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To obtain the perspectives of some small- and medium-sized organizations on the World Health Organization (WHO) prequalification programme for medicines and to ascertain organizations' unmet needs.We conducted an exploratory, qualitative study in 2018 among 17 representatives of 15 small- and medium-sized Belgian and non-Belgian organizations who purchase medicines for humanitarian, development or public programmes in low- and middle-income countries. We used semi-structured interviews to obtain respondents' views and experiences of using WHO prequalification guidance when procuring medicines. We identified emerging themes and formulated recommendations about the activities of the WHO Prequalification Team.Most respondents suggested expanding prequalification to essential antibiotics, particularly paediatric formulations; and insulin, antihypertensives and cancer treatments. Respondents were concerned about irregular availability of WHO-prequalified medicines in the marketplace and sometimes high prices of prequalified products. Small organizations, in particular, had difficulties negotiating low-volume purchases. Organizations working in primary health care and hospitals seldom referred to the prequalified lists.We recommend that the WHO-prequalified products be expanded to include essential antibiotics and medicines for noncommunicable diseases. The WHO Prequalification Team could require prequalified manufacturers to make publicly available the details of their authorized distributors and facilitate a process of harmonization of quality assurance policies across all donors. Prequalification of distributors and procurement agencies could help create more transparent and stringent mechanisms. We urge WHO Member States and funders to sustain support for the WHO Prequalification Team, which remains important for the fulfilment of universal health coverage.Connaître le point de vue de quelques petites et moyennes organisations vis-à-vis du Programme de préqualification des médicaments dirigé par l'Organisation mondiale de la Santé (OMS), et déterminer quels sont les besoins non satisfaits de ces organisations.Nous avons mené une étude qualitative exploratoire en 2018 auprès de 17 représentants de 15 petites et moyennes organisations belges et non belges qui se procurent des médicaments pour des programmes humanitaires, publics ou de développement dans des pays à faible et moyen revenu. Nous avons conduit des entretiens semi-structurés afin de recueillir les avis et expériences des répondants concernant les conseils de préqualification fournis par l'OMS au moment d'acheter des médicaments. Nous avons identifié de nouveaux thèmes et formulé des recommandations autour des activités de l'équipe de préqualification de l'OMSLa plupart des répondants ont suggéré d'élargir la préqualification aux antibiotiques essentiels, en particulier les formulations pédiatriques, ainsi qu'à l'insuline, aux antihypertenseurs et aux traitements contre le cancer. Plusieurs répondants ont exprimé leur inquiétude quant à la disponibilité irrégulière des médicaments préqualifiés par l'OMS sur le marché, mais aussi aux prix parfois élevés des produits préqualifiés. De leur côté, les petites organisations éprouvent des difficultés à négocier l'achat de faibles volumes. Enfin, les organisations qui travaillent dans le secteur des hôpitaux et soins de santé primaires se réfèrent rarement aux listes de préqualification.Nous recommandons de compléter la liste des produits préqualifiés établie par l'OMS afin d'inclure des médicaments et antibiotiques essentiels pour les maladies non transmissibles. Par ailleurs, l'équipe de préqualification de l'OMS pourrait exiger des fabricants préqualifiés de publier les coordonnées de leurs distributeurs agréés et de favoriser l'harmonisation des politiques d'assurance de la qualité chez tous leurs donateurs. La préqualification des distributeurs et des organismes d'achat pourrait contribuer à créer des mécanismes plus rigoureux et transparents. Nous encourageons les bailleurs de fonds et États Membres de l'OMS à soutenir durablement l'équipe de préqualification de l'OMS, qui demeure un outil important dans l'instauration d'une couverture maladie universelle.Obtener las perspectivas de algunas organizaciones pequeñas y medianas sobre el programa de precalificación de medicamentos de la Organización Mundial de la