Application of Basic Pharmacology and Dispensing Practice of Antibiotics in Accredited Drug-Dispensing Outlets in Tanzania.

Provision of pharmaceutical services in accredited drug-dispensing outlets (ADDOs) in Tanzania has not been reported. This study compared the antibiotics dispensing practice between ADDOs and part II shops, or duka la dawa baridi (DLDBs), in Tanzania. This was a cross-sectional study that was conducted in ADDOs and DLDBs. A simulated client method for data collection was used, and a total of 85 ADDOs, located in Mvomero, Kilombero, and Morogoro rural districts, were compared with 60 DLDBs located in Kibaha district. The research assistants posed as simulated clients and requested to buy antibiotics from ADDOs and DLDBs after presenting a case scenario or disease condition. Among the diseases presented were those requiring antibiotics and those usually managed only by oral rehydration salt or analgesics. The simulated clients wanted to know the antibiotics that were available at the shop. The posed questions set a convincing ground to the dispenser either to dispense the antibiotic directly, request a prescription, or refer the patient to a health facility. Proportions were used to summarize categorical variables between ADDOs and DLDBs, and the chi-square test was used to test for statistical difference between the two drug-outlet types in terms of antibiotic-dispensing practice. As many as 40% of trained ADDO dispensers no longer worked at the ADDO shops, so some of the shops employed untrained staff. A larger proportion of ADDOs than DLDBs dispensed antibiotics without prescriptions (P = 0.004). The overall results indicate that there was no difference between the two types of shops in terms of adhering to regulations for dispensing antibiotics. However, in some circumstances, eg, antibiotic sale without prescription and no referral made, for complicated cases, ADDOs performed worse than DLDBs. As many as 30% of DLDBs and 35% of ADDOs dispensed incomplete doses of antibiotics. In both ADDOs and DLDBs, fortified procaine penicillin powder was dispensed as topical application for injuries. There was no statistical difference between ADDOs and DLDBs in the violation of dispensing practice and both ADDOs and DLDBs expressed poor knowledge of the basic pharmacology of antibiotics

Comparison of Bioavailability Between the Most Available Generic Tablet Formulation Containing Artemether and Lumefantrine on the Tanzanian Market and the Innovator's Product.

Existence of anti-malarial generic drugs with low bioavailability marketed on sub-Saharan Africa has raised a concern on patients achieving therapeutic concentrations after intake of these products. This work compared bioavailability of one generic tablet formulation with innovator's product. Both were fixed dose combination tablet formulations containing artemether and lumefantrine.MethodologyThe study was conducted in Dar Es Salaam, Tanzania, in which a survey of the most abundant generic containing artemether-lumefantrine tablet formulation was carried out in retail pharmacies. The most widely available generic (Artefan(R), Ajanta Pharma Ltd, Maharashtra, India) was sampled for bioavailability comparison with Coartem(R) (Novartis Pharma, Basel, Switzerland) - the innovator's product. A randomized, two-treatment cross-over study was conducted in 18 healthy Tanzanian black male volunteers. Each volunteer received Artefan(R) (test) and Coartem(R) (as reference) formulation separated by 42 days of drug-free washout period. Serial blood samples were collected up to 168 hours after oral administration of a single dose of each treatment. Quantitation of lumefantrine plasma levels was done using HPLC with UV detection. Bioequivalence of the two products was assessed in accordance with the US Food and Drug Authority (FDA) guidelines. The most widely available generic in pharmacies was Artefan(R) from India. All eighteen enrolled volunteers completed the study and both test and reference tablet formulations were well tolerated. It was possible to quantify lumefantrine alone, therefore, the pharmacokinetic parameters reported herein are for lumefantrine. The geometric mean ratios for Cmax, AUC0-t and AUC0-[infinity] were 84% in all cases and within FDA recommended bioequivalence limits of 80% -- 125%, but the 90% confidence intervals were outside FDA recommended limits (CI 49--143%, 53 - 137%, 52 - 135% respectively). There were no statistical significant differences between the two formulations with regard to PK parameters (P > 0.05). Although the ratios of AUCs and Cmax were within the acceptable FDA range, bioequivalence between Artefan(R) and Coartem(R) tablet formulations was not demonstrated due to failure to comply with the FDA 90 % confidence interval criteria. Based on the observed total drug exposure (AUCs), Artefan(R) is likely to produce a similar therapeutic response as Coartem(R)

