Ermindo Paolo | University of Lausanne (original) (raw)

Papers by Ermindo Paolo

Swiss Medical Weekly

Background: Many medicines used in newborns, infants, children and adolescents are not licensed (... more Background: Many medicines used in newborns, infants, children and adolescents are not licensed ("unlicensed") or are prescribed outside the terms of the marketing authorization ("off-label"). Several studies have shown that this is a common practice in various healthcare settings in the USA, Europe and Australia, but data are scarce in Switzerland. Objectives: The aim of our prospective study was to determine the proportion of unlicensed or off-label prescriptions in paediatric patients. Methods: This pilot study was conducted prospectively over a six month period in the department of paediatrics of a university hospital. Results: Sixty patients aged from three days to 14 years were included in the study. A total of 483 prescriptions were written for the patients. More than half of all prescriptions (247; 51%) followed the terms of the marketing authorization. 114 (24%) were unlicensed and 122 (25%) off-label. All patients received at least one unlicensed or offlabel medicine. Conclusion: The use of unlicensed or off-label medicines to treat children was found to be common. Cooperation between the pharmaceutical industry, national regulatory authorities, clinical researchers, healthcare professionals and parents is required in order to ensure that children do not remain "therapeutic orphans".

European Journal of Pediatrics, 2020

Lactic acidosis is a common complication of status asthmaticus in adults. However, data is sparse... more Lactic acidosis is a common complication of status asthmaticus in adults. However, data is sparse in children. The aim of this study was to describe the prevalence and risk factors for lactic acidosis in children hospitalised for acute moderate or severe asthma. A total of 154 children 2–17 years of age were enrolled in a prospective observational study conducted in a tertiary hospital. All had capillary blood gas assessment 4 h after the first dose of salbutamol in hospital. The primary endpoint was the prevalence of lactic acidosis. Potential contributing factors such as age, sex, BMI, initial degree of asthma severity, type of salbutamol administration (nebuliser or inhaler), steroids, ipratropium bromide, and glucose-containing maintenance fluid represented secondary endpoints. All in all, 87% of patients had hyperlactatemia (lactate concentration > 2.2 mmol/l). Lactic acidosis (lactate concentration > 5 mmol/l and anion gap ≥ 16 mmol/l) was observed in 26%. In multivariat...

European Journal of Pediatrics, 2020

The name of the first author of the above mentioned published article has a double last name. The... more The name of the first author of the above mentioned published article has a double last name. The family name should have been "Ruman-Colombier" instead of "Ruman". The original article has been corrected. Publisher's note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Journal of Asthma, 2019

Abstract Introduction: Correct technique with a pressurized metered-dose inhaler (pMDI) equipped ... more Abstract Introduction: Correct technique with a pressurized metered-dose inhaler (pMDI) equipped with a valved holding chamber (VHC) or spacer provides an important advantage for adequate control of asthma and virus-induced wheezing in young children. The aim of this study was to assess the ability and knowledge of physicians and nurses to use a pMDI with a masked VHC in two pediatric emergency units. Methods: Study design: Two-center observational study. Inhaler use technique was assessed in 50 physicians and 50 nurses using a child mannequin and a validated videotaped nine-step scoring method. The participants’ knowledge was evaluated by a questionnaire. Results: The inhalation technique was perfectly mastered by 49% of the study participants and almost perfectly mastered by another 34% (mean score 8.3 ± 0.7; range 5–9). Nurses were more likely than doctors to demonstrate the technique perfectly (66% vs. 32%, p < 0.05). The two most common errors were forgetting to shake the pMDI between two consecutive puffs (38% of the participants) and putting the patient in an incorrect position (11%). About half of the participants reported that they checked each patient’s inhalation technique at every opportunity and knew how to clean the VHC. A large majority did not employ a reliable method to determine the amount of medication remaining in pMDIs without a counter. Conclusion: Healthcare professionals’ practical skills and knowledge on inhalation therapy were not completely mastered and could be improved with a mandatory training program.

European Journal of Pediatrics, 2018

Newborns are often exposed to medication errors in hospitals. Identification and understanding th... more Newborns are often exposed to medication errors in hospitals. Identification and understanding the causes and risk factors associated with medication errors will help to improve the effectiveness of medication. We sought to compare voluntary incident reports and direct observation in the identification of medication errors. We alsoidentifiedcorresponding risk factors in order to establish measures to prevent medication errors. Medication errors identified by a clinical pharmacist and those recorded in our incident reporting system by caregivers were analysed. Main outcomes were rates, type and severity of medication error, and other variables related to medication errors. Ultimately, 383 medication errors were identified by the clinical pharmacist, and two medication errors were declared by caregivers. Prescription errors accounted for 38.4%, preparation errors for 16.2%, and administration errors for 45.4%. The two variables significantly related to the occurrence of medication errors were gestational age < 32.0 weeks (p = 0.04) and the number of drugs prescribed (p < 0.01). Conclusion: Caregivers underreported the true rate of medication errors. Most medication errors were caused by inattention and could have been limited by simplifying the medication process. Risk of medication errors is increased in newborns < 32.0 weeks and increases with the number of drugs prescribed to each patient. What is Known: • Newborns in hospitals are particularly susceptible to medication errors. • Identification and understanding the reasons for medication errors should help us to establish preventive measures to reduce the occurrence of such errors. What is New: • Direct observation of the medication process, though time consuming, is essential to accurately assess the frequency of medication errors, which are underreported by caregivers. • Most medication errors are caused by inattention and could be limited by simplifying the medication process. • The risk of medication errors was significantly increased in very preterm newborns (< 32 weeks) and when the number of prescription per patient increased.

