Use Of Medicines In Children Research Articles

Validating the Children’s Medicines Use Questionnaire (CMUQ) in Australia

To pilot test the validity and reliability of the English version of the Children's Medicines Questionnaire (CMUQ) and to explore the attitudes of Australian caregivers towards the use of medicines in children. Survey of Australian parents and primary care givers of children 0-15 years. The questionnaire was translated from Finnish to English then back-translated to ensure semantic equivalence. A total of 153 parents/main caregiver of a child aged 0-15 years were recruited via convenience sampling. Construct validity of the attitudinal section of the CMUQ was performed using exploratory factor analysis. Reliability was assessed using the Cronbach's alpha coefficient as a marker of internal consistency. Three focus groups were conducted to explore participants' attitudes towards medicating children and to triangulate quantitative data. Construct validity and internal reliability of the CMUQ. Factor analysis generated a parsimonious four factor solution explaining 50% of variance in the data. The four subscales representing the four factor solution each returned a Cronbach's Alpha coefficient >0.6, indicating good internal consistency. Participants in focus groups were satisfied with the structure and content of the questionnaire. There were 5 emergent themes through focus group discussions with parents and primary care givers of children, regarding the perception of medicines use in children. These included, 'concerns about the negative effects of medicines', 'medicines are useful, necessary and safe in treating illnesses in children', 'the body's natural processes are sufficient in fighting illness', 'over the counter medicines are effective and useful in treating illness', 'perception of alternative medicines use in children'. The CMUQ is a valid and reliable tool to measure parents' medicine use for their children in an Australian sample. Although small modifications should be made, this instrument will be valuable in informing the development of medicines information for this cohort in the future.

Complementary alternative medicine use in children with type 1 diabetes mellitus in Erzurum, Turkey

The aims of this study were: (i) to determine the types of complementary and alternative medicine use among children with type I diabetes mellitus as reported by parents and (ii) to describe sociodemographic and medical factors associated with the use of such treatments in families residing in Eastern Turkey. Type 1 diabetes mellitus is a tremendously challenging and complex disease for children and families to manage. Therefore, the use of complementary and alternative medicines among children with type 1 diabetes is becoming increasingly popular. Survey. Parents of 100 paediatric patients (who were diagnosed with type 1 diabetes at least 6 months prior to the study) who visited the participating paediatric endocrinology multidisciplinary centres and clinics for diabetes management were included in the study. Data were collected by using a semi-structured questionnaire. Results. Fifty-two per cent of the parents reported the use of one or more complementary alternative medicine therapies. Most such users (59.6%) were using oral herbal preparations; including morus alba (leaves) aloe vera and stinging nettle. Since we found that 78.6% of those using herbals were satisfied with their results and 69.2% were planning to continue use, it is important for healthcare providers to have relevant knowledge about complementary alternative medicine use and learn about its efficacy and effects (positive and adverse) of these treatments. Relevance to clinical practice. Botanical substitute for insulin seems unlikely, but complementary alternative treatments may provide valuable clues for the development of new oral hypoglycaemic agents and simple dietary agents. It is important for healthcare providers to have up-to-date knowledge about the use and effects of complementary alternative medicines in the outpatient clinical care setting.

The use of complementary medicine in children

The use of complementary medicine in children

Developing a decision-making model on traditional and complementary medicine use for children

Aim To explore why parents choose traditional and complementary approaches to health for their children, particularly the influence of cultural beliefs and norms, and develop a conceptual model based on Andersen's sociobehavioural model. Materials and methods Focus groups with 92 parents from at least 20 different countries living in London, UK, explored the influence of predisposing, enabling, need factors and healthcare experience on traditional and complementary healthcare use for children. Themes were identified using Framework Analysis. Results Traditional home remedies including herbs, spices, foods, prayer and rituals were used by most parents, often as a first choice of treatment. Parents were categorised into one of seven typologies depending on how these approaches were used: informed, routine, committed, pragmatic, open, last resort and nonbeliever. All three components of the sociobehavioural model (predisposing, enabling, need) were involved in parents’ decision-making when using traditional and complementary healthcare for children. Conclusions The sociobehavioural model can be used to conceptualise parental decision-making process for child use of traditional and complementary healthcare. This process is crucial in promoting shared decision-making between primary care practitioners and parents and could inform service provision, delivery and policy.

