes
Yes
1. Self-screening tool to Self-administered identify patient risk hormonal factors (3 years) contraception with routes: a. Oral 2. Measure BP if b. Transdermal combined hormonal contraceptives 3. Ensure appropriate training in administration 4. Counseling 1. Health and history screening
Reimbursement Minors mandate
Statute or regulation
Yes
Yes
Self-administered hormonal contraceptives; emergency contraception drug therapy, Cal. Bus. & Prof. Code x 4052.3 (West) Title 16, California Code of Regulations x 1746.1
Not stated
Yes, with prior Rx Pharmacist may prescribe and dispense hormonal contraceptives; rules; insurance coverage
c. Vaginal
d. Depot Injection Self-administered hormonal contraception with routes: a. Oral 2. Pregnancy screening b. Transdermal 3. Medication screening
c. Vaginal
4. Blood pressure measurement
d. Depot injection
Or. Rev. Stat. Ann. x 689.683 (West)
5. Evaluate patient history and preference
Tennesseeb
April 27, 2016
Board of Pharmacy, Board of Not stated Medical Examiners, and Board of Osteopathic Examination
Not stated
Yes
6. Discuss strategy for treatment 7. Visit summary and notify provider 1. Self-screening risk assessment tool
Hormonal Yes contraceptive; self-administered drug or a transdermal patch approved by the FDA
Yes (if emancipated)
Tenn. Code Ann. x 63-10-219
Pharmacist-prescribed hormonal contraception
Oregon Medical Board, Not stated Oregon State Board of Nursing, and Oregon Health Authority, State Board of Pharmacy
12 months
Types authorized
2. Provide documentation about hormonal contraception provided to the patient
4. Provide the patient with contact information of a primary care practitioner 5. Dispense hormonal contraceptive (continued on next page)
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SCIENCE AND PRACTICE
3. Provide a standardized factsheet about the contraception
Statea
Colorado
Effective date or date of enactment or approval
Protocol approval body
Duration Prescription Education or Protocol between duration training summary provider visits
Types authorized
Reimbursement Minors mandate
Statute or regulation
Adopted March 17, 2017a
Colorado State Board of Pharmacy
3 Years
1. Complete Colorado Self-Screening Risk Assessment Questionnaire
Hormonal contraception with routes: a. Oral
Not stated
Collaborative Pharmacy Practice
2. Follow Colorado standard procedures algorithm 3. Prescribe the contraceptive 4. Provide visit summary
b. Transdermal
12 months
Yes
No
3 Colo. Code Regs. x 719-1:17.00.00
6. Refer patient to social service agency, if appropriate 7. Ensure appropriate space requirements are met June 9, 2017
New Mexico Board of Pharmacy
Not stated
12 months
Yes
1. Screening questionnaire
All selfadministered hormonal contraception
Not stated
Yes (capable of becoming pregnant)
Section 61-11-6.A(1) NMSA 1978
2. Blood pressure
Pharmacist Prescriptive Authority
3. Provide contraception choices 4. Provide patient information and education 5. Patient must sign informed consent form
N.M. Admin. Code 16.19.26
6. Advise patient’s provider Hawaii
July 1, 2017 (Passed in 2017, Hawaii State Board of first special session) Pharmacy
Not required
12 months
Yes
1. Provide selfscreening questionnaire 2. Provide Rx for contraception 3. Refer patient to PCP
All FDA-approved self-administered contraceptives
Yes
Not stated
Contraceptive supplies; authority to prescribe and dispense; requirements Haw. Rev. Stat. Ann. x 461-11.6 (West) PharmacistsdPrescriptive AuthoritydContraceptive SuppliesdReimbursement, 2017 Hawaii Laws Act 67 (S.B. 513)
Self-administered hormonal contraception
Yes
Not stated
Definitions of health occupations.
