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Background The South African (SA) public health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) in the public sector since 1996. To date no studies have reported on the process of selection of essential medicines for SA EMLs and how this may have changed over time. This study reports on the decision making process for the selection of essential medicines for SA EMLs, over the years, as described by various members of the National Essential Medicines List Committee (NEMLC) and their task teams. Methods Qualitative in-depth interviews, guided by an interview questionnaire, were conducted with 11 members of the SA NEMLC and their task teams (both past and present members) during the period January – April 2015. Interviews were recorded and transcribed verbatim. Transcripts were then coded by the first author and verified by the second author before being reconciled and input into NVIVO, a qualitative software, to facilitate analysis of the data. Results The interviews conducted suggest that the NEMLC process of medicine selection has been refined over the years. This together with the EML review process is now essentially predominantly an evidence based process where quality, safety and efficacy of a medicine is considered first followed by cost considerations which includes pharmacoeconomic evaluations, and pricing of medicines. Conclusions This is the first study in SA to report on how decisions are taken to include or exclude medicines on SA national EMLs and provides insight into the SA EML medicine selection, review and monitoring processes over time. The results show that the NEMLC has undergone tremendous transformation over the years. Whilst the membership of the committee largely remains unchanged, the committee has developed its policies and processes over the years. However there is still a need to strengthen the monitoring and evaluation aspects of the SA EML policy process.

Background In spite of being the ‘pharmacy of the world’, access to essential medicines for a large majority of Indians is constrained by both physical and financial reasons. According to an estimate, medicines account for 69% of household out-of-pocket spending on health care. To make quality generic medicine affordable, India’s People’s Medicine Scheme ( Jan Aushadhi ) was launched in 2008 and then revamped and rebranded as Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP) in 2015. The current study focuses on the availability, affordability and acceptability aspects of PMBJP essential medicines. Methods We have used a mixed-methods approach, with the survey-based quantitative component supplemented by a qualitative component consisting of in-depth interviews (IDIs). The survey was conducted in 11 PMBJP pharmacies in Mumbai and Palghar. Data were gathered on the availability, stock-outs, price and affordability of 35 essential medicines and 2 consumables. Results Apart from the limited coverage of essential medicines and the significant presence of Fixed dose combinations (FDCs) in the PMBJP medicine list, the availability of surveyed essential drugs was also found to be low (47%) in PMBJP outlets. Across Mumbai and Palghar districts, around 50% and 42% of medicines were found to be out of stock for the period of 3–6 months respectively. The cost of generic medicines of PMBJP outlets for treating various conditions range from 0.01 days’ wages to 0.47 days’ wages for the lowest paid unskilled worker in Maharashtra. Conclusions The study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings. But, in order to fully realise the potential of this scheme, some policy actions are urgently required. First, the PMBJP drug list must include all essential drugs that feature in NLEM. Second, BPPI should procure only those drugs that pass the bioequivalence test. Third, compulsory de-branding of generics should be done in a phased manner. Fourth, PMBJP’s medicine procurement and distribution policies must be reviewed to address the supply chain issues. Moreover, there is a need for major pharmaceutical policy reforms to promote generic medicines in a big way. Regulations to support mandatory generic prescribing and generic substitution by pharmacists are needed.

The World Health Organization’s Model List of Essential Medicines for Children (EMLc) presents a list of the most efficacious, safe, and cost-effective medicines for priority conditions, intended for use in children up to 12 years of age. However, gaps in global availability and use of age-appropriate formulations of medicines for children still exist. To address these shortcomings, a comprehensive analysis of the appropriateness of formulations of essential medicines for children is being undertaken through the Global Accelerator for Paediatric Formulations (GAP-f) network, a WHO network launched in 2020 to respond to the paediatric treatment gap. This article describes the development and application of a paediatric Quality Target Product Profile (pQTPP) tool by WHO, to retrospectively evaluate the paediatric age-appropriateness of formulations on the EMLc and identify potential formulation gaps, to inform the review of the EMLc in 2023. A combination of paediatric-centric and global health-focused attributes and targets were defined, taking into consideration regulatory agency paediatric development guidelines and literature sources, and a qualitative scoring system was developed and tested. Example evaluations of paracetamol and clofazimine are provided, illustrating the tool’s use. The assessment of EMLc formulations is ongoing and shortcomings and gaps in EMLc formulations have already been identified. The pQTTP tool may also be applied to national lists and prospectively when designing new paediatric formulations.

