Title: Prescription opioid analgesics for chronic non-cancer pain: developing a primary care-based intervention to prevent and reduce opioid dependence.
Funder: Department of Health and Social Care

Abstract: Background Over the last two decades, opioid analgesics have been increasingly prescribed for chronic non-cancer pain in many Western countries, despite a lack of evidence for their long-term effectiveness. Increased opioid prescribing has led to a significant increase in prescription opioid-related harms, including substance use disorders (opioid addiction and dependence), accidental poisoning, premature deaths, incident depression, major trauma and falls.Although opioids are often prescribed in secondary care settings, primary care is the main source of opioid prescriptions in the UK. National guidance highlights the importance of early intervention and treatment for prescription opioid dependent individuals. It also recognises that they differ from individuals who are dependent on illicit opioids. Therefore guidance recommends that commissioners of drug services provide specific services for prescription opioid dependence, preferably within primary care settings. Although GPs agree with these recommendations, they are often uncertain about how to manage opioid analgesic dependence. Additionally, previous research shows that GPs want more support with the management of chronic non-cancer pain and opioid prescribing. Currently, there are no specific services in primary care for opioid analgesic dependent patients. Therefore, we urgently need to develop primary care-based interventions to prevent and reduce opioid analgesic dependence in patients with chronic non-cancer pain.Aims and objectives The aim of the fellowship is to develop a complex primary care-based intervention to prevent and reduce prescription opioid dependence in chronic non-cancer pain (CNCP) patients.Specific objectives are to: Systematically review evidence regarding the prevalence of prescription opioid dependence in CNCP patients and the effectiveness of primary care-based interventions to prevent and reduce opioid dependence in this patient group Evaluate a locally commissioned pilot project in South Gloucestershire to reduce opioid analgesic dependence in CNCP patients Co-produce a complex multicomponent intervention with key stakeholders (including patients, commissioners, GPs and other healthcare professionals) that can be implemented in primary care to prevent and reduce prescription opioid dependence in CNCP patients. Plan of investigation First, I will perform a review of the literature to identify the prevalence of prescription opioid dependence in CNCP patients. I will also identify primary care-based interventions which may be used to prevent and reduce opioid dependence, including their clinical and cost effectiveness. Interventions may be targeted at GPs, patients or both groups and focused on reducing opioid dependence at three levels of prevention: Primary - appropriate pain management and opioid prescribing; improving understanding of opioid related harms; utilising prescribing systems and prescribing/medication reviews Secondary - screening/early recognition of opioid dependence and early intervention Tertiary - pharmacological and non-pharmacological treatment of opioid dependence. Second, I will use qualitative and quantitative methods to evaluate a local pilot service aimed at reducing opioid analgesic dependence in CNCP patients. The pilot is based on a shared care' model. This approach utilises the skills and knowledge of a range of healthcare professionals working together with shared responsibility for an individual's care. Findings from the literature review and the pilot evaluation will be used to inform the development of the new intervention. Patients and the public will be involved throughout the project to ensure that the proposed intervention is acceptable.Potential benefits to patients and the NHS Prescription opioid dependence impacts negatively on individuals, families and the wider community and is associated with significant healthcare, workplace and criminal justice costs. Therefore preventing and reducing prescription opioid dependence in CNCP patients should be a key UK Public Health priority. Developing an effective and acceptable primary care-based intervention to deal with this important issue would enable commissioners to address current gaps in service provision nationally and ultimately improve health outcomes in prescription opioid dependent patients.

Lay abstract: Aim To work together with key stakeholders (patients, GPs, hospital doctors, commissioners and other healthcare professionals) to develop a general practice-based intervention to reduce the number of people with long-term non-cancer pain who become dependent (i.e. hooked') on prescribed opioid painkillers.Background Over the last 20 years, opioid painkillers (for example codeine and tramadol) have been increasingly prescribed by GPs to treat chronic non-cancer pain (i.e. pain that lasts longer than three months and that is not cancer related) in many Western countries (USA, UK, Canada, Australia). This is despite a lack of evidence showing that opioid painkillers can effectively treat this type of pain. Although opioids are often prescribed in hospitals, most opioid prescribing in the UK occurs in general practices. The increased prescribing of opioid painkillers has led to an alarming increase in the number of people who are becoming addicted to these painkillers. There has also been a rise in the number of opioid painkiller-related overdose deaths.Opioid painkiller dependence can affect all age groups with negative impacts on individuals, families and society. It is associated with significant healthcare costs (due to excess hospitalisations and prescriptions), workplace costs (lost earnings due to unemployment and early death) and criminal justice costs (if it leads to illegal opioid use and crime to fund this habit). There is increasing awareness nationally around the harms of opioid painkillers. The issue of opioid painkiller dependence was highlighted in two recent BBC documentaries Hooked on Painkillers and The Doctor who gave up Drugs.National guidance highlights how important it is for people who are opioid painkiller dependent to receive early treatment. The guidance also recognises that services which treat people who are dependent on illegal opioids (such as heroin) are unlikely to be suitable for people who are prescription opioid painkiller dependent. Therefore, the guidance recommends that separate services are provided for this group, preferably situated within GP practices. Although GPs agree with these recommendations, they are often uncertain about how to manage opioid painkiller dependence. Previous research shows that GPs would also like more support with the management of long term non-cancer pain and opioid prescribing. Currently, there are no specific services in general practices for opioid painkiller dependent patients. We urgently need to develop general practice-based interventions to prevent and reduce opioid dependence in patients with long-term non-cancer pain.Design and methods First, I will review the literature to determine the percentage of people with long-term non-cancer pain who become opioid painkiller dependent. I will also identify interventions based in GP practices which are effective in reducing opioid painkiller dependence in these patients. Interventions which target GPs, patients or both groups will be considered as well as interventions which prevent people becoming dependent on opioid painkillers in the first place. These may include interventions which train GPs to manage pain and use opioid painkillers appropriately. Interventions may also focus on increasing GPs' and patients' understanding of opioid prescribing harms, recognising opioid painkiller dependence earlier or treating people who have already become dependent on prescribed opioids.Second, I will evaluate a pilot service aimed at reducing opioid painkiller dependence in non-cancer patients on long-term opioids. The pilot is currently based in two South Gloucestershire GP practices and uses a shared care' approach. This approach involves a range of health professionals working together and sharing responsibility for an individual's care. I will assess the pilot by talking to patients, GPs and other health care practitioners to find out their views. The information obtained from the literature review and the pilot evaluation will be used to develop a new intervention with help from key stakeholders.Patient and public involvement This research has been identified as high priority by patient groups locally (i.e. patient and public involvement groups associated with the Bristol Health Partners Integrated Pain Management and Treatment of Addictions Health Integration Teams) and nationally (the Painkiller Addiction Information Network charity). Patients will sit on the steering group of the project and contribute to study reporting and research dissemination. Patients will also be involved in evaluating the pilot and co-production of the intervention to make sure that the proposed intervention is acceptable. Dissemination I will use a variety of methods to share research findings including publishing in journals, conference presentations, newsletters, the Internet and social media. I will be pro-active in communicating the research findings to GPs, patient and public involvement groups and other stakeholders (such as local authority commissioners and policy makers) to ultimately improve health outcomes for prescription opioid dependent patients.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MENTAL HEALTH