- Email: [email protected]
Time and motion study of pharmacist prescribing of oral hormonal contraceptives in Oregon community pharmacies
SCIENCE AND PRACTICE Journal of the American Pharmacists Association xxx (2019) 1e6
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
RESEARCH NOTES
Time and motion study of pharmacist prescribing of oral hormonal contraceptives in Oregon community pharmacies Timothy P. Frost*, Donald G. Klepser, Danielle C. Small, Ian C. Doyle a r t i c l e i n f o
a b s t r a c t
Article history: Received 5 June 2018 Accepted 9 December 2018
Objectives: The aim of this time and motion study was to evaluate the procedural time and steps of performing an oral hormonal contraceptive pharmacist prescribing service in an Oregon community pharmacy. Methods: A standardized patient seeking oral hormonal contraception visited 13 community pharmacies throughout February 2018 in the tri-county Portland, Oregon, metropolitan area for pharmacist-prescribed hormonal contraception services for a total of 26 patient encounters. An observer was present at each encounter to record the time for each step and the total encounter time. Each pharmacist was asked to perform assessment procedures and prescribing for each of 2 standardized patient presentations: in cohort 1 (n ¼ 13), the pharmacist’s assessment resulted in a hormonal contraception prescription written; in cohort 2 (n ¼ 13), pharmacist’s assessment detected contraindications and resulted in a medical referral to another health care prescriber. Results: The average total patient time from arrival at the pharmacy to the generation of either a written prescription for hormonal contraception or referral to another health care provider was 17.9 and 14.1 minutes, respectively. Without accounting for documentation or dispensing the prescription, the average total pharmacist time to perform the service and issue a prescription, or refer the patient, was 7.8 and 5.4 minutes, respectively. Conclusion: The results indicate that the pharmacist prescribing service for oral hormonal contraception requires a modest amount of pharmacist time. Incorporation of practice into regular workflow appears to have an impact similar to other clinical services, such as immunizations and point-of-care testing. The patient time spent with the pharmacist was similar to other health care provider visits. © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Pharmacist prescriptive authority for hormonal contraception has gained significant momentum across the United States in recent years. In at least 17 states, pharmacists have the authority to enter into a population-specific collaborative practice agreement or collaborative drug therapy agreement with a partnering prescriber to provide hormonal contraception services.1 While SB 493 (2013) in California was the first legislation to statutorily authorize autonomous pharmacist prescribing of hormonal contraception, the implementation of HB 2879 (2015) in Oregon made it the first state to pass legislation and promulgate administrative rules to allow
Disclosure: The authors declare no conflicts of interest or financial interests in any product or service mentioned in this article. Previous presentation: Abstract presented previously at the American Pharmacists Association Annual Meeting, March 19, 2018, Nashville, TN. * Correspondence: Timothy P. Frost, PharmD, Pacific University School of Pharmacy, 222 SE Avenue, Hillsboro, OR 97123. E-mail address: [email protected] (T.P. Frost).
pharmacists to offer the service throughout the state.2,3 Since then, 4 additional statesdColorado, New Mexico, Hawaii, and Marylanddhave followed suit passing similar legislation giving pharmacists autonomous prescribing authority for hormonal contraceptives.4 Under Oregon administrative rules, a qualified pharmacist following standard procedures algorithm and medical eligibility criteria can prescribe and dispense injectable hormonal contraceptives or self-administered hormonal contraceptives to a patient who has completed the Oregon self-screening risk assessment questionnaire.5 Many of the other states have similar requirements for patient self-screening questionnaires, standard procedures algorithm, and application of medical eligibility criteria for contraceptive use. The Oregon prescribing process was predicated on evidence that pharmacist prescribing of hormonal contraception, without a physician's visit, safely improves access to contraception.6-8 In practice, a pharmacist will review the patient’s medical history and assessment of current health, resulting in
https://doi.org/10.1016/j.japh.2018.12.015 1544-3191/© 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
SCIENCE AND PRACTICE T.P. Frost et al. / Journal of the American Pharmacists Association xxx (2019) 1e6
providing the patient either a hormonal contraception prescription or referral to an appropriate health care provider. The purpose of this time and motion study is to evaluate the procedural time of performing a hormonal contraceptive pharmacist prescribing service in a community pharmacy. Methods The methods used in this study mirror previous community pharmacyebased time and motion studies that examined point-of-care testing services.9,10 Researchers contacted every independent pharmacy, mass-merchant grocery chain pharmacy, retail chain pharmacy, and hospital outpatient pharmacy district manager. For those pharmacy companies who provided consent and authorization to conduct the study in their pharmacies, selection of individual outlets was based on company name, location, and business hours. This time-andmotion study was conducted at 13 community pharmacy locations throughout February 2018 in the tri-county (Clackamas, Multnomah, Washington) Portland, Oregon, metropolitan area for a total of 26 patient encounters. Participating community pharmacy settings were classified according to the patient’s experience and included 5 retail chain, 5 mass merchant, and 3 hospital outpatient community pharmacies. A single standardized patient (i.e., a female postgraduate pharmacist learner, with script for encounter) was used to portray a patient seeking hormonal contraception at the participating pharmacies. The patient presented to each pharmacy location twice, each with 1 of 2 standardized presentations: cohort 1, uncomplicated patient history and pharmacist’s assessment resulting in a hormonal contraception prescription written; and cohort 2, complicated patient history and pharmacist’s assessment resulting in a medical referral to another health care provider. Pharmacists working at the time of the research visit were not informed of such upcoming patient encounters. Visits were made without the investigator’s knowledge of or regard for staffing or workload levels. On some occasions, the same pharmacist at that location made the evaluation of the 2 distinctly different patient scenarios, albeit not on the same date or time. A researcher trained in time and motion study methodologies observed patient visits. This study used the direct observation and timing techniques used in a traditional time and motion study, but the nature of this observed service, which lacks clearly defined steps, makes our study design a hybrid between a time and motion and a work-sampling study. The Pacific University Institutional Review Board approved the study. The methodologies for conducting this study were as follows. Each simulated encounter was divided into 9 timed categories. The time of the entire encounter was documented. Timed categories included: 1. Patient arrives and waits to be served 2. Initial contact with pharmacy staff member 3. Patient completion and intake of completed Oregon standardized self-screening assessment questionnaire 4. Waiting time until assessment initiated by pharmacist 5. Blood pressure measurement 6. Evaluation of patient history, method preference, and current method
