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Artemisinin-based combination therapy availability and use in the private sector of five AMFm phase 1 countries.

ABSTRACT: BACKGROUND: In 2009, the Global Fund to Fight AIDS, Tuberculosis and Malaria established the Affordable Medicines Facility-malaria (AMFm) in order to increase access to quality-assured artemisinin combination therapy (QAACT). AMFm Phase 1, which includes nine pilot programmes in eight countries, was launched in 2009. The objective of this study was to assess anti-malarial stock and purchase patterns at private outlets in five AMFm Phase 1 countries in regard to three of the core AMFm goals: increase the affordability of QAACT, increase the availability of QAACT, and crowd out artemisinin monotherapies and other substandard therapies. METHODS: The study was conducted between April and May 2012 and included interviews with personnel in 598 private pharmaceutical outlets in Ghana, Kenya, Nigeria, Tanzania, and Uganda. Questionnaires were administered at private retail outlets and the data were analyzed to assess within- and between-country differences in QAACT price, availability, and popularity. RESULTS: AMFm medications were less expensive than their non-AMFm counterparts, yet prices for both types were above country-specific suggested retail prices. Market penetration of AMFm QAACT in both urban and rural areas was high, although stock-outs of both AMFm and non-AMFm products were more common in rural compared with urban outlets in Ghana and Kenya (p = 0.0013). Government recommendation was the most significant factor influencing anti-malarial stock choices in urban (41.5%) and rural (31.9%) outlets. The three top-selling anti-malarials reported for both urban and rural areas in each country were, with the exception of rural Uganda and urban Nigeria, combination therapies. CONCLUSIONS: Results from this study indicate that the AMFm has not fully achieved its affordability and crowd-out objectives. Still, the final purchase price of AMFm QAACT was substantially lower than non-AMFm equivalents. Moreover, for both urban and rural areas, AMFm QAACT availability was found to be high, and the various forms of QAACT were the best-selling products among all anti-malarials. These findings suggest a continued need for initiatives like the AMFm that improve the affordability and accessibility of QAACT. Similar programmes may be especially effective if employed in combination with rapid diagnostic testing to ensure the appropriate use of these products.

SUBMITTER: Davis B

PROVIDER: S-EPMC3637826 | biostudies-other | 2013

REPOSITORIES: biostudies-other

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Artemisinin-based combination therapy availability and use in the private sector of five AMFm phase 1 countries.

Davis Ben B Ladner Joel J Sams Kelley K Tekinturhan Ebru E de Korte Donald D Saba Joseph J

Malaria journal 20130422

<h4>Background</h4>In 2009, the Global Fund to Fight AIDS, Tuberculosis and Malaria established the Affordable Medicines Facility-malaria (AMFm) in order to increase access to quality-assured artemisinin combination therapy (QAACT). AMFm Phase 1, which includes nine pilot programmes in eight countries, was launched in 2009. The objective of this study was to assess anti-malarial stock and purchase patterns at private outlets in five AMFm Phase 1 countries in regard to three of the core AMFm goal ...[more]

