Use Of Drugs In Children Research Articles

Off-Label Drug Use in Pediatric Practice: Unsolved Problems

The widespread «off-label» drug use and the prescribing of unlicensed medicines in pediatric practice is a major health problem. The authors discuss actual regulatory and legal issues of «off-label» drug use in children in the US, Europe and Russia. The results of different population-based studies from many countries, showing the structure and frequency of «off-label» drug use in children, are summarized in this article. It is shown that such practice increases the risk of adverse drug reactions. The authors offer practical recommendations for a safer use of drugs in pediatric practice. The priority issue is conducting high quality clinical trials with the participation of children, improving national pharmacovigilance and the monitoring of off-label drug use, developing pediatric formularies, improving doctors’ knowledge and awareness of safety and efficacy of medicines in pediatric population.

Drug use in French children: a population-based study

Background and objectiveTo provide an overview of drug use in outpatient children in France, a population-based study using a national reimbursement claims database representative of 90% of the French population...

English

Children are more vulnerable to adverse events related to use of drugs. It is therefore important to study drug use in children in order to optimize pharmacotherapy. The aim of this study was to compare drug utilization in paediatric outpatient departments of primary and secondary health care facilities. The patient and drug information of 600 patients was analyzed for World Health Organization (WHO) recommended prescribing indicators. The average number of drugs per prescription was significantly (p < 0.0005) lower in secondary (2.97) compared to primary (3.62) facilities, while average consultation time was shorter (p < 0.0005) in primary than secondary facilities. Percentages of drugs prescribed from Nigerian Essential Drug List (EDL, primary {89.78%}; secondary {91.79%}) and by generic name (primary {55.04%}; secondary {57.88%}) were insignificantly different between the facilities. The use of injectables was low (8.32% in primary versus 3.74% in secondary facilities) while antibiotic use was high (54.14% in primary to 60.28% in secondary facilities). Analysis of the dispensing indicators showed that the secondary facilities were significantly (p < 0.05) better than the primary facilities, even though not a single drug was adequately labeled in both the primary and secondary facilities. Prescription from EDL was found to be fair in the study area while use of injections was low. There is a need for improvement in case of medicines prescribed by generic name.

The use of neuropathic pain drugs in children with sickle cell disease is associated with older age, female sex, and longer length of hospital stay.

Although neuropathic pain is increasingly recognized in sickle cell disease (SCD), it is unknown how neuropathic pain drugs are used in children with SCD. Thus, we investigated use of these drugs and hypothesized older age and female sex are associated with increased neuropathic drug use and the use of these drugs is associated with longer length of stay. We analyzed the Pediatric Health Information System (2004 to 2009) including all inpatient visits aged 0 to 18 years with any SCD-related (all genotypes) discharge diagnosis. To limit confounding we excluded psychiatric and seizure visits. Antiepileptics, tricyclic antidepressants, and selective serotonin reuptake inhibitors were drugs of interest. Generalized Estimating Equations determined the impact of age and sex on neuropathic drug use and the impact of neuropathic drug use on length of stay. We analyzed 53,557 visits; 2.9% received≥1 neuropathic drugs. The odds of receiving a neuropathic drug increased significantly with age (reference group, 0 to 4 y: 5 to 10, odds ratio [OR], 5.7; 11 to 14: OR, 12.5; 15 to 18: OR, 22.8; all P<0.0001] and female sex (OR, 1.5; P=0.001). Neuropathic drug use was associated with longer length of stay (risk ratio, 8.3; P<0.0001). Neuropathic drug use in children with SCD was associated with older age, female sex, and longer length of stay.

Development and Psychometric Evaluation of the Child Neglect Questionnaire.

Neglect poses a significant risk for children throughout their development and is often linked with serious consequences that reach into adulthood. The Child Neglect Questionnaire (CNQ) fills existing gaps by incorporating multiple perspectives from both parents and the child, as well as measuring the complex phenomenon of neglect multidimensionally. Furthermore, this measure addresses the need for an instrument specifically developed for late childhood (ages 10-12), as much of the extant evidence and corresponding measures focus on young children and their mothers. A panel of three psychologists, using Cicchetti's model of child neglect as a theoretical guide, began by selecting items from an existing database. Results of exploratory and confirmatory factor analyses and item response theory demonstrated the unidimensionality of physical, emotional, educational, and supervision neglect as well as a second-order construct of child neglect. Analyses controlling for risk status due to father's substance use disorder, socioeconomic status, and child's ethnicity demonstrated that father's and mother's (parental) neglect, particularly in the child's versions, had sound concurrent and predictive validity. Concurrently, at age 10-12, the child's version of both parents' neglect correlated with their parenting behaviors evaluated by other available measures. Prospectively, from 10-12 years of age to 11-13 years of age, parental neglect predicted child's drug use frequency with coexisting psychological dysregulation, psychiatric symptoms, antisocial behavior, non-normative sexual behavior, involvement with deviant peers and leisure activities thus demonstrating sound predictive validity. Also, internal consistency and inter-rater reliability were excellent. The CNQ, particularly the child's version, may thus be useful for detecting children at high risk for parental neglect.