2
7. Pharmacist and patient choose contraception method 8. Discuss initiation strategy for treatment 9. Discuss and provide visit summary and prescription or referral The first timed category encompassed the time from the patient’s arrival at the community pharmacy counter until a member of the pharmacy staff acknowledged the patient’s presence. Once the patient’s presence was noted, timing of the second category began. This category included the discussion between the technician and patient about what brought the patient into the pharmacy. When the patient asked for hormonal contraception, the technician provided the patient with the Oregon standardized self-screening assessment questionnaire necessary for the pharmacist assessment. As the patient completed the questionnaire, the third timing category began and included the time it took for the patient to complete the questionnaire and the time for the technician to acknowledge and intake the completed questionnaire. The fourth timing category captured the patient time spent waiting in the waiting area or consultation room of the pharmacy until the pharmacist arrived for the patient assessment. The fifth timing category, which is the first with active participation by the pharmacist, began when the pharmacist performed the blood pressure assessment in the private area or consultation room. The sixth timing category started when the pharmacist reviewed and clinically evaluated the patient history from the self-screening questionnaire, contraception preference, and current contraception method. The start of the seventh timing category was signaled when the pharmacist began discussing and deciding what brand or generic drug name and quantity of oral contraceptive to prescribe considering the patient’s preference and medical history. The eighth timing category was defined as the time that the pharmacist spent counseling the patient how to initiate and adhere to oral contraception therapy safely and effectively. The final, ninth timing category timed the pharmacist discussing and providing a visit summary that included either a written prescription or referral to another health care provider, depending on the results of the pharmacist assessment in category 6. This study did not include the time necessary to process and dispense an oral hormonal contraceptive prescription, because that would be part of the existing pharmacy workflow. It would be no different from the pharmacy filling an oral hormonal contraceptive prescription brought in by a patient who had been seen by another health care prescriber. For dataanalysis, the time spent in each of the 9 timing categories for each cohort was assigned to the pharmacist or patient. The different allocated time measurements to the pharmacist and patient can be seen in Table 1. The standardized patient was a 26-year-old woman asking for a new hormonal contraceptive prescription, with no preferences beyond that of a daily pill, and did not ask questions unless prompted by the pharmacist. In cohort 1, her presentation to the pharmacist is characterized as an uncomplicated patient with no medical history requiring intervention and no previous use of hormonal contraception pills. In cohort 2, her presentation to the pharmacist is characterized as a patient with significant migraines with aura and history of medication nonadherence. If migraine with aura is present, the medical eligibility criteria and standard
Table 1 Grouping of pharmacist and patient time Cohort 1: pharmacist prescribes Oregon self-screening risk assessment questionnaire Selected “a daily pill” as the preferred method Selected “no” to all background questions Selected “no” to all medical history questions Selected “no” to all pregnancy screen questions When the pharmacist recommended combined oral contraception pills as an option, the patient verbally indicated agreement with that method of contraception
Pharmacist time (5) Blood pressure measurement (6) Evaluation of patient history, preference, and current method (7) Pharmacist and patient choose contraception method (8) Discuss initiation strategy for treatment (9) Discuss and provide visit summary and prescription or referral
Selected “a daily pill” as the preferred method Selected “no” to all background questions Selected “yes” on migraine headaches Selected “yes” on headaches that start with warnings or symptoms Selected “no” to all pregnancy screen questions When the pharmacist recommended progestin-only pills or depot medroxyprogesterone acetate as an option, the patient verbally indicated a history of medication nonadherence and denied the depot injection method
Patient time
Pharmacist time
Patient time
(1) Patient arrives and waits to be served (2) Initial contact with pharmacy staff member (3) Patient completion and intake of completed Oregon standardized self-screening assessment questionnaire (4) Waiting time until assessment initiated by pharmacist (5) Blood pressure measurement (6) Evaluation of patient history, preference, and current method (7) Pharmacist and patient choose contraception method (8) Discuss initiation strategy for treatment (9) Discuss and provide visit summary and prescription or referral
(5) Blood pressure measurement (6) Evaluation of patient history, preference, and current method (9) Discuss and provide visit summary and prescription or referral
(1) Patient arrives and waits to be served (2) Initial contact with pharmacy staff member (3) Patient completion and intake of completed Oregon standardized self-screening assessment questionnaire (4) Waiting time until assessment initiated by pharmacist (5) Blood pressure measurement (6) Evaluation of patient history, preference, and current method (9) Discuss and provide visit summary and prescription or referral
Pharmacist prescribing service for oral hormonal contraception
Cohort 2: pharmacist refers Oregon self-screening risk assessment questionnaire
SCIENCE AND PRACTICE
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SCIENCE AND PRACTICE T.P. Frost et al. / Journal of the American Pharmacists Association xxx (2019) 1e6
Table 2 Time to perform the service Timed categories
