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Codeine Use, Misuse and Dependence

Final Report Summary - CODEMISUSED (Codeine Use, Misuse and Dependence)

PUBLISHABLE SUMMARY REPORT

Title Over the Counter Codeine Use Misuse and Dependence
Acronym: CODEMISUSED
Funding Acknowledgement: The research leading to these results has received funding from the European Community's Seventh Framework Programme FP7/2007-2013 under grant agreement no 611736.
Project full title: Over the Counter Codeine Use, Misuse and Dependence
Project start date: 01/09/2013
Duration of the project: 48 months
Website: http://www.codemisused.org/

Contact Details:
Prof John Wells, CODEMISUSED Project Coordinator and Principal Investigator, Email: jswells@wit.ie
Margaret Walsh, CODEMISSUED Project Manager, Email: mwalsh@wit.ie

The CODEMISUSED project was selected for funding under the FP7 Marie Curie Industry Academia Partnership and Pathways strand in 2013 and valued at €2.04 million. It ranked 2nd place in Life Sciences Division with a score of 96/100. This 48 month project started on September 1st 2013.

The CODEMISUSED collaboration consists of 6 international partners across 3 jurisdictions: Waterford Institute of Technology, Ireland, Kings College London, UK, Medical Research Council, South Africa, Cara Pharmacy Group, Ireland, Weldricks Pharmacy, UK and Local Choice Pharmacy Group, South Africa.

The project was guided by a specialist and dedicated Expert Advisory Panel represented by Dr Kevin Blake, Clinical Pharmaco-epidemiologist working in the Pharmacovigilance Sector within the Patient Health Protection Unit (European Medicines Agency) and Dr Richard Cooper, Pharmacist and Lecturer in Public Health (School of Health and Related Research (ScHARR), University of Sheffield UK).

Industry (pharmacy chains) and academia exchanges in the form of secondments of staff, workshops, seminars and conferences have occurred throughout the duration of the 48 month project, and have been paramount to the informed success of work package design, implementation of research by virtue of the collaboration, exchange knowledge and expertise from academics and pharmacy staff. The project is fully delivered and 100% of the inter-sectorial secondment months have been completed. All Marie Curie Fellows have been actively involved in outreach when on secondment which involves dissemination within the host organisation, and home organisation on return from secondments, and also engaging with local services and key stakeholders whilst on secondment and whilst working on the scientific objectives of CODEMISUSED.

Highlights

ENCEPP
In September 2013, CODEMISUSED applied to the European Medicines Agency for registration onto the Pharmacoepidemiology and Pharmacovigilance (ENCePP) registry of research projects approved by the European Medicines Agency (EMA) for research in the EU. The project was accepted and the official reference number for the study ‘Over the Counter Codeine Use Misuse and Dependence’ is ENCEPP/SDPP/4708. CODEMISUSED presented at the European Medicines Agency ENCePP (Pharmacoepidemiology and Pharmacovigilance network), and engaged with members via email circulars.

EU-AFRICA Collaboration
CODEMISUSED was selected as success story for inclusion in publication by the Directorate General "Research and Innovation" of the European Commission. This publication highlights the results of EU-Africa collaboration on science, technology and innovation funded by the EU's 7th Research Framework program.

Van Hout, MC and the CODEMISUSED Team (2015) CODEMISUSED EU Cooperation with Africa Directorate General “Research & Innovation” EU Bulletin & Horizon 2020 website.

EURODURG
CODEMISUSED actively engaged with EURODURG (www.pharmacoepi.org/eurodurg) and were profiled in the Newsletter of the European Chapter of the Special Interest Group of Drug Utilisation Research (SIGDUR) of the International Society of Pharmacoepidemiology (ISPE).

Van Hout, MC and the CODEMISUSED Team (2015) CODEMISUSED. EuroDurg Bulletin www.pharmacoepi.org/eurodurg Newsletter of the European Chapter of the Special Interest Group of Drug Utilisation Research (SIG-DUR) OF THE International Society of Pharmacoepidemiology (ISPE).

