Acceptability of a proposed practice pharmacist-led review for opioid-treated patients with persistent pain: A qualitative study to inform intervention development.

Introduction: Regular review of patients prescribed opioids for persistent non-cancer pain (PCNP) is recommended but not routinely undertaken. The PROMPPT (Proactive clinical Review of patients taking Opioid Medicines long-term for persistent Pain led by clinical Pharmacists in primary care Teams) research programme aims to develop and test a pharmacist-led pain review (PROMPPT) to reduce inappropriate opioid use for persistent pain in primary care. This study explored the acceptability of the proposed PROMPPT review to inform early intervention development. Methods: Interviews (n = 15) and an online discussion forum (n = 31) with patients prescribed opioids for PCNP and interviews with pharmacists (n = 13), explored acceptability of a proposed PROMPPT review. A prototype PROMPPT review was then tested and refined through 3 iterative cycles of in-practice testing (IPT) (n = 3 practices, n = 3 practice pharmacists, n = 13 patients). Drawing on the Theoretical Framework of Acceptability (TFA), a framework was generated (including a priori TFA constructs) allowing for deductive and inductive thematic analysis to identify aspects of prospective and experienced acceptability. Results: Patients felt uncertain about practice pharmacists delivering the proposed PROMPPT review leading to development of content for the invitation letter for IPT (introducing the pharmacist and outlining the aim of the review). After IPT, patients felt that pharmacists were suited to the role as they were knowledgeable and qualified. Pharmacists felt that the proposed reviews would be challenging. Although challenges were experienced during delivery of PROMPPT reviews, pharmacists found that they became easier to deliver with time, practise and experience. Recommendations for optimisations after IPT included development of the training to include examples of challenging consultations. Conclusions: Uptake of new healthcare interventions is influenced by perceptions of acceptability. Exploring prospective and experienced acceptability at multiple time points during early intervention development, led to mini-optimisations of the prototype PROMPPT review ahead of a non-randomised feasibility study.

Risk of adverse outcomes during gabapentinoid therapy and factors associated with increased risk in UK primary care using the clinical practice research datalink: a cohort study.

ABSTRACT: Growing evidence from pharmacovigilance data and postmortem toxicology reports highlights the misuse potential of gabapentinoids. This study aimed to investigate the risk of serious adverse outcomes (drug misuse, overdose, major trauma), and their risk factors, in primary care patients who are prescribed gabapentinoids. Using the UK Clinical Practice Research Datalink, a matched cohort study calculated adverse event rates separately for gabapentinoid-exposed and unexposed cohorts. In the exposed cohort, event rates for exposure to a range of potential risk factors were calculated. Event rates were compared using Cox proportional hazards models, adjusted for age, sex, deprivation, previous mental health diagnosis, and coprescribing with potentially interacting medicines. Substance misuse (gabapentin adjusted hazard ratio [95% CI]: 2.40 [2.25-2.55]), overdose (2.99 [2.56-3.49]), and major trauma (0-2.5 years: 1.35 [1.28-1.42]; 2.5 to 10 years: 1.73 [1.56-1.95]) were more common among patients prescribed gabapentinoids than matched individuals who were not. The association with overdose was stronger for pregabalin than gabapentin. All adverse outcomes were significantly associated with smoking, history of substance misuse, overdose, or a mental health condition and prescription of opioids, benzodiazepines, antidepressants, and Z-drug hypnotics (eg, gabapentin hazard ratios for association of concurrent opioid use: misuse 1.49 [1.47-1.51]; overdose 1.87 [1.78-1.96]; major trauma 1.28 [1.26-1.30]). Our findings highlight the importance of careful patient selection when prescribing gabapentinoids and the need to educate prescribers about the risks of these drugs, particularly in combination with other central nervous system depressants.

Designing a primary care pharmacist-led review for people treated with opioids for persistent pain: a multi-method qualitative study.

