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      Regulating pharmacists as contraception providers: A qualitative study from Coastal Kenya on injectable contraception provision to youth

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          Abstract

          Introduction

          Young people worldwide are often reticent to access family planning services from public health facilities: instead, they choose to get contraception from private, retail pharmacies. In Kenya, certain contraceptives are available in pharmacies: these include injectables, which can be dispensed but not administered, according national guidelines. However, Kenya struggles with enforcement of its pharmacy regulations and addressing illegal activity. Therefore, in this qualitative study, we assessed private pharmacies as an existing source of injectable contraception for young Kenyans (age 18–24), and investigated the perceived quality of service provision.

          Methods

          This study used: focus group discussions (6) with young community members; in-depth interviews (18) with youth who had purchased contraception from pharmacies; key informant interviews with pharmacy personnel and pharmacy stakeholders (25); and a mystery shopper (visiting 45 pharmacies).

          Results

          The study found that for injectable contraception, private pharmacies had expanded to service provision, and pharmacy personnel’s roles had transcended formal or informal training previously received–young people could both purchase and be injected in many pharmacies. Pharmacies were perceived to lack consistent quality or strong regulation, resulting in young clients, pharmacy personnel, and regulators being concerned about illegal activity. Participants’ suggestions to improve pharmacy service quality and regulation compliance focused on empowering consumers to demand quality service; strengthening regulatory mechanisms; expanding training opportunities to personnel in private pharmacies; and establishing a quality-based ‘brand’ for pharmacies.

          Discussion

          Kenya’s recent commitments to universal health coverage and interest in revising pharmacy policy provide an opportunity to improve pharmacy quality. Multi-pronged initiatives with both public and private partners are needed to improve pharmacy practice, update and enforce regulations, and educate the public. Additionally, the advent of self-administrable injectables present a new possible role for pharmacies, and could offer young clients a clean, discreet place to self-inject, with pharmacy personnel serving as educators and dispensers.

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          Most cited references12

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          Performance of retail pharmacies in low- and middle-income Asian settings: a systematic review

          In low- and middle-income countries (LMIC) in Asia, pharmacies are often patients’ first point of contact with the health care system and their preferred channel for purchasing medicines. Unfortunately, pharmacy practice in these settings has been characterized by deficient knowledge and inappropriate treatment. This paper systematically reviews both the performance of all types of pharmacies and drug stores across Asia’s LMIC, and the determinants of poor practice, in order to reflect on how this could best be addressed. Poor pharmacy practice in Asia appears to have persisted over the past 30 years. We identify a set of inadequacies that occur at key moments throughout the pharmacy encounter, including: insufficient history taking; lack of referral of patients who require medical attention; illegal sale of a wide range of prescription only medicines without a prescription; sale of medicines that are either clinically inappropriate and/or in doses that are outside of the therapeutic range; sale of incomplete courses of antibiotics; and limited provision of information and counselling. In terms of determinants of poor practice, first knowledge was found to be necessary but not sufficient to ensure correct management of patients presenting at the pharmacy. This is evidenced by large discrepancies between stated and actual practice; little difference in the treatment behaviour of less and more qualified personnel and the failure of training programmes to improve practice to a satisfactory level. Second, we identified a number of profit maximizing strategies employed by pharmacy staff that can be linked to poor practices. Finally, whilst the research is relatively sparse, the regulatory environment appears to play an important role in shaping behaviour. Future efforts to improve the situation may yield more success than historical attempts, which have tended to concentrate on education, if they address the profit incentives faced by pharmacy personnel and the regulatory system.
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            Accrediting retail drug shops to strengthen Tanzania’s public health system: an ADDO case study

