Kentucky Pharmacists’ Perceptions Regarding Provision of Hormonal Contraception

Abstract

Background:

While Kentucky pharmacists recently gained authority to provide protocol-driven care for 13 conditions, provision of prescription hormonal contraception (HC) services is not currently authorized. A board-approved protocol allowing for provision of nonprescription (OTC) emergency contraception (EC) was recently approved by the Kentucky Board of Pharmacy, but has yet to be implemented.

Objectives:

The objectives of this study were to 1) assess Kentucky pharmacists’ interest in providing prescription HC and OTC EC services via protocol; and 2) identify perceived benefits/barriers regarding provision of prescription HC.

Methods:

An online questionnaire was disseminated electronically to a convenience sample of Kentucky pharmacists. The questionnaire collected: 1) demographic information; 2) opinions regarding provision of prescription HC and OTC EC; and 3) perceived benefits/barriers regarding provision of prescription HC. For analysis, responses were limited to pharmacists in community-based practice. McNemar’s test was used to identify significant differences in support by dosage form. In addition, a multivariable logistic regression model was used to examine associations between demographic factors and support for pharmacist provision of prescription HC.

Results:

We received 151 responses from community-based pharmacists. Support for provision of prescription HC was highest for oral (61%) and transdermal (54%) forms. We found no statistically significant differences in support among demographic factors other than years in practice, with more recent graduates being at higher odds of support. In addition, time, reimbursement, training, and belief in the need for pelvic exams were the most commonly cited barriers to implementation. With regard to OTC EC provision, pharmacists were largely supportive (62%) and confident in their abilities.

Conclusions:

Kentucky community-based pharmacists are supportive of provision of oral, vaginal, and transdermal prescription HC as well as OTC EC via protocol. Barriers, including time, reimbursement, training, and belief in the need for pelvic exams, should be addressed to increase support for prescription HC provision.

Background

Although unintended pregnancy rates have declined in recent years, nearly half of pregnancies in the United States remain unintended.¹ In Kentucky alone, government expenditures on unintended pregnancies totaled $248.3 million in 2006.² During the same year, government spending on unintended pregnancy nationwide was approximately $11.1 billion.² While there is cost associated with prevention of unintended pregnancy, studies based on recent expenditures have pointed to a $3-6 dollar savings for every dollar spent to provide publicly-funded contraception services. ^3,4

Access to prescription hormonal contraception (HC) plays a crucial role in mitigating unintended pregnancies. Almost half of unintended pregnancies occur in women who are sexually active but are not using any method of contraception.⁵ The remaining occur in women who report using some contraception during the month of conception (including methods less effective than prescription HC, such as the barrier method).⁵ Pharmacy access to prescription HC can serve to address the needs of both populations by increasing access to a highly effective method of contraception.

In 2016, California became the first state to implement pharmacist provision of prescription HC through statewide protocol, and other states soon followed.⁶ Currently, 17 states allow for pharmacist provision of prescription HC.⁶ In 2017, the Kentucky Board of Pharmacy promulgated administrative regulations (201 KAR 2:380) granting pharmacists the authority to provide protocol-driven care for 13 conditions.⁷ Specifically, the regulation provides for the circumstance by which a pharmacist may utilize a board-approved protocol to initiate the dispensing of prescription and nonprescription (OTC) medications. However, in contrast to other states, prescription HC does not fall under this authority.

Previous surveys of pharmacists practicing in other states have shown that pharmacists are supportive of provision of prescription HC^8–11 and are comfortable with their ability to screen for contraindications or provide prescription HC services.^8,12,13 Likewise, medical provider support also has been strong.^14,15 Surveys of women seeking prescription HC found that most would utilize pharmacy access,^16,17 especially uninsured and low-income women.¹⁶ While support is high among medical providers, pharmacists, and patients, there remain implementation concerns. Barriers include:^8,9,14,18

• Decreased reproductive health screening

• Insufficient pharmacist time

• Liability concerns

• Reimbursement

• The need for additional training

• The belief that a pelvic examination is necessary before provision of prescription HC

Although pharmacist provision of prescription HC services has been rapidly expanding in recent years, much remains to be studied in Kentucky. Before this study, no other research had collected Kentucky-specific data regarding pharmacist provision of prescription HC services from pharmacists, providers, or patients.

