- Email: [email protected]
Development and pilot of a prescription drug monitoring program and communication intervention for pharmacists
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Contents lists available at ScienceDirect
Research in Social and Administrative Pharmacy journal homepage: www.elsevier.com/locate/rsap
Development and pilot of a prescription drug monitoring program and communication intervention for pharmacists Lindsey Alleya, Kevin Novaka, Tyler Havlina, Adriane N. Irwinb, Jody Carsona, Kirbee Johnstonb, Nicole O'Kanea, Daniel M. Hartungb,∗ a b
Comagine Health, 650 NE Holladay St., Suite 1700, Portland, OR, 97232, USA Oregon State University, College of Pharmacy, 2730 SW Moody Ave., Mailcode: CL5CP, Portland, OR, 97201, USA
A R T I C LE I N FO
A B S T R A C T
Keywords: Community pharmacist Opioid safety PDMP Communication Toolkit Training
Background: Pharmacists' role in addressing the opioid crisis continues to expand, but lack of training specifically related to standardized prescription drug monitoring program (PDMP) use and communication strategies for provider and patient interactions remains a significant issue. We developed the Resources Encouraging Safe Prescription Opioid and Naloxone Dispensing (RESPOND) Toolkit to enhance community pharmacists’ understanding of their role in addressing opioid safety; improve integration of PDMP into daily workflow; and enhance communication between pharmacists, prescribers, and patients. Objective: To describe the development of RESPOND Toolkit and summarize findings from initial pilot testing. Methods: RESPOND development was informed by focus groups with patients, prescribers, and pharmacists and an external advisory committee. Materials developed include a patient screening & communication algorithm, a provider communication checklist and an online continuing education course with three distinct modules. The RESPOND Toolkit was pilot tested in six community pharmacies in Oregon across two 6-month intervention phases. Pilot data collection included a pre-post intervention survey, pre-post knowledge assessment quizzes within the online course, and post-intervention semi-structured interviews. Interview feedback informed revisions after each phase to shape the final content, flow, and delivery of RESPOND. Results: Sixteen of 21 pharmacists completed the online training, revealing a large, significant effect on knowledge gain across the three training modules (pre-score 57, post-score 84; p < 0.001; Cohen's d = 1.85). Of these participants, 10 also completed the baseline and post intervention survey and showed non-significant moderate improvements in knowledge, perceived behavioral control, and self-efficacy to address opioid safety issues. Conclusion: The RESPOND Toolkit has promise as an effective and scalable approach to providing community pharmacist-tailored training, especially in the areas of effective communication and workflow integration, to promote behavioral shifts supporting opioid safety for patients. Further development and testing in a larger sample is warranted.
Introduction The current opioid crisis in America has led to the expansion of public health efforts across multiple settings, including community pharmacies.1 The pharmacists' role in addressing opioid safety has grown substantially over the past five years,2,3 with an increasing number of interventions focused on improving prescription drug monitoring program (PDMP) use in pharmacy settings4 and pharmacy-based naloxone distribution.5 Yet, important barriers remain in pharmacists’ willingness to engage with these initiatives and, most importantly, their
willingness to engage with patients and prescribers to address opioid safety concerns. Among the most often reported barriers are 1) lack of experience and education using the PDMP, 2) fear of instigating patient confrontations and physical altercations, 3) concerns about losing customers/business, and 4) inadequate time to engage with at-risk patients.6–9 Each of these four barriers stem from two common themes: lack of education in available resources and use of effective communication strategies.
∗ Corresponding author. Oregon State University, Oregon Health & Science University College of Pharmacy, 2730 SW Moody Avenue, Mailcode: CL5CP, Portland, OR, 97201, USA. E-mail address: [email protected] (D.M. Hartung).
https://doi.org/10.1016/j.sapharm.2019.12.023 Received 7 June 2019; Received in revised form 29 December 2019; Accepted 29 December 2019 1551-7411/ © 2020 Elsevier Inc. All rights reserved.
Please cite this article as: Lindsey Alley, et al., Research in Social and Administrative Pharmacy, https://doi.org/10.1016/j.sapharm.2019.12.023
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Fig. 1. RESPOND toolkit development process.
multiple states) lacked any formal training for registering or operating their state's PDMP. However, those who received targeted training held more favorable attitudes toward their state's program. Likewise, pharmacists who expressed positive attitudes toward PDMPs and greater knowledge were more likely to register for and use the information when assessing prescriptions. Pharmacists also report inadequate collaboration with prescribers.1,15,16 Prior studies reporting on pharmacist and prescriber perspectives indicate pharmacists are more likely to contact physicians regarding a PDMP report than the reverse, and that many lack confidence to provide recommendations to the prescribers in response to patient-specific situations.1,8,17,18 As pharmacists and prescribers begin using PDMPs more often and more consistently, coordination of care between medical offices and pharmacies becomes more of a focal point for policymaking, intervention and research. To date, a standardized protocol for pharmacists to record subjective and objective data from patients’ profiles and communicate follow-up/recommendations with a prescribing provider have not been identified, though decision-making
PDMP screening and prescriber follow-up in community pharmacies PDMPs serve as a resource for providers to access a patient's history with controlled substance prescriptions and assess whether the patient appears to be taking medication(s) as prescribed (e.g., at appropriate refill intervals), determine if the patient is receiving potentially dangerous uncoordinated prescriptions, and identify potential signs of diversion or misuse. PDMPs are active in nearly every jurisdiction in the country, however, evidence that they reduce can reduce overdose is mixed.10,11 Studies suggest PDMPs with features that mandate use by prescribers hold the most promise.12,13 Currently, 40 states mandate providers query the PDMP for specific circumstances and 19 states also mandate use by dispensers.14 Even with enrollment and use mandates, in most regions of the US the decision whether to use the PDMP depends solely on the pharmacists' discretion, unless their pharmacy has a store or corporate-level policy. A recent scoping review4 on pharmacists' PDMP-related attitudes, knowledge, and utilization revealed that a majority of pharmacists recruited across 15 studies (representing 2
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algorithms have been developed in this vein.19,20
Methods The RESPOND Toolkit was developed based on focus group and external advisor feedback and refined using two phases of pilot testing across six community pharmacies in Oregon with multiple waves of post-phase feedback (see Fig. 1). During the time period of this pilot study, PDMP registration and use by pharmacists was not state mandated in Oregon; though the pharmacy setting for the pilot mandated use in some locations. However, follow-up actions (e.g., patient or provider consultation, changes in dispensing) were not mandated nor were policies in place for how to use the PDMP reports. This research was reviewed and approved by the Oregon Health & Science University Institutional Review Board.
Motivational interviewing to reduce stigma and improve opioid safety counseling As critical as provider consultation is, when warranted, to protect patients' safety, it is equally important that pharmacists provide compassionate care to patients at risk for opioid-related harms. Pharmacists' concerns about having ineffective, limited time to devote to patient counseling for opioid safety and potential misuse speak in part to the lack of available resources and education available to them for honing effective, standardized communication techniques. In the case that a practitioner may only see a patient once, motivational interviewing (MI) has been endorsed as an effective strategy for intervention, especially if the alternative is no intervention at all.21 MI is an evidencebased, patient-centered counseling strategy which, by definition, is meant to be brief (typically 5–15 min).22 The purpose of MI is to explore and resolve ambivalence around an activity in a way that directs the patients' own language and thoughts toward achieving positive goals.23 Often used in cases of substance use disorders,24–27 MI employs a defined set of strategies to build provider-patient trust, reduce or mitigate potential difficult conversations, and elicit “change talk.” Thus, training in MI techniques to address opioid safety could at least build pharmacists’ confidence to address risky situations and reduce difficult patient interactions, and at best help motivate patients for whom opioid use disorder is a concern to engage in dialogue with their providers about the risks and benefits of opioid therapy and possibly seek treatment. Though a full MI encounter is rarely feasible in the community pharmacy setting due to time limitations, training in the principles of MI – given its inherent brevity and proven utility – provides a basic checklist of techniques that pharmacists can use at their own discretion to improve patient communication. While multiple interventions have been piloted to encourage pharmacists’ use of the PDMP, few have provided specific training for patient and provider communication strategies to address patient safety. The purpose of this manuscript is to describe the development and pilot testing of Resources Encouraging Safe Prescription Opioid and Naloxone Dispensing, or the RESPOND Toolkit for community pharmacists. The toolkit was designed to incorporate materials and online education to improve PDMP workflow as well as opioid safety communication and consultation with providers and patients, respectively. Fig. 1 describes the overall RESPOND development process which we describe in detail below.
