Dataset Information

Promoting the integrated community case management of pneumonia in children under 5 years in Nigeria through the proprietary and patent medicine vendors: a cost-effectiveness analysis.

ABSTRACT:

Background

While evidence-based recommendations for the management pneumonia in under-5-year-olds at the community level with amoxicillin dispersible tablets (DT) were made by the World Health Organisation, initiatives to promote the integrated community case management (iCCM) of pneumonia through the proprietary and patent medicine vendors (PPMVs) have been poorly utilized in Nigeria, possibly due to low financial support and perceived benefit. This study provides costs, benefits and cost-effectiveness estimates and implications of promoting the iCCM through the PPMVs' education and support. The outcome of this study will help inform healthcare decisions in Nigeria.

Methods

This study was a cost-effectiveness analysis using a simulation-based Markov model. Two approaches were compared, the 'no promotion' and the 'promotion' scenarios. The health outcomes include disability-adjusted life years averted and severe pneumonia hospitalisation cost averted. The costs were expressed in 2019 US dollars.

Results

The promotion of iCCM through the PPMVs was very cost effective with an incremental cost-effectiveness ratio of US$143.77 (95% CI US$137.42-150.50)/DALY averted. The promotion will prevent 28,359 cases of severe pneumonia hospitalisation with an estimated healthcare cost of US$390,578. It will also avert 900 deaths in a year.

Conclusion

Promoting the iCCM for the treatment of pneumonia in children under 5 years through education and support of the PPMVs holds promise to harness the benefits of amoxicillin DT and provide a high return on investment. A nationwide promotion exercise should be considered especially in remote areas of the country.

SUBMITTER: Okafor CE

PROVIDER: S-EPMC7905852 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Promoting the integrated community case management of pneumonia in children under 5 years in Nigeria through the proprietary and patent medicine vendors: a cost-effectiveness analysis.

Okafor Charles E CE Ekwunife Obinna I OI Nduaguba Sabina O SO

Cost effectiveness and resource allocation : C/E 20210225 1

<h4>Background</h4>While evidence-based recommendations for the management pneumonia in under-5-year-olds at the community level with amoxicillin dispersible tablets (DT) were made by the World Health Organisation, initiatives to promote the integrated community case management (iCCM) of pneumonia through the proprietary and patent medicine vendors (PPMVs) have been poorly utilized in Nigeria, possibly due to low financial support and perceived benefit. This study provides costs, benefits and co ...[more]

PMID: 33632245

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Project description:BackgroundInterventions to reduce the burden of disease and mortality in sub-Saharan Africa increasingly recognize the important role that drug retailers play in delivering basic healthcare services. In Nigeria, owner-operated drug retail outlets, known as patent and proprietary medicine vendors (PPMVs), are a main source of medicines for acute conditions, but their practices are not well understood. Greater understanding of the role of PPMVs and the quality of care they provide is needed in order to inform ongoing national health initiatives that aim to incorporate PPMVs as a delivery mechanism.Objective and methodsThis paper reviews and synthesizes the existing published and grey literature on the characteristics, knowledge and practices of PPMVs in Nigeria. We searched published and grey literature using a number of electronic databases, supplemented with website searches of relevant international agencies. We included all studies providing outcome data on PPMVs in Nigeria, including non-experimental studies, and assessed the rigor of each study using the WHO-Johns Hopkins Rigor scale. We used narrative synthesis to evaluate the findings.ResultsWe identified 50 articles for inclusion. These studies provided data on a wide range of PPMV outcomes: training; health knowledge; health practices, including drug stocking and dispensing, client interaction, and referral; compliance with regulatory guidelines; and the effects of interventions targeting PPMVs. In general, PPMVs have low health knowledge and poor health treatment practices. However, the literature focuses largely on services for adult malaria, and little is known about other health areas or services for children.ConclusionsThis review highlights several concerns with the quality of the private drug retail sector in Nigeria, as well as gaps in the existing evidence base. Future research should adopt a more holistic view of the services provided by PPMV shops, and evaluate intervention strategies that may improve the services provided in this sector.

