European Journal of Hospital Pharmacy: Science and Practice, 2014
ABSTRACT Background Many drugs currently on the market have no specific authorisation for use in ... more ABSTRACT Background Many drugs currently on the market have no specific authorisation for use in children and are used outside the licensed indications (off-label use). Off-label use might be associated with an increased risk of adverse drug reactions (ADRs), therefore it is important to implement monitor it in order to provide more careful clinical surveillance of prescriptions. An online database could offer an active network of off-label drugs pharmacovigilance, helping paediatricians and hospital pharmacists in prescribing, assessment of efficacy, follow-up and collection of ADRs. Purpose To create an Italian online network and offer it to hospital pharmacists collaborating with paediatricians, so that they may share optimal off-label prescription practice and monitor possible adverse drug reactions. Materials and methods The project examined all off-label prescriptions and follow-ups of children aged 0–18 years in regional paediatric departments participating in a web-based Friuli-Venezia Giulia Italian region network developed in Hypertext Preprocessor (PHP), based on open-source tools. Physicians create an online prescription for each new patient, referencing the literature that supports the off-label use, recording the follow-up, and reporting any adverse reactions. The hospital pharmacist examines each off-label prescription in detail, and updates the relative off-label archive, integrating and reviewing literature references, and recording dispensing data of prescribed medications (date, amount and costs). Results We started to set up the Regional Pharmacovigilance Network in March 2013 and it is now almost ready to be used. Conclusions: If pharmacists and paediatricians cooperate successfully in this project, it will allow more complete and thorough monitoring of off-label treatment, to better protect paediatric patients’ health.
To assess the effectiveness of sublingual ketorolac versus sublingual tramadol in reducing the pa... more To assess the effectiveness of sublingual ketorolac versus sublingual tramadol in reducing the pain associated with fracture or dislocation of extremities in children. A double-blind, randomised, controlled, non-inferiority trial was conducted in the paediatric emergency department of a research institute. One hundred and thirty-one children aged 4-17 years with suspected bone fracture or dislocation were enrolled. Eligible children were randomised to ketorolac (0.5 mg/kg) and placebo, or to tramadol (2 mg/kg) and placebo by sublingual administration, using a double-dummy technique. Pain was assessed by the patients every 20 min, for a maximum period of 2 h, using the McGrath scale for patients up to 6 years of age, and the Visual Analogue Scale for those older than 6 years of age. The mean pain scores fell significantly from eight to four and five in the ketorolac and tramadol groups, respectively, by 100 min (Wilcoxon sign rank test, p<0.001). The mean pain scores for ketorolac were lower than those for tramadol, but these differences were not significant at any time point (Mann-Whitney U Test, p values: 0-20 min: 0.167; 20-40 min: 0.314; 40-60 min: 0.223; 60-80 min: 0.348; 80-100 min: 0.166; 100-120 min: 0.08). The rescue dose of paracetamol-codeine was administered in 2/60 children in the ketorolac group versus 8/65 in the tramadol group (Fisher exact test, p=0.098). There were no statistically significant differences between the two groups in the frequency of adverse effects. Both sublingual ketorolac and tramadol were equally effective for pain management in children with suspected fractures or dislocations.
otal Parenteral Nutrition (TPN) is defined as feeding a patient by infusing nutrients intravenous... more otal Parenteral Nutrition (TPN) is defined as feeding a patient by infusing nutrients intravenously, bypassing the usual process of eating and digestion. There are two kinds of TPN: short-term TPN may be used when a patient's digestive system is temporarily nonfunctional because of an interruption in its continuity; long-term TPN is used to treat patients with an impairment or a lack in nutrient absorption. TPN has extended the life of children born with nonexistent or severely deformed digestive organs and is a vital support for these patients. In Burlos Pediatric Department, pediatricians fill in a pharmacy request form in which nutritional needs are included for each patient. Subsequently, clinical pharmacists evaluate the patients individual data and decide which TPN formula to prepare. To enhance the TPN prescription process, an intranet web-based system has been developed to replicate the original paper-based forms. The software, developed in PHP and based on open source t...