Salud (OMS) y determinar las necesidades que las organizaciones no han cubierto.En 2018 se realizó un estudio cualitativo y exploratorio entre 17 representantes de 15 organizaciones pequeñas y medianas belgas y no belgas que compran medicamentos para programas humanitarios, de desarrollo o públicos en países de ingresos bajos y medios. Se utilizaron entrevistas semiestructuradas para conocer las opiniones y las experiencias de los encuestados sobre el uso de la orientación de precalificación de la OMS en la compra de los medicamentos. Se identificaron temas emergentes y se formularon recomendaciones sobre las actividades del Equipo de precalificación de la OMS.La mayoría de los encuestados sugirieron que se ampliara la precalificación a los antibióticos esenciales, en particular a los medicamentos pediátricos, y a la insulina, los antihipertensivos y los tratamientos contra el cáncer. Los encuestados se mostraron preocupados por la disponibilidad irregular de los medicamentos precalificados por la OMS en el mercado y, a veces, por los precios altos de los productos precalificados. En particular, las organizaciones pequeñas tenían dificultades para negociar las adquisiciones de bajo volumen. Las organizaciones que trabajaban en la atención primaria de la salud y en los hospitales se remitían a las listas de medicamentos precalificados pocas veces.Se recomienda que los productos precalificados por la OMS se amplíen para incluir los antibióticos y los medicamentos esenciales de las enfermedades no transmisibles. El Equipo de precalificación de la OMS podría exigir a los fabricantes precalificados que publiquen los datos de sus distribuidores autorizados y faciliten un proceso de armonización de las políticas relacionadas con la garantía de calidad para todos los donantes. La precalificación de los distribuidores y de las agencias de adquisiciones podría ayudar a crear mecanismos más transparentes y rigurosos. Se insta a los Estados miembros de la OMS y a los financiadores a que mantengan su apoyo al Equipo de precalificación de la OMS, que sigue siendo importante para el cumplimiento de la cobertura sanitaria universal.الغرض​ الحصول على وجهات النظر الخاصة ببعض المنظمات الصغيرة والمتوسطة الحجم بشأن برنامج التأهيل المسبق لمنظمة الصحة العالمية (WHO) للأدوية، والتأكد من الاحتياجات التي لم يتم الوفاء بها للمنظمات. الطريقة قمنا بإجراء دراسة استكشافية ونوعية في عام 2018 بين 17 ممثلاً عن 15 منظمة بلجيكية وغير بلجيكية صغيرة ومتوسطة الحجم، والتي قامت بشراء الأدوية للبرامج الإنسانية أو التنموية أو العامة في الدول المحدودة الدخل والمتوسطة الدخل. قمنا بالاستعانة بالمقابلات الشخصية شبه المنظمة للحصول عليها آراء وخبرات المشاركين حول استخدام إرشادات التأهيل المسبق الخاصة بمنظمة الصحة العالمية عند شراء الأدوية. وحددنا المواضيع الناشئة وقمنا بصياغة توصيات بخصوص أنشطة فريق التأهيل المسبق لمنظمة الصحة العالمية. النتائج اقترح معظم المشاركين توسيع التأهيل المسبق ليشمل المضادات الحيوية الأساسية، وبخاصة التركيبات الخاصة بالأطفال؛ والإنسولين، ومخفضات ضغط الدم المرتفع، وعلاجات السرطان. وأعرب المشاركون عن قلقهم من عدم انتظام توافر أدوية التأهل المسبق للمنظمة الصحة العالمية في السوق، وأحيانًا الأسعار المرتفعة لمنتجات التأهل المسبق. واجهت المنظمات الصغيرة، على وجه الخصوص، صعوبات في التفاوض بخصوص عمليات الشراء منخفضة الحجم. ونادراً ما تم الإشارة في قوائم التأهل المسبق إلى المنظمات العاملة في الرعاية الصحية الأولية والمستشفيات. الاستنتاج نحن نوصي بتوسيع منتجات التأهيل المسبق الخاصة بمنظمة الصحة العالمية، لتشمل المضادات الحيوية الأساسية وأدوية الأمراض غير المعدية. يمكن أن يطلب فريق التأهيل المسبق، التابع لمنظمة الصحة العالمية، من المصنعين المؤهلين مسبقاً أن يوفروا تفاصيل الموزعين المعتمدين لديهم بشكل علني، وتسهيل عملية تنسيق سياسات ضمان الجودة لدى كل الجهات المانحة. يمكن للتأهيل المسبق أن يساعد الموزعين ووكالات المشتريات في وضع آليات أكثر شفافية وصرامة. ونحن نحث الدول الأعضاء وجهات التمويل في منظمة الصحة العالمية، على مواصلة الدعم لفريق التأهيل المسبق بمنظمة الصحة العالمية، والذي لا يزال مهماً لتحقيق التغطية الصحية الشاملة.旨在了解一些中小型组织对世界卫生组织 (WHO) 药品资格预审项目的看法，并确定这些组织未满足的需求。.我们于 2018 年对 15 个中小型比利时和非比利时组织中的 17 名代表进行了探索性定性研究，这些代表购买的药物用于中低收入国家的人道主义、发展或公共项目。我们采用半结构式访谈的方式，获取了受访者对采购药品时使用世卫组织资格预审指南的看法和体验。我们确定了新主题，并对世卫组织资格预审小组的活动提出了建议。.大多数受访者建议扩大基本抗生素的资格预审范围，尤其是儿科制剂；以及胰岛素、降压药和癌症治疗药物。受访者担心世卫组织预审药品在市场上供应不稳定，有时预审产品的价格过高。特别是小型组织在商洽小批量采购时遭遇困难。初级医疗护理机构和医院的下属组织很少参考预审清单。.我们建议将世卫组织资格预审的药物扩大至包括基本抗生素和治疗非传染性疾病的药物。世卫组织资格预审小组可要求通过资格预审的制造商公开其授权经销商的详细信息，并帮助制定协调各捐助方之间质量保证政策的流程。经销商和采购机构的资格预审有助于建立更加透明和严格的机制。