Results from the 2012–2013 paediatric national survey on off-label drug use in children in Spain (OL-PED study)

Abstract Introduction Off-label drug use is a common practice in paediatrics. The aim of the present study was to estimate the knowledge of Spaniard paediatricians on off-label use. Materials and methods Cross-sectional, multicentre, descriptive and national study from July 2012 to March 2013 using an on-line questionnaire on off-label use in children. An e-mail was sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies. Results Out of 673 responses received, 75.1% of Spanish paediatricians knew the meaning of off-label use, 61% of them prescribed medicines outside the conditions authorised in their Summary of Product Characteristics (SPC) and 47% knew of the importance of noting the off-label use in the medical record. However, just under half of paediatricians informed parents, and only 22% wrote it down in the medical record. Conclusions Most Spanish paediatricians do not meet current regulations regarding off-label use. This regulation demands: justifying the decisions when off-label use is needed, and to write down in the medical record that, at least an oral consent from the parents has been obtained. This study reveals a fact that Spanish paediatricians must change. Meanwhile, it is a priority to continue with the implementation of consensus and clinical guidelines, to obtain more data on the efficacy and safety of off-label drug use in children, and to incorporate them into the SPC.

Psychotropic drug utilization in children with concurrent attention-deficit/hyperactivity disorder and anxiety

• We examined psychotropic drug use in children with ADHD and anxiety. • The overall follow-up time was occupied almost evenly by no treatment (∼30%), mono-(∼40%) and combination pharmacotherapy (∼30%). • Treatment prevalence of ADHD outweighed treatment of anxiety. • Both clinical and non-clinical factors had impact on combination pharmacotherapy. • Significant treatment differences exist among the 26 US study states.

Primary Care Interventions to Reduce Drug Use in Children and Adolescents: U.S. Preventive Services Task Force Recommendation Statement

Primary Care Interventions to Reduce Drug Use in Children and Adolescents: U.S. Preventive Services Task Force Recommendation Statement

Top of mind at APA meeting: Adherence, opioids, PTSD

The largest meeting for experts in psychiatric disorders, this month's 167th annual meeting of the American Psychiatric Association (APA) delivered information on several key issues related to managing patients with psychiatric disorders. Many important topics on the agenda are reviewed in this article: medication adherence (including how pharmacists can help), new antidepressants, opioid therapy, medical and recreational use of marijuana, management of posttraumatic stress disorder, and use of antipsychotics in vulnerable children.

Off-Label Use of Drugs in Children

The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has collectively resulted in an improvement in rational prescribing for children, including more than 500 labeling changes. However, off-label drug use remains an important public health issue for infants, children, and adolescents, because an overwhelming number of drugs still have no information in the labeling for use in pediatrics. The purpose of off-label use is to benefit the individual patient. Practitioners use their professional judgment to determine these uses. As such, the term "off-label" does not imply an improper, illegal, contraindicated, or investigational use. Therapeutic decision-making must always rely on the best available evidence and the importance of the benefit for the individual patient.

AAP updates policy on off-label drug use in children

AAP updates policy on off-label drug use in children

AAP updates policy on off-label drug use in children

AAP updates policy on off-label drug use in children

DI-105 Epidemiological monitoring of adverse drug reactions in paediatric emergency departments

BackgroundThe use of drugs in children presents several problems of safety and tolerability, mainly due to lack of information about the risk-benefit profile in real conditions of use. Pharmacovigilance could...

CP-090 Solid oral dosage forms in paediatric patients – a cost-savings investigation

BackgroundOral liquid drugs, commonly used in children, present numerous disadvantages. Solid oral forms have greater stability, provide higher drug compliance in children and markedly reduce costs. Two limits could explain...

Awareness about and views of parents on the off-label drug use in children.

