Introduction

Although opioid prescribing rates are decreasing, 16,706 overdose deaths involving a prescription opioid occurred in 2021 in the United States, a trend driven by combination with synthetic opioids such as fentanyl [1]. To take preventative actions to reduce overdose deaths and the risk of developing an opioid use disorder (OUD), healthcare professionals must recognize opioid misuse behaviors early. Efforts to address opioid misuse must not lead to inadequate pain management, especially among groups that receive disproportionately fewer opioid prescriptions, such as African American adults [2]. These issues can be addressed by leveraging community pharmacists who are highly accessible healthcare professionals, especially in rural areas with underinsured patients. Pharmacists have training in medication counseling, believe that screening for opioid misuse is important, and are interested in providing screening interventions [3, 4]. However, patients are not screened for opioid misuse behaviors when picking up their prescription opioids at the pharmacy. In the US, the role of the community pharmacist in OUD prevention and treatment has been mostly limited to dispensing medications for OUD and even then not at optimal levels [5]. There is a need to expand the role of the pharmacist in providing prevention interventions for OUD.

Nationally, calls to leverage community pharmacists as a resource in all types of OUD prevention, including screening and brief interventions (SBI), have increased [6]. Screening using prescription drug monitoring programs (PDMP) [7, 8] and brief interventions such as naloxone dispensing [9, 10] or opioid counseling [11] have been studied in pharmacy settings, but are rarely incorporated into one comprehensive SBI model [12]. Using a comprehensive SBI model to implement the interventions would increase their effectiveness and be more patient-centered. However, issues such as lack of clinical information and discomfort in talking to patients can act as intervention barriers [13].

We conducted a scoping review of pharmacy-based opioid misuse SBI and identified a few pilot-stage interventions and exploratory observational studies on this topic as well as two main research gaps [14]. While pharmacists were surveyed in development of these SBI, patient perspectives were not explored. Issues regarding private space, stigma, and method (in-person or digital) of the intervention as well as comfort with a pharmacist providing such interventions, all of which can impact SBI effectiveness, were not studied [14]. Patient-centered interventions that include individual patient preferences and values are holistic, respect patient’s autonomy, and empower them to make decisions about their own care [15]. Using a patient-centered approach to SBI development begins with exploring patient preferences and needs regarding participation. Our review also identified five qualitative studies that explored pharmacist perspectives regarding opioid misuse SBI but only one of the five studies had high credibility and trustworthiness [14]. There is a lack of in-depth, contextual information about pharmacist and patient perspectives of SBI, which is a significant limitation in development of effective interventions. Conducting qualitative exploration as the first step to designing the pharmacy-based opioid misuse SBI would help overcome this drawback.

To improve translation of SBI research into practice, it is useful to consider future implementation barriers at the design stage itself. The ‘designing for dissemination’ principles identify key actions in the process of designing interventions and the subsequent products [16]. These actions include engaging key stakeholders as early as possible, using implementation frameworks and dissemination constructs, documenting implementation barriers and outcomes [16]. Utilizing designing for dissemination and implementation principles at the development stage allows for more context-relevant interventions that addresses stakeholder needs and priorities.

The purpose of this study is to qualitatively explore and compare patient and pharmacist perceptions and needs regarding a pharmacy-based opioid misuse SBI and to identify relevant SBI features and future implementation strategies.

Methods

Consolidated framework for implementation research (CFIR)

The constructs under the CFIR domains that were appropriate for intervention design have been bolded (Additional file 1). The CFIR interview guide [17] was used to develop specific interview questions and the accompanying codebook template was used for initial deductive coding of interview data.

Study sample

Generally, 10–25 participants are considered sufficient for theory/model based qualitative studies using content analysis approaches [18, 19]. Our interviews had higher information power gained by sample specificity (purposive sampling [20] by targeting different pharmacy experiences and pain conditions rather than convenience sampling), using an applied conceptual framework (CFIR), the strong quality of dialogue (lengthy, in-depth interviews), and the exploratory nature of analysis (identifying patterns/themes rather than in-depth phenomenological description) [19]. Thus, interviews were conducted until data saturation was achieved, i.e. no new dimensions regarding the topic emerged [21] We conducted interviews with a purposive sample of adult, English speaking patients, living in a Midwestern state, who have been prescribed an opioid medication at least once in their lifetime for acute or chronic non-cancer pain. Patients diagnosed with an OUD, receiving opioids for cancer-related pain, or unable to participate in the interview (hospitalized, in hospice care, suffering from debilitating pain) were excluded from the sample. A purposive sample of English-speaking community pharmacists (those practicing in a non-clinical, community setting such as large national chain pharmacies, independent pharmacies, or specialty pharmacies) practicing in the same Midwestern state were included in the sample.

