O. Bourdon

Psychotropic medication use in the child and adolescent psychiatry wards of a French hospital

Objective The aim of this study was to investigate the use of psychotropic medication in children and adolescents hospitalised in a psychiatric ward. Methods A prospective analysis of psychotropic drug prescriptions was conducted for all patients hospitalised in two acute psychiatric hospitalisation units of a paediatric teaching hospital in Paris, France. The study group consisted of 187 patients and was characterised in terms of age, sex, prior psychiatric hospitalisation and DSM-IV-Tr diagnosis. All prescriptions were assessed for off-label use. Results Overall, 46% of patients received at least one dose of psychotropic medication. Antipsychotic drugs were the most frequently prescribed drugs (44%), regardless of diagnosis. Ninety percent of patients who received antipsychotic drugs did not have psychosis. We found that 69% of the 421 prescriptions written were for off-label uses. The percentage distribution of off-label prescriptions by medication class was as follows: antipsychotic drugs, 90%; anxiolytics, 28%; stimulants, 26%; antidepressants, 89%; antiepileptic drugs, 89% and antiparkinsonian drugs, 91%. Conclusion The extensive use of drugs for off-label indications in children and adolescents suggests that prospective post-marketing studies should be carried out to evaluate efficacy and safety.

A comparative pilot study of the professional ethical thinking of Quebec pharmacy residents and French pharmacy interns

Objective The main objective of this pilot study is to compare the professional ethical thinking of Quebec pharmacy residents and French pharmacy interns. The secondary objective is to compare the professional ethical thinking of Quebec pharmacy residents and first year French pharmacy interns. Setting Hospital pharmacy residents from Quebec, Canada and pharmacy interns from France. Methods This is a cross-sectional, descriptive, web-based survey. Main outcome measure For this study, professional ethical thinking was defined as the level of agreement/disagreement with statements about pharmacy ethics/dilemmas. Results A total of 208 usable questionnaires were completed (response rate 91% in Quebec and 11% in France). There were no significant differences between Quebec residents and French interns for 29/43 items (67%). However, there were significant differences in their level of agreement with 14/43 items (33%) surveyed by our questionnaire. The differences related to the following themes: economic aspects (four statements), pharmaceutical care, code of ethics, evaluation, clinical research (two statements each) and training and education, dispensing medications (one statement each). There were statistically significant differences between the two groups in terms of exposure to ethics during academic training and experiential practice. There were significant statistical differences between the two groups of first year pharmacy respondents for 11 statements (26%), with only two out of 11 statements being different from those reported in the overall comparison. Conclusion Published data on the professional ethical thinking of pharmacy residents and interns remain limited. We believe the higher exposure of Quebec residents to ethics during academic courses and experiential/practical training may have contributed to a higher level of agreement with some ethical statements.

How to Improve the Implementation of Academic Clinical Pediatric Trials Involving Drug Therapy? A Qualitative Study of Multiple Stakeholders

Objective The need for encouraging pediatric drug research is widely recognized. However, hospital-based clinical trials of drug treatments are extremely time-consuming, and delays in trial implementation are common. The objective of this qualitative study was to collect information on the perceptions and experience of health professionals involved in hospital-based pediatric drug trials. Methods Two independent researchers conducted in-depth semi-structured interviews with principal investigators (n = 17), pharmacists (n = 7), sponsor representatives (n = 4), and drug regulatory agency representatives (n = 3) who participated in institutionally sponsored clinical trials of experimental drugs in pediatric patients between 2002 and 2008. Results Dissatisfaction was reported by 67% (16/24) of principal investigators and pharmacists: all 7 pharmacists felt they were involved too late in the trial implementation process, whereas 11 (65%) principal investigators complained of an excessive regulatory burden and felt they were insufficiently involved in the basic research questions. Both groups perceived clinical trial implementation as burdensome and time-consuming. The sponsor and regulatory agency representatives reported a number of difficulties but were not dissatisfied. Conclusions The heavy burden related to regulatory requirements, and suboptimal communication across disciplines involved, seem to be the main reasons for the major delays in pediatric drug trial implementation. The pharmaceutical aspects are intrinsically tied to trial methodology and implementation and must therefore be examined, in particular by involving Clinical Research Pharmacists at early stages of study conception.

POPI; pédiatrie: Omissions et prescriptions inappropriées. Outil d'identification des prescriptions inappropriées chez l'enfant

[1] Geterud A, Bake B, Berthelsen B, et al. Laryngeal involvement in rheumatoid arthritis. Acta Otolaryngol 1991;111:990–8. [2] Abdel-Aziz M, Azab NA, Bassyouni IH, et al. Laryngeal involvement in juvenile idiopathic arthritis patients. Clin Rheumatol Tool of Older Persons’ Prescriptions)/START (Screening Tool to Alert doctors to Right Treatment) est un outil récent créé en Irlande en 2008. Cet outil permet aux prescripteurs d’identifier les PMI ainsi que les omissions de prescriptions considérées appropriées chez la personne âgée. En utilisant la liste START, Barry et al. avaient trouvé une ou plusieurs omissions de prescription chez 57,9 % des patients [4]. Le pourcentage de 2011;30(9):1251–6. [3] Bertolani MF, Bergamini BM, Marotti F, et al. Cricoarytenoid arthritis as an early sign of juvenile chronic arthritis. Clin Exp Rheumatol 1997;15:115–6. [4] Goldhagen JL. Cricoarytenoiditis as a cause of acute airway obstruction in children. Ann Emerg Med 1988;17:532–3. [5] Bamshad M, Rosa U, Padda G, Luce M. Acute upper airway obstruction in rheumatoid arthritis of the cricoarytenoid joints. South Med J 1989;82:507–11. PMI était de 35 % en utilisant la liste STOPP chez des personnes âgées hospitalisées [5]. La prescription en pédiatrie est souvent empirique, hors autó ` ́ ́ [6] Malleson P, Riding K, Petty R. Stridor due to cricoarytenoid arthritis in pauciarticular onset juvenile rheumatoid arthritis. J risation de mise sur le marche (AMM) a defaut d’etudes cliniques dans ce domaine, ce qui n’est pas sans risque [6]. Rheumatol 1986;13:952–3.

