Abstract

Introduction

The passage of Senate Bill 493 (SB 493) granted California pharmacists the ability to order and interpret lab tests without physician approval. Despite this legislation, not all pharmacists are aware of, or exercise, this authority. The goals of this study are to describe 1) pharmacists' willingness, 2) perceived factors influencing pharmacist preparedness, and 3) challenges and barriers to ordering laboratory tests in the community setting.

Methods

This is a prospective, descriptive survey study that was performed using online survey software from August 31, 2017, to October 4, 2017. An anonymous link was distributed to California pharmacists via California Society of Health-System Pharmacists (CSHP) and California Pharmacists Association (CPhA) email newsletters. Additionally, targeted interviews of pharmacists were conducted by phone to qualitatively assess barriers as well as successful practices. Institutional Review Board (IRB) approval was obtained prior to initiating the study.

Results

Sixty-six pharmacist respondents completed the online survey. The reported two biggest barriers to ordering lab tests identified by community pharmacists were 1) lack of available time and 2) compensation structure. Despite these barriers, most pharmacists were willing to order and interpret laboratory tests and accept the liability, regardless of a reimbursement guarantee.

Conclusions

Community pharmacists self-report preparedness to order and interpret laboratory tests. Barriers in carrying out this task include lack of staff, resources, compensation, and reimbursement structure.

Introduction

The passage of SB 493 in 2013 granted California pharmacists the authority to order and interpret laboratory tests for the purpose of monitoring as well as managing the efficacy and toxicity of drug therapies, as long as it is done in coordination with the patient's primary care provider or diagnosing provider.(1) SB 493 specifically states that a pharmacist “who orders and interprets tests pursuant to this paragraph shall ensure that the ordering of those tests is done in coordination with the patient's primary care provider or diagnosing prescriber, as appropriate, including promptly transmitting written notification to the patient's diagnosing prescriber or entering information in a patient record system shared with the prescriber, when available and as permitted by that prescriber.”(1) This is not a novel idea. Outpatient pharmacists practicing under a collaborative practice agreement (CPA), which is an agreement between a physician and a pharmacist, where in which the pharmacist is allowed to adjust and titrate either precontracted medications, or any medications per the agreement,(2) have been ordering and interpreting laboratory tests well before the passage of SB 493.(3) In addition, California pharmacists are also able to achieve advanced practice pharmacist (APh) designations to widen their scope of practice. Four states (California, Montana, North Carolina, and New Mexico) have created advanced practice pharmacist designations that require additional training and certification.(4) However, even with the enhanced scope of practice and possibility for additional advanced designations, laboratory value monitoring by pharmacists is largely absent in community pharmacies. Most adverse drug events (ADEs) are due to the lack of proper monitoring and adjustments, rather than improper initial prescriptions.(5) In fact, 54% of ADE-related hospitalizations for older adults are directly correlated with drugs requiring regular monitoring.(5) Taking advantage of SB 493 to the fullest extent would allow pharmacists to make necessary changes that can help reduce these adverse events. For example, pharmacists could assess a creatinine value and adjust the dose of metformin if the creatinine clearance shows the patient would not clear metformin well. This would reduce the risk of adverse events and renal dysfunction.

To maximize patient health outcomes and combat the imminent shortage of primary care physicians in the United States, pharmacists should have an active role in monitoring clinical lab values.(6) The goals of this study are to assess 1) pharmacists' willingness, 2) perceived factors influencing pharmacist preparedness, and 3) challenges and barriers to ordering laboratory tests in the community pharmacy setting. This study is intended to address the apparent gaps in modern health care, and the variable understanding of a pharmacist's complete scope of practice.

