Assessment of the compliance with minimum quality standards by public primary healthcare facilities in Nigeria.

Achieving universal health coverage (UHC) and the Sustainable Development Goals (SDG) by 2030 relies on the delivery of quality healthcare services through effective primary healthcare (PHC) systems. This necessitates robust infrastructure, adequately skilled health workers and the availability of essential medicines and commodities. Despite the critical role of minimum standards in benchmarking PHC quality, no global consensus on these standards exists. Nigeria has established minimum standards to enhance healthcare accessibility and quality, including the Revised Ward Health System Strategy (RWHSS) by the National Primary Health Care Development Agency (NPHCDA). This paper outlines the evolution of PHC minimum standards in Nigeria, evaluates compliance with RWHSS standards across all public PHC facilities, and examines the implications for ongoing PHC revitalization efforts. The study used a cross-sectional descriptive design to assess compliance across 25 736 public PHC facilities in Nigeria. Data collection involved a national survey using a standardized assessment tool focussing on infrastructure, staffing, essential medicines and service delivery. Compliance with RWHSS minimum standards was found to be below 50% across all facilities, with median compliance scores of 40.7%. Outreach posts had a median compliance of 32.6%, level 1 facilities 31.5% and level 2+ facilities 50.9%. Key findings revealed major gaps in health infrastructure, human resources and availability of essential medicines and equipment. Compliance varied regionally, with the North-west showing the highest number of facilities but varied performance across standards. The lessons learned underscore the urgent need for targeted interventions and resource allocation to address the identified deficiencies. This study highlights the critical need for regular, comprehensive compliance assessments to guide policy-makers in identifying gaps and strengthening PHC systems in Nigeria. Recommendations include enhancing monitoring mechanisms, improving resource distribution and focussing on infrastructure and human resource development to meet UHC and SDG targets. Addressing these gaps is essential for advancing Nigeria's healthcare system and ensuring equitable, quality care for all.

Evaluating essential medicines for treating childhood cancers: availability, price and affordability study in Ghana.

INTRODUCTION: Access to childhood cancer medicines is a critical global health challenge. There is a lack of sufficient context-specific data in Ghana on access to essential medicines for treating childhood cancers. Here, we present an analysis of essential cancer medicine availability, pricing, and affordability using the pediatric oncology unit of a tertiary hospital as the reference point. METHOD: Data on prices and availability of 20 strength-specific essential cancer medicines and eight non-cancer medicines were evaluated using the modified World Health Organization (WHO)/Health Action International method. Two pharmacies in the hospital and four private pharmacies around the hospital were surveyed. We assessed their median price ratio using the WHO international reference price guide. The number of days wages per the government daily wage salary was used to calculate the affordability of medicines. RESULTS: The mean availability of essential cancer medicines and non-cancer medicines at the hospital pharmacies were 27 and 38% respectively, and 75 and 84% respectively for private pharmacies. The median price ratio of cancer medicines was 1.85, and non-cancer medicines was 3.75. The estimated cost of medicines for treating a 30 kg child with Acute lymphoblastic leukaemia was GHÈ» 4928.04 (US$907.56) and GHÈ» 4878.00 (US$902.62) for Retinoblastoma, requiring 417 and 413-days wages respectively for the lowest-paid unskilled worker in Ghana. CONCLUSION: The mean availability of cancer medicines at the public and private pharmacies were less than the WHO target of 80%. The median price ratio for cancer and non-cancer medicines was less than 4, yet the cost of medicines appears unaffordable in the local setting. A review of policies and the establishment of price control could improve availability and reduce medicines prices for the low-income population.

Acceptability and feasibility of a national essential medicines list in Canada: a qualitative study of perceptions of decision-makers and policy stakeholders.

BACKGROUND: Policy approaches have been considered to address inconsistent and inequitable prescription drug coverage in Canada, including a national essential medicines list. We sought to explore key factors influencing the acceptability and feasibility of an essential medicines list in Canada. METHODS: We conducted semi-structured interviews with decision-makers and other key stakeholders from government or pan-Canadian institutions, civil society and the private sector across Canada. We analyzed data using inductive thematic analysis and by applying Kingdon's Multiple Streams Framework to analyze the emergent themes deductively. RESULTS: We conducted 21 interviews before thematic saturation was achieved. We categorized emergent themes to describe the problem, the essential medicines list policy (including content and process), and politics. There was consensus among participants that prescription drug coverage was an important problem to address. Participants differed in their views on how to define essential medicines and concerns about what would be excluded from an essential medicines list. There was consensus on important features for a process to develop an essential medicines list: an independent decision-making body, use of defined selection criteria based on quality evidence, and clear communication of the purpose of the essential medicines list. Federal government financing and the broader pharmacare model, engagement of various interest groups and changing political agendas emerged as core political factors to consider if developing a Canadian essential medicines list. INTERPRETATION: Although stakeholders' views on the content of a Canadian essential medicines list varied, there was consensus on the process to formulate and implement an essential medicines list or common national formulary, including choosing medicines based on best evidence. Greater understanding is now needed on how patients, clinicians and the public perceive the concept of an essential medicines list.

