Appropriate use of antifungal agents
DOI:
https://doi.org/10.7175/rhc.v4i1S.861Keywords:
Fungal infections, Off-label use, Unauthorized use, Exceptional use, AuthorizationsAbstract
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.
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
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