Time (seconds) Visit outcome: prescription
Patient arrives and waits to be served Initial contact with pharmacy staff member Patient completion and intake of completed questionnaire Waiting time until assessment initiated by pharmacist Blood pressure measurement Evaluation of patient history, preference, and method Pharmacist and patient choose contraception method Discuss initiation strategy for treatment Discuss and provide visit summary and prescription or referral Total patient time for patient encounter Total pharmacist time for patient encounter
procedures algorithm allow a pharmacist only to prescribe progestin-only pills or depot medroxyprogesterone acetate. In this cohort the pharmacist assessment and evaluation of the patient’s nonadherence and contraceptive method preference elicited a referral to another health care provider. The patient indicated all significant medical history by answering yes or no when completing the Oregon self-screening risk assessment questionnaire, as retrieved on the Oregon Board of Pharmacy website.5 Details of each patient encounter are described in Table 1. Results Twenty-six simulated patient visits were completed using the standardized patient at the 13 pharmacy locations. All visits took place over 7 weekdays in February 2018 between 9:00 AM and 6:00 PM. The timed results from the 13 pharmacies in this time and motion study are presented in Table 2 (time measured in seconds). The results of the 13 visits in the prescribing cohort indicate that the average total time to complete the entire patient encounter was 17.9 ± 4.5 minutes (range, 12.9-27.8 minutes). Of that composite time, the average time it took for the pharmacist to perform the patient assessment, evaluate patient history, choose contraception, discuss initiation strategy, and provide visit summary and written prescription was 7.9 ± 2.1 minutes (range, 4.4-10.9 minutes). Encounters in which the pharmacist assessment resulted in prescribing, pharmacists were involved in 44% of the encounter. The 3 most time-consuming steps for the pharmacist were performing the blood pressure assessment, evaluating patient history, and discussing contraception initiation strategy. The results of the 13 visits in the referral cohort indicate that the average total time it took to complete the entire patient encounter was 14.1 ± 3.8 minutes. Of that composite time, the average time it took for the pharmacist to perform the patient assessment, evaluate patient history, and provide a visit summary and refer to another health care provider was 5.4 ± 1.1 minutes. Encounters in which the pharmacist assessment resulted in a referral to another health care provider, pharmacists were involved in 38.3% of the encounter. Of note, the timing category with the most variability in both the prescribing and referral cohorts was the patient’s time spent waiting for the pharmacist assessment, with a minimum of 5 seconds and a maximum of 11.9 minutes. 4
75 79 252 198 134 118 45 140 34 1075 471
± ± ± ± ± ± ± ± ± ± ±
101 37 47 234 37 56 25 53 21 269 127
Visit outcome: referral 91 107 160 167 113 147 N/A N/A 63 849 323
± ± ± ± ± ±
97 75 42 222 22 67
± 30 ± 227 ± 68
Discussion Evaluating an uncomplicated patient for oral hormonal contraceptives in a community pharmacy using the Oregon standardized self-screening assessment questionnaire takes an average of 17.9 minutes. When evaluating this result and using it, for example, to assess methods for improving pharmacy workflow, it is important to recognize the limitations of this study. A primary limitation is the nonblinded study design with the presence of the observer. While the observer did not interact directly with the pharmacy staff members, they were aware of his presence. This awareness might have increased the anxiety of the staff members and thus affected the speed at which they performed the service activities. The use of a standardized patient ensured that all presentations were equal for each encounter; this enabled accurate time and motion data collection for each encounter and at each type of pharmacy. Pharmacists may have changed their normal patient interaction techniques when relating to a “fictitious” patient, compared with that of a “real” patient. Although the standardized patient was portrayed by a postgraduate pharmacist learner, the prescribing pharmacist was not aware of this. There might have been bias introduced to the portrayal of the patient secondary to her increased knowledge of contraceptive methods and shortened time to complete the survey because of her familiarity and repeated use of it. Another limitation relates to the third timing category (i.e., patient completion and intake of completed Oregon standardized self-screening assessment questionnaire). From the description above, it is evident this category required some pharmacist time for questionnaire intake, but it was minimal compared with the time the patient spent talking with other pharmacy staff members and filling out the self-screening questionnaire. Although the third category included numerous steps within the pharmacy’s hormonal contraception prescribing workflow, the entire time spent in this category was grouped under patient time in the results of this study. This was due to the fact, in this real-life pharmacy setting, that the observer was unable to see all the individual steps occurring behind the counter. Because this category did not always have clearly defined times assigned to the pharmacist, it is recognized as a limitation of the study. Furthermore, it is unknown whether the pharmacist spent any time during timing category 4 (i.e., patient waiting until assessment initiated by pharmacist) reviewing and assessing the patient questionnaire before performing the patient assessment.
SCIENCE AND PRACTICE Pharmacist prescribing service for oral hormonal contraception
As noted previously, the variability of timing category 4 was along the continuum of 5 seconds to 11.9 minutes. Although the total patient time would not be affected, pharmacist time spent during timing category 4 would increase the net pharmacist time spent performing the service. It also should be recognized that our standard patient’s profile will likely have had an effect on net pharmacist time. A patient with more complicated medical history than our uncomplicated standardized patient, and asking more questions about therapy, would require additional assessment and counseling time by the pharmacist. In addition, while documentation of patient encounters and dispensing prescriptions is already a part of current pharmacy workflow, both require a pharmacist evaluation and thus would increase time. Although on some occasions the cohort scenarios were evaluated by the same pharmacist at a test pharmacy on a different date and time, each cohort scenario’s patient information was highly independent of the other. We do not expect that the timing of one scenario affected the other, but we cannot rule out the possibility of this as a confounding variable. Wittrock et