Background: Medicines affect the environment throughout their lifecycle, from production and distribution to use and disposal. They contribute to the pollution of air, water, and soil, impacting ecosystems and human health. Recognizing these risks, regulatory bodies and organizations have highlighted pharmaceutical pollution as a global concern, emphasizing the need for environmental risk assessments and sustainable practices. Methods: This study reviewed the essential medicines lists (EMLs) from 158 countries and examined the available ecotoxicological data. Medicines with high bioaccumulation, persistence, and toxicity were identified and cross-referenced with their inclusion in EMLs. Additionally, we analyzed the presence of alternative medicines with similar therapeutic effects but potentially lower environmental risks. Results: Five medicines—ciprofloxacin, ethinylestradiol, levonorgestrel, ibuprofen, and sertraline—were selected as illustrative examples due to their high environmental persistence and toxicity. All were listed in the 2023 WHO model list, with ciprofloxacin appearing in 94.3% of national EMLs. Conclusions: This study underscores the limited availability of ecotoxicological data, which hinders environmental risk assessment for medicines. EMLs could serve as a tool to enhance the awareness and data mobilization of pharmaceutical pollution. Incorporating environmental criteria into EMLs could support more sustainable medicine selection and regulatory practices.

Introduction Redistribution of essential medicines and health supplies (EMHS) is a mechanism to address supply chain uncertainty by moving excess stock of health commodities from health facilities that are overstocked to health facilities with shortages, where it is most needed. It prevents the wastage of scarce resources and improves efficiency within a health supply chain system. Many public health facilities in Uganda experience stock-outs, overstocking, and expiry of essential medicines. This study assessed the compliance of public health facilities with the Uganda Ministry of Health redistribution strategy for EMHS in Mbale district, Eastern Uganda. Methods A mixed-methods study was conducted among 55 respondents at public health facility level and five key informants at the district level. Audio-recorded data were transcribed and coded to develop themes. Thematic analysis was performed using ATLAS.ti Version 8.5. Quantitative data were analysed using IBM SPSS Version 24.0. Results About a third (33%) of the surveyed health facilities complied with EMHS redistribution guidelines. Respondents agreed that EMHS redistribution had helped reduce health commodity expiries and stock-outs in health facilities. Respondents who did not know about the timely release of funds for redistribution were 68% less likely to comply, and those who said the guidelines were never shared were 88% less likely to comply with the guidelines. Conclusions Compliance with the EMHS redistribution guidelines was low and associated with failure to share the guidelines with staff and inadequate awareness about release funds for EMHS redistribution. The district local government should allocate more funds to the EMHS redistribution.

Background Universal access to high quality essential medicines is critical to sustainable development (SDG 3.8). However low- and middle-income countries struggle to ensure access to all medicines on their national essential medicines lists (EML). Market registration is the first step in determining both access and availability yet the extent to which essential medicines are registered for use at country level is not known. Companies apply for a marketing authorisation, however low price or lack of a market is a disincentive. Local production has been promoted to ensure availability of essential medicines but research in this area is also limited. Methods The study took place between 2011 and 2015. We systematically examined the registration status of medicines and vaccines listed in the Ugandan 2012 EML and conducted 20 interviews with regulators, ministry of health representatives, donors, and pharmaceutical producers and analysed quality assurance issues affecting registration, procurement, and local production of medicines in Uganda. In 2017 we conducted a further three interviews to clarify issues around non-registration of essential medicines highlighted by our analysis. Results Of the 566 essential medicines and vaccines nearly half (49%; 275/566) had no registered product in 2012. Of the 3130 registered products, just over a quarter (28%; 880/3130) were listed on the EML. Six local producers had registered 138 products of which 40 corresponded to 32 unique essential medicines. Interviews highlighted alternative routes to availability other than registration. Local producers faced considerable barriers to achieving international quality standards required for international procurement of medicines for the domestic market. Conclusions Monitoring and audit of the registration of essential and non-essential medicines should be a priority nationally and, regionally through harmonisation of registration requirements in the East African Community. National and regional manufacturing plans should consider local production of unregistered essential medicines.