PMID: 23607504

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Project description:BackgroundArtemisinin-based combination therapy (ACT) is the first-line malaria treatment throughout most of the malaria-endemic world. Data on ACT availability, price and market share are needed to provide a firm evidence base from which to assess the current situation concerning quality-assured ACT supply. This paper presents supply side data from ACTwatch outlet surveys in Benin, the Democratic Republic of Congo (DRC), Madagascar, Nigeria, Uganda and Zambia.MethodsBetween March 2009 and June 2010, nationally representative surveys of outlets providing anti-malarials to consumers were conducted. A census of all outlets with the potential to provide anti-malarials was conducted in clusters sampled randomly.Results28,263 outlets were censused, 51,158 anti-malarials were audited, and 9,118 providers interviewed. The proportion of public health facilities with at least one first-line quality-assured ACT in stock ranged between 43% and 85%. Among private sector outlets stocking at least one anti-malarial, non-artemisinin therapies, such as chloroquine and sulphadoxine-pyrimethamine, were widely available (> 95% of outlets) as compared to first-line quality-assured ACT (< 25%). In the public/not-for-profit sector, first-line quality-assured ACT was available for free in all countries except Benin and the DRC (US$1.29 [Inter Quartile Range (IQR): $1.29-$1.29] and $0.52[IQR: $0.00-$1.29] per adult equivalent dose respectively). In the private sector, first-line quality-assured ACT was 5-24 times more expensive than non-artemisinin therapies. The exception was Madagascar where, due to national social marketing of subsidized ACT, the price of first-line quality-assured ACT ($0.14 [IQR: $0.10, $0.57]) was significantly lower than the most popular treatment (chloroquine, $0.36 [IQR: $0.36, $0.36]). Quality-assured ACT accounted for less than 25% of total anti-malarial volumes; private-sector quality-assured ACT volumes represented less than 6% of the total market share. Most anti-malarials were distributed through the private sector, but often comprised non-artemisinin therapies, and in the DRC and Nigeria, oral artemisinin monotherapies. Provider knowledge of the first-line treatment was significantly lower in the private sector than in the public/not-for-profit sector.ConclusionsThese standardized, nationally representative results demonstrate the typically low availability, low market share and high prices of ACT, in the private sector where most anti-malarials are accessed, with some exceptions. The results confirm that there is substantial room to improve availability and affordability of ACT treatment in the surveyed countries. The data will also be useful for monitoring the impact of interventions such as the Affordable Medicines Facility for malaria.

Project description:BackgroundThe private sector supplies anti-malarial treatment for large proportions of patients in sub-Saharan Africa. Following the large-scale piloting of the Affordable Medicines Facility-malaria (AMFm) from 2010 to 2011, a private sector co-payment mechanism (CPM) provided continuation of private sector subsidies for quality-assured artemisinin combination therapies (QAACT). This article analyses for the first time the extent to which improvements in private sector QAACT supply and distribution observed during the AMFm were maintained or intensified during continuation of the CPM through 2015 in Kenya, Madagascar, Nigeria, Tanzania and Uganda using repeat cross-sectional outlet survey data.ResultsQAACT market share in all five countries increased during the AMFm period (p < 0.001). According to the data from the last ACTwatch survey round, in all study countries except Madagascar, AMFm levels of private sector QAACT availability were maintained or improved. In 2014/15, private sector QAACT availability was greater than 70% in Nigeria (84.3%), Kenya (70.5%), Tanzania (83.0%) and Uganda (77.1%), but only 11.2% in Madagascar. QAACT market share was maintained or improved post-AMFm in Nigeria, Tanzania and Uganda, but statistically significant declines were observed in Kenya and Madagascar. In 2014/5, QAACT market share was highest in Kenya and Uganda (48.2 and 47.5%, respectively) followed by Tanzania (39.2%), Nigeria (35.0%), and Madagascar (7.0%). Four of the five countries experienced significant decreases in median QAACT price during the AMFm period. Private sector QAACT prices were maintained or further reduced in Tanzania, Nigeria and Uganda, but prices increased significantly in Kenya and Madagascar. SP prices were consistently lower than those of QAACT in the AMFm period, with the exception of Kenya and Tanzania in 2011, where they were equal. In 2014/5 QAACT remained two to three times more expensive than the most popular non-artemisinin therapy in all countries except Tanzania.ConclusionsResults suggest that a private sector co-payment mechanism for QAACT implemented at national scale for 5 years was associated with positive and sustained improvements in QAACT availability, price and market share in Nigeria, Tanzania and Uganda, with more mixed results in Kenya, and few improvements in Madagascar. The subsidy mechanism as implemented over time across countries was not sufficient on its own to achieve optimal QAACT uptake. Supporting interventions to address continued availability and distribution of non-artemisinin therapies, and to create demand for QAACT among providers and consumers need to be effectively implemented to realize the full potential of this subsidy mechanism. Furthermore, there is need for comprehensive market assessments to identify contemporary market barriers to high coverage with both confirmatory testing and appropriate treatment.