European Journal of Hospital Pharmacy, 2017

Objective We aimed to monitor the physicochemical stability of prostaglandin E 1 (PGE 1) 1.5 and ... more Objective We aimed to monitor the physicochemical stability of prostaglandin E 1 (PGE 1) 1.5 and 15 µg/mL in 10% dextrose stored in polypropylene syringes. Methods We developed a liquid chromatography-high resolution mass spectrometry (LC-HRMS) method to detect and quantify levels of PGE 1. Method selectivity was performed with a mixture of PGE 1 and its degradation products. Forced degradation tests were performed to determine which degradation products were most likely to form. PGE 1 injection solutions in 10% dextrose were stored in unprotected and shieldedfrom-light polypropylene syringes in a climatic chamber. Samples were taken immediately after preparation (T 0) and after 24, 48, 72 and 168 hours for analysis. PGE 1 solutions were considered stable if ≥90.0% of the initial concentration was retained. results The LC-HRMS method was validated in the range of 0.086-0.200µg/mL PGE 1 with trueness values between 98.2% and 100.3%, and repeatability and intermediate precision values of <2.2%and <4.7%, respectively. The quantification and detection limits of the method were 0.086 and 0.026µg/mL, respectively. PGE 1 and its degradation products were resolved chromatographically. PGE 1 injection solutions were≥90.0%stable after 48hours in unprotected from light (UPL) syringes. The solutions remained clear without precipitation, colour or pH modification and subvisible particles within the permitted levels. Prostaglandin A 1 was the sole degradation product observed. Conclusions A LC-HRMS method to evaluate PGE 1 stability in a 10% dextrose was developed and validated. PGE 1 1.5 and 15µg/mL in 10% dextrose solution are stable for 48hours when stored at 30ºC in UPL polypropylene syringes.

Respiration; international review of thoracic diseases, Jan 5, 2016

Health management of cystic fibrosis (CF) patients should be maximized during pregnancy and breas... more Health management of cystic fibrosis (CF) patients should be maximized during pregnancy and breastfeeding because of its significant impact on the maternal and newborn outcomes. Thus, numerous drugs will have to be continued during pregnancy and lactation. Most of the drugs representing CF treatment lines cross the placenta or are excreted into human milk. Research addressing the risks and benefits of drugs used in CF patients during pregnancy and lactation is often incomplete or challenged by limited methodology, which often leads to conflicting or inconclusive results. Yet, potential treatment benefits for CF pregnant patients most often outbalance potential risks for the unborn child.

European Journal of Pediatrics, 2015

Purpose: CPOE reduce prescription errors, but their implementation is not available everywhere. W... more Purpose: CPOE reduce prescription errors, but their implementation is not available everywhere. We wanted to assess whether the introduction of a new preformatted medical order sheet coupled with an introductory course affected prescription quality and the frequency of errors during the prescription stage in a neonatal intensive care unit (NICU). Methods: Two-phase observational study consisting of two consecutive 4-month phases: pre-intervention (phase 0) and post-intervention (phase I) conducted in an eleven-bed NICU in a Swiss university hospital. Interventions consisted of the introduction of a new preformatted medical order sheet with explicit information supplied, coupled with a staff introductory course on appropriate prescription and medication errors. The main outcomes measured were formal aspects of prescription and frequency and nature of prescription errors. Results: Eighty-three and 81 patients were included in phase 0 and phase I, respectively. A total of 505 handwritten prescriptions in phase 0 and 525 in phase I were analysed. The rate of prescription errors decreased significantly from 28.9% in phase 0 to 13.5% in phase I (p<0.05). Compared with phase 0, dose errors, name confusion, and errors in frequency and rate of drug administration decreased in phase I, from 5.4% to 2.7% (p<0.05), 5.9% to 0.2% (p<0.05), 3.6% to 0.2% (p<0.05), and 4.7% to 2.1% (p<0.05), respectively. The rate of incomplete and ambiguous prescriptions decreased from 44.2% to 25.7% and 8.5% to 3.2% (p<0.05), respectively. Conclusion: Inexpensive and simple interventions can improve the intelligibility of prescriptions and reduce medication errors.