Data collection

For patients, recruitment initially occurred through regional pain clinics and primary care providers. To increase recruitment of individuals using in-person pharmacy services, pharmacists who completed study interviews were also asked to share study information with their patients. A study flyer describing interview procedures and other study information was sent to healthcare professionals to share with eligible patients. We briefed the healthcare professionals on the study purpose (i.e. exploring patient perspectives on SBI) and the larger goal of our research (i.e. designing a patient-centered opioid misuse SBI for pharmacy settings). We asked healthcare professionals to purposefully select individuals who may be good candidates for SBI. To recruit individuals with acute pain, we used the emergency department research coordinators. Patients were given the option to contact the study team themselves or allow their contact information to be shared with the study team. Pharmacists were recruited through emails sent to a practice-based research network and an informal list curated by the study team. Emails included study information and a screening and a contact information form.

Eligible and interested patients and pharmacists were contacted to schedule interviews conducted via telephone, web-conferencing software, or in-person. The lead researcher (DR) with training and prior experience in qualitative methods conducted all the interviews. Verbal informed consent was solicited prior to beginning the interview. The patient interviews were 30 min long and pharmacist interviews were 60-min long. Patients received $30 compensation and pharmacists received $50 compensation for completing interviews. All interviews were audio-recorded and transcribed, and transcriptions were used for further data analysis. The patient interviews focused on patient experiences in pharmacy and needs regarding their opioid medications in addition to the more SBI-specific questions. The pharmacist interviews were longer to accommodate additional questions focused on characteristics of their particular setting not directly related to patient care such as: organization goals and feedback, colleague networks and communication, and workplace culture. These data have been reported separately [22]. The interview guides were piloted in the first couple of interviews and probing questions were added as appropriate (ex. opioid experiences for patients, OUD prevention experiences for pharmacists). Patients were also prompted with examples of different types of interventions that pharmacists could potentially provide within the SBI model to generate richer discussions. The sample interview questions linked to the CFIR constructs for both pharmacists and patients are provided in Additional file 2. The Institutional Review Board at the author’s institution approved the study procedures after expedited review.

Data analysis

While a deductive analysis approach (based on CFIR) was planned initially, it was not suitable for the patient interview data as very little information could be coded using the CFIR constructs. Therefore, an inductive open coding approach was utilized for patient interviews. Two coders independently coded each interview transcript and discussed their coding in detail with DR as primary analyst and an undergraduate student as a secondary coder. Any conflicts in the coding were resolved at this stage. Finally, DR abstracted all categories into themes. Following content analysis of the patient interview data, a template approach was utilized to compare data from the patient and pharmacist interviews. The template was created based on the patient interviews first by listing the major themes resulting from the content analysis. Then pharmacist transcripts were analyzed using this template as the coding structure. Then, salient quotes from the two groups corresponding to the template themes were included in a matrix. This matrix was used to make comparisons and meta-inferences regarding pharmacists and patient perceptions of the SBI as well as report findings. Opposing views regarding the same themes across the two groups were also presented in the matrix. MAXQDA software was used for all qualitative analyses. DR created the template, conducted the analysis, and produced the matrix independently. Two researchers (OS, JF) who were not involved in the data collection process reviewed the final matrix to improve credibility and trustworthiness of the findings.

Rigor

Qualitative rigor was achieved by establishing credibility and confirmability through purposive sampling [20], achieving data saturation [21], using multiple coders for analysis (analyst triangulation), template analysis with patient and pharmacist data (triangulation of data sources), and peer debriefing [23]. The ‘Consolidated Criteria for Reporting Qualitative Studies (COREQ)’ checklist [24] has been completed for this study (Additional file 3).

