Ebba Holme Hansen

Caught in a Balancing Act: Parents’ Dilemmas Regarding Their ADHD Child’s Treatment With Stimulant Medication

The authors explored parents’ perceptions of and everyday experiences with the stimulant medication used to treat their child’s attention deficit hyperactivity disorder (ADHD) in this phenomenological study. They elicited experiences through semistructured interviews with 10 Canadian parents of children with ADHD. In the interviews, parents revealed the meaning the stimulant medication had taken on in the context of their everyday lives. Through the interview analysis, dilemma emerged as the dominant theme. Parents were caught in a dynamic balancing act, as they considered the medication’s desirable and undesirable effects in various settings. In addition, parents shared their expectations regarding the medication’s role in their child’s future. The study’s findings reinforce the necessity of further qualitative research in this area, given the growing number of families around the globe whose children have been diagnosed with ADHD.

Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006.

AbstractBackground: Reporting adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. Since 2003 in Denmark, consumers have been able to report ADRs directly to the authorities. The objective of this study was to compare ADRs reported by consumers with ADRs reported from other sources, in terms of their type, seriousness and the suspected medicines involved. Methods: The number of ADRs reported to the Danish ADR database from 2004 to 2006 was analysed in terms of category of reporter, seriousness, category of ADRs by system organ class (SOC) and the suspected medicines on level 1 of the anatomical therapeutic chemical (ATC) classification system. ADR reports from consumers were compared with reports from other sources (physicians, pharmacists, lawyers, pharmaceutical companies and other healthcare professionals). Chi-square and odds ratios (ORs) were calculated to investigate the dependence between type of reporter and reported ADRs (classified by ATC or SOC). Findings: We analysed 6319 ADR reports corresponding to 15 531 ADRs. Consumers reported 11% of the ADRs. Consumers’ share of’serious’ ADRs was comparable to that of physicians (approximately 45%) but lower than that of pharmacists and other healthcare professionals. When consumer reports were compared with reports from other sources, consumers were more likely to report ADRs from the following SOCs: ‘nervous system disorders’ (OR =1.27; 95% CI 1.05, 1.53); ‘psychiatric disorders’ (OR =1.70; 95% CI 1.31, 2.20) and ‘reproductive system and breast disorders’ (OR = 2.02; 95% CI 1.13, 3.61) than other sources. Compared with other sources, consumers reported fewer ADRs from the SOCs ‘blood and lymphatic system disorders’ (OR = 0.22; 95% CI 0.08, 0.59) and ‘hepatobiliary system disorders’ (OR = 0.14; 95% CI 0.04, 0.57). Consumers were more likely to report ADRs from the ATC group N (nervous system) [OR = 2.72; 95% CI 2.34, 3.17], ATC group P (antiparasitic products) [OR = 2.41; 95% CI 1.32, 4.52] and ATC group S (sensory organs) [OR = 4.79; 95% CI 2.04, 11.23] than other sources. Consumers reported fewer ADRs from the ATC group B (blood and blood-forming organs) [OR = 0.04; 95% CI 0.006, 0.32] and the ATC groups J (anti-infective for systemic use) [OR=0.44; 95% CI 0.33, 0.58], L (antioneoplastic and immunomodulating agents) [OR= 0.19; 95% CI 0.12,0.30] and V (various) [OR = 0.03; 95% CI 0.004, 0.21] than other sources. In the SOC ‘nervous system disorders’, consumers reported seven categories of ADRs that were not reported by the other sources. Conclusion: This study showed that compared with other sources, consumers reported different categories of ADRs for different types of medicines. Consumers should be actively included in systematic drug surveillance systems, including clinical settings, and their reports should be taken as seriously as reports from other sources.

Knowledge‐sharing enablers and barriers in pharmaceutical research and development

Purpose – Because selling innovative products is crucial to its livelihood, the pharmaceutical industry has a fundamental need to share knowledge to stimulate the process of knowledge creation. This study seeks to explore knowledge‐sharing enablers and barriers in pharmaceutical R&D.Design/methodology/approach – A case study was carried out in a pharmaceutical company in Denmark. R&D professionals were asked to identify organizational enablers and barriers to knowledge sharing. Their accounts were processed as text during workshops. Data were condensed thematically. The analysis was combined with the conceptualization of tacit and explicit knowledge as proposed by Nonaka and Takeuchi.Findings – The research shows that R&D professionals have different views and practices regarding engaging in knowledge sharing. This reveals that knowledge sharing is multi‐faceted and that one standard for R&D professionals does not exist. The enablers identified recognized the use of tacit knowledge. The existence of enabl...