Patients in paediatric intensive care units (PICU) often receive numerous medications by the pare... more Patients in paediatric intensive care units (PICU) often receive numerous medications by the parenteral route. Frequently two or more drugs are delivered simultaneously through the same line and the risk of physicochemical incompatibilities is thus important. The objectives of this study were 1) to identify prospectively the combinations of injectable drugs administered in the PICU of our university hospital and 2) to analyze them according to information found in the literature. The data were collected by a pharmacist over a 30-day period and classified in three categories: compatible, incompatible and undocumented. Nineteen patients were included in the study with a median age of 3.2 years. The mean number (± SD) of injectable drugs per patient and per day was 6.5 (± 2.8), for a total of 26 drugs and 7 solutes. 64 combinations of drugs were observed with 2 (31.3%), 3 (45.3%), 4 (10.9%) or 5 (12.5%) drugs. 81 drug-drug and 94 drug-solute combinations were recorded. Among these, 151 (86.3%) were compatible, 6 (3.4%) incompatible and 18 (10.3%) undocumented. The incompatibilities included furosemide (Lasix ®), a drug in alkaline solution and Vamina-Glucose ® , a total parenteral nutrition solution. No clinical consequences resulting from drug incompatibilities were shown in this study. We suggest that in vitro compatibility tests on standard drug combinations, as well as a training program for nurses on drug incompatibility problems would sensitively increase the security of parenteral drug administration.

European Journal of Pediatrics, 2015

We designed a double-blinded randomized clinical trial of zinc (10 or 20 mg of zinc sulphate for ... more We designed a double-blinded randomized clinical trial of zinc (10 or 20 mg of zinc sulphate for 2-5 month-old or 6-59 month-old children, respectively, during 10 days) vs. placebo in otherwise healthy children aged 2 months to 5 years who presented with acute diarrhoea (i.e. ≥3 stools/day for less than 72 h). Eighty-seven patients (median age 14 months; range 3.1-58.3) were analysed in an intention-to-treat approach. Forty-two patients took zinc and 45 placebo. There was no difference in the duration nor in the frequency of diarrhoea, but only 5 % of the zinc group still had diarrhoea at 120 h of treatment compared to 20 % in the placebo group (P=0.05). Thirty-one patients (13 zinc and 18 placebo) were available for per-protocol analyses. The median (IQR) duration of diarrhoea in zinc-treated patients was 47.5 h (18.3-72) and differed significantly from the placebo group (median 76.3; IQR 52.8-137) (P=0.03). The frequency of diarrhoea was also lower in the zinc group (P=0.02). Conclusion: zinc treatment decreases the frequency and severity of diarrhoea in children aged 2 months to 5 years living in Switzerland. However, the intention-to-treat analysis reveals compliance issues that question the proper duration of treatment and the choice of optimal pharmaceutical formulation.

International Journal of Clinical Pharmacy, 2012

Pediatric intensive care patients represent a population at high risk for drug-related problems. ... more Pediatric intensive care patients represent a population at high risk for drug-related problems. There are few studies that compare the activity of clinical pharmacists between countries. To describe the drug-related problems identified and interventions by four pharmacists in a pediatric cardiac and intensive care unit. Four pediatric centers in France, Quebec, Switzerland and Belgium. This was a six-month multicenter, descriptive and prospective study conducted from August 1, 2009 to January 31, 2010. Drug-related problems and clinical interventions were compiled from four pediatric centers in France, Quebec, Switzerland and Belgium. Data on patients, drugs, intervention, documentation, approval and estimated impact were compiled. Number and type of drug-related problems encountered in a large pediatric inpatient population. A total of 996 interventions were recorded: 238 (24 %) in France, 278 (28 %) in Quebec, 351 (35 %) in Switzerland and 129 (13 %) in Belgium. These interventions targeted 270 patients (median 21 months old, 53 % male): 88 (33 %) in France, 56 (21 %) in Quebec, 57 (21 %) in Switzerland and 69 (26 %) in Belgium. The main drug-related problems were inappropriate administration technique (29 %), untreated indication (25 %) and supra-therapeutic dose (11 %). The pharmacists&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; interventions were mostly optimizing the mode of administration (22 %), dose adjustment (20 %) and therapeutic monitoring (16 %). The two major drug classes that led to interventions were anti-infectives for systemic use (23 %) and digestive system and metabolism drugs (22 %). Interventions mainly involved residents and all clinical staff (21 %). Among the 878 (88 %) proposed interventions requiring physician approval, 860 (98 %) were accepted. This descriptive study illustrates drug-related problems and the ability of clinical pharmacists to identify and resolve them in pediatric intensive care units in four French-speaking countries.

Swiss Medical Weekly, 2012

BACKGROUND: The writing of prescriptions is an important aspect of medical practice. This activit... more BACKGROUND: The writing of prescriptions is an important aspect of medical practice. This activity presents some specific problems given a danger of misinterpretation and dispensing errors in community pharmacies. The objective of this study was to determine the evolution of the prescription practice and writing quality in the outpatient clinics of our paediatric university hospital. METHODS: Copies of prescriptions written by physicians were collected from community pharmacies in the region of our hospital for a two-month period in 2005 and 2010. They were analysed according to standard criteria, including both formal and pharmaceutical aspects. RESULTS: A total of 597 handwritten prescriptions were reviewed in 2005 and 633 in 2010. They contained 1,456 drug prescriptions in 2005 and 1,348 in 2010. Fifteen drugs accounted for 80% of all prescriptions and the most common drugs were paracetamol and ibuprofen. A higher proportion of drugs were prescribed as International Nonproprietary Names (INN) or generics in 2010 (24.7%) compared with 2005 (20.9%). Of the drug prescriptions examined, 55.5% were incomplete in 2005 and 69.2% in 2010. Moreover in 2005, 3.2% were legible only with difficulty, 22.9% were ambiguous, and 3.0% contained an error. These proportions rose respectively to 5.2%, 27.8%, and 6.8% in 2010. CONCLUSION: This study showed that fifteen different drugs represented the majority of prescriptions, and a quarter of them were prescribed as INN or generics in 2010; and that handwritten prescriptions contained numerous omissions and preventable errors. In our hospital computerised prescribing coupled with advanced decision support is eagerly awaited.