Knowledge and malaria treatment practices using artemisinin combination therapy (ACT) in Malawi: survey of health professionals

<p>Abstract</p> <p>Background</p> <p>Malaria still remains a life-threatening disease worldwide causing between 190 and 311 million cases of malaria in 2008. Due to increased resistance to sulphadoxine-pyrimethamine (SP), the Ministry of Health in Malawi, as in many sub-Saharan African countries, changed the malaria treatment policy to use artemisinin-based combination therapy (ACT). In order to optimize the correct use of this drug, and protect against the development of the parasite's resistance, it is important to assess the knowledge and practices of medical practitioners on the use of ACT and its impact on adherence to new treatment policy guidelines.</p> <p>Methods</p> <p>A cross-sectional survey was conducted to assess the knowledge and perceptions of Malawian medical doctors and pharmacists on the use of ACT and the drivers of treatment choice and clinical treatment decisions. Medical doctors and pharmacists who are involved in managing malaria patients in Malawi were recruited and a self-administered questionnaire was used to obtain information on socio-demographic characteristics of the study participants, knowledge on ACT, source of information on ACT and methods used to decide on the treatment of patients with malaria.</p> <p>Results</p> <p>Most of the participants (95.7%) know at least one form of ACT, 67.4% reported that different forms of ACT have different characteristics, 77.3% reported that there are special formulations for children. The most commonly mentioned ACT was artemether-lumefantrine (AL), by 94.6% of the participants and 75.0% of the participants indicated that they prefer to prescribe AL. 73.9% of participants had ever received information on ACT. However, only 31.5% had received training on management of malaria using ACT. There were 71.7% respondents who had heard of ACT causing side effects. Only 25.0% of the participants had received training on how to report SAEs.</p> <p>Conclusion</p> <p>It was found that most of the participants know about ACT and treatment guidelines for malaria. However, most of the participants have not received any training on how to use ACT and how to report adverse effects arising from the use of ACT. There is need for more training of health care professionals to ensure correct and effective use of ACT.</p

Quality of anti-malarial drugs provided by public and private healthcare providers in south-east Nigeria

BACKGROUND: There is little existing knowledge about actual quality of drugs provided by different providers in Nigeria and in many sub-Saharan African countries. Such information is important for improving malaria treatment that will help in the development and implementation of actions designed to improve the quality of treatment. The objective of the study was to determine the quality of drugs used for the treatment of malaria in a broad spectrum of public and private healthcare providers. METHODS: The study was undertaken in six towns (three urban and three rural) in Anambra state, south-east Nigeria. Anti-malarials (225 samples), which included artesunate, dihydroartemisinin, sulphadoxine-pyrimethamine (SP), quinine, and chloroquine, were either purchased or collected from randomly selected providers. The quality of these drugs was assessed by laboratory analysis of the dissolution profile using published pharmacopoeial monograms and measuring the amount of active ingredient using high performance liquid chromatography (HPLC). FINDINGS: It was found that 60 (37%) of the anti-malarials tested did not meet the United States Pharmacopoeia (USP) specifications for the amount of active ingredients, with the suspect drugs either lacking the active ingredients or containing suboptimal quantities of the active ingredients. Quinine (46%) and SP formulations (39%) were among drugs that did not satisfy the tolerance limits published in USP monograms. A total of 78% of the suspect drugs were from private facilities, mostly low-level providers, such as patent medicine dealers (vendors). CONCLUSION: This study found that there was a high prevalence of poor quality drugs. The findings provide areas for public intervention to improve the quality of malaria treatment services. There should be enforced checks and regulation of drug supply management as well as stiffer penalties for people stocking substandard and counterfeit drugs

