Falsified and substandard cardiovascular drugs in Africa: a need for continued monitoring strategies

Antignac, Marie; Diop, Ibrahima; Terline, Diane Macquart de; Bernard, Mélisande; Do, Bernard; Ikama, Méo Stéphane; N’Guetta, Roland; Balde, Dadhi M; Tchabi, Y.; Aly, A. Sidi; Toure, Ibrahim Ali; Zabsonre, Patrick; Damorou, Jean Marie; Takombe, Jean Laurent; Chatenet, Louise Boyer; Narayanan, Kumar; Marijon, Éloi; Empana, Jean Philippe; Jouven, Xavier

doi:10.7189/jogh.09.020302

Cited by 5 publications

(4 citation statements)

References 10 publications

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“…Monitoring the quality of NTI medicines is thus vital and has been recently advocated. 32 We found no prevalence data on low-dose (less than 150 mg) acetylsalicylic acid, only limited evidence on clopidogrel’s quality, and no data on vital acute care medicines such as dopamine, streptokinase, heparin and glycoprotein IIb/IIIa inhibitors.…”

Section: Discussionmentioning

confidence: 78%

The quality of medical products for cardiovascular diseases: a gap in global cardiac care

Bellingham

Newton

et al. 2021

BMJ Glob Health

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ObjectiveGood quality cardiovascular medicines and devices are crucial in the prevention and management of the ever-growing threats of cardiovascular diseases (CVDs) globally. Yet our current understanding of the extent and impact of substandard and falsified (SF) cardiovascular medical products is poor. Our objective was to review the available literature on SF cardiovascular medicines/devices, with a focus on prevalence studies to discuss their impacts on public health.MethodsSearches were conducted in Embase, PubMed, Web of Science, Google Scholar, Google and websites with interest in medicines/devices quality up to 31 August 2020. Articles in English and French identified in these searches were screened for eligibility. The Medicine Quality Assessment Reporting Guidelines was used to assess the quality of prevalence surveys, and we report according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.ResultsA total of 279 articles were included, which were subcategorised into prevalence surveys (n=28), equivalence studies (n=118), stability studies (n=5), routine quality control analyses (n=15), bioavailability studies (n=2), recalls/seizures/case reports (n=77), general discussions (n=24) and reviews (n=10). A failure frequency (defined as the proportion of samples that failed at least one quality test described in the report) of 525 (15.4%) was observed for the 3414 samples tested for quality in the 27 prevalence surveys with sufficient information for inclusion in our quantitative analysis. Nineteen surveys (70.4%) used convenience outlet sampling. The majority (88.8%, 3032/3414) of samples included in prevalence surveys were collected from low-income and middle-income countries. The most common defects were out-of-specification active ingredient(s) content, impurity/contaminant content and impaired dissolution. We found 26 incidents describing SF cardiovascular devices with 181 related deaths but no prevalence surveys.ConclusionThe data suggest that SF cardiovascular products are likely to be a serious public health problem that has received limited attention. We do not suggest that 15.4% of cardiovascular medicines are SF, and our findings highlight the need for more research with robust methodology to provide more accurate prevalence estimates in order to inform policy and implement measures to ensure the quality of cardiovascular medicines and devices within the supply chain. Ensuring that CVD medical products are of good quality would help ensure effectiveness and that the benefits of therapy are realised in the prevention and treatment of CVDs.