Parents' and guardians' perceptions on availability and pricing of medicines and healthcare for children in eThekwini, South Africa - a qualitative study.

BACKGROUND: Inadequate access to affordable essential medicines poses a challenge to achieving Universal Health Coverage. Access to essential medicines for children has been in the spotlight in recent research. However, information from the end users of medicines, i.e. patients is scarce. Obtaining information at a household level is integral to understanding how people access, obtain and use medicines. This study aimed to gather opinions and perceptions from parents/guardians on availability, affordability and quality of medicines and healthcare for children in SA. METHODS: Eight Focus group discussions were held with 41 individuals in eThekwini, South Africa (SA), from September-November 2016. Participants were parents/guardians of children up to 12 years from different ethnicities, ages, gender, and socio-economic backgrounds. Key informants identified by the principal researcher recruited participants using snowball sampling. Focus group discussions were recorded, transcribed verbatim, coded by the first author, verified by the second author, reconciled for consensus and imported into NVIVO for data analysis. RESULTS: Medicines and healthcare facilities are accessible in urban and peri-urban areas in eThekwini. Medicines may not always be available in public sector facilities due to medicine shortages, compelling parents to purchase medicines from private sector pharmacies. Common medicines were perceived as affordable for most socio-economic groups except the 'Poor' group. Quality of medicines was perceived as 'good' especially if obtained from the private sector but sometimes perceived as 'poor' and viewed with suspicion when received from public sector clinics. Quality of healthcare was perceived as 'good' but requires improvement for both sectors. CONCLUSIONS: This is the first study in SA to report on parent/guardian perceptions on availability, affordability and quality of medicines and healthcare for children. It has the potential to be up-scaled to a country-wide investigation to paint a national picture of parents' opinions of healthcare for children. This will allow for patient input into pharmaceutical and healthcare policy governing access to and availability of essential medicines and services within the country. The study recommends that patient input be sought to assess impact of policies on the intended target group in the country to ensure that the policy objectives are achieved.

Reforming the World Health Organization's Essential Medicines List: Essential but Unaffordable.

This Viewpoint proposes restructuring the WHO Essential Medicines List to remove consideration of cost and cost-effectiveness from the expert committee reviews of clinical effectiveness, safety, and public health value, and chartering a new framework for pooled global negotiation and procurement of costly medicines included in the list.

The impact of China's national essential medicine system on improving rational drug use in primary health care facilities: an empirical study in four provinces.

BACKGROUND: The National Essential Medicine System (NEMS) is a new policy in China launched in 2009 to improve the appropriate use of medications. This study aims to examine the outcomes of the NEMS objectives in terms of the rational use of medicines in primary health care facilities in China. METHODS: A total of 28,651 prescriptions were collected from 146 township health centers in four provinces of China by means of a field survey conducted in 2010-2011. Indicators of rational drug use were extracted and compared using a pre/post design and then evaluated with regard to the World Health Organization (WHO) Standard Guidelines and data from previous research. RESULTS: The average number of drugs per prescription decreased from 3.64 to 3.46 (p < 0.01) between 2009 and 2010. Little effect was found for the NEMS on the average number of antibiotics per prescription, but the percentage of prescriptions including antibiotics decreased from 60.26 to 58.48% (p < 0.01). Prescriptions for injections or adrenal corticosteroids also decreased, to 40.31 and 11.16% of all prescriptions, respectively. All these positive issues were also recorded in 2011. However, each of the above values remained higher than WHO standards. The percentage of drugs prescribed from the Essential Drug List increased after the implementation of the NEMS (p < 0.01). Where the available data allowed changes in costs to be assessed, the average expense per prescription increased significantly, from 25.77 to 27.09 yuan (p < 0.01). CONCLUSIONS: The NEMS effectively improved rational medicine use in China. However, polypharmacy and the over-prescription of antibiotics and injections remain common. There is still a large unfinished agenda requiring policy improvements. Treatment guidelines, intensive support supervision, and continuing training for both professionals and consumers are the essential actions that need to be taken.

The selection and use of essential medicines.

