Insights following change in drug policy: a descriptive study for antimalarial prescription practices in children of public sector health facilities in Jharkhand state of India.

BACKGROUND & OBJECTIVES: Widespread resistance to chloroquine was the mainstay to implement artemisinin-based combination therapy (ACT) in the year 2007 in few malaria endemic states in India including Jharkhand as the first line of treatment for uncomplicated Plasmodium falciparum malaria. This study was conducted in Jharkhand state of the country just after the implementation of ACT to assess the prevailing antimalarial drug prescribing practices, availability of antimalarial drugs and the acceptability of the new policy by the health professionals for the treatment of uncomplicated P. falciparum malaria patients particularly in children ≤ 15 yr of age. METHODS: This is a cross-sectional study in children aged ≤ 15 yr with malaria or to whom antimalarial drug was prescribed. Main outcome measure was prescription of recommended ACT in children aged ≤ 15 yr with malaria in the selected areas of Jharkhand. RESULTS: In the year 2008, artemisinin-based combination therapy (ACT) was implemented in 12 districts of the studied state; however, the availability of ACT was confirmed only in five districts. Antimalarial prescription was prevalent amongst the undiagnosed (8.4%), malaria negative (64.3%) and unknown blood test result (1.2%) suggesting the prevalence of irrational treatment practices. ACT prescription was very low with only 3.2% of confirmed falciparum malaria patients receiving it while others received either non-artesunate (NA) treatment (88.1%) including chloroquine (CQ) alone, CQ + Primaquine (PQ)/other drugs, sulphadoxine-pyrimethamine (SP) alone, SP + other drugs or artemisinin monotherapy (AM) treatment (6.3%). Still others were given non-antimalarial treatment (NM) in both malaria positive (0.3%) and malaria negative (2.1%) cases. INTERPRETATION & CONCLUSION: Despite the change in drug policy in the studied state the availability and implementation of ACT was a major concern. Nevertheless, the non-availability of blister packs for children aged ≤ 15 yr was the main hindrance in the implementation of the recommended antimalarial. Availability, training and participation of health professionals in decision-making are the key elements to improve adherence to new treatment guidelines. This study provided evidence for the requirement of age-specific blister packs in the country and the national programme has introduced age-specific blister packs in the country in 2010. This baseline information will be useful to monitor the progress in ACT implementation in the country.

Impact of community-based presumptive chloroquine treatment of fever cases on malaria morbidity and mortality in a tribal area in Orissa State, India.

BACKGROUND: In the Global Strategy for Malaria Control, one of the basic elements is early detection and prompt treatment of malaria cases, especially in areas where health care facilities are inadequate. Establishing or reviving the existing drug distribution centers (DDC) at the peripheral levels of health care can achieve this. The DDCs should be operationally feasible, acceptable by community and technical efficient, particularly in remote hard-core malaria endemic areas. METHODS: Volunteers from villages were selected for distribution of chloroquine and the selection was made either by villagers or head of the village. The services of the volunteers were absolutely free and voluntary in nature. Chloroquine was provided free of charge to all fever cases. The impact was evaluated based on the changes observed in fever days, fever incidence, parasite incidence and parasite prevalence (proportion of persons harbouring malaria parasite) in the community. Comparisons were made between 1st, 2nd and 3rd year of operation in the experimental villages and between the experimental and check areas. RESULTS: A total of 411 village volunteers in 378 villages in the experimental community health center with a population of 125,439 treated 88,575 fever cases with a mean annual incidence of 331.8 cases per 1,000 population during the three-year study period. The average morbid days due to fever (AFD) was reduced to 1.6 +/- 0.1 from 5.9 +/- 2.1 in the experimental villages while it remained at 5.0 +/- 1.0 in the check villages. There was a significant reduction, (p < 0.05) in Annual Fever Incidence (AFI) in the experimental hilltop and foothill villages in comparison to check villages. The change in Annual Parasite Incidence (API) was, however, not statistically significant (p > 0.05). In plain villages that were low endemic, the reductions in AFI and API in experimental villages were statistically significant (p < 0.05). There was significant reduction in the parasite prevalence in high endemic villages of the experimental area both during 2nd and 3rd year when compared with the check area (p < 0.05) but no such reduction was observed in low endemic areas (p > 0.0.5). Mortality due to malaria declined by 75% in the experimental villages in the adult age group whereas there was an increasing trend in check villages. CONCLUSION: The study demonstrated that a passive chloroquine distribution system operated by village volunteers in tribal areas is feasible and effective in reducing malaria-related morbidity and mortality.

Use of pre-packaged chloroquine for the home management of presumed malaria in Malagasy children.