我们敦促世卫组织成员国和资助者继续支持世卫组织资格预审小组，这对实现全民健康覆盖意义非凡。.Получить мнение некоторых малых и средних организаций по программе Всемирной организации здравоохранения по предварительной квалификации лекарственных средств и выяснить неудовлетворенные потребности организаций.В 2018 году авторы провели экспериментальное качественное исследование с участием 17 представителей от 15 организаций малого и среднего бизнеса в Бельгии и за ее пределами, которые закупают лекарственные средства для гуманитарных программ, программ по развитию или общественных программ, проводимых в странах с низким и средним уровнем дохода. Авторы использовали полуструктурированные интервью, чтобы узнать мнения и опыт респондентов в отношении использования руководства ВОЗ по предварительной квалификации при закупке лекарственных средств. Были определены новые темы, а также сформулированы рекомендации для деятельности группы предварительной квалификации ВОЗ.Большинство респондентов предложили распространить действие предварительной квалификации на основные антибиотики, особенно на педиатрические препараты, а также инсулин, гипотензивные средства и медицинские препараты для лечения рака. Респонденты были обеспокоены нерегулярным наличием лекарственных средств, предварительно квалифицированных ВОЗ, на рынке и высокими ценами на предварительно квалифицированные товары. В частности, малые организации сталкивались с трудностями при проведении переговоров о закупках в небольших объемах. Организации, работающие в учреждениях первичной медико-санитарной помощи и больницах, редко упоминались в списках предварительной квалификации.Авторы рекомендуют расширить список товаров, предварительно квалифицированных ВОЗ, включив в них основные антибиотики и лекарственные средства для лечения неинфекционных заболеваний. Группа предварительной квалификации ВОЗ может потребовать от предквалифицированных производителей публиковать подробную информацию об уполномоченных дистрибьюторах и содействовать процессу согласования политики обеспечения качества со всеми финансирующими организациями. Предварительная квалификация дистрибьюторов и закупочных организаций поможет создать более прозрачные и строгие механизмы контроля и управления. Авторы призывают государства-члены ВОЗ и спонсоров оказывать поддержку группе предварительной квалификации ВОЗ, которая важна для обеспечения всеобщего охвата медико-санитарными услугами.

ObjectivesThis paper presents the iterative process of participatory multistakeholder engagement that informed the development of a new national tuberculosis (TB) policy in Georgia, and the lessons learnt.MethodsGuided by realist evaluation methods, a multistakeholder dialogue was organised to elicit stakeholders’ assumptions on challenges and possible solutions for better TB control. Two participatory workshops were conducted with key actors, interspersed by reflection meetings within the research team and discussions with policymakers. Using concept mapping and causal mapping techniques, and drawing causal loop diagrams, we visualised how actors understood TB service provision challenges and the potential means by which a results-based financing (RBF) policy could address these.SettingThe study was conducted in Tbilisi, Georgia.ParticipantsA total of 64 key actors from the Ministry of Labour, Health and Social Affairs, staff of the Global Fund to Fight AIDS, TB and Malaria Georgia Project, the National Centre for Disease Control and Public Health, the National TB programme, TB service providers and members of the research team were involved in the workshops.ResultsFindings showed that beyond provider incentives, additional policy components were necessary. These included broadening the incentive package to include institutional and organisational incentives, retraining service providers, clear redistribution of roles to support an integrated care model, and refinement of monitoring tools. Health system elements, such as effective referral systems and health information systems were highlighted as necessary for service improvement.ConclusionsDeveloping policies that address complex issues requires methods that facilitate linkages between multiple stakeholders and between theory and practice. Such participatory approaches can be informed by realist evaluation principles and visually facilitated by causal loop diagrams. This approach allowed us leverage stakeholders’ knowledge and expertise on TB service delivery and RBF to codesign a new policy.

