Quality

Be-cause Health literature updates

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Téléchargez l’article en PDF: 2018 PLOS Quality Of Medicines In Southern Togo

Be-cause Health literature updates

Reference: Scha¨fermann S, Wemakor E, Hauk C, Heide L (2018) Quality of medicines in southern Togo: Investigation of antibiotics and of medicines for non-communicable diseases from pharmacies and informal vendors. PLoS ONE 13(11):e0207911. https://doi.org/10.1371/journal.pone.0207911

Dear Friend,

In this open-access paper, our friends from Tubingen University present the findings of a study where  samples of 12 essential medicines (solid dosages only), including antibiotics, antidiabetics, cardiac  and antiasthmatic medicines, were collected by a mystery shopper from six informal vendors and six licensed pharmacies in the southern part of Togo.

92 medicine samples were analyzed by visual examination, followed by chemical analysis for the identity, content and for the dissolution of the active pharmaceutical ingredients, according to the respective monographs of the US Pharmacopoeia. Overall, 7 samples (8%) did not comply with the pharmacopoeial specifications, and one sample (1%) showed extreme deviations. Despite the study limitations (such as the small sample size and the lack of randiomization), this prevalence is consistent with recent review published by the WHO which estimated the prevalence of substandard and falsified medicines in low and middle income countries to be 10.5.

None of the samples was obviously falsified. However, one sample of amoxicillin capsules contained only 47% of the declared content of the active pharmaceutical ingredient, indicating that it may represent amoxicillin capsules 250 mg, rather than 500mg as declared on the label. In addition, testing of selected samples of amoxicillin for related substances showed the presence of degradation products, thus suggesting that inappropriate transport and storage conditions may have been an important cause for substandard quality. This should be confirmed by further research, given the very small sample size for this part of the study.

Notably, the authors note that all antibiotics could be purchased without prescription from licensed pharmacies and informal vendors with equal ease. The high availability of antibiotics from informal vendors is worrisome due to the potential of antimicrobial resistance arising from the inappropriate use of antibiotics.

Have a nice reading …and hopefully a nice winter holiday!,

Raffaella

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QUAMED: flyer with information on the new QUAMED

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QUAMED presentation

QUAMED became at the beginning of 2017 an independent not-for-profit entity. At the meeting of the Be-cause Health Medicines WG of 31/01/2017, Jean-Michel Caudron and Cécile Cortina have presented the main features  of the new QUAMED ASBL.

The new QUAMED leaflet (attached, both in English and French), which details the mandate, activities and functioning of the new QUAMED. This is of interest  both for individuals and organizations, either for accessing QUAMED services or for becoming associative members.

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.

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