Paediatric Drugs (Pediatr Drugs)

Publications in this journal

• Article: Efficacy and Tolerability of Pharmacotherapies to Aid Smoking Cessation in Adolescents

  Steffani R. Bailey, Erin E. Crew, Emily C. Riske, Seth Ammerman, Thomas N. Robinson, Joel D. Killen
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  ABSTRACT: Adolescent smoking remains a public health problem. Despite concerns regarding adolescent nicotine dependence, few well-designed smoking cessation studies have been conducted with teen smokers. This is particularly true regarding pharmacologic treatments for nicotine dependence. Currently, pharmacologic aids are not recommended for treating adolescent nicotine dependence, as efficacy has not been shown in this population.This review includes studies that have examined the efficacy of pharmacotherapy for smoking abstinence and/or reduction in cigarette consumption among adolescent smokers who want to quit smoking, laboratory-based adolescent studies that have examined the efficacy of these medications in reducing cravings and/or withdrawal symptoms, and/or studies that have assessed the tolerability of medications for smoking cessation in adolescent smokers. It provides information on the pharmacologic action of each medication, the efficacy of each medication for adolescent smoking cessation, the tolerability of each medication based on reported adverse events, and compliance with the medication protocols.Thirteen relevant articles were identified and included in the review. Nicotine patch (NP), nicotine gum, nicotine nasal spray, bupropion, and varenicline have been studied in adolescent smokers. The adverse events reported in the studies on pharmacology for adolescent smoking suggest that the side effect profiles for nicotine replacement therapy, bupropion, and varenicline are similar to those reported in adult studies. There is some evidence of efficacy of NP and bupropion at the end of treatment (efficacy of varenicline has not been assessed), but none of the medications included in this review were efficacious in promoting long-term smoking cessation among adolescent smokers. It is noted that many of the study protocols did not follow the recommended dose or length of pharmacotherapy for adults, rendering it difficult to determine the true efficacy of medication for adolescent smoking cessation. Future efficacy studies are warranted before recommending pharmacotherapy for adolescent smoking cessation.
  Paediatric Drugs 03/2012; 14(2):91-108.
• Article: DTaP5-IPV-Hib Vaccine (Pediacel®)

  James E. Frampton
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  ABSTRACT: Pediacel® is a fully liquid formulation of a diphtheria, tetanus, five-component acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b combination vaccine, which does not require reconstitution. Both vial and prefilled syringe presentations of Pediacel® are available for use in the EU.In active-controlled clinical trials, primary and/or booster vaccination with Pediacel® was highly immunogenic, eliciting strong and sustained serologic responses against all its component toxoids/antigens when administered according to a variety of different schedules.In particular, pivotal studies showed that Pediacel® was generally similar and/or noninferior to reconstituted pentavalent and hexavalent diphtheria, tetanus, and acellular pertussis-based combination vaccines in terms of the seroprotection rates elicited against the diphtheria, tetanus, poliovirus, and Haemophilus influenzae type b components that these products have in common, as well as in terms of the seroresponse/booster response rates elicited against the acellular pertussis components that these products have in common. Differences in immune responses between Pediacel® and these vaccines were considered unlikely to be clinically significant.There was no clear evidence of clinically relevant changes in the immunogenicity of Pediacel® (or the coadministered vaccine) when given concomitantly with meningococcal group C conjugate, pneumococcal conjugate, or hepatitis B vaccines in clinical studies.Pediacel® was generally well tolerated and demonstrated low reactogenicity in clinical trials. It had an adverse event profile generally similar to that of other combination vaccines based on diphtheria, tetanus and acellular pertussis vaccine, including Infanrix®-IPV+Hib and Infanrix® hexa.
  Paediatric Drugs 11/2011; 13(6):401-415.
• Article: Pediatric Clinical Trials in Latin America and Guyana: Present Views of Local Practitioners and Ways to Embrace the Future