Peut-on se passer des anti-nauséeux en pédiatrie ?

S. Prot-Labarthea, D. Morela, M. Bellaı̈cheb, O. Bourdona,*,c a Pharmacie de l’hôpital Robert-Debré, faculté de pharmacie, université Paris Descartes, AP–HP, 48, boulevard Sérurier, 75019 Paris, France b Service de gastro-entérologie de l’hôpital Robert-Debré, AP–HP, 75019 Paris, France c Laboratoire de pédagogie de la santé EA 3412, université Paris 13-Bobigny, Sorbonne Paris Cité, 93000 Bobigny, France

Academic pediatric clinical research: factors associated with study implementation duration.

BackgroundThe ethical, methodological, and technical aspects of pediatric research, often results in complications and delays in implementation. Our objective was to identify factors associated with the implementation duration of hospital-based pediatric studies.MethodsAll hospital-based pediatric studies sponsored by AP-HP between 2002 and 2008 were retrospectively identified. Association of the funding mechanism and methodological factors with the implementation duration was assessed using a multivariable mixed linear model. Pharmaceutical factors were explored as part of a subgroup analysis restricted to the studies involving drug therapy. Given that we took an exploratory approach, factors associated with implementation duration with p < 0.10 were kept in the final models.ResultsA total of 139 studies were evaluated. The median implementation duration was 17.1 months (range: 0.9-55.3 months), and tended to increase over time (from 14.9 [25th percentile-75th percentile: 11.5-19.9] months in 2002 to 23.7 [15.2-31.0] months in 2008, p = 0.01). External (coefficient [95 % confidence interval]: -7.7 [-11.9;-3.5] months, p < 0.001) and internal funding (-5.3 95 % CI [-9.8;-0.8], p = 0.02) compared to governmental funding and number of centers (-0.1 95 % CI[-0.2;0.02] months for 1 center increase, p = 0.07) were associated with reduced duration, whereas interventional study (either involving drug therapy (6.0 95 % CI[0.7;11.3] months, p = 0.03 or not (3.5 95 % CI[-0.3;7.3] months, p = 0.06) was associated with increased duration compared to observational study. Regarding the 35 studies involving drug therapy, external funding decreased duration (-6.7 95 % CI[-13.2;-0.2] months, p = 0.05), whereas studies involving solely a pediatric population (7.8 95 % CI[1.1;14.5] months, p = 0.01) (compared to mixed adult-pediatric population), a placebo-controlled design (6.6 95 % CI[0.9;12.3] months, p = 0.01), and inappropriate drug formulation for at least one drug used in the study (6.9 95 % CI[-0.2;14.0] months, p = 0.06) were associated with increased duration.ConclusionImplementation of hospital-based pediatric studies primarily faced delays when they were interventional and, in particular, when they involved drug therapy. Regarding the latter, difficulties that resulted in delayed studies arose with respect to the supply of drugs and placebo in age-appropriate dosages and route of administration. Therefore, difficulties related to the use of pharmaceuticals need to be anticipated earlier in order to avoid implementation delays.

Paediatric clinical research from the perspective of hospital pharmacists from France and Canada

To compare pharmacy support for paediatric research services in France and Canada and to describe the perception of pharmacists and rank the paediatric clinical research issues.

The use of prn medication in a child and adolescent mental health inpatient service in France.

Objective. The aim of this study was to investigate the use of “as needed” (pro re nata or prn) psychotropic medication in a child and adolescent psychiatric inpatient population. The study was carried out on the psychiatry ward of a paediatric teaching hospital in Paris, France. Methods. A prospective analysis of prn psychotropic drug prescriptions and administrations was conducted for all patients hospitalised over a period of 4 months. The study group consisted of 187 patients. Results. In total, 93 prn prescriptions were written, for 27% of the patients (51) but only 14% (26) received a total of 76 administrations. Antipsychotic drugs accounted for 54% of the prescriptions, anxiolytics for 33%, antiepileptic drugs for 8%, antiparkinsonian drugs for 4% and hypnotic drugs for 1%. Anxiety was the reason given for 67% of the prn administrations, with hydroxyzine used in 69% of these cases. Disruptive behaviour accounted for 22% of prn administrations, with antipsychotic drugs accounting for 88% of these administrations. Insomnia accounted for 8% of prn administrations, and antipsychotic drug-induced dystonia accounted for 3% of such administrations. Conclusion. Controlled studies are required to assess the efficacy and safety of prn medication and the conditions in which its use is indicated.