Unintended Consequences and Hidden Obstacles in Medicine Access in Sub-Saharan Africa

Barton, Iain; Avanceña, Anton L. V.; Gounden, Nevashini; Anupindi, Ravi

doi:10.3389/fpubh.2019.00342

Cited by 11 publications

(14 citation statements)

References 24 publications

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“…1.0 1.0 1.1 3.1 A022 0.9 1.1 1.0 3.0 time, more recrudescence, and emergence of resistance. [21][22][23] This becomes very crucial in the treatment of malaria, particularly when artemether is considered for severe malaria cases. As earlier stated, many surveillance studies had reported on the quality of ACTs and other antimalarials in different locations and countries.…”

Section: Discussionmentioning

confidence: 99%

“…20 Unfortunately, poor-quality antimalarial drugs are often associated with a high rate of malaria treatment failure and poor health outcomes, as reported in many surveys. [21][22][23][24] Of additional interest is the scourge of development of antimalarial resistance, which has been correlated with the use of substandard antimalarial medicine. 20,22,23 In a survey by Hajjou et al, 25 antimalarial drugs were found to represent 52.5% of all substandard medicines and 92.6% of all falsified drugs detected.…”

Section: Introductionmentioning

confidence: 99%

“…[21][22][23][24] Of additional interest is the scourge of development of antimalarial resistance, which has been correlated with the use of substandard antimalarial medicine. 20,22,23 In a survey by Hajjou et al, 25 antimalarial drugs were found to represent 52.5% of all substandard medicines and 92.6% of all falsified drugs detected. 25 The previous report revealed that Nigeria is one of the worst-hit countries with drug falsification crimes.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Post-Marketing Surveillance of Quality of Artemether Injection Marketed in Southwest Nigeria

Hassan

Adegbola

Soyinka

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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Access to good-quality medicines remains a contentious issue in developing countries. This development is worrisome, particularly in a setting with a high incidence of malaria. Monitoring of antimalarial drugs in the commercial domain becomes necessary; thus, we evaluated the quality of artemether injection marketed in Southwest Nigeria. A cross-sectional survey was conducted to obtain 22 different brands of artemether injections within Southwest Nigeria. The samples were examined for their sources, lot numbers, containers for injection, oil base used for preparation, and dates of expiration. Further analysis involved visual inspection, assessment of extractable volume, identity tests, and an assay of active pharmaceutical ingredient. The pharmaceutical quality of each sample was determined according to the criteria set in the International Pharmacopoeia 2019. None of the products had any particulate matter, but there were certain irregularities in their presentation. Eighteen of the 22 products (81.7%) were packaged in plain instead of ambercolored ampoules, and 77.3% (17/22) did not indicate the oil base used as the vehicle on the label as against the pharmacopoeial standard. Sixteen products (72.7%) passed the extractable volume test, although the remaining 22.3% did not conform to the extractable volume per unit dose. Artemether was present in all the samples, although only 40.9% (9/22) met the recommended percentage content of 90-110% of artemether. The study revealed the presence of a high percentage of substandard artemether injection products marketed in Nigeria. Further surveillance is warranted to confirm the quality of artemether injection circulated in other regions within Nigeria.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Post-Marketing Surveillance of Quality of Artemether Injection Marketed in Southwest Nigeria

Hassan

Adegbola

Soyinka

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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“…The AU Model Law and AMRH initiative efforts are intended to support countries to rectify some of the regulatory challenges that they have been grappling with for many years [ 15 ]. The long term goal of the AMRH initiative is to establish the African Medicines Agency, which will have the mandate of overseeing the registration of specific medical products and coordinating regional harmonisation systems in Africa [ 14 , 37 ]. Therefore, the AU Model Law’s development is interpreted within the context of these overarching efforts towards regulatory harmonisation in Africa [ 14 ].…”

Section: Country-level Adoption Of the Au Model Lawmentioning

confidence: 99%

Establishment of the African Medicines Agency: progress, challenges and regulatory readiness