European Journal of Hospital Pharmacy: Science and Practice, 2014
ABSTRACT Background Many drugs currently on the market have no specific authorisation for use in ... more ABSTRACT Background Many drugs currently on the market have no specific authorisation for use in children and are used outside the licensed indications (off-label use). Off-label use might be associated with an increased risk of adverse drug reactions (ADRs), therefore it is important to implement monitor it in order to provide more careful clinical surveillance of prescriptions. An online database could offer an active network of off-label drugs pharmacovigilance, helping paediatricians and hospital pharmacists in prescribing, assessment of efficacy, follow-up and collection of ADRs. Purpose To create an Italian online network and offer it to hospital pharmacists collaborating with paediatricians, so that they may share optimal off-label prescription practice and monitor possible adverse drug reactions. Materials and methods The project examined all off-label prescriptions and follow-ups of children aged 0–18 years in regional paediatric departments participating in a web-based Friuli-Venezia Giulia Italian region network developed in Hypertext Preprocessor (PHP), based on open-source tools. Physicians create an online prescription for each new patient, referencing the literature that supports the off-label use, recording the follow-up, and reporting any adverse reactions. The hospital pharmacist examines each off-label prescription in detail, and updates the relative off-label archive, integrating and reviewing literature references, and recording dispensing data of prescribed medications (date, amount and costs). Results We started to set up the Regional Pharmacovigilance Network in March 2013 and it is now almost ready to be used. Conclusions: If pharmacists and paediatricians cooperate successfully in this project, it will allow more complete and thorough monitoring of off-label treatment, to better protect paediatric patients’ health.
To assess the effectiveness of sublingual ketorolac versus sublingual tramadol in reducing the pa... more To assess the effectiveness of sublingual ketorolac versus sublingual tramadol in reducing the pain associated with fracture or dislocation of extremities in children. A double-blind, randomised, controlled, non-inferiority trial was conducted in the paediatric emergency department of a research institute. One hundred and thirty-one children aged 4-17 years with suspected bone fracture or dislocation were enrolled. Eligible children were randomised to ketorolac (0.5 mg/kg) and placebo, or to tramadol (2 mg/kg) and placebo by sublingual administration, using a double-dummy technique. Pain was assessed by the patients every 20 min, for a maximum period of 2 h, using the McGrath scale for patients up to 6 years of age, and the Visual Analogue Scale for those older than 6 years of age. The mean pain scores fell significantly from eight to four and five in the ketorolac and tramadol groups, respectively, by 100 min (Wilcoxon sign rank test, p<0.001). The mean pain scores for ketorolac were lower than those for tramadol, but these differences were not significant at any time point (Mann-Whitney U Test, p values: 0-20 min: 0.167; 20-40 min: 0.314; 40-60 min: 0.223; 60-80 min: 0.348; 80-100 min: 0.166; 100-120 min: 0.08). The rescue dose of paracetamol-codeine was administered in 2/60 children in the ketorolac group versus 8/65 in the tramadol group (Fisher exact test, p=0.098). There were no statistically significant differences between the two groups in the frequency of adverse effects. Both sublingual ketorolac and tramadol were equally effective for pain management in children with suspected fractures or dislocations.
otal Parenteral Nutrition (TPN) is defined as feeding a patient by infusing nutrients intravenous... more otal Parenteral Nutrition (TPN) is defined as feeding a patient by infusing nutrients intravenously, bypassing the usual process of eating and digestion. There are two kinds of TPN: short-term TPN may be used when a patient's digestive system is temporarily nonfunctional because of an interruption in its continuity; long-term TPN is used to treat patients with an impairment or a lack in nutrient absorption. TPN has extended the life of children born with nonexistent or severely deformed digestive organs and is a vital support for these patients. In Burlos Pediatric Department, pediatricians fill in a pharmacy request form in which nutritional needs are included for each patient. Subsequently, clinical pharmacists evaluate the patients individual data and decide which TPN formula to prepare. To enhance the TPN prescription process, an intranet web-based system has been developed to replicate the original paper-based forms. The software, developed in PHP and based on open source t...
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