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INTRODUCTION: The burden of both community and hospital acquired adverse drug reactions (ADRs) are some of the important issues in pharmacotherapy. At the time of this study there was very scanty literature in this area from Africa. OBJECTIVE: This study was done to determine the frequency and characteristics of ADRs in patients admitted on medical wards in public hospitals. METHODS: This was a longitudinal observational study on 728 adult patients on medical wards in one regional and one district hospitals. Community and hospital acquired ADRs were assessed. RESULTS: Thirty three patients (4.5%) were admitted with suspected ADR, and an ADR was the reason for hospitalization in 1.5%. Most ADRs were due to antiparasitic products, mainly quinine (61%). Community acquired ADRs prolonged hospital stay, 5.6 days vs 4.0 days (p-value < 0.001). During hospitalization ADRs occurred in 49.5% of the patients. Antiparasitic products, predominantly quinine, were the commonest drugs class associated with ADRs (85.9%). Hospital acquired ADRs did not affect hospital stay, 4.2 days vs 3.9 (p-value 0.129). CONCLUSION: ADRs are an important cause of morbidity in patients, both in the community and in hospitals, and the majority are associated with the commonly used drugs.

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INTRODUCTION: Provision of access to drug information by prescribers and other health care professionals is important in pharmacotherapy. At the time of this study there was very scanty literature in this area from Africa. OBJECTIVE: To assess use of a pilot drug information centre (DIC) which was set up in a department of Pharmacology and Therapeutics in a university teaching hospital in Uganda. METHODS: This was a situational analysis with a prospective study design. The pilot DIC was established and its use over an eleven-month period was assessed. The received queries were evaluated for source of the query, reason for the query and type of query. RESULTS: During the 11 months 297 queries were received, 72.3% of which were from public hospitals. Most were from prescribing doctors (54.2%). Majority were on drug-drug interaction (41.2%), followed by therapy (23.2%). Out of 197 specific drug requests, 65.5% were on antiretroviral. CONCLUSION: We found that healthcare professionals were enthusiastically using the drug information centre. It is, therefore, necessary and feasible to establish a DIC in Uganda that will enable these professionals to readily access drug information.

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A quantitative reverse-phase HPLC method with UV detection, for lumefantrine (LF) and desbutyllumefantrine (DLF) in whole blood spotted on filter paper was developed. The analytes were stabilized on filter paper by treatment of blood with phosphoric acid (1.6 mol/L). Halofantrine was used as internal standard and the analytes were extracted from filter paper using methanol. The methanolic extract was extracted with di-isopropylether after addition of acidic phosphate buffer (pH 2). Chromatographic separation was carried out on a Zorbax Eclipse XDB-phenyl column (4.6 mm x 150 mm, particle size 5 microm) at a flow rate of 1 mL/min using a mobile phase of acetonitrile-ammonium acetate buffer (0.1M ammonium acetate and 0.01 M acetic acid, pH 6.5) (10:90). The absorbance of the compounds was monitored at 335 nm. The average extraction recovery from filter paper ranged between 45-51% for LF and 25-33% for DLF for a concentration range between 300 and 3000 nM. Inter- and intra-assay coefficients of variation for LF and DLF were < or =9.2. Limits of quantification for LF and DLF were 300 nM. The method has been applied in malaria patients. In conclusion, a simple procedure for blood sampling and quantitative measurement of lumefantrine and desbutyllumefantrine suitable for field studies in resource-limited laboratories was developed.

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A reversed-phase high performance liquid chromatographic method was developed and validated for the quantitative determination of amodiaquine (AQ) and its metabolite desethylamodiaquine (DAQ) in whole blood collected on filter paper. The structure analogue 4-(4-dimethylamino-1-methylbutylamino)-7-chloroquinoline was used as internal standard. Upon collection, blood was added to 10% phosphoric acid in a 1:1 ratio and then spotted onto filter paper. The samples were alkalinized (pH approximately 9.2) with potassium hydroxide at the time of assay and the compounds were extracted together with internal standard into di-isopropyl ether and then re-extracted into an aqueous phase with 0.1M phosphate buffer at pH 4. The chromatographic analysis was performed using an Agilent Technologies ChemStation LC System. The absorbance of the compounds was monitored at 333 nm. Mean extraction recoveries of AQ and DAQ were 49 and 48%, respectively. Intra-day and inter-day coefficients of variation were <10.5%. The limit of quantification was 50 nM for both compounds (sample size 100 microl). Both AQ and DAQ that were previously reported to be unstable have been stored on filter paper for at least 19 weeks. The method was applied on samples from healthy volunteers.

