Ed Vreeke – Page 7

Article on medicines quality in Tanzania

21 mars 2017 par Ed Vreeke

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.

Quality fact sheet

5 mars 2017 par Ed Vreeke

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

Please find enclosed an update of our informal “quality fact sheet”, in a “restyled” and(hopefully) a bit more user-friendly version.
As usual, do not hesitate to contact me if you wish to see the full version of any specific papers (new ones are in red).

Visite de Mgr Léon MUKANGA, Evêque Protestant ECC /42ème Communauté

22 février 201722 février 2017 par Ed Vreeke

Mgr Léon MUKANGA est PCA de la CAMESANK, il a rendu visite aux installations d’ASRAMES dans le cadre de comprendre le fonctionnement d’ASRAMES.

Un cas de médicaments falsifiés découverts en République démocratique du Congo

2 février 20172 février 2017 par Ed Vreeke

2017 Lancet GH An epidemic of dystonic reactions in central Africa

Message de BeCause Health (traduction Google):

Dans la correspondance jointe au Lancet Global Health, Peyraud et ses collègues rapportent un cas de médicaments falsifiés découverts en République démocratique du Congo (RDC), et déjà signalés par une alerte de l’OMS. L’enquête a été menée pour déterminer la cause d’un groupe de symptômes semblables à la méningite, qui n’étaient pas dus à une méningite bactérienne et qui ont finalement été classés comme «dystonie toxique». Les réactions dystoniques sont rarement mortelles, mais elles peuvent causer de la détresse, de la panique et de la stigmatisation, et elles peuvent même être liées à des «sorts / esprits mauvais».

Au cours de l’enquête, il a été noté que «dans cette région de la RDC, les patients reçoivent souvent du diazépam sans ordonnance pour traiter un large éventail de maladies pour lesquelles le diazépam ne devrait pas avoir été utilisé selon une prescription rationnelle». L’enquête a permis de conclure que «l’évidence suggère que cette importante flambée de réactions dystoniques, dans une région éloignée de l’Afrique centrale, était causée par la consommation de comprimés étiquetés comme diazépam mais qui contenait en fait de l’halopéridol non déclaré». Il s’agissait le plus souvent de médicaments falsifiés, faussement étiquetés comme s’ils étaient fabriqués par Centaur et AGOG. Ils ont été achetés chez un distributeur basé à Kampala. Lorsqu’ils ont été contactés par les chercheurs, AGOG Pharma Ltd (Vasai, Inde) a déclaré qu’elle ne fabriquait pas de diazépam mais qu’elle fournissait de l’halopéridol sous forme de cloques étiquetées «AGOHAL, Haloperidol tablette BP 10mg». Centaur Pharmaceuticals (Mumbai, Inde) a confirmé qu’il fabrique du diazépam mais pas de l’halopéridol.

Les auteurs rappellent à juste titre que «le besoin d’un appui national et international aux autorités de réglementation des médicaments dans les pays économiquement pauvres est important» et que «cette manifestation de toxicité grave par des médicaments falsifiés devrait être un appel d’urgence pour la communauté mondiale de la santé publique» S’assurer que tous les patients, en particulier ceux des communautés vulnérables, bénéficient d’une prescription rationnelle et de l’accès à des médicaments de bonne qualité ».

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

2 février 2017 par Ed Vreeke

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”.