BACKGROUND AND AIMS: Despite advances in our knowledge of effective services for people who use drugs over the last decades globally, coverage remains poor in most countries, while quality is often unknown. This paper aims to discuss the historical development of successful epidemiological indicators and to present a framework for extending them with additional indicators of coverage and quality of harm reduction services, for monitoring and evaluation at international, national or subnational levels. The ultimate aim is to improve these services in order to reduce health and social problems among people who use drugs, such as human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infection, crime and legal problems, overdose (death) and other morbidity and mortality. METHODS AND RESULTS: The framework was developed collaboratively using consensus methods involving nominal group meetings, review of existing quality standards, repeated email commenting rounds and qualitative analysis of opinions/experiences from a broad range of professionals/experts, including members of civil society and organisations representing people who use drugs. Twelve priority candidate indicators are proposed for opioid agonist therapy (OAT), needle and syringe programmes (NSP) and generic cross-cutting aspects of harm reduction (and potentially other drug) services. Under the specific OAT indicators, priority indicators included 'coverage', 'waiting list time', 'dosage' and 'availability in prisons'. For the specific NSP indicators, the priority indicators included 'coverage', 'number of needles/syringes distributed/collected', 'provision of other drug use paraphernalia' and 'availability in prisons'. Among the generic or cross-cutting indicators the priority indicators were 'infectious diseases counselling and care', 'take away naloxone', 'information on safe use/sex' and 'condoms'. We discuss conditions for the successful development of the suggested indicators and constraints (e.g. funding, ideology). We propose conducting a pilot study to test the feasibility and applicability of the proposed indicators before their scaling up and routine implementation, to evaluate their effectiveness in comparing service coverage and quality across countries. CONCLUSIONS: The establishment of an improved set of validated and internationally agreed upon best practice indicators for monitoring harm reduction service will provide a structural basis for public health and epidemiological studies and support evidence and human rights-based health policies, services and interventions.

Alcohol Drug and Tobacco Division Health and Wellbeing Directorate Public Health England London UK

Barcelona Institute of Global Health Hospital Clinic University of Barcelona Barcelona Spain

Centre d'Estudis Epidemiològics sobre les Infeccions de Transmissió Sexual i Sida de Catalunya Barcelona Spain

Centre for Global Governance Studies Leuven Belgium

Centre for Infectious Disease Control National Institute for Public Health and the Environment Bilthoven The Netherlands

Centro Studi Statistici e Sociali CE3S Rome Italy

CHIP Rigshospitalet University of Copenhagen Copenhagen Denmark

Consortium for Biomedical Research in Epidemiology and Public Health Madrid Spain

Department of Addictology 1st Faculty of Medicine Charles University and General University Hospital Prague Czech Republic

Department of Family Medicine and Public Health University of Tartu Tartu Estonia

Department of Health Wellington House London UK

Department of Hygiene Epidemiology and Medical Statistics Medical School National and Kapodistrian University of Athens Athens Greece

European Monitoring Centre for Drugs and Drug Addiction Praça Europa 1 Cais do Sodré 1249 289 Lisbon Portugal

French Monitoring Centre for Drugs and Drug Addiction Saint Denis France

Group of Activists on Treatments Lisbon Portugal

Health Research Board Dublin Ireland

Institute of Infectious Disease Research National Development and Research Institutes New York USA

Intercambios Civil Association and University of Buenos Aires Buenos Aires Argentina

Julius Center for Health Sciences and Primary Care University Medical Center Utrecht Utrecht The Netherlands

Leuven Institute of Criminology Faculty of Law University of Leuven Leuven Belgium

Marseille Univ INSERM IRD SESSTIM Marseille France

National Institute for Mental Health Prague Czech Republic

National Monitoring Centre for Drugs and Addiction Prague Czech Republic

ORS PACA Marseille France

Program of International Research and Training National Drug and Alcohol Research Centre The University of New South Wales Sydney Australia

Public Health Institute Faculty of Education Health and Community Liverpool John Moores University Liverpool UK

School of Social and Community Medicine University of Bristol Bristol UK

Spanish Field Epidemiology Training Program National Centre of Epidemiology Carlos 3 Health Institute Madrid Spain

The Romanian Association Against AIDS Bucharest Romania

Trinity College Dublin The University of Dublin Dublin Ireland

Uniting Medically Supervised Injecting Centre Sydney Australia

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