Sonia Prot-Labarthe

Pharmaceutical care in an inpatient pediatric hematopoietic stem cell transplant service

Introduction. Hematopoietic stem cell transplant patients represent a population at high risk for drug-related problems. Our objective is to describe pharmacist interventions in a hematopoietic stem cell transplant pediatric unit. Methods and Patients. The Hematopoietic Stem Cell Transplant Unit of the Centre Hospitalier Universitaire Sainte-Justine performs around 50 hematopoietic stem cell transplants per year. During a pharmaceutical care specialized residency program, a French pharmacist participated in certain clinical activities. Drug-related problems and clinical interventions were compiled over 31 nonconsecutive days using a tool developed by the Société Française de Pharmacie Clinique. Data concerning patients, drugs, intervention, documentation, approval (if needed), and estimated impact were compiled. Results. During the 31-day period, 525 interventions were collected (16.9 ± 3.7 per day), targeting 29 patients. The main drug-related problems were adverse drug reactions (N = 125, 23.8%), untreated indication (N = 92, 17.5%) and failure to receive drug (N = 89, 17.0%). The pharmacists interventions concerned mainly dose adjustment (N = 174, 33.1%) and drug monitoring (N = 132, 25.1%). Among the 324 (61.7%) interventions requiring a physicians approval, 302 (93.2%) were accepted without any change. Conclusion. A pharmacist is able to perform clinically relevant interventions in a hematopoietic stem cell transplant unit, given the complexity of the pharmacotherapy. Our description of drug-related problems and interventions may help other pharmacists already working or developing pharmaceutical care in a hematopoietic stem cell transplant unit to compare their practice and it is one of the few reported in the literature. J Oncol Pharm Practice (2008) 14: 147—152.

POPI (Pediatrics: Omission of Prescriptions and Inappropriate prescriptions): development of a tool to identify inappropriate prescribing.

Introduction Rational prescribing for children is an issue for all countries and has been inadequately studied. Inappropriate prescriptions, including drug omissions, are one of the main causes of medication errors in this population. Our aim is to develop a screening tool to identify omissions and inappropriate prescriptions in pediatrics based on French and international guidelines. Methods A selection of diseases was included in the tool using data from social security and hospital statistics. A literature review was done to obtain criteria which could be included in the tool called POPI. A 2-round-Delphi consensus technique was used to establish the content validity of POPI; panelists were asked to rate their level of agreement with each proposition on a 9-point Likert scale and add suggestions if necessary. Results 108 explicit criteria (80 inappropriate prescriptions and 28 omissions) were obtained and submitted to a 16-member expert panel (8 pharmacists, 8 pediatricians hospital-based −50%- or working in community −50%-). Criteria were categorized according to the main physiological systems (gastroenterology, respiratory infections, pain, neurology, dermatology and miscellaneous). Each criterion was accompanied by a concise explanation as to why the practice is potentially inappropriate in pediatrics (including references). Two round of Delphi process were completed via an online questionnaire. 104 out of the 108 criteria submitted to experts were selected after 2 Delphi rounds (79 inappropriate prescriptions and 25 omissions). Discussion Conclusion POPI is the first screening-tool develop to detect inappropriate prescriptions and omissions in pediatrics based on explicit criteria. Inter-user reliability study is necessary before using the tool, and prospective study to assess the effectiveness of POPI is also necessary.

Randomized Controlled Trial of Parent Therapeutic Education on Antibiotics to Improve Parent Satisfaction and Attitudes in a Pediatric Emergency Department

Objective To evaluate therapeutic education delivered in a pediatric emergency department to improve parents’ satisfaction and attitudes about judicious antibiotic use. Methods In an emergency department of a tertiary pediatric hospital, children aged 1 month to 6 years and discharged with an oral antibiotic prescription for an acute respiratory or urinary tract infection were randomized to a patient therapeutic education on antibiotic use (intervention group) or fever control (control group) delivered to the parents (in the presence of the children) by a pharmacist trained in therapeutic education. Education consisted in a 30-minute face-to-face session with four components: educational diagnosis, educational contract, education, and evaluation. The main outcome measure was parent satisfaction about information on antibiotics received at the hospital, as assessed by a telephone interview on day 14. The secondary outcome was attitudes about antibiotic use evaluated on day 14 and at month 6. Results Of the 300 randomized children, 150 per arm, 259 were evaluated on day 14. Parent satisfaction with information on antibiotics was higher in the intervention group (125/129, 96.9%, versus 108/130, 83.0%; P=0.002, exact Fisher test). Intervention Group parents had higher proportions of correct answers on day 14 to questions on attitudes about judicious antibiotic use than did control-group parents (P=0.017, Mann-Whitney U test). Conclusion Therapeutic education delivered by a clinical pharmacist in the pediatric emergency department holds promise for improving the use of antibiotics prescribed to pediatric outpatients. Trial Registration ClinicalTrials.gov NCT00948779 http://clinicaltrials.gov/show/NCT00948779

The role of community pharmacists in the management of hematopoietic stem cell transplant recipients: knowledge and training.

