Dataset Information

Stakeholder perspectives on the demand and supply factors driving substandard and falsified blood pressure lowering medications in Nigeria: a qualitative study.

ABSTRACT:

Objectives

Although substandard and falsified (SF) blood pressure (BP) lowering medications are a global problem, qualitative research exploring factors driving this in Nigeria has not been reported. This study provides information on factors driving demand for and supply of low-quality BP lowering medications in Nigeria and potential strategies to address these factors.

Methods

This was a cross-sectional qualitative study. Between August 2020 and September 2020, we conducted 11 in-depth interviews and 7 focus group discussions with administrators of health facilities, major manufacturers and distributors of BP lowering medications, pharmacists, drug regulators, patients and primary care physicians purposively sampled from the Federal Capital Territory, Nigeria. Data were analysed using directed content analysis, with the aid of Dedoose.

Results

We found that demand for SF BP lowering medications in Nigeria was driven by high out-of-pocket expenditure and stockouts of quality-assured BP lowering medications. Supply of low-quality BP lowering medications was driven by limited in-country manufacturing capacity, non-adherence to good manufacturing and distribution practices, under-resourced drug regulatory systems, ineffective healthcare facility operations, poor distribution practices, limited number of trained pharmacists and the COVID-19 pandemic which led to stockouts. Central medicine store procurement procedures, active pharmaceutical ingredient quality check and availability of trained pharmacists were existing strategies perceived to lower the risk of supply and demand of SF BP lowering medications.

Conclusion

Our findings suggest that demand for and supply of SF BP lowering medications in Nigeria are driven by multi-level, interrelated factors. Multi-pronged strategies need to target stakeholders and systems involved in drug production, distribution, prescription, consumption, regulation and pricing.

SUBMITTER: Shedul G

PROVIDER: S-EPMC9791447 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Stakeholder perspectives on the demand and supply factors driving substandard and falsified blood pressure lowering medications in Nigeria: a qualitative study.

Shedul Grace G Sanuade Olutobi Adekunle OA Ugwuneji Eugenia N EN Ojo Tunde M TM Vijay Aishwarya A Ponzing Patrick P Okpe Inuwa I Shedul Gabriel Lamkur GL Huffman Mark D MD Ojji Dike D Hirschhorn Lisa R LR

BMJ open 20221222 12

<h4>Objectives</h4>Although substandard and falsified (SF) blood pressure (BP) lowering medications are a global problem, qualitative research exploring factors driving this in Nigeria has not been reported. This study provides information on factors driving demand for and supply of low-quality BP lowering medications in Nigeria and potential strategies to address these factors.<h4>Methods</h4>This was a cross-sectional qualitative study. Between August 2020 and September 2020, we conducted 11 i ...[more]

PMID: 36549744

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Project description:IntroductionSubstandard and falsified medications pose significant risks to global health. Nearly one in five antimalarials circulating in low- and middle-income countries are substandard or falsified. We assessed the health and economic impact of substandard and falsified antimalarials on children under five in Nigeria, where malaria is endemic and poor-quality medications are commonplace.MethodsWe developed a dynamic agent-based SAFARI (Substandard and Falsified Antimalarial Research Impact) model to capture the impact of antimalarial use in Nigeria. The model simulated children with background characteristics, malaria infections, patient care-seeking, disease progression, treatment outcomes, and incurred costs. Using scenario analyses, we simulated the impact of substandard and falsified medicines, antimalarial resistance, as well as possible interventions to improve the quality of treatment, reduce stock-outs, and educate caregivers about antimalarial quality.ResultsWe estimated that poor quality antimalarials are responsible for 12,300 deaths and $892 million ($890-$893 million) in costs annually in Nigeria. If antimalarial resistance develops, we simulated that current costs of malaria could increase by $839 million (11% increase, $837-$841 million). The northern regions of Nigeria have a greater burden as compared to the southern regions, with 9,700 deaths and $698 million ($697-$700 million) in total economic losses annually due to substandard and falsified antimalarials. Furthermore, our scenario analyses demonstrated that possible interventions-such as removing stock-outs in all facilities ($1.11 billion), having only ACTs available for treatment ($594 million), and 20% more patients seeking care ($469 million)-can save hundreds of millions in costs annually in Nigeria.ConclusionsThe results highlight the significant health and economic burden of poor quality antimalarials in Nigeria, and the impact of potential interventions to counter them. In order to reduce the burden of malaria and prevent antimalarials from developing resistance, policymakers and donors must understand the problem and implement interventions to reduce the impact of ineffective and harmful antimalarials.