Objectives

The primary objective of this study was to assess Kentucky pharmacists’ interest in providing prescription HC and OTC EC services via a board-approved protocol. Secondary objectives were to identify perceived benefits and barriers associated with providing contraception services in Kentucky.

Methods

A 20-item questionnaire was developed and disseminated to a convenience sample of Kentucky pharmacists between January 14^th and February 7^th, 2020. The researchers invited Kentucky pharmacist members of the Kentucky Pharmacists Association, the Kentucky Society of Health-System Pharmacists, and the Advancing Pharmacy Practice in Kentucky Coalition to participate via email. The researchers also invited members of the Kentucky Pharmacist Network via a private Facebook¹⁹ group post. Non-pharmacist members of these groups received the invitation email/announcement but were instructed not to participate. The researchers administered the questionnaire electronically using REDCap, a secure web-based application for building and managing online surveys and databases, in compliance with applicable research privacy laws.²⁰ Data were collected anonymously over four weeks, with two reminder invitations being sent out at 1-week intervals following the initial invitation. The study offered no incentives for participation. The University of Kentucky Institutional Review Board approved the study protocol.

Survey Domains

The researchers drafted the questionnaire after reviewing current literature regarding pharmacist provision of HC services.^8–10,12,13 The questionnaire collected opinions regarding the provision of prescription HC and OTC EC services as well as perceived barriers and benefits associated with provision of prescription HC services. Opinions collected included:

• Support for provision of prescription HC and OTC EC services via board-approved protocol

• Intent to provide prescription HC and OTC EC services in their pharmacy

• Self-rated knowledge and comfort level in providing prescription HC and OTC EC services

The researchers gathered all opinions using a 5-point Likert scale, with possible responses ranging from “strongly disagree” to “strongly agree”. Likewise, the researchers gathered perceived barriers and benefits using a 3-point scale (“Not a barrier/benefit at all”, “Slight barrier/benefit”, “Significant barrier/benefit). For analysis, the researchers dichotomized scales to “agree” or “disagree/neutral” and to “barrier/benefit” or “no barrier/benefit”. The researchers also gathered opinions regarding an appropriate service fee, as Kentucky law did not allow for insurer reimbursement of pharmacist services at the time of the survey. The researchers informed pharmacists that this fee is a hypothetical fee for services provided only and does not include the cost of the medications or associated dispensing fees. Before dissemination, researchers pilot tested the questionnaire among a group of pharmacists employed by the University of Kentucky College of Pharmacy for functionality and face validity. The full questionnaire is included in the supplementary materials.

Demographic Variables

Demographics collected included: age, practice setting, years in practice, county (for classification as rural/urban), estimated daily prescription volume, and gender. Counties were classified, after data collection, as rural/urban using the U.S. Office of Management and Budget (OMB) Metropolitan Statistical Area Designation.²¹

Analyses

The researchers used descriptive analyses for all gathered information to characterize the sample and provide an overview of pharmacist opinions. For analysis, researchers limited respondents to community-based pharmacists, as these pharmacists would be most likely to provide this service. Researchers used a multivariable logistic regression model to analyze the association of various demographic factors with support for provision of prescription HC services. Due to similarities between age and years in practice, age was excluded as a factor from the regression model. All other collected demographic information were included as covariates in the model. Additionally, researchers used McNemar’s test to identify significant differences in support between various dosage form pairs. Data analysis was performed using RStudio.²²

Results

We received a total of 318 responses, of which 151 were from community-based pharmacists. Due to the nature of convenience sampling and unknown overlap between groups, we are unable to calculate a response rate.

Our sample included 41.1% male and 55.6% female respondents (Table 1). Reported practice site was evenly distributed, with 54.3% practicing in a chain setting and 45.7% in an independent setting. A large percentage of respondents (60.3%) reported practicing primarily in urban locations. Respondents also reported a wide range of experience, with the largest group being in practice ten years or less.

Table 1.

