title: Infliximab paediatric Crohn's disease educational plan: a European, cross-sectional, multicentre evaluation.
abstract: BACKGROUND
  The infliximab (Remicade; Schering-Plough, Kenilworth, NJ, USA) Risk Management Plan included the development, execution and tracking of an education programme directed towards prescribers of infliximab for patients with paediatric Crohn's disease (the Infliximab Paediatric Crohn's Disease Educational Plan). The programme content consisted of educational materials and communications aimed at educating prescribers on the risks associated with infliximab use.
  
  
  OBJECTIVE
  To evaluate the effectiveness of the risk minimization plan.
  
  
  METHODS
  Evaluation focused on two components: documentation of training of sponsors' personnel, and evaluation of awareness among prescribing physicians in European countries. Treating physicians, identified both independently of the sponsor (6 countries) and by the sponsor (24 countries), were surveyed using a structured questionnaire.
  
  
  RESULTS
  Training of internal staff on the educational programme was performed and completed by every person designated an appropriate candidate for the programme in all European countries. The independent survey conducted in Germany, France, Italy, Spain, Sweden and the UK indicated that around 90% of the physicians were either paediatric gastroenterologists (57%) or paediatricians (33%). The great majority (96%) of the interviewed physicians were currently treating paediatric Crohn's disease, and most were currently using infliximab in their treatment of the disease. More specifically, 82% of gastroentrologists treating paediatric Crohn's disease were using infliximab; among paediatricians, the proportion was lower (42%). Ninety-six percent of paediatric gastroenterologists or gastroenterologists declared themselves aware of the benefits and risks of using infliximab for the treatment of paediatric Crohn's disease; in comparison, fewer paediatricians (82%) declared themselves aware of these benefits and risks. The majority initially gained awareness through congresses and workshops, and at the time of the survey only 25% declared that they were made aware of the benefits and risks through the educational programme. However, the majority of physicians reported that they had been approached by the sponsor's personnel in France (98%), Italy (100%), Spain (83%) and Sweden (70%). In Germany and the UK this proportion was 42%. Almost all physicians were aware of the need to perform tuberculosis (TB) and cancer screening prior to initiating therapy with infliximab, and to screen for hypersensitivity reactions before, during and after treatment. Ninety percent of the physicians were aware of the need to update immunization therapy before initiating therapy and, except in Italy (92% aware), around 50% of the physicians were aware of the need to provide patients with the infliximab Patient Alert Card. In the other European countries where the survey took place among physicians identified by the sponsor, 99% of paediatric gastroenterologists and 90% of gastroenterologists or paediatricians declared themselves aware of the benefits and risks of using infliximab for the treatment of paediatric Crohn's disease, and all of them were aware of the risk of TB and opportunistic infections and the need to perform TB and cancer screening prior to initiating therapy with infliximab.
  
  
  CONCLUSIONS
  Overall, the results of the evaluation of the Infliximab Paediatric Crohn's Disease Educational Plan were satisfactory. The objective of education of internal personnel of the pharmaceutical companies distributing infliximab was completely achieved; over 90% of physicians reported being aware of the benefits and risks of infliximab for the treatment of paediatric Crohn's disease. Further work should be carried out across all countries to educate physicians on providing patients with the infliximab Patient Alert Card. In Germany and the UK in particular, where <50% of physicians reported having been approached by the sponsor's personnel, further work is needed to raise awareness of the educational programme.
authors.affiliation: RiskMR Pharmacovigilance Services, Zaragoza, Spain.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Arana
authors.forename: Sam
authors.initials: S
authors.lastname: Allen
authors.forename: Jörg
authors.initials: J
authors.lastname: Burkowitz
authors.forename: Valerio
authors.initials: V
authors.lastname: Fantoni
authors.forename: Ola
authors.initials: O
authors.lastname: Ghatnekar
authors.forename: María Teresa
authors.initials: MT
authors.lastname: Rico
authors.forename: Nathalie
authors.initials: N
authors.lastname: Vanhaverbeke
authors.forename: Charles E
authors.initials: CE
authors.lastname: Wentworth
authors.forename: Max
authors.initials: M
authors.lastname: Brosa
authors.forename: Felix M
authors.initials: FM
authors.lastname: Arellano
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D002648:Child; D003424:Crohn Disease / Q000188:drug therapy*; D019992:Databases as Topic; D004501:Education, Medical / Q000379:methods*; D005060:Europe; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D019983:Guideline Adherence / Q000706:statistics & numerical data; D006801:Humans; D000069285:Infliximab; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D015397:Program Evaluation; D012308:Risk Management / Q000379:methods*; D013192:Staff Development / Q000379:methods* / Q000706:statistics & numerical data
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab