Infliximab Paediatric Crohnʼs Disease Educational Plan

Abstract

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.

Methodological gaps in the assessment of risk minimization interventions: a systematic review

“…For studies that involved surveys, the definition of RMI effectiveness was not explicit, consisting mainly of a change in practice (change in medication dosage or drug, referral of patients to a specialist, performance of baseline assessment before initiation of a medical treatment, etc.) ( n = 5), knowledge retention ( n = 5), awareness of RMIs ( n = 5), and increase of disclosure of information ( n = 1) . In cases where effectiveness was defined as knowledge retention, there was no specification on what represented adequate knowledge retention or what information should the target population have retained …”

Effectiveness of the golimumab educational program in ensuring healthcare professionals’ awareness of risks described in the European risk management plan

“…The high overall level of risk awareness observed in the present study was comparable to that reported for similar studies surveying HCP risk awareness for other drugs for which additional educational materials had been distributed. 10–16 All of these studies reported risk awareness levels that generally ranged above 80%. 10–16 The two previous publications of HCP survey studies examining risk awareness for other anti-TNF-α antibodies, for which EPs had been implemented, reported very similar risk awareness levels to those observed in this study.…”

Biologics in Paediatric Crohn's Disease

“…This should include a careful history for risk factors for tuberculosis [95]. Anergy can limit the value of skin testing with PPD [92], and in vitro specific blood tests may be more sensitive and specific [96], though there is little information in children.…”

“…This anticipatory approach should also include annual influenza vaccination, pneumococcal vaccination, human papillomavirus vaccination to young females, and hepatitis B to seronegative patients [99]. A history of malignancy is also recognised to pose a risk factor [95]. There are significant disparities between countries in the practice and extent of screening before commencing a biological in children [95].…”

“…A history of malignancy is also recognised to pose a risk factor [95]. There are significant disparities between countries in the practice and extent of screening before commencing a biological in children [95]. …”