Project description:BackgroundPatent and Proprietary Medicine Vendors (PPMVs) play a major role in Nigeria's health care delivery but regulation and monitoring of their practice needs appreciable improvement to ensure they deliver quality services. Most PPMVs belong to associations which may be useful in improving their regulation. However, little is known about how the PPMV associations function and how they can partner with relevant regulatory agencies to ensure members' compliance and observance of good practice. This study sought to describe the PPMV associations' structure and operations and the regulatory environment in which PPMVs function. With this information we explore ways in which the associations could help improve the coverage of Nigeria's population with basic quality health care services.MethodsA mixed methods study was conducted across four rural local government areas (LGAs) (districts) in two Nigerian states of Bayelsa and Oyo. The study comprises a quantitative data collection of 160 randomly selected PPMVs and their shops, eight PPMV focus group discussions, in-depth interviews with 26 PPMV association executives and eight regulatory agency representatives overseeing PPMVs' practice.ResultsThe majority of the PPMVs in the four LGAs belonged to the local chapters of National Association of Patent and Proprietary Medicine Dealers (NAPPMED). The associations were led by executive members and had regular monthly meetings. NAPPMED monitored members' activities, provided professional and social support, and offered protection from regulatory agencies. More than 80% of PPMVs received at least one monitoring visit in the previous 6 months and local NAPPMED was the organization that monitored PPMVs the most, having visited 68.8% of respondents. The three major regulators, who reached 30.0-36.3% of PPMVs reported lack of human and financial resources as the main challenge they faced in regulation.ConclusionsQuality services at drug shops would benefit from stronger monitoring and regulation. The PPMV associations already play a role in monitoring their members. Regulatory agencies and other organizations could partner with the PPMV associations to strengthen the regulatory environment and expand access to basic quality health services at PPMV shops in Nigeria.

Project description:BackgroundCommunity Pharmacists (CPs) and Patent and Proprietary Medicine Vendors (PPMVs) are often the first point of care for many Nigerians, and when sufficiently trained, they contribute to the expansion of family planning services. Nigeria's task shifting policy and existing regulatory and licensing bodies provide the enabling environment for PPMVs to be stratified and trained. This study explored the perceptions of stakeholders toward the pilot three-tier accreditation system instituted by the Pharmacists Council of Nigeria with support from the IntegratE project.MethodsTwo rounds of qualitative phone interviews were conducted among stakeholders in Kaduna and Lagos states in 2020 and 2021. In addition, there were two rounds of phone interviews with CPs and PPMVs (program recipients) from Lagos and Kaduna states. All participants were purposively selected, based on their involvement in the IntegratE project activities. Interviews were recorded, transcribed, and coded using Atlas.ti software. Thematic analysis was conducted.ResultsFifteen stakeholders and 28 program recipients and 12 stakeholders and 30 program recipients were interviewed during the first and second rounds of data collection respectively. The data are presented around three main themes: 1) the pilot three-tier accreditation system; 2) enabling environment; and 3) implementation challenges. The accreditation system that allows for the stratification and training of PPMVs to provide family planning services was perceived in a positive light by majority of participants. The integrated supportive supervision team that included representation from the licensing and regulatory body was seen as a strength. However, it was noted that the licensing process needs to be more effective. Implementation challenges that need to be addressed prior to scale up include bottlenecks in licensing procedures and the deep-rooted mistrust between CPs and PPMVs.ConclusionScale up of the three-tier accreditation system has the potential to expand access to family planning services in Nigeria. In other resource-poor settings where human resources for health are in short supply and where drug shops are ubiquitous, identifying drug shop owners, training them to offer a range of family planning services, and providing the enabling environment for them to function may help to improve access to family planning services.

Project description:BackgroundThe low utilisation of modern contraceptives in many low- and middle-income countries remains a challenge. Patent medicine vendors (PMVs) that operate in the informal health sector, have the potential to address this challenge. Between 2015 and 2018, the Population Council, in collaboration with the Federal and State Ministries of Health and the Pharmacy Council of Nigeria, trained PMVs in six states to deliver injectable contraceptive services. Outcome evaluation demonstrated increased client uptake of injectable contraceptive services; however, there is limited information on how and why the intervention influenced outcomes. This study was conducted to elucidate the processes and mechanism through which the previous intervention influenced women's utilisation of injectable contraceptive services.MethodsThe study utilised a mixed methods, convergent parallel design guided by the UK Medical Research Council framework. Quantitative data were obtained from 140 trained PMVs and 145 of their clients in three states and 27 in-depth interviews were conducted among relevant stakeholders. The quantitative data were analysed descriptively, while the qualitative data were analysed thematically.ResultsThe results revealed that even after the completion of the PMV study which had a time-bound government waiver for injectable contraceptive service provision by PMVs, they continued to stock and provide injectables in response to the needs of their clients contrary to the current legislation which prohibits this. The causal mechanism that influenced women's utilisation of injectable contraceptives were the initial training that the PMV received; the favourable regulatory environment as demonstrated in the approval provided by government for PMVs to provide injectable contraceptives for the duration of the study; and the satisfaction and the confidence the female clients had developed in the ability of the PMVs to serve them. However, there were gaps with regards to the consistent supply of quality injectable contraceptive commodities and in PMVs use of job aids. Referral and linkages to government or private-owned facilities were also sub-optimal.ConclusionPMVs continue to play important roles in family planning service provision; this underscores the need to formalize and scale-up this intervention to aid their integral roles coupled with multi-faceted initiatives to enhance the quality of their services.