Subject Demographics (n = 151)

	n (%)
Years in Practice
≤10	59 (39.1)
11-30	46 (30.5)
>30	39 (25.8)
Missing	7 (4.6)
Gender
Male	62 (41.1)
Female	84 (55.6)
Other/Prefer to Self-Describe	0 (0.0)
Missing	5 (3.3)
Setting
Chain	82 (54.3)
Independent	69 (45.7)
Missing	0 (0.0)
Daily Prescription Volume
<250	61 (40.4)
250-449	53 (35.1)
≥450	34 (22.5)
Missing	3 (2.0)
Practice Location a
Urban	91 (60.3)
Rural	55 (36.4)
Missing	5 (3.3)

^aRural/Urban defined according to pharmacy county

Concerning knowledge and ability, pharmacists reported confidence in their ability to follow a protocol to determine eligibility to receive therapy for oral (59.6%), transdermal (57.0%), vaginal (53.6%), and injectable (51.0%) dosage forms. However, pharmacists also reported a need for additional training, particularly for injectable (68.2%) and vaginal (64.2%) dosage forms. When asked what an appropriate service fee would be, given that insurers in Kentucky did not reimburse pharmacists for services provided, the most common price ranges were $20.00-$24.99 (27.8%) and ≥$25.00 (27.8%).

Pharmacists were supportive of the provision of prescription HC services (Figure 1). Support was highest for oral (61%) and transdermal (54%) dosage forms. Support for injectable (38%) and vaginal (47%) forms was considerably lower. Differences in support level were statistically significant for all dosage form pairs, except for vaginal and transdermal (p=0.08). The most commonly cited barriers to implementation (Supplementary Figure 1) were reimbursement (98%), time (89%), training (78%), and belief in the need for pelvic examinations (77%). The least commonly cited barrier was personal beliefs, with only 13% of pharmacists citing it as a concern. Perceived benefits of implementation (Supplementary Figure 2) were somewhat evenly distributed, with the most commonly cited benefits being new business opportunities (90%), recognition of pharmacists as care providers (88%), and decreased unintended pregnancies (87%). The least commonly cited perceived benefit was professional development; however, it was still cited by 81% of pharmacists in the study sample. Pharmacists also reported willingness to offer access to oral (57.0%), transdermal (49.6%), vaginal (47.1%), and injectable forms (37.2%) in their pharmacy, were a board-approved protocol available.

Figure 1.

Hormonal Contraception Support Among Community-Based Pharmacists

Likewise, pharmacists supported the of provision of OTC EC via a board-approved protocol, with 65% of community-based pharmacists indicating support. Additionally, 57.9% indicated they would offer this service in their pharmacy. Pharmacists were confident in their ability to follow a protocol (79.8%); however, 54.9% indicated that additional training would be necessary.

Modeling showed no statistically significant differences in support level among demographic factors except years in practice (Supplementary Table 1). Pharmacists in practice 11-30 years and greater than 30 years were found to be at decreased odds of support for oral contraception provision. Compared to those in practice ten years or less, the odds of support for the provision of prescription HC were 72% less likely and 65% less likely among pharmacists in practice 11-30 years and more than 30 years, respectively. Additionally, the odds of support were significantly less likely for transdermal (62% less likely) and vaginal (74% less likely) dosage forms among pharmacists in practice 11-30 years compared to pharmacists in practice ten years or less. The researchers found no statistically significant differences among support for provision of the injectable dosage form.

Discussion

Pharmacist provision of prescription HC services is an ever-expanding aspect of pharmacy practice that could play a significant role in increasing contraception access and decreasing unintended pregnancy. While still an evolving area, the impacts are seen in states that have taken steps to authorize pharmacists to provide these services. From 2016-17, 10% of Medicaid patients in Oregon receiving oral or transdermal contraception had received theirs from a pharmacist.²³ In addition, expanding the scope of practice to prescribe HC was found to have averted 51 unintended pregnancies, saved $1.6 million in the first 24 months, and resulted in a gain of 158 quality-adjusted life years (QALYs) per 198,000 women.²⁴

Kentucky community-based pharmacists surveyed were supportive of the provision of oral and transdermal contraception. The logistic regression analyses suggest higher support levels for certain dosage forms among pharmacists who have been in practice for ten years or less. This may illustrate evolving opinions of pharmacists as care providers within the field and the results of training received within the pharmacy education system regarding contraception care. The Accreditation Council for Pharmacy Education (ACPE) released revised standards in 2007, focusing on preparing students for provision of care in a collaborative environment.²⁵ Also during this time, immunization delivery and state-level efforts to expand practice were beginning, with both possibly impacting this newer generation of pharmacists. Further research among current student pharmacists in Kentucky is necessary to further explore this trend and impact of evolving education.

