Appropriate use of antifungal agents

Elio Castagnola

DOI: https://doi.org/10.7175/rhc.v4i1S.861

Abstract

As knowledge increases faster and faster, authorizations for drug use often don’t report the most recent evidence. In addition, trials on pediatric populations are rare: as a consequence, a lot of drugs in pediatrics are prescribed out of their indications. This is called off-label use, if the drug isn’t approved for the treatment of a specific disease, or unauthorized use, if, for example, a dose isn’t written in the summary of product characteristics. These uses aren’t illegal, but physicians should take some steps in order to protect their liability: for example, the hospital should write documents based on shared scientific evidence, where the reasons supporting a choice are explained. Informed consent should be obtained, after an exhaustive explanation, from the parents. There is also the exceptional use, i.e. the use in desperate cases, where no other treatments are possible, but, for example, a study in an animal model has resulted in good outcomes. Even in this case, similar measures should be taken by the physician.

Keywords

Fungal infections; Off-label use; Unauthorized use; Exceptional use; Authorizations

Full Text

HTML PDF

References

  • Hope WW, Castagnola E, Groll AH, et al; ESCMID Fungal Infection Study Group. ESCMID* guideline for the diagnosis and management of Candida diseases 2012: prevention and management of invasive infections in neonates and children caused by Candida spp. Clin Microbiol Infect 2012; 18 Suppl 7: 38-52; http://dx.doi.org/10.1111/1469-0691.12040
  • Santoro G. Neonato morto a Roma: era sano, non ucciso da infezione. Oggi autopsia, risultati a metà agosto. Lunedì mamma da pm. ANSA, 2012. Disponibile all’indirizzo: http://www.ansa.it/web/notizie/rubriche/cronaca/2012/07/23/Neonato-morto-San-Giovanni-Balduzzi-invia-ispettori_7223728.html (ultimo accesso gennaio 2013)
  • Gazarian M, Kelly M, McPhee JR, et al. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006; 185: 544-8
  • Dati di postmarketing forniti da Astellas

Statistics

Abstract: 1210 views
HTML: 688 views
PDF: 168 views

Refbacks

  • There are currently no refbacks.




© SEEd srl