Ncube¹,

Dube²,

Ward³

2021

J of Pharm Policy and Pract

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Insufficient access to quality, safe, efficacious and affordable medical products in Africa has posed a significant challenge to public health for decades. In part, this is attributed to weak or absent policies and regulatory systems, a lack of competent regulatory professionals in National Medicines Regulatory Authorities (NMRAs) and ineffective regional collaborations among NMRAs. In response to national regulatory challenges in Africa, a number of regional harmonisation efforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the AU Model Law on Medical Products Regulation. The goals of the model law include to increase collaboration across countries and to facilitate the overall regional harmonisation process. The AMRH initiative is proposed to serve as the foundation for the establishment of the African Medicines Agency (AMA). The AMA will, as one of its mandates, coordinate the regional harmonisation systems that are enabled by AU Model Law domestication and implementation. In this paper, we review the key entities involved in regional and continental harmonisation of medicines regulation, the milestones achieved in establishing the AMA as well as the implementation targets and anticipated challenges related to the AU Model Law domestication and the AMA’s establishment. This review shows that implementation targets for the AU Model Law have not been fully met, and the AMA treaty has not been ratified by the minimum required number of countries for its establishment. In spite of the challenges, the AU Model Law and the AMA hold promise to address gaps and inconsistencies in national regulatory legislation as well as to ensure effective medicines regulation by galvanising technical support, regulatory expertise and resources at a continental level. Furthermore, this review provides recommendations for future research.

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“… 103 However, there still exists a deficiency in data, visibility, distribution and illegitimate drug control gap that medicines serialisation technology can fill. 104 These data can be leveraged to ascertain the specific location where an illegitimate drug entered the supply chain, allowing for precision and rapid recall. In addition, it can provide data on the incidence of falsified medicines, which is currently lacking and necessary for quantifying the problem, especially in LMICs.…”

Section: Adaptation Of Interventions From Hics To Lmicsmentioning

confidence: 99%

Tackling the global impact of substandard and falsified and unregistered/unlicensed anti-tuberculosis medicines

Akpobolokemi

Martínez-Nuñez

Raimi-Abraham

2022

The Journal of Medicine Access

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Substandard and falsified (SF) medicines are a global health challenge with the World Health Organization (WHO) estimating that 1 in 10 of medicines in low- and middle-income countries (LMICs) are SF. Antimicrobials (i.e. antimalarials, antibiotics) are the most commonly reported SF medicines. SF medicines contribute significantly to the global burden of infectious diseases and antimicrobial resistance (AMR). This article discusses the challenges associated with the global impact of SF and unregistered/unlicensed antimicrobials with a focus on anti-TB medicines. Tuberculosis (TB) is the 13th leading cause of death worldwide, and is currently the second leading cause of death from a single infectious agent, ranking after COVID-19 and above HIV/AIDS. Specifically in the case of TB, poor quality of anti-TB medicines is among the drivers of the emergence of drug-resistant TB pathogens. In this article, we highlight and discuss challenges including the emergence of SF associated AMR, patient mistrust and lack of relevant data. We also present study reports to inform meaningful change. Recommended solutions involve the adaptation of interventions from high-income countries (HICs) to LMICS, the need for improvement in the uptake of medication authentication tools in LMICs, increased stewardship, and the need for global and regional multidisciplinary legal and policy cooperation, resulting in improved legal sanctions.

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Unintended Consequences and Hidden Obstacles in Medicine Access in Sub-Saharan Africa

Cited by 11 publications

References 24 publications

Post-Marketing Surveillance of Quality of Artemether Injection Marketed in Southwest Nigeria

Post-Marketing Surveillance of Quality of Artemether Injection Marketed in Southwest Nigeria

Establishment of the African Medicines Agency: progress, challenges and regulatory readiness

Tackling the global impact of substandard and falsified and unregistered/unlicensed anti-tuberculosis medicines

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