While many pharmacists considered time to be a significant barrier, a recent Oregon study found that the average time for pharmacists to complete the service was about 7.8 minutes and was comparable to administering a vaccination.²⁶ These concerns, however, likely stem from staffing issues many pharmacists face. Addressing pharmacy workplace standards may increase support for prescription HC provision.

Reimbursement was also a prevalent concern among pharmacists surveyed. In March of 2021, Kentucky House Bill 48 (HB 48) was signed into law, making Kentucky the fifth state to require commercial insurance companies to reimburse pharmacists for services provided within their scope of the practice.^27,28 Taking this legislative step was seen by Kentucky pharmacists interested in service provision as a monumental victory.²⁹ As this occurred following the survey, its impact on perceived barriers and support remains unaccounted for in these results. In eliminating the barrier of reimbursement for pharmacists, however, HB 48 could have reaching impacts on all aspects of pharmacists’ provision of services, including a dramatic increase in support for the provision of prescription HC services.

Additionally, while training was cited by many as a concern, in states where pharmacist provision of prescription HC services is authorized, continuing education programs (CE) have begun addressing these concerns.³⁰ The Kentucky Board of Pharmacy requires completion of approved training programs before any protocol is offered in a pharmacy, thus the development of CE in Kentucky would be integral to implementation.

Finally, while many still consider pelvic examinations to be necessary before prescribing prescription HC, recent studies have refuted this idea.^31–33 As a result, the American College of Obstetrics and Gynecology no longer recommends mandatory screening for cervical cancer or STI’s before provision of prescription HC.³⁴ Pharmacist education and training can play a role in mitigating this concern and increasing support.

Shortly following this survey, the Kentucky Board of Pharmacy approved pharmacist-provision of OTC EC via a board-approved protocol, allowing pharmacists to initiate the dispensing of OTC EC prescriptions.³⁵ Provision of OTC EC via a board-approved protocol should enable pharmacists to bill health savings accounts (HSAs)/insurance – thus decreasing cost barriers associated with OTC EC utilization. Typical cost of OTC EC ranges between $25 and $50, making cost a barrier to access for many.³⁶ Additionally, levonorgestrel, the only OTC EC product available, can typically be provided at no cost to most Medicaid patients when billed as a prescription. In addition to providing pharmacists a method of billing insurance/HSAs for the cost of the patient’s prescription, pharmacists practicing in states that permit pharmacist-prescribed EC with completion of required CE have been shown to be associated with improved patient access to oral EC and more accurate patient counseling.³⁷ While pharmacists in the study sample supported the provision of OTC EC via a board approved protocol, note that this survey was taken at baseline, before protocol approval.

Limitations to this study should be considered as well. Due to the nature of convenience sampling, our sample may not be representative of the full population of Kentucky community-based pharmacists. Also, response bias may exist as responding members of the sampled groups may have differing opinions than those who did not respond. In addition, limited sample size may have impacted the logistic regression analysis, increasing the risk of type II error. While demographic factors other than years in practice were not found to significantly impact the odds of support, this could be due primarily to sample size rather than effect. Finally, language in this survey focused primarily on the contraceptive needs of cisgender women. Further studies may be necessary to determine whether opinions differ regarding the provision of prescription HC and OTC EC services to transgender and non-binary patients.

Conclusion

Kentucky community-based pharmacists surveyed indicate support for provision of oral, vaginal, and transdermal prescription HC via a board-approved protocol. Pharmacists remain divided regarding support for provision of injectable dosage forms. Concerns remain regarding barriers to implementation, including time, reimbursement, training, and belief in the need for a pelvic exam. Pharmacists are also supportive of provision of OTC EC via a board-approved protocol. Further education is necessary before provision of any form of contraception, not only to train pharmacists in provision of care, but to alleviate concerns regarding the necessity of pelvic exams before prescription HC provision.

Key Points:

What was already known:

• Pharmacists in several states are supportive of provision of prescription hormonal contraceptives;

• While the Kentucky Board of Pharmacy has the authority to implement board-approved protocols for 13 authorized conditions, the provision of prescription hormonal contraceptives is not currently authorized;

• A board-approved protocol for nonprescription emergency contraception was recently approved by the Kentucky Board of Pharmacy.

What this study adds:

• Pharmacists in Kentucky support provision of both prescription hormonal contraceptives and nonprescription emergency contraceptive services via a board-approved protocol;

• Concerns remain among pharmacists in Kentucky regarding certain barriers, including time and reimbursement.