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Analysis on the Status of Children’s Medication and Influence Factors of Serious Adverse Drug Reactions/Incidents

Author: ZhaoRuiLing
Tutor: WangSuPing
School: Shanxi Medical
Course: Epidemiology and Biostatistics,
Keywords: Medicines in children Serious adverse drug reactions Guardian behavior Awareness
CLC: R452
Type: Master's thesis
Year: 2011
Downloads: 317
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Abstract

Objective: To understand children's medication and serious adverse reaction / event status of the analysis of the problem of children using drugs, analyze cause the children serious adverse reactions / events causes children's medication is highly concerned about the problem for the whole society, and to ensure the safety of the child medication Important information. Method: Select the Children's Hospital of Shanxi Province as the research site, hospital pediatric drugs used in the package insert, and guardians of children reported to the National Adverse Drug Reaction Monitoring Center on Drug cognitive and 2008 from 1 May to December 2009, 30 days serious adverse drug reaction / incident report for the research, conducted the survey. The adoption Epidata3.02 software to build a database, data entry. The SPSS13.0 software related indicators of statistical description and statistical inference. Results: 1. 1.1 package insert of the child medication information project description of the drug in the surveyed hospitals for children to use the package insert for 507 kinds of drugs, including 393 kinds of chemical and biochemical drugs, 102 kinds of Chinese patent medicines, hospital preparations 12 . Manual project completeness compare the difference between the chemical and biochemical medicines and proprietary Chinese medicines were statistically significant (χ2 = 336.516, P lt; 0.001). Chemical and biochemical drugs in manual project complete 376 kinds, accounting for 95.7% (376/393), 17 incomplete projects, accounting for 4.3% (17/393). Proprietary Chinese medicines in the manual project complete 12 species, accounting for 11.8% (12/102), 90 kinds of incomplete projects, accounting for 88.2% (90/102). 1.2 children drug status of the investigation the hospital only 61 species (12.0%) children drugs as the Children's Hospital. From the formulation of the majority of child-specific drugs to the oral formulation, accounting for 93.4%, mainly ordinary tablets, granules, solutions, traditional dosage forms such as oral preparations not see children slow, controlled release formulations, new dosage forms. Proprietary Chinese medicines accounted for 54.1% (33/61), from the distribution of the drug category antibacterial drugs accounted for 13.1% (8/61), respiratory system drugs accounted for 9.8% (6/61), the nutritional medicine accounted for 9.8% (6/61) digestive system drugs accounted for 6.6% (4/61), antipyretic analgesic anti-inflammatory medicines accounted for 3.3% (2/61), nervous system drugs accounted for 1.6% (1/61), immunomodulatory drugs accounted for 1.6% ( 1/61). 1.3 non-child-specific drug package insert information about the child medication 1.3.1 non-child-specific drug package insert different formulations about injections of the child medication information situation 【Dosage】 children information on 137 species, accounting for 70.6% (137 / 194); the [Pediatric Use 133, accounting for 68.6% (133/194); Pharmacokinetics children information 8 species, accounting for 4.1% (8/194); oral agents [ usage and consumption of children's information 89 species, accounting for 41.7% (89/213); [the Pediatric Use 127, accounting for 59.6% (127/213); Pharmacokinetics] Children Information four kinds, accounting for 1.9% (4/213); topical formulations 【Dosage】 children nine kinds of children's information, accounting for 33.3% (9/27); [medication] 12 items, accounting for 44.4% ( 12/27); Pharmacokinetics】 children's information. Between the different formulations 【Dosage】 child medication information comparing the difference was statistically significant (χ 2 = 39.023, P lt; 0.01) between the different formulations [children] Item child medication medication information comparing the difference was not statistically significant (χ2 = 7.552, P gt; 0.01), [pharmacokinetics] between different formulations in children medication information comparing the difference was not statistically significant (χ2 = 1.915, P gt; 0.01). 1.3.2 non-child medication information comparing the difference in the classes of medication instructions project about different children medication information in the package insert of the different categories of child-specific drugs no statistically significant (χ2 = 2.089, P gt; 0.01; x2 = 1.537, P gt; 0.01 ; x2 = 1.787, P gt; 0.01) respiratory medication 【Dosage】 There are 31 kinds of children's information, accounting for 73.8% (31/42); There are [Pediatric Use 23, accounting for 54.8% (23 / 42); Pharmacokinetics children information 0; digestive medicine [usage] children information of 14 species, accounting for 66.7% (14/21); [Pediatric Use the 11, accounting for 52.4% (11/21); Pharmacokinetics】 children's information; nervous system drugs [Dosage] There are 21 kinds of children's information, accounting for 58.3% (21/36) ; Pediatric】 24, accounting for 66.7% (24/36); Pharmacokinetics] children information, accounting for 2.8% (1/36). 