Objectives

The objectives of this study included the following:

  1. Assess the willingness of community pharmacists in ordering and interpreting laboratory tests.

  2. Assess perceived factors influencing pharmacist preparedness in ordering and interpreting laboratory tests.

  3. Identify challenges and barriers to ordering laboratory tests in the community setting.

Methods

This is a prospective, descriptive survey study that utilized 1) an online questionnaire and 2) targeted interviews with practicing pharmacists who currently order and interpret laboratory tests at their community pharmacy. Inclusion criteria included pharmacists holding an active Board of Pharmacy license and practicing in a community setting in California. Community settings include independent community pharmacies, chain community pharmacies, and community outpatient pharmacies in health networks such as Kaiser. Exclusion criteria included pharmacists whose license has been inactivated, as well as those who have since switched to a different practice setting or state. Whether pharmacists were already performing lab testing and/or ordering at their respective practice sites was not considered an inclusion or exclusion criterion in this study. IRB approval was obtained through the University of Southern California IRB office prior to initiating the study (HS-17-00580). An anonymous link to the online questionnaire was distributed between August 31, 2017, to October 4, 2017, through CSHP and CPhA email newsletters weekly for a total of six times, and responses were gathered via the Qualtrics online survey software system. Perceived barriers were derived from literature search, as well as expert opinion. Respondents could not only select from a variety of perceived barriers in their response, but also indicate the specific barrier they have encountered in their respective practices via free text under the “other” option. Data from the survey was collected on a spreadsheet, and the median ranking of each factor (1 being a factor that contributes the least to preparedness and 9 being a factor that contributes the most to preparedness) or barrier (1 being a barrier that presents the smallest challenge and 9 being a barrier that presents the greatest challenge) was calculated. “Yes” or “No” questions assessed whether pharmacists were aware of their authority to lawfully order and interpret laboratory tests, whether they would be willing to perform such tasks if patient outcomes would improve, and whether they would be willing to accept liability that comes with performing these responsibilities. For “Yes” or “No” questions, the percentage of each “Yes” or “No” answer was calculated against the total number of respondents. With questions regarding factors that would provide further preparation for ordering and interpreting laboratory tests and which laboratory values would be needed for selecting and ensuring appropriate medication therapy, the total counts of each factors or lab values were calculated. Additionally, five targeted interviews were performed over the phone or in person by the study researchers in order to qualitatively assess the current barriers and successful practices. Candidates for interviews were selected by our advisors who have connections with community pharmacists in the Los Angeles area. Questions during the targeted interviews ranged from the incentives of ordering laboratory tests in the community setting, challenges and barriers to implementing a laboratory value ordering system, as well as the downside of implementing such a system for community pharmacists. Questions were scripted for each phone interview and took place after the survey results were collected, but the interviewees were not made aware of the results. In order to reduce inter-rater variability, interviewers were instructed to refrain from asking questions not listed on the prepared script. The interviewees were from independent pharmacies.

Results

There were 66 respondents to the online survey, with 57 complete responses meeting inclusion criteria (Table 1). After surveying community pharmacists, the majority reported that the factor that best prepared them for ordering/interpreting lab tests was post-graduate experience, such as work, residency, or fellowship. Amongst postgraduate trained (which includes residency and fellowship) stated that residency and work experience were the factors that prepared them the most to order and interpret laboratory tests. Non-postgraduate trained community pharmacists stated that work experience and Advanced Practice Pharmacy Experience (APPE) were the factors that prepared them most. Other notable factors that contributed to perceived preparedness, amongst both postgraduate trained and non-postgraduate trained pharmacists, include didactic coursework, internship, and continuing education coursework. The pharmacists surveyed, amongst both postgraduate trained and non-postgraduate trained pharmacists, reported that Introductory Pharmacy Practice Experience (IPPE) and postgraduate fellowships contributed least to preparing them for ordering and interpreting lab tests.

Table 1.