Focus groups To inform development of RESPOND, we conducted focus groups with patients (N = 3 groups (4–8 participants per group); Mage = 60.1; 71% female), and online with community pharmacists (N = 2 groups (7–12 participants per group); Mage = 39.0; 58% female) and prescribers (N = 1 group (8 participants); Mage = 47.9; 75% female) using Qualboard™, a proprietary software platform that facilitates online focus groups (20|20 Research; Nashville, TN). All focus group participants were reimbursed $100 for their time. Focus group recruitment, methods, analyses, and results are described elsewhere.17 External advisory committee Simultaneous with focus group recruitment and execution, an external advisory committee (EAC) was formed to provide high-level insight into lesson planning, community pharmacy culture, and current state and national initiatives that could affect development and dissemination of the RESPOND Toolkit. The EAC was comprised of representatives from a patient safety organization, state and local public health departments, the board of pharmacy, practicing pharmacists and physicians with experience in the area of pain, emergency medicine, and addiction. Focus group scripts, online course lesson plans and learning objectives, video scripts, and toolkit materials were sent to the EAC for review. Participation in the EAC was voluntary, and members were not compensated for their time. Course development The online continuing education course for RESPOND was developed in collaboration with Oregon State University College of Pharmacy. Building upon information gleaned from focus group participants and EAC feedback, a course curriculum, learning objectives, course slides and narration scripts were developed by the research team. The resulting asynchronous online program (0.2 CEUs) serves as the backbone of the RESPOND Toolkit and contains three required, distinct modules totaling approximately 20 min each. An additional, optional module on naloxone prescribing, also approximately 20 min in length, was available to participants, as well as a printed algorithm and checklist for use in the store locations throughout the 6-month intervention period. The first module focuses on providing history and context for the opioid epidemic in the United States and current public health initiatives (e.g., prescription take-back day, disposal locations, referral programs). The second focuses specifically on PDMPs; their history, effectiveness, usability, and “best practice” recommendations toward greater efficiency and effectiveness. The third module is aimed at communication between pharmacists, prescribers, and patients; it addresses interaction strategies in terms of order of operations, recommendations for information gathering and sharing, modes of communicating, as well as MI-inspired communication techniques to use with patients at the point of care. Relevant quotes from pharmacists and
Theoretical background The framework for developing and evaluating the RESPOND Toolkit was based in the theory of planned behavior (TPB),28 which has been widely used in pharmacy research to predict behaviors like PMDP registration and use.4,29 The theory states that an individual's beliefs, perception of others' beliefs, and perceived control over barriers and facilitators regarding a behavior predict their attitudes, subjective norms, and perceived behavioral control to engage in said behavior. Interventions built on this framework aim to normalize and internally incentivize a target behavior while providing tools to reduce known barriers for engagement, with the goal of creating favorable behavioral attitudes and increased self-efficacy. In RESPOND, normalization and justification for PDMP use and patient-provider communication were provided through a multi-module online course. Barriers to communication were addressed through MI technique training (within course) and printed onsite workflow reference materials, and evaluation measures assessed changes in participants' attitudes, perceived behavioral control, and self-efficacy.
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prescription is in question, use of the PDMP is [6-point sliding scale] bad/good”), PDMP general attitudes (5 items; e.g., “In general, using the PDMP is [6-point sliding scale] useless/useful),29 and perceived behavioral control to address OUD (7 items; e.g., “I am confident in my ability to discuss perceived opioid abuse issues with my patients.“).9 The follow-up survey was administered six-months following introduction of the Toolkit. To the extent possible, previously published and reliable measures were used in the pilot survey. Each of these measures employed a Likert-style 6-option response scale indicating ‘Strong Agreement’ to ‘Strong Disagreement.’ Recruitment. The research team worked closely with the pilot pharmacy partners to identify six stores most appropriate for intervention piloting based on overall prescription fill rates, community need, and location. Locations with high prescription opioid distribution rates were selected. Two urban and one rural location were chosen for each wave, and site criteria review ensured that the pharmacy characteristics were roughly similar between phases. Each site had three staff pharmacists and one pharmacy manager. Participants were asked to read the full study protocol and provide informed consent in the opening page of the baseline online survey (passive consent process) before they could progress to the survey measures. Survey responses were confidential; identifying information was gathered to allow the research team to match pre/post responses and track post-intervention interviews and course participation. All identifying information was purged once participants had concluded their participation in the study. Phase 1 was limited to only staff pharmacists due to restrictions placed by the study partner; however, it was evident during Phase 1 that manager buy-in was a critical piece to efficient adoption of the intervention. Thus, in Phase 2 pharmacy managers were invited to participate. The total available sample size for the pilot was 21 participants. Participant Tracking. The modules were housed within a Learning Management System platform allowed the project manager and investigators to easily view participants’ registration, initiation, and progress throughout all elements of the course. This also included the average amount of time users spent in each module, quiz grades, and time lapse between completing one module and beginning the next. As a required part of registration, users had to supply their email address, name, and store number; which was replicated in the online survey used for pre/post data collection, allowing research staff to see who had completed their baseline survey, course modules, and post survey. Participants with more than a two-week lapse between completion of any component of the intervention were contacted by a member of the research team (dedicated point-person) and encouraged to complete the training/survey. This team member also recorded any changes to the employment status of participants, addressed general questions or technical issues, and invited those who completed all components to participate in a phone interview. Post-intervention Semi-structured Interviews. Immediately following the 6-month intervention period for both Phase I and Phase II, feedback about the RESPOND online course, printed algorithm and checklist were collected from participants via semi-structured telephone interviews conducted by one trained research associate with expertise in qualitative data collection. Recommendations for improvement were also solicited. Intervention participants who participated in the postintervention interview received a $100 incentive in the form of a check or online gift card (their choice). See Appendix A for the full interview guide. The purpose of these interviews was to gather pointed, actionable feedback to support revisions/improvements to the RESPOND Toolkit. A formal qualitative analysis of the interview feedback was not performed. Common feedback and themes from the interviews have been summarized in the results to provide context for RESPOND intervention adaptations between Phases and following Phase 2.
patients who participated in the focus groups are provided throughout the second and third modules, to provide a relatable voice to the training and enhance engagement and participation. The third module also includes a training video, written and produced by the research team, using common difficult scenarios to illustrate the benefits of using MI strategies to de-escalate a challenging conversation on opioid safety, collect subjective information from the patient, and build in time to communicate recommendations and concerns with their prescribing provider. During the timeline for this pilot, Oregon passed its law allowing pharmacists to prescribe naloxone; as such, a fourth optional module (no pre/post-test) was included in RESPOND which focused on indicators for naloxone prescribing and recommended counseling techniques and language. Materials development To accompany the RESPOND Toolkit's online course, printed materials were also created as resources to be displayed within community pharmacies. These include a printed, laminated algorithm to aid pharmacists in their decision-making process for when and why to screen opioid prescriptions with the PDMP, and how best to address patients with pain in typical and/or difficult situations. The order of operations outlined in the algorithm was informed directly from pharmacist and patient focus group feedback outlining workflows and usual care practices commonly employed by community pharmacists. For instance, the majority of pharmacist participants indicated that they use their in-house dispensing systems to perform initial patient and prescription review, so “Conduct Prescription Drug Utilization Review (DUR)” is listed as the first step in the RESPOND process. However, there was a great deal of ambivalence or lack of training for community pharmacists regarding when to access PDMP data, (e.g., many queried the PDMP solely to investigate potential diversion) so the research team proposed a “best practices” approach, outlining the specific information only attainable through the PDMP and what triggers should lead a pharmacist to conduct a thorough review. Communication strategies outlined at the base of the algorithm are reflective of those outlined in the third module of the online training and derived primarily from the principles of MI. Finally, a checklist was created for placement at pharmacists’ computer monitors or beside their phones. Whereas the algorithm focuses mainly on protocol and communication as regards patient care, the checklist is aimed at facilitating effective correspondence with prescribers. The SOAP Note strategy (an acronym for subjective, objective, assessment, and plan), is a common protocol taught to prescribers and clinical pharmacists as part of their career training. As such, the format was used as a framework for our checklist to outline a step-by-step process for community pharmacists to gather relevant information, communicate that information back to the prescriber or medical staff efficiently and effectively, and create a plan for patient care that includes all relevant parties. Pilot testing The RESPOND Toolkit was piloted in six community pharmacies within one large grocery chain in two 6-month phases, with the period between phases used to revise and refine toolkit materials. Each phase consisted of a baseline and follow-up survey – approximately 15 min in length – to capture the outcomes of interest for the intervention based in the framework of the TPB: attitudes toward opioid use disorder (OUD; 5 items; e.g., “Improving pharmacist-patient communication would deter opioid abuse”),8 practice self-efficacy (4 items; “I feel I have a clear idea of my responsibilities in helping patients who misuse prescription opioids.“),30 service barriers (5 items; I have insufficient access to screening tools to assess prescription opioid misuse.“),30 PDMP safety attitudes (5 items; e.g., “When the safety of an opioid
Analysis plan Survey Assessment. TPB-based survey data were collected through 4
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the Research Electronic Data Capture (REDCap) application, which is a secure web-based survey and database manager.31 Survey data were exported into and analyzed with IBM SPSS Statistics for Windows, Version 25.0 on a Windows PC. Email addresses (if provided), store numbers (if provided), and participant demographic information were used to match participants’ pre- (time 1) and post-intervention responses (time 2), in listed order of priority. Survey timestamps were used to define whether a response was pre- or post-intervention. Due to the small sample size in matched survey responses across pilot phases, participants used in survey analyses were collapsed into one group, controlling for phase. Continuous variables from the multi-item scales for attitudes, selfefficacy, and perceived behavioral control in PDMP utilization listed previously were analyzed in a series of paired samples t-tests. Due to small sample size, effect sizes are reported and are the primary metric used during the interpretation of results based in Cohen's d using pooled variance. This analysis was chosen because the time 1 and time 2 variances for each continuous variable are heterogeneous and Cohen's d allows a more conservative effect size estimate.32 Knowledge Assessment. In addition to the survey, pre and post knowledge quizzes were built into each course module to assess knowledge, and grades were captured within Learning Management System. These data were exported and analyzed using the paired samples t-test to evaluate for any within-person significant changes in knowledge before and after training. Similar to the survey data, effect size was calculated using Cohen's d for repeated measures t-test.
Table 2 Paired Samples t-test for Attitudes and Level of Self-Efficacy in PDMP Utilization and Opioid Use Disorder (OUD). All survey items use a 6-point Likert scale. SD is standard deviation.
