Abstract

Background

California State Board of Pharmacy passed Senate Bill 493 authorizing pharmacists to furnish self-administered hormonal contraceptives, nicotine replacement products, and naloxone. Although California Senate Bill 493 expanded pharmacists’ scope of practice, limited implementation persists.

Objective

The objectives of this study were to assess the implementation of pharmacists’ prescriptive authority to furnish hormonal contraceptives, naloxone, and NRT in California as allowed by the Board of Pharmacy and availability of these services to patients in order to facilitate the development of strategies to expand them. The objective of the first part was to investigate reported awareness and barriers to implementation of services, while the second part was to report actual implementation rates.

Methods

This was an IRB-approved two-part cross-sectional survey that explored factors that may be associated with the limited implementation of the expanded scope of practice services.

Results

The two-part study had a total of 389 respondents. In the first part of the study, there were a total of 84 respondents. The majority reported that they were aware that pharmacists have the authority to furnish hormonal contraceptives, naloxone, and NRT, but services were limited. In the second part of the study, there were a total of 305 respondents, each responding to questions addressing only one of the three services: hormonal contraceptives (104 respondents), naloxone (101 respondents), and NRT (100 respondents). Within those subgroups, 19% of the respondents stated they offer hormonal contraceptives, 10% offer NRT, and 84% offer naloxone.

Conclusion

The results of the two-part study suggested that pharmacists’ authority to furnish these services were limited, thus patients’ access to these services were also limited.

Introduction

California Senate Bill 493 (2013) expanded pharmacists’ scope of practice by authorizing a pharmacist to furnish self-administered hormonal contraceptives, naloxone, and nicotine replacement therapy (NRT).(1) California approved the expansion of the scope of practice for pharmacists, but it was not implemented due to various barriers. The purpose of California Senate Bill 493 was to increase the accessibility of these services to patients. It was anticipated that the implementation of prescriptive authority would offer patients more access to their medication. While the law allowed pharmacists to furnish hormonal contraceptives, naloxone, and NRT in California, it did not require them to do so and implementation has been minimal. Previous research highlighted barriers to implementation of the aforementioned services, such as lack of time, lack of training, or lack of employees.(2,3,4,5,6) In addition to disparities in public awareness of pharmacists-initiated prescription therapy, patient utilization of these services remains restricted by the limited availability of these services in community pharmacies, even though they were permitted by the expansion of pharmacist scope of practice.

Objectives

The objectives of this study were to assess the implementation of pharmacists’ prescriptive authority to furnish hormonal contraceptives, naloxone, and NRT in California as allowed by the Board of Pharmacy and accessibility to these services by patients in order to facilitate the development of strategies to expand them. The objective of the first part was to investigate reported awareness and barriers to implementation of services, while the second part was to report actual implementation rates.

This study aimed to identify barriers and opportunities for pharmacists to implement services within their expanded scope of practice that promotes public health and safety.

Methods

This was an IRB-approved two-part cross-sectional survey that explored factors that may be associated with the limited implementation of the expanded scope of practice services. The two-part study was designed to gain insight on the accessibility of services that pharmacists are authorized to furnish and offer.

The first part of the study was designed to assess the implementation of pharmacists’ prescriptive authority to furnish hormonal contraceptives, naloxone, and NRT in California. Data were collected through an anonymous survey with an informed consent embedded into the survey via SurveyMonkey distributed by email utilizing local pharmacy organizations and social media such as LinkedIn (Appendix A). Respondents included pharmacists, intern pharmacists, and pharmacy technicians varying from 0 to 21 years of practice in different practice settings in California such as independent, chain, in-patient, and ambulatory care. All responses were collected anonymously and in aggregate. Respondents were entered into a raffle for one of three $25 gift cards for their participation. Data collection began in July 2019 and was completed in September 2019. The response rate of the survey was 80%. The survey consisted of ten questions designed to gather information regarding respondents’ awareness of pharmacists’ prescriptive authority. Respondents were asked about their awareness of pharmacists’ prescriptive authority for the following services: contraceptives, tobacco cessation, and naloxone. The survey also inquired about barriers that may contribute to the lack of offerings of the aforementioned services. These included lack of reimbursement, lack of training, unawareness of the ability to prescribe, discomfort with or the inability to prescribe, lack of time or lack of labor for consultation, lack of patient interest or demand, and corporate chain protocol restriction (Figure 1). Respondents were questioned whether they get requests for these services.

Figure 1.

First Part: Barriers to Providing Services

Figure 1.

