scholarly journals Promoting Appropriate Use of Drugs in Children

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Vijay N. Yewale ◽  
Dhanya Dharmapalan
Keyword(s):  
Drug Resistance ◽  
Adverse Effects ◽  
Significant Variation ◽  
Pediatric Population ◽  
Causative Organism ◽  
Drug Trials ◽  
Appropriate Use ◽  
Pediatric Drug ◽  
Off Label ◽  
Drug Studies

Promotion of appropriate and safe drugs in children is the need of the hour globally. Pediatric population by itself is a spectrum of different physiologies with significant variation in pharmacodynamics and pharmacokinetics. Unfortunately, 50–90% of drugs used in children today have never been actually studied in this population, and the results of drug studies done in adults are often extrapolated for use in children. Many medicines in pediatrics are off label or unlicensed. There is a spurt in drug resistance due to the overzealous prescription of antimicrobials not indicated, such as, using inadequate dosage or duration of drug regime leading to partially treated infections, using the wrong antimicrobial due to ignorance of causative organism, and finally using indigenous, irrational combinations. Availability of properly labeled and safe pediatric formulations, regular audit by pharmacists, judicious prescriptions, proper counseling about drug administration, surveillance of adverse effects, and pediatric drug trials can be the best possible interventions to offer appropriate medicines to children and thereby save millions of lives.

scholarly journals Perspectives in pediatric clinical trials: a review

2016 ◽  
Vol 3 (2) ◽  
pp. 52
Author(s):  
Vihang S. Chawan ◽  
Sagar V. Badwane ◽  
Kalpesh V. Gawand ◽  
Abhishek M. Phatak ◽  
Sandeep S. Chaubey
Keyword(s):  
Clinical Trials ◽  
Pediatric Population ◽  
Age Groups ◽  
Drug Trials ◽  
Off Label Use ◽  
Pediatric Drug ◽  
Off Label ◽  
Ich Guidelines ◽  
Adults And Children ◽  
Separate Population

<p class="abstract">Children are different from adults in many aspects of pharmacotherapy, including capacity to absorb, distribute, metabolize and excrete drugs and have their own taste preferences. International Conference on Harmonisation (ICH) guidelines classify pediatric age groups into five groups namely preterm, term new born infants, infants and toddlers, children and adolescents. United States conducts maximum number of pediatric drug trials as compared to developing countries. Most of the prescribed drugs are either unlicensed or have an off label use. That is these have not been evaluated for their safety and efficacy in children. As children are separate population entity and not mini-adults, these clinical trials with adults cannot be simply generalized or extrapolated to pediatric population. Thus it is mandatory to conduct clinical trials involving pediatric population in order to get full benefits to the children. To study this gap between adults and children for their wellbeing, disease prevention, diagnosis and treatment, high quality clinical trials are required<span lang="EN-US">.</span></p>

PEDIATRIC DRUG TRIALS IN CHINA

2015 ◽  
Vol 101 (1) ◽  
pp. e1.12-e1
Author(s):  
Guo-Xiang Hao ◽  
Xiao-Ling Wang ◽  
A-Dong Shen ◽  
Evelyne Jacqz-Aigrain ◽  
Wei Zhao
Keyword(s):  
Drug Development ◽  
Pediatric Population ◽  
Drug Trials ◽  
The European Union ◽  
Trial Registry ◽  
Pediatric Drug ◽  
Population Number ◽  
Pediatric Drug Development ◽  
Number Of Patients ◽  
Registry Database

Background and objectiveThe introduction of the Pediatric Regulation by the European Union, together with the renewal of the Pediatric Rule by the US Food and Drug Administration on the requirements for pediatric labeling made it mandatory for sponsors to develop drugs for the pediatric population and promotes the pediatric drug trials in Europe and US. However, very little is known about the situation of pediatric drug trials in other countries, particularly in China, home to nearly 300 millions children. In order to support the global research in pediatric drug development and clarify the specific characteristics of pediatric drugs trials in China, we analyzed the drug trials registered in the Chinese Clincial Trial Registry database.MethodsThe pediatric drug trials registered in Chinese Clincial Trial Registry database between 2007 and 2014 were analyzed. The following information was extracted from the database by two authors: type of the trial, registered time, drug name, inclusion and exclusion criteria, population, number of patients, and sponsor.ResultsAmong all (4786) trials registered, 729 trials (15.2%) involved the pediatric population, and only 308 trials (6.4%) were pediatric drug trials. From 2007 to 2013 pediatric drug trials increased from 3 to 121. There were 66 pediatric drug trials including Chinese traditional medicine.ConclusionOur results demonstrated for the first time the situation of pediatric drug trials in China. Consistent with the initiatives of promoting pediatric drug development in Europe and US, the pediatric drug trial in China made a significant progress after 2012. The pediatric drug legislation is urgently needed in China.

