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Background Stress ulcer prophylaxis (SUP) is recommended in some situations to prevent upper gastrointestinal bleeding and is a component of standard care for patients admitted to the intensive care unit (ICU). Proton pump inhibitors (PPIs), already among the most widely prescribed drug classes, are being increasingly used. Objective To describe PPI prescribing patterns and their changes after the dissemination of guidelines. Setting Paediatric ICU (PICU), Robert-Debré Teaching Hospital, Paris, France, which admits about 800 patients annually, from full-term neonates to 18-year-olds. Method Prospective observational study with two 6-week observation periods (July-August and September-October, 2013), before and after dissemination in the PICU of PPI prescribing guidelines. Main outcome measure Changes in PPI prescribing patterns (prevalence, dosage, and indication) after the guidelines. Results The number of patients admitted to the PICU was 77 (mean age 4.6 years [range 1 day-18 years]) before and 70 (mean age 3.8 years [range 1 day-17 years]) after the guidelines. During both periods, SUP was the most common reason for PPI prescribing. The proportion of patients prescribed PPIs dropped significantly, from 51% before the guidelines to 30% after the guidelines (p < 0.001). Mean daily dosage also decreased significantly, from 1.5 mg/kg/(range 0.5-4.4) to 1.1 mg/kg (range 0.7-1.8) (p < 0.002). None of the patients experienced upper gastrointestinal bleeding during either period. Conclusion Off-label PPI prescribing for SUP was common in our PICU. The introduction of guidelines was associated with a significant decrease in PPI use and dosage. This study confirms that guidelines can change PPI prescribings patterns in paediatric practice. [ABSTRACT FROM AUTHOR]

Background: Although many people are involved in the optimal use of a medication within this process, the use of medications carries risks of adverse events, which are greater in the pediatric population because of many factors.Objective: In this context, our aim was to develop a consensus-based list of criteria for the safety of the pediatric medication-use process or circuit (referred to from now on as the CIRCUS tool: CIRcuit-of-Child-drug-USe).Setting: Multicenter with a trio of experts from eight university hospitals.Methods: A literature search (1998-2013) was conducted in order to identify the different safety practice domains for the pediatric medication use process. Twenty-six safety practice domains were identified and 48 compliance criteria were formulated. In order to reach a consensus on the most relevant compliance criteria for safety practices, an international 24 French-speaking multidisciplinary panelists (8 doctors, 8 pharmacists and 8 nurses) selected to represent a broad range of experience levels and specialties took part in a two round Delphi survey which was conducted between March and July 2013. Each panelist was asked to rate each proposed criterion on a 1-9 Likert scale in order to show their level of agreement (i.e. 1 reflects strong disagreement and 9 reflects strong agreement).Main Outcome Measure: Development of a consensus-base list for safety practices in pediatrics.Results: Twenty-two of the 24 professionals invited to take part in this survey (92% participation rate) completed the two Delphi rounds. At the end of the two Delphi rounds, a total of 38/48 (79%) safety practice compliance criteria achieved consensus by the panelists. The criteria were grouped into 23 domains.Conclusion: This study presents the development of a self-assessment tool for safety practices in the pediatric drug-use process using a Delphi method. This tool may be used in order to record and compare the prevalence of best safety practices in the pediatric drug-use process. [ABSTRACT FROM AUTHOR]

Background: Unlicensed and off-label (UL/OL) prescriptions have been associated with an increased risk of drug-related problems. Data of their prevalence at hospital discharge remain insufficient. We aimed to describe the prevalence of UL/OL drugs in outpatient prescriptions at discharge in children. Methods: We conducted a retrospective study using the routinely collected health data of children at discharge from 2014 to 2016. The primary reference source for determining licensed labelling was the summaries of product characteristics (SPCs) in a French industry-independent formulary named Thériaque. We described the characteristics of UL/OL prescriptions at discharge and looked for predictors of UL/OL prescriptions. Results: We included 2536 prescriptions of 479 children. Licensed, OL, and UL prescriptions accounted for 58.6% (95% CI: 56.7–60.5), 39.2% (95% CI: 37.3–41.1), and 2.3% (95% CI: 1.7–2.9), respectively. A total of 323 (74%) children received at least one UL/OL drug. Among the licensed drugs, bronchodilators (8.8%) and analgesics (8.6%), and among the OL drugs, antibiotics (2.8%), were the most prescribed. The younger age of the children and higher number of drugs they received increased the probability of UL/OL prescriptions (unadjusted p-value of ≤0.05). Conclusion: The prevalence of UL/OL prescriptions is about 40% at discharge from a pediatric university hospital in France. [ABSTRACT FROM AUTHOR]