Background The South African (SA) health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) since 1996. To date no studies have reported the changes in SA STG/EMLs. This study describes these changes over time (1996–2013) and compares latest SA STG/EMLs with the latest World Health Organization (WHO) Model EMLs to assess alignment of these lists. Methods A quantitative evaluation of SA STGs/EMLs at 2 levels of healthcare was performed to assess changes in the number and ratio of molecules, dosage forms, and additions and deletions of medicines. The most recent WHO EMLs (18th list, 4th list for children) and 2012 priority life-saving medicines for women and children (PMWC) list were compared to the most recent available SA STG/EMLs (Primary Health Care (PHC 2008), Adult Hospital 2012, and Paediatric Hospital 2013) at the time of the research. Results The number of molecules over the years increased for PHC STG/EMLs but decreased slightly for Adult and Paediatric hospital STG/EMLs. The most additions and deletions over time occurred in the Adult hospital level STG/EML (27 in 2006 and 44 in 2012). A comparison between the most recent SA STG/EMLs and WHO Model EML (18th list) showed that a total of 112 medicines were absent on all SA STG/EMLs. A comparison of medicines for children between the 2013 SA Paediatric Hospital level STG/EML and PMWC indicated that these lists were somewhat aligned for most conditions as only 3 of 14 medicines and 11 of 20 vaccines were absent from SA STG/EMLs. Conclusion This is the first study in SA to investigate changes in National EMLs over time in relation to molecules, dosage forms and therapeutic classes. It is also the first to compare the latest SA STG/EMLs to the WHO Model lists. The results therefore provide insight into the trends and SA STG/EML processes over time.

The methodology of the functioning of the adaptive management system of a LEM is based on modeling technologies, system, process, marketing and institutional approaches, methods of marketing, economic and content analysis, SWOT analysis, as well as methods of strategic, operational and category management. According to the federal law No. 61-FL \"On Medicine Circulation\" dated April 12, 2010, the List of Vital and Essential Medicines is an annually approved by the Government of the Russian Federation list of medicines, which provides for priority health needs for the prevention and treatment of diseases, including those prevailing in the structure of morbidity in the Russian Federation. The management of the attributes of medicine as a product consists of ensuring its competitiveness, managing assortment, developing new medicines and recommendations concerning production, packaging and price. [...]it is related to decisions concerning medicines that should be promptly included or excluded from a LEM. A specific feature of the formation of a LEM is the lack of the possibility (due to the existence of an institutional standard) to fully influence the list of essential products. Since the main criteria for the effectiveness of adaptive systems are the criteria for maintaining economic stability and ensuring the competitiveness of an organization, preventive measures aimed to determine the financial burden on the activities of a pharmacy when medicine is included in its LEM is of vital importance from the point of view of the methodological basis for forming an adaptive management system for a LEM1, 19 - 20.

Background： The self-consciousness and practicality of preferentially prescribed essential medicines （EMs） are not high enough in county hospitals. The purposes of this study were to use the information-motivation-behavioral skills （IM B） model to identify the predictors of essential medicines prescribing behavior （EMPB） among doctors and to examine the association between demographic variables, IMB, and EMPB. Methods： A cross-sectional study was carried out to assess predictive relationships among demographic variables and IM B model variables using an anonymous questionnaire administered in nine county hospitals of Anhui province. A structural equation model was constructed for the I MB model to test the instruments using analysis of moment structures 17.0. Results： A total of 732 participants completed the survey. The average age of the participants was 37.7 ± 8.9 years old （range： 22-67 years old）. The correct rate of information was 90.64%. The average scores of the motivation and behavioral skills were 45.46 a： 7.34 （hundred mark system： 75.77） and 19.92 ± 3.44 （hundred mark system： 79.68）, respectively. Approximately half（50.8%） of respondents reported that the proportion of EM prescription was below 60%. The final revised model indicated a good fit to the data （x^2/df= 4.146, goodness of fit index = 0.948, comparative fit index = 0.938, root mean square error of approximation = 0.066）. More work experience （β = 0.153, P 〈 0.001 ） and behavioral skills （β = 0.449, P 〈 0.001 ） predicted more EMPB. Higher income predicted less information （β = -0.197, P 〈 0.001） and motivation （β =0.204, P 〈 0.001 ）. Behavioral skills were positively predicted by information （β = 0.135, P 〈 0.001 ） and motivation （β = 0.742, P 〈 0.001 ）. Conclusion： The present study predicted some factors of EMPB, and specified the relationships among the model variables. The utilization rate of EM was not high enough. Motivation and behavior skills were crucial factors affecting EMPB. The influence of demographic variables, such as income and work experience, on EMPB should be fully appreciated. Comprehensive intervention measures should be implemented from multiple perspectives.