Results

Sample characteristics

Eight semi-structured interviews were completed from May to October of 2021 virtually, over the phone, or face-to-face with patients taking opioid medications for non-cancer related acute (n = 2) or chronic (n = 6) pain. Patients used in-person pharmacy services, mail order, or drive through pharmacy services for their opioid medications. Most patient participants were white, older, and described living in suburban areas. Both men and women were recruited in the sample. Participants with chronic pain had used opioids consistently for 5–30 years, while participants with acute pain had used opioids after surgeries in the past 5 years. All participants were taking a combination of short -acting and long-acting opioids. While we did not ask participants to report opioid misuse behaviors directly, our recruitment method through healthcare professionals resulted in inclusion of individuals who had high opioid safety risks such as: requests for higher doses due to tolerance, development of hyperalgesia, family history of substance use disorders, possession of large quantities of unused opioids, and fills of prescriptions at different pharmacies. Eleven pharmacist interviews were completed from March to August of 2021 virtually. Pharmacists practiced in a variety of settings (large-chain, small independent, specialty) and roles (manager, owner, full-time, part-time pharmacist).

Template analysis findings

The results of the template analysis are presented in Table 1. The template consists of 14 themes including individual factors such as experiences with opioids/care, knowledge, beliefs, needs, and self-efficacy interpersonal factors such as stigma and patient- pharmacist-provider relationships, intervention factors that describe beliefs and views on intervention components, and implementation factors such as implementation needs and challenges. The template themes, summaries of the themes from patient and pharmacists interviews, exemplar quotes, and our interpretations for applications to future SBI design and potential implementation strategies are included in Table 1.

Table 1 Template themes, representative quotes, explanation, and application for the SBI
Full size table

Summary of results

Overall, we identified the following key findings related to individual, interpersonal, intervention, and implementation factors.

Individual factors

  1. 1.

    Experience with Opioids/Care: While providers used clinical judgement to taper opioids, patients did not trust them and perceived it as an access barrier to medications. Pharmacists were aware of these issues and tried providing education and counseling to patients. These findings indicate that patients may perceive SBI as another barrier to accessing medications rather than an opportunity to receive education about opioid use and safety.

  2. 2.

    Knowledge about Opioid safety: Patients had large knowledge gaps regarding opioid use (especially long-term use), opioid dependence, and opioid safety and the only directions given to them were to ‘take as prescribed’. Pharmacists were aware of these gaps and believed patient counseling would help. Therefore, patient education on chronic opioid use and opioid safety are important for the design of brief interventions (BI).

  3. 3.

    Beliefs about Opioid Safety and OUD: Patients believed that they were not at risk of opioid misuse, overdose, or developing OUD because it occurred among people who used opioids recreationally only. Pharmacists described these beliefs as barriers to opioid safety and naloxone dispensing. Addressing such common misperceptions and beliefs should be part of SBI design.

  4. 4.

    Opioid Care Needs: Patients discussed needs including recognizing tolerance, dependence, consequences of intentional and unintended misuse, non-opioid alternatives, managing an accidental overdose, and contra-indicated substances. Pharmacists suggested additional topics including pain management expectations and risk of addiction or accidental overdose, especially in patients who are older, are co-prescribed other medications, or have co-morbid conditions. Pharmacists also believed BI could help deliver this much-needed education. This indicates that BI could be beneficial to patients regardless of opioid misuse behaviors if education on long-term opioid use is included.

  5. 5.

    Self-efficacy: Patients’ confidence in taking opioids safely due to many years of experience made them reluctant to participate in SBI, indicating that SBI may be ideally delivered at index prescription. While pharmacists agreed with this, they had higher self-efficacy in providing SBI for established patients than new patients.

Interpersonal factors

  1. 1.

    Stigma: While only some pharmacists described being biased towards patients using opioids, most patients perceived stigma from healthcare professionals including pharmacists. This is huge barrier to potential SBI participation. Patient centered education and anti-bias training to address stigma against OUD may be necessary for pharmacists.

  2. 2.

    Patient-Pharmacist-Prescriber Relationships: Patients used informal sources such as the internet for medication questions or talked to prescribers rather than pharmacists who were not viewed as clinical healthcare providers. Some pharmacists had reservations about counselling patients. Pharmacists in our sample indicated they needed training. To overcome these role perceptions, marketing SBI as a clinical service is a potential implementation strategy that will need to be tested in future research.