Pharmaceutisch Weekblad Scientific Edition, 1990

Pharmacy World & Science, 2005

To determine how medical and nursing staff treat feverish children and compare the findings with ... more To determine how medical and nursing staff treat feverish children and compare the findings with their theoretical knowledge, evaluating how they might contribute to fever phobia in parents. Paediatric Emergency Department. In the first step, we analysed prospectively the files of all children having consulted the Paediatric Emergency Department with a history of fever or of body temperature above 38 degrees C during a 2-week period. The second step consisted of evaluating knowledge and perception of fever of doctors and nurses using a questionnaire. Prospective study: final diagnosis (viral, non- invasive bacterial disorders, invasive bacterial disorders), site of measurement and average temperature. Evaluation of theoretical knowledge: definition of fever, site of measurement, evaluation of the child&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s clinical state, antipyretic drug choice. A total of 114 children under 5 years of age were enrolled and 24 caregivers (12 doctors, 12 nurses, 90 of the staff) responded to the questionnaire. The results showed good consistency in theoretical knowledge, but an excessive fear about cerebral damage was also shown by doctors. This belief likely contributes to the transmission of fever phobia to parents. In contrast, analysis of children management showed that fever was often under-treated, especially by nurses and even more so by parents. Paracetamol remained the first-line antipyretic drug yet was often administered in insufficient doses. Non-steroidal anti-inflammatory drugs were seldom used, except by parents (16 of all the children). Contrary to literature, the favourite route of administration was the rectal one. Physical methods like sponging were largely used by nurses, despite the uncertainties in their real effectiveness and their known side-effects. Our study showed that the management of feverish children was globally correct in the Paediatric Emergency Department, but several improvement measures have been taken (e.g. tables of normal and abnormal ranges of temperature, recommended temperature measurement techniques, dosage regimen of antipyretic drugs, guidelines to parents), justifying the implementation of a pharmaceutical follow-up.

Pediatric Nephrology, 2005

Alteplase has been shown to be effective in preventing central venous access clotting in patients... more Alteplase has been shown to be effective in preventing central venous access clotting in patients on hemodialysis. Because of a high phosphorus content in its excipient, it can inadvertently contaminate blood samples, leading the physician in care of the patient to erroneously increase dialysis time or change diet in order to control the pseudo-hyperphosphatemia.

Pediatric Critical Care Medicine, 2005

To determine the influence of jet nebulizer brands and nebulization mode on albuterol delivery in... more To determine the influence of jet nebulizer brands and nebulization mode on albuterol delivery in a mechanically ventilated pediatric lung model. In vitro, laboratory study. Research laboratory of a university hospital. Using albuterol as a marker, six jet nebulizers (Microneb NA420, Sidestream, Acorn II, Cirrus, Upmist, Micro Mist) were tested in four nebulization modes in a bench model mimicking the ventilatory pattern of a 10-kg infant (Galileo ventilator, Hamilton Medical). The amounts of albuterol deposited on the inspiratory filters at the end of the endotracheal tube were determined, as well as the pressure, flow profiles, and particle size distribution of the jet nebulizers. Pooling the data of the six jet nebulizer brands (n = 30) indicated that intermittent nebulization during the expiratory phase was more efficient (6.5 +/- 2.5% of the initial dose, p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) than intermittent nebulization during the inspiratory phase (1.9 +/- 1.2%) and continuous nebulization with air from the ventilator (4.0 +/- 1.5%) or from an external source (4.2 +/- 1.4%). The particle size distribution at 6 L x min(-1) was between 2.81 and 3.30 microm. In our in vitro pediatric lung model, the quantity of inhaled drug was low. Jet nebulizer brands and nebulization modes significantly affected drug delivery, and in vitro models designed for adults cannot be extrapolated to infants.

Pediatric Blood & Cancer, 2008

We report the case of an 11-year-old female treated for mediastinal T-cell lymphoma who presented... more We report the case of an 11-year-old female treated for mediastinal T-cell lymphoma who presented renal failure following the second cycle of high-dose methotrexate (HDMTX). Because of life threatening plasma methotrexate (MTX) levels, carboxypeptidase G2 (CPDG2) was administered resulting in a dramatic decrease within 1 hr. The patient recovered from renal failure and no other side effects were observed. Homozygosity for the methylentetrahydrofolate reductase (MTHFR) C677T polymorphism diagnosed by molecular genetic analysis was the only explanation for this toxicity.

