Pharmaceutical services for endemic situations in the Brazilian Amazon: organization of services and prescribing practices for Plasmodium vivax and Plasmodium falciparum non-complicated malaria in high-risk municipalities

<p>Abstract</p> <p>Background</p> <p>In spite of the fact that pharmaceutical services are an essential component of all malaria programmes, quality of these services has been little explored in the literature. This study presents the first results of the application of an evaluation model of pharmaceutical services in high-risk municipalities of the Amazon region, focusing on indicators regarding organization of services and prescribing according to national guidelines.</p> <p>Methods</p> <p>A theoretical framework of pharmaceutical services for non-complicated malaria was built based on the Rapid Evaluation Method (WHO). The framework included organization of services and prescribing, among other activities. The study was carried out in 15 primary health facilities in six high-risk municipalities of the Brazilian Amazon. Malaria individuals ≥ 15 years old were approached and data was collected using specific instruments. Data was checked by independent reviewers and fed to a data bank through double-entry. Descriptive variables were analyzed.</p> <p>Results</p> <p>A copy of the official treatment guideline was found in 80% of the facilities; 67% presented an environment for receiving and prescribing patients. Re-supply of stocks followed a different timeline; no facilities adhered to forecasting methods for stock management. No shortages or expired anti-malarials were observed, but overstock was a common finding. On 86.7% of facilities, the average of good storage practices was 48%. Time between diagnosis and treatment was zero days. Of 601 patients interviewed, 453 were diagnosed for <it>Plasmodium vivax</it>; of these, 99.3% received indications for the first-line scheme. Different therapeutic schemes were given to <it>Plasmodium falciparum </it>patients. Twenty-eight (4.6%) out of 601 were prescribed regimens not listed in the national guideline. Only 5.7% individuals received a prescription or a written instruction of any kind.</p> <p>Conclusions</p> <p>The results show that while diagnostic procedure is well established and functioning in the Brazilian malaria programme, prescribing is still an activity that is actually not performed. The absence of physicians and poor integration between malaria services and primary health services make for the lack of a prescription or written instruction for malaria patients throughout the Brazilian Amazon. This fact may lead to a great number of problems in rational use and in adherence to medication.</p

Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005–2010 period

<p>Abstract</p> <p>Background</p> <p>Ensuring the quality of malaria medicines is crucial in working toward malaria control and eventual elimination. Unlike other validated tests that can assess all critical quality attributes, which is the standard for determining the quality of medicines, basic tests are significantly less expensive, faster, and require less skilled labour; yet, these tests provide reproducible data and information on several critical quality attributes, such as identity, purity, content, and disintegration. Visual and physical inspection also provides valuable information about the manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detect counterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistance to Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism to assess the quality of malaria medicines available to patients in decentralized regions.</p> <p>Methods</p> <p>Trained personnel from the National Malaria Control Programmes (NMCPs), often in collaboration with country’s Official Medicine Control Laboratory (OMCL), developed country- specific protocols that encompassed sampling methods, sample analysis, and data reporting. Sampling sites were selected based on malaria burden, accessibility, and geographical location. Convenience sampling was performed and countries were recommended to store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, such as disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory.</p> <p>Results</p> <p>Results were originally presented at regional meetings in a non-standardized format that lacked relevant medicines information. However, since 2008 information has been submitted utilizing a template specifically developed by PQM for that purpose. From 2005 to 2010, the quality of 1,663 malaria medicines from seven AMI countries was evaluated, mostly collected from the public sector, 1,445/1,663 (86.9%). Results indicate that 193/1,663 (11.6%) were found not to meet quality specifications. Most failures were reported during visual and physical inspection, 142/1663 (8.5%), and most of these were due to expired medicines, 118/142 (83.1%). Samples failing TLC accounted for 27/1,663 (1.6%) and those failing disintegration accounted for 24/1,663 (1.4%). Medicines quality failures decreased significantly during the last two years.</p> <p>Conclusions</p> <p>Basic tests revealed that the quality of medicines in the public sector improved over the years, since the implementation of this type of quality monitoring programme in 2005. However, the lack of consistent confirmatory tests in the quality control (QC) laboratory, utilizing methods that can also evaluate additional quality attributes, could still mask quality issues. In the future, AMI countries should improve coordination with their health authorities and their QC lab consistently, to provide a more complete picture of malaria medicines quality and support the implementation of corrective actions. Facilities in the private and informal sectors also should be included when these sectors constitute an important source of medicines used by malaria patients.</p

<i>Toll-like</i> receptors 2, 4, and 9 expressions over the entire clinical and immunopathological spectrum of American cutaneous leishmaniasis due to <i>Leishmania</i> <i>(V.) braziliensis</i> and <i>Leishmania (L.) amazonensis</i>

<div><p><i>Leishmania (V</i>.<i>) braziliensis</i> and <i>Leishmania(L</i>.<i>) amazonensis</i> are the most pathogenic agents of American Cutaneous Leishmaniasis in Brazil, causing a wide spectrum of clinical and immunopathological manifestations, including: localized cutaneous leishmaniasis (LCL^DTH+/++), borderline disseminated cutaneous leishmaniasis (BDCL^DTH±), anergic diffuse cutaneous leishmaniasis (ADCL^DTH-), and mucosal leishmaniasis (ML^DTH++++). It has recently been demonstrated, however, that while <i>L</i>. (<i>V</i>.) <i>braziliensis</i> shows a clear potential to advance the infection from central LCL (a moderate T-cell hypersensitivity form) towards ML (the highest T-cell hypersensitivity pole), <i>L</i>. (<i>L</i>.) <i>amazonensis</i> drives the infection in the opposite direction to ADCL (the lowest T-cell hypersensitivity pole). This study evaluated by immunohistochemistry the expression of <i>Toll-like</i> receptors (<i>TLRs</i>) 2, 4, and 9 and their relationships with CD4 and CD8 T-cells, and TNF-α, IL-10, and TGF-β cytokines in that disease spectrum. Biopsies of skin and mucosal lesions from 43 patients were examined: 6 cases of ADCL, 5 of BDCL, and 11 of LCL caused by<i>L</i>. (<i>L</i>.) <i>amazonensis</i>; as well as 10 cases of LCL, 4 of BDCL, and 6 of ML caused by<i>L</i>. (<i>V</i>.) <i>braziliensis</i>. CD4⁺ T-cells demonstrated their highest expression in ML and, in contrast, their lowest in ADCL. CD8⁺ T-cells also showed their lowest expression in ADCL as compared to the other forms of the disease. TNF-α⁺showed increased expression from ADCL to ML, while IL-10⁺and TGF-β⁺ showed increased expression in the opposite direction, from ML to ADCL. With regards to <i>TLR</i>2, 4, and 9 expressions, strong interactions of <i>TLR</i>2 and 4 with clinical forms associated with <i>L</i>. (<i>V</i>.) <i>braziliensis</i> were observed, while <i>TLR</i>9, in contrast, showed a strong interaction with clinical forms linked to <i>L</i>. (<i>L</i>.) <i>amazonensis</i>. These findings strongly suggest the ability of <i>L</i>. (<i>V</i>.) <i>braziliensis</i> and <i>L</i>. (<i>L</i>.) <i>amazonensis</i> to interact with those <i>TLRs</i> to promote a dichotomous T-cell immune response in ACL.</p></div