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Amodiaquine (AQ) is an affordable compound, chemically related to chloroquine (CQ) but often effective against CQ resistant Plasmodium falciparum. In Uganda, a pre-packed fixed-dose combination of CQ plus sulfadoxine/pyrimethamine (CQ+SP) called Homapak is used in the home based management of fever program (HBM). We performed a single blind randomized trial to determine the efficacy of AQ+SP in comparison with the fixed-dose CQ+SP (Homapak) in the treatment of uncomplicated falciparum malaria in Ugandan children aged 6 months to 5 years. The study was done in 2004 at Walkuba Health Center, a sub-urban area in Jinja district, Uganda. Primary outcome was the day 14 per protocol clinical and parasitological response according to the WHO. A total of 183 children were included (mean age 28 months) and 90% completed 28 days of follow up. The day 14 adequate clinical and parasitological response was 70.9% for CQ+SP and 97.4% for AQ+SP (p<0.001). In those given CQ+SP, treatment failure rates for the 6 months to 2 years age group were much higher (48.2%) than in the older children (18.2%, p=0.004). The day 28 PCR adjusted parasitological failure rates were also higher in the CQ+SP (31.3%) than in the AQ+SP group (13.1%) (p=0.003), with a higher gametocyte carriage among the CQ+SP group. We conclude that the efficacy of AQ+SP was significantly superior to the fixed-dose CQ+SP (Homapak), particularly among the youngest children. Thus, AQ could be used instead of CQ in combination with SP to improve the effectiveness against falciparum malaria in Uganda.

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BACKGROUND: A pre-packaged fixed-dose formulation of chloroquine (CQ) and sulfadoxine/pyrimethamine (S/P) combination (Homapak) is widely used for the treatment of falciparum malaria in Ugandan children. It is however a product whose pharmacokinetics and interactions have not been studied. OBJECTIVES: To explore possible pharmacokinetic interactions between CQ and S/P during co-administration, and to determine their bioavailability in the locally made Homapak compared to the Good Manufacturing Practice (GMP) made formulations. METHODS: Thirty-two adult healthy volunteers were randomized into four groups and given single oral doses of fixed-dose CQ+S/P combination (Homapak), or GMP formulations of S/P (Fansidar), CQ (Pharco), or their combination. Plasma samples were followed for 21 days, analysed by HPLC-UV methods, with pharmacokinetic modeling using the WinNonlin software. RESULTS: Sulfadoxine in Homapak was more rapidly absorbed (ka = 0.55 h(-1)) than in Fansidar + CQ (ka = 0.27 h(-1), p=0.004), but not more than S in Fansidar alone group (ka = 0.32 h(-1), p=0.03). No significant differences were observed in the other pharmacokinetic parameters of S, P and CQ when given together or separately. The relative bioavailability of CQ and S in Homapak showed bioequivalence to reference formulations. CONCLUSIONS: There were no pharmacokinetic interactions between CQ, S and P when the compounds were given together, however, more investigations would be needed to explore this further. Compared with GMP made drugs, both S and CQ are bioequivalent in Homapak, the Ugandan made fixed-dose formulation. Furthermore, the absorption of S was more rapid which could be advantageous in malaria treatment.