First Part: Barriers to Providing Services

The second part of the study aimed to identify the availability of hormonal contraceptives, naloxone and NRT in California when solicited by simulated patients. Data was gathered through an IRB-approved quantitative analysis of data collection using an anonymous questionnaire administered by simulated patients via telephone (Appendix B).(7) The questionnaire was distributed among licensed pharmacies across California. It was conducted without informed consent and prior notice to the pharmacies. IRB approved the research with a “waiver” of consent, as permitted in the U.S. federal regulations governing human subjects research. A list of local community pharmacies was generated by conducting a search online for independent pharmacies in California and was used for the second part of the study. Immediate responses were obtained via telephone and collected anonymously and in aggregate. Data collection started on December 6, 2019 and was completed on January 2, 2020. Original data were collected from human subjects without archival data and analyzed using Microsoft Excel. The survey consisted of three questions about the availability of one of the three mentioned services: NRT, naloxone, or hormonal contraceptives (Appendix B). The 5-minute survey, designed to gather information regarding implemented services that were allowed to be provided by a pharmacist, and whether or not these services are provided at a patients’ request. The simulated patients asked to speak to a pharmacist. They would ask about one of the aforementioned services and whether or not they would be able to get medications without a prescription. If respondents stated “no”, the simulated patient asked the respondent if they were certain and continued to explain that they had heard on the news that pharmacists can give medications related to these services without a physician’s prescription. If respondents stated “yes”, simulated patients asked how they would be able to get the medications and whether an appointment was needed, what the cost and length of the service was, and if insurance companies cover these services. At end of the survey, respondents were provided with the following pertinent information, “We are conducting a study to assess the implementation of pharmacists’ prescriptive authority to furnish hormonal contraceptives, naloxone and NRT in California from patients’ perspective as allowed by the Board of Pharmacy. The responses are confidential, we are not collecting any personal information. Thank you for your willingness to participate.” Participants had the option to withdraw from the study after they were informed.

Results

In the first part, there were a total of 84 respondents, which consisted of 48 (57%), pharmacists, 22 (26%) intern pharmacists, 4 (5%) pharmacy technicians, and 10 (12%) unidentified (Table 1). Fifty-four participants responded to the survey question pertaining to the years of practice, and 33 (61%) of them reported they had been practicing for five years or less. Seventy-four participant responded to the survey question regarding practice settings, and 34 (46%) of them reported they work in chain pharmacies. Most respondents were aware that pharmacists have the authority to furnish hormonal contraceptives, naloxone, and NRT.

Table 1.

First Part: Survey Results

First Part: Survey Results
First Part: Survey Results

The distribution of the various barriers to providing the services were about equal for the following: 26 (31%) respondents reported lack of time/labor for consultation/appointment, 24 (29%) respondents reported lack of reimbursement, and lack of training (Figure 1). Less common barriers included the following: 20 (24%) respondents reported a lack of interest or demand in patient population and 21 (25%) respondents reported corporate protocol restriction in chains. Least common reported barriers were the following: 5 (6%) respondents reported the lack of awareness about the ability to furnish and 9 (11%) respondents reported discomfort with or inability to provide services (Figure 1). Twenty-seven respondents (32%) reported that patients request the aforementioned services. Fifty (60%) respondents stated that patients did not request for services authorized by Senate Bill 493. All respondents except for one gave complete support to the expansion of the scope of practice.

In the second part of the study, there were a total of 305 respondents, each responding to questions addressing only one of the three services: 104 (34%) hormonal contraceptives, 100 (33%) naloxone, and 101 (33%) NRT. When asked about these categories, 20 (19%) respondents indicated that hormonal contraceptives were furnished at their pharmacies along with 10 (10%) respondents stating that NRT services were available in their respective pharmacies. However, when asked about naloxone, 85 (85%) respondents acknowledged that naloxone services were available for patients without a prescription; showing overwhelmingly positive results when compared to the previous two services (Table 2). Out of 305 total respondents, 189 (62%) respondents across all three categories stated services were not available (Figure 2). Fifty-seven (55%) respondents required appointments to offer hormonal contraceptives, 81 (80%) respondents to offer NRT, and 32 (32%) respondents to offer naloxone. The average time it takes for a pharmacist to consult for NRT and naloxone services was reported as 30 minutes. A consultation for hormonal contraceptives was reported to be 60 minutes. The average cost for hormonal contraceptives was $35 and $50 for NRT. The prices for Naloxone given by the respondents ranged between $125 to $200 out-of-pocket., the average price for Naloxone was $156. The majority of respondents stated that insurance did not cover NRT, while 90 (90%) respondents stated that it did cover naloxone. For hormonal contraceptives, the majority stated insurance coverage information would be provided more accurately during the time of service.

Table 2:

Second Part: Patients’ Access to Medications Without Prescriptions

Second Part: Patients’ Access to Medications Without Prescriptions
Second Part: Patients’ Access to Medications Without Prescriptions
Figure 2.

Second Part: Patients’ Access to Medications Without Prescription

Figure 2.

Second Part: Patients’ Access to Medications Without Prescription

Discussion

Pharmacists are the most accessible healthcare providers where anyone can walk into a community pharmacy to seek guidance or education regarding their health and well-being.(8) The expansion of pharmacists’ scope of practice creates an opportunity to provide immediate or near immediate access to frequent or common therapies and treatments. When those services are available, it relieves the burden on other providers, and it allows individuals to obtain prescription medications that they may not have sought out or obtained otherwise. Although Senate Bill 493 has been enacted for several years, this two-part study demonstrated that the services mentioned are not widely available in community pharmacies. If the pharmacists’ expanded scope of practice is not utilized and those services are not offered, the pharmacists’ role as healthcare providers is virtually unchanged.

