Quality July 2011

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Stay informed Twitter. RSS Feed. Related sites training. Using ASQA. The packaging of four counterfeits contained language errors with English and French combined 'Franglais' e. In comparison to the genuine samples, the text was less clearly printed and lacked a hologram. Genuine hologram in red circle. Both Ghanaian samples contained no detectable artemether or lumefantrine but did contain pyrimethamine 6. All tablets analysed were yellow, which in the case of genuine Coartem results from the presence of lumefantrine.

An insoluble in weak acid yellow pigment was detected in both counterfeit samples but no amodiaquine, another yellow anti-malarial, was detected by HPLC or MS. The yellow pigment was adsorbed on a nylon filter membrane and eluted with alkaline methanol and had maximum absorbance at nm but could not be identified by MS.

The genuine Coartem samples contained Dacrydium pierrei pollen, a tree growing in southernmost China and in the mountains of northern SE Asia. The counterfeiters confused 'm' with 'rn' in 'lagern' German for storing and printed the packets with the word 'lagem' in error. Interestingly, it was reported that 'the fake CoArtem contains three strips, each with eight tablets and sold at GH 6.

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Differences from genuine sample Figure 16 in red circles. These consisted of blisters of six tablets, labelled as made in , containing no artemether-lumefantrine, but containing pyrimethamine and sulphadiazine. This suggests that the criminals producing them differed from the counterfeiters operating in Ghana or that they changed their packaging in response to changes made by Novartis. This wide diversity of different counterfeit and substandard anti-malarials from eight sub-Saharan African countries are cause of great concern. However, this study has important limitations, especially since it involved ad hoc collection and estimates of the frequency of poor quality anti-malarials cannot be deduced from these data.

Tablet dissolution was not measured. The sampling method will bias towards finding counterfeit, rather than substandard, anti-malarials. It provides early warning, worrying for public health, as would a case series of new rapidly fatal epidemic influenza strains. However, that counterfeit formulations of ACT have been found at all is extremely alarming and will increase treatment failure, death and morbidity, yield covert unprotected monotherapy, increase the frequency of anti-malarial drug resistance and produce unexpected and clinically confusing adverse events.

There are no data available that allow accurate estimation of the prevalence of poor quality anti-malarials in Africa, but enough information is available to know that it is a serious problem. Public health bodies should not wait for large-scale evidence based on random surveys to decide on interventions, as these data will take years to acquire.

Unless action is taken quickly, poor ACT quality and profligate use of monotherapy whether genuine or poor quality will contribute to the failure of ACT.

Although, the correlation between artemisinin resistance and poor drug quality has not been proven, modeling strongly suggests that underdosing is an important factor in the spread of P. Poor quality anti-malarials, usually substandards, resulting in blood concentrations between those that kill resistant and sensitive parasites and those that kill only sensitive parasites will select for drug resistance. Counterfeits may also aid and abet this process by increasing the risk of hyperparasitaemia and recrudescence and the co-circulation of substandard and counterfeit medicines may be especially prone to engender drug resistance especially where patients 'shop' around when treatments fail.

The discovery of unexpected APIs in counterfeit anti-malarials have important public health implications [ 37 ]. Unexpected pyrimethamine, especially if taken repeatedly, could give rise to clinically-confusing adverse effects, such as bone marrow suppression, rash and insomnia [ 38 ]. Depending on the background level of P.

Pyrimethamine, in combination with sulphadoxine, is still used in sub-Saharan Africa, especially for Intermittent Preventive Treatment in pregnancy IPTp [ 4 ]. The presence of pyrimethamine as hidden monotherapy in counterfeits will engender the further spread of P.

Covert consumption of anti-malarials will also confuse our understanding of changes through time of the frequency of clinical failure and molecular markers of chloroquine and SP resistance [ 39 — 41 ]. The consequences could be severe especially as this drug is contraindicated in those with hypotension and myocardial ischaemia. In addition, patients may be exposed to dangerous drug interactions between covert consumption and other medicines patients may take, such as sildenafil with anti-HIV medication and chloroquine and pyrimethamine with anti-epileptics [ 38 ].