1.4 non-child-specific drugs antimicrobial drugs manual about the Children medication information situation antibiotic 【Dosage】 children information for 67 species, accounting for 67.7% (67/99); [] 13 children medication, accounting for 13.1% (13/99); 【Pharmacokinetics of nine kinds of children's information, accounting for 9.1% (9/99); antiviral Dosage there are four kinds of children's information, 44.4% (4 / 9);, Pediatric Use the species, accounting for 44.4% (4/9); Pharmacokinetics] children information, accounting for 11.1% (1/9); antifungal 【Dosage】 children information species, accounting for 16.7% (1/6); [Pediatric Use 2, accounting for 33.3% (2/6); Pharmacokinetics】 Children Information 0. 1.5 non-child-specific drugs TCM injections instructions in the information about the child medication information 【Dosage】 item 3 species, accounting for 42.8% (3/7); reduction or prescribed by a doctor two kinds, accounting for 28.6% (2 / 7); missing items, accounting for 28.6% (2/7). [Pediatric Use item specific content types accounted for 28.6% (2/7); reduce it, or as directed species, accounting for 14.3% (1/7); missing items, accounting for 57.1% ( 4/7). 2. Guardian of the child medication awareness survey 2.1 surveyed guardians of children using drugs investigation guardian, that children's use of medicines has the particularity of 62 people, accounting for 68.9% (62/90); that discretion by the amount of adult reduction to 26 people, accounting for 28.8% (26/90); think about 2 people and adults, accounting for 2.2% (2/90). That currently on the market specific drugs for children many varieties and 76 more, accounting for 84.4% of the total surveyed; think less and less 12 people, accounting for 15.6%. 2.2. Guardian drug-related behavior before medication for children carefully read the manual and 86, accounting for 88.9% (86/90); higher proportion concerned with the main content of the description of the drug, accounted for 80% (72/90) or so; prescribed medication better behavior Dosage of drugs by doctors opened on time and give the child medication ratio of 96.7%, not make changes to perform a clinical dose accounted for 83.3%; poor efficacy that can not increase the amount of drugs and taking The 2001 study improved significantly improve the efficacy of those drugs varieties accounted for about 60.0%; 97.8% of the families personally custody of the child medication; management more aware of the family's spare drugs Ren Yanming, amounted to about 86.0%. 2.3 guardians crowd of awareness of the adverse drug reactions are relatively poor understanding of adverse drug reactions, and only 55.6% knew what adverse drug reactions; think that children use drugs more prone to adverse reactions accounted for only 50.0%; children with family members want the knowledge of adverse drug reactions (93.3%), although for adverse reactions from different sources, but a more systematic and standardized publicity, training, little, information about adverse reactions from the communities of adverse drug reactions lectures only 5.6 %, 83.3% did not receive ADR-related knowledge, education; constantly enhance the the guardianship awareness medicines in children, can take the initiative to observe a number of vital signs, clinical symptoms of adverse reactions occur in the course of medication, the child can take a more effective method processing. Child medication to cause serious adverse reactions / events 3.1 medication wrongly led to ADE in drugs reach of children, a higher incidence of central nervous system drugs, circulatory system drugs and digestive system drugs. Oral intake of six cases of central nervous system drugs, accounting for 27.2% (6/22), the circulatory system drugs five cases, accounting for 22.7% (5/22), digestive system drugs four cases, accounting for 18.2% (4/22). Children these drugs commonly used drugs for adult or elderly family occurred mainly due to the misuse of drugs is the improper storage of the families of these drugs, making the easy reach of children, mistaken for candy and other oral intake. 3.2 irrational drug use lead in the ADE in 19 cases ADE caused by the improper use of medicines, anti-cold medicine, anti-microbial drug performance is more concentrated, and other types of drugs are not obvious characteristics of the distribution. Irrational use of anti-cold medicine 7 cases, accounting for 36.8% (7/19); the antimicrobial drugs five cases, accounting for 26.3% (5/19). 3.3 suspicious drugs cause serious ADR ADR child medication in the correct Dosage of drugs mainly antibiotics, central nervous system drugs, anti-cold medicine, traditional Chinese medicine injection four major categories. Conclusion: Children serious lack of drugs, scarce research data existing for children's use of medicines for children. Families of children with adverse drug reactions of low awareness and use of drugs for children, there are security risks. Oral intake of drugs, irrational drug use, serious adverse reactions is a major risk factor for children's medication.

Analysis on the Status of Children’s Medication and Influence Factors of Serious Adverse Drug Reactions/Incidents

Abstract

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