The first part of the study was oriented towards pharmacists and pharmacy staff identified barriers to offer aforementioned services. When pharmacist respondents were asked directly, they indicated awareness of their prescriptive authority, but the primary barriers to providing services were centered on business logistics: cost, labor, training, and demand. When providing any service in any industry, there are associated costs for implementation and maintenance. Unlike services offered in physician’s offices, hospitals, and clinics, there is currently no definitive structure for reimbursement for pharmacist-provided consultations. Pharmacists have not yet been granted provider status on a national level. While legislation that expands or otherwise affects the scope of practice is completely unrelated to billing for services, this inconsistency may be a barrier to developing reimbursement agreements with insurance providers that can be investigated in further studies. Pharmacists’ inability to definitively secure payment for services provided creates a self-propagating barrier. When services are not provided, they are not being promoted. If they are not being promoted, fewer patients will be aware that these services may be offered by pharmacists. If patients are unaware that pharmacists are able to provide these services, there will be limited demand for that service.

The second part of the study was oriented towards the availability of services when solicited by a patient. In contrast with the first part of the study, in which 79% of all respondents indicated awareness of ability when posing as a patient, 62% of all respondents stated that pharmacists were not permitted to furnish or prescribe the specified medication. After the caller cited another source, such as a news article, indicating that pharmacists were, in fact, permitted to provide the specified service, some of the respondents directed the caller to “try somewhere else.” While there may be a multitude of reasons for this discrepancy, the two simplest explanations are: (1) the respondent was truly unaware that pharmacists are permitted to offer the service, or (2) it was simpler to refer the caller somewhere else. Although callers requested to speak directly to a pharmacist, it cannot be reliably verified that the respondent is indeed a pharmacist. Regardless, the first possibility would indicate that the clerk, technician, or pharmacist was unaware of the ability of pharmacists to provide the specific service and was relaying incorrect information to the patient. If patients are being given incorrect information, the pharmacy itself is creating an additional barrier to patient access to these services. In that respect, the second scenario is much more harmful; the pharmacy is inadvertently creating that barrier.

Batra, et al in a previous study that evaluated the implementation of pharmacists’ prescriptive authority of hormonal contraceptives in California had an implementation rate of 5.1%.(2) In comparison, the second part of this study showed an implementation rate of 19%, an increase from the previous study,(2) yet the implementation of pharmacists’ prescriptive authority remains low.

Disparity within the profession only further complicates the issue. Independent or private pharmacy owners have discretion as to offer services that are practical, effective, and sustainable to implement at their business. While pharmacists working at chain pharmacies although have the same scope of practice as those at independent pharmacies, are bound to company policies. For this reason, were not candidates for participation in the second part of the study. As of January 15, 2020, there are 6,389 pharmacies licensed in the state of California, including thousands of chain community pharmacies.(9) The majority of patients will utilize chain community pharmacies, or at the very least recognize and be familiar with chain pharmacies. Availability of services provided by pharmacists in chain pharmacies is an undeniably significant factor in public awareness. Additionally, the lack of company protocol for providing a service may also influence pharmacist awareness of inherent authority to provide a service within the scope of their license.

Study Limitations

Study limitations include a lack of verification of the inclusion criteria of the respondents that consisted of pharmacists, pharmacist interns, and pharmacy technicians.

Conclusion

The results of the two-part study suggested that pharmacists’ authority to furnish these services were limited, thus patients’ access to these services were limited. To ensure services are offered, additional time, additional pharmacists, and educational training on furnishing self-administered services are required. Implementation of the aforementioned services would continue to be limited if pharmacy staff members remain unaware of the authority to furnish and perform services. Although California Senate Bill 493 grants pharmacists to furnish hormonal contraceptives, naloxone, and NRT, a minority of pharmacies offer these services. Research has shown that the demand for the services were mostly limited by awareness of their availability in the pharmacy and the lack of training. Expanding awareness and availability of the aforementioned services would provide patients more access and less limitations. Based on this research, most pharmacies offering these services required a fee, specifically retail chain pharmacies. Even when some pharmacies offered these services, it was not available at all times. Only one pharmacist claimed to be trained and patients must visit the pharmacy when the trained pharmacist was working. This could potentially still present a barrier to the availability and accessibility of the services. Expansion of pharmacists’ authority to furnish and perform services improved and promoted patient health. Pharmacy practice is continually evolving to include more patient-oriented services. By providing comprehensive services as pharmacists, we are able to increase the availability and accessibility of healthcare to patients.

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About the Authors

Janet Petrosyan is a 2022 PharmD Candidate at West Coast University School of Pharmacy. Ms. Petrosyan has no conflicts of interest to report.

Tina Tchalikian is a 2022 PharmD Candidate at West Coast University School of Pharmacy. Ms. Tchalikian has no conflicts of interest to report.

Alicia O’Connor is a 2021 PharmD Candidate at West Coast University School of Pharmacy. Ms. O’Connor has no conflicts of interest to report.

Juliana Avakeretyan is a 2021 PharmD Candidate at West Coast University School of Pharmacy. Ms. Avakeretyan has no conflicts of interest to report.