Paediatric Respiratory Reviews, 2010

Paediatric Respiratory Reviews, 2010

Swiss Medical Weekly

Background: Many medicines used in newborns, infants, children and adolescents are not licensed (... more Background: Many medicines used in newborns, infants, children and adolescents are not licensed ("unlicensed") or are prescribed outside the terms of the marketing authorization ("off-label"). Several studies have shown that this is a common practice in various healthcare settings in the USA, Europe and Australia, but data are scarce in Switzerland. Objectives: The aim of our prospective study was to determine the proportion of unlicensed or off-label prescriptions in paediatric patients. Methods: This pilot study was conducted prospectively over a six month period in the department of paediatrics of a university hospital. Results: Sixty patients aged from three days to 14 years were included in the study. A total of 483 prescriptions were written for the patients. More than half of all prescriptions (247; 51%) followed the terms of the marketing authorization. 114 (24%) were unlicensed and 122 (25%) off-label. All patients received at least one unlicensed or offlabel medicine. Conclusion: The use of unlicensed or off-label medicines to treat children was found to be common. Cooperation between the pharmaceutical industry, national regulatory authorities, clinical researchers, healthcare professionals and parents is required in order to ensure that children do not remain "therapeutic orphans".

European Journal of Pediatrics, 2020

Lactic acidosis is a common complication of status asthmaticus in adults. However, data is sparse... more Lactic acidosis is a common complication of status asthmaticus in adults. However, data is sparse in children. The aim of this study was to describe the prevalence and risk factors for lactic acidosis in children hospitalised for acute moderate or severe asthma. A total of 154 children 2–17 years of age were enrolled in a prospective observational study conducted in a tertiary hospital. All had capillary blood gas assessment 4 h after the first dose of salbutamol in hospital. The primary endpoint was the prevalence of lactic acidosis. Potential contributing factors such as age, sex, BMI, initial degree of asthma severity, type of salbutamol administration (nebuliser or inhaler), steroids, ipratropium bromide, and glucose-containing maintenance fluid represented secondary endpoints. All in all, 87% of patients had hyperlactatemia (lactate concentration > 2.2 mmol/l). Lactic acidosis (lactate concentration > 5 mmol/l and anion gap ≥ 16 mmol/l) was observed in 26%. In multivariat...

European Journal of Pediatrics, 2020

The name of the first author of the above mentioned published article has a double last name. The... more The name of the first author of the above mentioned published article has a double last name. The family name should have been "Ruman-Colombier" instead of "Ruman". The original article has been corrected. Publisher's note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Journal of Asthma, 2019

Abstract Introduction: Correct technique with a pressurized metered-dose inhaler (pMDI) equipped ... more Abstract Introduction: Correct technique with a pressurized metered-dose inhaler (pMDI) equipped with a valved holding chamber (VHC) or spacer provides an important advantage for adequate control of asthma and virus-induced wheezing in young children. The aim of this study was to assess the ability and knowledge of physicians and nurses to use a pMDI with a masked VHC in two pediatric emergency units. Methods: Study design: Two-center observational study. Inhaler use technique was assessed in 50 physicians and 50 nurses using a child mannequin and a validated videotaped nine-step scoring method. The participants’ knowledge was evaluated by a questionnaire. Results: The inhalation technique was perfectly mastered by 49% of the study participants and almost perfectly mastered by another 34% (mean score 8.3 ± 0.7; range 5–9). Nurses were more likely than doctors to demonstrate the technique perfectly (66% vs. 32%, p < 0.05). The two most common errors were forgetting to shake the pMDI between two consecutive puffs (38% of the participants) and putting the patient in an incorrect position (11%). About half of the participants reported that they checked each patient’s inhalation technique at every opportunity and knew how to clean the VHC. A large majority did not employ a reliable method to determine the amount of medication remaining in pMDIs without a counter. Conclusion: Healthcare professionals’ practical skills and knowledge on inhalation therapy were not completely mastered and could be improved with a mandatory training program.

European Journal of Pediatrics, 2018

Newborns are often exposed to medication errors in hospitals. Identification and understanding th... more Newborns are often exposed to medication errors in hospitals. Identification and understanding the causes and risk factors associated with medication errors will help to improve the effectiveness of medication. We sought to compare voluntary incident reports and direct observation in the identification of medication errors. We alsoidentifiedcorresponding risk factors in order to establish measures to prevent medication errors. Medication errors identified by a clinical pharmacist and those recorded in our incident reporting system by caregivers were analysed. Main outcomes were rates, type and severity of medication error, and other variables related to medication errors. Ultimately, 383 medication errors were identified by the clinical pharmacist, and two medication errors were declared by caregivers. Prescription errors accounted for 38.4%, preparation errors for 16.2%, and administration errors for 45.4%. The two variables significantly related to the occurrence of medication errors were gestational age < 32.0 weeks (p = 0.04) and the number of drugs prescribed (p < 0.01). Conclusion: Caregivers underreported the true rate of medication errors. Most medication errors were caused by inattention and could have been limited by simplifying the medication process. Risk of medication errors is increased in newborns < 32.0 weeks and increases with the number of drugs prescribed to each patient. What is Known: • Newborns in hospitals are particularly susceptible to medication errors. • Identification and understanding the reasons for medication errors should help us to establish preventive measures to reduce the occurrence of such errors. What is New: • Direct observation of the medication process, though time consuming, is essential to accurately assess the frequency of medication errors, which are underreported by caregivers. • Most medication errors are caused by inattention and could be limited by simplifying the medication process. • The risk of medication errors was significantly increased in very preterm newborns (< 32 weeks) and when the number of prescription per patient increased.

