Inadequate Prescription Research Articles

Spanish list of potentially inappropriate drugs in the elderly (ES-PIA project).

In the last decades, different criteria have been developed for detecting inappropriate prescription in older patients. In Spain, translations and adaptations of international lists are available but it would be necessary a national list which could cope with the peculiarities of our health system, existing pharmaceutical market, and prescription habits. We propose in this project the creation of a Spanish potentially inappropriate drugs list which could be applicable in our clinical scenario. We use a Delphi method involving 25 experts from different backgrounds (Clinical Pharmacology, Geriatrics, Rational Use of Drugs and Pharmacy, Primary Care and Pharmacoepidemiology, and Pharmacovigilance) that were asked to participate in two-round questionnaires. For analysis, current recommendations of Worth and Pigni were applied, and every statement was classified into one of three groups: strong, moderate, or low agreement. Statements with strong agreement were accepted to be part of the inadequate prescription list. Moderate agreement statements were selected to enter the second questionnaire, and statements with low agreement were further analyzed to determine if it was due to heterogeneity or due to dispersion in the answers. The first questionnaire consisted of 160 proposed sentences, of which 106 reached a high agreement, 32 a moderate agreement, and 22 a low agreement. All sentences proposed in the second questionnaire reached a strong agreement. The total accepted sentences were 138. We offer a list of inadequate prescription in older patients adapted to the Spanish pharmacopeia and according to the prescription habits in our environment.

Impacto de un programa de intervención destinado a la mejora de la prescripción potencialmente inapropiada en pacientes ancianos hospitalizados

Introduction and objectivesPotentially inappropriate prescription (PIP) is common in elderly people. It has become a global public health problem due to its association with adverse drug effects (ADE), increased morbidity and mortality, emergency care visits and resource use. The main aim of this study was to determine whether the use of a notification program of PIP in elderly patients admitted in the hospital led to a reduction of their prescription. MethodA quasi-experimental before-after study was conducted. PIP were identified by using Beers (2012 update) and STOPP-START criteria (2008 version). An individualized report on PPI was prepared and the effect of this intervention was evaluated. Results174 patients were included who presented 284 PIP. 54% (153) of the recommendations were accepted. Barthel index was the only variable that proved to contribute to the presence of PIP modifications. The patients whose PIP drugs were modified were significantly more dependent (p=0.005), presented cognitive impairment (p=0.001) and were more institutionalized (p=0.039) than those without any modifications. There were fewer readmissions, emergency care visits and mortality within six months after intervention comparing patients with and without PIP modifications, but without significant differences. 32 ADE were detected, 29 related with PIP drugs. Adverse events were significantly associated with PIP drugs, versus other medications (p<0.001), odds ratio 242.5 (CI95%: 56.9-1023.6). ConclusionsReview of medication in elderly patients, along with the use of tools that help in the identification of dangerous drugs, entail a reduction of inadequate prescription and significantly contribute to the continuous improvement of chronic medication in elders.

A new approach of assessing patient safety aspects in routine practice using the example of "doctors handwritten prescriptions".

Aims and objectivesTo test the method of self‐ and external assessment as a feedback system to decrease illegibility and incorrectness of handwritten prescriptions and to reduce additional workload for nursing staff.BackgroundIllegibility and incorrectness of handwritten prescriptions occur very often and are the most crucial factors affecting patient safety.DesignSelf‐ versus external assessment using a 15 items checklist.MethodsNurses randomly selected five fever charts of their wards. Each fever chart was self‐ as well as externally assessed. Nurses and doctors took part in the self‐assessment, and the external assessment was performed by external experts. According to a monitor suspension system, assessment results were considered “green,” “yellow” or “red.” After the first assessment and issuing feedback of the results “red” scored wards by the external assessment, additional trainings were performed. Thereafter, a second assessment was performed to rate eligibility and completeness of prescriptions. The research and reporting methodology followed squire 2.0.ResultsIn total, 580 fever charts were self‐ as well as externally assessed (290 in each of the two assessment periods). Out of the 58 participating wards, 31 were surgical and 27 were non‐surgical wards. Averaging over all checklist items, surgical and non‐surgical wards improved only slightly over time. Linear regression models for ward means showed that there were significant improvements over time for non‐surgical wards.ConclusionsThis method directly involves those who commit errors and stimulate learning from errors. The approach of self‐ and external assessment was a useful instrument to detect inadequate prescriptions and to monitor improvements.Relevance to clinical practiceSignificant improvements were achieved regarding correctness and legibility of handwritten prescription and helped to decrease additional workload for nursing staff and thereby enhanced patient safety.

