Multidose drug dispensing and discrepancies between medication records

Beskriver en kontrollert studie hvor hensikten var å undersøke om innføring av multidose hos hjemmeboende påvirker grad av samstemt legemiddelinformasjon hos fastlege og hjemmesykepleien.Background: the objective of this study was to investigate whether implementation of multidose drug dispensing (MDD) for elderly outpatients is associated with a change in the number of discrepancies in the medication record at the general practitioners (GPs) and at the community home-care services. Methods: a controlled follow-up study with paired design of patients’ medication records was performed during implementation of MDD. Medication records from the home care units and from the GPs were reviewed, and the discrepancies were noted. The discrepancies were rated into four classes based upon the potential harm, and a risk score system was applied, giving the potentially most harmful discrepancies the highest score. Results: medication records from 59 patients with a mean age of 80 years were included. The number of discrepancies was reduced from 203 to 133 (p<0.001), and the total risk score decreased from 308 to 181 (p<0.001) after the implementation of MDD. For both drugs subject to MDD and drugs not suitable for MDD, the reductions in discrepancies were significant (39% and 31% reduction respectively). Conclusions: calculated health risk due to discrepancies between the medication records from the home-care service and from the GPs decreased during the time of implementation of the MDD system. It seems likely that most of the positive effect was caused by the change in routines and enhanced focus on the medication process rather than by MDD per se

Using the Norwegian Mother and Child Cohort Study to determine risk factors for delayed development and neuro-psychiatric symptoms in the offspring of parents with epilepsy

Introduction: Antiepileptic drug (AED) teratogenicity is suspected to be the main cause of impaired development in children of women with epilepsy. However, many factors may confound the reported risks. The purpose of this review is to characterize the epilepsy cohort in the Norwegian Mother and Child Cohort Study (MoBa) and show how it can be used to detangle various risk factors for adverse outcome in children of mothers with epilepsy. Methods: MoBa is a large, long-term prospective, family-based cohort study. The database is linked to the Medical Birth Registry of Norway. The epilepsy cohort consists of mothers and their children representing more than 700 pregnancies. Blood samples were obtained from the mother during pregnancy and from the umbilical cord after delivery, and AED concentrations were measured. Validated screening tools determined the frequency of maternal confounding risk factors and adverse offspring outcomes. Risk estimates were reported as adjusted odds ratios with confidence intervals using the remaining MoBa cohort as a reference (n=107,597). Outcome in offspring of women with epilepsy without AED treatment in pregnancy and of fathers with epilepsy were used to separate the effect of epilepsy from the effect of in utero exposure to AEDs. Results: Socioeconomic and psychiatric risk factors for adverse offspring outcomes were more frequent in mothers with epilepsy. The frequency of adverse offspring outcome was increased at 6, 18 and 36 months for verbal, motor and social development. Children of women with epilepsy without AED treatment and of fathers with epilepsy were generally similar to children of women without epilepsy. Conclusion: Children of mothers with epilepsy are at risk of adverse outcomes. AED exposure emerges as the most important risk factor.publishedVersio

The Norwegian General Practice (NORGEP) criteria for assessing potentially inappropriate prescriptions to elderly patients

Beskriver utvikling av en klinisk relevant liste med eksplisitte kriterier for farmakologisk uhensiktsmessige medikamentforeskrivinger for eldre ≥ 70 år i allmennpraksis.Objective. To establish a clinically relevant list with explicit criteria for pharmacologically inappropriate prescriptions in general practice for elderly people ]70 years. Design. A three-round Delphi process for validating the clinical relevance of suggested criteria (n 37) for inappropriate prescriptions to elderly patients. Setting. A postal consensus process undertaken by a panel of specialists in general practice, clinical pharmacology, and geriatrics. Main outcome measures. The Norwegian General Practice (NORGEP) criteria, a relevance-validated list of drugs, drug dosages, and drug combinations to be avoided in the elderly (570 years) patients. Results. Of the 140 invited panellists, 57 accepted to participate and 47 completed all three rounds of the Delphi process. The panellists reached consensus that 36 of the 37 suggested criteria were clinically relevant for general practice. Relevance of three of the criteria was rated significantly higher in Round 3 than in Round 1. At the end of the Delphi process, a significant difference between the different specialist groups’ scores was seen for only one of the 36 criteria. Conclusion. The NORGEP criteria may serve as rules of thumb for general practitioners (GPs) related to their prescribing practice for elderly patients, and as a tool for evaluating the quality of GPs’ prescribing in settings where access to clinical information for individual patients is limited, e.g. in prescription databases and quality improvement interventions

Antihistamine use during breastfeeding with focus on breast milk transfer and safety in humans - a systematic literature review.