Off-label use of drugs is widely prevalent in children mainly due to a limited data generated in children during drug development process. Parents play a critical role in giving consent for their child to participate in clinical trials. Very few studies have assessed the opinion of the parents regarding such use and permitting their child to participate in clinical trials. In view of lack of information about the awareness among parents regarding both off-label drug use in children as well as about allowing their child to participate in clinical research especially from a developing country, this study was conducted. Adults accompanying patients in a tertiary care hospital were administered a validated, structured questionnaire following written informed consent. The questionnaire consisted of 18 items broadly divided into 5 themes - parental views on safety and labelled use of drugs in children, awareness of off-label drug use in children, communication from healthcare worker about it, parental views on off-label drug use in children and willingness to allow their child to participate in a clinical trial. Chi-square or Fisher's exact probability test and McNemar's test were used for analysis. Initially, a majority of the participants felt that the drugs used in children in hospital (89.5%) and prescribed by a family physician (80.3%) were either safe or extremely safe while after the concept of off-label drug use is explained, a significant reduction in the proportion (59.3% in hospital and 59.8% by family physician) of parents felt the same. Only 30% parents were aware of off-label drug use in children. Ninety-three percent of the parents wanted to be informed whenever a doctor prescribes a drug in an off-label manner and a similar percentage felt the off-label drug use would increase the side-effects. Seventy three percent parents felt the off-label drug use is illegal and 57% would ask for change to a labelled drug in case of such prescription in their children. A majority of the parents would allow their child to participate in case of a life-threatening condition (59.8%) or in case of a chronic illness (51.3%) but significantly less when their child is healthy. The present study has found a low level of awareness regarding the concept of off-label drug use in children amongst the public. Our study also shows that parents expect that the doctor explains the fact to them, although they appear to vest a large amount of trust in the doctor's judgement in doing the best for their sick child. Parents were more willing to allow their child's participation in clinical research if their child was seriously ill than if healthy, indicating the need to educate the society about the need for clinical research so that they could take more informed decisions.

医薬品の適正使用について ―未承認薬・適応外薬の使用にあたって―

医薬品の適正使用について ―未承認薬・適応外薬の使用にあたって―

Drug abuse in paediatric dentistry: a cross-sectional study.

Compared to adult medicine, drug use in children is not extensively researched. The objective of present study is to find out drug prescribing pattern in the Department of Pedodontics and Preventive Dentistry and Orthodontics in teaching hospitals in Rajasthan, India. A prospective study was conducted in June 2011. A total of 619 prescriptions were collected randomly. Prescribing pattern was analyzed using WHO basic drug indicator. The average number of drugs and antimicrobial agent prescribed per prescription were 2.24 and 0.81 respectively. Antimicrobial agent contained 81.74% of all prescriptions. Most common groups of drugs prescribed by pedodontist were NSAIDS & Antipyretics (37.7%), Antimicrobial (36.4%) and Vitamins (12.3%). Prophylactic use of antimicrobial agents was 5.5 ± 0.5 days. Fixed dose combination (45.6%) frequently used by brand name. twelve percent generic drugs were used. Most of the drugs were from Essential Drug List especially a only one drug was prescribed. There is a need of mass awareness amongst dentists about good prescribing habit. Every institution must have Drugs and Therapeutic Committees. The five steps of WHO Program on Rational Use of Drugs (RUD) should be followed for rational prescribing of drugs.

Conocimiento sobre el uso de fármacos off-label en Pediatría. Resultados de una encuesta pediátrica nacional 2012-2013 (estudio OL-PED)

IntroductionOff-label drug use is a common practice in paediatrics. The aim of the present study was to estimate the knowledge of Spaniard paediatricians on off-label use. Material and methodsCross-sectional, multicentre, descriptive and national study from July 2012 to March 2013 using an on-line questionnaire on off-label use in children. An e-mail was sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies. ResultsOut of 673 responses were received, 75.1% of Spanish paediatricians knew the meaning of off-label use, 61% of them prescribed medicines outside the conditions authorised in their Summary of Product Characteristics (SPC) and 47% knew of the importance of noting the off-label use in the medical record. However, just under half of paediatricians informed parents, and only 22% wrote it down in the medical record. ConclusionsMost Spanish paediatricians do not meet current regulations regarding off-label use. This regulation demands: justifying the decisions when off-label use is needed, and to write down in the medical record that, at least an oral consent from the parents has been obtained. This study reveals a fact that Spanish paediatricians must change. Meanwhile, it is a priority to continue with the implementation of consensus and clinical guidelines, to obtain more data on the efficacy and safety of off-label drug use in children, and to incorporate them into the SPC.

Off-label drug use in children increases risk of ADRs

Off-label drug use in children increases risk of ADRs

The evolution of juvenile animal testing for small and large molecules

Recent formalised regulatory requirements for ensuring safe use of new drugs in children has increased the requirement, when considered relevant, to perform juvenile animal testing before commencing paediatric clinical trials. A key goal of this work is to identify or examine for a developmental or toxicity finding not seen in other toxicology testing. With our current knowledge, this paper examines what types of testing are occurring, what novel findings are being seen and their relevance in the safety evaluation process. Furthermore, trends for now and the future in the type of juvenile animal testing will be described including a need for more focused study designs and more published data on modern cross-species postnatal development.