European Journal of Hospital Pharmacy, 2017

Objective We aimed to monitor the physicochemical stability of prostaglandin E 1 (PGE 1) 1.5 and ... more Objective We aimed to monitor the physicochemical stability of prostaglandin E 1 (PGE 1) 1.5 and 15 µg/mL in 10% dextrose stored in polypropylene syringes. Methods We developed a liquid chromatography-high resolution mass spectrometry (LC-HRMS) method to detect and quantify levels of PGE 1. Method selectivity was performed with a mixture of PGE 1 and its degradation products. Forced degradation tests were performed to determine which degradation products were most likely to form. PGE 1 injection solutions in 10% dextrose were stored in unprotected and shieldedfrom-light polypropylene syringes in a climatic chamber. Samples were taken immediately after preparation (T 0) and after 24, 48, 72 and 168 hours for analysis. PGE 1 solutions were considered stable if ≥90.0% of the initial concentration was retained. results The LC-HRMS method was validated in the range of 0.086-0.200µg/mL PGE 1 with trueness values between 98.2% and 100.3%, and repeatability and intermediate precision values of <2.2%and <4.7%, respectively. The quantification and detection limits of the method were 0.086 and 0.026µg/mL, respectively. PGE 1 and its degradation products were resolved chromatographically. PGE 1 injection solutions were≥90.0%stable after 48hours in unprotected from light (UPL) syringes. The solutions remained clear without precipitation, colour or pH modification and subvisible particles within the permitted levels. Prostaglandin A 1 was the sole degradation product observed. Conclusions A LC-HRMS method to evaluate PGE 1 stability in a 10% dextrose was developed and validated. PGE 1 1.5 and 15µg/mL in 10% dextrose solution are stable for 48hours when stored at 30ºC in UPL polypropylene syringes.

Respiration; international review of thoracic diseases, Jan 5, 2016

Health management of cystic fibrosis (CF) patients should be maximized during pregnancy and breas... more Health management of cystic fibrosis (CF) patients should be maximized during pregnancy and breastfeeding because of its significant impact on the maternal and newborn outcomes. Thus, numerous drugs will have to be continued during pregnancy and lactation. Most of the drugs representing CF treatment lines cross the placenta or are excreted into human milk. Research addressing the risks and benefits of drugs used in CF patients during pregnancy and lactation is often incomplete or challenged by limited methodology, which often leads to conflicting or inconclusive results. Yet, potential treatment benefits for CF pregnant patients most often outbalance potential risks for the unborn child.

European Journal of Pediatrics, 2015

Purpose: CPOE reduce prescription errors, but their implementation is not available everywhere. W... more Purpose: CPOE reduce prescription errors, but their implementation is not available everywhere. We wanted to assess whether the introduction of a new preformatted medical order sheet coupled with an introductory course affected prescription quality and the frequency of errors during the prescription stage in a neonatal intensive care unit (NICU). Methods: Two-phase observational study consisting of two consecutive 4-month phases: pre-intervention (phase 0) and post-intervention (phase I) conducted in an eleven-bed NICU in a Swiss university hospital. Interventions consisted of the introduction of a new preformatted medical order sheet with explicit information supplied, coupled with a staff introductory course on appropriate prescription and medication errors. The main outcomes measured were formal aspects of prescription and frequency and nature of prescription errors. Results: Eighty-three and 81 patients were included in phase 0 and phase I, respectively. A total of 505 handwritten prescriptions in phase 0 and 525 in phase I were analysed. The rate of prescription errors decreased significantly from 28.9% in phase 0 to 13.5% in phase I (p<0.05). Compared with phase 0, dose errors, name confusion, and errors in frequency and rate of drug administration decreased in phase I, from 5.4% to 2.7% (p<0.05), 5.9% to 0.2% (p<0.05), 3.6% to 0.2% (p<0.05), and 4.7% to 2.1% (p<0.05), respectively. The rate of incomplete and ambiguous prescriptions decreased from 44.2% to 25.7% and 8.5% to 3.2% (p<0.05), respectively. Conclusion: Inexpensive and simple interventions can improve the intelligibility of prescriptions and reduce medication errors.