  Sara Arenas-López, Carlos Fajardo, Adolf Valls i. Soler, Jorge Raúl García-Corzo, Ma Victoria Lima-Rogel,, Graciela Calle, Roberio Leite, Edgard Lobos, Querida Hume-Wright, Stuart MacLeod
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  ABSTRACT: Background Global pediatric research has recently received increased attention by health professionals, and research and government institutions. Since the approval of the FDA Pediatric Exclusivity Provision and the EU Paediatric Regulation, pharmaceutical companies have begun to look to developing/transitional countries for international pediatric research collaboration as a way of facilitating the recruitment of patients to clinical trials. Among countries identified as being `developing/transitional' some were in the North, Central, and South American regions.Objective and Methods The aim of this study was to ascertain views from local practitioners on awareness and understanding of pediatric clinical research and to clarify resources and training required by pediatricians engaging in such research in the North, Central, and South American regions. A brief survey was disseminated via Sociedad Iberoamericana de Neonatología (SIBEN) and several other randomly selected pediatric institutions. This survey provided information for a Paediatric Global Research meeting at WorldPharma 2010 (Copenhagen, Denmark).Results Pediatricians (n = 55) from seven countries in Latin America and Guyana replied to the survey. They appeared to be enthusiastic about embracing the opportunity to participate in meaningful research to improve treatment of children worldwide. However, some challenges remain to be addressed around Good Clinical Practice in the conduct of trials, education, and training of professionals, and the availability and use of resources.Conclusion The survey indicated a considerable depth of interest in the improvement of the pediatric clinical research environment in Latin America. There is some momentum toward the development of a Latin American network for the facilitation and supervision of pediatric clinical research.
  Paediatric Drugs 07/2011; 13(4):257-265.
• Article: Potential vitamin-drug interactions in children: at a pediatric emergency department.

  Ran D Goldman, Sunita Vohra, Alex L Rogovik
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  ABSTRACT: A significant increase in vitamin use has been observed in recent years and interactions between vitamins and medications have been reported. To determine the frequency and types of potential interactions between vitamins and medications in children arriving at a large tertiary, pediatric emergency department. We also compared family characteristics of children with potential interactions with those of children with no potential interactions, in order to determine children at a higher risk. A cross-sectional study in which a survey was conducted of parents/caregivers and/or patients aged 0-18 years registered at a large pediatric emergency department in Canada. A total of 1804 families underwent a face-to-face interview. The main outcome measure was the rate of potential vitamin interactions in the preceding 3 months. A considerable number of patients (11% of our cohort) had potential vitamin-medication interactions in the preceding 3 months, which could theoretically result in adverse events, and over one-third of these children had more than one potential interaction. Patients with potential interactions and their parents were significantly older (p < 0.001 for the child and mother, p = 0.02 for the father), the children were much more likely to have a chronic illness (p < 0.001) and concurrently receive prescribed or over-the-counter medication (p < 0.001), and more children with potential interactions were completely immunized (p = 0.02). The child's sex, parental education, employment status, family income, and primary language spoken at home were not associated with potential interactions. Taking into account the high rate of potential vitamin-drug interactions, especially among older children and patients with chronic illness, parents and healthcare providers need to balance the potential benefit of concurrent vitamin-medication use with its potential harms.
  Paediatric Drugs 09/2009; 11(4):251-7.
• Article: Optimal drug therapy for children: Canadian initiatives.

  Michael Rieder
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  ABSTRACT: Canada has a long tradition of undertaking research and training in pediatric clinical pharmacology, and has one of the longest continuous enterprises in this field in the world. Training in pediatric clinical pharmacology in Canada is nationally accredited and rigorous. Canada has the largest number of pediatric clinical pharmacologists per capita of any country on earth, but to date there have been no federally supported initiatives for child-focused drug research. The recent development of a unique national network focused on drug safety - the Genotypic Approaches to Therapy in Children - has provided a framework that it hopes will facilitate networking as well as the development of coordinated national and hopefully international initiatives in pediatric therapeutics.
  Paediatric Drugs 02/2009; 11(1):48-51.
• Article: The global alliance for pediatric pharmacology: the future is here and now.

