Community Pharmacists' Roles in Optimising Opioids Therapy for Chronic Non-malignant Pain Patients: a Qualitative Study.


 Background: Opioids are currently widely used to manage chronic non-malignant pain, but there is a growing concern about harm resulting from opioid misuse, and the need for medicine optimisation, in which pharmacists could potentially play a key role.Objective: This study seeks to identify challenges to community pharmacists’ role in optimizing prescribed opioids for Chronic Non-Malignant Pain (CNMP).Setting: Community pharmacies in the UK.Method: Semi-structured interviews based on the Theoretical Domains Framework were conducted with 20 community pharmacists recruited through professional networks and analysed thematically.Result: Pharmacists perceive themselves as guardians of patients’ welfare and aspire to contribute to prescribed opioid optimisation. However, they are challenged by the lack of relevant training, inadequate time and resources, infrastructural and systemic constraints (such as repeat prescribing and prescription delivery services, lack of access to medical records and information about diagnosis), personal factors, including communication with doctors, and relationship with patients.Conclusion: The role of community pharmacists in optimising chronic opioid therapy is neither well-defined nor implemented in the UK. Utilisation of their potential skills and knowledge in this area requires an appropriate training curriculum, tackling the infrastructural and systemic constraints, support and resources to facilitate pharmacists’ engagement in patient monitoring and education. The findings in this study can contribute to inform policy makers with potentials to enhance pharmacists’ role in opioids therapy optimisation and, hence, ensure patients' safety when using prescribed opioids.


Introduction 39
Chronic pain is defined as pain that persists for more than three months [1]. Data suggests that up 40 to 19% of the population in Europe and 46% in the UK suffer from chronic non-malignant pain 41 (CNMP) [2]. Managing CNMP is costly to health services. The direct cost of prescribed 42 analgesics in the UK reached £537 million in 2016, while the indirect cost in lost productivity 43 was estimated as £10.7 billion between 2013-2014 [3]. 44 Opioids have long been used in pain management. However, concerns about chronic opioid 45 therapy (COT) effectiveness, safety, and abuse in CNMP have grown, especially with the 46 alarming death rate related to medical and illicit use of opioids in North America [4]. This has 47 A dominant theme throughout the interviews, arising from the TDF domain, Social and 124 Professional Role and Identity, was pharmacists' perception of themselves as guardians of 125 patient welfare. Some expressed this in general terms, as an intrinsic part of their professional 126 role. Others elaborated on particular safety concerns, including appropriate dosage, ensuring that 127 patients derive optimum benefit from their medication and do not suffer undesirable physical or 128 mental consequences, and looking out for signs of risk. When such concerns arose, they felt a 129 responsibility to take action. Some viewed COT optimisation as a specific responsibility, but 130 others viewed their role as secondary with the clinician having the main role as one interviewee 131 explained. 132 133 Pharmacists highlighted specific activities they performed pursuant to their safeguarding role, 134 particularly medicine use review (MURs) in which they asked about patients' use of the 135 medication and any problems they encountered explained. At these interviews, they might also 136 ask patients about their alcohol consumption and over-the-counter medications, but admitted that 137 they did not routinely raise these issues. Another safeguarding activity was the provision of 138 education and advice, including warning of possible side effects. In the event of serious 139 concerns, pharmacists reported deferring supply of medicine and referring back to the 140 prescribers, for example, to query the dose, highlight interactions with other medications, or 141 report suspicions of a patient's misuse or abuse of prescribed medication or other substances. 142

Theme 2: Capability 143
The theme Capability is related to the pharmacists' competencies for a potential role in COT 144 optimisation, rising from the TDF domains, Knowledge, Skills and Beliefs about Capabilities. 7 In performing their role, pharmacists relied on their professional judgement around supply of 146 prescribed opioids and drawing on knowledge and skills derived from training and experiences 147 was deemed to be key. They displayed an understanding of the meaning of COT optimisation as 148 ensuring the balance between effective control of patients' condition and avoiding harmful side 149 effects. They highlighted opioid-related problems including dependence, tolerance and addiction, 150 as well as physical and psychological side-effects such as depression. They showed awareness of 151 other treatment options, including non-opioid medication and complementary, non-152 pharmacological therapies that might reduce the need for PO. 153 Although a few described that they had specific knowledge of pain control, the majority reported 154 having little or no formal training on how to review opioid prescriptions and identify misuse; 155 only "one lecture or something" (CPRO1) but "no sort of course" (CPMZH1). Some, moreover, 156 admitted that their knowledge might not be up-to-date. Nevertheless, they generally felt 157 confident in dispensing PO and also suggested that, over time, they acquired an "intuition kind of 158 thing" (CPMYM) that helped them to identify warning signs of misuse, such as over-ordering, 159 early re-ordering and taking multiple medications. Despite their knowledge, skills and 160 experience, however several interviewees were pessimistic about their capability to contribute 161 effectively in COT optimisation, due to their lack of authority since "we're sort of almost the end 162 point before the patient gets their medication, so apart from the medication check, there's very 163 little I can do"(CPMZH1). 164

Theme 3: Infrastructure and systemic constraints 165
Pharmacists also highlighted specific constraints preventing them from playing a more direct and With regard to patient information, for example, it was pointed out that, although pharmacists 174 could access summary care records, in practice, they would not do it without a specific reason, 175 and in any case, the information contained might be too brief to be really helpful. Where 176 guidelines existed, their effectiveness, it was suggested, was undermined by ambiguity or 177 inconsistency. 178