Patients in paediatric intensive care units (PICU) often receive numerous medications by the pare... more Patients in paediatric intensive care units (PICU) often receive numerous medications by the parenteral route. Frequently two or more drugs are delivered simultaneously through the same line and the risk of physicochemical incompatibilities is thus important. The objectives of this study were 1) to identify prospectively the combinations of injectable drugs administered in the PICU of our university hospital and 2) to analyze them according to information found in the literature. The data were collected by a pharmacist over a 30-day period and classified in three categories: compatible, incompatible and undocumented. Nineteen patients were included in the study with a median age of 3.2 years. The mean number (± SD) of injectable drugs per patient and per day was 6.5 (± 2.8), for a total of 26 drugs and 7 solutes. 64 combinations of drugs were observed with 2 (31.3%), 3 (45.3%), 4 (10.9%) or 5 (12.5%) drugs. 81 drug-drug and 94 drug-solute combinations were recorded. Among these, 151 (86.3%) were compatible, 6 (3.4%) incompatible and 18 (10.3%) undocumented. The incompatibilities included furosemide (Lasix ®), a drug in alkaline solution and Vamina-Glucose ® , a total parenteral nutrition solution. No clinical consequences resulting from drug incompatibilities were shown in this study. We suggest that in vitro compatibility tests on standard drug combinations, as well as a training program for nurses on drug incompatibility problems would sensitively increase the security of parenteral drug administration.

European Journal of Pediatrics, 2015

We designed a double-blinded randomized clinical trial of zinc (10 or 20 mg of zinc sulphate for ... more We designed a double-blinded randomized clinical trial of zinc (10 or 20 mg of zinc sulphate for 2-5 month-old or 6-59 month-old children, respectively, during 10 days) vs. placebo in otherwise healthy children aged 2 months to 5 years who presented with acute diarrhoea (i.e. ≥3 stools/day for less than 72 h). Eighty-seven patients (median age 14 months; range 3.1-58.3) were analysed in an intention-to-treat approach. Forty-two patients took zinc and 45 placebo. There was no difference in the duration nor in the frequency of diarrhoea, but only 5 % of the zinc group still had diarrhoea at 120 h of treatment compared to 20 % in the placebo group (P=0.05). Thirty-one patients (13 zinc and 18 placebo) were available for per-protocol analyses. The median (IQR) duration of diarrhoea in zinc-treated patients was 47.5 h (18.3-72) and differed significantly from the placebo group (median 76.3; IQR 52.8-137) (P=0.03). The frequency of diarrhoea was also lower in the zinc group (P=0.02). Conclusion: zinc treatment decreases the frequency and severity of diarrhoea in children aged 2 months to 5 years living in Switzerland. However, the intention-to-treat analysis reveals compliance issues that question the proper duration of treatment and the choice of optimal pharmaceutical formulation.

International Journal of Clinical Pharmacy, 2012

Pediatric intensive care patients represent a population at high risk for drug-related problems. ... more Pediatric intensive care patients represent a population at high risk for drug-related problems. There are few studies that compare the activity of clinical pharmacists between countries. To describe the drug-related problems identified and interventions by four pharmacists in a pediatric cardiac and intensive care unit. Four pediatric centers in France, Quebec, Switzerland and Belgium. This was a six-month multicenter, descriptive and prospective study conducted from August 1, 2009 to January 31, 2010. Drug-related problems and clinical interventions were compiled from four pediatric centers in France, Quebec, Switzerland and Belgium. Data on patients, drugs, intervention, documentation, approval and estimated impact were compiled. Number and type of drug-related problems encountered in a large pediatric inpatient population. A total of 996 interventions were recorded: 238 (24 %) in France, 278 (28 %) in Quebec, 351 (35 %) in Switzerland and 129 (13 %) in Belgium. These interventions targeted 270 patients (median 21 months old, 53 % male): 88 (33 %) in France, 56 (21 %) in Quebec, 57 (21 %) in Switzerland and 69 (26 %) in Belgium. The main drug-related problems were inappropriate administration technique (29 %), untreated indication (25 %) and supra-therapeutic dose (11 %). The pharmacists&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; interventions were mostly optimizing the mode of administration (22 %), dose adjustment (20 %) and therapeutic monitoring (16 %). The two major drug classes that led to interventions were anti-infectives for systemic use (23 %) and digestive system and metabolism drugs (22 %). Interventions mainly involved residents and all clinical staff (21 %). Among the 878 (88 %) proposed interventions requiring physician approval, 860 (98 %) were accepted. This descriptive study illustrates drug-related problems and the ability of clinical pharmacists to identify and resolve them in pediatric intensive care units in four French-speaking countries.

Swiss Medical Weekly, 2012

BACKGROUND: The writing of prescriptions is an important aspect of medical practice. This activit... more BACKGROUND: The writing of prescriptions is an important aspect of medical practice. This activity presents some specific problems given a danger of misinterpretation and dispensing errors in community pharmacies. The objective of this study was to determine the evolution of the prescription practice and writing quality in the outpatient clinics of our paediatric university hospital. METHODS: Copies of prescriptions written by physicians were collected from community pharmacies in the region of our hospital for a two-month period in 2005 and 2010. They were analysed according to standard criteria, including both formal and pharmaceutical aspects. RESULTS: A total of 597 handwritten prescriptions were reviewed in 2005 and 633 in 2010. They contained 1,456 drug prescriptions in 2005 and 1,348 in 2010. Fifteen drugs accounted for 80% of all prescriptions and the most common drugs were paracetamol and ibuprofen. A higher proportion of drugs were prescribed as International Nonproprietary Names (INN) or generics in 2010 (24.7%) compared with 2005 (20.9%). Of the drug prescriptions examined, 55.5% were incomplete in 2005 and 69.2% in 2010. Moreover in 2005, 3.2% were legible only with difficulty, 22.9% were ambiguous, and 3.0% contained an error. These proportions rose respectively to 5.2%, 27.8%, and 6.8% in 2010. CONCLUSION: This study showed that fifteen different drugs represented the majority of prescriptions, and a quarter of them were prescribed as INN or generics in 2010; and that handwritten prescriptions contained numerous omissions and preventable errors. In our hospital computerised prescribing coupled with advanced decision support is eagerly awaited.