Intervention factors

  1. 1.

    Beliefs about SBI: Despite the interpersonal challenges discussed above, patients were interested in pharmacy based SBI as long as it was focused on patient autonomy. While all patients found a short screening acceptable, some patients stated that individuals may not self-report opioid misuse. Their motivation to participate was primarily to obtain education about opioid use and safety. Pharmacists believed SBI would be helpful but were wary of stigmatizing the patients. Pharmacists described needing training and a protocol to provide SBI such that the interventions are integrated into routine care. They also suggested introducing SBI as personalized clinical care.

  2. 2.

    Screening Component: Both groups recommended short (< 5 min), standardized, self-reported screening and discussed potential screening formats such as online, in-person, or telephonic methods. Pharmacists also suggested using pharmacy technicians to help conduct the screening. However, feasibility perceptions among pharmacists and patient preferences for these methods varied.

  3. 3.

    Brief Intervention Components: Naloxone dispensing, patient counseling, and contacting prescribers (with non-stigmatizing scripts, handouts, and protocols) were discussed as potential BI.

Implementation factors

  1. 1.

    Implementation Needs: Patients wanted SBI implemented in a manner that offered privacy and autonomy. Multiple formats of SBI may be needed to offer patients the individualized service they are seeking. Pharmacists needed training and protocols that fit within workflow. If contacting prescribers were part of SBI, pharmacists suggested engaging prescribers as stakeholders.

  2. 2.

    Implementation Challenges: Three potential implementation challenges that were discussed included time, stigma, and pharmacist roles. Both patients and pharmacists were interested in an intervention no longer than 15 min. Alternate formats and using technicians may help reduce time burden. Offering SBI in a private space where available, integrating SBI into telehealth services, or using digital health technologies could potentially provide privacy and reduce perceived stigma. Marketing SBI as a clinical service provided by pharmacists and involving prescribers as stakeholders may help address pharmacist role challenges.

Discussion

Our study is an initial exploration of pharmacist and patient needs regarding opioid misuse SBI for pharmacy settings. A short-self-reported screening and brief interventions including counseling, naloxone, and involving prescribers were discussed by both groups. We found that patients needed education on opioid safety and general opioid use in a private and convenient format, regardless of opioid use behaviors. Pharmacists described needing patient-centered training, protocols, and scripts to increase comfort in providing SBI. Through this qualitative study, we have obtained critical stakeholder data that can be used to design SBI in future research.

Patients in our sample had long-term experience with opioids, with issues related to medication access. This is similar to other study findings that show recent opioid prescribing guidelines [25] may have led to inadequate pain management [2]. Patients in our study did not trust healthcare professionals when they discussed opioid tapering. Research suggests that lack of trust in healthcare professionals does not promote optimal pain care [26] and may be exacerbated by prevention interventions that are not patient-centered and focus solely on reducing prescribing rates [27]. These are important considerations for future SBI design.

Despite their long-term experience taking opioids, there was a severe lack of knowledge regarding opioid safety among patients, with ‘take as prescribed’ being the only direction provided to them. Patients reported using informal and unverified sources of information such as the internet or other patients. Research indicates that this lack of opioid safety knowledge, especially related to overdose risks and naloxone, is very common among patients with chronic pain [28, 29]. As most harm reduction efforts are targeted towards people using illicit drugs, patients using prescribed opioids may have lower knowledge regarding opioid safety [30]. These findings indicate that patient education, irrespective of opioid misuse behaviors, is important for future SBI design.

Beliefs such as not being at risk of opioid misuse, overdose, or developing OUD were also very common. Pharmacists believed this led to patients practicing risky behaviors such as storing large quantities of opioids and refusing naloxone. Research suggests that individuals who believe that opioid addiction risk is personally irrelevant have a higher risk of opioid misuse [31]. However, patients in our sample were comfortable with pharmacists providing information about opioid safety as part of SBI, if done in a non-stigmatizing manner.