scholarly journals The Revolution in Pediatric Drug Development and Drug Use: Therapeutic Orphans No More

2020 ◽  
Vol 25 (7) ◽  
pp. 565-573
Author(s):  
Gilbert J. Burckart ◽  
Clara Kim
Keyword(s):  
Drug Development ◽  
Pediatric Population ◽  
Scientific Evidence ◽  
Pediatric Drug ◽  
Drug Dosing ◽  
Pediatric Drug Development ◽  
Lack Of Information ◽  
Lifetime Achievement ◽  
Pediatric Pharmacology ◽  
Drug Studies

This lecture was given by Dr. Burckart in association with presentation of the 2014 Sumner J. Yaffe Lifetime Achievement Award in Pediatric Pharmacology and Therapeutics, which is selected by the Pediatric Pharmacy Association. Multiple factors make conducting drug studies in the pediatric population difficult, resulting in a historic lack of information surrounding safe and efficacious drug dosing in children. The paradigm in pediatric drug development has shifted from normal science being that children are therapeutic orphans in the drug development system, to a model drift caused by pediatric legislation, to a model crisis caused by failed pediatric drug development trials, to finally a model revolution that includes pediatric patients routinely in drug development. Major regulatory actions and the accumulation of scientific evidence has created an environment where clinicians can expect properly labeled drug usage information for the pediatric population.

Intra-anal use of imiquimod: what is the clinical evidence?

2019 ◽  
Vol 30 (10) ◽  
pp. 1018-1024
Author(s):  
Ioannis D Gkegkes ◽  
Christos Iavazzo ◽  
Apostolos P Stamatiadis
Keyword(s):  
Human Papillomavirus ◽  
Adverse Effects ◽  
Clinical Evidence ◽  
Complete Healing ◽  
Burning Sensation ◽  
High Grade ◽  
Imiquimod Cream ◽  
Off Label ◽  
Anal Lesions ◽  
Intraepithelial Lesions

Imiquimod has been demonstrated to be rather effective in patients with anal as well as perianal high-grade squamous intraepithelial lesions (HSILs). Nevertheless, until now the intra-anal use of imiquimod has been considered off-label. The aim of this study is to review the clinical evidence related to the intra-anal use of imiquimod in the treatment of human papillomavirus-related anal lesions. A systematic search in PubMed and Scopus was performed. In total, 422 patients were included. The most common referred comorbidity was HIV infection (281 patients, 66.6%). The principal clinical entities, which were treated with intra-anal imiquimod, were HSILs. The most frequent formulation was self-applied imiquimod cream. In the HSIL group, there was complete healing in 74 patients (35%) and partial in 44 patients (20.9%), while in the wart group, there was complete healing in 128 patients (67%). Recurrence of HSIL was present in 19 patients (15%), while in cases with warts recurrence was present in 38 patients (19.8%). The most common adverse events were pain, itching, and burning sensation. In conclusion, the adverse effects associated with the intra-anal use of imiquimod seem to be minor. The present clinical evidence suggests that imiquimod may be proposed as effective, safe, and relatively well tolerated treatment.