This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model Lists of Essential Medicines. It contains a summary of the Committee's considerations and justifications for additions and changes to the Model Lists, including its recommendations. Annexes to the main report include the revised version of the WHO Model List of Essential Medicines (18th edition) and the WHO Model List of Essential Medicines for Children (4th edition). In addition there is a list of all the items on the Model Lists sorted according to their Anatomical Therapeutic Chemical (ATC) classification codes.

Quality of Essential Medicines from Different Sources in Enugu and Anambra, Nigeria.

This study investigated the quality of 13 essential medicines in the states of Enugu and Anambra, Nigeria. A total of 260 samples were purchased from licensed pharmaceutical manufacturers and wholesalers and from vendors in pharmaceutical markets with unclear licensing status. Samples were analyzed for identity, content, and dissolution according to the United States Pharmacopeia (USP) 42 monographs. Forty-five samples of this study could be examined for authenticity with the Mobile Authentication Service scheme of the Nigerian National Agency for Food and Drug Administration and Control. Out of all samples, 25.4% did not comply with the USP 42 specifications. Strikingly, 21 out of 22 dexamethasone tablet samples (95%) were out of specification (OOS). Nine out of 19 glibenclamide samples (47%) failed dissolution testing, and 7 out of 17 cotrimoxazole samples (41%) failed assay testing. Medicines against noncommunicable diseases showed a slightly higher percentage of OOS samples than anti-infectives (21.2% versus 17.6%). The rates of OOS samples were similar in medicines stated to be produced in Nigeria, India, and China but were very different between individual manufacturers from each of these countries of origin. Therefore, prequalification of products, manufacturers, and suppliers are very important for quality assurance in medicine procurement. Unexpectedly, the total proportions of OOS samples were similar from licensed vendors (25.2%) and from markets (25.5%). Four samples (1.5%), all collected in markets, were clearly falsified and did not contain the declared active pharmaceutical ingredients. The proportion of falsified medicines was found to be lower than frequently reported in the media for Nigeria.

WHO expert committee on specifications for pharmaceutical preparations.

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

National list of essential medicines of India: the way forward.

Essential medicines lists have been shown to improve the quality and cost-effectiveness of health care delivery when combined with proper procurement policies and good prescribing practices. The Ministry of Health, Government of India revised the National List of Essential Medicines of India (NLEMI 2011) in June 2011, eight years after the last revision. The NLEMI 2011 contains 348 medicines and was prepared over one and a half years by 87 experts. Though there are some positive aspects to the list such as the documentation of a detailed description of the revision process, inclusion of many experts from various fields in the review committee, well written description of the essential medicines concept and others, a critical review of the list reveals areas of major and minor concerns. Improper medicine selection like the inclusion of a nearly obsolete medicine such as ether, an anesthetic agent; non-inclusion of pediatric formulations; spelling errors; and errors in the strengths of formulations diminishes the significance of the NLEMI 2011. In its present form, the NLEMI 2011 did not align with the Indian Pharmacopoeia, and the National Health Programs as well as the National Formulary of India 2010. Formatting errors, non-inclusion of an index page, syntax and spelling errors may also undermine the usefulness of the NLEMI 2011 as a reference material. An urgent revision of the NLEMI 2011 is suggested so as to avert misinforming the wider international and local readers.

The selection and use of essential medicines.

This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model Lists of Essential Medicines. It contains a summary of the Committee's considerations and justifications for additions and changes to the Model Lists, including its recommendations. Annexes to the main report include the revised version of the WHO Model List of Essential Medicines (17th edition) and the WHO Model List of Essential Medicines for Children (3rd edition). In addition there is a list of all the items on the Model Lists sorted according to their Anatomical Therapeutic Chemical (ATC) classification codes. An additional annex covers the Report of a Supplementary Meeting of the Expert Committee on the Selection and Use of Essential Medicines which took place in Geneva in January 2010 to consider treatment of the pandemic influenza virus.

Availability of essential medicines in Pakistan-A comprehensive document analysis.