A correction to the article "Development of a Consensus-base List of Criteria for Prescribing Medication in a Pediatric Population" by A. Guerin, R. Boulkedid and O. Bourdon published on September 11, 2015 is presented. [ABSTRACT FROM AUTHOR]

Despite legislative enforcement on authorized drugs, off-label and unapproved pediatric drug use is prevalent. The present study aimed to assess the global prevalence of off-label and unlicensed prescriptions among hospitalized children via meta-analysis. A comprehensive examination of articles published between 1990 and 2023 from the PubMed, Scopus, Excerpta Medica Database, Web of Science and Google Scholar databases was conducted. Key word-based advanced searches were executed using the aforementioned databases. A total of 45 studies that reported the prescriptions of off-label and unlicensed drugs to pediatric patients were included. The global prevalence of off-label and unlicensed drug prescriptions to children in pediatrics or neonatal departments was 56%. Patient sample sizes varied from 40-13,426, with a range of 240-8,891 total prescriptions issued. Of the 45 studies examined, 22 studies originated from Europe, 13 from Asia, 3 from South America, 3 from Africa, and 2 each from North America and Australia. Africa had the highest prevalence rate at 66%, followed by Asia, South America, North America, Australia and Europe. The present meta-analysis demonstrated that the prevalence of off-label and unlicensed drug prescriptions given to pediatric patients was notably high and geographically diverse. Therefore, drug authorities should standardize pediatric prescription practices in future. [ABSTRACT FROM AUTHOR]

Objective: Prescribing a drug for a child is not an easy task and requires using the best available evidence as a guide, especially when a drug is used off-label. The practice of prescribing a drug for off-label use is fairly widespread worldwide. The FDA does not regulate prescribing patterns or practices of individual practitioners and, therefore, allows off-label use. The main objective of this study is to evaluate off-label prescribing among the pediatric population in the Kingdom of Saudi Arabia (KSA). Method: This is a retrospective, simple random selection observational study of children (≤15 years) who visited pediatric clinics and had at least 1 drug prescribed over a 12-month period (January to December 2018). Results: A total of 865 drugs (mean 1 and SD 0.24) were prescribed to 326 children. Off-label was identified in 39.4% of the drugs with a frequency of 512 (as 1 drug may belong to more than 1 off-label category). The most common reason for off-label prescribing was related to doses that were "higher or lower than the recommended use" (48.6%), and the most frequently identified drug class prescribed for off-label use was anti-infective drugs for systemic use (39.9%). The percentage of off-label drug use was found to be higher in girls and in the age group of 1 month to 2 years (P =.001) for both variables. In addition, a significant association was found between off label drug use and the total number of drugs prescribed, P <.001. Conclusion: The findings of this study showed a high incidence of off-label prescribing mainly related to dosing and indication. The results of this observational study support the need to establish a unified national pediatric dosing formulary guide to ensure safe drug use in pediatrics. [ABSTRACT FROM AUTHOR]

Background: Dispensing errors, known to result in significant patient harm, are preventable if their nature is known and recognized. However, there is a scarcity of such data on dispensing errors particularly in resource poor settings, where healthcare is provided free-of-charge. Therefore, the purpose of this study was to determine the types, and prevalence of dispensing errors in a selected group of hospitals in Sri Lanka.Methods: A prospective, cross sectional, multi-center study on dispensing errors was conducted, in a single tertiary care, and two secondary care hospitals, in a cohort of 420 patients attending medical, surgical, diabetic and pediatric clinics. The patients were selected according to the population size, through consecutive sampling. The prescription audit was conducted in terms of dispensing errors which were categorized as i) content, ii) labelling, iii) documentation, iv) concomitant, and v) other errors based on in-house developed definitions.Results: A total of 420 prescriptions (1849 medicines) were analyzed (Hospital-I, 248 prescriptions-1010 medicines; Hospital-II, 84 prescriptions-400 medicines; Hospital-III, 88 prescriptions-439 medicines), and a cumulative total of 16,689 dispensing errors (at least one dispensing error in a prescription) were detected. Labelling errors were the most frequent dispensing error (63.1%; N = 10,523; Mostly missing information on the dispensing label), followed by concomitant prescribing and dispensing errors (20.5%; N = 3425; Missing prescribing information overlooked by the pharmacist), documentation errors (10.6%; N = 1772 Missing identification of pharmacist on dispensing label), clinically significant medication interactions overlooked by pharmacists (0.5%; N = 82), content errors (4.9%; N = 812; Discrepancies between medication dispensed and prescription order), medications dispensed in unsuitable packaging (0.4%; N = 74), and lastly medication dispensed to the wrong patient (0.01%; N = 1).Conclusions: Dispensing errors are frequent in Sri Lankan hospitals which operate with limited resources and provide free healthcare to all citizenry. Over one half of the errors were labeling errors with minimal content errors. Awareness on common types of dispensing errors and emphasis on detecting them could improve medication safety in Sri Lankan hospitals. [ABSTRACT FROM AUTHOR]