Survey Respondent Demographics

Survey Respondent Demographics
Survey Respondent Demographics

In addition to looking at factors that pharmacists feel prepared them for ordering/interpreting lab tests, barriers that deter pharmacists from taking on this task were also explored. The greatest challenges to ordering/interpreting lab tests that pharmacists reported, with median rankings of 7, with a median ranking of 9 being the most challenging and a median ranking of 1 being least challenging, included lack of time and compensation structure. Increased liability and increased responsibility had median rankings of 6, indicating that these barriers were less challenging compared to the two aforementioned barriers with median rankings of 7. Finally, the least challenging barriers, with median rankings of 5, included lack of knowledge/experience and lack of access to patient records, while four pharmacists indicated the lack of usefulness for lab values.

When asked whether or not pharmacists would be willing to order and interpret lab values without reimbursement, the majority (78%) stated that they would. In addition, more than 88% of pharmacists stated that they would be willing to accept the responsibility and liability that come with ordering lab values if it meant improving patient safety.

To get more detailed explanations of the perceived barriers, targeted phone interviews were conducted, in which the topic of ordering lab tests was discussed with local community pharmacists. One pharmacist stated that they were hesitant to order lab tests because they did not want to duplicate orders the physician had already made, since communication between doctors and pharmacists is limited without a protocol in place. Furthermore, there was a concern with the ability to follow up on results. The two main issues with follow-up were trying to find the time to schedule a meeting with the patient, and describing what those results mean. In addition, in order to provide active medication management, pharmacists typically need a CPA with a physician. If there is a CPA, and the pharmacist is counseling a patient on what changes to medications are necessary based on test results, there may be conflicting information conveyed between the pharmacist and the patient's other providers. Additionally, 60% of interviewed pharmacists raised concern regarding the lack of structure for reimbursement of clinical pharmacy services. Finally, one pharmacist mentioned that in order to provide these services effectively, the community pharmacy needs to move toward a more clinical setting model with a private clinic room.

Discussion

Passage of Senate Bill 493 in 2013 granted to pharmacists licensed in California statewide recognition as providers of healthcare. Along with this title, pharmacists were given the ability to perform a number of clinical tasks, which once required collaborative practice agreement with a physician. Subsection 4052.(a)(12) of this Senate Bill granted pharmacists the authority to order and interpret laboratory tests in all practice settings, for the explicit purpose of monitoring and managing the efficacy and toxicity of drug therapies, in coordination with the patient's primary care provider.(3) While the passage of this legislation greatly expanded the scope of practice of pharmacists, and paved the way for reimbursement of said activities, there is no available literature addressing the pharmacists' perceived barriers to implementing this clinical task in the community setting. This article is the first of its kind to address these barriers, as perceived by the pharmacists who may be performing this therapeutic drug monitoring in the community.

Results show the biggest barrier to ordering and interpreting lab values was lack of available time. Utilization of laboratory tests in a community setting was not limited due to lack of knowledge, inexperience, or increased pharmacist liability; rather, the greatest obstacle community pharmacists faced was with the time constraints associated with workflow. Additionally, lack of compensation structure was reported as another barrier to implementation. Reimbursement for tests ordered will vary across different practice sites. This may range from negotiated fees for specific tests to shared payments under reimbursement contracts.(1)

Despite these acknowledged barriers, respondents felt prepared and willing to order and interpret laboratory values. In fact, 88% of respondents were willing to accept the increased responsibility and liability associated with ordering and interpreting laboratory tests.

The majority of interviewed pharmacists were primarily concerned about duplicate laboratory orders from both the physician and pharmacist. If data collected by pharmacists is not shared with other members of the healthcare team, it may lead to duplicative tests being ordered.(7) This would lead to increased unnecessary costs and extra time burden for patients. In order to prevent this, the interviewed pharmacists suggested creating clear practice protocols addressing lab ordering to avoid redundancy and patient inconvenience. Future plans would include more targeted interviews from independent, chain, and network pharmacies, as these different settings experience different issues and have different business models that allow or limit them to expand their practice.

Another barrier to implementation pharmacists highlighted was time constraint. Many pharmacists at high volume practice sites may not have sufficient time to effectively interpret laboratory values. This lack of time can potentially lead to poor patient outcomes, such as lack of follow-up or confusion amongst physicians due to this lack of follow-up or lack of communication.