INTRODUCTION: Access to essential medicines (EMs) is a basic human right. Non-availability and shortages of EMs are reported for Pakistan but there is insufficient data to define the nature and magnitude of this problem. The current study is designed to systematically analyze the medicines included in the National Essential Medicines List (NEML) for their availability through comprehensive document analysis. METHODS: An expanded list of medicinal items was developed using the NEML of Pakistan (2018) to enlist individual medicines with their specifications. Registration status of the medicines was searched using three publicly accessible information sources; Pharmaguide 25th Edition, 2018-19, the on-line Drug Information System, and the Mobile Application Pharmapedia followed by a later 3-step validation of the data. The unregistered EMs were then further categorized into three subgroups in accordance with their possible remedial strategies. FINDINGS: The 19 studied categories comprised 690 EMs and it was found that 179 (26%) of these EMs don not have a registration status. However, it was also identified that the availability of 47 (26.2%) out of 179 unregistered EMs can be enssured by strengthening compounding services, and prioritizing registration of age-appropriate formulations. Availability of another 39 (21.7%) such medicines can be ensured by revising the NEML or the product registrations for the slight differences in their different specifications. The categories showing high proportion of unregistered medicines included anti-Parkinson's medicines (100%), antidotes and other substances used in poisoning (60%), diuretics (47%), anticonvulsants/antiepileptics (42%), hormones and other endocrine medicines and contraceptives (38%), medicines for mental and behavioral disorders (30%), anti-infectives (27%), medicines for pain and palliative care (26%), medicines for neonatal care (25%), medicines for diseases of joint (25%), gastrointestinal medicines (24%) and cardiovascular medicines (15%). CONCLUSION: The study shows the absence of registration status of a significant number of EMs in Pakistan. This could be major barrier in their access. Strategies are needed to strengthen the processes of their registration on priority basis.

Prevalence of Substandard Amoxicillin Oral Dosage Forms in the National Capital District of Papua New Guinea.

Antibiotics are commonly reported as being substandard or falsified in low- to middle-income countries, having potential to contribute to the development of antimicrobial resistance and drug-resistant infections. Amoxicillin, used to treat a number of infections and listed by the WHO as an essential medicine, presented as a good drug candidate for this study. We aimed to measure the prevalence of substandard and falsified amoxicillin oral products (tablets, capsules, and suspensions) in the National Capital District of Papua New Guinea (PNG). These oral products were surveyed in 2018 and 2019 from retail pharmacies, private and public health facilities, and the Area Medical Store, representing more than 90% of licensed medicine outlets. The product packaging was visually inspected, and the samples were analyzed for amoxicillin content using a validated high-performance liquid chromatography method. Although no falsified products were identified, 15% of the 190 products analyzed contained substandard amounts of amoxicillin. Quality varied with the dosage form (P = 0.002), with capsules exhibiting the lowest incidence of substandard content (4% in 2019) and tablets collected in 2018 experiencing the highest failure rate (50%). Suspension (40%) quality was compromised by failure to achieve homogeneity on reconstitution. A higher incidence of substandard content (P = 0.002) was associated with one major retail group. Routine testing of medicines by resource-poor countries is often unachievable, leading to the circulation of poor quality drugs, which is a global public health concern. Our study highlighted that substandard amoxicillin oral products are indeed prevalent in the NCD of PNG.

WHO Expert Committee on specifications for pharmaceutical preparations.

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file.

Identifying the most effective essential medicines policies for quality use of medicines: A replicability study using three World Health Organisation data-sets.

BACKGROUND: Poor quality use of medicines (QUM) has adverse outcomes. Governments' implementation of essential medicines (EM) policies is often suboptimal and there is limited information on which policies are most effective. METHODS: We analysed data on policy implementation from World Health Organisation (WHO) surveys in 2007 and 2011, and QUM data from surveys during 2006-2012 in developing and transitional countries. We compared QUM scores in countries that did or did not implement specific policies and regressed QUM composite scores on the numbers of policies implemented. We compared the ranking of policies in this and two previous studies, one from the same WHO databases (2003-2007) the other from data obtained during country visits in South-East Asia (2010-2015). The rankings of a common set of 17 policies were correlated and we identified those that were consistently highly ranked. FINDINGS: Fifty-three countries had data on both QUM and policy implementation. Forty policies were associated with effect sizes ranging from +13% to -5%. There was positive correlation between the composite QUM indicator and the number of policies reported implemented: (r) = 0.437 (95% CI 0.188 to 0.632). Comparison of policy rankings between the present and previous studies showed positive correlation with the WHO 2003-7 study: Spearman's rank correlation coefficient 0.498 (95% CI 0.022 to 0.789). Across the three studies, five policies were in the top five ranked positions 11 out of a possible 15 times: drugs available free at the point of care; a government QUM unit; undergraduate training of prescribers in standard treatment guidelines, antibiotics not available without prescription and generic substitution in the public sector. INTERPRETATION: Certain EM policies are associated with better QUM and impact increases with co-implementation. Analysis across three datasets provides a policy short-list as a minimum investment by countries trying to improve QUM and reduce antimicrobial drug misuse.

Selection of Blood, Blood Components, and Blood Products as Essential Medicines in 105 Low- and Middle-Income Countries.