            Introduction Retail drug sellers are a major source of health care and medicines in many countries. In Tanzania, drug shops are widely used, particularly in rural and underserved areas. Previously, the shops were allowed to sell only over-the-counter medicines, but sellers who were untrained and unqualified often illegally sold prescription drugs of questionable quality. Case description In 2003, we worked with Tanzania’s Ministry of Health and Social Welfare to develop a public-private partnership based on a holistic approach that builds the capacity of owners, dispensers, and institutions that regulate, own, or work in retail drug shops. For shop owners and dispensers, this was achieved by combining training, business incentives, supervision, and regulatory enforcement with efforts to increase client demand for and expectations of quality products and services. The accredited drug dispensing outlet (ADDO) program’s goal is to improve access to affordable, quality medicines and pharmaceutical services in retail drug outlets in rural or peri-urban areas with few or no registered pharmacies. The case study characterizes how the ADDO program achieved that goal based on the World Health Organization’s health system strengthening building blocks: 1) service delivery, 2) health workforce, 3) health information systems, 4) access to essential medicines, 5) financing, and 6) leadership and governance. Discussion and evaluation The ADDO program has proven to be scalable, sustainable, and transferable: Tanzania has rolled out the program nationwide; the ADDO program has been institutionalized as part of the country’s health system; shops are profitable and meeting consumer demands; and the ADDO model has been adapted and implemented in Uganda and Liberia. The critical element that was essential to the ADDO program’s success is stakeholder engagement—the successful buy-in and sustained commitment came directly from the effort, time, and resources spent to fully connect with vital stakeholders at all levels. Conclusions Beyond improving the quality of medicines and dispensing services, availability of essential medicines, and the regulatory system, the impact of a nationwide accredited drug seller approach on the pharmaceutical sector promises to provide a model framework for private-sector pharmaceutical delivery in the developing world that is sustainable without ongoing donor support.
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              Private local pharmacies in low- and middle-income countries: a review of interventions to enhance their role in public health.

              To review the evidence regarding the potential of pharmacy services to play an enhanced role in contributing to health care and policy initiatives in low- and middle-income countries. Literature search, using computer and hand searching, to identify original research reporting the results of interventions to improve services from private local pharmacies in low- and middle-income countries. Eighteen studies were identified which spanned all regions: 12 evaluations of training initiatives, three studies evaluating the impact of policy of regulatory interventions, one regarding a collaboration of pharmacy services with a national TB programme, and two evaluating a pharmaceutical care initiative for patients with hypertension. A total of 14 studies used advice and recommendations to simulated clients as the primary outcome measures. Whilst most studies reported some improvements to practice, these were often small, limited to specific outcomes and believed to be short-lived. The studies in this review demonstrate international interest in enhancing the place of pharmacy services in the provision and delivery of health care. But the small number of studies provides inadequate evidence on how to assure the quality of local pharmacy services can be assured, or how to develop them within a wider reform framework.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Writing – original draft
                Role: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Funding acquisitionRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                19 December 2019
                2019
                : 14
                : 12
                : e0226133
                Affiliations
                [1 ] Department of Reproductive Health and Research including UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization, Geneva, Switzerland
                [2 ] Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland
                [3 ] University of Basel, Basel, Switzerland
                [4 ] International Centre for Reproductive Health Kenya, Mombasa, Kenya
                [5 ] Department of Human Anatomy, University of Nairobi, Nairobi, Kenya
                [6 ] Ghent University, Ghent, Belgium
                USC Keck School of Medicine, Institute for Global Health, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                http://orcid.org/0000-0003-2409-5043
                Article
                PONE-D-19-21933
                10.1371/journal.pone.0226133
                6922368
                31856196
                0e345aa5-02c7-4d08-a877-e2cfb2c37e05
                © 2019 Gonsalves et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 3 August 2019
                : 18 November 2019
                Page count
                Figures: 0, Tables: 2, Pages: 14
                Funding
                This study was partially supported by the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP). The funders had no role in study design, data collection and analysis, decision to public or preparation of the manuscript.
                Categories
                Research Article
                Medicine and Health Sciences
                Women's Health
                Obstetrics and Gynecology
                Contraception
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Drug Regulation
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Contraceptives
                Biology and Life Sciences
                Bioengineering
                Biotechnology
                Medical Devices and Equipment
                Contraceptives
                Engineering and Technology
                Bioengineering
                Biotechnology
                Medical Devices and Equipment
                Contraceptives
                Medicine and Health Sciences
                Medical Devices and Equipment
                Contraceptives
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Pharmacists
                People and Places
                Geographical Locations
                Africa
                Kenya
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Drug Licensing
                Medicine and Health Sciences
                Pharmaceutics
                Drug Therapy
                Drug Administration
                Biology and Life Sciences
                Toxicology
                Toxic Agents
                Toxins
                Medicine and Health Sciences
                Pathology and Laboratory Medicine
                Toxicology
                Toxic Agents
                Toxins
                Custom metadata
                Data cannot be shared publicly because consent procedures for participants did not include making full interview and focus group discussion transcripts publicly available. Excerpts from transcripts are available on request from corresponding author and following approval from the University of Nairobi/Kenyatta National Hospital Ethics Committee (contact via uonknh_erc@ 123456uonbi.ac.ke ) for researchers who meet the criteria for access to confidential data.

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