Project description:The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low- and middle-income countries. However, no country has measured the market-wide extent of the problem, and no standardized methods exist to estimate the prevalence of either substandard or falsified medicines. This is, in part, because the task seems overwhelming; medicine markets are huge and diverse, and testing medicines is expensive. Many countries do operate some form of postmarket surveillance of medicine, but their methods and goals differ. There is currently no clear guidance on which surveillance method is most appropriate to meet specific public health goals. In this viewpoint, we aimed to discuss the utility of both case finding and risk-based sentinel surveillance for substandard and falsified medicines, linking each to specific public health goals. We posit that choosing the system most appropriate to the goal, as well as implementing it with a clear understanding of the factors driving the production and sale of substandard and falsified medicines, will allow for surveillance resources to be concentrated most efficiently. We adapted principles used for disease outbreak responses to suggest a case-finding system that uses secondary data to flag poor-quality medicines, proposing risk-based indicators that differ for substandard and falsified medicines. This system potentially offers a cost-effective way of identifying "cases" for market withdrawal, enhanced oversight, or another immediate response. We further proposed a risk-based sentinel surveillance system that concentrates resources on measuring the prevalence of substandard and falsified medicines in the risk clusters where they are most likely to be found. The sentinel surveillance system provides base data for a transparent, spreadsheet-based model for estimating the national prevalence of substandard and falsified medicines. The methods we proposed are based on ongoing work in Indonesia, a large and diverse middle-income country currently aiming to achieve universal health coverage. Both the case finding and the sentinel surveillance system are designed to be adaptable to other resource-constrained settings.

Project description:BackgroundGlobally, millions of people have been affected by fraudulent pharmaceutical products, particularly those in developing countries. Although the problem of falsified and substandard drugs is acknowledged, the extent of the issue is ever-changing, has a dynamic nature, and should be quantified and captured in a recent snapshot.ObjectiveThis systematic review seeks to examine the data that can quantify and provide a current snapshot of the prevalence of SF antimicrobials in selected east Africa countries.MethodsScientific studies on antimicrobial quality were searched in PubMed, Embase, Scopus, and Google Scholar from 2017 to February 2023. The search strategy focused on scientific articles published in peer-reviewed scientific journals written in English and the studies exclusively done in any of the selected countries of east Africa. The articles were carefully reviewed by two individuals for inclusion independently, first by title followed by abstract and the full-text retrieval. To minimize bias associated with the methodology used for data collection, the quality of the studies was assessed for quality according to the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). The reporting of this systematic review was done following Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA).ResultsFifteen studies that estimated the prevalence of poor-quality antimicrobial medicines in selected four east African countries were included. The overall percentage of samples of antimicrobials that failed at least one quality test was 22.6% (151/669) with each class's prevalence of 17% in antibiotics (73/432), 24% in antimalarial (41/171), and 56% in anthelmintics (37/66). Quality control parameters of API content were the most commonly examined in the included studies, accounting for 14/15 (93%) studies. Fifty (33.1%) of the failing samples failed assay API- content determination, while 26.5% (n = 40) failed the visual inspection and packaging analysis; 19.2% (29) failed dissolution; 14% (n = 21) flawed hardness or friability; 4%(n = 6) failed uniformity, as well as 3.2% (n = 5) failed disintegration test of the quality control parameter.ConclusionIt was found that this review was general in these selected east African countries and was a catalyst for combating the menace of poor-quality medications that affect millions of lives.