New paediatric research initiatives in the European Union

In contrast to the situation concerning adults, most medicines used to treat the children of Europe have not been tested on children and are not authorised for use in children. Therefore, the health and quality of life of children in the EU countries may suffer from a lack of testing and authorisation of medicines for their use. In particular, 46% of medicines prescribed to children in hospital are either unlicensed for their age group or, if they are, have been done so off-label [1]. Of the children who receive medication in hospital this figure rises to 67% [1], and in the context of intensive care up to 90% of paediatric medicines used are not licensed [2]. Although there may be concerns voiced about conducting trials in the paediatric population, this has to be balanced by the ethical concerns related to giving medicines to a population in which they have not been tested and therefore their effects, positive or negative, are unknown. The European Parliament and Council Regulation on Medicinal Products for Paediatric Use [3] aims to improve the health of the children of Europe by increasing the research, development and authorisation of medicines for use in children, and as such represents a major breakthrough in paediatrics research. Its policy objectives are: to increase the development of medicines for use in children; to ensure that medicines used to treat children are subject to high quality research; to ensure that medicines used to treat children are appropriately authorised for use in children; to improve the information available on the use of medicines in children; and to achieve the above while avoiding unnecessary studies in children. Ensuring that children have access to high-quality, effective and safe medicines, accompanied by high-quality information based on robust evidence, is crucial to giving children and their doctors the ability to make informed decisions about the treatment of disease and ensuring that the chosen medicines improve health. However, the diseases suffered by children often differ considerably from those suffered by adults, and the bodies of children tolerate drugs differently from those of adults. The dose of a medicine to treat a childhood disease cannot always be extrapolated from the adult dose: medicinal products used in the paediatric population have never been specifically studied or authorised (licensed) for use in that age group. This leaves no alternative for the prescriber than to use products off-label – i.e. the use

Off-label and unlicensed use of medicines for children

The lack of specific drugs and labelling recommendations for the paediatric population is a longstanding problem. Physicians frequently prescribe marketed medicines as off-label on the basis of clinical practice and medical knowledge. Moreover ‘unapproved’ drugs are employed in different formulations, routes, combinations to adapt them to children. TEDDY studied the definitions of off-label and unlicensed use of medicines in paediatrics as defined by regulatory agencies and by scientific literature. This study confirmed the need for a common definition for unlicensed and off-label uses to be incorporated into the European legislation. On the basis of the results of this investigation, TEDDY conducted a survey in order to reach a common definition with the intention to favour the use of a European official regulatory terminology and facilitate pharmaco-epidemiological research. The definitions will be circulated within the scientific community and recommended to be adopted by relevant regulatory authorities.

What Affects Asthma Medicine Use in Children? Australian Asthma Educator Perspectives

The global burden of childhood asthma is significant. Health care systems are faced with increasing financial costs, while children with asthma and their caretakers are faced with poorer physical health, emotional health, and quality of life. Despite the availability of effective treatment, the quality use of asthma medicines in children remains suboptimal. An investigation was conducted to explore issues related to children's asthma medicine usage from the perspective of the health care professional. Although current literature has elicited the views of caretakers and children, the health care professional viewpoint has been relatively unexplored. Semi-structured qualitative interviews were conducted with a convenience sample of 21 Australian asthma educators. Interviews were audiotaped and transcribed, and transcripts were thematically analyzed with the assistance of NVivo 7. Emergent themes associated with health care professionals, parents, medicines, children, and educational resources were found. Major issues included a lack of information provided to parents, poor parental understanding of medicines, the high cost of medicines and devices, child self-image, the need for more child responsibility over asthma management, and the lack of standardization, access to, and funding for educational resources on childhood asthma. There are multitudes of key issues that may affect asthma medicines usage in children. This research will help inform the development of educational tools on the use of medicines in childhood asthma that can be evaluated for their effectiveness in getting key messages to target audiences such as children, caretakers, and teachers.