Introduction: While drug prescription should be based on established recommendations stemming from clinical trials but in pediatrics, many drugs are used without marketing authorization. Consequently recommendations are often based on clinical experience and the risk of inappropriate prescription (IP) is high. A tool for detecting IP in pediatrics—called POPI (Pediatrics: Omission of Prescriptions and Inappropriate prescriptions)—has been developed in France. However the relevance of its use at an international level is not known. Our aim has been to adapt POPI for a worldwide use. Material and method: A two-round Delphi online questionnaire was completed and validated by international experts to identify consensual items. They were asked to rate the validity of each items taking into account the recommendations and practices in their countries. Only propositions obtaining a median score in the upper tertile with an agreement of more than 75% of the panel—for the first round—and 85%—for the second round—were retained. Results: Our panel included 11 pharmacists (55%) and 9 physicians (45%). The panelists came from 12 different countries: England, Belgium, Brazil, Canada, China, Ivory Coast, Ireland, Malaysia, Portugal, Switzerland, Turkey and Vietnam. At the end of the first round, of the 105 items of the original POPI tool, 80 items were retained including 16 items reworded and 25 items were deleted. In the second round, 14 experts participated in the study. This final international POPI tool is composed of 73 IP and omissions of prescriptions in the fields of neuropsychiatry, dermatology, infectiology, pneumology, gastroenterology, pain and fever. Discussion and conclusion: This study highlights international consensus on prescription practice in pediatrics. The use of this tool in everyday practice could reduce the risk of inappropriate prescription. The impact of the diffusion of POPI tool will be assessed in a prospective multicentric study. [ABSTRACT FROM AUTHOR]

Background: Data on off-label and unlicensed prescribing in children in Indonesia is limited. The aims of this study were to determine the prevalence of off-label and unlicensed prescribing for paediatric patients in a public hospital, Indonesia. Method: A retrospective cross-sectional study of 200 randomly selected paediatric patients admitted to hospital between August and October 2014, collected patient details and all drugs prescribed. Licensed drugs were classified as off-label if there was a non-compliance with the Product Information for age, weight, indication, dose, frequency and route of administration, if there was a contraindication, special precautions or not recommended for children. Unlicensed drugs were those not approved for use in Indonesia. The main outcome was the prevalence of off-label or unlicensed prescribing to infants, children and adolescents and the impact of age group on off-label prescribing. Results: A total of 200 patients received 1961 medicines of which 1807/1961 (92.1%) were licensed and 154/1961 (7.9%) were unlicensed. There were 1403/1961 (71.5%) drugs prescribed off-label. More than half of the total drugs (n = 1066; 54.4%) were administered parenterally. Every patient was prescribed at least one off-label drug. Indication (n = 810; 34.6%) was the most common reason for off-label prescribing. Ranitidine was the most frequent drug prescribed off label. Darplex® (dihydroartemisinin and piperaquine), although manufactured in Indonesia, was unlicensed. There was a significant difference between age group and off-label prescribing in that children were prescribed significantly less off-label drugs (p<0.0003). Conclusion: This study revealed a high prevalence of off-label and unlicensed drug use in paediatric patients in this hospital, exposing them to drug treatments or regimens that had not been approved by regulatory authorities. The high incidence of invasive parenteral prescribing is of concern for paediatric patients. Incentives are needed to encourage specific drug evaluation in paediatric populations. [ABSTRACT FROM AUTHOR]