Project description:ObjectiveSubstandard and falsified (SF) medical products are a global public health threat. The presence and spread of SF drugs negatively affect (1) patients' safety and health outcomes, (2) national economy, (3) public trust in the healthcare system, and (4) the international fight against serious health challenges such as malaria and antimicrobial resistance. The objective of the current study was to investigate and provide a snapshot analysis of the evolution and developmental patterns of global research publications on SF products.MethodsA bibliometric approach was adopted using terms such as fake, falsified, counterfeit, substandard, and others. No language restriction was made. The study period was from 1900 up to 2020. The search strategy was validated and implemented using Scopus database.ResultsThe search strategy retrieved 978 documents authored by 2861 researchers from 100 different countries and published in 421 different journals. The retrieved documents received 11,237 citations (11.5 citations per document) with an H-index of 53. The 978 documents retrieved from Scopus were published from 1961 to 2020, giving an average of 16.6 publications per year. The present study indicated that research on SF medical products: (a) has experienced a steep growth from 2001 to 2012 followed by a steady-state growth; (b) was disseminated in a wide range of journals, mainly in the fields of the pharmaceutical industry, analytical chemistry, public health, infectious diseases, and internal medicine; (c) was published by scholars with diverse and distant geographical backgrounds; (d) was mainly produced in the United States, United Kingdom, and Germany; (d) has fragmented research networks and a limited number of researchers per network; (e) has limited cross-country collaboration except for that between the US and the UK in one hand and countries in the Mekong region in the other hand; (f) emphasized on medications related to malaria and sexual stimulants; and (g) received relatively inadequate funding.ConclusionsResearch on SF medical products is important and should remain a priority to ensure good quality of medications. Research activity in the field needs to be encouraged in world regions such as Africa and the Middle East where drug regulations are unsatisfactory and cross-border trade of illegal medications is common.

Project description:ImportanceSafer supply programs were implemented in Canada to provide pharmaceutical-grade alternatives to the toxic unregulated drug supply. While research shows clinical benefits and reduced overdose mortality among safer supply patients, medication diversion remains a concern.ObjectiveTo examine provider (prescribing clinicians and allied health professionals) and patient perspectives on diversion of opioids prescribed in safer supply programs.Design, setting, and participantsIn 2021, qualitative interviews and sociodemographic questionnaires were conducted with patients and providers across 4 safer supply programs in Ontario, Canada. Interviews with 21 providers (physicians, nurse practitioners, and allied health professionals) and 52 patients examined experiences implementing safer supply or receiving care. Initial data analysis was conducted from December 2021 to March 2022, and the subanalysis focused on diversion was conducted from December 2023 to March 2024.ExposuresParticipation in safer supply program as a patient or provider.Main outcomes and measuresData about diversion were coded, extracted, and thematically analyzed.ResultsOf 52 patient participants, 29 (55.8%) were men and 23 (44.2%) were women; 1 was Black (1.9%), 9 (17.3%) were Indigenous, 1 was Latino (1.9%), and 41 (78.8%) were White; and the mean (SD) age was 46.5 (9.6) years. Of 21 provider participants, 6 (28.6%) were men, 13 (61.9%) were women, and 2 (9.5%) were nonbinary; and the mean (SD) age was 37.6 (7.6) years. Participants characterized diversion as a spectrum ranging from no diversion, to occasional medication sharing and loss, to selling all prescribed doses of safer supply (considered rare and easy to detect). Most patients reported they consumed all or most of their prescribed medications and rarely shared or sold their doses. However, providers and patient participants shared that people might share, trade, and/or sell some of their medications with other opioid-using people for multiple reasons. Most prominent reasons for diversion were (1) compassionate sharing with intimate partners and friends to manage withdrawal and overdose risk; (2) selling or trading medications to address their own unmet substance use needs (eg, high opioid tolerance); and (3) medication loss due to poverty, homelessness, and associated vulnerabilities to theft and coercion. Programs used nonpunitive urine drug screening practices and patient self-report to monitor medication use. When diversion was identified, providers described using nonjudgmental conversations to understand patients' needs and develop mitigation strategies that addressed underlying reasons for diversion, including changing doses and medications prescribed to better match patients' needs, enrolling eligible intimate partners, and developing safety plans to mitigate vulnerabilities to theft and coercion.Conclusions and relevanceDiversion encompasses a wide spectrum of practices (selling, sharing, and loss of medications), and occurs for complex reasons that surveillance and punitive measures are unlikely to mitigate. Diversion may be best addressed by expanding medication options to better match patients' diverse substance use needs and high tolerance, alongside wraparound social supports.

