Dataset Information

Quality of Artemisinin-Containing Antimalarials in Tanzania's Private Sector--Results from a Nationally Representative Outlet Survey.

ABSTRACT: Ensuring that artemisinin-containing antimalarials (ACAs) are of good quality is a key component of effective malaria treatment. There are concerns that a high proportion of ACAs are falsified or substandard, though estimates are rarely based on representative data. During a nationally representative survey in Tanzania, ACAs were purchased from private retail drug outlets, and the active pharmaceutical ingredient (API) was measured. All 1,737 ACAs contained the labeled artemisinin derivative, with 4.1% being outside the 85-115% artemisinin API range defined as acceptable quality. World Health Organization (WHO) prequalified drugs had 0.1 times the odds of being poor quality compared with non-prequalified ACAs for the artemisinin component. When partner components of combination therapies were also considered, 12.1% were outside the acceptable API range, and WHO prequalified ACAs had 0.04 times the odds of being poor quality. Although the prevalence of poor quality ACAs was lower than reported elsewhere, the minority of samples found to be substandard is a cause for concern. Improvements in quality could be achieved by increasing the predominance of WHO prequalified products in the market. Continued monitoring of quality standards is essential.

SUBMITTER: Act Consortium Drug Quality Project Team And The Impact Study Team

PROVIDER: S-EPMC4455080 | biostudies-other | 2015 Jun

REPOSITORIES: biostudies-other

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Quality of Artemisinin-Containing Antimalarials in Tanzania's Private Sector--Results from a Nationally Representative Outlet Survey.

Act Consortium Drug Quality Project Team And The Impact Study Team

The American journal of tropical medicine and hygiene 20150420 6 Suppl

Ensuring that artemisinin-containing antimalarials (ACAs) are of good quality is a key component of effective malaria treatment. There are concerns that a high proportion of ACAs are falsified or substandard, though estimates are rarely based on representative data. During a nationally representative survey in Tanzania, ACAs were purchased from private retail drug outlets, and the active pharmaceutical ingredient (API) was measured. All 1,737 ACAs contained the labeled artemisinin derivative, wi ...[more]

PMID: 25897065

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Project description:Since 2004, Kenya's national malaria treatment guidelines have stipulated artemisinin-based combination therapy (ACT) as first-line treatment for uncomplicated malaria, and since 2014, confirmatory diagnosis of malaria in all cases before treatment has been recommended. A number of strategies to support national guidelines have been implemented in the public and private sectors in recent years. A nationally-representative malaria outlet survey, implemented across four epidemiological zones, was conducted between June and August 2016 to provide practical evidence to inform strategies and policies in Kenya towards achieving national malaria control goals.A total of 17,852 outlets were screened and 2271 outlets were eligible and interviewed. 78.3% of all screened public health facilities stocked both malaria diagnostic testing and quality-assured ACT (QAACT). Sulfadoxine-pyrimethamine (SP) for intermittent preventive treatment in pregnancy was available in 70% of public health facilities in endemic areas where it is recommended for treatment. SP was rarely found in the public sector outside of the endemic areas (< 0.5%). The anti-malaria stocking private sector had lower levels of QAACT (46.7%) and malaria blood testing (20.8%) availability but accounted for majority of anti-malarial distribution (70.6% of the national market share). More than 40% of anti-malarials were distributed by unregistered pharmacies (37.3%) and general retailers (7.1%). QAACT accounted for 58.2% of the total anti-malarial market share, while market share for non-QAACT was 15.8% and for SP, 24.8%. In endemic areas, 74.9% of anti-malarials distributed were QAACT. Elsewhere, QAACT market share was 49.4% in the endemic-prone areas, 33.2% in seasonal-transmission areas and 37.9% in low-risk areas.Although public sector availability of QAACT and malaria diagnosis is relatively high, there is a gap in availability of both testing and treatment that must be addressed. The private sector in Kenya, where the majority of anti-malarials are distributed, is also critical for achieving universal coverage with appropriate malaria case management. There is need for a renewed commitment and effective strategies to ensure access to affordable QAACT and confirmatory testing in the private sector, and should consider how to address malaria case management among informal providers responsible for a substantial proportion of the anti-malarial market share.

