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      Assessing the impact of law enforcement to reduce over-the-counter (OTC) sales of antibiotics in low- and middle-income countries; a systematic literature review

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          Abstract

          Background

          Many low- and middle-income countries (LMIC) are moving towards enforcing prescription-only access to antibiotics. This systematic literature review aims to assess the interventions used to enforce existing legislation prohibiting over-the-counter (OTC) sales of antibiotics in LMICs, their impact and examine the methods chosen for impact measurement including their strengths and weaknesses.

          Methods

          Both PubMed and Embase were systematically searched for studies reporting on impact measurement in moving towards prescription only access to antibiotics in LMICs. The PRISMA methodological review framework was used to ensure systematic data collection and analysis of literature. Narrative data synthesis was used due to heterogeneity of study designs.

          Results

          In total, 15 studies were included that assessed policy impact in 10 different countries. Strategies employed to enforce regulations prohibiting OTC sales of systemic antibiotics included retention of prescriptions for antibiotics by pharmacies, government inspections, engaging pharmacists in the design of interventions, media campaigns for the general public and educational activities for health care workers. A variety of outcomes was used to assess the policy impact; changes in antimicrobial resistance rates, changes in levels of antibiotic use, changes in trends of antibiotic use, changes in OTC supply of antibiotics, and changes in reported practices and knowledge of pharmacists, medicine sellers and the general public. Differences in methodological approaches and outcome assessment made it difficult to compare the effectiveness of law enforcement activities. Most effective appeared to be multifaceted approaches that involved all stakeholders. Monitoring of the impact on total sales of antibiotics by means of an interrupted time series (ITS) analysis and analysis of pharmacies selling antibiotics OTC using mystery clients were the methodologically strongest designs used.

          Conclusions

          The published literature describing activities to enforce prescription-only access to antibiotics in LMICs is sparse and offers limited guidance. Most likely to be effective are comprehensive multifaceted interventions targeting all stakeholders with regular reinforcement of messages. Policy evaluation should be planned as part of implementation to assess the impact and effectiveness of intervention strategies and to identify targets for further activities. Robust study designs such as ITS analyses and mystery client surveys should be used to monitor policy impact.

          Electronic supplementary material

          The online version of this article (10.1186/s12913-019-4359-8) contains supplementary material, which is available to authorized users.

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          Most cited references37

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          Antibiotic resistance-the need for global solutions.

          The causes of antibiotic resistance are complex and include human behaviour at many levels of society; the consequences affect everybody in the world. Similarities with climate change are evident. Many efforts have been made to describe the many different facets of antibiotic resistance and the interventions needed to meet the challenge. However, coordinated action is largely absent, especially at the political level, both nationally and internationally. Antibiotics paved the way for unprecedented medical and societal developments, and are today indispensible in all health systems. Achievements in modern medicine, such as major surgery, organ transplantation, treatment of preterm babies, and cancer chemotherapy, which we today take for granted, would not be possible without access to effective treatment for bacterial infections. Within just a few years, we might be faced with dire setbacks, medically, socially, and economically, unless real and unprecedented global coordinated actions are immediately taken. Here, we describe the global situation of antibiotic resistance, its major causes and consequences, and identify key areas in which action is urgently needed. Copyright © 2013 Elsevier Ltd. All rights reserved.
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            Antimicrobial resistance in developing countries. Part I: recent trends and current status.

            The global problem of antimicrobial resistance is particularly pressing in developing countries, where the infectious disease burden is high and cost constraints prevent the widespread application of newer, more expensive agents. Gastrointestinal, respiratory, sexually transmitted, and nosocomial infections are leading causes of disease and death in the developing world, and management of all these conditions has been critically compromised by the appearance and rapid spread of resistance. In this first part of the review, we have summarised the present state of resistance in these infections from the available data. Even though surveillance of resistance in many developing countries is suboptimal, the general picture is one of accelerating rates of resistance spurred by antimicrobial misuse and shortfalls in infection control and public health. Reservoirs for resistance may be present in healthy human and animal populations. Considerable economic and health burdens emanate from bacterial resistance, and research is needed to accurately quantify the problem and propose and evaluate practicable solutions. In part II, to be published next month, we will review potential containment strategies that could address this burgeoning problem.
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              Anthropological and socioeconomic factors contributing to global antimicrobial resistance: a univariate and multivariable analysis

              Understanding of the factors driving global antimicrobial resistance is limited. We analysed antimicrobial resistance and antibiotic consumption worldwide versus many potential contributing factors.
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                Author and article information

                Contributors
                t.g.jacobs@uu.nl
                robertsonj@who.int
                H.A.vandenHam@uu.nl
                iwamotok@who.int
                pedersenh@who.int
                +31 30 253 7324 , a.k.mantel@uu.nl
                Journal
                BMC Health Serv Res
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central (London )
                1472-6963
                31 July 2019
                31 July 2019
                2019
                : 19
                : 536
                Affiliations
                [1 ]ISNI 0000000120346234, GRID grid.5477.1, WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Division of Pharmacoepidemiology & Clinical Pharmacology, , Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, ; David de Wied building, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands
                [2 ]ISNI 0000 0004 0639 2949, GRID grid.420226.0, World Health Organization (WHO) Regional Office for Europe, ; UN City, Marmorvej 51, 2100 Copenhagen, Denmark
                [3 ]ISNI 0000 0000 8831 109X, GRID grid.266842.c, University of Newcastle Calvary Mater Hospital, ; Edith St & Platt St, Waratah NSW, Newcastle, 2298 Australia
                Author information
                http://orcid.org/0000-0001-5738-5528
                http://orcid.org/0000-0003-4330-2829
                Article
                4359
                10.1186/s12913-019-4359-8
                6670201
                31366363
                d13a755f-7634-4a2a-a204-5d284ed9ab7e
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 14 May 2019
                : 18 July 2019
                Funding
                Funded by: WHO Regional Office for Europe
                Award ID: -
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2019

                Health & Social care
                law enforcement,antibiotics,over-the-counter,prescription-only,policy change,impact measurement

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