5 (50%)
p-value
Cohen's dpooled
α
Attitude towards OUD - pre Attitude towards OUD - post Practice Self- Efficacy -pre Practice Self- Efficacy -post Service Barriers - pre Service Barriers - post PDMP Safety Attitude - pre PDMP Safety Attitude - post PDMP General Attitude - pre PDMP General Attitude - post Perceived Behavioral Control - pre Perceived Behavioral Control post
3.76 3.84 3.28 3.58 2.77 2.97 5.56 5.88 5.26 5.80 3.49 3.49
0.50 0.67 1.11 0.89 0.56 0.59 0.94 0.83 1.24 0.71 0.74 0.58
0.73
0.110
0.1
0.680
0.34
0.328
0.47
0.237
0.37
0.367
1.00
0.000
0.60 0.59 0.61 0.63 0.78 0.78 0.84 0.81 0.85 0.85 0.64 0.60
Knowledge assessment Overall, participants in the RESPOND online course showed significant improvement from baseline (mean score = 57.4, SD = 12.8) to post (mean score = 84.4, SD = 8.5; p= < 0.001). A calculation of Cohen's d for effect size in paired samples analysis revealed a large effect of the course on participant knowledge (Cohen's d = 1.85). Across the three modules, participants showed the lowest percentage of improvement in first module (16% improvement), which focused on the background of the epidemic. Grades on the second module revealed a 31% increase in scores; this module focused on PDMP workflow and safety triggers. The greatest improvement in scores was shown in the third module (36% improvement), which focused on communication strategies for provider and patient communication, using the SOAP note format and MI techniques, respectively. TPB-based Survey Assessment Table 2 summarizes results of the paired-samples t-test and effect size analyses for outcomes measuring attitudes, practice self-efficacy, perceived behavioral control, and barriers. Although there were no statistically significant changes in any of the six outcomes, as expected with a small sample size, four yielded moderate to high effect size values. Changes in practice self-efficacy yielded a moderately high effect size (Cohen's dpooled = 0.68) indicating that participants' confidence in addressing prescription opioid misuse increased from time 1 to time 2. Participants also perceived fewer service barriers post-intervention (Cohen's dpooled = 0.33), meaning that they felt they had more training, more screening tools, and more skills needed to help patients with prescription safety issues. Attitudes toward the PDMP as a safety tool also increased from time 1 to time 2 (Cohen's dpooled = 0.24), as did general attitudes toward the PDMP as an effective tool (Cohen's dpooled = 0.37).
Table 1 Self-reported participant demographics and practice characteristics (n = 10).
Female Race White Asian Education BS PharmD PDMP duration of use 1–2 years 3–5 years > 5 years Age Years in profession Hours worked per week Prescriptions filled per day PDMP queries per weeka
SD
intervention survey.
Of the approximately 18 pharmacists and 3 pharmacy managers (managers included in Phase 2 only; 21 potential participants) employed across six recruited pharmacies, 16 fully participated in the online course (Mage = 43; 81% pharmacy staff; 50% female). Of these, 10 completed both pre- and post-intervention participant surveys that were able to be reliably matched and participated in post-intervention interviews (Mage = 43; 60% pharmacy staff; 80% PharmD; Tables 1 and 2). Six participants’ survey data were unable to be used for analyses: two left their stores before completing the intervention, and the remaining four provided inconsistent identifying information to reliably match their pre/post responses. Participants reported querying the PDMP an average of 18 times a week, although there was marked variability between individuals that ranged from 1 to 100 queries per week. There were no significant differences between participant phases for pre/post module knowledge assessment or survey outcomes, or between baseline scores for those who did or did not complete the post-
Count (%)/Average (SD; range)
mean
Note. Cohen's d: 0.2 = small effect, 0.5 = medium effect, 0.8 = large effect.
Results
Characteristic
Measure (n = 10)
5 (50%) 5 (50%) 2 (20%) 8 (80%) 1 (10%) 5 (50%) 4 (40%) 41.4 (12.9; 31 to 66) 13.4 (13.4; 5 to 36) 33.6 (11.2; 8 to 40) 374 (115; 100 to 500) 18.1 (31.3; 1 to 100)
Post-intervention feedback and toolkit revisions/finalization Phase 1 Participant Feedback Summary. Phase 1 interview participants’ feedback (N = 4) indicated that the guidance around mitigating difficult conversations and prescriber outreach were the most favored aspects of the training and materials. One site that had strong managerial support for participation yielded more favorable views of the training and onsite materials. Most pharmacists indicated that the information in the first module was less useful, as it was primarily a
a Estimate of how many times per week participants query the PDMP during their clinical practice.
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workflow, findings from preliminary focus groups with patients, pharmacists, and prescribers revealed an additional need for training in communication strategies. Thus, the final RESPOND Toolkit ultimately included three required online training modules tailored to community pharmacists to improve knowledge of the opioid crisis, PDMP use and workflow, and pharmacist-patient and pharmacist-prescriber communication techniques based in MI. Reorientation of RESPOND to emphasize communication strategies also acknowledges that the PDMP is just one facet of providing safe and compassionate care to patients who may be at higher risk for opioid-related harms. As PDMPs, and the evidence supporting their effectiveness, evolve it will be important reevaluate how pharmacists incorporate them in their practice. Across phases of testing, results indicate the strongest gains were in participant knowledge and self-efficacy, with smaller positive effects on attitudes and perceived practice barriers to providing opioid safety consultation. As expected with a small sample size, the majority of results – though showing moderate and strong effect sizes – were nonsignificant, though significant large gains were made in knowledge through the online training. During interviews, participants indicated that the checklist and algorithm were useful tools for practice, though pharmacy managers varied in their ability to consistently post and encourage use of these materials onsite. Some felt the bulk of the online course would be best suited to new hires and/or recent pharmacy graduates, as the basic opioid safety and PDMP information was redundant with their current knowledge. Many reported that they increased use of the PDMP as a result of participating in the course and that they now feel more confident engaging with patients and especially prescribers regarding opioid safety concerns. MI was chosen as the optimal communication strategy on which to build the RESPOND Toolkit due to its proven effectiveness in substance use interventions, ability to be delivered in brief sessions (5–15 min), and ability to reduce stigmatization and empower patients. MI has been shown effective even when used by providers who are non-specialists in substance use treatment.26 It is important to note that in MI, the counselor is directing the conversation, but the patient should be doing the work to resolve their own ambivalence and create a plan toward change. For RESPOND, MI strategies are recommended to encourage the patient to ask questions about their own safety, learn more about opioid risks, and allow time for the pharmacist to consult with their prescribing provider. Common MI communication strategies that were encouraged in the RESPOND Toolkit include use of open-ended questions (e.g., “What do you currently know about … ?“), reflective listening (e.g., “It sounds like you may be concerned about …“), asking permission before giving advice/resources (e.g., “Would it be okay if I offer you … ?“), normalizing client concerns (e.g., “Many people say they feel the way you do, and are having a hard time, too.“), and providing affirmations for change talk (e.g., “I really like that you are thinking about your safety. That is the most important thing.“). In the RESPOND online course, a video produced by the research team is used to illustrate the effective implementation of these strategies to mitigate a difficult opioid safety conversation. As pharmacists' roles continue to expand to address the current opioid crisis, tools and resources to improve workflow, attitudes, and self-efficacy are increasingly necessary to improve the experiences of pharmacists and their patients. By enhancing and streamlining opioid safety workflow, pharmacists are more likely to engage with the PDMP using defined, objective criteria, and more confident in their understanding of its importance as a resource. By improving pharmacists’ consultation/communication skills, they become more willing to engage in potentially difficult opioid safety conversations with patients at high-risk. A growing literature indicates communication-based interventions like RESPOND are increasingly needed in community pharmacy practice to accompany the current and increasing opioid safety and harm reduction tasks being asked of pharmacists. Echoing earlier work by Hagemeier et al.8 and Lafferty et al.,33 a recent qualitative study by Fleming and colleagues identified several factors that inhibit
review of known opioid statistics and initiatives. Pharmacists liked the training video in third module, and some indicated that the video made them feel more confident to engage in conversations with patients. Others felt the SOAP note checklist and prescriber communication strategies were the most empowering toward change. Participants were divided about the audience that would most benefit from the materials. Some felt the materials would be most useful for new pharmacists who are integrating opioid safety into their training currently, while others felt it would be best for senior pharmacists who may be more hesitant to engage with screening resources and additional training. Two pharmacists found it difficult to access and navigate the online training program. Post-Phase 1 Revisions. Following feedback from the Phase 1 pilot interviews, multiple changes were made to the RESPOND format. The course modules were shortened as appropriate, and the information was updated to reflect current statistics and guidelines. In response to usability feedback, the research team identified a different learning management system to host the full training and toolkit package with improved branding and cohesion to improve access and navigation issues. Finally, the messaging on the printed materials was reduced and altered to include fewer subjective safety triggers and include references for naloxone prescribing/distribution. One change was also made to the pilot protocol: it was determined that pharmacy managers should be included as participants in Phase 2, to improve dissemination and buy-in among pharmacists in the recruited sites. Phase 2 Participant Feedback Summary. Following the Phase 2 pilot phase, all interviewees (N = 6) felt that the course covered information they already knew but felt it was a nice refresher. Three respondents specifically said that they would recommend the course and particularly to new pharmacists. All of the respondents agreed that the printed algorithm and checklist were useful, clearly written, and easy to follow. Two of the interviewees mentioned that the communication-related education was especially useful. One said that the training had helped them approach prescribers without making prescribers defensive, by emphasizing patient safety as their top priority. Another respondent felt that the training helped them to approach patients in a non-confrontational manner and mentioned that they now feel more comfortable discussing naloxone with patients. Three of the participants mentioned that since the training, they are using the PDMP more frequently, both when receiving a new opioid prescription and when preparing to contact a prescriber. All three mentioned working to incorporate the PDMP into their daily workflows. One interviewee explained that they now use the PDMP with every opioid prescription and feel like this kind of education highlights the importance of incorporating the PDMP into pharmacist workflows. Phase 2 Finalization. Feedback from Phase 2 interviews confirmed that the messaging in the course, algorithm, and checklist were appropriate and helpful for facilitating improved reporting and communication behaviors. To improve the scalability and endurance of the toolkit, slides were removed that contained data or information that were either state- or time-specific. A graphic design team was hired to finalize all toolkit materials to improve aesthetic appeal and streamline the information presented. The final RESPOND Toolkit is now available free of charge on its independent website (www.pharmacistrespond. org) or through the Oregon State University College of Pharmacy for continuing education for a nominal charge to support administrative costs (no member of the research team receives compensation from the course). Fig. 2 illustrates suite of RESPOND Toolkit resources. Discussion The RESPOND Toolkit was developed and refined through multiple rounds of feedback from external advisors and community pharmacists gathered over a three-year period, from 2015 through 2018. Although the original purpose of toolkit development was to create a package of resources and trainings to promote improved PDMP knowledge and 6
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Fig. 2. Suite of RESPOND toolkit resources.
