Understanding and fighting the medicine counterfeit market

Dégardin, Klara; Roggo, Yves; Margot, Pierre

doi:10.1016/j.jpba.2013.01.009

Cited by 168 publications

(133 citation statements)

References 64 publications

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“…The advent of internet-based businesses that cannot be inspected by pharmaceutical inspectors because of lack of physical storage facilities within the same location as the registered address of the business, the ease of reproducing original documents due to improved printing technology and the lack of quality assurance skills and systems in several developing countries, constitute some of the other factors that encourages the illegal international trade of medicines as well as the unfortunate existence of unscrupulous manufacturers and criminal syndicates [73][74][75][76][77]. …”

Section: Why International Trade Of Medicines Is Prone To Illicit Andmentioning

confidence: 99%

Risks Associated with International Trading of Medicines by Non-Licensed Entities and Non-Professionals

Malangu¹

2017

International Trade - On the Brink of Change

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The making, distribution and trading of medicines can be traced back as far as antiquity. When talking about trading, sale or dispensing of medicines, it is almost impossible to separate this topic with the profession of pharmacy or pharmacists. Although most countries introduced legislations that put the trading of medicines largely in the hand of licensed businesses and professionals mainly pharmacists, informal and international trading of medicines and related substances has continued to be practiced in almost all countries due to loopholes in legislations among other reasons. This chapter highlights the risks associated with the trading of medicines by unlicensed organisations and non-professionals. These risks include the production and sale of counterfeit medicines, encouraging abuse and misuse of medicines, anti-competitive behaviour and so on. The major indings are that concessions made to allow non-licensed businesses and nonprofessionals to trade in medicines have resulted in several consequences that are threatening the whole world. It is this realisation that has prompted the recommendation that courage from decision makers is required for them to take a stand and hand over back the trading of medicines irmly in the hands of licensed professionals while outlawing loopholes that sustained the trade of medicines by unlicensed entities and non-professionals.Keywords: informal, illegal, trade, medicines, non-licensed, non-professional IntroductionThe making, distribution and trading of medicines can be traced back as far as antiquity. The making, production or manufacturing of medicines, mixtures, admixtures and other dosages forms have been performed over the years by a wide categories of people including lay peo- ple, priests, herbalists, traditional healers, midwives, medical doctors, nurses and pharmacists. As elaborated below, the practice of the art of healing was based on Arab, Egyptian, Greek and Roman texts, particularly those of Hippocrates, Aristotle, Dioscorides, Galen and others. The making of medicines was the domain of monasteries and local healers as medical training was not formalised then. The formal training and development of preparation techniques of medicinal mixtures based on standardised processes of harvesting, drying and distillation led to the abandonment of the old-fashioned herbal preparations practices by lay people who fell out of favour with the professionalization of the healing/medical community. But the distribution, sale as well as the local and international trade of medicines have been performed, in addition, by licensed and non-licensed people and businesses. This paper aims to describe and report on the risks associated with the trading of medicines by non-licensed business entities and non-professionals. In doing so, the paper elaborates on the reasons why international trade is prone to being conducted by unlicensed businesses and non-professionals, as well as on the sources of medicines traded.In order to accomplish the above, the literature search, wit...

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Section: Why International Trade Of Medicines Is Prone To Illicit Andmentioning

confidence: 99%

Risks Associated with International Trading of Medicines by Non-Licensed Entities and Non-Professionals

Malangu¹

2017

International Trade - On the Brink of Change

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“…The development of rapid screening tools to assure that stockpiled medicines are authentic is important in light of recent reports of infiltration of counterfeits in the antibiotic and antiviral supply chain [2]. Unlike vaccines that require yearly updating to match the expected strain of seasonal influenza, antiviral drugs-particularly solid oral dosage forms-can be stockpiled by governments for use in the event of an outbreak years in advance.…”

Section: Introductionmentioning

confidence: 99%

Field-Deployable Raman Anti-Counterfeit Screening of Tamiflu Capsules

Loethen¹,

Rodriguez²

2015

AJAC

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In an effort to promote the availability of safe and effective drugs, the US Food and Drug Administration is developing spectroscopic methods to assess the quality of drugs in the field. Here we report a rapid screening classification method for Tamiflu (oseltamivir phosphate) capsules using a portable Raman spectrometer to perform screening on three solid oral dosage strengths of Tamiflu, 30 mg, 45 mg and 75 mg. Tamiflu is an antiviral drug that is stockpiled for use in the event of pandemic influenza outbreak. The qualitative classification methods reported were developed using the Raman spectra of intact capsules. The classification algorithms used were able to reliably distinguish the three dosage strengths of Tamiflu. These qualitative models are validated with additional Tamiflu samples from different batches and simulated counterfeits of Tamiflu. The probability that a test sample belongs to each dosage strength class is calculated, and strict class predictions are used to assign each sample to a particular class. The classification methods reported here enable development of user-independent, field-deployable methods for finished drug products and are able to correctly assign 92% of the validation samples using authentic Tamiflu and 100% of the simulated counterfeits.

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“…Counterfeiters are now also focusing on prescription medicines including 'lifesaving' medicines for cancer and heart disease [1][2][3]. For patients the use of counterfeit medicines can result in unexpected side effects, treatment failure or even death.…”

Section: Introductionmentioning

confidence: 99%

“…• USA: the lifestyle medications provide the major examples [2,3] and counterfeit anti-cancer drugs are also a concern [14] possibly due to the high cost of the genuine products.…”

Section: Introductionmentioning

confidence: 99%

Counterfeit Tablet Investigations: Can ATR FT/IR Provide Rapid Targeted Quantitative Analyses?

Lawson¹

2014

J Anal Bioanal Tech

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Counterfeit medicines are now a global public health problem. In developed countries up to 1% of medicines are reported to be counterfeit whilst in developing countries the level is ~30-40%. In this research the potential of Attenuated Total Reflection (ATR) FT/IR techniques to provide rapid quantitative analyses of suspect tablet formulations is reported. Unlike conventional tablet analyses where several tablets are crushed and solvent extracted, ATR FT/IR methods require that only a single tablet be crushed prior to analysis. This provides a considerable time saving over the solvent extraction protocols cited in the British Pharmacopoeia. Reference ATR FT/IR spectra of the active pharmaceutical ingredient (API) and excipients, from crushed tablets, were recorded for identification purposes. Quantitative data was obtained from ATR FT/IR spectra of calibrated mixtures of the API in the excipients. Tablet samples from various countries, India, Africa, China, Belgium and the UK were examined. Initial results showed the API could be identified down to ca 5% w/w of the tablet. Quantification was linear with selected characteristic peak areas for each API/excipient mixture. The analysis of the tablet samples generally showed good agreement with expectation. This was confirmed by conventional extractive analyses followed by UV quantification. ATR FT/IR can therefore identify counterfeit tablets rapidly without the need for solvents. Whilst LC-MS/MS and NMR techniques may be the 'gold standards' of the analytical world they are of much reduced value in sub-Saharan African countries whereas a portable ATR FT/IR may prevent the use of counterfeit antimalarial tablets and contribute to improvements in patient health.

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Understanding and fighting the medicine counterfeit market

Cited by 168 publications

References 64 publications

Risks Associated with International Trading of Medicines by Non-Licensed Entities and Non-Professionals

Risks Associated with International Trading of Medicines by Non-Licensed Entities and Non-Professionals

Field-Deployable Raman Anti-Counterfeit Screening of Tamiflu Capsules

Counterfeit Tablet Investigations: Can ATR FT/IR Provide Rapid Targeted Quantitative Analyses?

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