Access to artesunate-amodiaquine, quinine and other anti-malarials: policy and markets in Burundi

BACKGROUND: Malaria is the leading cause of morbidity and mortality in post-conflict Burundi. To counter the increasing challenge of anti-malarial drug resistance and improve highly effective treatment Burundi adopted artesunate-amodiaquine (AS-AQ) as first-line treatment for uncomplicated Plasmodium falciparum malaria and oral quinine as second-line treatment in its national treatment policy in 2003. Uptake of this policy in the public, private and non-governmental (NGO) retail market sectors of Burundi is relatively unknown. This study was conducted to evaluate access to national policy recommended anti-malarials. METHODS: Adapting a standardized methodology developed by Health Action International/World Health Organization (HAI/WHO), a cross-sectional survey of 70 (24 public, 36 private, and 10 NGO) medicine outlets was conducted in three regions of Burundi, representing different levels of transmission of malaria. The availability on day of the survey, the median prices, and affordability (in terms of number of days' wages to purchase treatment) of AS-AQ, quinine and other anti-malarials were calculated. RESULTS: Anti-malarials were stocked in all outlets surveyed. AS-AQ was available in 87.5%, 33.3%, and 90% of public, private, and NGO retail outlets, respectively. Quinine was the most common anti-malarial found in all outlet types. Non-policy recommended anti-malarials were mainly found in the private outlets (38.9%) compared to public (4.2%) and NGO (0%) outlets. The median price of a course of AS-AQ was US$0.16 (200 Burundi Francs, FBu) for the public and NGO markets, and 3.5-fold higher in the private sector (US$0.56 or 700 FBu). Quinine tablets were similarly priced in the public (US$1.53 or 1,892.50 FBu), private and NGO sectors (both US$1.61 or 2,000 FBu). Non-policy anti-malarials were priced 50-fold higher than the price of AS-AQ in the public sector. A course of AS-AQ was affordable at 0.4 of a day's wage in the public and NGO sectors, whereas, it was equivalent to 1.5 days worth of wages in the private sector. CONCLUSIONS: AS-AQ was widely available and affordable in the public and NGO markets of hard-to-reach post-conflict communities in Burundi. However greater accessibility and affordability of policy recommended anti-malarials in the private market sector is needed to improve country-wide policy uptake

Assessing health worker performance in malaria case management of underfives at health facilities in a rural Tanzanian district.

OBJECTIVE: To study the quality of malaria case management of underfives at health facilities in a rural district, 2 years after the Tanzanian malaria treatment policy change in 2001. METHODS: Consultations of 117 sick underfives by 12 health workers at 8 health facilities in Mkuranga District, Tanzania were observed using checklists for history taking, counselling and prescription. Diagnoses and treatment were recorded. Exit interviews were performed with all mothers/guardians and blood samples taken from the underfives for the detection of malaria parasites and antimalarial drugs. Quality of care was measured using indicators adopted from the integrated management of childhood illnesses multi-country evaluation. RESULTS: Quality of care measured by indicator scores averaged 31% of what was considered optimal. The poorest results were for history taking. Nevertheless, 89% of febrile children were treated with antimalarials, in line with national guidelines for fever treatment. Of these, 61% had a parasitaemia > or =2000/microl. There was no difference in treatment given to those with parasitological malaria compared with those without parasites. Pre-treatment levels of chloroquine and sulphadoxine/pyrimethamine were low and detected in 2% and 13%, respectively. CONCLUSION: Although most febrile children were given antimalarial treatment, quality of care in terms of history taking and counselling was sub-optimal. Despite this, the study community had changed behaviour from self-treatment to seeking care at health facilities. This is encouraging for introduction of artemisinin-based combination therapies policies as one could focus resources into improving care at health facilities and still reach out with treatment to most febrile children