Project description:BackgroundChild mortality remains unacceptably high, with Northern Nigeria reporting some of the highest rates globally (e.g. 192/1000 live births in Jigawa State). Coverage of key protect and prevent interventions, such as vaccination and clean cooking fuel use, is low. Additionally, knowledge, care-seeking and health system factors are poor. Therefore, a whole systems approach is needed for sustainable reductions in child mortality.MethodsThis is a cluster randomised controlled trial, with integrated process and economic evaluations, conducted from January 2021 to September 2022. The trial will be conducted in Kiyawa Local Government Area, Jigawa State, Nigeria, with an estimated population of 230,000. Clusters are defined as primary government health facility catchment areas (n = 33). The 33 clusters will be randomly allocated (1:1) in a public ceremony, and 32 clusters included in the impact evaluation. The trial will evaluate a locally adapted 'whole systems strengthening' package of three evidence-based methods: community men's and women's groups, Partnership Defined Quality Scorecard and healthcare worker training, mentorship and provision of basic essential equipment and commodities. The primary outcome is mortality of children aged 7 days to 59 months. Mortality will be recorded prospectively using a cohort design, and secondary outcomes measured through baseline and endline cross-sectional surveys. Assuming the following, we will have a minimum detectable effect size of 30%: (a) baseline mortality of 100 per 1000 livebirths, (b) 4480 compounds with 3 eligible children per compound, (c) 80% power, (d) 5% significance, (e) intra-cluster correlation of 0.007 and (f) coefficient of variance of cluster size of 0.74. Analysis will be by intention-to-treat, comparing intervention and control clusters, adjusting for compound and trial clustering.DiscussionThis study will provide robust evidence of the effectiveness and cost-effectiveness of community-based participatory learning and action, with integrated health system strengthening and accountability mechanisms, to reduce child mortality. The ethnographic process evaluation will allow for a rich understanding of how the intervention works in this context. However, we encountered a key challenge in calculating the sample size, given the lack of timely and reliable mortality data and the uncertain impacts of the COVID-19 pandemic.Trial registrationISRCTN 39213655 . Registered on 11 December 2019.

Project description:Background: Shufeng Jiedu (SFJD) capsules can be used as adjunctive treatment for patients with community-acquired pneumonia, but the effectiveness and safety of SFJD are not clear. This review aims to evaluate the effectiveness and safety of SFJD based on randomized controlled trials (RCTs). Methods: A systematic review was conducted by searching PubMed, Embase, Scopus, Web of Science, CENTRAL, CNKI, VIP, CBM, Wanfang and trial registry platforms from their inception to March 2022. Two reviewers screened studies, extracted the data and assessed risk of bias independently. The data were pooled for meta-analysis or presented narratively. Results: Seventeen RCTs involving 1840 participants were included. All trials compared SFJD plus antibiotics to antibiotics, or combined with symptomatic treatment in both groups. The overall certainty of evidence was assessed as moderate to very low certainty. Compared with routine treatment (antibiotics alone or antibiotics plus symptomatic treatment), SFJD plus routine treatment showed beneficial effects in resolution of fever (MD -1.20 days, 95%CI -1.73 to -0.67; 10 RCTs; very low certainty), cough (MD -1.02 days, 95%CI -1.23 to -0.81; 9 RCTs; moderate certainty), phlegm (MD -1.46 days, 95%CI -2.84 to -0.08; 6 RCTs; very low certainty), pulmonary crepitations (MD -1.61 days, 95%CI -2.64 to -0.59; 8 RCTs; low certainty), shortness of breath (MD -2.80 days, 95%CI -2.88 to -2.72; 2 RCTs; low certainty) and chest pain (MD -2.85 days, 95%CI -3.01 to -2.69; 1 RCT; low certainty). There was no significant difference in pathogen clearance (1 RCT). No serious adverse events were reported, but 2.60% (5/192) patients reported nausea in the SFJD groups, 1.04% (2/192) participants in routine group, and no significant difference was identified. Conclusions: Current evidence suggests that adding SFJD may shorten the duration of symptom relief in community-acquired pneumonia for 1-2 days. The adverse events were minor and controllable, and no serious adverse events were reported. Well-reported trials and potential of reducing antibiotics were expected in the future studies.

Project description:BackgroundNot all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as "evergreening", can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market.Materials and methodsWe focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration's Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product's device patents and medicine patents.ResultsUnexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3-15.2 years).ConclusionIncremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes "evergreening" depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic improvements in the standard of care, which is highly debatable.

Dataset Information

Promoting the integrated community case management of pneumonia in children under 5 years in Nigeria through the proprietary and patent medicine vendors: a cost-effectiveness analysis.

Background

Methods

Results

Conclusion

Publications

Promoting the integrated community case management of pneumonia in children under 5 years in Nigeria through the proprietary and patent medicine vendors: a cost-effectiveness analysis.

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