  Gideon Koren, Michael Rieder, Stuart M MacLeod
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  ABSTRACT: The vast majority of drugs prescribed for children have not been approved by regulatory agencies for the pediatric age group and, in many cases, have not been studied appropriately. In July 2008, at a meeting of pediatric pharmacologists from over 30 countries and 5 continents in Toronto, ON, Canada, it became apparent that numerous pediatric drug studies are being conducted, often duplicating studies done elsewhere. This is also true for pharmacokinetic and pharmacodynamic studies, as well as for the development of pediatric formulations. Finding simple ways to inform the world about existing data may save time and facilitate efforts.
  Paediatric Drugs 02/2009; 11(1):4-5.
• Article: Both parental psychopathology and prenatal maternal alcohol dependency can predict the behavioral phenotype in children.

  Arthur Staroselsky, Ellen Fantus, Reuven Sussman, Paul Sandor, Gideon Koren, Irena Nulman
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  ABSTRACT: To identify whether a child's behavior phenotype can be predicted by parental psychopathology and/or prenatal maternal alcohol dependency by using the Child Behavior List (CBCL) as a screening tool. A retrospective cohort of four non-exclusive groups of children (aged 8-15 years) was studied: (i) children exposed to alcohol in utero (n = 25); (ii) children not exposed to alcohol in utero (n = 46); (iii) children exposed to parental psychopathology (n = 37); (iv) children not exposed to parental psychopathology (n = 34). To distinguish between the effects of alcohol and parental psychopathology, the children were further subdivided into groups with alcohol exposure in utero and parental psychopathology (n = 23), and psychopathology without alchohol exposure (n = 14). Each child was assessed with the CBCL. Subscale scores and selected subscale items were compared between the groups using t-tests and regression analysis. Children exposed to alcohol in utero scored significantly lower than unexposed children on school competency (p = 0.015). They were more likely to attend special classes (p = 0.048), repeat a grade (p = 0.011), and display more disobedience (p = 0.039) and vandalism (p = 0.033). For special classes and disobedience at school, gender proved to be a significant predictor, while maternal alcohol dependency was a significant predictor of vandalism and repeated grades. Children with parental psychopathology differed from children without parental psychopathology in the anxious/depressed (p = 0.04), social problems (p = 0.004), and attention problems (p = 0.04) subscales. The subscale items that were significantly different between the groups were nervousness (p = 0.002), self-consciousness (p = 0.019), feelings of worthlessness (p = 0.041), loneliness (p = 0.005), and difficulty with concentration (p = 0.02). Parental psychopathology was a significant predictor of all five items. Age and gender, however, were significant predictors only of difficulty with concentration. No significant differences were found when the groups with alcohol exposure in utero and parental psychopathology, and psychopathology without alcohol exposure were compared. In summary, parental psychopathology was a significant predictor of a child's internalizing behavior, as well as social problems, whereas alcohol exposure was more predictive of externalizing behaviour. Parental psychopathology and prenatal exposure to maternal alcohol can contribute to the child's behavioral phenotype as measured by the CBCL. Therefore, the CBCL can be used to screen for such behaviors.
  Paediatric Drugs 02/2009; 11(1):22-5.
• Article: Pediatric palliative care: use of opioids for the management of pain.