Acute Otitis Media in Childhood - Use of Guidelines for Diagnosis and Treatment in Emergency Rooms

Background: AOM is characterized by its high prevalence and morbidity but low lethality. It is estimated that 70% of children will have had one episode prior to completing five years of age Compliance with the guidelines for acute otitis media (AOM) may avoid complications. This study aimed at determining whether pediatricians follow the guidelines for AOM management. Methods: A prospective, cross-sectional study involving pediatricians working in emergency centers in Recife. A specific questionnaire was used to collect data. Results: Of the 71 pediatrics interviewed around 98% gave importance to crying/irritability and otalgia when diagnosing otitis and all recognized the significance of otorrhoea. All the professionals gave importance to bulging tympanic membrane, 98.6% to acute tympanic membrane perforation, 97.1% to purulent effusion and 46.5% to bilateral hyperemia of the tympanic membrane. Regarding antibiotic therapy, 70.4% used standard doses of amoxicillin as first-line treatment (81.7% prescribing for 10 days). Furthermore only 47.9% double the dose in case of therapeutic failure. Conclusion: Pediatricians working in emergency departments need to be better informed about the guidelines to decrease inappropriate prescription of antibiotics for AOM. We believe that adoption of the “wait and see” strategy, even in emergency rooms, would be an important means of reducing the inadequate prescription of antibiotics in cases of AOM, thus contributing towards reducing bacterial resistance.

Trends and Predictors of Oral Anticoagulation in Patients with Atrial Fibrillation: A Serial Cross-Sectional Study from 2011 to 2016

Abstract Background: Despite the efficacy of vitamin K antagonists against stroke in patients with atrial fibrillation (AF), the underuse of this therapy is well documented. Objectives: To evaluate trends and predictors of oral anticoagulants utilization in patients with AF. Methods: Observational, retrospective, serial cross-sectional study between 2011-2016. Comparisons between groups were performed using the Student t, Mann-Whitney and Chi-square tests. Logistic regression was used to identify independent predictors of anticoagulation. A p value < 0.05 was considered significant. Results: A total of 377 patients were analyzed. The mean age was 70 ± 15 years; 52% were male and 75% were anticoagulated (20% with VKA and 55% with DOAC). Over 5 years, the overall frequency of anticoagulation increased by 22.4%. The use of DOACs increased from 29% to 70%, whereas the use of VKA decreased from 36% to 17%. The use of antiplatelet agents alone also fell from 21% to 6%. The predictors of anticoagulation were previous episodes of AF (OR 3.1, p < 0.001), hypertension (OR 3.0, p < 0.001) and HASBLED score (OR 0.5, p < 0.001). The predictors of DOAC use were serum creatinine (OR 0.2, p = 0.002), left atrial size (OR 0.9, p = 0.003) and biological valve prosthesis (OR 0.1, p = 0.007). Of the 208 patients using DOACs, 63 (30%) received inadequate prescriptions: 5 with severe drug interactions and 58 with incorrect dosing. Conclusions: Between 2011 and 2016, DOACs were rapidly incorporated into clinical practice, replacing AVKs and antiplatelets, and contributing to greater use of anticoagulation in patients with AF.

Assessing the overall medication use by elderly people in a Brazilian hospital using the start/stopp criteria version 2

To estimate the frequency of the use of medicines listed in the Screening Tool to Alert Doctors to the Right Treatment (START) and Screening Tool of Older Person’s Prescriptions (STOPP) criteria version 2 among the elderly. A cross-sectional study was conducted on elderly who were attended in medical clinic and cardiology sectors in a hospital in southern Brazil attended at a hospital from February through September 2016. A data-collection tool was used to obtain information on variables, such as demographic and clinical data, and medications used before and during the hospitalization period. The adequacy of the medicines taken was examined with regard to omission (START) or inappropriate use (STOPP). This study was approved by the Research Ethics Committee of the University of Southern Santa Catarina. A total of 307 subjects were included in the final sample. The mean age was 75.2 years (SD = 8; range 65-102). Of the total, 93.5% had had at least one potential prescribing omission (PPO) listed in the START criteria, whereas 95.4% used at least one medicine of the STOPP criteria. PPO was significantly associated with lower mean age (74.9 years, SD = 7.9 versus 79.0 years, SD = 8.8) among the elderly who did not have PPOs detected by the START criteria (p-value=0.03). Furthermore, PPO was associated with longer hospital stay (18 versus 9 days; p-value=0.03). This study revealed inadequate prescription affecting 99.3% of the participating patients. To the best of our knowledge, this was the first to use the START and STOPP criteria, version 2, in Brazil.