evaluations of this intervention will require a larger sample across multiple pharmacies, ideally including a variety of community pharmacy settings (e.g., grocery store, independent pharmacies) and/or chains, to establish whether these positive outcomes are generalizable. Though objective changes in knowledge were assessed in the RESPOND pilot, additional objective outcomes such as PDMP queries and store dispensing patterns should be considered in a large-scale follow-up evaluation. Elements of the RESPOND Toolkit have been adapted into a new educational intervention, RESPOND TO PREVENT (https:// respondtoprevent.org) which is currently being tested in a large cluster randomized trial in four states in two larger pharmacy chains. Further, the level of engagement from pharmacy managers varied between sites. Some were enthusiastic to have their staff trained while others viewed it as burdensome given their limited time. Research staff encouraged participation and buy-in with repeated phone call and email reminders. Because the effectiveness of the full toolkit relies upon the presence and use of the on-site tools, the intervention may have been hindered in stores where managers failed to promote these tools. Future evaluations should consider asking pharmacists to participate in the online training and consider the tools on their own time by providing incentives for training completion; in this pilot, pharmacists participated in all elements while at work and were only incentivized for surveys and interviews. Moreover, for non-independent pharmacies (chain, grocery store) leadership Buy-in is vital to ensure pharmacist training is encouraged and supported. Finally, this pilot – as with all
community pharmacists from engaging patients who may be misusing prescriptions opioids.34 Lack of training and time constraints were among commonly identified barriers addressed through resources embedded in RESPOND. Although schools of pharmacy have modestly increased substance use education in their curriculum,35 there remains an urgent need to provide education and training for practicing pharmacists. Similar to RESPOND, efforts by Strand et al.36 and Rickles et al.37 also provide a structured framework to identify and manage potential prescription opioid misuse in a community pharmacy setting. Although these pilot projects are promising, the effectiveness of these approaches needs to be evaluated across a diversity of community pharmacy practice settings.
Limitations There were several challenges and limitations during the development and pilot testing process for RESPOND. First, study sites for testing RESPOND were purposefully selected by the research team and corporate management. Consequently, participants may not reflect practice or attitudes of pharmacists practicing in other settings and may have been more amendable to this type of practice-based research. Though results of the RESPOND Toolkit pilot indicated moderate to large effects on knowledge and self-efficacy, with significant gains in knowledge, the limited sample size of the toolkit pilot precludes the ability to make substantial claims about these impacts. Future 7
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current opioid safety interventions – was limited by historical context. The toolkit was developed and tested in 2016–2017, overlapping with the release of the CDC Guidelines for Prescribing Opioids for Chronic Pain38 in addition to multiple other opioid safety initiatives at the federal, state, and community-level. Thus, when Phase I of the toolkit rolled out pharmacists were less educated on PDMP use and general opioid safety recommendations than they were at the start of Phase 2; community pharmacists now, as pharmacy-based naloxone continues to be promoted, are more educated still on opioid safety. However, the RESPOND Toolkit is unique in its promotion of MI-inspired communication, skills to mitigate difficult opioid safety conversations, and prescriber communication tools (e.g., SOAP Note Checklist) to boost pharmacists’ empowerment and self-efficacy to address concerns seen in PDMP reports. Thus, though the opioid safety and PDMP lessons may be perceived as increasingly unneeded, the communication components on which RESPOND relies heavily are timeless and critical as a refresher at every stage of employment.
References 1. Delcher C, Wang Y, Goodin A, Freeman PR, Reisfield GM. Rapid expansion of the opioid ecosystem: national implications for prescriber-pharmacist communication. Am J Prev Med. 2018;55:656–661. 2. Compton WM, Jones CM, Stein JB, Wargo EM. Promising roles for pharmacists in addressing the U.S. opioid crisis. Res Soc Adm Pharm. 2019;15:910–916. 3. Bach P, Hartung D. Leveraging the role of community pharmacists in the prevention, surveillance, and treatment of opioid use disorders. Addict Sci Clin Pract. 2019;14:30. 4. Johnston K, Alley L, Novak K, Haverly S, Irwin A, Hartung D. Pharmacists' attitudes, knowledge, utilization, and outcomes involving prescription drug monitoring programs: a brief scoping review. J Am Pharm Assoc. 2018;58:568–576. 5. Thakur T, Frey M, Chewning B. Pharmacist roles, training, and perceived barriers in naloxone dispensing: a systematic review. J Am Pharm Assoc. 2019;19:S1544–S3191. 6. Fleming ML, Barner JC, Brown CM, Shepherd MD, Strassels SA, Novak S. Pharmacists' training, perceived roles, and actions associated with dispensing controlled substance prescriptions. J Am Pharm Assoc. 2014;54:241–250. 7. Gavaza P, Fleming M, Barner JC. Examination of psychosocial predictors of Virginia pharmacists' intention to utilize a prescription drug monitoring program using the theory of planned behavior. Res Soc Adm Pharm. 2014;10:448–458. 8. Hagemeier NE, Murawski MM, Lopez NC, Alamian A, Pack RP. Theoretical exploration of Tennessee community pharmacists' perceptions regarding opioid pain reliever abuse communication. Res Soc Adm Pharm. 2014;10:562–575. 9. Hagemeier NE, Alamian A, Murawski MM, Pack RP. Factors associated with provision of addiction treatment information by community pharmacists. J Subst Abus Treat. 2015;52:67–72. 10. Fink DS, Schleimer JP, Sarvet A, et al. Association between prescription drug monitoring programs and nonfatal and fatal drug overdoses: a systematic review. Ann Intern Med. 2018;168:783–790. 11. Wilson MN, Hayden JA, Rhodes E, Robinson A, Asbridge M. Effectiveness of prescription monitoring programs in reducing opioid prescribing, dispensing, and use outcomes: a systematic review. J Pain. 2019;20:1383–1393. 12. Haffajee RL. Prescription drug monitoring programs — friend or folly in addressing the opioid-overdose crisis? N Engl J Med. 2019;381:699–701. 13. Wen H, Schackman BR, Aden B, Bao Y. States with prescription drug monitoring mandates saw A reduction in opioids prescribed to medicaid enrollees. Health Aff (Millwood). 2017;36:733–741. 14. TTAC P. http://www.pdmpassist.org/content/pdmp-maps-and-tables; 2019 Accessed February 9, 2019. 15. Curran GM, Freeman PR, Martin BC, et al. Communication between pharmacists and primary care physicians in the midst of a U.S. opioid crisis. Res Soc Adm Pharm. 2019;15:974–985. 16. Hagemeier NE, Tudiver F, Brewster S, Hagy EJ, Hagaman A, Pack RP. Prescription drug abuse communication: a qualitative analysis of prescriber and pharmacist perceptions and behaviors. Res Soc Adm Pharm. 2016;12:937–948. 17. Hartung DM, Hall J, Haverly SN, et al. Pharmacists’ role in opioid safety: a focus group investigation. Pain Med. 2018;19:1799–1806. 18. Hagemeier NE, Tudiver F, Brewster S, et al. Interprofessional prescription opioid abuse communication among prescribers and pharmacists: a qualitative analysis. Subst Abus. 2018;39:89–94. 19. Strand MA, Eukel H, Burck S. Moving opioid misuse prevention upstream: a pilot study of community pharmacists screening for opioid misuse risk. Res Soc Adm Pharm. 2019;15:1032–1036. 20. Rickles NM, Huang AL, Gunther MB, Chan WJ. An opioid dispensing and misuse prevention algorithm for community pharmacy practice. Res Soc Adm Pharm. 2019;15:959–965. 21. Rubak S, Sandbaek A, Lauritzen T, Christensen B. Motivational interviewing: a systematic review and meta-analysis. Br J Gen Pract. 2005;55:305–312. 22. Rollnick S, Heather N, Bell A. Negotiating behaviour change in medical settings: the development of brief motivational interviewing. J Ment Health. 1992;1:25–37. 23. Rollnick S, Miller WR. What is motivational interviewing? Behav Cognit Psychother. 1995;23:325–334. 24. Lundahl B, Moleni T, Burke BL, et al. Motivational interviewing in medical care settings: a systematic review and meta-analysis of randomized controlled trials. Patient Educ Couns. 2013;93:157–168. 25. Dunn C, Deroo L, Rivara FP. The use of brief interventions adapted from motivational interviewing across behavioral domains: a systematic review. Addiction. 2001;96:1725–1742. 26. Smedslund G, Berg RC, Hammerstrom KT, et al. Motivational interviewing for substance abuse. The Cochrane Database of Systematic Reviews. 2011; 2011 Cd008063. 27. Forman DP, Moyers TB. With odds of a single session, motivational interviewing is a good bet. Psychotherapy (Chic). 2019;56:62–66. 28. Ajzen I. The theory of planned behavior. Organ Behav Hum Decis Process. 1991;50:179–211. 29. Fleming ML, Barner JC, Brown CM, Shepherd MD, Strassels S, Novak S. Using the theory of planned behavior to examine pharmacists' intention to utilize a prescription drug monitoring program database. Res Soc Adm Pharm. 2014;10:285–296. 30. Cochran G, Field C, Lawson K, Erickson C. Pharmacists' knowledge, attitudes and beliefs regarding screening and brief intervention for prescription opioid abuse: a survey of Utah and Texas pharmacists. J Pharm Health Serv Res. 2013;4:71–79. 31. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform X. 2009;42:377–381. 32. Morris SB. Estimating effect sizes from pretest-posttest-control group designs. Organ
Conclusion The RESPOND Toolkit is a potentially effective and scalable approach to provide community pharmacists tailored training and resources promoting enhanced opioid safety workflow and patient communication. The tools contained therein have been thoroughly refined based on participant and expert feedback, and have been made freely available through a dedicated website (https://pharmacistrespond.org) or for Continuing Education credit through Oregon State University (https://pharmacy.oregonstate.edu/online_ce). Qualitative results from participant interviews indicated that pharmacists found the communication strategies and resources to be the most useful components for their daily work experience. Future evaluations of the RESPOND Toolkit should employ a larger sample size incorporating multiple pharmacy chains and provide incentives to reduce burden on the pharmacists’ workflow by allowing for training outside of working hours. Funding This work was supported by the Agency for Healthcare Research and Quality, USA (AHRQ 5R18HS024227-02). The funding source had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. CRediT authorship contribution statement Lindsey Alley: Conceptualization, Formal analysis, Project administration, Writing - original draft, Writing - review & editing. Kevin Novak: Formal analysis, Writing - review & editing. Tyler Havlin: Writing - review & editing. Adriane N. Irwin: Methodology, Writing review & editing. Jody Carson: Writing - review & editing. Kirbee Johnston: Formal analysis, Writing - review & editing. Nicole O'Kane: Conceptualization, Funding acquisition, Writing - review & editing. Daniel M. Hartung: Conceptualization, Funding acquisition, Supervision, Project administration, Methodology, Writing - review & editing. Declaration of competing interest None. Appendix A. Supplementary data Supplementary data to this article can be found online at https:// doi.org/10.1016/j.sapharm.2019.12.023. 8
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study of community pharmacists screening for opioid misuse risk. Res Soc Adm Pharm. 2019;15:1032–1036. 37. Rickles NM, Huang AL, Gunther MB, Chan WJ. An opioid dispensing and misuse prevention algorithm for community pharmacy practice. Res Soc Adm Pharm. 2019;15:959–965. 38. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain–United States, 2016. MMWR Recomm Rep (Morb Mortal Wkly Rep). 2016;315:1624–1645.