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INTRODUCTION: Uganda began implementation of a structural adjustment programme (SAP) in July 1994 in order to improve social services. The decentralization of health services administration to district level was intended to improve the quality of health services and pharmaceutical supplies in the hospitals, with resultant increase in the level of utilization of health facilities. OBJECTIVE: This study evaluated the impact of the decentralization policy on health facility utilization; availability of essential drugs, and prescribing patterns for acute respiratory infections (ARI), diarrhoea, and malaria in two district hospitals in Uganda. DESIGN: Mixed method evaluation design, involving both quantitative and qualitative methods. Time series analyses of data from utilization, pharmacy stock, and prescription records before and after the policy change. Key informant interviews and focus group discussions to obtain information on perceptions and attitude of stakeholders on the process of the policy implementation. STUDY SETTING AND POPULATION: The study was conducted in two district hospitals in northern Uganda. A total of seven years of utilization and pharmacy stock data including 5040 patient records from the hospitals were analysed retrospectively. In-depth interviews were conducted among 11 politicians from each district; 100 open-ended questionnaires were administered to patients in each hospital; 86 health care workers were interviewed using semi-structured questionnaires; and focus group discussions were conducted with 23 health care providers. MAIN OUTCOME MEASURES: Facility utilization was evaluated by average monthly attendance in the outpatient department and paediatric ward admissions. Availability was assessed as average number of drugs per month. Prescribing indicator outcomes included: for malaria, percent chloroquine tablets and percent chloroquine injection; for ARI, percent receiving antibiotics or injections; for diarrhoea, use of oral rehydration salts (ORS), antidiarrhoeal mixtures, and antibiotics. The average number of drugs prescribed assessed polypharmacy. RESULTS: There was a general increase in patient attendance in both hospitals, although the initial increase later declined in Apac. Drug availability was erratic and not always adequate. The situation was better in Lira where funding for drug procurement was more accessible. Prescribing patterns varied, with improvement in some indicators, while others showed no change or even worsened. CONCLUSIONS: The decentralization policy led to increased utilization of health facilities. The perception was that the policy was good because it "empowered the community in terms of creating a sense of responsibility in the stakeholders, and a sense of ownership that facilitated sustainability" of public institutions. In spite of the views expressed by the stakeholders, the policy failed to improve drug shortages, inefficient utilization of resources, and low morale among hospital staff. Staff should be re-trained and better remunerated in order to cope with the implementation of the policy. Local politicians should clearly understand their roles and responsibility under the new policy. Efficient utilization of funds at all levels of the district administrative structures should be ensured.

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BACKGROUND: In Uganda, the decentralization of administrative functions, management, and responsibility for health care to districts, which began in 1994, resulted in fundamental changes in health care delivery. Since the introduction of the policy in Uganda, little information has been available on stakeholders' perceptions about the benefits of the policy and how decentralization affected health care delivery. OBJECTIVES: To identify the perceptions and beliefs of key stakeholders on the impact and process of decentralization and on the operations of health services in two districts in Uganda, and to report their suggestions to improve future implementation of similar policies. DESIGN: We used qualitative research methods that included focus group discussions with 90 stakeholders from both study districts. SETTING: The sample population comprised of 12 health workers from the two hospitals, 11 district health administrators, and 67 Local Council Leaders. MAIN OUTCOME MEASURES: Perceptions and concerns of stakeholders on the impact of decentralization on district health services. RESULTS: There was a general consensus that decentralization empowered local administrative and political decision-making. Among stakeholders, the policy was perceived to have created a sense of ownership and responsibility. Major problems that were said to be associated with decentralization included political harassment of civil servants, increased nepotism, inadequate financial resources, and mismanagement of resources. CONCLUSIONS: This study elicited perceptions about critical factors upon which successful implementation of the decentralization policy depended. These included: appreciation of the role of all stakeholders by district politicians; adequate availability and efficient utilization of resources; reasonably developed infrastructure prior to the policy change; appropriate sensitisation and training of those implementing policies; and the good will and active involvement of the local community. In the absence of these factors, implementation of decentralization of services to districts may not immediately make economic and administrative sense.

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INTRODUCTION: Private physicians in urban Uganda treat a large percentage of common adult illnesses. Improving their prescribing would not only encourage more rational drug use, but also reduce costs to patients. Interventions to improve drug use are generally more successful when face-to-face educational methods are included. OBJECTIVES: To determine the effectiveness of a face-to-face educational intervention on the treatment of acute respiratory infections (ARI), malaria, and non-dysenteric diarrhoea by private physicians in three urban areas of Uganda. METHODS: The study used an intervention with comparison group design to evaluate the impact of the educational intervention. A total of 108 private physicians was divided into intervention (n = 30) and control (n = 78) groups. Surrogate patients, trained to simulate presenting symptoms and signs of the target conditions, were used to collect data on the medical practices and prescribing behaviours of the physicians. Intervention physicians were invited to a one-day interactive educational seminar facilitated by local opinion leaders that covered principles of rational drug use and the National Standard Treatment Guidelines for treating the target conditions. Physicians were also provided with data about baseline practices. RESULTS: Baseline data indicated high rates of inappropriate treatment practices by both intervention and control groups. There was nearly universal antibiotic use for ARI (over 90%), high rates of injections recommended for malaria (over 30%), and high rates of polypharmacy (over thee drugs per patient). After the intervention, some significant improvements in key practices were observed in the intervention group. Compared to control physicians, antibiotic prescribing for ARI decreased by 23% in the intervention group, use of combination products for malaria declined by 28%, there were trends towards better adherence to guidelines for ARI and malaria, and marginal decreases in drug costs. However, the overall impacts of the intervention were limited, especially on quality indicators concerning history taking, adequate examination, and advice to patients. CONCLUSION: The face-to-face educational intervention resulted in some small improvements in key prescribing practices of private physicians. However, an intervention that involved repeated contacts with prescribers and which addressed economic considerations would be needed to obtain larger improvements. Private physicians need to be sensitized to and encouraged to use the National Standard Treatment Guidelines, and attempts to improve their prescribing should be supported by community education.