Pollen analyses of the counterfeit anti-malarials were consistent with an origin in eastern Asia, but do not prove this. In Guangzhou police arrested Nigerian and Chinese men for production of counterfeit halofantrine [ 42 ]. No evidence was found, from pollen analysis, of counterfeit pharmaceutical production in Africa. However, production facilities for counterfeit anti-malarial packaging have been seized in Nigeria [ 43 ]. Multiple parallel strategies are urgently needed to improve the quality of medicines people take and to ensure that they are available and taken at the recommended doses.

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The enormous investment in the development, evaluation and deployment of anti-malarials is wasted if the medicines that patients actually take are, due to criminality or carelessness, sub-therapeutic. Objective data on the epidemiology of poor quality anti-malarials are needed to allow quantification and mapping of the problem [ 40 ], the relative public health importance of counterfeit and substandard 'products', determine intervention prioritization and, through following changes through time, evaluate their effectiveness.

MRAs are keystones for crucial interventions to improve medicine quality and without them most interventions are doomed. There are only three countries with WHO pre-qualified Quality Control medicine analysis laboratories in the whole of malarious Africa [ 47 ]. Investment in African MRAs and quality-assured medicine quality laboratories would facilitate countries ability to regulate medicines.

There is a danger of poor quality medicines use in clinical trials, likely to bias results and therefore mandatory testing of such medicines should be carried out, preferably at one of the WHO-prequalified laboratories. Third, increasing the reach of affordable good quality ACT will reduce mortality [ 2 , 3 ] and undercut the counterfeiters, by reducing their profit margins. Stockouts of ACT may encourage poor quality anti-malarial distribution.

Fourth, artemisinin monotherapies are still very widely available in large quantities [ 37 , 48 ], despite appeals to restrict their use, and their removal where patients have access to ACT is a key intervention.


Fifth, much more attention needs to be paid to substandard medicines, with inspection and facilitation of good quality production. Sixth, increased cooperation between MRAs, police, customs, malaria control programmes, pharmaceutical companies and international organizations is vital in countering the trade in counterfeit medicines.

Seventh, new portable and rapid techniques, based on Raman and Near-Infrared spectroscopy, have been used in the screening of medicine quality and assisted in recent seizure of imported counterfeit ACT in Nigeria [ 21 ]. Although which technique is the most accurate and appropriate remains unclear, they could potentially empower drug inspectors in the screening of pharmacy stock for poor quality medicines. Eighth, we are woefully ignorant as to how best to tackle poor medicine quality in different situations and there has been a damaging lack of public health, civil society and political will to tackle the problem, which those combating the fake Chinchona bark and quinine scandals in the 17 th th centuries would have found puzzling [ 10 ].

Importantly, African heads of state and President Chirac issued the Cotonou Appeal for more action against counterfeit medicines in Africa [ 49 ]. With artemisinin resistance in Asia, authorities there have a duty to contain resistant parasites so that they do not spread to Africa. African countries may wish to lobby for more political will in Asia for containment and for financial and human capacity support of African MRAs.

In the IHR "disease" means an "illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans". Poor quality medicines and inappropriate monotherapies-being man-made public health hazards-fall within this definition and the IHR could be invoked to try to stop the spread of poor quality medicines. In addition, a treaty, drafted under the auspices of the WHO, to bring international agreement on interventions to reduce the frequency of both substandard and counterfeit medicines would allow coordinated action [ 51 ].

Action is needed immediately or the hopes of controlling malaria in Africa may, again, be dashed. The description of a wide diversity of different counterfeit and substandard anti-malarials from eight sub-Saharan African countries are cause of great concern.

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With the threatening spread of artemisinin resistance to Africa, much greater investment is required to ensure the quality of ACT and removal of artemisinin monotherapies. Support for MRAs is likely to be a key intervention. The International Health Regulations may need to be invoked to counter these poor quality medicines. White NJ: Qinghaosu artemisinin : the price of success.

World Health Organization: Country antimalarial drug policies: by region. Counterfeit medical products.

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Accessed 12 March PLoS Medicine. World Health Organization: What are substandard medicines?. Trop Med Int Health. Emerg Infect Dis. Antimicrobial Resistance in Developing Countries. Am J Trop Med Hyg. J Clin Phar Ther. Malar J. N Engl J Med.

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