Res Methods. 2007;11:364–386. 33. Lafferty L, Hunter TS, Marsh WA. Knowledge, attitudes and practices of pharmacists concerning prescription drug abuse. J Psychoact Drugs. 2006;38:229–232. 34. Fleming ML, Bapat SS, Varisco TJ. Using the theory of planned behavior to investigate community pharmacists' beliefs regarding engaging patients about prescription drug misuse. Res Soc Adm Pharm. 2019;15:992–999. 35. Thomas K, Muzyk AJ. Surveys of substance use disorders education in US pharmacy programs. Ment Health Clin. 2018;8:14–17. 36. Strand MA, Eukel H, Burck S. Moving opioid misuse prevention upstream: a pilot
9
Contents lists available at ScienceDirect
Research in Social and Administrative Pharmacy journal homepage: www.elsevier.com/locate/rsap
Development and pilot of a prescription drug monitoring program and communication intervention for pharmacists Lindsey Alleya, Kevin Novaka, Tyler Havlina, Adriane N. Irwinb, Jody Carsona, Kirbee Johnstonb, Nicole O'Kanea, Daniel M. Hartungb,∗ a b
Comagine Health, 650 NE Holladay St., Suite 1700, Portland, OR, 97232, USA Oregon State University, College of Pharmacy, 2730 SW Moody Ave., Mailcode: CL5CP, Portland, OR, 97201, USA
A R T I C LE I N FO
A B S T R A C T
Keywords: Community pharmacist Opioid safety PDMP Communication Toolkit Training
Background: Pharmacists' role in addressing the opioid crisis continues to expand, but lack of training specifically related to standardized prescription drug monitoring program (PDMP) use and communication strategies for provider and patient interactions remains a significant issue. We developed the Resources Encouraging Safe Prescription Opioid and Naloxone Dispensing (RESPOND) Toolkit to enhance community pharmacists’ understanding of their role in addressing opioid safety; improve integration of PDMP into daily workflow; and enhance communication between pharmacists, prescribers, and patients. Objective: To describe the development of RESPOND Toolkit and summarize findings from initial pilot testing. Methods: RESPOND development was informed by focus groups with patients, prescribers, and pharmacists and an external advisory committee. Materials developed include a patient screening & communication algorithm, a provider communication checklist and an online continuing education course with three distinct modules. The RESPOND Toolkit was pilot tested in six community pharmacies in Oregon across two 6-month intervention phases. Pilot data collection included a pre-post intervention survey, pre-post knowledge assessment quizzes within the online course, and post-intervention semi-structured interviews. Interview feedback informed revisions after each phase to shape the final content, flow, and delivery of RESPOND. Results: Sixteen of 21 pharmacists completed the online training, revealing a large, significant effect on knowledge gain across the three training modules (pre-score 57, post-score 84; p < 0.001; Cohen's d = 1.85). Of these participants, 10 also completed the baseline and post intervention survey and showed non-significant moderate improvements in knowledge, perceived behavioral control, and self-efficacy to address opioid safety issues. Conclusion: The RESPOND Toolkit has promise as an effective and scalable approach to providing community pharmacist-tailored training, especially in the areas of effective communication and workflow integration, to promote behavioral shifts supporting opioid safety for patients. Further development and testing in a larger sample is warranted.
Introduction The current opioid crisis in America has led to the expansion of public health efforts across multiple settings, including community pharmacies.1 The pharmacists' role in addressing opioid safety has grown substantially over the past five years,2,3 with an increasing number of interventions focused on improving prescription drug monitoring program (PDMP) use in pharmacy settings4 and pharmacy-based naloxone distribution.5 Yet, important barriers remain in pharmacists’ willingness to engage with these initiatives and, most importantly, their
willingness to engage with patients and prescribers to address opioid safety concerns. Among the most often reported barriers are 1) lack of experience and education using the PDMP, 2) fear of instigating patient confrontations and physical altercations, 3) concerns about losing customers/business, and 4) inadequate time to engage with at-risk patients.6–9 Each of these four barriers stem from two common themes: lack of education in available resources and use of effective communication strategies.
∗ Corresponding author. Oregon State University, Oregon Health & Science University College of Pharmacy, 2730 SW Moody Avenue, Mailcode: CL5CP, Portland, OR, 97201, USA. E-mail address: [email protected] (D.M. Hartung).
https://doi.org/10.1016/j.sapharm.2019.12.023 Received 7 June 2019; Received in revised form 29 December 2019; Accepted 29 December 2019 1551-7411/ © 2020 Elsevier Inc. All rights reserved.
Please cite this article as: Lindsey Alley, et al., Research in Social and Administrative Pharmacy, https://doi.org/10.1016/j.sapharm.2019.12.023
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Fig. 1. RESPOND toolkit development process.
multiple states) lacked any formal training for registering or operating their state's PDMP. However, those who received targeted training held more favorable attitudes toward their state's program. Likewise, pharmacists who expressed positive attitudes toward PDMPs and greater knowledge were more likely to register for and use the information when assessing prescriptions. Pharmacists also report inadequate collaboration with prescribers.1,15,16 Prior studies reporting on pharmacist and prescriber perspectives indicate pharmacists are more likely to contact physicians regarding a PDMP report than the reverse, and that many lack confidence to provide recommendations to the prescribers in response to patient-specific situations.1,8,17,18 As pharmacists and prescribers begin using PDMPs more often and more consistently, coordination of care between medical offices and pharmacies becomes more of a focal point for policymaking, intervention and research. To date, a standardized protocol for pharmacists to record subjective and objective data from patients’ profiles and communicate follow-up/recommendations with a prescribing provider have not been identified, though decision-making
PDMP screening and prescriber follow-up in community pharmacies PDMPs serve as a resource for providers to access a patient's history with controlled substance prescriptions and assess whether the patient appears to be taking medication(s) as prescribed (e.g., at appropriate refill intervals), determine if the patient is receiving potentially dangerous uncoordinated prescriptions, and identify potential signs of diversion or misuse. PDMPs are active in nearly every jurisdiction in the country, however, evidence that they reduce can reduce overdose is mixed.10,11 Studies suggest PDMPs with features that mandate use by prescribers hold the most promise.12,13 Currently, 40 states mandate providers query the PDMP for specific circumstances and 19 states also mandate use by dispensers.14 Even with enrollment and use mandates, in most regions of the US the decision whether to use the PDMP depends solely on the pharmacists' discretion, unless their pharmacy has a store or corporate-level policy. A recent scoping review4 on pharmacists' PDMP-related attitudes, knowledge, and utilization revealed that a majority of pharmacists recruited across 15 studies (representing 2
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algorithms have been developed in this vein.19,20
Methods The RESPOND Toolkit was developed based on focus group and external advisor feedback and refined using two phases of pilot testing across six community pharmacies in Oregon with multiple waves of post-phase feedback (see Fig. 1). During the time period of this pilot study, PDMP registration and use by pharmacists was not state mandated in Oregon; though the pharmacy setting for the pilot mandated use in some locations. However, follow-up actions (e.g., patient or provider consultation, changes in dispensing) were not mandated nor were policies in place for how to use the PDMP reports. This research was reviewed and approved by the Oregon Health & Science University Institutional Review Board.