Project description:Falsified and substandard drugs are a global health problem, particularly in low- and middle-income countries (LMIC) that have weak pharmacovigilance and drug regulatory systems. Poor quality medicines have important health consequences, including the potential for treatment failure, development of antimicrobial resistance, and serious adverse drug reactions, increasing healthcare costs and undermining the public's confidence in healthcare systems. This article presents a review of the methods employed for the analysis of pharmaceutical formulations. Technologies for detecting substandard and falsified drugs were identified primarily through literature reviews. Key-informant interviews with experts augmented our methods when warranted. In order to aid comparisons, technologies were assigned a suitability score for use in LMIC ranging from 0-8. Scores measured the need for electricity, need for sample preparation, need for reagents, portability, level of training required, and speed of analysis. Technologies with higher scores were deemed the most feasible in LMICs. We categorized technologies that cost $10,000 USD or less as low cost, $10,000-100,000 USD as medium cost and those greater than $100,000 USD as high cost technologies (all prices are 2013 USD). This search strategy yielded information on 42 unique technologies. Five technologies were deemed both low cost and had feasibility scores between 6-8, and an additional four technologies had medium cost and high feasibility. Twelve technologies were deemed portable and therefore could be used in the field. Many technologies can aid in the detection of substandard and falsified drugs that vary from the simplest of checklists for packaging to the most complex mass spectrometry analyses. Although there is no single technology that can serve all the requirements of detecting falsified and substandard drugs, there is an opportunity to bifurcate the technologies into specific niches to address specific sections within the workflow process of detecting products.

Project description:BackgroundSubstandard and falsified (SF) medicines are a serious threat to public health in low- and middle-income countries (LMICs). Visual inspection of medicines and screening analysis using the Global Pharma Health Fund (GPHF)-Minilab are important in medicine quality surveillance in low-resource settings.MethodsRecently, 260 medicine samples from Nigeria had been investigated for assay and dissolution according to the United States Pharmacopeia (USP). In the present study, these results were compared to the results of the investigation of the same samples by visual inspection and by GPHF-Minilab analysis by local personnel in Nigeria.ResultsVisual inspection identified many deficiencies of dosage units and packaging information in SF medicines. All four falsified medicines were readily identifiable, primarily from serious spelling errors in the labelling, and from manufacturer names which could not be verified using internet resources. In GPHF-Minilab disintegration testing, two samples did not disintegrate even after 60 min; both were found to fail USP dissolution testing with extreme deviations. Of the 20 samples which deviated in USP assay analysis by more than 20% from the declared API amount, seven (35%) were detected as non-compliant in TLC analysis. Evaluation by TLC image analysis with a recently developed smartphone application (named TLCyzer) increased sensitivity to 62.5% but led to an unacceptably low specificity (75.2%). Additional training of the local personnel improved the results of both TLC analysis and TLCyzer evaluation. Photographs of the visual deficiencies and of the TLC analysis results of the SF medicines are provided as PowerPoint and PDF slides with this publication, for future training courses of pharmacy staff and health workers in LMICs.ConclusionVisual inspection, and screening analysis with simple, rapid and inexpensive methods, are important in the surveillance for SF medicines in LMICs. This study provides data on the potential and the limitations of such screenings.

Dataset Information

Stakeholder perspectives on the demand and supply factors driving substandard and falsified blood pressure lowering medications in Nigeria: a qualitative study.

Objectives

Methods

Results

Conclusion

Publications

Stakeholder perspectives on the demand and supply factors driving substandard and falsified blood pressure lowering medications in Nigeria: a qualitative study.

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