Safety monitoring of treatment in bipolar disorder in a tertiary care setting in Sri Lanka and recommendations for improved monitoring in resource limited settings.

BACKGROUND: Safety monitoring of medicines is essential during therapy for bipolar disorder (BD). We determined the extent of safety monitoring performed according to the International Society for Bipolar Disorders (ISBD) guidelines in patients with BD attending the main tertiary care psychiatry clinics in Sri Lanka to give realistic recommendations for safety monitoring in resource limited settings. METHODS: Patients diagnosed with BD on mood stabilizer medications for more than 1 year were recruited. Data were collected retrospectively from clinic and patient held records and compared with the standards of care recommended by ISBD guidelines for safety monitoring of medicines. RESULTS: Out of 256 patients diagnosed with BD, 164 (64.1%) were on lithium. Only 75 (45.7%) had serum lithium measurements done in the past 6 months and 96 (58.5%) had concentrations recorded at least once in the past year. Blood urea or creatinine was measured in the last 6 months only in 30 (18.3%). Serum electrolytes and thyroid-stimulating hormone (TSH) concentrations were measured in the last year only in 34 (20.7%) and 30 (18.3%) respectively. Calcium concentrations were not recorded in any patient. None of the patients on sodium valproate (n = 119) or carbamazepine (n = 6) had blood levels recorded to establish therapeutic concentrations. Atypical antipsychotics were prescribed for 151 (59%), but only 13 (8.6%) had lipid profiles and only 31 (20.5%) had blood glucose concentration measured annually. Comorbidities experienced by patients influenced monitoring more than the medicines used. Patients with diabetes, hypothyroidism and hypercholesterolemia were more likely to get monitored for fasting blood glucose and (p < 0.001), TSH (p < 0.001) and lipid profiles (p < 0.001). Lithium therapy was associated with TSH monitoring (p < 0.05). Therapy with atypical antipsychotics was not associated with fasting blood glucose or lipid profile monitoring (p > 0.05). A limitation of the study is that although some tests were performed, the results may not have been recorded. CONCLUSIONS: Safety monitoring in BD was suboptimal compared to the ISBD guidelines. ISBD standards are difficult to achieve in resource limited settings due to a multitude of reasons. Realistic monitoring benchmarks and recommendations are proposed for methods to improve monitoring in resource limited settings based on our experience.

Validation of the Sinhala version of the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)

Introduction: Only the Mini mental state examination (MMSE) and Montreal Cognitive Assessment scale have been validated in a Sri Lankan population for the assessment of cognitive functions. Both tests are deficient in the number of domains assessed. Therefore validation of Repeatable Battery for Assessment of Neuropsychological Status is important as it assesses most of the cognitive domains. Objectives: To culturally adapt RBANS and investigate the validity and reliability of culturally adapted RBANS (RBANS-S). Methods: Fifty four participants with major neurocognitive disorder and 60 normal controls aged >50 were administered with RBANS-S at the Cognitive Assessment Unit, Faculty of Medicine, Colombo and National Hospital of Sri Lanka. The participants were selected after a detailed clinical assessment according to Diagnostic and Statistical Manual ­ 5 criteria. Data were analysed using SPSS data package. Results: The mean age of the sample was 69.5 years. RBANS-S total scale correlated highly with MMSE total score, (Pearson correlational coefficient = 0.793 p=0.01). Criterion validity was assessed using receiver operating curve characteristic analysis and the area under the curve was 0.937. RBANS-S showed strong concurrent validity us indicated by its significant correlations with the MMSE. All of the RBANS-S subtests demonstrated significant correlations with the MMSE subsets. The sensitivity and specificity for RBANS-S was 89% and 85% respectively at a totals score of 80.5. The RBANS-S yielded a reliability coefficient of 0.929. Conclusions: Culturally adapted RBANS-S is a valid and reliable instrument which can be used in assessment of cognitive functions.

Antipsychotic medication and tobacco use among outpatients with schizophrenia: a cross-sectional study.

