Off label and unlicensed drugs use in paediatric cardiology.

OBJECTIVES: The use of drugs in an off label or unlicensed manner to treat children is a widespread phenomenon in Europe and the United States. The incidence of unlicensed and off label prescribing in paediatric cardiology practice has not been studied to date. This study was designed to assess the extent and nature of off label and unlicensed drug use in paediatric cardiology inpatients. METHODS: In a prospective study, drug prescriptions in a paediatric cardiology ward were reviewed during a 2-year period. Data were collected and analyzed by special software created for this purpose. RESULTS: The children (n = 544) studied varied in age from 4 h to 18 years. One or more off label and unlicensed prescriptions were given to 414 (76%) patients. Of the 2,130 prescriptions given during the 2-year period, more than one-half were unlicensed (11%) or off label (47%). While children aged 2-11 years received most of the unlicensed drug prescriptions (17%), neonates, who did not receive unlicensed drugs, led (64%) in the use of off label drugs. CONCLUSIONS. This study showed that the problem of off label and unlicensed drug use also exists in paediatric cardiology. The findings imply that the phenomenon of off label and unlicensed use of drugs in children can be correlated with the deficiency of paediatric drug formulations on the global market and insufficient data from clinical studies which must be performed to confirm the efficacy and safety of drugs in the paediatric population. Therefore, efforts to improve paediatric labelling are important and need the full support of all involved.

Electron scattering from perfluorocyclobutane (c-C4F8).

We report experimental results for electron scattering from perfluorocyclobutane, c-C(4)F(8), obtained from measurements in our two laboratories. A set of differential, integral, and momentum transfer cross sections is provided for elastic scattering for incident electron energies from 1.5 to 100 eV. Inelastic scattering (vibrational excitation) cross sections have been measured for incident electron energies of 1.5, 2, 5, 6, and 7 eV. In order to investigate the role of intermediate negative ions (resonances) in the scattering process we have also measured an excitation function for elastic scattering and vibrational excitation of the ground electronic state of C(4)F(8) for incident energies between 0.6 and 20 eV. These results are compared with the limited amount of data available in the literature for scattering from this molecule.

Electron scattering from tetrafluoroethylene.

We report experimental results for electron scattering from tetrafluoroethylene, C2F4, obtained from measurements in two laboratories. An extensive set of differential, integral, and momentum transfer cross sections is provided for elastic scattering for incident electron energies from 1 to 100 eV and inelastic (vibrational excitation) scattering for incident electron energies at 3, 6, 7.5, 8, and 15 eV, and for scattering angles ranging from 10 degrees to 130 degrees. To highlight the role of intermediate negative ions (resonances) in the scattering process we have also measured excitation functions for elastic scattering and vibrational excitation of the ground electronic state of C2F4 for incident energies between 1.5 and 20 eV. Our results are compared with recent theoretical calculations and a limited number of other experimental results.

Absolute collision cross sections for low energy electron scattering from NO: the role of resonances in elastic scattering and vibrational excitation.

Absolute measurements of elastic scattering and vibrational excitation of the NO molecule by low energy electron impact (0.4-2.5 eV) are presented. They show that previous estimates of these cross sections may be in error by as much as a factor of 3 and provide compelling evidence for a reassessment of the balance between elastic scattering and vibrational excitation at incident energies below 2 eV. They also confirm the critical contribution that intermediate negative ion resonances (NO-) make to the various scattering processes for this molecule at low incident energies.