4. Provide record of contraception for PCP
District of Columbia
October 1, 2017
Board of Pharmacy, Board of Not stated Medicine, American Congress of Obstetricians and Gynecologists
12 months
Yes
5. Dispense contraception 1. Self-screening tool
2. Referral to patient’s PCP
D.C. Code Ann. x 3-1201.02
C.R. Tak et al. / Journal of the American Pharmacists Association 59 (2019) 633e641
5. Advise consultation with provider
New Mexico
SCIENCE AND PRACTICE
636
Table 1 (continued )
Maryland
July 1, 2017; to be enacted January 1, 2019
The Board, in consultation Not stated with the State Board of Physicians, the State Board of Nursing, the Maryland Chapter of the American College of Obstetricians and Gynecologists, the Maryland Chapter of the American Academy of Pediatrics, the Maryland Pharmacists Association, the Maryland Affiliate of the American College of Nurse-Midwives, the Maryland Nurses Association, Planned Parenthood of Maryland, the Maryland Association of Chain Drug Stores, and other interested health professional associations and stakeholders
12 months
Yes
1. Self-screening tool
Contraceptive medications and self-administered contraceptive devices approved by the FDA
Not stated
Not stated
2. Patient assessment
Pharmacists prescribing and dispensing contraceptives
Md. Code Ann., Health Occ. x 12-511 (West)
Utah
Washington
May 8, 2018
1979
Board of Pharmacy and Physicians Licensing Board
Pharmacy Quality Assurance Commission
24 months
Not stated
Not stated
Not stated
Yes
Yes
1. Self-screening risk assessment questionnaire
Self-administered hormonal contraceptives approved by the FDA (oral hormonal contraceptive, hormonal vaginal ring, and a hormonal contraceptive patch)
2. Refer to provider, if appropriate 3. Patient education or counseling 1. Self-screening risk Contraceptive assessment tool patches, contraceptive rings, and oral contraceptives
6. Dispense the contraception
Abbreviations used: BP, blood pressure; Rx, prescription; FDA, U.S. Food and Drug Administration; PCP, primary care provider. a Other states have introduced pharmacist-prescribed hormonal contraception legislation that are not listed here (updated as of November 2018). b Not yet implemented.
No
Pharmacist Dispensing Authority Amendments
2018 Ut. SB 184
Yes
Yes (with prior Rx)
Pharmacist Prescriptive Authority Protocol
WAC 246-863-100 RCW 48.43.094
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SCIENCE AND PRACTICE
2. Select contraceptive product 3. Refer patient to primary care practitioner 4. Provide written record to patient
Not stated
Pharmacist-prescribed hormonal contraception
3. Referral to patient’s primary care provider 4. Provide a visit summary 5. Document visit
SCIENCE AND PRACTICE C.R. Tak et al. / Journal of the American Pharmacists Association 59 (2019) 633e641
medication (with or without moral objection) compared with male pharmacists. Before implementation of the pharmacist-prescribed HC model in Oregon, Rodriguez et al.15 examined all practicing pharmacists’ knowledge and interest toward prescriptive authority. Under the assumption of payer reimbursement and educational training, pharmacists were overall interested in prescribing hormonal contraception (57%) and helping women to manage their hormonal contraception (54%); however, fewer (39.1%) expressed intent to actually prescribe hormonal contraception. This finding may be due to insufficient education on HC. Fewer than half indicated that they were knowledgeable of various forms of HC: combined pill (46.0%), patch (41.7%), ring (42.1%), and progestin-only pill (46.8%). The largest positive predictor of pharmacists planning to prescribe HC were willingness to dispense EC (odds ratio [OR], 2.23; 95% CI, 1.47-3.40); negative predictors included practicing in rural locations (OR, 0.58; 95% CI, 0.37-0.89) and being male (OR, 0.67; 95% CI, 0.42-1.00).