Salicylate, pharmacokinetics, and the pediatrician

PEDIATRICS ◽  
1974 ◽  
Vol 54 (6) ◽  
pp. 670-672
Author(s):  
Alan K. Done
Keyword(s):  
Clinical Pharmacology ◽  
Volume Of Distribution ◽  
Pediatric Drug ◽  
Legal Constraints ◽  
Drug Studies

Clinicians may, at first glance, wonder why the paper in this issue by Levy and Yaffe1 on the volume of distribution of salicylate in children should concern them or, indeed, why it even appears in their journal. This important and excellent study is a prime example of the growing influence and involvement of clinical pharmacology and pharmacokinetics in medicine generally and pediatrics particularly. Already substantial, with the growing complexity of pediatric therapeutics, this relationship stands to become even more widespread and intense as a result of increasing emphasis on more and better pediatric drug studies. Evolving ethical-legal constraints notwithstanding,2 these must and will expand.

scholarly journals Opioid Use and the Risk of Respiratory Depression and Death in the Pediatric Population

2013 ◽  
Vol 18 (4) ◽  
pp. 269-276 ◽  
Author(s):  
Marianne R. Whittaker
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Respiratory Depression ◽  
Pediatric Patients ◽  
Pediatric Population ◽  
Opioid Use ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Increased Risk ◽  
Significant Difference

BACKGROUND Pediatric patients may be at an increased risk of adverse effects from various medications. Recently, there have been a number of serious adverse events, including several pediatric patients experiencing severe respiratory depression and death as a result of the use of codeine for pain control following tonsillectomy and adenoidectomy. OBJECTIVE To assess the safety of opioid agonists in pediatric patients undergoing operative procedures or have experienced trauma and to evaluate the risk of respiratory depression and death among this population. METHODS PubMed and Medline were searched to identify randomized controlled studies from 1994 to 2012 addressing postsurgery/trauma opioid use in pediatric patients. Relative risks and confidence intervals (CIs) were calculated using data available in clinical trials. RESULTS A total of 16 clinical trials were evaluated for this review. Randomized controlled trials included studies comparing opioids versus non-opioids for a variety of painful conditions. The relative risk of respiratory depression associated with opioid use in 1 trial was 1.63 (95% CI: 0.64–6.13). The remaining 15 trials reviewed described no significant difference in respiratory depression or adverse effects associated with treatment. No deaths were attributed to opioid use in any of these studies. CONCLUSION Opioid-associated respiratory depression was very rare and no deaths were reported in the reviewed studies. These findings under the well-defined conditions of controlled studies may not be the best means of determining overall opioid-associated side effects in pediatric patients.

Pharmacologic Differences in Children

2018 ◽  
Author(s):  
Raymond Park ◽  
Lauren Kelly Ugarte
Keyword(s):  
Adverse Effects ◽  
Key Words ◽  
Pediatric Anesthesia ◽  
Propofol Infusion Syndrome ◽  
Anesthetic Care ◽  
Off Label ◽  
Anesthesia Providers ◽  
Increased Risk ◽  
Neurotoxic Effects ◽  
Pharmacologic Agents

Children are physiologically different from adults. Their anesthetic care requires ample consideration of the pharmacologic effects of medications on their minds and bodies to provide an overall pleasant and safe experience. There are many available pharmacologic agents that can be used in the course of a child’s anesthetic. It is essential to be aware of the potential uses and risks of each. Pediatric anesthesia providers must consider physiologic differences in children versus adults that affect pharmacodynamics. They should also consider various medication routes that are available to initiate sedation or anesthesia, dosing changes that need to be made due to metabolism immaturity and increased risk of medication toxicity, concern for possible neurotoxic effects of medications on the developing brain, and adverse effects of medication due to congenital issues or undiagnosed pathology. Medications we use in pediatric anesthesia have always been off label due to limited studies in this population of patients and ongoing studies will help enhance our practice.   This review contains 4 figures, 7 tables, and 64 references. Key Words: anesthetic neurotoxicity, anesthesia uptake, apnea risk, benzodiazepine effects, neonates, midazolam bioavailability, opioids, opioid-sparing medications, premedication routes, propofol infusion syndrome, succinylcholine complications, sugammadex, uptake and distribution in infants.

scholarly journals Evaluation of Psychotropic Drug Use in Adolescents Accessing a General Emergency Medical Department for Mental Disorders

Adolescents ◽  
2020 ◽  
Vol 1 (1) ◽  
pp. 1-9
Author(s):  
Martina Buttera ◽  
Antonio Clavenna ◽  
Lucia Tansini ◽  
Erica Maselli ◽  
Alessandro Albizzati ◽  
...  
Keyword(s):  
Drug Use ◽  
Mental Disorders ◽  
Mental Disorder ◽  
Psychotropic Drug ◽  
Pediatric Population ◽  
Drug Prescription ◽  
University Hospital ◽  
Medical Department ◽  
Off Label ◽  
Psychotropic Drug Use