IntroductionAccess to quality-assured medicines is an essential prerequisite for universal health coverage, and pharmaceutical distributors play an important role to assure the quality of medicines along the supply chain.MethodsWe retrospectively assessed the compliance with WHO quality standards, that is, the Model Quality Assurance System for Procurement Agencies (MQAS) or the good distribution practices (GDP), of a convenience sample of 75 public, private-for-profit and non-for-profit distributors, audited by QUAMED in 14 low-income and middle-income countries (LMICs) between 2017 and 2019. We calculated the compliance per quality assurance activity, and we defined the percentage of compliant distributors, that is, the percentage (%) of distributors with MQAS or GDP levels of >2 for each activity.ResultsThe distributors in our sample were mainly private for-profit (66/75). Only one MQAS-audited distributor out of 11 was found compliant with all MQAS-activities, while none out of 64 GDP-assessed distributors were found compliant with all GDP activities. The GDP-assessed distributors were generally less compliant with WHO standards than MQAS-audited distributors. Common weaknesses and strengths were observed. The activities with lowest compliance were quality control, and physical storage conditions, while those with highest compliance were warehouse organisation and stock control.ConclusionsThe quality systems of pharmaceutical distributors in LMICs remain weak. For preventing harm caused by poor-quality medicines, a comprehensive and stringent regulatory oversight should be urgently implemented; the WHO MQAS-standards and GDP-standards should be incorporated in national regulations; and reliable information on the quality systems of distributors (and manufacturers from which they buy) should be publicly available.

Background Nowadays, health systems are generally acknowledged to be complex social systems. Consequently, scholars, academics, practitioners, and policy-makers are exploring how to adopt a complexity perspective in health policy and system research. While leadership and complexity has been studied extensively outside health, the implications of complexity theories for the study of leadership in healthcare have received limited attention. We carried out a scoping review of complex leadership (CL) in healthcare to investigate how CL in healthcare has been defined, theorised and conceptualised and to explore how ‘CL’ has been applied in healthcare settings. Methods We followed the methodological steps proposed by (Arksey and O’Malley, 2005): (1) specifying the research question, (2) identifying relevant studies, (3) study selection, (4) charting the data, (5) collating and summarizing the findings, and (6) reporting the results. We searched using Medline, Psychinfo, Wiley online library, and Google Scholar. Our inclusion criteria were: publication type (peer reviewed articles, theses, and book chapters); phenomenon of interest: complex leadership; context: healthcare and period of publication: between 2000 and 2016. Results Our search and selection resulted in 37 papers (16 conceptual papers, 14 empirical studies and 7 advocacy papers). We note that empirical studies on CL are few and almost all research reported by these papers was carried out in the North (mainly in USA and UK). We found that there is some variation in definitions of CL. Furthermore, the research papers adopt mostly an explorative or explanatory approach and do not focus on assessing effectiveness of CL approaches. Finally, we found that the majority of researchers seem to adhere to the mathematical complexity perspective. Conclusion Complexity concepts derived from natural sciences may not automatically fit management of health services. Further research into how social complexity theories may offer researchers useful grounds to empirically test CL theories in health settings is warranted. Specific attention should be paid to the multi-layered nature of leadership.

Climate change is one of today's major challenges, and among the causes of population movement and international migration. Climate migrants impact health systems and how their ability to respond and adapt to their needs and patterns. To date, the resilience of health systems in the context of climate change has barely been explored. The purpose of this article is to show the importance of studying the relationship between climate change, migration, and the resilience of health systems from an interdisciplinary perspective. Resilience is an old concept, notably in the field of psychology, and is increasingly applied to the study of health systems. Yet, no research has analysed the resilience of health systems in the context of climate change. While universal health coverage is a major international goal, little research to date focused on the existing links between climate, migration, health systems and resilience. We propose an interdisciplinary approach relying on the concept of health system resilience to study adaptive and transformative strategies to articulate climate change, migration and health systems.