Blood products of human origin are essential treatment options for several diseases, for example, hemophilia. We studied the alignment of national essential medicines lists (NEMLs) of low- and middle-income countries (LMICs) with the World Health Organization (WHO) Model List for the selection of blood products of human origin. The most recent versions of NEMLs from all LMICs were studied for the inclusion of blood products of human origin (blood and blood components, plasma products, and immunoglobulins). Data obtained from 105 NEMLs were compared to the 2017 WHO Model List. The median number of blood products of human origin on the NEMLs was 4 (range: 0-10). Immunoglobulins were most frequently included (73%). Blood and blood components were the least selected products (15%). The uptake of plasma products was around 50%. Nine countries did not have any blood products of human origin on their NEMLs. Some NEMLs included blood products not listed on the WHO Model List (albumin, hepatitis A immunoglobulin, and cryoprecipitate). We observed variation in selection according to WHO region, income level, and year of NEML update. Alignment of NEMLs with the WHO Model List varied greatly for different groups of blood products, ranging from good uptake for immunoglobulins, reasonable uptake for plasma products, to poor uptake for blood and blood components. This heterogeneity in selection and inclusion of blood products of human origin on NEMLs may be partly explained as being due to specific country characteristics, but some of it may not be explained. Policy makers need to rely on evidence in making decisions about which blood products to select, include, and remove on their NEMLs.

Importance of medicine quality in achieving universal health coverage.

OBJECTIVE: To assess the importance of ensuring medicine quality in order to achieve universal health coverage (UHC). METHODS: We developed a systems map connecting medicines quality assurance systems with UHC goals to illustrate the ensuing impact of quality-assured medicines in the implementation of UHC. The association between UHC and medicine quality was further examined in the context of essential medicines in low- and middle-income countries (LMICs) by analyzing data on reported prevalence of substandard and falsified essential medicines and established indicators for UHC. Finally, we examined the health and economic savings of improving antimalarial quality in four countries in sub-Saharan Africa: the Democratic Republic of the Congo (DRC), Nigeria, Uganda, and Zambia. FINDINGS: A systems perspective demonstrates how quality assurance of medicines supports dimensions of UHC. Across 63 LMICs, the reported prevalence of substandard and falsified essential medicines was found to be negatively associated with both an indicator for coverage of essential services (p = 0.05) and with an indicator for government effectiveness (p = 0.04). We estimated that investing in improving the quality of antimalarials by 10% would result in annual savings of $8.3 million in Zambia, $14 million in Uganda, $79 million in two DRC regions, and $598 million in Nigeria, and was more impactful compared to other potential investments we examined. Costs of substandard and falsified antimalarials per malaria case ranged from $7 to $86, while costs per death due to poor-quality antimalarials ranged from $14,000 to $72,000. CONCLUSION: Medicines quality assurance systems play a critical role in reaching UHC goals. By ensuring the quality of essential medicines, they help deliver effective treatments that lead to less illness and result in health care savings that can be reinvested towards UHC.

Newborn Service Readiness of Primary Level Health Facilities of Eastern Mountain Region of Nepal.

BACKGROUND: Newborn service readiness is facility's observed capacity to provide newborn services and a pre-requisite for quality. Newborn services are priority program of government and efforts are focused on infrastructure and supplies at peripheral health facilities. Study describes health facility readiness for newborn services in four domains of general requirements, equipment, medicines and commodities, and staffing and guidelines. METHODS: Convergent parallel mixed method using concurrent triangulation was done in public health facilities providing institutional deliveries of two randomly selected districts- Taplejung and Solukhumbu of Eastern Mountain Region of Nepal. Face to face interview and observation of facilities were done using structured questionnaire and checklist; in-depth interviews were done using interview guideline from November 2016 to January 2017. Ethical clearance was taken. Descriptive analysis and deductive thematic analysis were done. RESULTS: Mean score of newborn service readiness was 68.7±7.1 with range from 53.3 to 81.4 out of 100. Domains of general requirement, equipment, medicine and commodity, supervision, staffing and guideline were assessed. The gaps identified in general requirements were availability of uninterrupted power supply, means of communication and referral vehicle. Clean wrappers and heater for room temperature maintenance were identified during interviews to be part of the readiness. All health facilities had trained staff while retention of skill was of concern. There was felt need of enforcing adequate training coverage to suffice the need of human resources in remote. CONCLUSIONS: Efforts of improving transportation, heater for room temperature maintenance, trainings with skill retention strategy, utilization of guidelines, availability of skilled birth attendance could result increased and improved newborn service readiness.