Despite these potential difficulties, the interviewed pharmacists felt there were incentives for pharmacists to order and interpret laboratory tests in the community setting, namely the potential for improvements in patient care. Accessibility of quality healthcare has continuously remained an issue in the United States, and pharmacists are amongst the most accessible health care practitioners, and are often the point of first contact for people with acute illnesses.(7) Implementation of ordering and interpreting laboratory tests in the community setting will increase healthcare accessibility for patients and, as a result, potentially result in improved outcomes for these patients. As well as improved outcomes, this would allow pharmacists to directly see and assess how patients are responding to the medications they are taking, and take appropriate action regarding the alterations of the patients' medications.

Given the willingness of pharmacists to take on this clinical task, and preparedness to do so, future steps would involve opening discussions between pharmacy stakeholders and insurance companies to establish a payment structure for reimbursing pharmacists who order and interpret laboratory tests in their community setting. Payment models must take into account the time spent by pharmacists in assessing a patient's need for laboratory tests, interpreting the tests themselves, and contacting the primary care physician to discuss changes in drug therapy. Additional steps should be taken to increase the scope of practice of pharmacy technicians, for example, in providing initial verification of filled medications, to provide community pharmacists with more time to allot for clinical duties (including interpreting laboratory tests and adjusting therapy accordingly). Furthermore, efforts must be made to inform physicians of the new role of community pharmacists in ordering and interpreting laboratory tests, including a discussion of the great body of evidence demonstrating improvements in healthcare quality measures, medication safety, and healthcare costs when pharmacists take on this task.(3)

Limitations

One of the major limitations of our study was the small sample size of 66 pharmacists. The issue with having a small sample population is that it may reduce the generalizability of the results, as the 66 pharmacists who submitted the survey may not be representative of all 47,053 pharmacists in California. Additionally, the surveyed pharmacists were members of CSHP and CPhA. Pharmacists associated with these state organizations may have different perspectives and knowledge levels regarding this issue. This could potentially be reflected in the survey results. For future surveys, reaching out to every major pharmacy organization, which encompasses community pharmacies in order to distribute the survey, would be a beneficial strategy. Time restrictions to interviews of pharmacists in network and chain community pharmacies only allowed us to have five targeted interviews. With interviews only being conducted with independent pharmacy owners, our discussion may not be comprehensive when it comes to discussing what pharmacists see as barriers in ordering and interpreting lab results. Likewise, increasing the number of times the survey is announced and released would increase the number of respondents as well. Thirty-one of the respondents (54.4% of respondents) attended pharmacy school in Southern California, which also presents an additional limitation to the external validity of this data. Twenty-eight (49.1%) were pharmacists from Kaiser, which is almost half the number of respondents in the inclusion criteria, and may have skewed our results as operations and business are done differently at Kaiser as compared to chain and independent community pharmacies. Twenty-eight (49.1%) of the respondents were residency trained, which is relatively high for the community setting. Our data revealed that the majority of respondents who were residency trained came from either Kaiser or an independent community pharmacy. As well, twelve (21.1%) respondents had board-certified specialties, such as Board Certified Pharmacotherapy Specialist (BCPS) and so on, a result that is rather high for the community setting. Almost all of these board-certified pharmacists came from Kaiser. Likewise, we had a few respondents who selected managed care and industry as their work setting. This may be their primary work setting, yet the pharmacists in nontraditional settings responded that they still work weekends or cover shifts occasionally in the community setting. Moreover, the survey was only sent to California pharmacists. There is no information regarding pharmacists from other states who have legal authority to order and interpret lab tests, and their abilities in the ordering and monitoring of labs.

Conclusions

Community pharmacists appear prepared and willing to order and interpret lab tests if given adequate resources and staff to utilize clinical skills taught in the current pharmacy curriculum. After surveying and interviewing community pharmacists, a majority stated that lack of time was a major barrier to ordering pertinent lab tests, in addition to either adjusting pharmacotherapy or making medication recommendations.