Antimicrobial agent prescription: a prospective cohort study in patients with sepsis and septic shock.

To assess the true association between appropriate prescription of antibiotics and prognosis in patients with sepsis, a key issue in health care and quality improvement strategies. Prospective cohort study in three university hospitals to determine whether the empirical prescription of antibiotics was adequate or inadequate, and to compare hospital death rates and length of stay according to different classifications of antibiotics prescription. Logistic regression models for risk estimation were fitted. A total of 705 patients with severe sepsis were included. No differences were found in positive-culture patients (n=545) regarding the risk of death with insufficient spectrum antibiotics, compared to patients who received adequate spectrum antibiotics (OR=0.90; 95% CI=0.55-1.48). Delay in initiating antibiotics was not associated with the risk of death in patients with adequate spectrum of antibiotics, either with positive (OR=1.04; 95% CI=0.99-1.08) or negative cultures (OR=0.98; 95% CI=0.92-1.04). There were no differences in the length of hospital stay, according to the antibiotic prescription (median 11days, IQR=7-18days for the whole cohort). No associations were found between inadequate antibiotic prescription or delay to initiate therapy and mortality or length of stay.

PMD5 - Fluid Overload and Diuretics Prescribing in Chronic Kidney Disease Patients

Fluid overload is a major presentation in late chronic kidney disease (CKD) patients and is frequently present in mild to moderate CKD cases. Abnormal fluid status has been associated with hypertension, congestive heart failure (CHF), left ventricular hypertrophy (LVH) as well as edema (pulmonary, pedal). Diuretics are frequently prescribed to control blood pressure and symptomatic relief of fluid overload. The clinical assessment of fluid status is relatively difficult and diuretics are mostly prescribed on the basis of high blood pressure and physical signs of edema in clinical settings. Although edema can roughly estimate excess extravascular volume but it is of limited value in assessing excess intravascular volume. Current study was conducted to assess fluid status and prescribing pattern of diuretics among CKD patients. Bioimpedance spectroscopy was used to assess fluid status followed by patient routine visit to consulting physician. Neither patient nor physician was aware of BCM results. A total of 312 patients with moderate to severe CKD were enrolled. Overall diuretic use was observed in 144 (46%) patients. Out of 144 patients, majority 81 (56%) of the patients were hypervolemic, followed by euvolemic 44 (30.5%) and hypovolemic 19(13.1%) patients. Loop diuretics were predominantly prescribed in hypervolemic (79%) patients while thiazides were more frequently prescribed in hypovolemic (71%) and euvolemic (68%) patients. Our findings suggest inadequate prescribing of diuretics in hypervolemic patients while over prescribing in hypovolemic and euvolemic patients. Implementation of bioimpedance spectroscopy in routine clinical practice is therefore highly recommended.

Pre Frail 80: Multifactorial Intervention to Prevent Progression of Pre-Frailty to Frailty in the Elderly.

Preventing or delaying frailty has important benefits in the elderly, and in health and social services. Studies have demonstrated the effectiveness of multifactorial interventions in the frail elderly, but there are fewer studies on community-dwelling pre-frail individuals. Identifying pre-frail individuals susceptible to intervention could prevent or delay frailty and its consequences and associated disability and might reverse the state from pre-frail to robust. To evaluate a multifactorial, interdisciplinary primary care intervention in community-dwelling pre-frail elderly patients aged ≥ 80 years. Randomized clinical trial in a Barcelona primary healthcare centre. We included 200 community-dwelling subjects aged ≥ 80 years meeting the Fried pre-frailty criteria. Participants were randomized to intervention and control groups. The intervention group received a 6-month interdisciplinary intervention based on physical exercise, Mediterranean diet advice, assessment of inadequate prescribing in polypharmacy patients and social assessment, while the control group received standard primary healthcare treatment. 173 pre-frail participants (86.5%) completed the study; mean age 84.5 years, 64.5% female. At twelve months, frailty was lower in the intervention group (RR 2.90; 95%CI 1.45 to 8.69). Reversion to robustness was greater in the intervention group (14.1% vs.1.1%, p <0.001). Functional and nutritional status, adherence to Mediterranean diet, quality of life, and functional mobility were improved in the intervention group (p ≤0.001). A multifactorial, interdisciplinary primary healthcare intervention focused on physical exercise, nutrition, review of polypharmacy and social assessment prevented frailty in pre-frail elderly patients, and improved functional capacity, quality of life and adherence to the Mediterranean diet.

