Effects of pharmaceutical care on adherence and persistence to bisphosphonates in postmenopausal osteoporotic women.

WHAT IS KNOWN AND OBJECTIVE: Studies have shown that comprehensive interventions by pharmacists can improve adherence and persistence to osteoporosis therapy, but the association between adherence and bone turnover markers (BTMs) has never been studied. Therefore, the aim of this study was to evaluate the effects of pharmaceutical care on medication adherence (and its effects on BTMs), as well as persistence of postmenopausal osteoporotic women to prescribed bisphosphonates. METHODS: A randomized controlled trial was conducted from 2005 to 2009 in the University Malaya Medical Centre, Malaysia. INCLUSION CRITERIA: postmenopausal osteoporotic women diagnosed with osteoporosis with a T-score ≤ -2·5 or who had a low-trauma fracture and prescribed weekly alendronate/risedronate. Intervention participants received counselling on osteoporosis, risk factors, lifestyle modifications, goals of therapy, side effects and the importance of adherence. Adherence was assessed at months 3, 6 and 12, and persistence at month 12. Feedback on BTMs was provided at months 4 and 7. The control group received no counselling. Two BTMs were used: serum C-terminal cross-linking telopeptide of type I collagen (CTX-I) and serum osteocalcin (OC). MAIN OUTCOMES MEASURED: medication adherence, BTMs and persistence. RESULTS AND DISCUSSION: Intervention participants who received pharmaceutical care reported significantly higher medication adherence at 6 (P = 0·015) and 12 months (P = 0·047) compared with the control group; but this effect was not shown by the BTMs. This is probably due to the long effect of bisphosphonates in bone. A significant difference was found between serum CTX-I and OC in identifying non-responders to anti-resorptive therapy (P < 0·001), indicating the usefulness of BTMs as an objective marker. However, pharmaceutical care did not affect persistence to osteoporosis therapy within a 1-year period [log rank (Mantel-Cox) χ² = 0·496, P = 0·481]. The proportion of participants who were persistent with bisphosphonate therapy after 12 months was 89·8% and 87·0% in the control and intervention group respectively. WHAT IS NEW AND CONCLUSION: The provision of pharmaceutical care improved medication adherence but not persistence. BTMs were not appropriate objective measures for assessing adherence to weekly bisphosphonates but were useful for identifying non-responders to treatment within 3-6 months, much earlier than using bone mineral density. The study indicates that pharmacists have a role in improving medication adherence, but its long-term effect on persistence warrants further studies with longer duration.

Determination of trimester specific reference intervals for thyroid hormones during pregnancy in Malaysian women.

OBJECTIVE: To establish trimester specific reference intervals for thyroid hormones during pregnancy in Malaysian women. STUDY DESIGN: Cross-sectional observational study performed in the Obstetric Clinic, University Malaya Medical Centre. A single blood sample from 626 women at various trimesters of pregnancy was analyzed for thyroid function. TSH, FT4, TT4, FT3 and TT3 values at each trimester of pregnancy were calculated. RESULTS: From the TSH, FT4, TT4, FT3 and TT3 results, reference values based on mean +/- 2SD was calculated for the hormones at each trimester of pregnancy. CONCLUSION: We calculated clinically relevant trimester-specific reference values for thyroid function tests through pregnancy to facilitate improved management of thyroid disease in pregnancy in our local population.

The prevalence of enamel opacities in permanent teeth of 11-12 year-old school children in Kuala Lumpur, Malaysia.

OBJECTIVE: To determine the prevalence, distribution, severity and treatment need of enamel opacities among 11-12 year-old school children in a fluoridated urban community. DESIGN: A cross-sectional descriptive survey of enamel opacities in 11-12 year-old schoolchildren. CLINICAL SETTING: A questionnaire survey and a clinical examination of erupted teeth using the Modified DDE Index was conducted on schoolchildren in randomly selected schools. PARTICIPANTS: 957 schoolchildren from government schools in Kuala Lumpur comprising the three major ethnic groups of Malay, Chinese and Indian children. MAIN OUTCOME MEASURES: The severity of enamel opacities was assessed by the extent of buccal surface involvement. Normative treatment need was based on severity of opacities. RESULTS: Enamel opacities were found in 90.7% of subjects and 47.2% of teeth. Malays have the highest prevalence with Chinese the least. Although ethnic differences is statistically significant (p < 0.01), the differences in prevalence between ethnicity is small. The most common type of defect was "diffuse opacities" (88.6% of subjects). Most subjects (70%) showed bilateral distribution of diffuse opacities indicating a systemic disturbance. Posterior teeth were twice more commonly affected (p < 0.05). The majority of opacities in anterior teeth (66.7%) were minor, involving less than 1/3 of the labial surface. Only 0.6% of the whole sample required some form of aesthetic intervention. CONCLUSION: Despite the high prevalence of enamel opacities, the degree of severity is very mild with only minimal aesthetic and public health concern.

Performance evaluation of the Arkray Adams HA-8160 HbA1c analyser.