Prescription and non-prescription medicine use in Denmark: association with socio-economic position

ObjectiveTo analyse the association among different types of medicine use and different measures of socio-economic position (SEP) in one and the same general population.MethodsData from The Danish Health and Morbidity Survey 2000 were analysed. The survey was conducted by face-to-face interviews with a representative sample of the adult Danish population (n=16,690). The associations between prescription and over-the-counter (OTC) medicine use and education, occupation and income were assessed by logistic regression analyses. All analyses were adjusted for age, gender and two measures of health status.ResultsThis cross-sectional analysis of medicine use in a large representative sample of the Danish population found greater use of prescription medicines among disability pensioners and “others” than in salaried employees. Disability pensioners and self-employed individuals used less OTC medicine than salaried employees. Individuals with low income used more prescription medicines but not more OTC medicines, than those with high income. No major differences were found in prescription medicine use with respect to education, but men within the two middle educational groups tended to use prescription medicine less frequently than both lower and higher educated men. A similar trend was not found for women. OTC medicine use was not associated with education for either gender.ConclusionsThe prevalence of prescription medicine use increases with declining SEP, after adjusting for health status. Such an association does not exist for OTC medicine use. The results show that the least affluent have access to prescription medicine. The difference between prescription and OTC medicine use may be explained by a compensation mechanism.

A qualitative systematic review of morphine treatment in children with postoperative pain.

Background:  Postoperative pain management in children is often empirical rather than evidence based. Morphine is the pharmacological treatment most widely used and although considered safe for children, adequate scientific data on morphine’s pharmacokinetics, efficacy and safety are lacking. This systematic review aimed to evaluate the available literature examining different pediatric morphine regimens with respect to dosage, analgesic efficacy and incidence of side effects.

Self-reported medicine use among 11- to 15-year-old girls and boys in Denmark 1988-1998

Aims: To describe the self-reported medicine use for common health complaints among 11 - 15-year-olds in Denmark during a ten year period, 1988 - 1998. The paper focuses on medicine for headache, stomach ache, cough, cold, nervousness, and difficulties in getting to sleep. Methods: Four cross-sectional surveys of 11 - 15-year-old students in random samples of schools in Denmark, conducted in 1988 (n=1,671), 1991 (n=1,860), 1994 (n=4,046) and 1998 (n=5,205). The surveys were similar with regard to sampling and data collection. Data were collected by self-administered questionnaires in the classroom. Results: A large proportion of 11 - 15-year-olds reported medicine use during the past month. It was most common to take medicines for headache (used by 55% of 15-year-old girls and 36% of 15-year-old boys in 1998) and stomach ache (33% among 15-year-old girls in 1998). Pain reliever use was higher among girls than boys and this sex difference increased with age. There was an upward trend in reported medicine use from 1988 to 1998, in particular regarding medicine for stomach-ache among 13- and 15-year-old girls. A large proportion of girls were frequent users of medicine for headache, stomach-ache, and sleeping difficulties. Conclusion: A high proportion of 11 - 15-year-old girls and boys reported medicine use in relation to common health complaints. The proportion of users increased during the past decade. It is suggested that more information about medicine be built into health education programs in the future.

Is victimization from bullying associated with medicine use among adolescents? A nationally representative cross-sectional survey in Denmark

OBJECTIVE. The goal was to examine whether being a victim of bullying was associated with medicine use, taking into account the increased prevalence of physical and psychological symptoms. METHODS. The study population included all students in grades 5, 7, and 9 (mean ages: 11.6, 13.6, and 15.6 years, respectively) in a random sample of schools in Denmark (participation rate: 88.5%; N = 5205). The students reported health problems, medicine use, bullying, and a range of psychosocial conditions in an anonymous standardized questionnaire. The outcome measure was self-reported medicine use for headache, stomachache, difficulties in getting to sleep, and nervousness. The determinant was frequency of exposure to bullying, measured with 1 item. RESULTS. In multivariate models adjusted for age and social class, we found that adolescent victims of bullying used medicine for pains and psychological problems more often than did adolescents who were not bullied. The increased odds of using medicine were not explained by the higher prevalence of symptoms among the bullied children. CONCLUSIONS. We found victimization from bullying to be associated with medicine use, even when we controlled for the higher prevalence of symptoms among bullied victims. The medications that adolescents use can have adverse effects, in addition to the potentially health-damaging effects of bullying. Policy makers, health care professionals, and school staff should be aware that the adolescent victims of bullying are prone to excess use of medicine, and preventive actions should be taken to decrease the level of bullying as well as the use of medicine among adolescents.