Through targeted interviews and further literature research, the most effective and streamlined models to having pharmacists order and interpret lab tests is through a collaborative practice agreement. Typically, specialized pharmacists with residencies utilize CPAs, which removes them from the filling and dispensing aspects of pharmacy, and allows them to focus more on the clinical outcomes of the patient. Therefore, in order for community pharmacists to be able to incorporate their expanded provider status under SB 493, there have to be workflow and process improvements in community pharmacy, or hiring of additional staff, which can incorporate medication therapy management, immunizations, and medication titrations or additions.

References

References
1.
California Pharmacist Provider Status Act of 2013, 113th Congress, SB-493 Chapter 469. 2013.
2.
Centers for Disease Control and Prevention. Collaborative Practice Agreements and Pharmacists' Patient Care Services: A Resource for Pharmacists [Internet]. Atlanta, GA: U.S. Dept. of Health and Human Services, Centers for Disease Control and Prevention. 2013. Available from: https://www.cdc.gov/dhdsp/pubs/docs/Translational_Tools_Pharmacists.pdf.
3.
Chen
S,
Chun
R,
Cupp
R,
et al.
Guidelines for Pharmacists Ordering and Managing Tests to Ensure Safe and Appropriate Medication Therapy (Version 5) [Internet]
.
California Pharmacists Association
.
2014
.
4.
Frost
TP,
Adams
AJ.
Are advanced practice pharmacist designations really advanced?
Res Social Adm Pharm.
2018
May
;
14
(
5
):
501
504
.
5.
Schiff
GD,
Klass
D,
Peterson
J,
et al.
Linking laboratory and pharmacy opportunities for reducing errors and improving care
.
Arch Intern Med.
2003
Apr
28
;
163
(
8
):
893
900
.
6.
Manolakis
PG,
Skelton
JB.
Pharmacists' contributions to primary care in the United States collaborating to address unmet patient care needs: the emerging role for pharmacists to address the shortage of primary care providers
.
Am J Pharm Educ.
2010
Dec
15
;
74
(
10
):
S7
.
7.
Gronowski
A,
Adams
A,
Ball
C,
et al.
Pharmacists in the laboratory space: friends or foes?
Clin Chem.
2016
May
;
62
(
5
):
679
83
.

About the Authors

Angelica Del Rosario, PharmD, graduated from the USC School of Pharmacy in 2020. Dr. Del Rosario has no conflicts of interest to report.

Kathleen Feng, PharmD, graduated from the USC School of Pharmacy in 2019. Dr. Feng has no conflicts of interest to report.

Lena Haddad, PharmD, graduated from the USC School of Pharmacy in 2019. Dr. Haddad has no conflicts of interest to report.

Brian Lee, PharmD, graduated from the USC School of Pharmacy in 2020. Dr. Lee has no conflicts of interest to report.

Ryan Murakami, PharmD, graduated from the USC School of Pharmacy in 2019. Dr. Murakami has no conflicts of interest to report.

Eric Pinashin, PharmD, graduated from the USC School of Pharmacy in 2019. Dr. Pinashin has no conflicts of interest to report.

Ashley Tuttle, PharmD, graduated from the USC School of Pharmacy in 2020. Dr. Tuttle has no conflicts of interest to report.

Kevin Young, PharmD, graduated from the USC School of Pharmacy in 2020. Dr. Young has no conflicts of interest to report.

Melissa J. Durham, PharmD, MACM, APh, BCACP, is an Associate Professor of Clinical Pharmacy at the USC School of Pharmacy. Dr. Durham is an expert in pain management and community pharmacy practice. She has no conflicts of interest to report.

Edith Mirzaian, PharmD, BCACP, is an Associate Professor of Clinical Pharmacy at the USC School of Pharmacy. She has no conflicts of interest to report.