Motivational interviewing to reduce stigma and improve opioid safety counseling As critical as provider consultation is, when warranted, to protect patients' safety, it is equally important that pharmacists provide compassionate care to patients at risk for opioid-related harms. Pharmacists' concerns about having ineffective, limited time to devote to patient counseling for opioid safety and potential misuse speak in part to the lack of available resources and education available to them for honing effective, standardized communication techniques. In the case that a practitioner may only see a patient once, motivational interviewing (MI) has been endorsed as an effective strategy for intervention, especially if the alternative is no intervention at all.21 MI is an evidencebased, patient-centered counseling strategy which, by definition, is meant to be brief (typically 5–15 min).22 The purpose of MI is to explore and resolve ambivalence around an activity in a way that directs the patients' own language and thoughts toward achieving positive goals.23 Often used in cases of substance use disorders,24–27 MI employs a defined set of strategies to build provider-patient trust, reduce or mitigate potential difficult conversations, and elicit “change talk.” Thus, training in MI techniques to address opioid safety could at least build pharmacists’ confidence to address risky situations and reduce difficult patient interactions, and at best help motivate patients for whom opioid use disorder is a concern to engage in dialogue with their providers about the risks and benefits of opioid therapy and possibly seek treatment. Though a full MI encounter is rarely feasible in the community pharmacy setting due to time limitations, training in the principles of MI – given its inherent brevity and proven utility – provides a basic checklist of techniques that pharmacists can use at their own discretion to improve patient communication. While multiple interventions have been piloted to encourage pharmacists’ use of the PDMP, few have provided specific training for patient and provider communication strategies to address patient safety. The purpose of this manuscript is to describe the development and pilot testing of Resources Encouraging Safe Prescription Opioid and Naloxone Dispensing, or the RESPOND Toolkit for community pharmacists. The toolkit was designed to incorporate materials and online education to improve PDMP workflow as well as opioid safety communication and consultation with providers and patients, respectively. Fig. 1 describes the overall RESPOND development process which we describe in detail below.
Focus groups To inform development of RESPOND, we conducted focus groups with patients (N = 3 groups (4–8 participants per group); Mage = 60.1; 71% female), and online with community pharmacists (N = 2 groups (7–12 participants per group); Mage = 39.0; 58% female) and prescribers (N = 1 group (8 participants); Mage = 47.9; 75% female) using Qualboard™, a proprietary software platform that facilitates online focus groups (20|20 Research; Nashville, TN). All focus group participants were reimbursed $100 for their time. Focus group recruitment, methods, analyses, and results are described elsewhere.17 External advisory committee Simultaneous with focus group recruitment and execution, an external advisory committee (EAC) was formed to provide high-level insight into lesson planning, community pharmacy culture, and current state and national initiatives that could affect development and dissemination of the RESPOND Toolkit. The EAC was comprised of representatives from a patient safety organization, state and local public health departments, the board of pharmacy, practicing pharmacists and physicians with experience in the area of pain, emergency medicine, and addiction. Focus group scripts, online course lesson plans and learning objectives, video scripts, and toolkit materials were sent to the EAC for review. Participation in the EAC was voluntary, and members were not compensated for their time. Course development The online continuing education course for RESPOND was developed in collaboration with Oregon State University College of Pharmacy. Building upon information gleaned from focus group participants and EAC feedback, a course curriculum, learning objectives, course slides and narration scripts were developed by the research team. The resulting asynchronous online program (0.2 CEUs) serves as the backbone of the RESPOND Toolkit and contains three required, distinct modules totaling approximately 20 min each. An additional, optional module on naloxone prescribing, also approximately 20 min in length, was available to participants, as well as a printed algorithm and checklist for use in the store locations throughout the 6-month intervention period. The first module focuses on providing history and context for the opioid epidemic in the United States and current public health initiatives (e.g., prescription take-back day, disposal locations, referral programs). The second focuses specifically on PDMPs; their history, effectiveness, usability, and “best practice” recommendations toward greater efficiency and effectiveness. The third module is aimed at communication between pharmacists, prescribers, and patients; it addresses interaction strategies in terms of order of operations, recommendations for information gathering and sharing, modes of communicating, as well as MI-inspired communication techniques to use with patients at the point of care. Relevant quotes from pharmacists and
Theoretical background The framework for developing and evaluating the RESPOND Toolkit was based in the theory of planned behavior (TPB),28 which has been widely used in pharmacy research to predict behaviors like PMDP registration and use.4,29 The theory states that an individual's beliefs, perception of others' beliefs, and perceived control over barriers and facilitators regarding a behavior predict their attitudes, subjective norms, and perceived behavioral control to engage in said behavior. Interventions built on this framework aim to normalize and internally incentivize a target behavior while providing tools to reduce known barriers for engagement, with the goal of creating favorable behavioral attitudes and increased self-efficacy. In RESPOND, normalization and justification for PDMP use and patient-provider communication were provided through a multi-module online course. Barriers to communication were addressed through MI technique training (within course) and printed onsite workflow reference materials, and evaluation measures assessed changes in participants' attitudes, perceived behavioral control, and self-efficacy.
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prescription is in question, use of the PDMP is [6-point sliding scale] bad/good”), PDMP general attitudes (5 items; e.g., “In general, using the PDMP is [6-point sliding scale] useless/useful),29 and perceived behavioral control to address OUD (7 items; e.g., “I am confident in my ability to discuss perceived opioid abuse issues with my patients.“).9 The follow-up survey was administered six-months following introduction of the Toolkit. To the extent possible, previously published and reliable measures were used in the pilot survey. Each of these measures employed a Likert-style 6-option response scale indicating ‘Strong Agreement’ to ‘Strong Disagreement.’ Recruitment. The research team worked closely with the pilot pharmacy partners to identify six stores most appropriate for intervention piloting based on overall prescription fill rates, community need, and location. Locations with high prescription opioid distribution rates were selected. Two urban and one rural location were chosen for each wave, and site criteria review ensured that the pharmacy characteristics were roughly similar between phases. Each site had three staff pharmacists and one pharmacy manager. Participants were asked to read the full study protocol and provide informed consent in the opening page of the baseline online survey (passive consent process) before they could progress to the survey measures. Survey responses were confidential; identifying information was gathered to allow the research team to match pre/post responses and track post-intervention interviews and course participation. All identifying information was purged once participants had concluded their participation in the study. Phase 1 was limited to only staff pharmacists due to restrictions placed by the study partner; however, it was evident during Phase 1 that manager buy-in was a critical piece to efficient adoption of the intervention. Thus, in Phase 2 pharmacy managers were invited to participate. The total available sample size for the pilot was 21 participants. Participant Tracking. The modules were housed within a Learning Management System platform allowed the project manager and investigators to easily view participants’ registration, initiation, and progress throughout all elements of the course. This also included the average amount of time users spent in each module, quiz grades, and time lapse between completing one module and beginning the next. As a required part of registration, users had to supply their email address, name, and store number; which was replicated in the online survey used for pre/post data collection, allowing research staff to see who had completed their baseline survey, course modules, and post survey. Participants with more than a two-week lapse between completion of any component of the intervention were contacted by a member of the research team (dedicated point-person) and encouraged to complete the training/survey. This team member also recorded any changes to the employment status of participants, addressed general questions or technical issues, and invited those who completed all components to participate in a phone interview. Post-intervention Semi-structured Interviews. Immediately following the 6-month intervention period for both Phase I and Phase II, feedback about the RESPOND online course, printed algorithm and checklist were collected from participants via semi-structured telephone interviews conducted by one trained research associate with expertise in qualitative data collection. Recommendations for improvement were also solicited. Intervention participants who participated in the postintervention interview received a $100 incentive in the form of a check or online gift card (their choice). See Appendix A for the full interview guide. The purpose of these interviews was to gather pointed, actionable feedback to support revisions/improvements to the RESPOND Toolkit. A formal qualitative analysis of the interview feedback was not performed. Common feedback and themes from the interviews have been summarized in the results to provide context for RESPOND intervention adaptations between Phases and following Phase 2.