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INTRODUCTION: Previous studies in the public sector in Uganda have demonstrated major prescribing problems due to polypharmacy and irrational use of antibiotics and injections. Little is known about prescribing in the private sector although there is little government regulation influencing practice in this sector. The introduction of policies such as the Uganda National Standard Treatment Guidelines (UNSTG) was expected to improve prescribing practices in the public and private sectors. This paper measures appropriateness of prescribing practices in the public and private sectors in Uganda for the treatment of Acute Respiratory Infections (ARI) and malaria in adult patients. DESIGN AND SAMPLING: We combined a prospective survey of treatment for simulated patients presenting with symptoms of malaria and ARI in 119 randomly selected private clinics and a retrospective survey of 600 prescription records for malaria and ARI (300 for each condition) randomly selected from 10 public health units in the Kampala, Masaka, and Jinja urban areas. OUTCOME MEASURES: Percentage of drug appropriately prescribed in each condition, % injection prescription, percentage antibiotic prescription, average number of drugs per case, average standardized cost per prescription, distribution of types of drugs prescribed. RESULTS: The overall appropriateness of prescribing for ARI and malaria was poor in both public and private sectors. Treatment of malaria was significantly less appropriate in the public sector compared to the private sector (14% vs. 27%, p = 0.002), with injectable chloroquine much more commonly prescribed. Prescribing of antibiotics for ARI was nearly universal in both sectors, with some prescriptions containing up to three antibiotics; newer, more expensive antibiotics were more commonly prescribed in the private sector. Polypharmacy and unnecessary prescribing of vitamins were common in both conditions and both sectors. CONCLUSIONS: Prescribing for adult malaria and ARI by both private and public practitioners did not conform to the UNSTGs. Although practitioners were largely the same in both sectors, prescribing practices often differed dramatically. The extent of inappropriate prescribing in both sectors calls for in-depth investigation of the system factors and motivations that underlie problem practices, and the development of interventions that target these causative factors.

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BACKGROUND: In Uganda, although private retail pharmacies and drug shops are the most common sources of drugs for the majority of the population, the quality of care received from these outlets has been reported as suboptimal. It is believed that lack of adequate knowledge is an important underlying factor to such practices. OBJECTIVES: In this study, we investigated the impact of a face-to-face educational intervention on counter attendants' dispensing behaviour for mild and severe acute respiratory infections (ARI) in children at private pharmacies and drug shops. STUDY DESIGN AND SETTING: We used a quasi-experimental research design with comparison groups to analyse counter attendants' management of ARI before and after an intervention. The study was conducted in Kampala District, and used a sample of 191 registered drug outlets (27 pharmacies and 164 drug shops), stratified into two groups: 1) An experimental group that received training; 2) A control group unexposed to training. Data on the practices in the drug outlets from both groups were collected at two time-points: seven months before the intervention, and at one-month after the intervention. OUTCOME MEASURES: Two main outcome measures were considered: a) Assessment of the child's condition. b) The dispensing practices of counter attendants. RESULTS: The study found that despite the training, the assessment of the child's condition remained inadequate in both groups, where the child's age was the only question asked in more than 90% of cases. High levels of inappropriate dispensing practices for both mild and severe ARI were still persistent in both groups after the intervention. Antibiotic prescribing for both conditions was very common, and barely any advice or instruction was given with dispensed drugs. Client demand for particular drugs, competition among drug outlets, and inability of most clients to afford the recommended treatments were the main reported barriers that emerged from the focus group discussions with the counter attendants. CONCLUSIONS: The evaluation of the practices one month after the face-to-face educational intervention showed that the management of ARI did not improve in the drug outlets. While study design issues may have contributed to such findings, there are many other factors not related to knowledge and education that may indirectly hamper the promotion of appropriate dispensing in the private pharmacies and drug shops in Uganda. It is possible that a combination of interventions may contribute to improved management of ARI by counter attendants in the private drug shops and pharmacies in Uganda.