Вопросы спектра и локальной чувствительности Е. coli у пациенток с острой неосложненной инфекцией нижних мочевыводящих путей – обзор результатов исследования M. Seitz и собственных наблюдений

Acute uncomplicated lower urinary tract infections (AULUTI) are one of the most common diseases in urological practice. The management of cystitis is commonly based on antibacterial therapy. Despite the high efficiency, inadequate prescription of antibiotics leads to an increase in microorganisms resistance. In light of these matters, the selection of antibacterial agents to which the sensitivity of bacteria is the highest is becoming increasingly challenging. To estimate the spectrum and local sensitivity of E. coli in patients with AULUTI. The present study analyzed the results of bacterial culture sampled from 45 patients with AULUTI. The mean age of the patients was 44+/-17 years. All bacterial cultures were obtained in out-patient settings in the framework of a multicenter initiative study on the prevention of recurrent AULUTI with d-mannose. Microbiological studies of the urine of patients with AULUTI revealed the growth of E. coli in concentrations ranging from 104 to 107 CFU/ml. Assessment of sensitivity demonstrated 100% sensitivity of Escherichia coli to fosfomycin trometamol. According to the findings of microbiological studies, the patients with the AULUTI retain the highest sensitivity level of E.coli to phosphomycin trometamol, which allows it to be used as a first-line drug.

SIADH with Severe Hyponatremia in an Elderly Man with Herpes Zoster Infection: A Causal or Casual Association?

Syndrome of inappropriate antidiuretic hormone (SIADH) secretion is the most common cause of hypotonic hyponatremia in hospitalized patients. An elderly man with severe symptomatic hyponatremia (109 mEq/L) was diagnosed with SIADH that was likely secondary to large cutaneous herpes zoster (HZ) infection. Hypertonic saline and tolvaptan improved the patient's sodium levels and clinical condition. A one month after discharge, tolvaptan was withdrawn, due to inadequate prescription criteria, after which hyponatremia relapsed several times and was properly treated; eventually fever and sopor occurred and the patient died. SIADH secondary to HZ may induce life-threatening and long-lasting hyponatremia, which requires a prompt diagnosis and treatment.

Drug Prescribing for Patients with Chronic Kidney Disease in General Practice: a Cross-Sectional Study

Many drugs require dose adjustment or are contraindicated in patients with chronic kidney disease (CKD) to avoid adverse events. The aims of this study were to assess if medication was appropriately dose adjusted in patients with CKD in primary care, to identify medications that were frequently prescribed inappropriately and to identify factors predicting mal-prescription. We conducted a cross-sectional observational study in 34 general practioners' offices, assessing the medication of patients with CKD stage ≥ 3 according to the corresponding pharmaceutical product information. Additional information was extracted from recommendations of scientific societies and regulatory authorities. Contraindicated and overdosed medications were identified. Predictive factors for inadequate prescribing were analyzed with multiple logistic regression. 589 patients (Ø 78 years, 63 % female) with CKD stage ≥ 3 were included. A total of 5102 medications were extracted from the medication sheets (94,6 % regular, 5,4 % "as needed"). 4,2 % were judged as being inadequate according to pharmaceutical information (2,1 % contraindicated, 2,1 % overdosed). 173 patients (29 %) had ≥ 1 inadequate prescription. The proportion of inadequate prescriptions fell to 3,5 % after adjustment for the most recent recommendations of scientific societies and regulatory authorities. Most frequent inappropriate prescriptions were ACE-inhibitors, diuretics, oral antidiabetic drugs, methotrexate and potassium supplements. Most important predictors for inadequate prescriptions were CKD stage ≥ 3b and number of medications. A quarter of all patients had a least one inadequate prescription. The overall proportion of inadequately prescribed drugs was low. Adjustment for recommendations by scientific societies and regulatory authorities further reduced the number of inadequate prescriptions. Valid data on the clinical relevance of inadequate prescriptions is scarce and further research is required. Because of the time and effort needed to assess all medications, future quality improvement projects should focus on CKD stage ≥ 3b, patients with polypharmacy and crucial medication.