  Boris Zernikow, Erik Michel, Finella Craig, Brian J Anderson
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  ABSTRACT: Pediatric palliative care (PPC) is provided to children experiencing life-limiting diseases (LLD) or life-threatening diseases (LTD). Sixty to 90% of children with LLD/LTD undergoing PPC receive opioids at the end of life. Analgesia is often insufficient. Reasons include a lack of knowledge concerning opioid prescribing and adjustment of opioid dose to changing requirements. The choice of first-line opioid is based on scientific evidence, pain pathophysiology, and available administration modes. Doses are calculated on a bodyweight basis up to a maximum absolute starting dose. Morphine remains the gold standard starting opioid in PPC. Long-term opioid choice and dose administration is determined by the pathology, analgesic effectiveness, and adverse effect profile. Slow-release oral morphine remains the dominant formulation for long-term use in PPC with hydromorphone slow-release preparations being the first rotation opioid when morphine shows severe adverse effects. The recently introduced fentanyl transdermal therapeutic system with a drug-release rate of 12.5 microg/hour matches the lower dose requirements of pediatric cancer pain control. Its use may be associated with less constipation compared with morphine use. Though oral transmucosal fentanyl citrate has reduced bioavailability (25%), it inherits potential for breakthrough pain management. However, the gold standard breakthrough opioid remains immediate-release morphine. Buprenorphine is of special clinical interest as a result of its different administration routes, long duration of action, and metabolism largely independent of renal function. Antihyperalgesic effects, induced through antagonism at the kappa-receptor, may contribute to its effectiveness in neuropathic pain. Methadone also has a long elimination half-life (19 [SD 14] hours) and NMDA receptor activity although dose administration is complicated by highly variable morphine equianalgesic equivalence (1 : 2.5-20). Opioid rotation to methadone requires special protocols that take this into account. Strategies to minimize adverse effects of long-term opioid treatment include dose reduction, symptomatic therapy, opioid rotation, and administration route change. Patient- or nurse-controlled analgesia devices are useful when pain is rapidly changing, or in terminal care where analgesic requirements may escalate. In this article, we present detailed pediatric pharmacokinetic and pharmacodynamic data for opioids, their indications and contraindications, as well as dose-administration regimens that include practical strategies for opioid switching and dose reduction. Additionally, we discuss the problem of hyperalgesia and the use of adjuvant drugs to support opioid therapy.
  Paediatric Drugs 02/2009; 11(2):129-51.
• Article: The European paediatric initiative: 1 year of experience.

  Agnès Saint-Raymond, Nathalie Seigneuret
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  ABSTRACT: The European Regulation on medicines for pediatric use entered into force on 26 January 2007. It changes dramatically the way medicines are developed for children. This regulation will increase availability of and information on pediatric medicines through high quality, ethical research.
  Paediatric Drugs 02/2009; 11(1):9-10.
• Article: Pediatric formulations: international issues and potential solutions.

  David C Knoppert
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  ABSTRACT: Appropriate dosage forms of medication are often not available for use in newborns, infants, and young children. This is a worldwide phenomenon, but especially in developing countries. The WHO's 'Make medicines child size' campaign emphasizes this shortcoming. Professional organizations, industry, and government from the international arena have the resources to address this and need to work together to create solutions.
  Paediatric Drugs 02/2009; 11(1):55-6.
• Article: Medication errors in children.

  Eran Kozer
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  ABSTRACT: Medication errors commonly involve children, with dosing errors being the most common. Medication errors are more frequent among the most sick patients who have urgent and complex medical conditions. Physicians who are less experienced, tired, depressed, and burnt out make more errors. The systems approach views every medical error as a system failure. The focus is on how to change the system in order to prevent errors. Adopting the systems approach will enhance patients' safety. Strategies that have been found to be effective in reducing medication errors include the use of computerized physician order entry systems, pre-printed order forms, color-coded systems, and involving pharmacists in clinical care.
  Paediatric Drugs 02/2009; 11(1):52-4.
• Article: Pediatric pharmacotherapy issues in Africa.

  Andy Gray
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  ABSTRACT: Pediatric pharmacotherapy in Africa is constrained by a variety of factors, not all of them unique to the continent. While affordability of medicines and the availability of sustainable financing for healthcare are constant challenges to African health systems, other issues of particular importance for pediatric care are also hampering access. These include the burden of disease in such settings, the lack of appropriate human resources for health, and the lack of child-appropriate dosage forms, especially for ambulatory care. Access to medicines for children has been recognized as a global priority. Examples of developments that have the potential to improve pediatric pharmacotherapy in resource-constrained settings are the WHO Essential Medicines List for Children and the 'Make medicines child size' campaign.
  Paediatric Drugs 02/2009; 11(1):6-8.
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  Article: Etiology, diagnosis, and pharmacologic treatment of pediatric pulmonary hypertension.

