| objectives:To understand the problems of Children's medication and the status and analyze reasons of children's severe adverse drug reactions/events(SADRs) and in order to provide improtant information of improving attention to children's drug problems and ensuring children's drug safety.methods:Children's hospital of shanxi was as the research site. Manuals of Children's medication in pediatrics, the levels of knowledge of parents on Children's medication and SADRs reported to national adverse drug reaction monitoring center between January 1 st,2008 and December 30th,2009 were studied. Database were established by epidata 3.02 software and data were analyzed by SPSS 13.0 software.RESULTS:1.The infermation on Children's medication in the dispensatory1.1 The items of dispensatory507 kinds of children's dispensatories were found with 393 kinds of chemical and biochemical drugs,102 kinds of chinese patent drug and 102 preparation made in hospital. Integrity of instruction items between chemical biochemical drugs and chinese patent medicine was different statistically(x2=336.516,P<0.001).376 kinds of chemical and biochemical drugs had full items. The residual were uncomplete. Meanwhile,12 kinds of chinese patent medicine had full items but the residual were uncpmplete. 1.2 The status of children's mediationThere were only 61(12.0%) kinds of medicine used specially for children. Most of them(about 93.4%) were oral preparations. The dosage forms were almost traditional, including tablets, drug granules and liquores. Sustained-release preparations and controlled-release preparation used for children were hardly used. According to drug classification, ratio of chinese patent medicine was 54.1%(33/61) and rates of antibacterials, respiratory medicine, nutrition medicine, digestive system medicine, antipyretic analgesics, nervous system medicine, immune adjustment medicine were 13.1%(8/61),9.8%(6/61),9.8%(6/61),6.6%(4/61), 3.3%(2/61),1.6%(1/61),1.6%(1/61).1.3 the information of children's medication in the dispensatory not used specially for children1.3.1 the information of children's medication in dispensatory of different dosages not used specially for childrenIn items of injections, the number of injections with item of children's medication in item of dosage, Pediatric Use, pharmacokinetics were 137(70.6%),133(68.6%) and 8(4.1%).In items of oral dosages, the number of injections with item of children's medication in item of dosage, Pediatric Use, pharmacokinetics were 89(41.7%),127(59.6%) and 4(1.9%). In items of external dosages, the number of injections with item of children's medication in item of dosage, Pediatric Use, pharmacokinetics were 9(33.3%),12(44.4%) and 0.The differences of information of usage for children among different dosage forms had remarkably statistical significance(x2=39.023, P<0.01) and the differences of information of special-purpose for children and pharmacokinetics among different dosage forms had no statistical significance(x2=7.552,P>0.01),(x2=1.915,P>0.01). 1.3.2 the information of children's medication in dispensatory of different formulations not used specially for childrenThe differences of instruction items of special usage for children among different kind of formulations had no statistical significance(x2=2.089, P>0.01;x2=1.537, P>0.01; x2=1.787, P>0.01).In items of formulations used for respiratory, the number of formulations with information of children in the item of dosage, items of children's medication and pharmacokinetics were 31(73.8%),23(54.8%) and 0.In items of formulations used for digestive systerm, the number of formulations with information of children in the item of dosage, items of children's medication and pharmacokinetics were 14(66.7%),11(52.4%) and 0. In items of formulations used for nervous systerm, the number of formulations with information of children in the item of dosage, items of children's medication and pharmacokinetics were 21(58.3%),24(66.7%) and 1(2.8%). 1.4 the information of children's medication in the dispensatory of antibiotics not used specially for childrenIn items of antibiotics, the number of items with information of children in the item of dosage, items with children's medication and with information of children in the item of pharmacokinetics were 67(67.7%),13(13.1%) and 9(9.1%). In items of anti-virus, the number of items with information of children in the item of dosage, items with children's medication and with information of children in the item of pharmacokinetics were 4(44.4%),4(44.4%) and 1(11.1%). In items of antifungal, the number of items with information of children in the item of dosage, items with children's medication and with information of children in the item of pharmacokinetics were 1(16.7%),2(33.3%) and 0. 1.5 The information of children's medication of Chinese drug injections not used specially for childrenThe rate of usage which contained concrete contents was 42.8%(3/7),the rate of discount or obey medical order was 28.6%(2/7) and the rate of no information was 28.6%(2/7). The rate of items of children's medicine which contained concrete contents was 28.6%(2/7), the rate of discount or obey medical order was 14.3%(1/7) and the rate of no information was 57.1%(4/7). 2. The survey of guardian'knowledge of children's medicine 2.1 The guardian'attitude towards children's medicineThe rate of presuming specificity of children's medication, discounting according to adult and equally to adult was respectively 68.9%(62/90),28.8%(26/90) and 2.2%(2/90). The rates of considering many and litter andkinds of drug used specially for children were 84.4%(76/88) and 15.6%(12/88). 2.2 The drug use behavior of guardianThe rate of reading instruction before taking medicine and paying more attention to contents and obeying medical order were respectively 88.9%(86/90), about 80% and 96.7%. The rate of not changing dosages, believing that it can't improve the efficacy of drugs through increasing doses and kind of drugs when poor efficacy, believing monitoring drug use by himself were 83.3%,60.0% and 97.8%, The consciousness of management of drugs for domestic was enhanced better than the study by ren yanming in 2001. 2.3 The level of guardian'knowledge of adverse drug reactionApparently, the level of guardian's knowledge of adverse drug reaction was low. Only 55.6% of respondents knew what the adverse drug reaction was and half of them considered that children were more inclined to perform adverse drug reaction, Most guardian (93.3%) hoped to obtain knowledge about ADRs from different ways, concluding propaganda, training, lecture, etc, so they can take good care of children and settle the problems occurred unexpectedly. 3. The SADRs/affairs induced by children's medication 3.1 The ADRs induced by misuse of medicineThe high rate of ADRs by misuse of medicine were induced by center nervous system medicine (27.2%), cardiovascular agents (22.7%) and digestive system medicine(18.2%). These medicine that usually taken by adult and the older were kept unsafe place, so children can get in touch with them, As a result, tragedy took place. 3.2 The ADRs induced by non-rational use of drugIt discovered that the ADRs were caused mostly by antimicrobial drug(36.8%)and anti-cold medicine(26.3%).The rest kinds of drugs had no traits of tendency. 3.3 The information of ADRs caused by suspicious drugsThe drugs which induced ADRs with normal usage were focused mainly on antibiotics, center nervous system medicine, anti-cold medicine and traditional Chinese drug injections.CONCLUTIONS:There were short of medicine developed and data researched specially for children. The low level of knowledge of guardian and the deposition of medicine were two hidden danger induced ADRs. The risk factors were concentrated mainly on misuse of medicine, drug use irrationality and ADRs. |
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