Fake pharmaceuticals: A review of current analytical approaches

Bottoni, Paola; Caroli, Sergio

doi:10.1016/j.microc.2019.104053

Cited by 24 publications

(14 citation statements)

References 45 publications

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“…The impacts of fake medicines include treatment failure, antimicrobial resistance, morbidity, and mortality increase [ 2 ]. It has been estimated that approximately 10% of medicines administered worldwide are of poor quality [ 3 – 5 ]. Even if all pharmacological classes are affected, vital drugs like antimalarials remain ones of the most falsified, particularly in developing countries [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Detection of Falsified Antimalarial Sulfadoxine-Pyrimethamine and Dihydroartemisinin-Piperaquine Drugs Using a Low-Cost Handheld Near-Infrared Spectrometer

Yabré

Sakira

Bandé

et al. 2022

Journal of Analytical Methods in Chemistry

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Falsified drugs are of serious concern to public health worldwide, particularly for developing countries where quality control of drugs is inefficient. In law enforcement against such fake medicines, there is a need to develop reliable, fast, and inexpensive screening methods. In this work, the ability of an innovative low-cost handheld near-infrared spectrometer to identify falsifications among two antimalarial fixed dose combination tablets, dihydroartemisinin/piperaquine and sulfadoxine/pyrimethamine, has been investigated. Analyzed samples were collected in Burkina Faso mainly in rural transborder areas that could be infiltrated by illicit drugs. A principal component analysis was applied on the acquired near-infrared spectra to identify trends, similarities, and differences between collected samples. This allowed to detect some samples of dihydroartemisinin/piperaquine and sulfadoxine/pyrimethamine which seemed to be falsified. These suspicious samples were semiquantitatively analyzed by thin-layer chromatography using Minalab® kits. Obtained results allowed to confirm the falsifications since the suspected samples did not contain any of the expected active pharmaceutical ingredients. The capacity of the low-cost near-infrared device to identify specifically a brand name of dihydroartemisinin/piperaquine or sulfadoxine/pyrimethamine has been also studied using soft independent modelling of class analogy (SIMCA) in the classical and data driven versions. The built models allowed a clear brand identification with 100% of both sensitivity and specificity in the studied cases. All these results demonstrate the potential of these low-cost near-infrared spectrometers to be used as first line screening tools, particularly in resource limited laboratories, for the detection of falsified antimalarial drugs.

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Section: Introductionmentioning

confidence: 99%

Detection of Falsified Antimalarial Sulfadoxine-Pyrimethamine and Dihydroartemisinin-Piperaquine Drugs Using a Low-Cost Handheld Near-Infrared Spectrometer

Yabré

Sakira

Bandé

et al. 2022

Journal of Analytical Methods in Chemistry

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“…Silva and Mattos [ 17 ] identified the critical success factors for an effective PSC and prioritized them using the analytic hierarchy process (AHP) to achieve effective drug traceability. Bottoni and Caroli [ 18 ] and Bolla et al [ 19 ] discussed the technologies used to check the chemical characteristics of drugs and detect counterfeits in the active pharmaceutical ingredients (APIs).…”

Section: Introductionmentioning

confidence: 99%

Critical Success Factors and Traceability Technologies for Establishing a Safe Pharmaceutical Supply Chain

Haji

Kerbache

Sheriff

et al. 2021

MPs

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Drug counterfeits have been an international issue for almost two decades, and the latest statistics show that fake medications will continue to penetrate legitimate pharmaceutical supply chains (PSCs). Therefore, identifying the issues faced by PSCs is essential to combat the counterfeit drug problem, which will require the implementation of technologies in various phases of the PSC to gain better visibility. In this regard, a literature review was conducted to fulfill the following objectives: (i) review the application of traceability technologies in various PSC phases to detect counterfeits; (ii) analyze the various barriers affecting the establishment of a safe PSC and the critical success factors used to overcome those barriers; and (iii) develop a conceptual framework and guidelines to demonstrate the influence of traceability technologies and success factors on overcoming the various barriers in different phases of the PSC. The major finding of this review was that traceability technologies and the critical success factors have a significant influence on overcoming the barriers to establishing a safe PSC.

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“…They could also be the result of repackaging of unapproved drugs to resemble approved ones or could be the result of theft and resale of approved drugs, (b) “substandard” (also called “out of specification”): they are products that have been authorized but fail to meet their quality standards and/or specifications. Could be the result of improper manufacture or storage or products that have expired (deteriorated authentic pharmaceuticals), and (c) “unregistered/unlicensed”: they are products that have not undergone evaluation and/or approval [2] , [3] , [4] .…”

Section: Introductionmentioning

confidence: 99%

“…Counterfeits are always inferior in terms of quality, safety and efficacy compared to original pharmaceuticals; they pose an unacceptable risk to public health and lead to loss of confidence in medicines, healthcare providers, and health systems [3] , [5] , [6] . In the past decades (before the outbreak of the COVID-19 pandemic) a constant trend of increased trafficking was reported [3] , [7] . The pandemic though has reshaped the demand for goods and services worldwide exposing even more the vulnerabilities of the global health care systems [8] .…”

Section: Introductionmentioning

confidence: 99%

Trends in counterfeit drugs and pharmaceuticals before and during COVID-19 pandemic

Ziavrou

Noguera

Boumba

2022

Forensic Science International

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Fake pharmaceuticals: A review of current analytical approaches

Cited by 24 publications

References 45 publications

Detection of Falsified Antimalarial Sulfadoxine-Pyrimethamine and Dihydroartemisinin-Piperaquine Drugs Using a Low-Cost Handheld Near-Infrared Spectrometer

Detection of Falsified Antimalarial Sulfadoxine-Pyrimethamine and Dihydroartemisinin-Piperaquine Drugs Using a Low-Cost Handheld Near-Infrared Spectrometer

Critical Success Factors and Traceability Technologies for Establishing a Safe Pharmaceutical Supply Chain

Trends in counterfeit drugs and pharmaceuticals before and during COVID-19 pandemic

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