Project Summary
CODEMISUSED is a collaborative study between academic and pharmacy partners that aims to quantify and explore prescribed, over the counter (OTC) and web retailed codeine use, misuse and dependence in model countries across three regulatory regimes: Ireland (IR), United Kingdom (UK) and South Africa (SA). The multi-disciplinary team included members from existing internationally recognised addiction research groups at the School of Health Sciences at Waterford Institute of Technology, Ireland (WIT), the Institute of Psychiatry at King’s College London, United Kingdom (KCL), and the Alcohol and Drug Abuse Research Unit at the South African Medical Research Council (MRC) who worked together with experienced Chief Superintendent Pharmacists from each national pharmacy chain, namely; CARA Pharmacy Group (IR), Weldricks Ltd (UK) and the Leading Pharmacy Group (South Africa) whose staff in the form of Designated Pharmacy Researchers were involved in secondments to academic partners. The CODEMISUSED collaboration investigated a growing public health issue in order to present data on prescribed and over the counter codeine use, misuse and dependence in partner countries and from a variety of perspectives (codeine patients, prescribers, pharmacists, addiction treatment specialists, drug users, customers and addiction treatment patients) so as to inform the design of patient information, professional competency training and education, primary care and pharmacy risk detection, surveillance and monitoring, referral, treatment and detoxification initiatives for innovative use in the pharmaceutical, pharmacy medical and treatment professions. It aimed to carry out a national and international collaborative study to estimate levels of therapeutic and non-therapeutic codeine use, misuse and dependence in partner countries from a variety of sources and perspectives (meta-analysis of literature, prescribed, OTC and web sourced users, pharmacies, general practitioner (GP) and pain management specialists, and addiction treatment providers), and successfully encouraged knowledge, expertise and practice between IR, UK and SA pharmacies around the issue of prescribed, OTC and web based codeine sales, customer intervention, monitoring and tracking, referral and treatment design. All prescribed and OTC combination codeine products were targeted, including those containing dihydrocodeine and where possible the data will be extrapolated to provide detail with regard to product (e,g. Solpadeine, Nurofen Plus). Commonalities and differences were investigated in attitudes and trajectories of therapeutic and non-therapeutic OTC and web purchased codeine use, misuse and dependence within the general population and identifiable risk groups such as youth, women, elderly, recreational and problematic drug users, opiate dependents. Consideration was given to the ‘hidden nature’ of codeine use, misuse and dependence, and the potential drug displacement patterns occurring between prescribed, OTC and web sourced codeine. CODEMISUSED is aligned with broader attempts in the pharmacy profession, not only to enhance research capacity, but also give pharmacists the opportunity to become directly involved in the research process supported by CODEMISUSED’s team of expert academics in the fields of public health, addiction, pharmacy and internet drug sales.

EMCDDA have called for increased research efforts into the broad and ‘hidden’ spectrum of therapeutic and non-therapeutic patterns of codeine use, identifiable risk cohorts, and treatment uptakes. Research on a scale such as CODEMISUSED has never been done before in the EU, and is much needed to estimate and create a codeine user profile of use, misuse and dependence, with particular attention to sourcing, trajectories of use and displacement between prescribed and OTC. A clearer understanding of the general public’s awareness on the potential risks of codeine use, misuse and dependence, and impact of pharmacy dispensing of codeine will ultimately allow professional pharmacy, pharmaceutical, medical, drug and health organisations in the EU to amend and generate new EU standards and guidelines for the prescribing, dispensing and monitoring of codeine and other medicines of misuse. Demonstration of high levels of professional conduct and utility in tackling this issue will help persuade EU commissioners to invest further in Community Pharmacy Services. CODEMISUSED as a multidisciplinary project builds on the strategic links between the partners through the exchange of expert academic and pharmacy practitioners, which will enhance the exchange of information, practices and innovation via rigorous and professional scientific steering and cross-fertilisation of ideas. Outputs will inform pharmacy practice innovation relating to the design and evaluation of brief point of sale interventions in pharmacies (face to face and online), improved brand packaging, educational informational signage and store design, unified inter pharmacy customer tracking systems, recommendations and guidelines for codeine based treatment systems and expert training programmes on OTC and Rx’ed medicines of abuse for medical, health and pharmacist professionals, which in turn will benefit customer and patient care. These unique outputs are intended for implementation across the EU via the EMA Pharmacovigilance and Risk Management Sector (Patient Health Protection Unit, EMA), EMA-CHMP, EMA-HPWG, EGPRN, EMCDDA National Focal Point REITOX Network, EMCDDA Pharmacovigilence Steering Group and via the South African SACENDU, and have the potential to act as model templates for use in the generic area of medicinal misuse and dependence.