patients who participated in the focus groups are provided throughout the second and third modules, to provide a relatable voice to the training and enhance engagement and participation. The third module also includes a training video, written and produced by the research team, using common difficult scenarios to illustrate the benefits of using MI strategies to de-escalate a challenging conversation on opioid safety, collect subjective information from the patient, and build in time to communicate recommendations and concerns with their prescribing provider. During the timeline for this pilot, Oregon passed its law allowing pharmacists to prescribe naloxone; as such, a fourth optional module (no pre/post-test) was included in RESPOND which focused on indicators for naloxone prescribing and recommended counseling techniques and language. Materials development To accompany the RESPOND Toolkit's online course, printed materials were also created as resources to be displayed within community pharmacies. These include a printed, laminated algorithm to aid pharmacists in their decision-making process for when and why to screen opioid prescriptions with the PDMP, and how best to address patients with pain in typical and/or difficult situations. The order of operations outlined in the algorithm was informed directly from pharmacist and patient focus group feedback outlining workflows and usual care practices commonly employed by community pharmacists. For instance, the majority of pharmacist participants indicated that they use their in-house dispensing systems to perform initial patient and prescription review, so “Conduct Prescription Drug Utilization Review (DUR)” is listed as the first step in the RESPOND process. However, there was a great deal of ambivalence or lack of training for community pharmacists regarding when to access PDMP data, (e.g., many queried the PDMP solely to investigate potential diversion) so the research team proposed a “best practices” approach, outlining the specific information only attainable through the PDMP and what triggers should lead a pharmacist to conduct a thorough review. Communication strategies outlined at the base of the algorithm are reflective of those outlined in the third module of the online training and derived primarily from the principles of MI. Finally, a checklist was created for placement at pharmacists’ computer monitors or beside their phones. Whereas the algorithm focuses mainly on protocol and communication as regards patient care, the checklist is aimed at facilitating effective correspondence with prescribers. The SOAP Note strategy (an acronym for subjective, objective, assessment, and plan), is a common protocol taught to prescribers and clinical pharmacists as part of their career training. As such, the format was used as a framework for our checklist to outline a step-by-step process for community pharmacists to gather relevant information, communicate that information back to the prescriber or medical staff efficiently and effectively, and create a plan for patient care that includes all relevant parties. Pilot testing The RESPOND Toolkit was piloted in six community pharmacies within one large grocery chain in two 6-month phases, with the period between phases used to revise and refine toolkit materials. Each phase consisted of a baseline and follow-up survey – approximately 15 min in length – to capture the outcomes of interest for the intervention based in the framework of the TPB: attitudes toward opioid use disorder (OUD; 5 items; e.g., “Improving pharmacist-patient communication would deter opioid abuse”),8 practice self-efficacy (4 items; “I feel I have a clear idea of my responsibilities in helping patients who misuse prescription opioids.“),30 service barriers (5 items; I have insufficient access to screening tools to assess prescription opioid misuse.“),30 PDMP safety attitudes (5 items; e.g., “When the safety of an opioid
Analysis plan Survey Assessment. TPB-based survey data were collected through 4
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the Research Electronic Data Capture (REDCap) application, which is a secure web-based survey and database manager.31 Survey data were exported into and analyzed with IBM SPSS Statistics for Windows, Version 25.0 on a Windows PC. Email addresses (if provided), store numbers (if provided), and participant demographic information were used to match participants’ pre- (time 1) and post-intervention responses (time 2), in listed order of priority. Survey timestamps were used to define whether a response was pre- or post-intervention. Due to the small sample size in matched survey responses across pilot phases, participants used in survey analyses were collapsed into one group, controlling for phase. Continuous variables from the multi-item scales for attitudes, selfefficacy, and perceived behavioral control in PDMP utilization listed previously were analyzed in a series of paired samples t-tests. Due to small sample size, effect sizes are reported and are the primary metric used during the interpretation of results based in Cohen's d using pooled variance. This analysis was chosen because the time 1 and time 2 variances for each continuous variable are heterogeneous and Cohen's d allows a more conservative effect size estimate.32 Knowledge Assessment. In addition to the survey, pre and post knowledge quizzes were built into each course module to assess knowledge, and grades were captured within Learning Management System. These data were exported and analyzed using the paired samples t-test to evaluate for any within-person significant changes in knowledge before and after training. Similar to the survey data, effect size was calculated using Cohen's d for repeated measures t-test.
Table 2 Paired Samples t-test for Attitudes and Level of Self-Efficacy in PDMP Utilization and Opioid Use Disorder (OUD). All survey items use a 6-point Likert scale. SD is standard deviation.
5 (50%)
p-value
Cohen's dpooled
α
Attitude towards OUD - pre Attitude towards OUD - post Practice Self- Efficacy -pre Practice Self- Efficacy -post Service Barriers - pre Service Barriers - post PDMP Safety Attitude - pre PDMP Safety Attitude - post PDMP General Attitude - pre PDMP General Attitude - post Perceived Behavioral Control - pre Perceived Behavioral Control post
3.76 3.84 3.28 3.58 2.77 2.97 5.56 5.88 5.26 5.80 3.49 3.49
0.50 0.67 1.11 0.89 0.56 0.59 0.94 0.83 1.24 0.71 0.74 0.58
0.73
0.110
0.1
0.680
0.34
0.328
0.47
0.237
0.37
0.367
1.00
0.000
0.60 0.59 0.61 0.63 0.78 0.78 0.84 0.81 0.85 0.85 0.64 0.60
Knowledge assessment Overall, participants in the RESPOND online course showed significant improvement from baseline (mean score = 57.4, SD = 12.8) to post (mean score = 84.4, SD = 8.5; p= < 0.001). A calculation of Cohen's d for effect size in paired samples analysis revealed a large effect of the course on participant knowledge (Cohen's d = 1.85). Across the three modules, participants showed the lowest percentage of improvement in first module (16% improvement), which focused on the background of the epidemic. Grades on the second module revealed a 31% increase in scores; this module focused on PDMP workflow and safety triggers. The greatest improvement in scores was shown in the third module (36% improvement), which focused on communication strategies for provider and patient communication, using the SOAP note format and MI techniques, respectively. TPB-based Survey Assessment Table 2 summarizes results of the paired-samples t-test and effect size analyses for outcomes measuring attitudes, practice self-efficacy, perceived behavioral control, and barriers. Although there were no statistically significant changes in any of the six outcomes, as expected with a small sample size, four yielded moderate to high effect size values. Changes in practice self-efficacy yielded a moderately high effect size (Cohen's dpooled = 0.68) indicating that participants' confidence in addressing prescription opioid misuse increased from time 1 to time 2. Participants also perceived fewer service barriers post-intervention (Cohen's dpooled = 0.33), meaning that they felt they had more training, more screening tools, and more skills needed to help patients with prescription safety issues. Attitudes toward the PDMP as a safety tool also increased from time 1 to time 2 (Cohen's dpooled = 0.24), as did general attitudes toward the PDMP as an effective tool (Cohen's dpooled = 0.37).
Table 1 Self-reported participant demographics and practice characteristics (n = 10).
Female Race White Asian Education BS PharmD PDMP duration of use 1–2 years 3–5 years > 5 years Age Years in profession Hours worked per week Prescriptions filled per day PDMP queries per weeka
SD
intervention survey.
Of the approximately 18 pharmacists and 3 pharmacy managers (managers included in Phase 2 only; 21 potential participants) employed across six recruited pharmacies, 16 fully participated in the online course (Mage = 43; 81% pharmacy staff; 50% female). Of these, 10 completed both pre- and post-intervention participant surveys that were able to be reliably matched and participated in post-intervention interviews (Mage = 43; 60% pharmacy staff; 80% PharmD; Tables 1 and 2). Six participants’ survey data were unable to be used for analyses: two left their stores before completing the intervention, and the remaining four provided inconsistent identifying information to reliably match their pre/post responses. Participants reported querying the PDMP an average of 18 times a week, although there was marked variability between individuals that ranged from 1 to 100 queries per week. There were no significant differences between participant phases for pre/post module knowledge assessment or survey outcomes, or between baseline scores for those who did or did not complete the post-
Count (%)/Average (SD; range)
mean
Note. Cohen's d: 0.2 = small effect, 0.5 = medium effect, 0.8 = large effect.
Results
Characteristic
Measure (n = 10)
5 (50%) 5 (50%) 2 (20%) 8 (80%) 1 (10%) 5 (50%) 4 (40%) 41.4 (12.9; 31 to 66) 13.4 (13.4; 5 to 36) 33.6 (11.2; 8 to 40) 374 (115; 100 to 500) 18.1 (31.3; 1 to 100)
Post-intervention feedback and toolkit revisions/finalization Phase 1 Participant Feedback Summary. Phase 1 interview participants’ feedback (N = 4) indicated that the guidance around mitigating difficult conversations and prescriber outreach were the most favored aspects of the training and materials. One site that had strong managerial support for participation yielded more favorable views of the training and onsite materials. Most pharmacists indicated that the information in the first module was less useful, as it was primarily a
a Estimate of how many times per week participants query the PDMP during their clinical practice.