Protein-energy adequacy and nutritional evolution of preterm infants in neonatal intensive care unit

ABSTRACT Objective To evaluate the prescription of protein-calorie nutrition and its adequacy to the requirements of preterm newborns. Methods Prospective study with 30 preterm infants from a neonate intensive unit care. Anthropometric and nutritional therapy data were collected daily. Nutritional demands were defined according to the national guidelines. Protein-calorie nutritional support was considered adequate when it reached 70% of the calculated demand. The evolution of nutritional status was evaluated according to the growth curves of preterm infants. Statistical analyses were performed with the Statistical Package for Social Sciences 20.0, at a 5% significance level. Results The means of demand, prescription and infusion significantly differed from each other. The values of calories and proteins prescribed and infused were inadequate according to the calculated ones. There was no significant difference between the volume of prescribed and administered nutrition (p&gt;0.05). At birth, 30% of the children were small, 66.7% were adequate, and 3.3% were large for gestational age. At discharge, the percentages were 33.3%; 63.3%; 3.3%, respectively. The values at birth significantly differed from those at discharge (p&lt;0.01). Conclusion In the Unit of Neonatal Care studied, inadequate nutrient prescription and support is a factor that can compromise the nutritional status of the newborns at hospital discharge.

Which drugs in Hemato-Oncology are Unnecessary or Inappropriate for Use in the Elderly?

There is a vast amount of drugs and therapeutic regimens available today to treat hemato-oncological diseases. This offers new opportunities to close known gaps of undertreatment in older individuals with cancer, but also increases the risk of overtreatment in this patient group. Currently available criteria (drug listings) for potentially inadequate prescribing in the elderly are not matured enough to serve hemato-oncologists as a guidance when trying to identify unnecessary or inappropriate cancer medication in routine clinical practice. In some clinical situations (e. g., decision-making for adjuvant treatment), online tools that allow for a rough prediction of remaining life expectancy (without or with cancer) as well as chemotherapy toxicity could help todetect risks of overtreatment in individual patients, however. Avoiding chemotherapy in distinct therapeutic situations has become possible for some hematological and solid tumors due to a growing number of novel targeted (i. e. non-cytostatic) drugs. This development appears of particular benefit for elderly patients. The present review discusses tools that generally could support the identification of overtreatment in older patients with such diseases. Drug examples are presented for some common hemato-oncological entities.

Home Medication Cabinets and Medication Taking Behavior of the Staffs in a University in China

Background: A growing sum of medicines is stored in home medication cabinets in China, with the behavior of self-medication increasing. Although responsible self-medication can help prevent and treat ailments that do not need professional consultation, it bears the risk of misuse of medicines issued on prescription due to inadequate prescription medicine administration. Objective: The objective of this study was to investigate the condition and safety of medication storage and intended self-medication in a University in China. Method: The study was conducted over 10 month period (May 2015–March 2016) and involved a random sample of households. The questionnaire survey and personal insight into household medicine supplies was performed by a team of trained pharmacy staffs. Interviewees (N = 398, aged 16–88 y) were visited door to door and the home medication cabinets were catalogued after the participants were interviewed. Results: The majority (89.71%) households have home medicine cabinets. The total number of medicine items in the 398 households was 5600, with a median of 14 per household. The most frequently encountered categories of registered medicines were cough and cold medcines (47.8%), antibacterials for systemic use (30.0%), topical products for joint and muscular pain(26.1%), vitamins (23.2%), medication for functional gastrointestinal disorders (23.2%), oral and external forms have not kept separately(55.1%). The most treatment related problems recorded were curative effect not ideal (57.9%). 68% of the sample population would choose doctors as medication consultation object about medicines purchased. Conclusion: Large sum of medicines were found per household, with a high prevalence of cough and cold medcines. Public services in China, mainly government and health organizations, need put more effort on educating people on how to store medicines, as well as finding a way to raise awareness of the public in promoting behavioral change about medication use.