By profiling the extent of prescribed, OTC and web sourced codeine use, misuse and dependence, the pharmacy profession as primary point of sale can start to:
• Address the problems associated with problematic use and dependence;
• Strengthen national pharmacy sales monitoring systems for codeine purchase;
• Improve product health warnings, educational informational signage elements and store design;
• Deliver targeted continuing professional development (CPD) modules on codeine and other medicines of abuse;
• Design pharmacy and online brief interventions, customer monitoring, tracking and referral systems,
• Design specific codeine dependence treatment protocols.

CODEMISUSED’s inter-sectorial exchanges were used to inform, guide, implement and disseminate findings from each work package which commenced with a meta-analysis and systematic review of literature on codeine, existing national data sources and codeine sales trends, and was followed by national pharmacist, medical professional and treatment provider surveying, sweep surveys of individuals purchasing OTC and prescribed codeine in pharmacies, internet-based codeine user focus groups targeting web-sourcing, and in-depth face to face interviews with codeine users, misusers and dependents in each partner country. Academic and pharmacy partner exchanges supported the research and subsequent development of innovative practice with regard to retailing of codeine products, improvements in customer and patient care, and professional training. Frontline pharmacy practitioners (chief pharmacists, pharmacists, dispensing technicians and frontline pharmacy staff) who have extensive experience in dispensing codeine products will assist in study designs, actively participated in fieldwork and disseminated project outputs on return to their national pharmacy chains.

Completed Outputs
Recommendations identified in Work Packages 1-9 were disseminated via the Dedicated CODEMISUSED Project website including a public health portal and short technical reports and factsheets. Dissemination occurred also via project workshops, seminars, national and international conferences at various stages, and via the publication of national EU and international reports and scientific papers. Scientific papers and reports were forwarded to the EMA Pharmaco-vigilance and Risk Management Sector, EMACHMP, EMA-HPWG, EGPRN and EMCDDA for dissemination via the REITOX Network of National Focal Points, the Pharmaco Vigilant Steering Group and for consideration in ‘Special Issue’ monographs, and other relevant international organisations (INCB, UNODC, WHO). Findings were sent to each partner countries’ Proprietary or Pharmaceutical Associations so as to boost involvement with product manufacturers. Marie Curie Ambassadors (both academics and pharmacy secondees) visiting educational institutions delivered short public seminars and training for students, workshops, conference seminars, podcasts via the CODEMISUSED website, e-Newsletters and E-bulletins and national media coverage. Other work completed include 1 European publication (EU-Africa); 1 EU Research publication (Summer 2017 Issue); 1 published (invited) a book chapter; the Cochrane Review publication on dihydrocodeine substitution and detoxification which was accepted by the Cochrane Drug and Alcohol group in April 2015; a journal paper designing a cognitive behavioural therapy (CBT) model for understanding codeine addiction as distinct from other opiate addiction; a second journal paper on medical professional attitudes; two journal papers on pharmacist perceptions of codeine misuse, and the identification of codeine misusing customers, the interviewing of addiction professionals and addiction patients, and internet monitoring and surveying in the UK, and data analysis of customer sweep surveying in three countries. Innovations arising from CODEMISUSED were discussed at national key stakeholder meetings and round table discussions in partner countries in late 2015 and 2016 and two innovation reports have been developed based on consultations with national stakeholders and interviews with key informants. Three national clinical audit templates for auditing the training of pharmacy staff in the safe supply of non-prescription codeine containing products, and auditing the safe supply of non-prescription codeine containing products in partner countries; development of three country factsheets for use in pharmacy for staff training; factsheets for addiction treatment professionals; the combined and national survey reports on medical prescriber and pharmacy perspectives on codeine misuse and dependence; a three country focus group study on pharmacists experiences of the issue; the Irish and South African country reports on addiction treatment professional perspectives.

