PhV （pharmacovigilance） knowledge has the outcome of being inadequate in particular due to the lack of instruction. Pediatricians have to face the realization that over-the-counter medicines increments the peril of ...PhV （pharmacovigilance） knowledge has the outcome of being inadequate in particular due to the lack of instruction. Pediatricians have to face the realization that over-the-counter medicines increments the peril of ADRs （adverse drug reactions） has become a public health concern. The purpose of this article is to disseminate knowledge of the PhV and to highlight the cultural and organizational difficulties for its implementation. The objectives of promoting the organization of specific training courses and research projects aimed at： （1） to foster the culture of iatrogenic disease in pediatrics; （2） to improve the appropriateness of prescribing drugs in children; （3） to enco.urage spontaneous reporting of ADRs in children; （4） to involve Pediatricians in PASS （post-authorization safety studies） according to GCP, GVP and ENCEPP Code of Conduct. An up to date proposal of PhV, a procedure of preparation improves the productivity of creating novel informative reports which can be utilized for a benefit/risk scrutiny making strides in medicine prescription. In this context, FP-MCRN （family paediatficians-medicines for children research network） established with the aim of developing competence, infrastructure and education for paediatric clinical trials, plays a crucial role in paediatric PhV, through an improvement of PhV training, a correct research methodology and very strong relationship with the families. The initial necessity is cultural, implementing culture of iatrogenic illnesses and a watchful evaluation of the importance of PASS by FPs （family pediatricians）. Participation in clinical trials that generates a precise database administered by FPs together with follow-up outcomes becomes relevant and vital for a scrupulous and accurate assessment of ADRs. PASS can foresee on one hand training and information regarding the proper use of drugs in children and possible iatrogenic pathologies caused by their improper use, the other to constitute a territorial survey in the prescriptive appropriateness and safety of pediatric drugs aimed at evaluating the risk-benefit balance on usage.展开更多
Intravenous immunoglobulin(IVIG) is biological product, which is extensively used in pediatric patients, with high adverse effects on children among different brand preparations. In the present study, we aimed to desc...Intravenous immunoglobulin(IVIG) is biological product, which is extensively used in pediatric patients, with high adverse effects on children among different brand preparations. In the present study, we aimed to describe the adverse events of pediatric patients given IVIG infusions in China. Data were collected from all patients receiving IVIG infusion at the largest children’s hospital in Ningbo of China form January 2015 to December 2017. Descriptive statistics was used. A total of 2100 patients received IVIG infusion. All the patients who experienced adverse reactions were children(0.48%), with the highest frequency of infusion among those age 1 to 3 years old(40%). Among 10 infusions with adverse reactions, the most common indication was Kawasaki disease(40%) followed by severe pneumonia(30%). Rash was the most common adverse event(80%), followed by chest pain & cough(50%) and cyanosis(40%). Adverse events were observed to occur most frequently within 30 min from onset of infusion. Most of the reactions occurred with the large dose and the indications of used for. Since the hospital changed the brand, the incidence of adverse reactions was decreased from 1.39% to 0.13%. In this study, 0.48% of pediatric patients given IVIG infusions experienced adverse events. Anaphylactoid reaction was the most common manifestation. Symptoms occurred within 30 min from onset of infusion, which were affected by the dose, the value of lgE, the indications and the different brands.展开更多
文摘PhV （pharmacovigilance） knowledge has the outcome of being inadequate in particular due to the lack of instruction. Pediatricians have to face the realization that over-the-counter medicines increments the peril of ADRs （adverse drug reactions） has become a public health concern. The purpose of this article is to disseminate knowledge of the PhV and to highlight the cultural and organizational difficulties for its implementation. The objectives of promoting the organization of specific training courses and research projects aimed at： （1） to foster the culture of iatrogenic disease in pediatrics; （2） to improve the appropriateness of prescribing drugs in children; （3） to enco.urage spontaneous reporting of ADRs in children; （4） to involve Pediatricians in PASS （post-authorization safety studies） according to GCP, GVP and ENCEPP Code of Conduct. An up to date proposal of PhV, a procedure of preparation improves the productivity of creating novel informative reports which can be utilized for a benefit/risk scrutiny making strides in medicine prescription. In this context, FP-MCRN （family paediatficians-medicines for children research network） established with the aim of developing competence, infrastructure and education for paediatric clinical trials, plays a crucial role in paediatric PhV, through an improvement of PhV training, a correct research methodology and very strong relationship with the families. The initial necessity is cultural, implementing culture of iatrogenic illnesses and a watchful evaluation of the importance of PASS by FPs （family pediatricians）. Participation in clinical trials that generates a precise database administered by FPs together with follow-up outcomes becomes relevant and vital for a scrupulous and accurate assessment of ADRs. PASS can foresee on one hand training and information regarding the proper use of drugs in children and possible iatrogenic pathologies caused by their improper use, the other to constitute a territorial survey in the prescriptive appropriateness and safety of pediatric drugs aimed at evaluating the risk-benefit balance on usage.
基金Wenzhou Science and Technology Program(Grant No.Y20160012)
文摘Intravenous immunoglobulin(IVIG) is biological product, which is extensively used in pediatric patients, with high adverse effects on children among different brand preparations. In the present study, we aimed to describe the adverse events of pediatric patients given IVIG infusions in China. Data were collected from all patients receiving IVIG infusion at the largest children’s hospital in Ningbo of China form January 2015 to December 2017. Descriptive statistics was used. A total of 2100 patients received IVIG infusion. All the patients who experienced adverse reactions were children(0.48%), with the highest frequency of infusion among those age 1 to 3 years old(40%). Among 10 infusions with adverse reactions, the most common indication was Kawasaki disease(40%) followed by severe pneumonia(30%). Rash was the most common adverse event(80%), followed by chest pain & cough(50%) and cyanosis(40%). Adverse events were observed to occur most frequently within 30 min from onset of infusion. Most of the reactions occurred with the large dose and the indications of used for. Since the hospital changed the brand, the incidence of adverse reactions was decreased from 1.39% to 0.13%. In this study, 0.48% of pediatric patients given IVIG infusions experienced adverse events. Anaphylactoid reaction was the most common manifestation. Symptoms occurred within 30 min from onset of infusion, which were affected by the dose, the value of lgE, the indications and the different brands.