Project description:BackgroundThe containment of artemisinin resistance in Myanmar, historically an important probable origin and route of anti-malarial resistance to the India sub-continent and beyond, is crucial to global malaria control and elimination. This paper describes what is currently known about the sale and distribution of oral artemisinin monotherapy (AMT) across Myanmar, where this medicine is commonly found.MethodsA nationally representative 2015 outlet survey was conducted in the private sector, and among community health workers across four geographical domains. A national sample of outlets was screened for availability of malaria testing and treatment, and an audit was completed for all anti-malarials.ResultsA total of 3859 outlets across Myanmar had an anti-malarial in stock on the day of survey. Of the 3859 anti-malarial stocking outlets, 988 outlets stocked oral AMT. Availability of oral AMT was highest among outlets in the Western border (36.8%) versus other domains (Eastern, 15.0%; Central, 19.3% Coastal, 10.7%). Over 90% of the oral AMT service delivery points were private sector outlets: general retailers (49.4%), pharmacies (23.5%), and itinerant drug vendors (14.2%). Eleven unique oral AMT products were audited. The most common product audited was Artesunate®, manufactured by Mediplantex in Vietnam, which accounted for 79.9% of the oral AMT market share. Other oral AMT products were manufactured in China and in Myanmar. Over 60% of oral AMT products had a shelf life at purchase of greater than 2 years and only 14.7% were expired. The median number of oral AMT tablets typically dispensed to treat malaria was two tablets, approximately one tenth of a full adult course. The median price of a 50 mg tablet was $0.16.ConclusionsGiven the high availability and distribution of oral AMT, it is possible that Myanmar has become the last remaining viable market for any oral AMT in the region for manufacturers. National and international organizations need to act quickly and effectively to stop the production and distribution to both improve malaria control within Myanmar and reduce risk of artemisinin resistance spreading to India and Africa.

Project description:BackgroundMalaria is endemic throughout Malawi, but little is known about quality of malaria case management at publicly-funded health facilities, which are the major source of care for febrile patients.MethodsIn April-May 2011, we conducted a nationwide, geographically-stratified health facility survey to assess the quality of outpatient malaria diagnosis and treatment. We enrolled patients presenting for care and conducted exit interviews and re-examinations, including reference blood smears. Moreover, we assessed health worker readiness (e.g., training, supervision) and health facility capacity (e.g. availability of diagnostics and antimalarials) to provide malaria case management. All analyses accounted for clustering and unequal selection probabilities. We also used survey weights to produce estimates of national caseloads.ResultsAt the 107 facilities surveyed, most of the 136 health workers interviewed (83%) had received training on malaria case management. However, only 24% of facilities had functional microscopy, 15% lacked a thermometer, and 19% did not have the first-line artemisinin-based combination therapy (ACT), artemether-lumefantrine, in stock. Of 2,019 participating patients, 34% had clinical malaria (measured fever or self-reported history of fever plus a positive reference blood smear). Only 67% (95% confidence interval (CI): 59%, 76%) of patients with malaria were correctly prescribed an ACT, primarily due to missed malaria diagnosis. Among patients without clinical malaria, 31% (95% CI: 24%, 39%) were prescribed an ACT. By our estimates, 1.5 million of the 4.4 million malaria patients seen in public facilities annually did not receive correct treatment, and 2.7 million patients without clinical malaria were inappropriately given an ACT.ConclusionsMalawi has a high burden of uncomplicated malaria but nearly one-third of all patients receive incorrect malaria treatment, including under- and over-treatment. To improve malaria case management, facilities must at minimum have basic case management tools, and health worker performance in diagnosing malaria must be improved.

Project description:IntroductionAvoidable blindness is a significant public health problem in India. Nationally representative RAAB surveys (Rapid Assessment of Avoidable Blindness) are being conducted periodically in the country to know the current status of blindness in the country. The current study describes the findings from the RAAB survey conducted during 2015-19 in India.MethodologyA cross-sectional, population-based survey was conducted across the entire country among persons aged 50 years and above using RAAB version 6 methodology. Presenting and pinhole visual acuity was recorded followed by lens examination using a torchlight. In order to estimate the prevalence of blindness and visual impairment in overall population in India, district weights were assigned to each of the 31 surveyed districts and the prevalence was standardized using the RAAB software.ResultsThe overall weighted, age-gender standardized, prevalence of blindness (presenting visual acuity <3/60 in better eye) in population aged ≥50 years was 1.99% (95% CI 1.94%, 2.13%) and of visual impairment (VI) (presenting visual acuity <6/12 in better eye) was 26.68% (95% CI 26.57-27.17%). On multivariate analysis, adjusted odds ratio showed that blindness was associated with age ≥ 80 years (OR = 20.3, 95% CI: 15.6-26.4) and being illiterate (OR = 5.6, 95% CI: 3.6-8.9). Blindness was not found to be significantly associated with either gender or locality.ConclusionThe results of the survey demonstrate that currently more than one fourth of persons aged 50 years and above are visually impaired (PVA<6/12 in better eye) in India. The prevalence of blindness among them is 1.99%, and older age and illiteracy are significantly associated with blindness. Major causes of blindness included cataract (66.2%), corneal opacity (CO) (8.2%), cataract surgical complications (7.2%), posterior segment disorders (5.9%) and glaucoma (5.5%). The proportion of blindness and visual impairment that is due to avoidable causes include 92.9% and 97.4% respectively.