al.11 presented results of a feasibility project of pharmacist-prescribed hormonal contraception in a community pharmacy with 18 simulated patient visits at 1 participating pharmacy. The timed categories also included and required documentation to be completed by the pharmacist during the visit and demonstrated that the pharmacist time to complete the prescribing service increased to 17.8 minutes. Taking our study limitations and the supplemental evidence from Wittrock et al.11 into account, the average pharmacist time to perform the service could be estimated as 15-20 minutes. The results of this analysis show that a hormonal contraception prescribing service in a community pharmacy requires time similar to that of other prescribing providers.12-16 During site evaluations, some pharmacists indicated that they have been trained and prescribing for a year, whereas others noted that they completed training during the month preceding our study procedures. In fact, a few pharmacists stated that the simulated standardized patient was the first “real” experience in providing the service. Many pharmacists indicated they had the self-screening risk assessment questionnaire, standard procedures algorithm, and medical eligibility criteria memorized, whereas a few pharmacists relied on reviewing the treatment algorithm and medical eligibility criteria with the patient. As such, some pharmacies were probably not at peak efficiency for the time and motion study. However, there was enough variation between pharmacies and visits to suggest the achievement of a fairly representative sample. When considering the possibility of incorporating hormonal contraception prescribing in a community pharmacy, it might be worth comparing it to the time required for other successful pharmacist-delivered services. Corn et al.9 reported the total patient and pharmacist time when performing point-of-care testing (POCT) for group A streptococcus and prescribing based on the test results was 25.3 and 12.7 minutes, respectively. Klepser et al.10 found that trained pharmacy technicians performing the simple POCT and collecting vital signs can further reduce the pharmacist time performing the group A streptococcus POCT service to 4.95 minutes. A pharmacist survey study reported that the
average wait period and vaccination time for a patient receiving a flu shot is approximately 12 minutes.17 In addition, Bright et al.18 found that the time to complete pharmacogenomics POCT in a medication optimization service was 9.49 minutes.18 Of note, our time results reflect similarly to those of previously implemented clinical services in community pharmacies. As evidenced by previous time and motion studies, pharmacy technicians can play a key role in supplementing pharmacist prescribing activities by performing the technical functions of the service such as collecting vital signs.16,18 States considering legislative action and administrative rule promulgation to allow pharmacist prescriptive authority for hormonal contraception should consider language that does not preclude trained pharmacy technicians from aiding the pharmacist in the delivery of the service.19,20 Conclusion The captured time categories indicate that a pharmacist hormonal contraception prescribing service can successfully be incorporated into a community pharmacy with modest disruption to workflow. To assess feasibility of the service fully, further study is needed for examining the time needed for complex patients, patient acceptance and demand of service, willingness to pay for service, and reimbursement for services provided. References 1. Adams AJ, Krystalyn KW. The continuum of pharmacist prescriptive authority. Ann Pharmacother. 2016;50(9):778e784. 2. California Legislative Information. SB 493 pharmacy practice. Available at: https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id¼2 01320140SB493. Accessed November 18, 2018. 3. Oregon State Legislature. HB 2879 enrolled. Available at: https://olis.leg. state.or.us/liz/2015R1/Downloads/MeasureDocument/HB2879/Enrolled. Accessed November 18, 2018. 4. National Alliance of State Pharmacy Associations. Pharmacists provide access to care: contraceptive prescribing. Available at: https://naspa.us/ resource/rph-access-contraceptives/. Accessed November 18, 2018. 5. Oregon Board of Pharmacy. Oregon pharmacists prescribing of contraceptive therapy. Available at: https://www.oregon.gov/pharmacy/Pages/ ContraceptivePrescribing.aspx. Accessed November 18, 2018. 6. Gardner JS, Miller L, Downing DF, Le S, Blough D, Shotorbani S. Pharmacist prescribing of hormonal contraceptives: results of the Direct Access study. J Am Pharm Assoc (2003). 2008;48(2): 212e226. 7. Rodriguez MI, Anderson L, Edelman AB. Pharmacists begin prescribing hormonal contraception in Oregon: implementation of House Bill 2879. Obstet Gynecol. 2016;128(1):168e170. 8. Anderson L, Borgelt LM, Clark P, Moore G. Encouraging comprehensive and consistent pharmacist education for provision of contraception. J Am Pharm Assoc (2003). 2018;58(1):113e116. 9. Corn CE, Klepser DG, Dering-Anderson AM, Brown TG, Klepser ME, Smith JK. Observation of a pharmacist-conducted group A streptococcal pharyngitis point-of-care test: a time and motion study. J Pharm Pract. 2018;31(3):284e291. 10. Klepser D, Dering-Anderson A, Morse J, Klepser M, Klepser S, Corn C. Time and motion study of influenza diagnostic testing in a community pharmacy. Innov Pharm. 2014;5(2). Article 159. 11. Wittock K, O’Conner S, McKay K, Garrett B. Feasibility of incorporating a pharmacist-prescribed hormonal contraception program into the workflow of a community pharmacy. Poster presented at: American Pharmacist Association 2018 Annual Meeting; March 16-19, 2018; Nashville, TN. 12. Tarn DM, Paterniti DA, Kravitz RL, et al. How much time does it take to prescribe a new medication? Patient Educ Couns. 2008;72(2):311e319. 13. Tai-Seale M, McGuire TG, Zhang W. Time allocation in primary care office visits. Health Serv Res. 2007;42(5):1871e1894.
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14. Chen LM, Farwell WR, Jha AK. Primary care visit duration and quality: does good care take longer? Arch Intern Med. 2009;169(20): 1866e1872. 15. Carr-Hill R, Jenkins-Clarke S, Dixon P, Pringle M. Do minutes count? Consultation lengths in general practice. J Health Serv Res Policy. 1998;3(4):207e213. 16. Abbo ED, Zhang Q, Zelder M, Huang ES. The increasing number of clinical items addressed during the time of adult primary care visits. J Gen Intern Med. 2008;23(12):2058e2065. 17. Prosser LA, O’Brien MA, Molinari NA, et al. Non-traditional settings for influenza vaccination of adults: costs and cost effectiveness. Pharmacoeconomics. 2008;26(2):163e178. 18. Bright DR, Klepser ME, Murry L, Klepser DG. Pharmacist-provided pharmacogenetic point-of-care testing consultation service: a time and motion study. J Pharm Technol. 2018;34(4):139e143. 19. Adams AJ. Advancing technician practice: deliberations of a regulatory board. Res Social Admin Pharm. 2018;14(1):1e5.
