The purpose of the study is to identify perception of doctors and pharmacists on drug promotion practices adopted by pharmaceutical representatives. Material and Methods: A total of 72 pharmacists and 65 doctors responded to a questionnaire about their perceptions on drug promotion practices by pharmaceutical representatives, both in relation to pharmacists and doctors in the relationship. Variables such as age, work environment (urban, rural), seniority, were considered. Of all pharmacists who responded to the questionnaire, a percentage of 47.8% say they have no information about the existence of an ethical code of the pharmaceutical company, and 52.1% believe that there is such a code. Pharmacists estimated that over 75% of pharmaceutical representatives promote clearly the products; the information provided is accurate, complete and balanced enough to compete. Meanwhile, the percent estimated by doctors is 73%. Informal gifts are more often offered to doctors, in both category's opinion. Conclusion: medical doctors have a more positive evaluation about pharmaceutical representative's attitude than pharmacists.

Abstract

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.

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.