En pédiatrie, la prescription médicamenteuse est une activité très fréquente et essentielle pour préserver la qualité de la santé infantile. La problématique essentielle de la prescription dans cette population réside dans le manque de présentations pharmaceutiques pédiatriques, induisant le recours aux prescriptions en dehors de l'autorisation de mise sur le marché (AMM), qui représente toutefois une source potentielle de iatrogénie, souvent sous-évaluée. Cette mise au point a pour principal objectif de résumer la littérature existante concernant les particularités influençant la prescription médicamenteuse et orientant l'analyse pharmaceutique dans la population pédiatrique, et qu'il est donc nécessaire de connaître. [ABSTRACT FROM AUTHOR]

Objective: To investigate the impact of national implementation of age restriction on fluoroquinolone prescription in children and adolescents. Methods: Data collected from the database of Health Insurance Review and Assessment Service in South Korea, a national health insurance system to analyze fluoroquinolone prescribing practice in children and adolescents younger than 18 years, between 2007 and 2015. The age restriction was implemented in December 2009. The annual prescription rate of FQ per 100,000 person-years was calculated and an autoregressive model was used to predict the prescription pattern if an intervention had not occurred. Results: A total of 505,859 children received systemic fluoroquinolone during the study period—297,054 ciprofloxacin, and 208,805 levofloxacin. After implementation of the drug utilization review program, the annual prescription rate for ciprofloxacin declined by 97.5% (from 840 to 21 per 100,000 person-years, P < 0.001), and for levofloxacin by 96.4% (from 598 to 11 per 100,000 person-years, P < 0.001). The decline was more dramatic in the outpatient setting than in the inpatient setting for both drugs. Conclusion: The dramatic and sustained decline in prescription number and change in prescription pattern after the regulatory action suggests that the implementation under drug utilization review program was successful in controlling excessive and inappropriate use of fluoroquinolones in children, possibly guiding towards more judicious and selective prescription behavior. [ABSTRACT FROM AUTHOR]

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What is known and objective Bundle interventions are becoming increasingly used as patient safety interventions. The objective of this study was to describe and categorize which bundle interventions are used to reduce prescribing errors ( PEs) and administration errors ( AEs) in hospitalized children and to assess the quality of the published literature. Methods Articles published in English and Arabic between 1985 and September 2015 were sought in MEDLINE, EMBASE and CINHAL. Bibliographies of included articles were screened for additional studies. We included any study with a comparator group reporting rates of PEs and AEs. Two authors independently extracted data, classified interventions in each bundle and assessed the studies for potential risk of bias. Constituent interventions of the bundles were categorized using both the Cochrane Effective Practice and Organization of Care Group ( EPOC) taxonomy of intervention and the Behavioural Change Wheel ( BCW). Results and discussion Seventeen studies met the inclusion criteria. All bundles contained interventions that were either professional, organizational or a mixture of both. According to the BCW, studies used interventions with functions delivering environmental restructuring (17/17), education (16/17), persuasion (4/17), training (3/17), restriction (3/17), incentivization (1/17), coercion (1/17), modelling (1/17) and enablement (1/17). Nine studies had bundles with two intervention functions, and eight studies had three or more intervention functions. All studies were low quality before/after studies. Selection bias varied between studies. Performance bias was either low or unclear. Attrition bias was unclear, and detection bias was rated high in most studies. Ten studies described the interventions fairly well, and seven studies did not adequately explain the interventions used. What is new and conclusion This novel analysis in a systematic review showed that bundle interventions delivering two or more intervention functions have been investigated but that the study quality was too poor to assess impact. [ABSTRACT FROM AUTHOR]

Cabazitaxel is a second line chemotherapy drug recently approved for the treatment of metastatic castration-resistant prostate cancer. A first panel of French experts and a second independent panel of European experts were convened to assess the conformity of prescription of cabazitaxel with a Delphi consensus method. A two-round modified Delphi consensus process was conducted. This methodology is based on experts’ opinion obtained in a systematic manner. The process was divided into five steps: (i) elaboration of the questionnaire, (ii) rating, (iii) analysis, (iv) discussion of the points with absence of consensus following rating of the questionnaire, and (v) final reporting. Consensus was defined according to RAND method and all analyses were conducted according to the same methodology. At the end of the two rounds of rating and a synthesis meeting, of the 26 items included in the Summary of Product Characteristics (SPC), 11 items were judged appropriate with strong consensus by the two independent panels of experts. These items can therefore be considered of prime importance to evaluate conformity of cabazitaxel prescription in the context of observatory studies as well as in further clinical trials using this new taxane. Our findings further provide important evidence about the value of the Delphi consensus and highlight a requirement for “conformity” standards to assist practitioners in a safe chemotherapy drug prescription. [ABSTRACT FROM AUTHOR]