BNF for Children 2008 – The Essential Resource for Clinical Use of Medicines in ChildrenBNF for Children 2008 – The Essential Resource for Clinical Use of Medicines in Children

BNF for Children 2008 – The Essential Resource for Clinical Use of Medicines in ChildrenBNF for Children 2008 – The Essential Resource for Clinical Use of Medicines in Children

BNF for Children 2008 – The Essential Resource for Clinical Use of Medicines in Children960pp BNF for Children 2008 – The Essential Resource for Clinical Use of Medicines in Children £29.95 978 0 85369 780 0 0853697809

BNF for Children 2008 – The Essential Resource for Clinical Use of Medicines in Children960pp BNF for Children 2008 – The Essential Resource for Clinical Use of Medicines in Children £29.95 978 0 85369 780 0 0853697809

Use of complementary and alternative medicines for children with chronic health conditions in Lagos, Nigeria

BackgroundThe use of complementary and alternative medicine (CAM) is on the increase globally with a high prevalence in children and adults with chronic illnesses. Many studies have evaluated the epidemiology of medicine use for children in developing countries but none has evaluated the use of CAM for children with chronic illnesses. The aim of this study was therefore to determine the prevalence, pattern of use, parental sources of information, perceived benefits, cost, and adverse effects of CAM in children with epilepsy, sickle cell anaemia and asthma in Lagos, Nigeria.MethodsParents of children with epilepsy (122), asthma (78) or sickle cell anaemia (118) who presented consecutively to the paediatric neurology, respiratory and haematology clinics of the Lagos State University Teaching Hospital (LASUTH), Ikeja were interviewed with a structured open- and close-ended questionnaire. The information obtained comprised the demography of both the patients and their parents; past and present treatments received by the patients; the type of CAM, if any, used by the patients; and the sources, cost, benefits and adverse effects of the CAM used.ResultsA total of 303 CAMs were used by the patients, either alone or in combination witother CAM. CAM was reportedly used by 99 (31%) patients (epilepsy -38%, sickle cell anaemia – 36% and asthma – 25%). The majority (84%) of these patients were currently using CAM. The use of CAM was stopped six months prior to the study by 16 patients (16%). Biological products were the most frequently used CAMs (58%), followed by alternative medical systems (27%) and mind-body interventions (14%). Relations, friends and neighbours had a marked influence on 76% of the parents who used CAM for their children. Eighty-five (86%) parents were willing to discuss the use of CAM with their doctors but were not asked. CAM use was associated with adverse reactions in 7.1% of the patients.ConclusionParental use of CAMs to treat their children with epilepsy, asthma and sickle cell anaemia is common in Nigeria. Efforts should be made by doctors taking care of these patients to identify those CAM therapies that are beneficial, harmless and cheap for possible integration with conventional therapy.

Public awareness and views on unlicensed use of medicines in children

To explore awareness and views of the general public on unlicensed use of medicines in children and on the participation of children in clinical trials. Members of the public completed a questionnaire survey administered by face-to-face interview in public areas in N. Ireland. The main outcome measures were the views on unlicensed use of medicines in children and on clinical trials in children. One thousand participants (59.2% female) took part; 610 were parents. Most participants (86%) had no previous knowledge about unlicensed use of medicines in children. Being a parent did not influence this nor did being a parent of a child who suffered from a health problem (P > 0.05). Most participants (92%) felt that parents should be told about unlicensed use of medicines, with the doctor most frequently selected as the person who should inform parents. At the outset, only 1.8% of participants felt that the use of medicines in children was unsafe. However, having been informed about unlicensed use of medicines, this proportion increased dramatically (62.4%; P < 0.001). Views on whether participants would enter a child of their own into a clinical trial varied according to the health status of the child (P < 0.05) i.e. a child in good health (3.9%) vs a child with a life-threatening condition (41.9%). There is limited public knowledge of unlicensed use of medicines in children and a general reluctance to involve children in clinical trials unless the child to be involved has a life-threatening condition.