Adverse Drug Reactions in the Paediatric Population in Denmark

AbstractBackground: The potential risk of adverse drug reactions (ADRs) in the paediatric population has become a public health concern and regulatory agencies in Europe and the US have acknowledged that there is a need for more research in this area. Spontaneous reporting systems can provide important new information about ADRs. Objective: To characterize ADRs in children reported in Denmark over a period of one decade. Methods: We analysed ADRs reported to the Danish Medicines Agency from 1998 to 2007 for individuals aged from birth to 17 years. Data were analysed with respect to time, age and sex, category of ADR (System Organ Class [SOC]), seriousness, suspected medicines (level 2 of the Anatomical Therapeutic Chemical [ATC] Classification System) and type of reporter. Results: 2437 ADR reports corresponding to 4500 ADRs were analysed. On average, 234 ADR reports were submitted annually, corresponding to approximately two ADRs per report. From 2003 to 2005, an increasing number of ADRs submitted per report were observed, but after 2005 the reporting rate decreased. One-half of ADRs were reported for infants from birth to 2 years of age. Similar total numbers of ADRs were reported for boys and girls. The majority of ADRs reported were from the following SOCs: general disorders and administration site conditions (31%), skin and subcutaneous tissue disorders (18%) and nervous system disorders (15%). Reports encompassed medicines from ATC group J: vaccines and anti-infectives for systemic use (65%); and ATC group N: nervous system (17%). On average, 42% of ADRs were classified as serious. ATC group N had the highest proportion of ADRs that were classified as serious. Although physicians reported approximately 90% of the ADRs, a relatively large proportion of serious ADRs were reported by other sources. Conclusion: In Denmark, the ADR reporting rate in the paediatric population has declined since 2005. The majority of ADRs reported in young children were reported for vaccines and anti-infectives, but also a high number of serious ADRs were reported for medicines from ATC group N. The Danish Medicines Agency should monitor prescribing patterns more tightly to identify potential risks in the paediatric population in relation to the evolving pattern of medicine use among children.

Using text-mining techniques in electronic patient records to identify ADRs from medicine use

This literature review included studies that use text-mining techniques in narrative documents stored in electronic patient records (EPRs) to investigate ADRs. We searched PubMed, Embase, Web of Science and International Pharmaceutical Abstracts without restrictions from origin until July 2011. We included empirically based studies on text mining of electronic patient records (EPRs) that focused on detecting ADRs, excluding those that investigated adverse events not related to medicine use. We extracted information on study populations, EPR data sources, frequencies and types of the identified ADRs, medicines associated with ADRs, text-mining algorithms used and their performance. Seven studies, all from the United States, were eligible for inclusion in the review. Studies were published from 2001, the majority between 2009 and 2010. Text-mining techniques varied over time from simple free text searching of outpatient visit notes and inpatient discharge summaries to more advanced techniques involving natural language processing (NLP) of inpatient discharge summaries. Performance appeared to increase with the use of NLP, although many ADRs were still missed. Due to differences in study design and populations, various types of ADRs were identified and thus we could not make comparisons across studies. The review underscores the feasibility and potential of text mining to investigate narrative documents in EPRs for ADRs. However, more empirical studies are needed to evaluate whether text mining of EPRs can be used systematically to collect new information about ADRs.

What is the difference between dependence and withdrawal reactions? A comparison of benzodiazepines and selective serotonin re‐uptake inhibitors

AIMS To explore the rationale for claiming that benzodiazepines cause dependence while selective serotonin re-uptake inhibitors (SSRIs) do not. METHODS We analysed the definitions of dependence and withdrawal reactions as they had appeared over time in the Diagnostic Statistical Manual of Mental Diseases (DSM) and the International Classification of Diseases (ICD). We also compared the discontinuation symptoms described for the two drug groups in a systematic review. RESULTS The definition of substance dependence has changed over time in both the DSM and ICD. In the most recent classifications several criteria, including behavioural, physiological and cognitive manifestations, must be fulfilled. This change was published with the revision of the DSM-III revision in 1987 (DSM-IIIR), after the recognition of benzodiazepine dependence and just before the SSRIs were marketed in 1987-88. We found that discontinuation symptoms were described with similar terms for benzodiazepines and SSRIs and were very similar for 37 of 42 identified symptoms described as withdrawal reactions. CONCLUSIONS Withdrawal reactions to selective serotonin re-uptake inhibitors appear to be similar to those for benzodiazepines; referring to these reactions as part of a dependence syndrome in the case of benzodiazepines, but not selective serotonin re-uptake inhibitors, does not seem rational.