179
Pharmacists also pointed to a lack of funding and resources, especially lack of time as a barrier to 180 more effective COT optimisation. They expounded on the difficulty of finding time to review, 181 monitor and educate the huge number of patients they encountered and perceived involvement in 182 COT optimisation as an additional burden on an already heavy workload. As interviewees 183 pointed out that devoting the necessary time to review each opioids prescription and having a 184 detailed conversation with every patient would not be feasible without additional staff. 185 186 Additionally, lack of funding was discussed as a particular issue for many. 187 188 Several participants suggested that opioid prescription review needed to be a commissioned, 189 funded service, to persuade pharmacies to undertake such activity, and for pharmacists to devote 190 their time to it. Currently, they reported the number of MURs performed annually was being 191 reductions forthcoming. Moreover, the reviews were being limited to specific categories of 193 medication, which did not include pain management. Ideally, it was suggested, MURs should not 194 only embrace a wider range of conditions and medications that is commonly the case but also 195 should be more frequent, perhaps every six months. One experienced pharmacist suggested the 196 need for a facilitative tool such as a short questionnaire to assess alcohol intake, break-through 197 pain and the like, to guide pharmacists in collecting the information needed to inform 198 optimisation interventions. oriented, compared to physicians who use more sophisticated problem-solving strategies, 254 including cognitive reasoning in ambiguous situations, reasoning from basic knowledge, 255 guidelines/ algorithms or experimental-based pattern recognition [24,25]. Moreover, both new 256 graduate and senior pharmacists in this study mentioned that prescribing opioids and chronic 257 opioid therapy in CNMP,, misuse and addiction were barely addressed in the pharmacy 258 undergraduate curriculum nor a focus of continuing education. The findings aligns with previous 12 claims that pharmacists lack a "role" as clinical decision-makers, and not trained to take on the 260 responsibility for patient outcomes [26,27]. This highlights the importance of adopting a 261 purpose-built curriculum and new teaching methods that match the NHS aim of enhancing the 262 pharmacists' role to become more patient-centred, and ensure they understand key concepts, 263 such as addiction and physical dependence and how to use recently developed screening e.g. 264 (SIB) and/or revised risk (ORT-R) questionnaires [28]. Prescription drug monitoring programmes (PDMPs) are a vital tool that provides an overview of 297 the patient's history of opioid dispensing. However, in this study, the majority of participants 298 described PDMP as "not helpful" and unlikely to eliminate PO misuse or optimise PO use, as 299 these prescriptions come from trusted sources. Also, participants highlighted some of the 300 drawbacks of using e-prescription, such as the automatic repeated prescription of opioids which 301 could be problematic. This is contrary to some North American and European health care 302 providers who are optimistic about the potential for electronic prescribing of controlled 303 substances (EPCS) to improve practice [17,32]. 304 medication-related problems, yet participants stated that even during MURs, PO were not their 306 priority, as they usually focused on other chronic diseases such as hypertension and diabetes 307 mellitus. It may be that pharmacists prefer to focus on patients with less complicated medicine 308 regimes. Pharmacists often underrate their capability and cite a need for better patient 309 information when conducting MUR [33]. It would be reasonable for them to have access to 310 diagnosis and information on co-morbidities to increase the clinical relevance of pharmacist 311 recommendations and improve communications with other healthcare providers. 312 Research suggests that stigmatised groups such as COT, CNMP, opioid use disorder, and those 313 coming off opioids may be reluctant to seek advice from their healthcare providers, yet, in our 314 study, only one participant expressed empathy toward COT patients. Empathy lends patients a 315 sense of fulfilment and connectedness that encourages them to reveal their "true state of affairs" 316 and optimises the effectiveness of pharmacist-patient consultations but relatively neglected in 317 healthcare [34]. A systematic review found a clear connection between patients with substance 318 use disorders and negative attitudes, mostly implicit, of healthcare professionals resulting in 319 shorter periods of patient engagement or avoidance of patients [35]. Also, it is reported that once 320 a problematic medication-taking behaviour has been identified, community pharmacists may 321 avoid confronting patients, due to the sensitive nature of PO use, and the potential for patients' 322 perceived sense of stigma. Motivational interviewing training for pharmacists could be very 323 beneficial in helping patients change behaviours [36]. 324 This study is not without its limitations. The convenience sample involved in this study was 325 relatively small, and the subjective findings may not be generalisable. Also, topic sensitivity may 326 have resulted in some responses bias. The findings in this study are consistent with research in 327 other settings. The use of the TDF ensured incorporation of a wide range of factors and will 328 allow the mapping of the finding to theories of behaviour changes. 329

Implications for practice 330
Implications for practice include the need for a clearer definition and guidelines on the use of 331 COT in CNMP and the optimisation role f pharmacists. More education and training on CNMP, 332 CNMP and opioid use disorder are needed, consistent the with NHS vision of the expanded role 333 of pharmacists in clinical aspects of patient care. There is also a need for direction and support 334 from pharmacy organisations, for example, reimbursement, to empower pharmacists as opioid 335 risk educators and gatekeepers. 336

Conclusion 337
The role of community pharmacists in optimising chronic opioid therapy is neither well-defined 338 nor implemented in the UK. There is a potential to use community Pharmacist's skills and 339 knowledge to facilitate their engagement with CNMP patients using COT and involvement in 340 monitoring and education. However, there is a need for appropriate training curriculum, tackling 341 of the infrastructural and systemic constraints direction, support and resources. The findings in 342 this study research can contribute to inform policy makers with potentials to enhance 343 pharmacists' role in opioids therapy optimisation and, hence, ensure patients' safety when using 344 prescribed opioids. Nevertheless, further insight into pharmacists' potential role and factors 345 affecting it could be obtained by interviewing pharmacists in other settings such as GP surgeries 346 and hospitals, and other stakeholders such as GPs and pain specialists, pharmacy educators and 347 policymakers. There is also a need for a deeper understanding of the needs and perspectives of 348 patients themselves.