BACKGROUND: Opioids are frequently prescribed for persistent non-cancer pain despite limited evidence of long-term effectiveness and risk of harm. Evidence-based interventions to address inappropriate opioid prescribing are lacking. AIM: To explore perspectives of people living with persistent pain to understand barriers and facilitators in reducing opioids in the context of a pharmacist-led primary care review, and identify review components and features for optimal delivery. DESIGN & SETTING: Primary care multi-method qualitative study. METHOD: Adults with experience of persistent pain and taking opioids participated in semi-structured interviews (n=15, 73% female) and an online discussion forum (n=31). The Theoretical Domains Framework (TDF) provided a framework for data collection and thematic analysis, involving deductive analysis to TDF domains, inductive analysis within-domains to generate subthemes, and subtheme comparison to form across-domain overarching themes. The behaviour change technique taxonomy v.1 and motivational behaviour change technique classification system were used to systematically map themes to behaviour change techniques to identify potential review components and delivery features. RESULTS: 32 facilitator and barrier subthemes for patients reducing opioids were identified across 13 TDF domains. These combined into six overarching themes: learning to live with pain, opioid reduction expectations, assuming a medical model, pharmacist-delivered reviews, pharmacist-patient relationship and patient engagement. Subthemes mapped to 21 unique behaviour change techniques, yielding 17 components and five delivery features for the proposed PROMPPT review. CONCLUSION: This study generated theoretically-informed evidence for design of a practice pharmacist-led PROMPPT review. Future research will test the feasibility and acceptability of the PROMPPT review and pharmacist training.

Prognosis of Patients With Neuropathic Low Back-Related Leg Pain: An Exploratory Study Using Prospective Data From UK Primary Care.

This prospective cohort study investigates the prognosis of patients with neuropathic low back-related leg pain consulting in UK primary care. Data from 511 patients were collected using standardised baseline clinical examinations (including magnetic resonance imaging scan findings), self-report questionnaires at baseline, 4 months, 12 months, and 3 years. Cases of possible neuropathic pain (NP) and persistent-NP were identified using either of 2 definitions: 1) clinical diagnosis of sciatica, 2) self-report version of leeds assessment for neurological symptoms and signs (s-LANSS). Mixed-effects models compared pain intensity (highest of mean leg or mean back pain [0-10 Numerical Rating Scale]) over 3-years between persistent-NP versus non-persistent-NP based on 1) clinical diagnosis, 2) s-LANSS. Logistic regression examined associations between potential prognostic factors and persistent-NP at 4 months based on the 2 NP definitions. At 4-months, using both definitions: 1) approximately 4 out of 10 patients had persistent-NP, 2) mean pain intensity was higher for patients with persistent-NP at all follow-up points compared to those without, 3) only pain self-efficacy was significantly associated with persistent-NP (s-LANSS: OR .98, sciatica: .98), but it did not predict cases of persistent-NP in either multivariable model. Based on factors routinely collected from self-report and clinical examination, it was not possible to predict persistent-NP in this population. PERSPECTIVE: This study provides evidence that neuropathic back-related leg pain in patients consulting in primary care is not always persistent. Patients with persistent neuropathic pain had worse outcomes than those without. Neither leg pain intensity, pain self-efficacy nor MRI scan findings predicted cases of persistent neuropathic pain in this patient population.

Trends in gabapentinoid prescribing in UK primary care using the Clinical Practice Research Datalink: an observational study.

Background: The UK government reclassified gabapentin and pregabalin as 'controlled drugs' from April 2019. This study aimed to describe the trends in gabapentinoid prescribing before and immediately after reclassification, in the UK Clinical Practice Research Datalink, an electronic primary care health record broadly representative of the UK. Methods: Separately for gabapentin and pregabalin, we calculated annual incident and prevalent prescribing rates from year of UK approval (April 1997 and 2004 respectively) to September 2019, and monthly incident and prevalent prescribing rates (October 2017-September 2019). Significant changes in temporal trends were determined using joinpoint regression. We also described potential prescribing indications, prior pain-related prescribing, and co-prescribing with potentially interacting medicines. Findings: Incident gabapentin prescribing increased annually, peaking in 2016-17, at 625/100,000 patient years before falling steadily to 2019. Incident pregabalin prescribing peaked at 329/100,000 patient years in 2017-18 and did not fall significantly until 2019. Prevalent gabapentin and pregabalin prescribing increased annually to 2017-18 and 2018-19 respectively, before plateauing. Gabapentinoids were commonly co-prescribed with opioids (60%), antidepressants (52%), benzodiazepines (19%), and Z-drugs (10%). Interpretation: Following a dramatic rise, incident gabapentinoid prescribing has started to fall but the specific impact of reclassification on prescribing rates remains unclear. Limited change in prevalent gabapentinoid prescribing during the 6 months following their reclassification as controlled drugs suggests little immediate impact on continued gabapentinoid prescribing for existing users. Funding: National Institute for Health and Care Research (NIHR) Research for Patient Benefit Programme. NIHR Applied Research Collaboration West Midlands. NIHR School for Primary Care Research.