Project description:BackgroundArtemisinin-based combination therapy (ACT), used to treat uncomplicated malaria cases, is one of the main strategies of malaria control and elimination. One of the main objectives of the Benin National Malaria Control Program's (NMCP) strategic plan is to ensure that at least 80% of uncomplicated malaria is treated with ACT within 24 h. Therefore, it was of great interest to measure whether the country case management of fever amongst children under five, adhered to the NMCP's strategic plan and look into the barriers to the use of ACT.MethodsA cross-sectional survey based on a cluster and multi-stage sampling was conducted in two rural health districts in Benin. We recruited 768 and 594 children under five years were included in the northern and in the southern respectively. Data was collected on the general use of ACT and on the correct use of ACT that adheres to the NMCP's strategy, as well as the barriers that prevent the proper management of fever amongst children. To assess the certain predictors of ACT usage, logistic regression was used, while taking into account the cluster random effect.ResultsAmong febrile children aged 6 to 59 months, 20.7% in the south and 33.9% in north received ACT. The correct use of ACT, was very low, 5.8% and in southern and 8.6% northern areas. Caregivers who received information on ACT were 3.13 time more likely in the south and 2.98 time more likely in the north to give ACT to their feverish child, PPR = 3.13[1.72-4.15] and PPR = 2.98 [2.72-3.11] respectively. Chloroquine and quinine, other malaria treatments not recommended by NMCP, were still being used in both areas: 12.3 and 3.3% in the south and 11.4 and 3.0% in the north.ConclusionIn Benin, the use and the correct use of ACT for febrile children remains low. The study also showed that having received information about the use of ACT is positively associated with the use of ACT. This point highlights the fact that efforts may not have been sufficiently integrated with social communication, which should be based on the behavioural determinants of populations.

Project description:BackgroundArtemisinin-based combination therapies are recommended by the World Health Organisation (WHO) as first-line treatment for Plasmodium falciparum malaria, yet medication must be of good quality for efficacious treatment. A recent meta-analysis reported 35% (796/2,296) of antimalarial drug samples from 21 Sub-Saharan African countries, purchased from outlets predominantly using convenience sampling, failed chemical content analysis. We used three sampling strategies to purchase artemisinin-containing antimalarials (ACAs) in Enugu metropolis, Nigeria, and compared the resulting quality estimates.MethodsACAs were purchased using three sampling approaches--convenience, mystery clients and overt, within a defined area and sampling frame in Enugu metropolis. The active pharmaceutical ingredients were assessed using high-performance liquid chromatography and confirmed by mass spectrometry at three independent laboratories. Results were expressed as percentage of APIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified.ResultsContent analysis of 3024 samples purchased from 421 outlets using convenience (n=200), mystery (n=1,919) and overt (n=905) approaches, showed overall 90.8% ACAs to be of acceptable quality, 6.8% substandard, 1.3% degraded and 1.2% falsified. Convenience sampling yielded a significantly higher prevalence of poor quality ACAs, but was not evident by the mystery and overt sampling strategies both of which yielded results that were comparable between each other. Artesunate (n=135; 4 falsified) and dihydroartemisinin (n=14) monotherapy tablets, not recommended by WHO, were also identified.ConclusionRandomised sampling identified fewer falsified ACAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling frame and sampling approach if representative information on drug quality is to be obtained.

Project description:Community health education improves members health-seeking and utilization behaviours. To enhance the community knowledge and optimize the use of Artemisinin-based combination therapy (ACT), we carried out a community training in Kamuli District, Uganda. The Analysis, Design, Development, Implementation and Evaluation (ADDIE) model was adopted. A total of 3420 community members were trained, 384 sampled to participate in pre-post-test assessment, with 76 healthcare workers (HCW). Community members were sampled by simple random sampling while the HCW were purposively selected. Community trainings occurred for two days at each of 42 public health facilities and one day at 27 parishes. A paired sample t-test and effect size was computed to establish effect with statistical significance tested at p < 0.05. Overall, a total of 3496 participants, majority 2705 (77.4%) females were trained. A total of 3420 community members, majority 2659 (77.7%) females trained, and 76 HCW, majority 46 (60.5%) females trained. The median age of community participants was 32 years, and interquartile range (IQR) = 17 years. The median age of HCW was 32 years, and IQR = 8 years. The training had a positive and significant effect on the community members knowledge: malaria transmission (T-test = 9.359; p < 0.0001) causes of malaria (T-test = 6.738; p < 0.0001), malaria symptoms (T-test = 5.403; p < 0.0001), dangerous malaria species (T-test = 12.088; p < 0.0001), Plasmodium vivax malaria cycle and occurrence every 48 h (T-test = 7.470; p < 0.0001), assessing whether a patient with malaria may suffer from jaundice (T-test = 7.228; p < 0.0001), organs affected by Plasmodium falciparum (T-test = 12.214; p < 0.0001), malaria diagnosis (T-test = 9.765; p < 0.0001), Plasmodium associated with malaria relapse (T-test = 10.250; p < 0.0001), and malaria prevention and control (T-test = 9.278; p < 0.0001). The intervention also had a significant and positive effect on HCW knowledge on all domains except on malaria transmission (T-test = 1.217; p = 0.228) where it didn't have any statistically significant increase on their knowledge. The education intervention improved the knowledge of participants significantly. There is need to adopt and scale-up the current intervention at all levels of care to enhance proper use of medicines.