Complementary and Alternative Medicine Use in Children With Cancer and General and Specialty Pediatrics

The objective of this survey is to determine the frequency, reasons, and factors influencing use of complementary and alternative medicine (CAM) in general and specialty pediatrics within the same geographic area. Of the 281 surveys completed, CAM use was higher in children with epilepsy (61.9%), cancer (59%), asthma (50.7%), and sickle cell disease (47.4%) than in general pediatrics (36%). Children most often used prayer (60.5%), massage (27.9%), specialty vitamins (27.2%), chiropractic care (25.9%), and dietary supplements (21.8%). Parents who used CAM for themselves (68.7%) were more likely to access CAM for their child. Most parents (62.6%) disclosed some or all of their child's use of CAM to providers. This study confirms that within the same geographic region, children with chronic and life-threatening illness use more CAM therapies than children seen in primary care clinics. Children with cancer use CAM for different reasons than children with non-life-threatening illnesses.

Defining off-label and unlicensed use of medicines for children: Results of a Delphi survey

The aim of this Delphi survey is to develop common definitions for unlicensed and off-label drug use in children to be used for research and regulatory purposes. After a literature review on the current status of unlicensed/off-label definitions, a two-stage, web-based Delphi survey was conducted among experts in Europe. Their opinion on concerns, rules and scenarios regarding the unlicensed and off-label use of medicines were obtained. Results were then consulted with the European Medicines Agency (EMEA) before the final proposal was circulated to participants. Eighty-four experts were invited to participate (scientists, health professionals, pharmaceutical companies, regulatory agencies), 34 responded to the first round questionnaire and participated in subsequent rounds. Consensus was reached for the majority of questions. The lowest level of consensus reached was for questions related to a different formulation or if a drug was given although contraindicated. At the final step, 85% of the responding experts agreed on the proposed definition for off-label (use of a drug already covered by a Marketing Authorisation, in an unapproved way) and 80% on the definition for unlicensed (use of a drug not covered by a Marketing Authorisation as medicinal for human use), respectively. Results will facilitate the conduct of pharmacoepidemiological studies and allow comparison between different countries. The Delphi panel agreed that the definitions should be circulated within the scientific community and recommended to be adopted by relevant regulatory authorities.

Off-label use of medicines in children: can available evidence avoid useless paediatric trials?

In some cases of drug therapy, the available evidence might be sufficient to extend the indications to children without further clinical studies. We reviewed the available evidence for one of the categories of drugs most frequently used off-label in children: proton pump inhibitors (PPIs) used for the treatment of gastroesophageal reflux disease (GERD). A classification of the appropriateness of off-label use of PPIs in children with GERD was also performed. Of the five PPIs evaluated, only omeprazole has a paediatric indication in Europe. Overall, 19 clinical trials were retrieved and evaluated on the basis of pharmacokinetics, efficacy and safety data. The off-label use of omeprazole, esomeprazole and lansoprazole in children was evaluated as appropriate given the consistent available evidence retrieved in literature. This study demonstrates the existence of a large body of clinical evidence on the use of PPIs in children. Regulatory agencies and ethical committees should cope with this issue for ethical reasons to avoid unnecessary trial replication.

Complementary and Alternative Medicine Use in Children with Type 1 Diabetes: A Pilot Survey of Parents

The aim of this study was to examine the prevalence and characteristics of complementary and alternative medicine (CAM) use among children with diabetes. Anonymous surveys were completed by guardians of children with diabetes attending an urban diabetes clinic over three months. The survey included demographics, parent and child CAM use (excluding vitamins), and perceived opinions of health providers about CAM use. The representativeness of the surveyed sample was evaluated and analyses examined associations with child CAM use. Children in the analysis (N = 86, 33% response rate) were similar to the potential population for age, gender, insurance type, and age at diabetes diagnosis. Children analyzed were mean 10.9 years of age (SD 3.9), 56% male, 71% Caucasian, 83% privately insured, and 90% spoke English at home. Parents were 22% foreign born and 45% college graduates; 19% of children and 45% of parents had tried CAM. There were 30 CAM use occurrences among 16 children; 60% were CAM activities (ie, faith healing, chiropractic treatments, relaxation techniques) and 40% were CAM supplements (ie, herbs, nutritional supplements, herbal teas). Child CAM use was more common if a parent had used CAM (33% vs 6%; P = .002) and among children with foreign-born parents (37% vs 13%; P = .04). CAM was used to decrease diabetes complications and improve overall health. Parents were comfortable discussing CAM with the diabetes team and their child's primary care provider. Children with diabetes were using CAM as an adjunctive therapy for diabetes. The diabetes healthcare team needs an increased awareness about CAM.