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20. Adams AJ. Pharmacist delegation: an approach to pharmacy technician regulation. Res Social Admin Pharm. 2018;14(5):505. Timothy P. Frost, PharmD, Pharmacy Regulatory Affairs Advisor, CVS Health, Portland, OR; and Affiliate Instructor of Pharmacy Practice, School of Pharmacy, Pacific University, Hillsboro, OR; at time of this work: Regulatory Affairs and Academia Fellow, School of Pharmacy, Pacific University, Hillsboro, OR Donald G. Klepser, PhD, MBA, Associate Professor and Vice Chair, Department of Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE Danielle C. Small, PharmD, Postgraduate Year 2 Resident, William S. Middleton Memorial Veterans Hospital, Madison, WI; at the time of this work: Academic and Ambulatory Care Fellow, School of Pharmacy, Pacific University, Hillsboro, OR Ian C. Doyle, PharmD, FOSHP, Associate Professor and Assistant Dean for Pharmacy Practice, School of Pharmacy, Pacific University, Hillsboro, OR
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
RESEARCH NOTES
Time and motion study of pharmacist prescribing of oral hormonal contraceptives in Oregon community pharmacies Timothy P. Frost*, Donald G. Klepser, Danielle C. Small, Ian C. Doyle a r t i c l e i n f o
a b s t r a c t
Article history: Received 5 June 2018 Accepted 9 December 2018
Objectives: The aim of this time and motion study was to evaluate the procedural time and steps of performing an oral hormonal contraceptive pharmacist prescribing service in an Oregon community pharmacy. Methods: A standardized patient seeking oral hormonal contraception visited 13 community pharmacies throughout February 2018 in the tri-county Portland, Oregon, metropolitan area for pharmacist-prescribed hormonal contraception services for a total of 26 patient encounters. An observer was present at each encounter to record the time for each step and the total encounter time. Each pharmacist was asked to perform assessment procedures and prescribing for each of 2 standardized patient presentations: in cohort 1 (n ¼ 13), the pharmacist’s assessment resulted in a hormonal contraception prescription written; in cohort 2 (n ¼ 13), pharmacist’s assessment detected contraindications and resulted in a medical referral to another health care prescriber. Results: The average total patient time from arrival at the pharmacy to the generation of either a written prescription for hormonal contraception or referral to another health care provider was 17.9 and 14.1 minutes, respectively. Without accounting for documentation or dispensing the prescription, the average total pharmacist time to perform the service and issue a prescription, or refer the patient, was 7.8 and 5.4 minutes, respectively. Conclusion: The results indicate that the pharmacist prescribing service for oral hormonal contraception requires a modest amount of pharmacist time. Incorporation of practice into regular workflow appears to have an impact similar to other clinical services, such as immunizations and point-of-care testing. The patient time spent with the pharmacist was similar to other health care provider visits. © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Pharmacist prescriptive authority for hormonal contraception has gained significant momentum across the United States in recent years. In at least 17 states, pharmacists have the authority to enter into a population-specific collaborative practice agreement or collaborative drug therapy agreement with a partnering prescriber to provide hormonal contraception services.1 While SB 493 (2013) in California was the first legislation to statutorily authorize autonomous pharmacist prescribing of hormonal contraception, the implementation of HB 2879 (2015) in Oregon made it the first state to pass legislation and promulgate administrative rules to allow
Disclosure: The authors declare no conflicts of interest or financial interests in any product or service mentioned in this article. Previous presentation: Abstract presented previously at the American Pharmacists Association Annual Meeting, March 19, 2018, Nashville, TN. * Correspondence: Timothy P. Frost, PharmD, Pacific University School of Pharmacy, 222 SE Avenue, Hillsboro, OR 97123. E-mail address: [email protected] (T.P. Frost).
pharmacists to offer the service throughout the state.2,3 Since then, 4 additional statesdColorado, New Mexico, Hawaii, and Marylanddhave followed suit passing similar legislation giving pharmacists autonomous prescribing authority for hormonal contraceptives.4 Under Oregon administrative rules, a qualified pharmacist following standard procedures algorithm and medical eligibility criteria can prescribe and dispense injectable hormonal contraceptives or self-administered hormonal contraceptives to a patient who has completed the Oregon self-screening risk assessment questionnaire.5 Many of the other states have similar requirements for patient self-screening questionnaires, standard procedures algorithm, and application of medical eligibility criteria for contraceptive use. The Oregon prescribing process was predicated on evidence that pharmacist prescribing of hormonal contraception, without a physician's visit, safely improves access to contraception.6-8 In practice, a pharmacist will review the patient’s medical history and assessment of current health, resulting in
https://doi.org/10.1016/j.japh.2018.12.015 1544-3191/© 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
SCIENCE AND PRACTICE T.P. Frost et al. / Journal of the American Pharmacists Association xxx (2019) 1e6
providing the patient either a hormonal contraception prescription or referral to an appropriate health care provider. The purpose of this time and motion study is to evaluate the procedural time of performing a hormonal contraceptive pharmacist prescribing service in a community pharmacy. Methods The methods used in this study mirror previous community pharmacyebased time and motion studies that examined point-of-care testing services.9,10 Researchers contacted every independent pharmacy, mass-merchant grocery chain pharmacy, retail chain pharmacy, and hospital outpatient pharmacy district manager. For those pharmacy companies who provided consent and authorization to conduct the study in their pharmacies, selection of individual outlets was based on company name, location, and business hours. This time-andmotion study was conducted at 13 community pharmacy locations throughout February 2018 in the tri-county (Clackamas, Multnomah, Washington) Portland, Oregon, metropolitan area for a total of 26 patient encounters. Participating community pharmacy settings were classified according to the patient’s experience and included 5 retail chain, 5 mass merchant, and 3 hospital outpatient community pharmacies. A single standardized patient (i.e., a female postgraduate pharmacist learner, with script for encounter) was used to portray a patient seeking hormonal contraception at the participating pharmacies. The patient presented to each pharmacy location twice, each with 1 of 2 standardized presentations: cohort 1, uncomplicated patient history and pharmacist’s assessment resulting in a hormonal contraception prescription written; and cohort 2, complicated patient history and pharmacist’s assessment resulting in a medical referral to another health care provider. Pharmacists working at the time of the research visit were not informed of such upcoming patient