Introduction: The patients receiving hematopoietic stem cell transplantation (HSCT) require routine management: the role of the pharmacist has not been extensively considered. This study had 2 aims: to explore the knowledge of community pharmacists relating to pediatric HSCT and to evaluate their expectations in terms of training needs. Materials and Methods: We interviewed 40 community pharmacists in May and June 2010 in Paris (France) with a 3 parts questionnaire: information concerning the community pharmacy, analysis of 2 pediatric prescriptions and knowledge about HSCT and professional training. Results: Twenty-nine (72.5%) of the 40 community pharmacies agreed to participate in the study. When asked what pharmacological advice they would give for an episode of fever, 13% of the pharmacists asked said that they would deliver acetaminophen without asking any further questions. Concerning hypertrichosis in patients treated with corticosteroids and ciclosporin, none mentioned the role of ciclosporin. The erroneous indications for HSCT given included road accidents (1 pharmacist; 3.4%) and hemophilia (3 pharmacists; 10.3%). Almost 80% of the pharmacists questioned considered their HSCT knowledge insufficient for their professional practice. An E-learning session adapted to their needs was of interest to almost three quarters of the pharmacists questioned.

Fluoroquinolones in pediatrics: review of hospital prescription use over 2 years.

OBJECTIVE Numerous studies have shown that the tolerance of children to fluoroquinolones (FQs) is satisfactory, and some indications have been recently agreed upon. However, vigilance is required when prescribing FQ to children. The aim of our study was to describe the prescription of FQs to children hospitalized in our hospital. MATERIALS AND METHODS This is a chart retrospective observational study at the Robert-Debré teaching Hospital between January 2009 and December 2010. Data was collected about patients (name, sex, weight, age) and prescribed treatments (indication, international nonproprietary names, dose, number of doses per day, administration route). Quality of collected data was assessed by analyzing the clinical files of 32 randomly selected patients. RESULTS We analyzed data for 397 patients (3 days - 18 years old and 640 g - 115 kg). Ciprofloxacin was prescribed for 382 patients (96%), ofloxacin for 10 patients (3%), and levofloxacin for 5 patients (1%). Febrile neutropenia was the most common indication (108 patients, i.e., 27%), followed by inflammatory bowel disease (50 patients, 13%). Doses conformed to recommendations for 88% of the patients. Analysis of the 32 cases indicated an overall compliance percentage of 94.4%. CONCLUSION This is the first study to collect so much data on FQ prescriptions for hospitalized children. Use in practice went beyond the licensed indication. Doses were consistent with those for recommended indications.

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

La pédiatrie, toujours exclue de l’innovation pharmaceutique ?

OBJECTIVE The development of therapeutic strategies for children depends unequivocally on the commercial launching of drugs with pediatric indications. New therapeutic drugs differ from one country to another, particularly considering children. The objective of this study was to compare access to new drugs by children in France (FR) and Canada (CA). MATERIAL AND METHODS Retrospective study comparing newly marketed drugs in FR and CA from 1 January to 31 December 2009. Data were collected through independent sources: (HAS, Thériaque, ANSM for FR and CEPMB, BDPP for CA). RESULTS Respectively, 37 and 30 new drugs were put on the market in 2009 in FR and CA. Among them, 38% (n=14) and 27% (n=8) had a pediatric indication. For 91% (FR) and 95% (CA) of the drugs not indicated for children, no clinical study has been planned to define pediatric indications. All the drugs (100%) with pediatric indications presented dosages based on age or weight, but it should be noted that two drugs had no form adapted to children. Fifty-seven percent of these drugs were first available on the French market and later on the Canadian market, with a median delay of 8.5months. CONCLUSION This study highlights the obvious lack of pediatric drugs contributing to large prescriptions of off-label drugs for children, with no dosage or adapted pharmaceutical form for this population.