Articole semnate de acelasi autor in Revista Romana de Pediatrie:

ETICA PRESCRIERII OFF-LABEL A MEDICAMENTELOR LA COPII. DILEMA SILDENAFILULUI

Revista Romana de PEDIATRIE | Volumul LXIV, Nr. 2, An 2015

ISSN 1454-0398 | e-ISSN 2069-6175
ISSN-L 1454-0398
DOI: 10.37897/RJP

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Laszlo-Zoltan Sztankovszky, Magdalena Iorga, Cristian Gheonea and Georgiana Russu

REZUMAT

Prescripţia „off-label“ reprezintă administrarea medicamentelor pe o cale neaprobată, într-o formulare sau doză neaprobată la copii, sau sub intervalul de vârstă indicat pe prospectul aprobat al produsului. Cu toate acestea, tratamentul cu indicaţii off-label este un fenomen larg răspândit în clinicile de pediatrie. Deoarece multe dintre medicamentele prescrise nu au fost testate în mod adecvat la copii, această populaţie de pacienţi rămâne vulnerabilă. Pe de o parte, folosirea indicaţiilor off-label la copii determină o mulţime de controverse, pe de altă parte, fără această posibilitate, unii pacienţi ar putea fi lipsiţi de şansa de a fi trataţi. Lucrarea prezintă amplitudinea fenomenului de prescriere a medicamentelor cu indicaţii off-label la copii, evaluată în studii ştiinţifice din SUA şi Europa. În multitudinea de medicamente prescrise off-label la copii se înscrie şi Sildenafil. Autorii îşi propun prezentarea situaţiei din România cu privire la medicamentul Sildenafil şi utilizarea acestuia în unităţile de cardiologie pediatrică.

Cuvinte cheie: etica, medicamente, copii, prescriere, off-label

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Laszlo-Zoltan Sztankovszky

THE ETHICS OF PRESCRIBING OFF-LABEL DRUGS IN CHILDREN. THE DILEMMA OF SILDENAFIL

ISSN 1454-0398 | e-ISSN 2069-6175
ISSN-L 1454-0398
DOI: 10.37897/RJP

National Awards “Science and Research”

NEW! RJP has announced the annually National Award for "Science and Research" for the best scientific articles published throughout the year in the official journal.

ICMJE- Recommendations

Read the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals.

Promoting Global Health

Laszlo-Zoltan Sztankovszky, Magdalena Iorga, Cristian Gheonea and Georgiana Russu

ABSTRACT

The off-label prescription means that medicines are administered by an unlicensed route, in an unlicensed formulation or dosage or to a child below the stated age range. The use of drugs in an off-label or unlicensed manner to treat children is widespread. Because many prescribed treatments for children have not been adequately tested in children, this population of patients remains a vulnerable one. On the one hand, prescribing off-label use drugs in children determines a lot of controversies but, one the other hand, without this possibility, could be deprived of a chance to be treated. The paper presents the widespread phenomenon of off-label us drugs in children, reflecting in scientific studies in USA and Europe. An important focus is on Romanian statistic of Sildenafil prescription and on dilemmatic use of it in pediatric cardiology unit.

Keywords: ethics, drugs, children, prescribing, off-label

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Laszlo-Zoltan Sztankovszky