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BACKGROUND: In Uganda, private pharmacies and drug shops are important sources of drugs for the majority of the population. In addition to selling drugs, these outlets often serve as primary sources of information about illness and drug therapy. However, the appropriateness of dispensing by staff in these drug outlets has been found to be suboptimal. Yet there has been no study documenting the determinants that underlie the dispensing pattern at these outlets. This study evaluated counter attendants' training background, their knowledge of acute respiratory infections (ARI), and their reported behaviour in the management of ARI in order to identify factors associated with dispensing behaviours. STUDY DESIGN AND SETTING: This descriptive study was conducted in Kampala District, Uganda and used a cross-sectional survey research design to analyse the practice of 197 drug outlets including 28 pharmacies and 169 drug stores. MAIN OUTCOME MEASURES: Counter attendants' training background; their knowledge of the causes, signs and symptoms of ARI; their perception of the dangers of ARI; and the drugs and advice offered for the management of mild and severe ARI. RESULTS: Majority of the counter attendants had medical or pharmacy training. Most of them were nurses. The attendants' workload was generally low. High levels of self-medication among clients were reported at the outlets. Staff at a management level had low knowledge of the aetiology, signs and symptoms, and dangers of ARI. Prescribing an antibiotic was found to be the usual practice for managing ARI cases. Counter attendants at those outlets seldom gave advice or referrals for ARI cases. In particular, patient demand was a main barrier to appropriate dispensing. Strategies suggested by attendants for improving rational dispensing were to educate the public, provide training for the attendants, and re-enforce government supervision of drug outlets. CONCLUSIONS: This study identified several self-reported inappropriate behaviours in the outlets. The formal training background and workload of counter attendants at drug shops and pharmacies were not found to be important contributors to irrational prescribing. The results of this study suggest that a combination of regulatory and educational interventions may yield to improvement in counter attendants' practices in private drug outlets.

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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.

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We present a small study of four cases of malaria treated using a traditional herbal remedy at Rukararwe, Uganda. Our results demonstrate that this remedy has the potential to cure malaria clinically and parasitologically.

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Onchocerciasis affects 7% of Uganda's population and 1.5 million more people are at risk of infection with Onchocerca volvulus, the nematode that causes the disease. This paper reports the results of part of a multi-centre study whose objective was to determine the prevalence of onchocercal skin disease and its associated psychosocial importance in Uganda. The study employed a standardised clinical dermatological survey method along with the use of structured questionnaires, focus group discussions and key informant interviews. Out of a total of 993 persons examined to determine the prevalence of onchocercal skin lesions 253 persons were interviewed to determine the psychosocial importance of the disease. The results indicate that onchocercal skin disease is associated with a variety of psychosocial, physical and economic effects. The disease also leads to stigmatisation of affected persons and their families. It is suggested that dermatological effects of onchocerciasis should be recognised as an important cause of morbidity in Uganda.

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A cross-sectional survey of 770 subjects in onchocerciasis hyperendemic villages and 223 subjects from a control community in Nebbi District in the West Nile region of Uganda revealed a high prevalence of onchocercal skin disease of 48% in endemic villages. The most common skin problem was troublesome itching (40%); and the prevalent skin lesions were chronic papular onchodermatitis (16%), depigmentation (4%), lichenified onchodermatitis (2%) and acute papular onchodermatitis (1%). Other typical varieties of onchocercal skin diseases such as, hanging groin, lymphoedema and marked lymphadenopathy were infrequent, and considered rare. Pityriasis vergicolor was the most common non-onchocercal skin lesion in both control and endemic communities, accounting for 37% of all non-onchocercal skin lesions. These skin lesions were associated with a variety of psycho-social and economic impact; and there was a positive correlation between the prevalence of troublesome itching and the prevalence of modules (correlation coefficient r = 0.62, p = 0.00). Given the prospects of onchocerciasis control based on mass ivermectin distribution in communities where blindness is common, we recommend that treatment be extended to communities where blindness is less common, but skin disease known to be predominant.

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