BACKGROUND: HbA1c measurement is currently routinely used to predict long term outcome of diabetes, thus playing a fundamental role in the management of diabetes. The relationship between HbA1c value and long term diabetic complications has been established by a randomised control Diabetes Control and Complications Trial (DCCT) which used high performance liquid chromatography (HPLC) as a reference method for HbA1c assay. To ensure that HbA1c results from a variety HbA1c assay methods are similar to the DCCT values, the American Diabetes Association (ADA) recommended that all laboratories should use methods certified by the National Glycohemoglobin Standardization Programme (NGSP) with interassay coefficient variation (CV) of < 5% (ideally < 3%). The International Federation of Clinical Chemistry (IFCC) working group on HbA1c standardisation has set a CV < 2.5% as a criteria for its reference laboratories. OBJECTIVES: To evaluate the performance of Arkray Adams HA-8160 HbA1c analyser which uses a cation exchange HPLC method and its correlation to HbA1c assay on Cobas Integra 800 which is an immunoturbidimetric method. METHODS: For the imprecision study, patient samples and control material of two levels were analysed on HA-8160 analyser 20 times in a single run (within-run imprecision) and twice a day on five consecutive days (between-run imprecision). For the recovery study, two samples each with high and low values were selected and mixed in ratios of 1:3, 1:1 and 3:1, and were analysed by HA-8160. Sixty samples were analysed by both Cobas Integra 800 and HA-8160 for method comparison study. Ten uraemic samples and ten thalassaemic samples were assayed on Cobas Integra 800 and HA 8160 for interference study. RESULTS: Within-run CVs were 0.6% and 0.7% for medium and high value samples respectively, 0.6% and 0.7% for low and high level controls respectively. Between-run CVs were 0.5% and 0.4% for medium and high value samples respectively, 0.5% and 0.6% for low and high level controls respectively. The mean recovery was 100.1%. A good correlation between the 2 methods (Adams = 1.00 Cobas - 0.11, r = 0.98) was observed. CONCLUSIONS: The Akray Adams HA-8160 HbA1c analyser performed within the target CV of < 2.5% and showed a good correlation with the Cobas Integra 800.

Interference of hemoglobinA1c (HbA1c) detection using ion-exchange high performance liquid chromatography (HPLC) method by clinically silent hemoglobin variant in University Malaya Medical Centre (UMMC)--a case report.

BACKGROUND: Glycated hemoglobin, measured as HbA1c is used as an index of mean glycemia in diabetic patients over the preceding 2-3 months. Various assay methods are used to measure HbA1c and many factors may interfere with its measurement according to assay method used, causing falsely high or low results. OBJECTIVE: To report a case of diabetic patient with clinically silent hemoglobin variant, causing undetectable HbA1c concentration using ion-exchange high performance liquid chromatography (HPLC) method. CASE SUMMARY: Our patient is a 65-year-old female with type 2 diabetes mellitus on diet control, hypertension and hypercholesterolemia. Her fasting blood glucose concentrations ranged from 6.2 to 7.8 mmol/L. Her HbA1c concentrations measured with immunoturbidimetry method (Cobas Integra, Roche Diagnostics) ranged from 6.11 to 7.23%, but were undetectable when measured with ion-exchange HPLC [Arkray HA8160, Diabetes Mode (also known as Menarini HA8160)]. Hemoglobin analysis identified the presence of a hemoglobin variant--Hemoglobin D Punjab. CONCLUSIONS: Clinical laboratories should be aware of limitations of the HbA1c assay method used, such as potential interference with hemoglobin variant as depicted by our case. Alternative methods for monitoring glycemic control in these patients should be considered.

Evaluation of a urinary metanephrines reagent kit: an automated approach.

INTRODUCTION: We report the results of a laboratory evaluation of the BioRad Urinary Metanephrines Reagent Kit. The test was designed for the quantitative measurement of normetanephrine and metanephrine in urine by high performance liquid chromatography. The kit was evaluated in view of improving assay reliability and specificity as compared to the manual method based on cation exchange chromatography and spectrophotometry. METHODS: Performance was evaluated for precision, linearity, accuracy, sensitivity and detection limit based on National Committee on Clinical Laboratory Standards (NCCLS) protocols. Analytical precision was evaluated using commercial controls and patient sample. Accuracy was evaluated by assessing recovery. Linearity was determined using aqueous standards. RESULTS: The within-run coefficient of variation (CV) for metanephrine and normetanephrine were 1.9 percent and 2.4 percent (low control); 4.2 percent and 3.5 percent (high control); 3.8 percent and 3.3 percent (patient sample), respectively. The between-day precisions were 3.8 percent and 4.3 percent (low control); and 5.5 percent and 3.7 percent (high control) for metanephrine and normetanephrine, respectively. The linearity curve showed metanephrine and normetanephrine to be linear with concentrations, to at least 1,600 microgramme per litre and 2,000 microgramme per litre, respectively. Analytical recovery averaged 102 percent for metanephrine and 95 percent for normetanephrine. Levels as low as 23 microgramme per litre normetanephrine and 10 microgramme per litre metanephrine were measured with this method. The detection limit was 3.3 microgramme per litre for metanephrine. CONCLUSION: The performance characteristics of automated sample preparation and auto-injection facilitate handling of larger number of samples as well as improve assay reliability.