encounters. Visits were made without the investigator’s knowledge of or regard for staffing or workload levels. On some occasions, the same pharmacist at that location made the evaluation of the 2 distinctly different patient scenarios, albeit not on the same date or time. A researcher trained in time and motion study methodologies observed patient visits. This study used the direct observation and timing techniques used in a traditional time and motion study, but the nature of this observed service, which lacks clearly defined steps, makes our study design a hybrid between a time and motion and a work-sampling study. The Pacific University Institutional Review Board approved the study. The methodologies for conducting this study were as follows. Each simulated encounter was divided into 9 timed categories. The time of the entire encounter was documented. Timed categories included: 1. Patient arrives and waits to be served 2. Initial contact with pharmacy staff member 3. Patient completion and intake of completed Oregon standardized self-screening assessment questionnaire 4. Waiting time until assessment initiated by pharmacist 5. Blood pressure measurement 6. Evaluation of patient history, method preference, and current method
2
7. Pharmacist and patient choose contraception method 8. Discuss initiation strategy for treatment 9. Discuss and provide visit summary and prescription or referral The first timed category encompassed the time from the patient’s arrival at the community pharmacy counter until a member of the pharmacy staff acknowledged the patient’s presence. Once the patient’s presence was noted, timing of the second category began. This category included the discussion between the technician and patient about what brought the patient into the pharmacy. When the patient asked for hormonal contraception, the technician provided the patient with the Oregon standardized self-screening assessment questionnaire necessary for the pharmacist assessment. As the patient completed the questionnaire, the third timing category began and included the time it took for the patient to complete the questionnaire and the time for the technician to acknowledge and intake the completed questionnaire. The fourth timing category captured the patient time spent waiting in the waiting area or consultation room of the pharmacy until the pharmacist arrived for the patient assessment. The fifth timing category, which is the first with active participation by the pharmacist, began when the pharmacist performed the blood pressure assessment in the private area or consultation room. The sixth timing category started when the pharmacist reviewed and clinically evaluated the patient history from the self-screening questionnaire, contraception preference, and current contraception method. The start of the seventh timing category was signaled when the pharmacist began discussing and deciding what brand or generic drug name and quantity of oral contraceptive to prescribe considering the patient’s preference and medical history. The eighth timing category was defined as the time that the pharmacist spent counseling the patient how to initiate and adhere to oral contraception therapy safely and effectively. The final, ninth timing category timed the pharmacist discussing and providing a visit summary that included either a written prescription or referral to another health care provider, depending on the results of the pharmacist assessment in category 6. This study did not include the time necessary to process and dispense an oral hormonal contraceptive prescription, because that would be part of the existing pharmacy workflow. It would be no different from the pharmacy filling an oral hormonal contraceptive prescription brought in by a patient who had been seen by another health care prescriber. For dataanalysis, the time spent in each of the 9 timing categories for each cohort was assigned to the pharmacist or patient. The different allocated time measurements to the pharmacist and patient can be seen in Table 1. The standardized patient was a 26-year-old woman asking for a new hormonal contraceptive prescription, with no preferences beyond that of a daily pill, and did not ask questions unless prompted by the pharmacist. In cohort 1, her presentation to the pharmacist is characterized as an uncomplicated patient with no medical history requiring intervention and no previous use of hormonal contraception pills. In cohort 2, her presentation to the pharmacist is characterized as a patient with significant migraines with aura and history of medication nonadherence. If migraine with aura is present, the medical eligibility criteria and standard
Table 1 Grouping of pharmacist and patient time Cohort 1: pharmacist prescribes Oregon self-screening risk assessment questionnaire Selected “a daily pill” as the preferred method Selected “no” to all background questions Selected “no” to all medical history questions Selected “no” to all pregnancy screen questions When the pharmacist recommended combined oral contraception pills as an option, the patient verbally indicated agreement with that method of contraception
Pharmacist time (5) Blood pressure measurement (6) Evaluation of patient history, preference, and current method (7) Pharmacist and patient choose contraception method (8) Discuss initiation strategy for treatment (9) Discuss and provide visit summary and prescription or referral
Selected “a daily pill” as the preferred method Selected “no” to all background questions Selected “yes” on migraine headaches Selected “yes” on headaches that start with warnings or symptoms Selected “no” to all pregnancy screen questions When the pharmacist recommended progestin-only pills or depot medroxyprogesterone acetate as an option, the patient verbally indicated a history of medication nonadherence and denied the depot injection method
Patient time
Pharmacist time
Patient time
(1) Patient arrives and waits to be served (2) Initial contact with pharmacy staff member (3) Patient completion and intake of completed Oregon standardized self-screening assessment questionnaire (4) Waiting time until assessment initiated by pharmacist (5) Blood pressure measurement (6) Evaluation of patient history, preference, and current method (7) Pharmacist and patient choose contraception method (8) Discuss initiation strategy for treatment (9) Discuss and provide visit summary and prescription or referral
(5) Blood pressure measurement (6) Evaluation of patient history, preference, and current method (9) Discuss and provide visit summary and prescription or referral
(1) Patient arrives and waits to be served (2) Initial contact with pharmacy staff member (3) Patient completion and intake of completed Oregon standardized self-screening assessment questionnaire (4) Waiting time until assessment initiated by pharmacist (5) Blood pressure measurement (6) Evaluation of patient history, preference, and current method (9) Discuss and provide visit summary and prescription or referral
Pharmacist prescribing service for oral hormonal contraception
Cohort 2: pharmacist refers Oregon self-screening risk assessment questionnaire
SCIENCE AND PRACTICE
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Table 2 Time to perform the service Timed categories
Time (seconds) Visit outcome: prescription