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Section: Discussionmentioning

confidence: 78%

The quality of medical products for cardiovascular diseases: a gap in global cardiac care

Bellingham

Newton

et al. 2021

BMJ Glob Health

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“…The presence of substandard and falsified medicines is a challenge in many LMICs, especially Africa, and regulatory capacity is inadequate. A recent study in Africa reported 16.3% poor quality cardiovascular medicines [ 28 ]. Amlodipine and captopril have been reported with a higher poor quality [ 28 ] Heart medicines are among the 5th most frequently reported (5%) substandard class of medicines in the WHO monitoring system [ 29 ].…”

Section: Resultsmentioning

confidence: 99%

Access to cardiovascular medicines in low- and middle-income countries: a mini review

Harrison

Marfo

Annan

et al. 2023

glob health res policy

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Background Many cardiovascular (CV) medicines are required for long term. However, with their limited resources, low- and middle-income countries (LMICs) may have challenges with access to cardiovascular medicines. The aim of this review was to provide a summary of available evidence on access to cardiovascular medicines in LMICs. Methods We searched PubMed and Google scholar for English language articles on access to cardiovascular medicines for the period 2010–2022. We also searched for articles reporting measures for challenges in access to CV medicines from 2007 to 2022. Studies conducted in LMICs, and reporting availability and affordability were included for review. We also reviewed studies reporting affordability or availability using the World Health Organisation/Health Action International (WHO/HAI) method. Levels of affordability and availability were compared. Results Eleven articles met the inclusion criteria for review on availability and affordability. Although availability appears to have improved, many countries did not meet the availability target of 80%. Between economies and within countries, there are equity gaps in access to CV medicines. Availability is lower in public health facilities than private facilities. Seven out of 11 studies reported availability less than 80%. Eight studies which investigated availability in the public sector reported less than 80% availability. Overall, CV medicines, especially combined treatments are not affordable in the majority of countries. Simultaneous achievement of availability and affordability target is low. In the studies reviewed, less than 1–53.5 days wages were required to purchase one month supply of CV medicines. Failure to meet affordability was 9–75%. Five studies showed that, on average 1.6 days’ wages of the Lowest-Paid Government Worker (LPGW) was required to purchase generic CV medicines in the public sector. Efficient forecasting and procurement, increased public financing and policies to improve generic use, among others are measures for improving availability and affordability. Conclusions Significant gaps exist in access to cardiovascular medicines in LMICs, and in many low—and lower middle—income countries access to cardiovascular medicines is low. To improve access and achieve the Global Action Plan on non-communicable diseases in these countries, policy interventions must be urgently instituted.

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“…Cardiovascular drugs are the next most counterfeited medicines with 11.6% penetration in legitimate supply chains [ 27 ]. As per the data presented in the SEVEN study conducted in 10 sub-Saharan countries, there was a high prevalence of inferior-quality cardiovascular drugs, with almost one in every six samples failing to meet the required standards [ 28 ].…”

Section: Categories Of Drugs Being Counterfeitedmentioning

confidence: 99%

Tackling Counterfeit Drugs: The Challenges and Possibilities

et al. 2023

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Drugs that have been manufactured or packaged fraudulently are referred to as counterfeit/fake/spurious/falsified drugs because they either lack active ingredients or have the incorrect dosages. Counterfeiting of drugs has become a global issue with which the whole world is grappling. The World Health Organization states the frightening figure in which almost 10.5% of the medications worldwide are either subpar or fake. Although developing and low-income countries are the targets of the large-scale drug counterfeiting activities, fake/substandard drugs are also making their way into developed nations including the USA, Canada, and European countries. Counterfeiting of drugs is leading to not only economic loss but is also playing its part in the morbidity and mortality of patients. The recent COVID-19 pandemic fuelled the demand for certain categories of medicines such as antipyretics, remdesivir, corticosteroids, vaccines, etc., thus increasing the demand and manufacture of subpar/fake medicines. This review articulates the current trends and global impact of drug counterfeiting, current and potential measures for its prevention and the role of different stakeholders in tackling the menace of drug counterfeiting.

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Falsified and substandard cardiovascular drugs in Africa: a need for continued monitoring strategies

Cited by 5 publications

References 10 publications

The quality of medical products for cardiovascular diseases: a gap in global cardiac care

The quality of medical products for cardiovascular diseases: a gap in global cardiac care

Access to cardiovascular medicines in low- and middle-income countries: a mini review

Tackling Counterfeit Drugs: The Challenges and Possibilities

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