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Background: The effects of drugs on laboratory tests may lead to misinterpretation of laboratory data, unnecessary tests, higher costs and missed diagnoses. This study compared the information on drug-laboratory effects (DLE) described in 200 drug labels with that in Young's book. Methods: Information on DLE was searched in the drug labels of 200 frequently prescribed drugs using the keywords 'interfer*', 'influence', and 'laborator*'. This information was compared with the information in Young's book. Each item of information scored 1 point if it was specific and exactly the same. Primary outcome was the percentage of DLE with completely the same information. Results: In 23 (11.5%) of the 200 drug labels 83 DLE were described. Most DLE were described in drug labels of contraceptives (71%) and antibacterials (15%). The most frequently affected laboratory tests were adrenal gland (17%), urine tests (15%), liver tests (10%) and renal function tests (10%). Comparison of six DLE with Young's book was not possible because the information was not described in the book. Twelve (14.5%) DLE of the information in the drug label was identical to that in Young's book. Detailed information about nature of the effect, strength of the effect and body fluid was not described in the drug labels. Conclusions: In a limited number of DLE in the drug labels the information was the same as in Young's book. Overall, the information on DLE provided in drug labels is unclear, inconsistent and incomplete and does not support healthcare professionals in making evidence-based monitoring decisions. [ABSTRACT FROM AUTHOR]

Background: Monitoring drug treatment is important to assess the therapeutic effects and to prevent adverse drug reactions. Unfortunately, the clinical evidence for monitoring is often missing. To attain evidence-based laboratory monitoring and to improve patient safety it is mandatory for the clinical chemist to develop effective and rational methods for monitoring. The legal source for this evidence-based information is the drug label. We analysed frequency, nature, and applicability of instructions on laboratory monitoring described in 200 drug labels. Methods: The applicability of instructions was assessed with an adapted Systematic Information for Monitoring score. Seven items of information were evaluated: why to monitor, what to monitor (essential), when to start or stop monitoring, how frequently to monitor, critical value (essential) and how to respond (essential). Each item scored one point when information was described specifically, otherwise the score was zero. Instructions were applicable if all three essential items scored. Results: In 131 drug labels, 566 instructions on laboratory monitoring were identified, an average of 2.8 per drug label. Kidney, liver, electrolyte, and drug monitoring were important biomarker categories (71%). The median applicability score was 2.1 (0-6) and 95 (17%) instructions were applicable. Six determinants were associated with applicable instructions: kidney (OR 7.0; 95% CI 4.4-11.3), creatine phosphokinase (4.5; 1.5-13.6), drug selection (6.8; 4.0-11.7), dose adjustments (2.4; 1.5-3.7), year on the market 2000-2007 (2.6; 1.1-6.1) and statins (4.8; 2.5-9.0). Conclusions: Drug labels frequently describe instructions on laboratory monitoring, but these are ambiguous and incomplete and clinical applicability for the professional is limited. [ABSTRACT FROM AUTHOR]

Objective: The aim of the study was to assess monitoring of adverse drug reaction (ADR)-related parameters in children, youth, and young adults treated with second-generation antipsychotic drugs (SGAs) prescribed by general practitioners (GPs). Methods: This retrospective follow-up study included children, youth, and young adults aged 0 - 24 years, who had an initial prescription of an SGA recorded in the Clinical Practice Research Datalink between 2000 and 2017, and who were prescribed an SGA more than once for a duration of at least 6 months. It included an assessment of which ADR-related physical parameters (weight, height, body-mass index, waist circumference, pulse, blood pressure, and heart examination) and laboratory parameters (glucose, HbA1c, lipids, and prolactin) were monitored in children, youth, and young adults at least once every 6-month period, stratified by sex, age categories, and calendar years. Results: In total, 7006 patients were included and the mean duration of follow-up was 1.6 years. Monitoring frequencies of all parameters were below 25%. Blood pressure and weight were monitored in 23.6% and 23.4%, respectively, of all children, youth, and young adults during the first half year; waist circumference was monitored in 0.2%. Females were monitored more often than males, some differences between age categories were observed, and monitoring frequencies increased after 2000, but did not exceed 35% in any year. Conclusion: Monitoring frequencies of ADR-related parameters in children, youth, and young adults treated with SGAs prescribed by a GP were low. Monitoring in primary care should be improved to enable a better evaluation of the benefit-risk balance during antipsychotic drug therapy. [ABSTRACT FROM AUTHOR]

Abstract: To optimize seizure control it is important to identify modifiable factors. We conducted a case–control study to explore to what extent drug treatment-related factors are associated with seizures. Eighty-six patients with epilepsy were evaluated: 45 cases (recently experienced a seizure) and 41 controls (seizure-free for at least 2 months). There was a significant association between low AED serum concentration and seizures (odds ratio (OR)=8.9, 95% confidence interval (CI)=1.7–47.8), compliance was not associated with seizures (OR=0.9, 95% CI=0.2–4.0), and changes in medication (mainly non-AEDs) were more frequently observed in the case group than in the control group (OR=4.1, 95% CI=0.9–18.3). These findings indicate that patients with low AED serum levels have a nine times higher risk of seizures compared with patients with therapeutic AED levels and that changes in medication regimens in patients with epilepsy should be made with care. [Copyright &y& Elsevier]