Patient arrives and waits to be served Initial contact with pharmacy staff member Patient completion and intake of completed questionnaire Waiting time until assessment initiated by pharmacist Blood pressure measurement Evaluation of patient history, preference, and method Pharmacist and patient choose contraception method Discuss initiation strategy for treatment Discuss and provide visit summary and prescription or referral Total patient time for patient encounter Total pharmacist time for patient encounter
procedures algorithm allow a pharmacist only to prescribe progestin-only pills or depot medroxyprogesterone acetate. In this cohort the pharmacist assessment and evaluation of the patient’s nonadherence and contraceptive method preference elicited a referral to another health care provider. The patient indicated all significant medical history by answering yes or no when completing the Oregon self-screening risk assessment questionnaire, as retrieved on the Oregon Board of Pharmacy website.5 Details of each patient encounter are described in Table 1. Results Twenty-six simulated patient visits were completed using the standardized patient at the 13 pharmacy locations. All visits took place over 7 weekdays in February 2018 between 9:00 AM and 6:00 PM. The timed results from the 13 pharmacies in this time and motion study are presented in Table 2 (time measured in seconds). The results of the 13 visits in the prescribing cohort indicate that the average total time to complete the entire patient encounter was 17.9 ± 4.5 minutes (range, 12.9-27.8 minutes). Of that composite time, the average time it took for the pharmacist to perform the patient assessment, evaluate patient history, choose contraception, discuss initiation strategy, and provide visit summary and written prescription was 7.9 ± 2.1 minutes (range, 4.4-10.9 minutes). Encounters in which the pharmacist assessment resulted in prescribing, pharmacists were involved in 44% of the encounter. The 3 most time-consuming steps for the pharmacist were performing the blood pressure assessment, evaluating patient history, and discussing contraception initiation strategy. The results of the 13 visits in the referral cohort indicate that the average total time it took to complete the entire patient encounter was 14.1 ± 3.8 minutes. Of that composite time, the average time it took for the pharmacist to perform the patient assessment, evaluate patient history, and provide a visit summary and refer to another health care provider was 5.4 ± 1.1 minutes. Encounters in which the pharmacist assessment resulted in a referral to another health care provider, pharmacists were involved in 38.3% of the encounter. Of note, the timing category with the most variability in both the prescribing and referral cohorts was the patient’s time spent waiting for the pharmacist assessment, with a minimum of 5 seconds and a maximum of 11.9 minutes. 4
75 79 252 198 134 118 45 140 34 1075 471
± ± ± ± ± ± ± ± ± ± ±
101 37 47 234 37 56 25 53 21 269 127
Visit outcome: referral 91 107 160 167 113 147 N/A N/A 63 849 323
± ± ± ± ± ±
97 75 42 222 22 67
± 30 ± 227 ± 68
Discussion Evaluating an uncomplicated patient for oral hormonal contraceptives in a community pharmacy using the Oregon standardized self-screening assessment questionnaire takes an average of 17.9 minutes. When evaluating this result and using it, for example, to assess methods for improving pharmacy workflow, it is important to recognize the limitations of this study. A primary limitation is the nonblinded study design with the presence of the observer. While the observer did not interact directly with the pharmacy staff members, they were aware of his presence. This awareness might have increased the anxiety of the staff members and thus affected the speed at which they performed the service activities. The use of a standardized patient ensured that all presentations were equal for each encounter; this enabled accurate time and motion data collection for each encounter and at each type of pharmacy. Pharmacists may have changed their normal patient interaction techniques when relating to a “fictitious” patient, compared with that of a “real” patient. Although the standardized patient was portrayed by a postgraduate pharmacist learner, the prescribing pharmacist was not aware of this. There might have been bias introduced to the portrayal of the patient secondary to her increased knowledge of contraceptive methods and shortened time to complete the survey because of her familiarity and repeated use of it. Another limitation relates to the third timing category (i.e., patient completion and intake of completed Oregon standardized self-screening assessment questionnaire). From the description above, it is evident this category required some pharmacist time for questionnaire intake, but it was minimal compared with the time the patient spent talking with other pharmacy staff members and filling out the self-screening questionnaire. Although the third category included numerous steps within the pharmacy’s hormonal contraception prescribing workflow, the entire time spent in this category was grouped under patient time in the results of this study. This was due to the fact, in this real-life pharmacy setting, that the observer was unable to see all the individual steps occurring behind the counter. Because this category did not always have clearly defined times assigned to the pharmacist, it is recognized as a limitation of the study. Furthermore, it is unknown whether the pharmacist spent any time during timing category 4 (i.e., patient waiting until assessment initiated by pharmacist) reviewing and assessing the patient questionnaire before performing the patient assessment.
SCIENCE AND PRACTICE Pharmacist prescribing service for oral hormonal contraception
As noted previously, the variability of timing category 4 was along the continuum of 5 seconds to 11.9 minutes. Although the total patient time would not be affected, pharmacist time spent during timing category 4 would increase the net pharmacist time spent performing the service. It also should be recognized that our standard patient’s profile will likely have had an effect on net pharmacist time. A patient with more complicated medical history than our uncomplicated standardized patient, and asking more questions about therapy, would require additional assessment and counseling time by the pharmacist. In addition, while documentation of patient encounters and dispensing prescriptions is already a part of current pharmacy workflow, both require a pharmacist evaluation and thus would increase time. Although on some occasions the cohort scenarios were evaluated by the same pharmacist at a test pharmacy on a different date and time, each cohort scenario’s patient information was highly independent of the other. We do not expect that the timing of one scenario affected the other, but we cannot rule out the possibility of this as a confounding variable. Wittrock et al.11 presented results of a feasibility project of pharmacist-prescribed hormonal contraception in a community pharmacy with 18 simulated patient visits at 1 participating pharmacy. The timed categories also included and required documentation to be completed by the pharmacist during the visit and demonstrated that the pharmacist time to complete the prescribing service increased to 17.8 minutes. Taking our study limitations and the supplemental evidence from Wittrock et al.11 into account, the average pharmacist time to perform the service could be estimated as 15-20 