Análisis de la utilización de inhibidores de la bomba de protones en Atención Primaria

ObjectiveThe increase in the consumption of anti-ulcer drugs is accompanied by a high rate of incorrect use. The objectives of this study were to analyse the adequacy of repeat prescriptions of proton pump inhibitors (PPIs) in a Medical Centre, and to evaluate the efficacy of an improvement intervention. Material and methodA cross-sectional, descriptive and observational study of prevalence was conducted on patients in a medical centre under treatment with PPIs for at least 3consecutive months (November 2016-January 2017). An analysis was performed that included the indication, dosage and time of treatment with PPIs, drug interactions, and possible risks that could be related with their use. An intervention was carried out to optimise rational and efficient prescribing of these medicines. ResultsA total of 703 patients were included in the study, which is 5.4% of the total adult patients that are assigned to the centre. Adequacy criteria were not met by 436 (62.0%). Of these, 52.5% were women, 70.0% were over 65 years old, and had been on treatment for a mean of 2.7 ± 1.9 years. Interactions were observed in 48.1%, and 29.0% had some risk factors. After the intervention, the inadequate prescribing was corrected in 112 (25.7%) patients, which was a reduction of 46.1% (P<.001). ConclusionsThere is a high prevalence of prescription and inadequacy of PPIs in the long term. This suggests that it is necessary to improve training of professionals to strengthen rational use and to reduce risks. The launch of an intervention programme has led to the revision and optimisation of treatments.

Analgesic use in patients with knee and/or hip osteoarthritis referred to an outpatient center: a cross-sectional study within the Amsterdam Osteoarthritis Cohort.

Although analgesics are widely recommended in current guidelines, underuse and inadequate prescription of analgesics seem to result in suboptimal treatment effects in patients with knee and/or hip osteoarthritis (OA). This study aimed (i) to describe the use of analgesics; and (ii) to determine factors that are related to analgesic use in patients with knee and/or hip OA referred to an outpatient center. A cross-sectional study with data from 656 patients with knee and/or hip OA referred to an outpatient center (Amsterdam Osteoarthritis (AMS-OA) cohort) was conducted. Self-reported use of analgesic (yes/no) was administered and subdivided into acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs, including coxibs) and opioids. Logistic regression analyses were performed to analyze the association between analgesic use and disease-related, predisposing and enabling factors. Analgesic use was reported by 63% of the patients, with acetaminophen, NSAIDs and opioid use reported by 50, 30 and 12%, respectively. Factors related to analgesic use were higher pain severity, longer duration of symptoms, higher radiographic hip OA severity, overweight/obesity and psychological distress. These factors explained 21% of the variance of analgesic use. More than one-third of patients with established knee and/or hip OA referred to an outpatient center did not use any analgesics. Although multiple, mostly disease-related associated factors were found, analgesic use remained predominantly unexplained. Our study seems to indicate that prescription of analgesics should be guided more dominantly by clinical symptoms and needs, and preceded by a thorough shared decision-making process between patient and physician.

ASSESSMENT OF THE EFFECTIVENESS OF ANTICONVULSANT THERAPY IN PREGNANT WOMEN WITH EPILEPSY

96 pregnant women with epilepsy aged 17 years to 41 years have been studied. Partial forms of epilepsy have been determined in 65 women (68%), generalized forms - in 31 (32%). In 11 (11%) women seizures first appeared during this pregnancy. The seizure frequency increased in 23 (27%), decreased in 21 (25%), remained unchanged in 14 (16%), 27 (32%) of women were seizure-free during pregnancy (10 of them were seizure-free during one year before pregnancy). 68 (71%) pregnant women received antiepileptic drugs (AED), 22 (23%) - did not received, 6 (6%) stopped taking AEDs from 7-9 weeks of pregnancy. Monotherapy received 63 (93%), polytherapy 5 (7%) of pregnant women. In monotherapy the seizure frequency increased in 18 (30.5%), decreased in 10 (16.95%), remained unchanged in 10 (16.95%), 21 (35.6%) pregnant women remained seizure-free. In polytherapy seizure frequency increased in 2 women, decreased in 2, remained unchanged in 1. We have identified the inadequate prescribing of the carbamazepine (CBZ) in Juvenile Absence Epilepsy in 1 pregnant and recommended to replace CBZ by other AED after delivery; correction of therapy in 9 women was conducted before (in 2) and during (in7) pregnancy. As result of our correction of the therapy seizure frequency decreased in 5, remained unchanged in 1 pregnant women, 3 women were seizure-free. In general, as result of dynamic monitoring of pregnant women and appropriate choice of AED and its dose the significant control of seizures (seizure frequency decreased in 25%, seizure-free women - 32%) has been achieved in majority of surveyed pregnant women with epilepsy.