Project description:The World Health Organization guidelines have recommended that all cases of suspected malaria should receive a confirmatory test with microscopy or a malaria rapid diagnostic test (RDT), however evidence from sub-Saharan Africa (SSA) illustrates that only one-third of children under five with a recent fever received a test. The aim of this study was to evaluate availability, price and market share of microscopy and RDT from 2009/11 to 2014/15 in 8 SSA countries, to better understand barriers to improving access to malaria confirmatory testing in the public and private health sectors.Repeated national cross-sectional quantitative surveys were conducted among a sample of outlets stocking anti-malarial medicines and/or diagnostics. In total, 169,655 outlets were screened. Availability of malaria blood testing among all screened public health facilities increased significantly between the first survey wave in 2009/11 and the most recent in 2014/15 in Benin (36.2, 85.4%, p < 0.001), Kenya (53.8, 93.0%, p < 0.001), mainland Tanzania (46.9, 89.9%, p < 0.001), Nigeria (28.5, 86.2%, p < 0.001), Katanga, the Democratic Republic of the Congo (DRC) (76.0, 88.2%, p < 0.05), and Uganda (38.9, 95.6%, p < 0.001). These findings were attributed to an increase in availability of RDTs. Diagnostic availability remained high in Kinshasa (the DRC) (87.6, 97.6%) and Zambia (87.9, 91.6%). Testing availability in public health facilities significantly decreased in Madagascar (88.1, 73.1%, p < 0.01). In the most recent survey round, the majority of malaria testing was performed in the public sector in Zambia (90.9%), Benin (90.3%), Madagascar (84.5%), Katanga (74.3%), mainland Tanzania (73.5%), Uganda (71.8%), Nigeria (68.4%), Kenya (53.2%) and Kinshasa (51.9%). In the anti-malarial stocking private sector, significant increases in availability of diagnostic tests among private for-profit facilities were observed between the first and final survey rounds in Kinshasa (82.1, 94.0%, p < 0.05), Nigeria (37.0, 66.0%, p < 0.05), Kenya (52.8, 74.3%, p < 0.001), mainland Tanzania (66.8, 93.5%, p < 0.01), Uganda (47.1, 70.1%, p < 0.001), and Madagascar (14.5, 45.0%, p < 0.01). Blood testing availability remained low over time among anti-malarial stocking private health facilities in Benin (33.1, 20.7%), and high over time in Zambia (94.4, 87.5%), with evidence of falls in availability in Katanga (72.7, 55.6%, p < 0.05). Availability among anti-malarial stocking pharmacies and drug stores-which are the most common source of anti-malarial medicines-was rare in all settings, and highest in Uganda in 2015 (21.5%). Median private sector price of RDT for a child was equal to the price of pre-packaged quality-assured artemisinin-based combination therapy (QAACT) treatment for a two-year old child in some countries, and 1.5-2.5 times higher in others. Median private sector QAACT price for an adult varied from having parity with an RDT for an adult to being up to 2 times more expensive. The exception was in both Kinshasa and Katanga, where the median price of QAACT was less expensive than RDTs.Significant strides have been made in the availability of testing, mainly through the widespread distribution of RDT, and especially in public health facilities. Significant barriers to universal coverage of diagnostic testing can be attributed to very low availability in the private sector, particularly among pharmacies and drug stores, which are responsible for most anti-malarial distribution. Where tests are available, price may serve as a barrier to uptake, particularly for young children. Several initiatives that have introduced RDT into the private sector can be modified and expanded as a means to close this gap in malaria testing availability and promote universal diagnosis.