Background: Given the paucity of data concerning the care of adolescents attending an emergency department (ED) for mental disorders, we performed an observational study with the aim to describe psychotropic drug use in an Italian ED. Methods: A retrospective chart review of adolescents (13–17 years) visited in the ED of the San Paolo University Hospital in Milan for mental disorders between January and June 2018 was conducted. Information concerning age, gender, type of disorder, psychotropic drug use in the ED and outcome of the visit were analyzed, using an anonymous patient code. Results: A total of 1298 adolescents, 13–17 years old, were visited in the ED, 56 (4%) of whom had a diagnosis of mental disorder (34 females and 22 males). The most common disorder was anxiety (21 patients), followed by predominant psychomotor disorder (13 patients). In all, 30 adolescents received a psychotropic drug. Benzodiazepines were the most commonly used drugs (73% of the subjects), and delorazepam was administered/prescribed to 17 adolescents, despite the fact that evidence on its safety, efficacy, and its off-label use in the pediatric population is lacking. Conclusions: One out of two adolescents attending the ED for an acute episode of mental disorder received a psychotropic drug prescription, mainly in an off-label manner. More evidence is needed to guide the pharmacological management of acute episodes of mental disorders.

Oxford Handbook of Clinical Pharmacy

2012 ◽  
Author(s):  
Philip Wiffen ◽  
Marc Mitchell ◽  
Melanie Snelling ◽  
Nicola Stoner
Keyword(s):  
Adverse Effects ◽  
Clinical Pharmacy ◽  
Medicinal Products ◽  
Appropriate Use ◽  
Reference Guide ◽  
Practical Information

The overall goal of clinical pharmacy is to promote the correct and appropriate use of prescription and non-prescription medicinal products and devices, and to minimize adverse effects. This is the definitive quick reference guide to clinical pharmacy, providing practising and student pharmacists with a wealth of practical information.

scholarly journals Cardiac safety of off-label COVID-19 drug therapy: a review and proposed monitoring protocol

2020 ◽  
Vol 9 (3) ◽  
pp. 215-221 ◽  
Author(s):  
Niyada Naksuk ◽  
Sorin Lazar ◽  
Thoetchai (Bee) Peeraphatdit
Keyword(s):  
Adverse Effects ◽  
Qt Interval ◽  
Point Of Care ◽  
Cardiac Injury ◽  
Torsade De Pointes ◽  
Heart Association ◽  
Outpatient Setting ◽  
Off Label ◽  
Care Protocol ◽  
Investigational Drugs

More than 2,000,000 individuals worldwide have had coronavirus 2019 disease infection (COVID-19), yet there is no effective medical therapy. Multiple off-label and investigational drugs, such as chloroquine and hydroxychloroquine, have gained broad interest due to positive pre-clinical data and are currently used for treatment of COVID-19. However, some of these medications have potential cardiac adverse effects. This is important because up to one-third of patients with COVID-19 have cardiac injury, which can further increase the risk of cardiomyopathy and arrhythmias. Adverse effects of chloroquine and hydroxychloroquine on cardiac function and conduction are broad and can be fatal. Both drugs have an anti-arrhythmic property and are proarrhythmic. The American Heart Association has listed chloroquine and hydroxychloroquine as agents which can cause direct myocardial toxicity. Similarly, other investigational drugs such as favipiravir and lopinavir/ritonavir can prolong QT interval and cause Torsade de Pointes. Many antibiotics commonly used for the treatment of patients with COVID-19, for instance azithromycin, can also prolong QT interval. This review summarizes evidenced-based data regarding potential cardiac adverse effects due to off-label and investigational drugs including chloroquine and hydroxychloroquine, antiviral therapy, monoclonal antibodies, as well as common antibiotics used for the treatment of COVID-19. The article focuses on practical points and offers a point-of-care protocol for providers who are taking care of patients with COVID-19 in an inpatient and outpatient setting. The proposed protocol is taking into consideration that resources during the pandemic are limited.

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