  Robert Tulloh
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  ABSTRACT: Major advances have been made in the understanding and treatment of pulmonary hypertension in the last few years. Without treatment (medication) for idiopathic pulmonary arterial hypertension, which is a rare and potentially fatal condition, the survival time is only about 3 years after diagnosis. However, if pulmonary hypertension is secondary to other causes such as congenital heart disease, it is possible to survive for 30 years or more without treatment. The condition can affect children at any age, from fetal life to adulthood. Patients with pulmonary hypertension can present to the respiratory pediatrician with unresponsive asthma, to the neurologist with faints, or to the general pediatrician with failure to thrive. Over the last few years there have been significant developments in the available therapy for managing this complicated disease. There is now a generally recognized ladder of long-term therapy for chronic pulmonary hypertension. Treatment can start with oxygen at home at night or even during the day. Next is the use of oral phosphodiesterase inhibitors, mostly type V, such as sildenafil, which enhance endogenous nitric oxide. More potent are the endothelin receptor antagonists and the most potent are the prostanoids, especially epoprostenol, which is given by constant intravenous infusion. In addition to interventional catheterization with atrial septostomy, these agents have improved the prognostic outlook. This article reviews the current knowledge about the etiology, investigation, and treatment of children with pulmonary hypertension in the clinical setting.
  Paediatric Drugs 02/2009; 11(2):115-28.
• Article: Non-infectious pediatric uveitis: an update on immunomodulatory management.

  Srilakshmi M Sharma, Andrew D Dick, Athimalaipet V Ramanan
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  ABSTRACT: Pediatric non-infectious uveitis remains a rare but potentially sight-threatening group of diseases. However, early screening and treatment can improve outcomes. No single agent has proven to be efficacious in all cases. A wide variety of long-term immunomodulatory treatments are available; these agents differ in both their potency and side effect profiles. Corticosteroids remain an extremely valuable form of treatment in the short-term management of uveitis. Other major groups of immunomodulatory treatments include the calcineurin inhibitors and antimetabolites such as methotrexate, which is frequently used as the first-line agent. The biologics, including anti-tumor necrosis factor agents and interferons, are newer and potentially very useful therapies although side effects limit their use. Successful outcomes may be achieved with appropriate immunosuppressant therapy given early in the disease, although clinical trials are required to define the true efficacy of this strategy.
  Paediatric Drugs 02/2009; 11(4):229-41.
• Article: Micafungin: a review of its use in the prophylaxis and treatment of invasive Candida infections in pediatric patients.

  Natalie J Carter, Gillian M Keating
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  ABSTRACT: Intravenous micafungin (Mycamine; Funguard) is an echinocandin indicated in Japan and the EU for the treatment of pediatric patients (including neonates) with invasive candidiasis and as prophylaxis against Candida infection in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). In the EU, micafungin is also indicated in pediatric patients who are expected to have neutropenia for >/=10 days. In Japan, children may also receive micafungin for the treatment of, or as prophylaxis against, invasive Aspergillus infection. Micafungin is not currently approved for use in pediatric patients in the US. Micafungin has very good antifungal activity against a wide range of Candida spp. in vitro. It has a favorable pharmacokinetic profile allowing for once-daily administration, has few drug-drug interactions, and reports of resistance are rare. The results of pediatric substudies indicate that intravenous micafungin is effective in a majority of patients for the treatment of candidemia and other types of invasive candidiasis, and provides effective prophylaxis against invasive fungal infections in pediatric patients undergoing HSCT. The tolerability profile of micafungin in pediatric patients was generally acceptable. In the EU, micafungin is indicated for use when other antifungal medications are not appropriate. Therefore, micafungin provides an alternative to other antifungal agents used in the management of candidemia and invasive candidiasis in pediatric patients, or as prophylaxis against fungal infections in pediatric patients undergoing HSCT.
  Paediatric Drugs 02/2009; 11(4):271-91.
• Article: Training clinicians in pediatric pharmacology-toxicology: the Toronto model.