minutes. The results of this analysis show that a hormonal contraception prescribing service in a community pharmacy requires time similar to that of other prescribing providers.12-16 During site evaluations, some pharmacists indicated that they have been trained and prescribing for a year, whereas others noted that they completed training during the month preceding our study procedures. In fact, a few pharmacists stated that the simulated standardized patient was the first “real” experience in providing the service. Many pharmacists indicated they had the self-screening risk assessment questionnaire, standard procedures algorithm, and medical eligibility criteria memorized, whereas a few pharmacists relied on reviewing the treatment algorithm and medical eligibility criteria with the patient. As such, some pharmacies were probably not at peak efficiency for the time and motion study. However, there was enough variation between pharmacies and visits to suggest the achievement of a fairly representative sample. When considering the possibility of incorporating hormonal contraception prescribing in a community pharmacy, it might be worth comparing it to the time required for other successful pharmacist-delivered services. Corn et al.9 reported the total patient and pharmacist time when performing point-of-care testing (POCT) for group A streptococcus and prescribing based on the test results was 25.3 and 12.7 minutes, respectively. Klepser et al.10 found that trained pharmacy technicians performing the simple POCT and collecting vital signs can further reduce the pharmacist time performing the group A streptococcus POCT service to 4.95 minutes. A pharmacist survey study reported that the
average wait period and vaccination time for a patient receiving a flu shot is approximately 12 minutes.17 In addition, Bright et al.18 found that the time to complete pharmacogenomics POCT in a medication optimization service was 9.49 minutes.18 Of note, our time results reflect similarly to those of previously implemented clinical services in community pharmacies. As evidenced by previous time and motion studies, pharmacy technicians can play a key role in supplementing pharmacist prescribing activities by performing the technical functions of the service such as collecting vital signs.16,18 States considering legislative action and administrative rule promulgation to allow pharmacist prescriptive authority for hormonal contraception should consider language that does not preclude trained pharmacy technicians from aiding the pharmacist in the delivery of the service.19,20 Conclusion The captured time categories indicate that a pharmacist hormonal contraception prescribing service can successfully be incorporated into a community pharmacy with modest disruption to workflow. To assess feasibility of the service fully, further study is needed for examining the time needed for complex patients, patient acceptance and demand of service, willingness to pay for service, and reimbursement for services provided. References 1. Adams AJ, Krystalyn KW. The continuum of pharmacist prescriptive authority. Ann Pharmacother. 2016;50(9):778e784. 2. California Legislative Information. SB 493 pharmacy practice. Available at: https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id¼2 01320140SB493. Accessed November 18, 2018. 3. Oregon State Legislature. HB 2879 enrolled. Available at: https://olis.leg. state.or.us/liz/2015R1/Downloads/MeasureDocument/HB2879/Enrolled. Accessed November 18, 2018. 4. National Alliance of State Pharmacy Associations. Pharmacists provide access to care: contraceptive prescribing. Available at: https://naspa.us/ resource/rph-access-contraceptives/. Accessed November 18, 2018. 5. Oregon Board of Pharmacy. Oregon pharmacists prescribing of contraceptive therapy. Available at: https://www.oregon.gov/pharmacy/Pages/ ContraceptivePrescribing.aspx. Accessed November 18, 2018. 6. Gardner JS, Miller L, Downing DF, Le S, Blough D, Shotorbani S. Pharmacist prescribing of hormonal contraceptives: results of the Direct Access study. J Am Pharm Assoc (2003). 2008;48(2): 212e226. 7. Rodriguez MI, Anderson L, Edelman AB. Pharmacists begin prescribing hormonal contraception in Oregon: implementation of House Bill 2879. Obstet Gynecol. 2016;128(1):168e170. 8. Anderson L, Borgelt LM, Clark P, Moore G. Encouraging comprehensive and consistent pharmacist education for provision of contraception. J Am Pharm Assoc (2003). 2018;58(1):113e116. 9. Corn CE, Klepser DG, Dering-Anderson AM, Brown TG, Klepser ME, Smith JK. Observation of a pharmacist-conducted group A streptococcal pharyngitis point-of-care test: a time and motion study. J Pharm Pract. 2018;31(3):284e291. 10. Klepser D, Dering-Anderson A, Morse J, Klepser M, Klepser S, Corn C. Time and motion study of influenza diagnostic testing in a community pharmacy. Innov Pharm. 2014;5(2). Article 159. 11. Wittock K, O’Conner S, McKay K, Garrett B. Feasibility of incorporating a pharmacist-prescribed hormonal contraception program into the workflow of a community pharmacy. Poster presented at: American Pharmacist Association 2018 Annual Meeting; March 16-19, 2018; Nashville, TN. 12. Tarn DM, Paterniti DA, Kravitz RL, et al. How much time does it take to prescribe a new medication? Patient Educ Couns. 2008;72(2):311e319. 13. Tai-Seale M, McGuire TG, Zhang W. Time allocation in primary care office visits. Health Serv Res. 2007;42(5):1871e1894.
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14. Chen LM, Farwell WR, Jha AK. Primary care visit duration and quality: does good care take longer? Arch Intern Med. 2009;169(20): 1866e1872. 15. Carr-Hill R, Jenkins-Clarke S, Dixon P, Pringle M. Do minutes count? Consultation lengths in general practice. J Health Serv Res Policy. 1998;3(4):207e213. 16. Abbo ED, Zhang Q, Zelder M, Huang ES. The increasing number of clinical items addressed during the time of adult primary care visits. J Gen Intern Med. 2008;23(12):2058e2065. 17. Prosser LA, O’Brien MA, Molinari NA, et al. Non-traditional settings for influenza vaccination of adults: costs and cost effectiveness. Pharmacoeconomics. 2008;26(2):163e178. 18. Bright DR, Klepser ME, Murry L, Klepser DG. Pharmacist-provided pharmacogenetic point-of-care testing consultation service: a time and motion study. J Pharm Technol. 2018;34(4):139e143. 19. Adams AJ. Advancing technician practice: deliberations of a regulatory board. Res Social Admin Pharm. 2018;14(1):1e5.
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20. Adams AJ. Pharmacist delegation: an approach to pharmacy technician regulation. Res Social Admin Pharm. 2018;14(5):505. Timothy P. Frost, PharmD, Pharmacy Regulatory Affairs Advisor, CVS Health, Portland, OR; and Affiliate Instructor of Pharmacy Practice, School of Pharmacy, Pacific University, Hillsboro, OR; at time of this work: Regulatory Affairs and Academia Fellow, School of Pharmacy, Pacific University, Hillsboro, OR Donald G. Klepser, PhD, MBA, Associate Professor and Vice Chair, Department of Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE Danielle C. Small, PharmD, Postgraduate Year 2 Resident, William S. Middleton Memorial Veterans Hospital, Madison, WI; at the time of this work: Academic and Ambulatory Care Fellow, School of Pharmacy, Pacific University, Hillsboro, OR Ian C. Doyle, PharmD, FOSHP, Associate Professor and Assistant Dean for Pharmacy Practice, School of Pharmacy, Pacific University, Hillsboro, OR