BackgroundImproving access to paediatric HIV treatment requires large-scale antiretroviral treatment programmes and medication adapted to infants and children's needs. The World Health Organisation recommends lopinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors as first-line treatment for all HIV-infected children younger than three years, usually given as a syrup. A pellet formulation (i.e. tiny cylinders of compressed medication put in capsules) was developed to overcome the syrup formulation's disadvantages such as bitterness, toxicity and cold storage. This study assessed multi-level factors influencing caregivers' acceptance of and adherence to lopinavir/ritonavir pellets as well as their underlying mechanisms.MethodsA realist evaluation (a theory-driven evaluation method considering the social context and mechanisms of change), embedded in a clinical trial was carried out in three hospital settings in Kenya. Data were collected through document review, observations (n = 34) in home and clinic settings and semi-structured interviews (n = 44) with caregivers and providers. Data analysis was based on realist principles.ResultsHigh levels of treatment initiation and adherence were observed. Taste masking, neutral packaging and easy storage made the new formulation highly acceptable. Caregivers developed individual strategies to deliver the treatment, particularly to overcome specific problems e.g. in case of just-weaned babies or food shortage. A refined program theory emerged from the triangulated findings showing that ease of administration combined with increased self-efficacy and competences of the caregivers, and effective provider support contributed to high levels of adherence.ConclusionsFormulating combined antiretroviral treatment in the form of pellets is clearly a more acceptable solution for infants and children and their caregivers compared to the syrup. Further research in non-trial settings may shed light on factors related to providers, services and the health system that contribute to better adherence of such formulations.

IntroductionThe rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors.MethodsThis descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private pharmaceutical distributors in 13 LMICs. We assessed the distributors’ compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines ’Model Quality Assurance System (MQAS) for procurement agencies'. Descriptive statistics describe the compliance for the whole sample, for distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs).ResultsLocal private pharmaceutical distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups.ConclusionThe poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private pharmaceutical distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes.

IntroductionIn 2016, Georgian researchers and policymakers were developing a policy to improve the performance of the national tuberculosis (TB) control programme. The research programme ‘Designing and Evaluating Provider Results-Based Financing for Tuberculosis Care in Georgia: Understanding Costs, Mechanisms of Effect and Impact (Results4TB)’ was initiated to inform the policy formulation phase, document the policy implementation and assess the effectiveness, cost-effectiveness and the processes of change. To achieve this, the research team intends to combine an impact evaluation, a cost-effectiveness study and a realist evaluation (RE) within an overarching theory-informed design. This protocol is the RE component of the programme.MethodsA realist methodological approach will be adopted to guide the research design and evaluation. RE answers the question of ‘what works in which conditions for whom?’ and starts with the development of an initial programme theory (IPT). The IPT will feed into other phases of the realist research cycle (study design, data collection, data analysis and synthesis and theory refinement). Data will be collected in a multiple embedded case study design (five intervention and three control sites) through document reviews, in-depth interviews, non-participant observations and context mapping at facility and national levels. Additional data from other research components (cost-effectiveness and impact evaluation) will aid data triangulation.Ethics and disseminationThe Institutional Review Boards of the National Centre for Disease Control and Public Health in Georgia (ref. IRB # 2018–019) and the Institute of Tropical Medicine, Antwerp (ref. IRB #- 1240/18) have granted ethical approval to the study.Trial registration numberISRCTN14667607

Background Improving access to paediatric HIV treatment requires both large-scale treatment programmes and medication that is adapted to infants and children9s needs. The WHO recommends lopinavir/ritonavir as first-line antiretroviral therapy for all HIV-infected children younger than 3 years. There is currently little evidence on the acceptability of, and adherence to, a formulation of this combination treatment if given in the form of pellets. This protocol presents how we will carry a realist evaluation to assess the factors that contribute to the acceptability and adherence to the new pellets formulation in 3 hospitals in Kenya. Methods We structured the protocol along the realist evaluation cycle following 4 steps: (1) the initial programme theory, (2) the study design, (3) the data collection methods and (4) the data analysis plan. Theories of behavioural sciences were reviewed for frames that could provide insights into how using such new formulations may contribute to better acceptability and adherence. Ethics and dissemination This study was approved by the Institutional Review Board of the Institute of Tropical Medicine, the Ethical Committee of the University Hospital Antwerp and the Kenyatta National Hospital/University of Nairobi Ethics and Research Committee. We aim to disseminate the findings through international conferences and peer-reviewed journals and to share them with Drugs for Neglected Diseases initiative9s (DNDi) programme managers and with the Kenyan healthcare providers. Discussion In developing this study, we encountered some challenges. First, methods to measure the acceptability of any formulation and adherence to it are not standardised. The second challenge is common in realist evaluation and relates to how to choose from different potentially interesting theoretical frameworks. We identified relevant and empirically tested theories from behavioural science that may be helpful in our study. We will test them in 3 settings by exploring the multilevel factors that influence acceptability and adherence of this new paediatric Antiretroviral (ARV) formulation.