BACKGROUND: Many studies have shown that the prevalence of smoking in schizophrenia is higher than in the general population. Biological, psychological and social factors influence smoking in patients with schizophrenia. METHODS: The study was carried out in psychiatry outpatient clinics in a tertiary care hospital in Sri Lanka. Every third patient was selected using systematic sampling from patients diagnosed with schizophrenia according to ICD-10 clinical criteria. Smoking behaviours were assessed using self-reports. Severity of illness was assessed using Brief Psychiatric Rating Scale (BPRS). Fagerstrom Test for Nicotine Dependence assessed level of dependence. Readiness to Change Questionnaire assessed motivation to change smoking behaviour. RESULTS: The sample consisted of 306 patients with schizophrenia. Mean age was 38.93 years (SD 10.98). There were 148 males (48.4%). Mean duration of illness was 12.63 years (SD 8.38). Current medication was oral atypical antipsychotics 103, clozapine 136, oral typicals 29 and depot typicals 38. Prevalence of tobacco use among males was 30.41% (95% CI 22.91 to 37.90) and among females 1.90% (95% CI -0.25 to 4.05). Prevalence of current smoking among males was 20.27% (95% CI 13.72 to 26.82). None of the females smoked. Prevalence of smokeless tobacco use among males was 10.14 (95% CI 5.22 to 15.05) and among females 1.90 (95% CI -0.03 to 4.05). When patients treated with clozapine were excluded from the analysis, prevalence of tobacco use was 41.6% among males and 3.2% among females and prevalence of smoking was 29.9% among males. Prevalence of tobacco use was lowest in patients treated with clozapine 18.31 (95% CI 9.09 to 27.53) and highest in those treated with depot antipsychotics 47.83 (95% CI 25.74 to 69.91). CONCLUSIONS: Prevalence of smoking was less than in many countries. This is influenced by prevalence in the general population and low affordability. Risk of tobacco use was significantly less among patients treated with clozapine.

Direct and indirect cost of schizophrenia in outpatients treated in a tertiary care psychiatry unit.

OBJECTIVE: To estimate the direct and indirect cost of care incurred by patients with schizophrenia attending a tertiary care psychiatry unit in Colombo. METHODS: Study was carried out at the National Hospital of Sri Lanka. Systematic sampling selected every second patient with an ICD-10 clinical diagnosis of schizophrenia presenting to the clinic during a two month period. Investigator administered semi-structured questionnaire was used for data collection. RESULTS: Sample consisted of 91 patients. Direct cost was defined as cost incurred by the patient (out of pocket expenditure) for outpatient care. Mean cost of a clinic visit was Rs. 500. Of the clinic visit cost, highest proportions were travel cost (39.8%) and medication (26.4%). Sixty four (70.3%) had received informal care. The mean cost of informal care during the entire course of the illness was Rs. 33, 540. Mean indirect cost was Rs. 150,190. CONCLUSIONS: Despite low direct cost of care, indirect cost and cost of informal treatment results in substantial economic impact on patients and their families. It is recommended that economic support should be provided for patients with disabling illnesses such as schizophrenia, especially when patients are unable to engage in full time employment. There is a need to educate the public regarding higher cost of care by traditional healers and other informal modes of treatment compared to Western medical care.

Association between concurrent alcohol and tobacco use and poverty.

INTRODUCTION AND AIMS: The harm from alcohol and tobacco use in low- and middle-income countries includes substantial economic cost to the individual. Our aim was to describe the expenditure on concurrent alcohol and tobacco use in relation to family income in two districts in Sri Lanka. DESIGN AND METHODS: A community-based cross-sectional study was carried out in two districts in Sri Lanka. We sampled 2684 men over 18 years of age using multistage cluster sampling. Cost of alcohol and cigarettes was calculated using the retail price for each brand and multiplying by the amount consumed. RESULTS: Among current alcohol users 63.1% were also smokers. Among current smokers 61.9% were also using alcohol. Prevalence of concurrent alcohol and tobacco use in urban areas was 20.1% and in rural areas 14%. The two lowest income categories (<$US76 per month) spent more than 40% of their income on concurrent use while the next category ($US76-143 per month) spent 34.8% of their income on concurrent use. DISCUSSION AND CONCLUSIONS: The poor spent less than those with higher income on alcohol and tobacco, but the expenditure constituted a much larger slice of their income thus compromising their ability to meet basic needs. In low-income countries, damaging economic consequences start at lower levels of alcohol and tobacco consumption and affect a significant proportion of the population. Defining risk levels and guidelines on safe limits based purely on individual health harm has, at best, little meaning in such settings.