Impact of pharmacist-driven services The advanced practice role of the pharmacist has been supported by the National Governors’ Association, the Centers for Disease Control and Prevention, and the Patient Centered Primary Care Collaborative.16-18 Previous literature has described the health outcomes benefits of increased pharmacist involvement in patient care. For example, when some states began allowing pharmacists to administer vaccines without a patient-specific prescription order (either through prescriptive authority or broad protocols), vaccination rates increased.19,20 Several studies have examined the impact that pharmacist involvement can have on EC and OC. Raine et al.21 examined the effect of pharmacist-provided EC compared with advanced provision and clinic-provided EC.21 The results demonstrate that there was no significant difference between pharmacist-provided and clinic-provided EC for adverse events. This finding implies that although pharmacies do not provide a significant benefit over other means of accessing EC, it also does not provide any additional risk to patients. That is, pharmacist-provided EC appears to be as safe as other means of provision. In the Direct Access study conducted in Washington on the implementation of a collaborative drug therapy protocol for improved pharmacy access to contraception, pharmacists were involved in the identification of women who were at risk for unintended pregnancy and evaluated patients for safe use of OC, among other contraceptives.10 Of the 200 women who participated, 70% continued their use of OC after 1 year.10 This points to the role that greater access has to improved medication adherence. Expanding access could also improve uptake. Foster et al.22 examined the economic benefit that wider availability of OC in the pharmacy can have. Under the assumption that OC would be available without a prescription, the results indicate that with low out-of-pocket (OOP) payments, estimates on the proportion of OC users would increase 11%, from 31% to 42%. The majority of these would be from women who previously were using less effective forms of birth control; however, for increasing levels of cost, the proportion of women switching from less effective forms of birth control to OC decreases. To increase adoption of OC within the pharmacy, particularly for 638
those without insurance coverage, affordability needs to be considered. Although allowing patients to obtain OC directly from a pharmacy would improve access, it may be limited to areas where pharmacies are available, are willing, and have policies and procedures in place. For example, Rodriguez found that pharmacists in rural locations were less likely to be willing to prescribe OCs.15 However, urban-based patient may also face issues with access. Chisholm-Burns et al.23 examined dispar-vis drug pricing, ities that minority populations can face vis-a pharmacy services, and pharmacy access.23 The investigators’ findings indicate that poor pharmacy access and the likelihood of fewer pharmacy services are significantly greater in areas with predominantly minority populations.
Legal considerations As indicated earlier, some pharmacists may be unwilling to dispense HC, particularly those who identify with certain religious affiliations. The federal government and many states have passed legislation to allow pharmacists and other health care professionals to legally object to providing certain services on the grounds of moral opposition, religious or otherwise. These laws were traditionally formed around the provision of abortion services but have since been interpreted to include other services. For example, conscience clauses that many states have adopted permit pharmacists to refuse to dispense contraception, some of which may have accommodation requirements (e.g., referral to another pharmacist). The Guttmacher Institute reports that, as of December 2017, 12 states have some type of conscience clause specifically allowing health care providers to refuse dispensing or prescribing contraception.24 The exact language and protections vary by state. All 12 states extend these protections to individual providers, and 6 states mention pharmacists specifically.24 Multiple legal events have led to the current landscape of conscientious objection. After Roe v Wade, the U.S. Congress passed the Church Amendment to allow health care professionals with religious or moral objections who receive federal funding to refuse to perform abortions and sterilizations.25 Furthermore, legislation such as the Religious Freedom Restoration Act (RFRA), has facilitated individuals to claim religious objections to providing health care services.26,27 Many states have followed suit with their own legislation to extend conscience clauses and religious objection at the state level.25 On the ground, these legal developments signify that health care providers, including pharmacists, are able to opt out of providing health care services constitutionally.27-29 Multiple professional organizations have also weighed in on conscientious objection, ranging from full support to no support.2,8,30,31, The American Pharmacist Association “recognizes the individual pharmacist’s right to exercise conscientious refusal.” The American College of Obstetricians and Gynecologists issued a statement emphasizing that “patient autonomy supersedes the healthcare provider’s moral objections.” Finally, the American Medical Association supports “legislation that requires referral to other pharmacies if a pharmacist objects to filling a legal prescription.” Although most pharmacists indicate a willingness to dispense forms of contraception, it is unknown how conscientious objection may impact those populations most at-risk of unintended pregnancy.