Current data on use of antihistamines during breastfeeding and risks to the breastfed infant are insufficient. The aim of this systematic review was to provide an overview of studies measuring the levels of antihistamines in human breast milk, estimating the exposure for breastfed infants, and/or reporting possible adverse effects on the breastfed infant. An additional aim was to review the antihistamine product labels available in EU and the US. We searched seven online databases and identified seven human lactation studies that included 25 mother-infant pairs covering cetirizine, clemastine, ebastine, epinastine, loratadine, terfenadine and triprolidine. In addition, one study investigated the impact of chlorpheniramine or promethazine on prolactin levels among 17 women, and one study investigated possible adverse drug reactions in 85 breastfed infants exposed to various antihistamines. The relative infant dose was below 5% for all antihistamines, ranging from 0.3% for terfenadine to 4.5% for clemastine. Most product labels of the ten antihistamines with available information in both EU and the US, reported lack of evidence and recommended to avoid use during breastfeeding. The knowledge gap on antihistamines and lactation is extensive, and further human studies are warranted to ensure optimal treatment of breastfeeding women with allergy

Antidepressant exposure in pregnancy and child sensorimotor and visuospatial development

Motor development underlies many aspects of education and learning. There has been uncertainty about the impact of exposure of antidepressant medication in pregnancy on child motor outcomes. This paper examines whether exposure to antidepressants in utero increases the risk of poorer motor development in two areas: sensorimotor and visuospatial processing. Data were obtained from 195 women and children across 3 groups: women with untreated depression in pregnancy, women treated with antidepressants and control women. Data were collected across pregnancy, postpartum and until 4 years for mother and child. Maternal depression was established at baseline with the Structured Clinical Interview for DSM-IV. Antidepressant exposure, including type, dose and timing, was measured through repeated self-report across pregnancy and the postpartum, medical records at delivery and in cord blood samples collected at delivery. Child sensorimotor and visuospatial outcomes were assessed at 4 years of age with four subtests from the NEPSY-II. Our study found for sensorimotor development, visuomotor precision completion time was associated with better performance for antidepressant exposed children compared to those with mothers with untreated depression. Yet another measure of sensorimotor development, motor manual sequences, was poorer in those exposed to antidepressants. One subtest for visuospatial processing, block construction, was associated with poorer performance in antidepressant-exposed children who had poor neonatal adaptation and those exposed to a higher dose of antidepressant. These findings suggest an inconsistent association between sensorimotor development and antidepressant use in pregnancy. However, the findings for visuospatial processing would support further exploration of antidepressant associated poor neonatal adaption and later motor development

Language impairment in children aged 5 and 8 years after antiepileptic drug exposure in utero – the Norwegian Mother and Child Cohort Study

Background and purpose: The purpose was to examine the consequences of antiepileptic drug (AED) exposure during pregnancy on language abilities in children aged 5 and 8 years of mothers with epilepsy. Methods: The study population included children of mothers with and without epilepsy enrolled in the Norwegian Mother and Child Cohort Study 1999–2008. Mothers prospectively provided information on epilepsy diagnosis, AED use during pregnancy and the child’s language abilities at age 5 and 8 years, in questionnaires with validated language screening tools. AED concentrations in gestation week 17–19 and in the umbilical cord were measured. Results: The study population included 346 AED‐exposed and 388 AED‐unexposed children of mothers with epilepsy, and 113 674 children of mothers without epilepsy. Mothers of 117 and 121 AED‐exposed children responded to the questionnaires at age 5 and 8 years, respectively. For AED‐exposed children, the adjusted odds ratio for language impairment was 1.6 [confidence interval (CI) 1.1–2.5, P = 0.03] at age 5 years and 2.0 (CI 1.4–3.0, P < 0.001) at age 8 years, compared to children of mothers without epilepsy. Children exposed to carbamazepine monotherapy had a significantly increased risk of language impairment compared to control children at age 8 years (adjusted odds ratio 3.8, CI 1.6–9.0, P = 0.002). Higher maternal valproate concentrations correlated with language impairment at age 5 years. Periconceptional folic acid supplement use protected against AED‐associated language impairment. Conclusion: Foetal AED exposure in utero is associated with an increased risk of language impairment in children aged 5 and 8 years of mothers with epilepsy. Periconceptional folic acid use had a protective effect on AED‐associated language impairment.publishedVersio

Relationship Between Time Consumption and Quality of Responses to Drug-Related Queries : A Study From Seven Drug Information Centers in Scandinavia

Paid Open Acces

Physiologically-Based Pharmacokinetic Models for CYP1A2 Drug-Drug Interaction Prediction: A Modeling Network of Fluvoxamine, Theophylline, Caffeine, Rifampicin, and Midazolam

This study provides whole-body physiologically-based pharmacokinetic models of the strong index cytochrome P450 (CYP)1A2 inhibitor and moderate CYP3A4 inhibitor fluvoxamine and of the sensitive CYP1A2 substrate theophylline. Both models were built and thoroughly evaluated for their application in drug-drug interaction (DDI) prediction in a network of perpetrator and victim drugs, combining them with previously developed models of caffeine (sensitive index CYP1A2 substrate), rifampicin (moderate CYP1A2 inducer), and midazolam (sensitive index CYP3A4 substrate). Simulation of all reported clinical DDI studies for combinations of these five drugs shows that the presented models reliably predict the observed drug concentrations, resulting in seven of eight of the predicted DDI area under the plasma curve (AUC) ratios (AUC during DDI/AUC control) and seven of seven of the predicted DDI peak plasma concentration (Cmax ) ratios (Cmax during DDI/Cmax control) within twofold of the observed values. Therefore, the models are considered qualified for DDI prediction. All models are comprehensively documented and publicly available, as tools to support the drug development and clinical research community