Main findings illustrate the public health issue of medication misuse, codeine’s potential for misuse and dependence, characteristics of codeine misuse, particularly OTC codeine products, problems with scheduling solutions, prescriber screening, support of those experiencing problems and potential for community pharmacy based interventions. Innovative outputs for potential use across the EU (and internationally) emerged from the project to include recommendations for prescribing policies and brand packaging, medical monitoring of patient codeine use and networking with pharmacists; design of brief point of sale interventions in pharmacies (face to face and online), development of inter pharmacy tracking systems for customers misusing codeine; design of educational informational signage and other in store design issues, a series of specific recommendations and guidelines for codeine based treatment systems, model country specific referral and treatment leaflets for problematic codeine use, and educational material on OTC and Rx’ed medicines of abuse for pharmacist, health and addiction professional continuing education. CODEMISUSED findings inform EU pharmacy, medicine and professional training standards. Training modules have been provided to all national health and pharmacy stakeholders and incorporated into the existing Centre for Pharmacy Postgraduate Education (CPPE) system at the University of Manchester (www.cppe.ac.uk) UK by Professor Christopher Cutts, Director of the CPPE. The ‘Codeine Wise’ Project has also been developed by The Local Choice Pharmacy Group to train their pharmacy staff as a direct output of CODEMISUSED. National CODEMISUSED conferences and events took place in each partner country: Ireland, the UK and South African. We have actively liaised with the European Medicines Agency ENCePP (Pharmacoepidemiology and Pharmacovigilance network), and have engaged in dialogue with the European Monitoring Centre for Drugs and Drug Addiction. We have also actively engaged with the EURODURG (www.pharmacoepi.org/eurodurg) Newsletter of the European Chapter of the Special Interest Group of Drug Utilisation Research (SIG-DUR) of the International Society of Pharmacoepidemiology (ISPE). Professor Parry, Medical Research Council South Africa has presented CODEMISUSED to United Nations Office on Drugs and Crime (UNODC). The establishment of codeine referral pathways into pharmacy, primary care and community drugs services will help integrate this public health issue further with other healthcare providers, strengthen links and provide a template for other areas of practice, such as alcohol and other forms of substance misuse. Findings as they relate to prevalence, medical, pharmacy, addiction treatment, health promotion and proprietary/pharmaceutical practices, and their respective policies were launched both via the dedicated CODEMISUSED Project website, with links to associated projects and national Pharmaceutical and Drug Research organisations, and in each country in their respective drugs and health research website, for example Ireland, "http://www.drugsandalcohol.ie”; UK, "http://www.drugscope.org.uk"; and South Africa "http://www.sahealthinfo.org". Subsequent scientific papers and reports were also forwarded to the EMA Pharmacovigilance and Risk Management Sector, EMA-CHMP, EMA-HPWG, EGPRN and EMCDDA for dissemination via the REITOX Network of National Focal Points, the Pharmaco Vigilant Steering Group and for consideration in ‘Special Issue’ monographs, and other relevant international organisations (INCB, UNODC, WHO). Alongside our membership of the ENCePP network at the European Medicines Agency, we planned the creation of an Expert Post CODEMISUSED Panel (Safer Use of Pharmaceuticals of Potential for Misuse, SUPPM), with members drawn from across the EU and some world class experts from non-EU countries. This protocol is completed. This report was generated on conclusion of CODEMISUSED.