Project description:BackgroundWHO estimates that about 170,000 deaths by suicide occur in India every year, but few epidemiological studies of suicide have been done in the country. We aimed to quantify suicide mortality in India in 2010.MethodsThe Registrar General of India implemented a nationally representative mortality survey to determine the cause of deaths occurring between 2001 and 2003 in 1·1 million homes in 6671 small areas chosen randomly from all parts of India. As part of this survey, fieldworkers obtained information about cause of death and risk factors for suicide from close associates or relatives of the deceased individual. Two of 140 trained physicians were randomly allocated (stratified only by their ability to read the local language in which each survey was done) to independently and anonymously assign a cause to each death on the basis of electronic field reports. We then applied the age-specific and sex-specific proportion of suicide deaths in this survey to the 2010 UN estimates of absolute numbers of deaths in India to estimate the number of suicide deaths in India in 2010.FindingsAbout 3% of the surveyed deaths (2684 of 95,335) in individuals aged 15 years or older were due to suicide, corresponding to about 187,000 suicide deaths in India in 2010 at these ages (115,000 men and 72,000 women; age-standardised rates per 100,000 people aged 15 years or older of 26·3 for men and 17·5 for women). For suicide deaths at ages 15 years or older, 40% of suicide deaths in men (45,100 of 114,800) and 56% of suicide deaths in women (40,500 of 72,100) occurred at ages 15-29 years. A 15-year-old individual in India had a cumulative risk of about 1·3% of dying before the age of 80 years by suicide; men had a higher risk (1·7%) than did women (1·0%), with especially high risks in south India (3·5% in men and 1·8% in women). About half of suicide deaths were due to poisoning (mainly ingestions of pesticides).InterpretationSuicide death rates in India are among the highest in the world. A large proportion of adult suicide deaths occur between the ages of 15 years and 29 years, especially in women. Public health interventions such as restrictions in access to pesticides might prevent many suicide deaths in India.FundingUS National Institutes of Health.

Project description:The private for-profit sector is an important source of treatment for malaria. However, private patients face high prices for the recommended treatment for uncomplicated malaria, artemisinin combination therapies (ACTs), which makes them more likely to receive cheaper, less effective non-artemisinin therapies (nATs). This study seeks to better understand consumer antimalarial prices by documenting and exploring the pricing behaviour of retailers and wholesalers. Using data collected in 2009-10, we present survey estimates of antimalarial retail prices, and wholesale- and retail-level price mark-ups from six countries (Benin, Cambodia, the Democratic Republic of Congo, Nigeria, Uganda and Zambia), along with qualitative findings on factors affecting pricing decisions. Retail prices were lowest for nATs, followed by ACTs and artemisinin monotherapies (AMTs). Retailers applied the highest percentage mark-ups on nATs (range: 40% in Nigeria to 100% in Cambodia and Zambia), whereas mark-ups on ACTs (range: 22% in Nigeria to 71% in Zambia) and AMTs (range: 22% in Nigeria to 50% in Uganda) were similar in magnitude, but lower than those applied to nATs. Wholesale mark-ups were generally lower than those at retail level, and were similar across antimalarial categories in most countries. When setting prices wholesalers and retailers commonly considered supplier prices, prevailing market prices, product availability, product characteristics and the costs related to transporting goods, staff salaries and maintaining a property. Price discounts were regularly used to encourage sales and were sometimes used by wholesalers to reward long-term customers. Pricing constraints existed only in Benin where wholesaler and retailer mark-ups are regulated; however, unlicensed drug vendors based in open-air markets did not adhere to the pricing regime. These findings indicate that mark-ups on antimalarials are reasonable. Therefore, improving ACT affordability would be most readily achieved by interventions that reduce commodity prices for retailers, such as ACT subsidies, pooled purchasing mechanisms and cost-effective strategies to increase the distribution coverage area of wholesalers.

Dataset Information

Quality of Artemisinin-Containing Antimalarials in Tanzania's Private Sector--Results from a Nationally Representative Outlet Survey.

Publications

Quality of Artemisinin-Containing Antimalarials in Tanzania's Private Sector--Results from a Nationally Representative Outlet Survey.

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