Combatting pain after orthopedic/trauma surgery- perioperative oral extended-release tapentadol vs. extended-release oxycodone/naloxone

BackgroundHigh post-operative pain scores after “minor” orthopedic/trauma surgery are in part attributed to inadequate prescription of opioid analgesics. Novel concepts aiming to achieve sufficient analgesia while minimizing opioid-related side effects by avoiding fluctuating plasma levels are based on perioperative oral administration of extended-release opioids beginning with the first dose pre-operatively. This is the first study to evaluate analgesic efficacy and side effect rates of extended-release tapentadol compared to oxycodone/naloxone following orthopedic/trauma surgery.MethodsThis randomized, observer-blinded, active-controlled prospective clinical trial had 2 co-primary endpoints: (1) Analgesic efficacy: Mean pain level on a numeric rating scale (NRS) from 0 to 10 during exercise over 5 days. (2) Safety: Side effect sum score of the following events: Nausea, vomiting, constipation, sedation, vertigo, somnolence. The study was powered to detect superiority of tapentadol for at least one endpoint pending statistical proof of non-inferiority for both endpoints in a first step.ResultsTwo hundred sixty-six trauma patients were randomized to receive either tapentadol (n = 133) or oxycodone/naloxone (n = 133). Analgesic efficacy: Mean (±SD) daily pain levels in the first five post-operative days were 2.8 ± 1.3 in both groups. Mean maximum pain intensity during exercise in the first 24 h after surgery was 3.8 ± 1.9 (tapentadol) and 3.8 ± 2.1 (oxycodone/naloxone). Statistically tapentadol was non-inferior but not superior to oxycodone/naloxone. Safety: Vomiting on day 1 occurred in 11%, constipation in 35% of the tapentadol patients and in 16% and 30% of the oxycodone/naloxone patients (p = 0.60 and 0.33), respectively. The incidence of sedation/ vertigo was <10%, that of somnolence <2% in both groups (p > 0.3, respectively). The sum score of side effect events was 51% in the tapentadol vs. 49% in the oxycodone/naloxone group; risk difference 3% [95% CI, −8 to 14%]; p = 0.6). Non-inferiority of tapentadol could not be concluded as the pre-defined non-inferiority margin was exceeded.ConclusionsWith both concepts, mean maximum pain intensity during exercise within the first 24 h after orthopedic/trauma surgery was reduced to a score of <4. This analgesic efficacy came at the cost of mainly gastro-intestinal side effects. Thus, we now use a prophylaxis against nausea and vomiting and pre-emptive laxatives as part of these concepts.Trial registrationhttps://eudract.ema.europa.eu (EudraCT- Nr. 2011–003238-15); October 24th, 2012.

The Spectroscopy and H-band Imaging of Virgo Cluster Galaxies (SHIVir) Survey: Scaling Relations and the Stellar-to-total Mass Relation

Abstract We present parameter distributions and fundamental scaling relations for 190 Virgo cluster galaxies in the SHIVir survey. The distribution of galaxy velocities is bimodal about V circ ∼ 125 km s−1, hinting at the existence of dynamically unstable modes in the inner regions of galaxies. An analysis of the Tully-Fisher relation (TFR) of late-type galaxies (LTGs) and the fundamental plane (FP) of early-type galaxies (ETGs) is presented, yielding a compendium of galaxy scaling relations. The slope and zero-point of the Virgo TFR match those of field galaxies, while scatter differences likely reflect distinct evolutionary histories. The velocities minimizing scatter for the TFR and FP are measured at large apertures where the baryonic fraction becomes subdominant. While TFR residuals remain independent of any galaxy parameters, FP residuals (i.e., the FP “tilt”) correlate strongly with the dynamical-to-stellar mass ratio, yielding stringent galaxy formation constraints. We construct a stellar-to-total mass relation (STMR) for ETGs and LTGs and find linear but distinct trends over the range M * = 108–11 M ⊙. Stellar-to-halo mass relations (SHMRs), which probe the extended dark matter halo, can be scaled down to masses estimated within the optical radius, showing a tight match with the Virgo STMR at low masses; possibly inadequate halo abundance matching prescriptions and broad radial scalings complicate this comparison at all masses. While ETGs appear to be more compact than LTGs of the same stellar mass in projected space, their mass-size relations in physical space are identical. The trends reported here may soon be validated through well-resolved numerical simulations.