Pharmaceutisch Weekblad Scientific Edition, 1990

Pharmacy World & Science, 2005

To determine how medical and nursing staff treat feverish children and compare the findings with ... more To determine how medical and nursing staff treat feverish children and compare the findings with their theoretical knowledge, evaluating how they might contribute to fever phobia in parents. Paediatric Emergency Department. In the first step, we analysed prospectively the files of all children having consulted the Paediatric Emergency Department with a history of fever or of body temperature above 38 degrees C during a 2-week period. The second step consisted of evaluating knowledge and perception of fever of doctors and nurses using a questionnaire. Prospective study: final diagnosis (viral, non- invasive bacterial disorders, invasive bacterial disorders), site of measurement and average temperature. Evaluation of theoretical knowledge: definition of fever, site of measurement, evaluation of the child&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s clinical state, antipyretic drug choice. A total of 114 children under 5 years of age were enrolled and 24 caregivers (12 doctors, 12 nurses, 90 of the staff) responded to the questionnaire. The results showed good consistency in theoretical knowledge, but an excessive fear about cerebral damage was also shown by doctors. This belief likely contributes to the transmission of fever phobia to parents. In contrast, analysis of children management showed that fever was often under-treated, especially by nurses and even more so by parents. Paracetamol remained the first-line antipyretic drug yet was often administered in insufficient doses. Non-steroidal anti-inflammatory drugs were seldom used, except by parents (16 of all the children). Contrary to literature, the favourite route of administration was the rectal one. Physical methods like sponging were largely used by nurses, despite the uncertainties in their real effectiveness and their known side-effects. Our study showed that the management of feverish children was globally correct in the Paediatric Emergency Department, but several improvement measures have been taken (e.g. tables of normal and abnormal ranges of temperature, recommended temperature measurement techniques, dosage regimen of antipyretic drugs, guidelines to parents), justifying the implementation of a pharmaceutical follow-up.

Pediatric Nephrology, 2005

Alteplase has been shown to be effective in preventing central venous access clotting in patients... more Alteplase has been shown to be effective in preventing central venous access clotting in patients on hemodialysis. Because of a high phosphorus content in its excipient, it can inadvertently contaminate blood samples, leading the physician in care of the patient to erroneously increase dialysis time or change diet in order to control the pseudo-hyperphosphatemia.

Pediatric Critical Care Medicine, 2005

To determine the influence of jet nebulizer brands and nebulization mode on albuterol delivery in... more To determine the influence of jet nebulizer brands and nebulization mode on albuterol delivery in a mechanically ventilated pediatric lung model. In vitro, laboratory study. Research laboratory of a university hospital. Using albuterol as a marker, six jet nebulizers (Microneb NA420, Sidestream, Acorn II, Cirrus, Upmist, Micro Mist) were tested in four nebulization modes in a bench model mimicking the ventilatory pattern of a 10-kg infant (Galileo ventilator, Hamilton Medical). The amounts of albuterol deposited on the inspiratory filters at the end of the endotracheal tube were determined, as well as the pressure, flow profiles, and particle size distribution of the jet nebulizers. Pooling the data of the six jet nebulizer brands (n = 30) indicated that intermittent nebulization during the expiratory phase was more efficient (6.5 +/- 2.5% of the initial dose, p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) than intermittent nebulization during the inspiratory phase (1.9 +/- 1.2%) and continuous nebulization with air from the ventilator (4.0 +/- 1.5%) or from an external source (4.2 +/- 1.4%). The particle size distribution at 6 L x min(-1) was between 2.81 and 3.30 microm. In our in vitro pediatric lung model, the quantity of inhaled drug was low. Jet nebulizer brands and nebulization modes significantly affected drug delivery, and in vitro models designed for adults cannot be extrapolated to infants.

Pediatric Blood & Cancer, 2008

We report the case of an 11-year-old female treated for mediastinal T-cell lymphoma who presented... more We report the case of an 11-year-old female treated for mediastinal T-cell lymphoma who presented renal failure following the second cycle of high-dose methotrexate (HDMTX). Because of life threatening plasma methotrexate (MTX) levels, carboxypeptidase G2 (CPDG2) was administered resulting in a dramatic decrease within 1 hr. The patient recovered from renal failure and no other side effects were observed. Homozygosity for the methylentetrahydrofolate reductase (MTHFR) C677T polymorphism diagnosed by molecular genetic analysis was the only explanation for this toxicity.

Paediatric Respiratory Reviews, 2010

Paediatric Respiratory Reviews, 2010