OBJECTIVE: The main objective of this study was to assess the quality of home malaria management with pre-packaged chloroquine in two areas in the Moramanga district of Madagascar. The knowledge, attitude and practices of care providers in terms of home treatment options were evaluated and compared. The availability of treatment options by studying retailers and community-based service providers was also investigated. METHODS: A cross-sectional investigation in two communities, in the hamlets and villages located close to carers, retailers, community-based service providers and primary health centres was carried out. RESULTS: Carers in the two districts were equally well aware of the use of pre-packaged chloroquine. Their first response to the onset of fever was to treat children with this antimalarial drug at home. The dose administered and treatment compliance were entirely satisfactory (100%) with pre-packaged chloroquine and rarely satisfactory (1.6% to 4.5%) with non pre-packaged chloroquine. In cases of treatment failure, the carers took patients to health centres. Chloroquine was supplied principally by private pharmacies and travelling salesmen selling unpackaged chloroquine tablets. Non pre-packaged chloroquine was the most common drug used at health centres. The frequency of positive rapid malaria tests (P = 0.01) was significantly higher in children treated with non pre-packaged chloroquine (38%) than in children treated with pre-packaged chloroquine (1.3%). CONCLUSION: Home malaria management should be improved in Madagascar. Efforts should focus on communication, the training of community-based service providers, access to pre-packaged drugs and the gradual withdrawal of pre-packaged chloroquine and its replacement by pre-packaged artemisinin-based combination therapies.

Decreased availability of antimalarials in the private sector following the policy change from chloroquine to sulphadoxine-pyrimethamine in the Kilombero Valley, Tanzania.

BACKGROUND: Malaria control strategies emphasize the need for prompt and effective treatment of malaria episodes. To increase treatment efficacy, Tanzania changed its first-line treatment from chloroquine to sulphadoxine-pyrimethamine (SP) in 2001. The effect of this policy change on the availability of antimalarials was studied in rural south-eastern Tanzania. METHODS: In 2001 and 2004, the study area was searched for commercial outlets selling drugs and their stocks were recorded. Household information was obtained from the local Demographic Surveillance System. RESULTS: From 2001 to 2004, the number of general shops stocking drugs increased by 15% and the number of drug stores nearly doubled. However, the proportion of general shops stocking antimalarials dropped markedly, resulting in an almost 50% decrease of antimalarial selling outlets. This led to more households being located farther from a treatment source. In 2004, five out of 25 studied villages with a total population of 13,506 (18%) had neither a health facility, nor a shop as source of malaria treatment. CONCLUSION: While the change to SP resulted in a higher treatment efficacy, it also led to a decreased antimalarial availability in the study area. Although there was no apparent impact on overall antimalarial use, the decline in access may have disproportionately affected the poorest and most remote groups. In view of the imminent policy change to artemisinin-based combination therapy these issues need to be addressed urgently if the benefits of this new class of antimalarials are to be extended to the whole population.

The quality of antimalarials available in Yemen.

BACKGROUND: Malaria has always been a major public health problem in Yemen. Several studies in developing countries have demonstrated ineffective and poor quality drugs including antimalarials. Therefore, quality assessment of antimalarial drugs is of crucial importance. This study aimed to assess the quality of antimalarials (chloroquine and sulfadoxine/pyrimethamine) available in Yemen and to determine whether the quality of these products was related to the level of the distribution chain at which the samples were collected or related to the manufacturers. METHODS: Four samples from each antimalarial product were collected from each of the various levels of the distribution chain. One sample was kept with the research team. Two were tested at Sana'a and Aden Drug Quality Control Laboratories. The fourth was sent to the Centre for Quality Assurance of Medicines in Potchefstroom, South Africa, for analysis. Quality indicators measured were the content of the active ingredient and dissolution rate (for tablets only) in comparison to standard specifications for these products in the relevant pharmacopoeia. RESULTS: The results identified several problems of sub-standard products within the drug distribution chain. They included high and low failures in ingredient content for chloroquine tablets and chloroquine syrup. There was some dissolution failure for chloroquine tablets, and high sulfadoxine/pyrimethamine tablets dissolution failures. Failures with the dissolution of the pyrimethamine were found at most of the collection points. No clear relationship neither between the quality products and the level of the distribution chain, nor between locally manufactured and imported products was observed. CONCLUSION: There are sub-standard antimalarial products circulating within the drug distribution chains in the country, which will have serious implications on the reduced therapeutic effectiveness and on the development of drug resistance. This appears to be due to non-compliance with Good Manufacturing Practice guidelines by manufacturers in the production of the antimalarials.

Vivax malaria: a continuing health threat to the Republic of Korea.