SCIENCE AND PRACTICE Pharmacist-prescribed hormonal contraception
Key takeaways Pharmacists tend to be generally supportive of pharmacistprescribed HC. This is especially pronounced in female pharmacists or who have no religious objections. However, this support does not necessarily mean that the pharmacist will indeed implement HC prescribing practices, even when reimbursement mechanisms exist; this may be due to lack of education, as a significant number of pharmacists reported relatively little expertise with HC. As states develop training and educational processes for contraception provision, it is likely that schools and colleges of pharmacy will adapt student training to meet these requirements. California law specifically states that a curriculum-based training program completed on or after 2014 in an accredited California school of pharmacy is equivalent to the training requirement.32 Expanded access, where available, can improve rates of use and adherence. Conscientious objection will likely not be a prohibitive factor for many patients. For example, in areas where many pharmacies are available or the option to defer to another pharmacist is available, the patient will likely experience little to no barrier. However, in rural regions and in areas where pharmacies are less available, such as some innercity areas, it is possible that refusal to prescribe will present a major obstacle.8 Although prescribing privileges are relatively new for pharmacists, the role of pharmacists in the United States has been constantly evolving.33 As has happened with vaccinations, it is likely that as more states and pharmacies implement pharmacist-prescribed HC and as barriers such as reimbursement are resolved, pharmacist prescribing will become part of regular practice. Demand-side landscape Support for pharmacist-prescribed contraception Several studies have been conducted examining women’s experience with procurement of contraception within a pharmacy, either through pharmacist-prescribed means or OTC. Grossman et al.34 found that 62.2% of women in the United States would support OTC OC.34 However, despite the broad support, fewer women indicated that they would actually use OTC OC (37.1%). Across demographic strata, younger women, women who indicated they had never been married, women in the South, women with private or no insurance, and current OC users were more likely to want use OTC OC. Similarly, Landau et al.35 surveyed a nationally representative sample of women in the United States to understand the readiness that women have to obtain EC and hormonal contraception in a pharmacy. Of the 811 respondents, greater than 60% of them support access to OC in a pharmacy, and greater than 70% of them would be “very likely” to use a pharmacy to procure contraception. Predictors of willingness to use a pharmacy for EC included women without insurance coverage, low-income women, women who identified as African American or Latina, women who had previously encountered EC barriers, and women who had previous experienced an unintended pregnancy. Furthermore, younger women (18-25 years old) indicated more often that they would be likely to use a pharmacy (74%) compared with
women who were 26-35 years old (68%) and 36-44 years old (63%). Concerns Prospective users of pharmacy-procured contraception have also expressed some concerns. In a report by Baum et al.,36 female consumers believed that greater access might yield some health risks by improper use and possible early initiation of sex. The potential for sustained OOP costs to women at high risk of unintended pregnancy also poses a major concern. Young people in particular have often encountered barriers with cost, including unawareness of health plan coverage or lack of insurance.37 These results are corroborated by Foster et al.,22 who found that OC uptake was directly related to OOP expenditures. Key takeaways It appears that women broadly support accessing contraception within a pharmacy. Regarding likelihood to use these services, women who are at higher risk for unintended pregnancy, such as younger women and women without health insurance, might be willing to use the pharmacy for HC procurement. Some of the perceived benefits as indicated by the studies include an increased sense of privacy and increased availability of HC. However, even with high levels of willingness, women expressed concerns with health risks. Evidence suggests that these concerns can be addressed, as studies have shown that pharmacists and women as patients can safely screen for HC use.10,38 The issue of cost remains to be explored. Although women appear to be willing to pay for HC consultations with pharmacists,10 it is unknown what their willingness-to-pay threshold might be or what reimbursement levels for these consults are; moreover, if the contraception itself remains cost-prohibitive, uptake might not improve significantly. Current legislation and implementation Currently, 7 states (California, Oregon, Colorado, Hawaii, Maryland, Utah, and Tennessee) and Washington, DC, have passed legislation to permit pharmacist-prescribed HC.11 New Mexico and Washington have had statutory authority since the 1970s for pharmacists to prescribe a wide array of medications under the regulation of statewide protocols approved the state board of pharmacy; this has recently included HC as well.11 Other states, including Illinois, Minnesota, Missouri, New Hampshire, and Iowa, are all considering legislation to promote or advance pharmacist-prescribed HC models.11 A number of similarities and differences exist among the states who have passed pharmacist-prescribed HC legislation. The types of contraception authorized are approved selfadministered HCs approved by U.S. Food and Drug Administration, including oral, transdermal, vaginal, and the depot injection. Not all states permit all forms of self-administered HC. For example, Colorado currently permits only oral and transdermal forms of HC, and Utah permits oral contraceptives, hormonal vaginal rings, and the hormonal contraceptive patch. All states require an educational or training component that pharmacists must undergo before prescribing. The states vary