Use of Complementary and Alternative Medicine by Pediatric Patients With Functional and Organic Gastrointestinal Diseases: Results From a Multicenter Survey

Many pediatric patients use complementary and alternative medicine, especially when facing a chronic illness for which treatment options are limited. So far, research on the use of complementary and alternative medicine in patients with functional gastrointestinal disease has been scarce. This study was designed to assess complementary and alternative medicine use in children with different gastrointestinal diseases, including functional disorders, to determine which factors predicted complementary and alternative medicine use and to assess the willingness of parents to participate in future studies on complementary and alternative medicine efficacy and safety. The prevalence of complementary and alternative medicine use was assessed by using a questionnaire for 749 children visiting pediatric gastroenterology clinics of 9 hospitals in the Netherlands. The questionnaire consisted of 35 questions on the child's gastrointestinal disease, medication use, health status, past and future complementary and alternative medicine use, reasons for its use, and the necessity of complementary and alternative medicine research. In this study population, the frequency of complementary and alternative medicine use was 37.6%. A total of 60.3% of this group had used complementary and alternative medicine specifically for their gastrointestinal disease. This specific complementary and alternative medicine use was higher in patients with functional disorders than organic disorders (25.3% vs 17.2%). Adverse effects of allopathic medication, school absenteeism, age <or=11 years, and a low effect of conventional treatment were predictors of specific complementary and alternative medicine use. Almost all (93%) of the parents considered it important that pediatricians initiate complementary and alternative medicine research, and 51% of parents were willing to participate in future complementary and alternative medicine trials. Almost 40% of parents of pediatric gastroenterology patients are turning to complementary and alternative medicine for their child. Lack of effectiveness of conventional therapy, school absenteeism, and adverse effects of allopathic medication are more important predictors of complementary and alternative medicine use than the type of gastrointestinal disease. Because evidence on most complementary and alternative medicine modalities in children with gastrointestinal disorders is lacking, there is an urgent need for research in this field.

Cough medicines: actions, uses and prescribing rationale

This article provides an overview of the different types of cough medicine. There is a consideration of the mechanism of action of each group and the evidence base for the use of cough medicines. The use of cough medicines in children is highlighted as guidelines in this area have recently changed. The prescriber is reminded of some common prescribing issues relating to this group of medicines.

BNF for Children 2007 – The Essential Resource for Clinical Use of Medicines in ChildrenBNF for Children 2007 – The Essential Resource for Clinical Use of Medicines in Children

BNF for Children 2007 – The Essential Resource for Clinical Use of Medicines in ChildrenBNF for Children 2007 – The Essential Resource for Clinical Use of Medicines in Children

An independent contribution to the growth of paediatric clinical pharmacology in Italy

Providing young researchers with an education is one of the priorities of the Mario Negri Institute, the main, private, non-profit Italian research foundation. Between 1994 and 2006, 21 research fellows from different health-care areas were selected for a problem-oriented fellowship in paediatric clinical pharmacology in the Laboratory of Mother and Child Health. Of these, 18 received at least 2 years of training and 12 completed a formal pharmacology research course focused on paediatrics. One research fellow received a PhD degree, and another is currently working towards a PhD. The majority of these research fellows are currently employed in the private health sector, four work in the public National Health Service, and four continue to work as senior scientists at the Mario Negri Institute. To guarantee a safer and more effective use of medicines in children, more post-doctoral fellows should receive training in paediatric clinical pharmacology. Financial resources must be raised to support an adequate education, training, and research programme in this field. A possible challenge could be a European network of interested, expert institutions collaborating in a joint initiative in the interest of paediatric clinical pharmacology, and, more importantly, in the interest of rational therapies for children.

Access to Essential Medicines for Children: The World Health Organization's Global Response

In many instances medicines are the most cost-effective health-care intervention in saving lives and alleviating the suffering of children in situations of public health concern. The major difference between medicines for adults and medicines for children is that use of medicines in children is much less of an evidence-based process.