Project description:BackgroundPrompt and effective malaria diagnosis and treatment is a cornerstone of malaria control. Case management guidelines recommend confirmatory testing of suspected malaria cases, then prescription of specific drugs for uncomplicated malaria and for severe malaria. This study aims to describe case management practices for children aged 1-59 months seeking treatment with current or recent fever from public and private, rural and urban health providers in Mali.MethodsData were collected at sites in Sikasso Region and Bamako. Health workers recorded key information from the consultation including malaria diagnostic testing and result, their final diagnosis, and all drugs prescribed. Children with signs of severe diseases were ineligible. Consultations were not independently observed. Appropriate case management was defined as both 1) tested for malaria using rapid diagnostic test or microscopy, and 2) receiving artemisinin combination therapy (ACT) and no other antimalarials if test-positive, or receiving no antimalarials if test-negative.ResultsOf 1602 participating children, 23.7% were appropriately managed, ranging from 5.3% at public rural facilities to 48.4% at community health worker sites. The most common reason for 'inappropriate' management was lack of malaria diagnostic testing (50.4% of children). Among children with confirmed malaria, 50.8% received a non-ACT antimalarial (commonly artesunate injection or artemether), either alone or in combination with ACT. Of 215 test-negative children, 44.2% received an antimalarial drug, most commonly ACT. Prescription of multiple drugs was common: 21.7% of all children received more than one type of antimalarial, while 51.9% received an antibiotic and antimalarial. Inappropriate case management increased in children with increasing axillary temperatures and those seeking care over weekends.ConclusionsMultiple limitations in management of febrile children under five were identified, including inconsistent use of confirmatory testing and apparent use of severe malaria drugs for uncomplicated malaria. While we cannot confirm the reasons for these shortcomings, there is a need to address the high use of non-ACT antimalarials in this context; to minimize potential for drug resistance, reduce unnecessary expense, and preserve life-saving treatment for severe malaria cases. These findings highlight the challenge of managing febrile illness in young children in a high transmission setting.

Project description:Private for-profit outlets are important treatment sources for malaria in most endemic countries. However, these outlets constitute only the last link in a chain of businesses that includes manufacturers, importers and wholesalers, all of which influence the availability, price and quality of antimalarials patients can access. We present evidence on the composition, characteristics and operation of these distribution chains and of the businesses that comprise them in six endemic countries (Benin, Cambodia, Democratic Republic of Congo, Nigeria, Uganda and Zambia).We conducted nationally representative surveys of antimalarial wholesalers during 2009-2010 using an innovative sampling approach that captured registered and unregistered distribution channels, complemented by in-depth interviews with a range of stakeholders. Antimalarial distribution chains were pyramidal in shape, with antimalarials passing through a maximum of 4-6 steps between manufacturer and retailer; however, most likely pass through 2-3 steps. Less efficacious non-artemisinin therapies (e.g. chloroquine) dominated weekly sales volumes among African wholesalers, while volumes for more efficacious artemisinin-based combination therapies (ACTs) were many times smaller. ACT sales predominated only in Cambodia. In all countries, consumer demand was the principal consideration when selecting products to stock. Selling prices and reputation were key considerations regarding supplier choice. Business practices varied across countries, with large differences in the proportions of wholesalers offering credit and delivery services to customers, and the types of distribution models adopted by businesses. Regulatory compliance also varied across countries, particularly with respect to licensing. The proportion of wholesalers possessing any up-to-date licence from national regulators was lowest in Benin and Nigeria, where vendors in traditional markets are important antimalarial supply sources.The structure and characteristics of antimalarial distribution chains vary across countries; therefore, understanding the wholesalers that comprise them should inform efforts aiming to improve access to quality treatment through the private sector.

Dataset Information

Artemisinin-based combination therapy availability and use in the private sector of five AMFm phase 1 countries.

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Artemisinin-based combination therapy availability and use in the private sector of five AMFm phase 1 countries.

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