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with respect to prescribing to minors. Two states, Colorado and Utah, require periodic visits (3 years and 2 years, respectively) to a primary care practitioner before receiving a pharmacistprescribed HC. Table 1 summarizes the statutes and regulations. In a telephone survey of pharmacies in California conducted 1 year after implementation of pharmacist-prescribed HC, Gomez39 found that approximately 11% of pharmacies have adopted this expanded practice. This rate of adoption was consistent across pharmacy type and rural versus urban settings.39 For pharmacies that administer pharmacist-prescribed HC, more than two thirds (68%) have established a fee requirement for the consultation, the majority of which charge $45 or more.39 The types of HC available include OC (78%), vaginal ring (40%), patch (38%), and depot medroxyprogesterone acetate (9%).39 A recent study conducted in California and Oregon examined characteristics associated with HC prescriptions written by pharmacists at a large supermarket chain.40 The findings suggest that the majority of women seeking pharmacistprescribed contraception are between the ages of 18 and 35 (81%), have insurance (74%), have seen their primary care provider within the prior year (89%), and have previously used HC (91%).40
and after legislative changes to facilitate pharmacist contraception provision. Pharmacies that have implemented HC prescriptions have begun to establish reimbursement fees for HC consultation. Several states have mandated reimbursement for these consults. In the case of California and Oregon, state legislatures have approved reimbursement for patients with Medicaid coverage; however, only Oregon has established mechanisms for private insurance reimbursement.39 Women have shown a willingness to pay for improved access to contraception.10 It is unknown whether this willingness to pay, particularly for those without insurance who are at risk of unintended pregnancy, is aligned with current consultation fees, such as those implemented in California. This factor is significant because unintended pregnancy rates are disproportionately higher among women who are unable to afford contraception.8 It remains to be seen what effect, if any, conscientious objection will have on implementation and uptake of pharmacistprescribed HC. States in which conscientious objection might be more prevalent need to consider appropriate means to ensure, as NeJaime and Siegel concluded, that these laws do not “undermine, rather than advance, pluralistic values.”41 States should understand the willingness of local pharmacists to prescribe HC in areas of high need and, if necessary, work to overcome barriers that arise.
Discussion The reduction of unintended pregnancies in the United States remains a goal outlined in the U.S. Department of Health and Human Services’ Healthy People 2020.2 Innovative methods to improve access to contraception, including the use of pharmacist-prescribed HC, have been explored in the literature. The current legislative landscape suggests that widespread adoption of pharmacist-prescribed HC authorization might be imminent: an ever-increasing number of states are looking to this model to improve contraception access. Expanded access to HC in the pharmacy generally has broad support from pharmacists and providers, and it appears to be of interest to patients. Pharmacists are a valued member of the health care team and are trained to provide medication therapy management and a number of wellness and prevention clinical services. Prescribing HC presents a novel opportunity for pharmacists to expand their clinical services portfolio and become more engaged in the delivery of patient care. Pharmacist-prescribed HC will likely improve the availability of HC; however, early adopters need to recognize there remain barriers to overcome. The low uptake by pharmacies suggests that the operationalization presents a significant obstacle. Despite general support for HC prescriptive authority, pharmacists have expressed reservation to adoption because of increased workflow burdens. Educational and other regulatory requirements, such as patient screening and provider referrals, could pose additional difficulties with implementation. Another concern is poor accessibility in populations hindered by prohibitive cost-sharing requirements. It remains to be determined whether pharmacist-prescribed HC will improve access in low-income or uninsured populations who face barriers to access. As such, it is important for policy makers and community advocates to understand the impact that any potential legislation would have on their community and work to develop targeted solutions. It is key to recognize barriers in order to address them systematically, both before 640
Conclusion As health care providers collaborate on goals for their patients, such as contraception access, and develop effective means at delivering those goals, optimal health outcomes are more likely to result.42 Expanding access to HC through pharmacist-prescriptive authority, therefore, may help to curb the rates of unintended pregnancy in the United States. Despite the barriers that pharmacist-prescribed HC might face and the ambiguity of its implementation, it appears that pharmacists are well positioned for such a role. As the practice of pharmacist-prescribed HC continues to spread to other states and becomes routine, the lessons learned from the current laboratories will serve as a guide for policy makers to inform improved access and patient care.
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