Vivax malaria reemerged in the Republic of Korea in 1993. Most of the cases occurred among soldiers in the region adjacent to the Demilitarized Zone (DMZ) until 1995. To determine the rate of dispersion of vivax malaria, we evaluated its epidemiologic characteristics. Of 13,903 cases of vivax malaria reported in 2000, 40.1% (5,577) were reported among Republic of Korea military personnel, 26.2% (3,641) among veterans discharged less than two years from the military, and 33.7% (4,685) among civilians. Cases of vivax malaria have rapidly increased annually among counties bordering the DMZ, and have spread to approximately 40 km south of the DMZ. Chemoprophylaxis administered to military personnel may have been responsible for the decreasing number of cases among the Republic of Korea military population. The first mosquito-transmitted cases appeared in early June. Therefore, chemoprophylaxis should be instituted in early April to reduce the number of infected mosquitoes. Extensive intervention is warranted to reduce the spread of vivax malaria in the Republic of Korea.

Vendor-to-vendor education to improve malaria treatment by private drug outlets in Bungoma District, Kenya.

BACKGROUND: Private outlets are the main suppliers of uncomplicated malaria treatment in Africa. However, they are so numerous that they are difficult for governments to influence and regulate. This study's objective was to evaluate a low-cost outreach education (vendor-to-vendor) programme to improve the private sector's compliance with malaria guidelines in Bungoma district, Kenya. The cornerstone of the programme was the district's training of 73 wholesalers who were equipped with customized job aids for distribution to small retailers. METHODS: Six months after training the wholesalers, the programme was evaluated using mystery shoppers. The shoppers posed as caretakers of sick children needing medication at 252 drug outlets. Afterwards, supervisors assessed the outlets' knowledge, drug stocks, and prices. RESULTS: The intervention seems to have had a significant impact on stocking patterns, malaria knowledge and prescribing practices of shops/kiosks, but not consistently on other types of outlets. About 32% of shops receiving job aids prescribed to mystery shoppers the approved first-line drug, sulfadoxine-pyremethamine, as compared to only 3% of the control shops. In the first six months, it is estimated that 500 outlets were reached, at a cost of about $8000. CONCLUSIONS: Changing private sector knowledge and practices is widely acknowledged to be slow and difficult. The vendor-to-vendor programme seems a feasible district-level strategy for achieving significant improvements in knowledge and practices of shops/kiosks. However, alternate strategies will be needed to influence pharmacies and clinics. Overall, the impact will be only moderate unless national policies and programmes are also introduced.

A community-based programme to provide prompt and adequate treatment of presumptive malaria in children.

A community-based programme to ensure prompt and adequate treatment of presumptive episodes of clinical malaria in children has been established in a rural province of Burkina Faso. The implementation strategy was based on training a core group of mothers in every village and supplying community health workers with essential antimalarial drugs specially packed in age-specific bags containing a full course of treatment. Drugs were sold under a cost-recovery scheme. The programme was run in 1994 by the national malaria control centre (CNLP), and in 1995 it was developed to the provincial health team (PHT). Knowledge and awareness of malaria increased with the intervention. Drug consumption by age group was compatible with the distribution of disease, and no major problem of misuse emerged. The actual implementation costs of the intervention were US$ 0.06 per child living in the province. An evaluation of the impact of the intervention on the severity of malaria, using routine data from the health information system and taking as an indicator the proportion of malaria cases which were recorded as severe in health centres, was performed. In 1994, when the intervention was implemented on a provincial scale by CNLP, this proportion was lower than the average of the 4 preceding years (3.7% vs. 4.9%). In 1995, when the programme was implemented by the PHT, the proportion of severe cases was lower in health centres achieving a programme coverage of > or = 50% in their catchment area compared with the others (4.2% vs. 6.1%). Our experience shows that a low-cost, community-based intervention aimed at providing children with prompt and adequate treatment of presumptive episodes of clinical malaria is feasible, and suggests that it may lead to a reduction in the morbidity from severe malaria.