  Gideon Koren
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  ABSTRACT: Established in 1979, the Toronto Program in Pediatric Pharmacology has trained pediatricians and pharmacists from over 30 countries and five continents. Within the training guidelines of the Royal College of Physicians and Surgeons of Canada, the philosophy of the program is tailoring the goals to meet the specific needs and career goals of each trainee. The program will continue to prepare pediatricians for the rapidly changing challenges of rational drug therapy for children.
  Paediatric Drugs 02/2009; 11(1):60-2.
• Article: Clinical investigation in pediatrics: challenges and opportunities in Toronto, Canada.

  Shinya Ito
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  ABSTRACT: We discuss the challenges and opportunities we face at The Hospital for Sick Children in Toronto, ON, Canada in conducting clinical investigation in children. Three areas are discussed: (i) the program structure of the Research Institute; (ii) the Toronto Centre for Phenogenomics as a common platform for preclinical studies across the university campus; and (iii) evolving clinical research infrastructure. Because preclinical and clinical investigation are becoming increasingly resource-intensive, we are witnessing a trend toward functional amalgamation of research teams, centralization of major experimental facilities, and the expansion of research infrastructure at local and national levels. Although these trends are common to clinical research in all age groups, pediatric investigation is further challenged by its relative paucity of research-related human resources, and patient numbers at local and even national levels. To promote drug research in children, these organizational changes in the research framework need to be seen on a much broader international level.
  Paediatric Drugs 02/2009; 11(1):67-8.
• Article: Training clinicians in Maternal-Fetal Pharmacology: closing a conceptual gap.

  Gideon Koren
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  ABSTRACT: Developmental pharmacology is a science that does not start at birth, but rather preconceptionally. However, training for obstetricians, perinatologists, and neonatologists in this field is almost nonexistent. The novel Summer Institute in Maternal-Fetal Pharmacology is presented, with preliminary indications that it fulfils its mandate.
  Paediatric Drugs 02/2009; 11(1):72-3.
• Article: The National Institutes of Health and the Best Pharmaceuticals for Children Act.

  Anne Zajicek
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  ABSTRACT: The majority of drugs used to treat children are not labeled for use in children. The Best Pharmaceuticals for Children Act of 2002, re-authorized as the US FDA Amendments Act of 2007, directs the National Institutes of Health (NIH) to sponsor pediatric clinical trials of drugs lacking patent protection, if the FDA request for studies has been declined. The NIH is currently sponsoring 17 clinical studies. Challenges encountered include a paucity of investigators who are trained in pediatric clinical pharmacology; inadequate knowledge of the mechanisms of drug action in a growing child; and lack of pediatric formulations.
  Paediatric Drugs 02/2009; 11(1):45-7.
• Article: Training pediatric clinical pharmacology and therapeutics specialists of the future: the needs, the reality, and opportunities for international networking.

  Madlen Gazarian
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  ABSTRACT: In recent years there has been a rapid and marked increase in global recognition of the need for better medicines for children, with various initiatives being implemented at global and regional levels. These exciting developments are matched by recognition of the need to build greater capacity in the field of pediatric clinical pharmacology and therapeutics to help deliver on the promise of better medicines for children. A range of pediatric medicines researchers, educators, clinical therapeutics practitioners, and experts in drug evaluation, regulation, and broader medicines policy are needed on a larger scale, in both developed and developing world settings. The current and likely future training needs to meet these diverse challenges, the current realities of trying to meet such needs, and the opportunities for international networking to help meet future training needs are discussed from a global perspective.
  Paediatric Drugs 02/2009; 11(1):63-6.