Patients described needing education on long-term opioid use and recognizing opioid dependence along with patient-centered opioid safety knowledge. These needs could be met as part of patient-centered counseling (BI), ideally at index prescription when patients may be most receptive. A recent web-based digital intervention that met some of these needs increased patient knowledge and was rated as highly acceptable by patients [32].

Most patients described being stigmatized by healthcare professionals, including pharmacists when accessing opioid medications. Although few pharmacists openly discussed having bias towards patients in our interviews, many mentioned concerns about coming across as stigmatizing. Research indicates that pharmacists commonly distance themselves from patients who misuse opioids and hesitate to form therapeutic relationships with them [33]. While all patients were comfortable with the pharmacist providing opioid related information, very few had the experience of receiving patient-centered counseling regarding opioid safety. Research suggests that stigma is a barrier to participation in opioid-related interventions for both groups because patients are wary of feeling interrogated or labeled, and pharmacists are wary of making patients uncomfortable [34]. Pharmacists may require anti-bias training and patient-centered education. Such trainings have been shown to increase pharmacist knowledge about opioid misuse and decrease stigma [35]. Packaging SBI as a value added clinical service for all patients taking opioids may also help improve the patient-pharmacist interaction. Future studies should evaluate these strategies to design effective SBI.

Both groups were comfortable with a short self-reported screening tool, in addition to routine practice (using PDMP and technician help). This model that has been studied previously [36], where standardized tools such as the Prescription Opioid Misuse Index, [36, 37] the Opioid Risk Tool [38,39,40,41], or the Routine Opioid Outcome Monitoring tool [42, 43] were used. These studies also show promising potential for effectiveness of pharmacy-based SBI for opioids. Both groups also expressed support for pharmacy-based SBI focused on patient education regarding both opioid safety as well as general chronic opioid use, regardless of misuse behaviors. Since most opioid safety initiatives are not designed to be universal prevention [30], such SBI could potentially fill the gap in a patient population that is often overlooked. However, in busy large-chain pharmacies or those without private space, alternate formats of counseling such as telephone-based, telehealth, or digital applications may be more feasible and acceptable [44, 45].

Participants also discussed naloxone and contacting prescribers as potential brief interventions. A recent pharmacy-based SBI has found some success in increasing naloxone uptake [38,39,40,41]. However, pharmacists may need non-stigmatizing scripts focused on patient autonomy [46]. While pharmacists contacting prescribers could potentially reduce inappropriate prescriptions, research indicates that prescriber-pharmacist relationships and communication are often tense, ineffective, and a barrier to improving pharmacist roles in OUD prevention and treatment [47, 48]. Pharmacists in our study suggested that stakeholder engagement with prescribers to ensure their support of SBI may be needed.

Patients described needing a SBI delivery format that offers privacy and autonomy. Pharmacists needed a protocol and training to be able to efficiently provide SBI. Lack of time, role limitations, and stigma/privacy were the main implementation challenges. Research suggests that these role limitations hamper pharmacists’ self-efficacy in providing opioid safety services [13]. These challenges could potentially be overcome by offering alternative formats such as digital SBI, training pharmacists, fitting intervention within pharmacy workflows, and marketing SBI as a clinical service. Such strategies can be included in designing SBI in future research.

This study has some limitations. Patient interviews were conducted with a sample diverse in terms of pain chronicity and pharmacy experience but most patients were white, had insurance, and lived in suburban areas. As health disparities regarding opioids and OUD treatment are common in racial and ethnic minority groups, underinsured, and more rural populations, involving patients from these groups could lead to different themes. Therefore, findings from the patient interviews cannot be transferred to all patients using opioids. Future research should focus on engaging these groups individually and developing SBI that target their specific needs rather than a one-size-fits-all approach. Our study focused only on the screening and brief intervention portion of the SBIRT model. Referral to treatment is an important component that was not explored thoroughly in our study.

Conclusion

In this implementation-focused qualitative study comparing patient and pharmacist views on opioid misuse SBI, we found that patients needed education on opioid safety and general opioid use, regardless of misuse behaviors. Pharmacists described the need for patient-centered training, protocols, and scripts to provide SBI. A short-self-reported screening and brief interventions including counseling, naloxone, and involving prescribers were discussed by both groups. Alternate formats of SBI using digital health technologies may be needed for effective design and implementation.