Prevalence, Characteristics, and Clinical Course of Neuropathic Pain in Primary Care Patients Consulting With Low Back-related Leg Pain.

OBJECTIVES: Little is known about the epidemiology of neuropathic pain in primary care patients consulting with low back-related leg pain. We aimed to describe prevalence, characteristics, and clinical course of low back-related leg pain patients with and without neuropathic pain, consulting with their family doctor in the United Kingdom. MATERIALS AND METHODS: This was a prospective cohort study. Data were collected using a standardized baseline clinical examination and self-report questionnaires at baseline, 4, 12, and 36 months. We identified cases of neuropathic pain using 3 definitions: 2 based on clinical diagnosis (sciatica, with and without evidence of nerve root compression on magnetic resonance imaging), one on the self-report version of Leeds Assessment for Neurological Symptoms and Signs. Differences between patients with and without neuropathic pain were analyzed comparing each definition. Clinical course (mean pain intensity measured as the highest of leg or back pain intensity: mean of 3 Numerical Rating Scales, each 0 to 10) was investigated using linear mixed models over 36 months. RESULTS: Prevalence of neuropathic pain varied from 48% to 74% according to definition used. At baseline, patients with neuropathic pain had more severe leg pain intensity, lower pain self-efficacy, more patients had sensory loss than those without. Distinct profiles were apparent depending on neuropathic pain definition. Mean pain intensity reduced after 4 months (6.1 to 3.9 [sciatica]), most rapidly in cases defined by clinical diagnosis. DISCUSSION: This research provides new information on the clinical course of neuropathic pain and a better understanding of neuropathic pain in low back-related leg pain patients consulting in primary care.

Neuropathic Pain in Low Back-Related Leg Pain Patients: What Is the Evidence of Prevalence, Characteristics, and Prognosis in Primary Care? A Systematic Review of the Literature.

This systematic review synthesizes literature describing prevalence, characteristics, and prognosis of low back-related leg pain (LBLP) patients with neuropathic pain in primary care and/or similar settings. Inclusion and exclusion criteria were developed and used by independent reviewers to screen citations for eligibility. The initial search yielded 24,948 citations; after screening 12 studies were included. Neuropathic pain was identified using case ascertainment tools (n = 5), clinical history with examination (n = 4), and using LBLP samples assumed neuropathic (n = 3). Neuropathic pain prevalence varied from 19% to 80%. There was consistent evidence for higher back-related disability (n = 3), poorer health-related quality of life (n = 2), and some evidence for more severe depression (n = 2), anxiety (n = 3), and pain intensity (n = 4) in patients with neuropathic pain. Results were less consistent when cases were identified through clinical history with examination than those identified using case ascertainment tools. Prognosis (n = 1) of LBLP patients with neuropathic pain was worse compared with those without, in all outcomes (leg pain intensity, leg and back-related disability, self-reported general health) except back pain intensity. No studies described prognostic factors. This systematic review highlights the evidence gap in neuropathic pain in LBLP in primary care, especially with respect to prognosis. PERSPECTIVE: Patients with LBLP may have neuropathic pain. This systematic review emphasizes the paucity of evidence describing the characteristics and prognosis of neuropathic pain in this patient population. Future research investigating prognosis of these patients with neuropathic pain is likely to contribute to better understanding and management.