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workflow, findings from preliminary focus groups with patients, pharmacists, and prescribers revealed an additional need for training in communication strategies. Thus, the final RESPOND Toolkit ultimately included three required online training modules tailored to community pharmacists to improve knowledge of the opioid crisis, PDMP use and workflow, and pharmacist-patient and pharmacist-prescriber communication techniques based in MI. Reorientation of RESPOND to emphasize communication strategies also acknowledges that the PDMP is just one facet of providing safe and compassionate care to patients who may be at higher risk for opioid-related harms. As PDMPs, and the evidence supporting their effectiveness, evolve it will be important reevaluate how pharmacists incorporate them in their practice. Across phases of testing, results indicate the strongest gains were in participant knowledge and self-efficacy, with smaller positive effects on attitudes and perceived practice barriers to providing opioid safety consultation. As expected with a small sample size, the majority of results – though showing moderate and strong effect sizes – were nonsignificant, though significant large gains were made in knowledge through the online training. During interviews, participants indicated that the checklist and algorithm were useful tools for practice, though pharmacy managers varied in their ability to consistently post and encourage use of these materials onsite. Some felt the bulk of the online course would be best suited to new hires and/or recent pharmacy graduates, as the basic opioid safety and PDMP information was redundant with their current knowledge. Many reported that they increased use of the PDMP as a result of participating in the course and that they now feel more confident engaging with patients and especially prescribers regarding opioid safety concerns. MI was chosen as the optimal communication strategy on which to build the RESPOND Toolkit due to its proven effectiveness in substance use interventions, ability to be delivered in brief sessions (5–15 min), and ability to reduce stigmatization and empower patients. MI has been shown effective even when used by providers who are non-specialists in substance use treatment.26 It is important to note that in MI, the counselor is directing the conversation, but the patient should be doing the work to resolve their own ambivalence and create a plan toward change. For RESPOND, MI strategies are recommended to encourage the patient to ask questions about their own safety, learn more about opioid risks, and allow time for the pharmacist to consult with their prescribing provider. Common MI communication strategies that were encouraged in the RESPOND Toolkit include use of open-ended questions (e.g., “What do you currently know about … ?“), reflective listening (e.g., “It sounds like you may be concerned about …“), asking permission before giving advice/resources (e.g., “Would it be okay if I offer you … ?“), normalizing client concerns (e.g., “Many people say they feel the way you do, and are having a hard time, too.“), and providing affirmations for change talk (e.g., “I really like that you are thinking about your safety. That is the most important thing.“). In the RESPOND online course, a video produced by the research team is used to illustrate the effective implementation of these strategies to mitigate a difficult opioid safety conversation. As pharmacists' roles continue to expand to address the current opioid crisis, tools and resources to improve workflow, attitudes, and self-efficacy are increasingly necessary to improve the experiences of pharmacists and their patients. By enhancing and streamlining opioid safety workflow, pharmacists are more likely to engage with the PDMP using defined, objective criteria, and more confident in their understanding of its importance as a resource. By improving pharmacists’ consultation/communication skills, they become more willing to engage in potentially difficult opioid safety conversations with patients at high-risk. A growing literature indicates communication-based interventions like RESPOND are increasingly needed in community pharmacy practice to accompany the current and increasing opioid safety and harm reduction tasks being asked of pharmacists. Echoing earlier work by Hagemeier et al.8 and Lafferty et al.,33 a recent qualitative study by Fleming and colleagues identified several factors that inhibit
review of known opioid statistics and initiatives. Pharmacists liked the training video in third module, and some indicated that the video made them feel more confident to engage in conversations with patients. Others felt the SOAP note checklist and prescriber communication strategies were the most empowering toward change. Participants were divided about the audience that would most benefit from the materials. Some felt the materials would be most useful for new pharmacists who are integrating opioid safety into their training currently, while others felt it would be best for senior pharmacists who may be more hesitant to engage with screening resources and additional training. Two pharmacists found it difficult to access and navigate the online training program. Post-Phase 1 Revisions. Following feedback from the Phase 1 pilot interviews, multiple changes were made to the RESPOND format. The course modules were shortened as appropriate, and the information was updated to reflect current statistics and guidelines. In response to usability feedback, the research team identified a different learning management system to host the full training and toolkit package with improved branding and cohesion to improve access and navigation issues. Finally, the messaging on the printed materials was reduced and altered to include fewer subjective safety triggers and include references for naloxone prescribing/distribution. One change was also made to the pilot protocol: it was determined that pharmacy managers should be included as participants in Phase 2, to improve dissemination and buy-in among pharmacists in the recruited sites. Phase 2 Participant Feedback Summary. Following the Phase 2 pilot phase, all interviewees (N = 6) felt that the course covered information they already knew but felt it was a nice refresher. Three respondents specifically said that they would recommend the course and particularly to new pharmacists. All of the respondents agreed that the printed algorithm and checklist were useful, clearly written, and easy to follow. Two of the interviewees mentioned that the communication-related education was especially useful. One said that the training had helped them approach prescribers without making prescribers defensive, by emphasizing patient safety as their top priority. Another respondent felt that the training helped them to approach patients in a non-confrontational manner and mentioned that they now feel more comfortable discussing naloxone with patients. Three of the participants mentioned that since the training, they are using the PDMP more frequently, both when receiving a new opioid prescription and when preparing to contact a prescriber. All three mentioned working to incorporate the PDMP into their daily workflows. One interviewee explained that they now use the PDMP with every opioid prescription and feel like this kind of education highlights the importance of incorporating the PDMP into pharmacist workflows. Phase 2 Finalization. Feedback from Phase 2 interviews confirmed that the messaging in the course, algorithm, and checklist were appropriate and helpful for facilitating improved reporting and communication behaviors. To improve the scalability and endurance of the toolkit, slides were removed that contained data or information that were either state- or time-specific. A graphic design team was hired to finalize all toolkit materials to improve aesthetic appeal and streamline the information presented. The final RESPOND Toolkit is now available free of charge on its independent website (www.pharmacistrespond. org) or through the Oregon State University College of Pharmacy for continuing education for a nominal charge to support administrative costs (no member of the research team receives compensation from the course). Fig. 2 illustrates suite of RESPOND Toolkit resources. Discussion The RESPOND Toolkit was developed and refined through multiple rounds of feedback from external advisors and community pharmacists gathered over a three-year period, from 2015 through 2018. Although the original purpose of toolkit development was to create a package of resources and trainings to promote improved PDMP knowledge and 6
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Fig. 2. Suite of RESPOND toolkit resources.
evaluations of this intervention will require a larger sample across multiple pharmacies, ideally including a variety of community pharmacy settings (e.g., grocery store, independent pharmacies) and/or chains, to establish whether these positive outcomes are generalizable. Though objective changes in knowledge were assessed in the RESPOND pilot, additional objective outcomes such as PDMP queries and store dispensing patterns should be considered in a large-scale follow-up evaluation. Elements of the RESPOND Toolkit have been adapted into a new educational intervention, RESPOND TO PREVENT (https:// respondtoprevent.org) which is currently being tested in a large cluster randomized trial in four states in two larger pharmacy chains. Further, the level of engagement from pharmacy managers varied between sites. Some were enthusiastic to have their staff trained while others viewed it as burdensome given their limited time. Research staff encouraged participation and buy-in with repeated phone call and email reminders. Because the effectiveness of the full toolkit relies upon the presence and use of the on-site tools, the intervention may have been hindered in stores where managers failed to promote these tools. Future evaluations should consider asking pharmacists to participate in the online training and consider the tools on their own time by providing incentives for training completion; in this pilot, pharmacists participated in all elements while at work and were only incentivized for surveys and interviews. Moreover, for non-independent pharmacies (chain, grocery store) leadership Buy-in is vital to ensure pharmacist training is encouraged and supported. Finally, this pilot – as with all
community pharmacists from engaging patients who may be misusing prescriptions opioids.34 Lack of training and time constraints were among commonly identified barriers addressed through resources embedded in RESPOND. Although schools of pharmacy have modestly increased substance use education in their curriculum,35 there remains an urgent need to provide education and training for practicing pharmacists. Similar to RESPOND, efforts by Strand et al.36 and Rickles et al.37 also provide a structured framework to identify and manage potential prescription opioid misuse in a community pharmacy setting. Although these pilot projects are promising, the effectiveness of these approaches needs to be evaluated across a diversity of community pharmacy practice settings.
Limitations There were several challenges and limitations during the development and pilot testing process for RESPOND. First, study sites for testing RESPOND were purposefully selected by the research team and corporate management. Consequently, participants may not reflect practice or attitudes of pharmacists practicing in other settings and may have been more amendable to this type of practice-based research. Though results of the RESPOND Toolkit pilot indicated moderate to large effects on knowledge and self-efficacy, with significant gains in knowledge, the limited sample size of the toolkit pilot precludes the ability to make substantial claims about these impacts. Future 7
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current opioid safety interventions – was limited by historical context. The toolkit was developed and tested in 2016–2017, overlapping with the release of the CDC Guidelines for Prescribing Opioids for Chronic Pain38 in addition to multiple other opioid safety initiatives at the federal, state, and community-level. Thus, when Phase I of the toolkit rolled out pharmacists were less educated on PDMP use and general opioid safety recommendations than they were at the start of Phase 2; community pharmacists now, as pharmacy-based naloxone continues to be promoted, are more educated still on opioid safety. However, the RESPOND Toolkit is unique in its promotion of MI-inspired communication, skills to mitigate difficult opioid safety conversations, and prescriber communication tools (e.g., SOAP Note Checklist) to boost pharmacists’ empowerment and self-efficacy to address concerns seen in PDMP reports. Thus, though the opioid safety and PDMP lessons may be perceived as increasingly unneeded, the communication components on which RESPOND relies heavily are timeless and critical as a refresher at every stage of employment.
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Conclusion The RESPOND Toolkit is a potentially effective and scalable approach to provide community pharmacists tailored training and resources promoting enhanced opioid safety workflow and patient communication. The tools contained therein have been thoroughly refined based on participant and expert feedback, and have been made freely available through a dedicated website (https://pharmacistrespond.org) or for Continuing Education credit through Oregon State University (https://pharmacy.oregonstate.edu/online_ce). Qualitative results from participant interviews indicated that pharmacists found the communication strategies and resources to be the most useful components for their daily work experience. Future evaluations of the RESPOND Toolkit should employ a larger sample size incorporating multiple pharmacy chains and provide incentives to reduce burden on the pharmacists’ workflow by allowing for training outside of working hours. Funding This work was supported by the Agency for Healthcare Research and Quality, USA (AHRQ 5R18HS024227-02). The funding source had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. CRediT authorship contribution statement Lindsey Alley: Conceptualization, Formal analysis, Project administration, Writing - original draft, Writing - review & editing. Kevin Novak: Formal analysis, Writing - review & editing. Tyler Havlin: Writing - review & editing. Adriane N. Irwin: Methodology, Writing review & editing. Jody Carson: Writing - review & editing. Kirbee Johnston: Formal analysis, Writing - review & editing. Nicole O'Kane: Conceptualization, Funding acquisition, Writing - review & editing. Daniel M. Hartung: Conceptualization, Funding acquisition, Supervision, Project administration, Methodology, Writing - review & editing. Declaration of competing interest None. Appendix A. Supplementary data Supplementary data to this article can be found online at https:// doi.org/10.1016/j.sapharm.2019.12.023. 8
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study of community pharmacists screening for opioid misuse risk. Res Soc Adm Pharm. 2019;15:1032–1036. 37. Rickles NM, Huang AL, Gunther MB, Chan WJ. An opioid dispensing and misuse prevention algorithm for community pharmacy practice. Res Soc Adm Pharm. 2019;15:959–965. 38. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain–United States, 2016. MMWR Recomm Rep (Morb Mortal Wkly Rep). 2016;315:1624–1645.
Res Methods. 2007;11:364–386. 33. Lafferty L, Hunter TS, Marsh WA. Knowledge, attitudes and practices of pharmacists concerning prescription drug abuse. J Psychoact Drugs. 2006;38:229–232. 34. Fleming ML, Bapat SS, Varisco TJ. Using the theory of planned behavior to investigate community pharmacists' beliefs regarding engaging patients about prescription drug misuse. Res Soc Adm Pharm. 2019;15:992–999. 35. Thomas K, Muzyk AJ. Surveys of substance use disorders education in US pharmacy programs. Ment Health Clin. 2018;8:14–17. 36. Strand MA, Eukel H, Burck S. Moving opioid misuse prevention upstream: a pilot
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