PIP: A low-cost, community-based pilot program established in a rural province (Sourou) in Burkina Faso in 1994 by the National Center for Malaria Control successfully provided children 0-5 years of age with prompt, adequate treatment of presumptive episodes of clinical malaria and was devolved to the provincial health team in 1995. In preparation for program implementation, a core group of mothers in every village was trained in diagnostic criteria and community health workers were supplied with essential antimalarial drugs packed in age-specific bags containing a full course of treatment. The drugs were sold under a cost-recovery scheme. During the first year of program implementation (1994), the proportion of malaria cases recorded as severe in health centers (3.7%) was lower than the average of the 4 preceding years (4.9%). In 1995, when the program was implemented locally, the proportion of severe cases was lower in health centers achieving a program coverage of 50% and above in their catchment area (4.2%) than in those with program coverage levels under 50% (6.1%). The proportion of mothers seeking help from anyone in the village (primarily a community health worker) for their child's malaria episode increased from 21% at baseline to 54% at the end of 1995, while use of chloroquine and paracetamol for treatment rose from 25% to 46%. Only brief periods of drug nonavailability occurred in 1994, generally during periods of heavy rainfall. In 1995, when the program was implemented at the provincial level, drugs were available on only 69% of total health center days. The cost of the project was US$0.06 per child living in the province. The sustainability and continued effectiveness of this program depend largely on the availability of drugs at the health center level.

Community chloroquine distribution for malaria control in Bushenyi district of Uganda.

OBJECTIVE: To document successful community chloroquine distribution for malaria control in Bushenyi district, southwestern Uganda. DESIGN: A cross sectional survey immediately after a four-month community chloroquine distribution exercise. One hundred sixty seven distributors in 140 out of 166 parishes in Bushenyi district did the chloroquine distribution during the 2001 malaria epidemic. PARTICIPANTS: A cluster random sample of 215 heads of households or their spouses were interviewed using a pre-tested questionnaire. MAIN OUTCOME MEASURES: Socio-demographic characteristics, malaria/fever morbidity, health seeking behaviour in the previous four months, knowledge about chloroquine distribution, opinions about the chloroquine distribution exercise and whether the household had used the service of the chloroquine distributors. RESULTS: Thirty per cent of the people surveyed had suffered from malaria in the previous four months. Seventy per cent of the households were aware of the chloroquine distribution and 56% of the patients who had malaria in the previous four months accessed the services of chloroquine distributors. People who were aware of chloroquine distributors were less likely to use services where a fee is levied. The total cost of chloroquine distribution was about 20,000 United States dollars. CONCLUSIONS: Community chloroquine distribution can increase access to treatment and can be done in a short time at an affordable cost.

Quality of oral and parenteral chloroquine in Kampala.

Malaria remains an important public health problem in Uganda. The mainstay of treatment is still chloroquine. However, recently there have been several reports of poor response to chloroquine treatment. We do not know whether the reported poor response is due to true resistance or poor quality of the drug in the market. This study was done to assess the quality of chloroquine dosage forms in Kampala. The study was cross-sectional; end-point designed to assess the amount of the active ingredient in the tablet and injection dosage forms of the drug. The quality assay was based on the BP, 1988 standard, using both visual and potentiometric analysis technique. The study demonstrated that there is a problem with the quality of chloroquine in the market. Upto 30% of the tablet samples and 33% of injection samples contained less than the stated amount of the active ingredient. This may be one of the reasons for the reported poor response of malaria to chloroquine treatment in Uganda. Given that routine laboratory testing of active ingredients in pharmaceuticals is not practised in Uganda, this study has demonstrated the necessity for establishment of a drug quality control laboratory in the country.

Determination of the percentage purity, active ingredients and other parameters in paracetamol and chloroquine syrups.

In this paper the percentage purity, active ingredients, specific gravity and the pH of paracetamol and chloroquine syrups were determined. For paracetamol the percentage purity ranged from 102.6-106.67, while the active ingredients (in mg/5 ml base) ranged from 123.2-128. The specific gravity ranged from 1.13-1.24 and the pH from 4.16-5.32. For the chloroquine the percentage purity ranged from 97-106.3, and the active ingredient 48.5-53.13, the specific gravity 1.17-1.27 and the pH 2.44-4.17. The results are discussed in relation to the purity, active ingredients and sources of the drugs. The drugs were coded. The paracetamol had a code of 1p-5p while the chloroquine was coded from 1c-5c.

[Sale of chloroquine in the street in Niamey (Niger)]. / Les ventes de chloroquine dans la rue à Niamey (Niger).

Self-treatment of malaria with chloroquine is extremely common in West Africa for the febrile attacks self-diagnosed as a presumed malaria case. A survey was conducted for one year in Niamey to assess the importance of the self-treatment practice. Transmission of malaria is permanent along the river banks and seasonal in some suburbs. Chloroquine is made available by local ambulatory sellers. A sample of 199 persons purchase on average four tablets each which is less than the curative dose recommended by WHO. Self-medication is an adequate practice for reaching the primary goal of malaria strategy in sub-Saharan Africa, i.e. to reduce morbidity and mortality through prompt therapy. Developing this practice is a top public health priority. Even if the dose is not appropriate, self-medication protects against serious attacks without preventing immunization and does not seem to induce greater risk of extension of chloroquine-resistance.