Introduction: Data on drug use in paediatrics are scarce in Senegal. The objective of this study was to assess the prescribing indicators in a paediatric population seen in an outpatient consultation at a Health Centre in Dakar, Senegal. Methods: A retrospective and analytical study was conducted. The study population consisted of prescriptions for children aged 0 to 14 years who were seen in ambulatory consultation between 1 June and 30 November 2019. The sample size was 600 prescriptions. The systematic survey was then conducted. Five prescription indicators recommended by the World Health Organization were calculated. The R software was used for descriptive analysis, bivariate analysis and binomial logistic regression. Results: The average number of drugs per prescription was 2.56. The proportion of drugs prescribed under the International Nonproprietary Name (INN) was 18.9%, while the proportion of drugs on the National Essential Medicines List (NEML) was 41.3%. The proportions of prescriptions with at least one antibiotic and one injectable product were 41.5% and 1.3%, respectively. Conclusions: This study showed that prescribing habits were inadequate. Thus, it would be necessary to move towards continuing training of prescribers in the wise use of medicines. [ABSTRACT FROM AUTHOR]

Background: Any event involving drug therapy that may interfere in a patient's desired clinical outcome is called a drug related problem (DRP). DRP are very common in intensive therapy, however, little is known about DRP in the Neonatal Intensive Care Unit (NICU). The purpose of this study was to determine the incidence of DRPs in NICU patients and to characterize DRPs according to type, cause and corresponding pharmaceutical conducts.Methods: Prospective observational study conducted in the NICU at a teaching hospital in Brazil from January 2014 to November 2016. The data were collected from the records of the clinical pharmacy service, excluding neonates admitted for less than 24 h and those who had no drugs prescribed. DRPs were classified according to the Pharmaceutical Care Network Europe system and evaluated for relevance-safety.Results: Six hundred neonates were included in the study, with mean gestational age of 31.9 ± 4.1 weeks and mean birth weight of 1779 ± 885 g. The incidence of DRPs in the NICU was 6.8% patient-days (95%CI 6.2-7.3%) and affected 59.8% of neonates (95% CI 55.8-63.8%). Sub-optimal effect (52.8%) and inappropriate dose selection (39.75%) were the most common problem and cause, respectively. Anti-infectives was the medication class most involved in DRPs. More than one-third of neonates were exposed to DRP of significant or high safety-relevance. Most of the pharmaceutical interventions were related with drug prescription, with over 90% acceptance by attending physicians.Conclusion: DRP are common in NICU, predominating problems of sub-optimal treatment, mainly due to inappropriate dose selection. [ABSTRACT FROM AUTHOR]

Background: Medication errors (MEs) are unintended failures in the drug treatment process that can occur during prescription, dispensing, storing, preparation or administration of medications. High alert medications (HAMs) are defined as those medications that bear the highest risk of causing significant patient harm when used incorrectly, either due to their serious adverse events or to a narrow therapeutic window. Nurses are responsible for administration of HAMs; incorrect administration can have a significant clinical outcome. This study aimed to assess the level of knowledge of HAMs among nurses in government hospitals in West Bank, Palestine. Methods: A cross-sectional study was conducted in 2015, in West Bank, Palestine. Data were collected via a face to face interview questionnaire, which was taken from a previous study. Data were collected by convenient sampling. The questionnaire consisted of four parts: demographic characteristics of the nurses, drug administration knowledge (10 true-false questions), drug regulation knowledge (10 true-false questions), and self-evaluation. Results: A total of 280 nurses participated in the study; these nurses were working in the emergency room (ER), intensive care unit (ICU), paediatric or medical ward. The response rate was 93%. Nurses were found to have insufficient knowledge about HAMs; 67.1% of participants had a score of less than 70%, with a mean total score of 59.9 ± 15.1. Factors associated with sufficient knowledge among nurses were HAMs training and ICU training, both with p-values of 0.002. Nurses with a master degree, those working in the ICU ward, head nurses, and male nurses were the most knowledgeable groups, with a p-values < 0.001. 81.8% of respondents hoped to obtain additional training. The leading obstacles reported were inconsistent opinions between doctors and nurses (37.9%), and no established standard operating procedure for HAMs (37.1%). Conclusions: Lack of knowledge was one of the obstacles that nurses encountered during administration of HAMs which might result in MEs. Nurses reported that they would like to have additional training to update their pharmacology knowledge. Nurses could benefit from additional continuing education and training programs. [ABSTRACT FROM AUTHOR]