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British Medical Journal: Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes?

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Source: QUAMED

Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes?

Dear BeCause Health friends, dear friends of the new QUAMED,

I am very happy to share this  open-access publication (also available at http://gh.bmj.com/content/2/2/e000172), which resulted from the first analysis of data derived from QUAMED operational activities. The analysis was carried out in the framework of Ariadna Nebot’s master thesis at ITM.

We evaluated the compliance of a sample of pharmaceutical distributors active in sub-Saharan Africa (either based in Europe or in sub-Saharan Africa) with the standards of the WHO guideline ‘Model Quality Assurance System (WHO MQAS) for procurement agencies’. This part of the study (the “quantitative” one) consisted of a retrospective secondary analysis of data collected by QUAMED auditors. In a second part of the study (the “qualitative survey”) we investigated factors favoring or hindering the adequate implementation of the MQAS; this was done by means of formal and informal interviews with key informants.

Overall, our findings  suggests that international distributors based in Europe perform, on average, better than those based in sub-Saharan Africa. However, some weaknesses are ubiquitous and concern the most critical processes, such as the initial selection of the products and the ongoing reassessment of their quality. According to  our “qualitative” findings,  this is due to several different factors: weak regulatory oversight, insufficient human/financial resources, weak negotiating power, limited judicial autonomy and/or lack of institutional commitment to quality. Even if based on a small, convenient sample of distributors, these  findings suggest that pharmaceutical distributors active in sub-Saharan Africa generally do not apply stringent criteria for selecting products and suppliers. Therefore, product quality is not consistently assured but depends on the requirements of purchasers.

While long-term solutions are awaited, we strongly suggest that collaboration and transparent exchange of information between regulators from the North and the South should be pursued; and that the WHO MQAS guideline should be used by all concerned stakeholders as an evaluation and training tool to upgrade the current standards of practice of pharmaceutical distributors active in sub-Saharan Africa.

Article on medicines quality in Tanzania

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Ref: Ref. Kaale E, Manyanga V, Chambuso M  et al. (2016) The Quality of Selected Essential Medicines Sold in Accredited Drug Dispensing Outlets and Pharmacies in Tanzania. PLoS ONE 11(11): e0165785.

2017 PlosOne Quality of Selected Essential Medicines in Tanzania
Dear BeCause Health friends, dear friends of the new QUAMED,

This study, recently published in Plos One, investigated the quality of a select group of medicines sold in accredited drug dispensing outlets and pharmacies in different regions of Tanzania. The researchers collected and analysed  242 samples of amoxicillin trihydrate, artemether-lumefantrine (ALu), co-trimoxazole, ergometrine maleate, paracetamol, and quinine. The study was designed as “a risk-based assessment to identify pharmaceutical quality issues with a higher risk profile analysis”, with focus on the identity and content of the medicines. Therefore, as it often happens in this kind of survey, dissolution and impurity testing were not conducted.

Overall the study revealed a high rate of 92.6% of samples that met the quality standards for identity and content in active ingredient. This may be seen as an indicator that the supply chain is well secured (even if we have to keep in mind that the quality assessment was not comprehensive).

The overall failure rate of 7.4%, was largely limited to ergometrine maleate, and likely due to poor distribution and storage rather than poor manufacturing practices (ergometrine maleate injections are sensitive to tropical temperatures and light, and the sampled outlets and pharmacies do not have refrigeration). The Authors conclude that policy makers need to reconsider putting emphasis on the need of refrigeration for ergometrine maleate, and that the regulatory authority could revise its post marketing surveillance strategy to use ergometrine maleate as a surrogate marker for the integrity of the cold chain.

A case of falsified medicines discovered in the Democratic Republic of Congo

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2017 Lancet GH An epidemic of dystonic reactions in central Africa

Message from BeCause Health:

In the attached correspondence to the Lancet Global Health, Peyraud and colleagues reports on a case of falsified medicines discovered in the Democratic Republic of Congo (DRC), and already reported through a WHO Alert. The investigation was conducted to ascertain the cause of a cluster of meningitis-like symptoms, which were not due to bacterial meningitis, and which were eventually classified as “toxic dystonia”. Dystonic reactions are rarely life-threatening, but they may cause distress, panic and stigma, and they may even be linked to “evil spells/spirits”.

During the investigation, it was noted that “in this area of DRC, patients frequently receive diazepam over the counter to treat a wide range of illnesses for which diazepam should not have been used according to rational prescribing”. The investigation came to the conclusion that “evidence suggests that this large outbreak of dystonic reactions, in a remote area of central Africa, was caused by the consumption of tablets labelled as diazepam but which in fact contained undeclared haloperidol”. These were most likely falsified medicines, falsely labelled as if they were manufactured by Centaur and AGOG. They were bought at a distributor based in Kampala. When contacted by the researchers, AGOG Pharma Ltd (Vasai, India) stated that it does not manufacture diazepam but that it supplies haloperidol in blisters labelled as “AGOHAL, Haloperidol tablet BP 10mg”. Centaur Pharmaceuticals (Mumbai, India)  confirmed that it manufactures diazepam but not haloperidol.

The authors correctly remind that “there is a great need for national and international support for medicines regulatory authorities in economically poor countries” and that “this outbreak of severe toxicity through falsified medicines should be a wake-up call for the global public health community to ensure that all patients, especially those in vulnerable communities, benefit from rational prescribing and access to good quality medicines”.

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