| Objectives1.To investigate the distribution and effectiveness of interventions toward medication errors related with drug allergy and skin test among inpatients in a large tertiary university teaching hospital.2.To investigate the occurrence rate of positive skin test of cephalosporins and penicillin and related influencing factors,describe the value of β-lactam skin test for predicting drug allergy,especially under the premise that "cephalosporin generally does not require skin test" and in the clinical situation where skin test is still required,and provide references for clinical practice.Methods1.Records during 2014～2017 were aggregated and analyzed by utilizing inappropriate physician orders documented by auditing pharmacists,medication administration errors derived from nursing administration system and medication errors derived from an online no-fault reporting system.Quality improvement measures were discussed.2.A retrospective utilization study was conducted by extracting medical/nursing records and physician orders for inpatients receiving skin test of penicillin or cephalosporins(i.e.cefazolin sodium,cefuroxime sodium,cefathiamidine,cefoperazone sodium/sulbactam sodium,ceftriaxone sodium,cefotaxime sodium,cefotiam,cefepime,ceftazidime sodium,ceftizoxime sodium,cefoselis,cefodizime sodium,cefmenoxime,cefminox sodium,cefmetazole sodium)during May 2010～May 2016.Data mining were performed on information on age,gender,clinical department,manufacture company,results of skin test,history of allergy,whether to have an allergy after medication administration of antibiotics following negative skin test result.In univariate analysis,chi-square test was used to analyze the counting data,and independent sample t test was used to analyze the measurement data variables with statistical significance in univariate analysis were included in Logistic regression for multivariate analysis.Results1.The total number of related near misses decreased year by year,with the ratio of the number of near misses to discharged patients reducing from 0.2773%to 0.1164%(2014 vs 2017,P=0.0000)and relative proportion of annual near misses decreasing from 8.82%to 2.12%(2014 vs 2017,P=0.0000);the ratio of the number of adverse events to discharged patients decreased from 0.0163%to 0.0059%(2014 vs 2017,P=0.0097),2.The incidence,susceptibility factors and predictive value of positive β-lactam antibiotic skin test in large sample size inpatients(1)In patients older than 14 years,the overall positive rate of cephalosporins was 2.98%and that of penicillin was 1.79%,and the difference was statistically significant(P=0.0000).Among the 15 cephalosporin drugs,the positive rate of ceftizoxime skin test was the highest,reaching 5.7%.(2)The results of cephalosporin skin test were significantly affected by age,gender,inpatient department,history of allergy,and origin of drug.Women(OR=1.20,P=0.0001)and imported drugs(OR=1.20,P=0.0002)were independent risk factors for positive skin test,patients with a history of allergy were independent risk factors for negative skin test and protective factors for positive skin test(OR=0.22,P<0.0001).The skin test positive rate of surgery(OR=0.75,P<0.0001)and ICU system(OR=0.51,P=0.0014)was significantly lower than that of internal medicine system.Among the age factors,the skin test positive rate was significantly lower in the youth group,the middle-aged group,the aged group and the super-aged group than the juvenile group.The OR range was 0.18-0.60(P<0.0001),and the OR value gradually decreased with the increase of age.(3)With respect to penicillin skin test,the positive rate of female skin test was higher than that of male in patients older than 14 years(OR=1.38,P<0.0001).Compared with internal medicine patients,the ICU system is a protective factor for the positive rate of skin test(OR=0.51,P<0.0001).Unlike cephalosporin-like skin test positive susceptibility factors,surgery is a risk factor for penicillin skin test positive rate(OR=1.19,P=0.0180).Among the age factors,compared with the juvenile group,the positive rate of skin test was significantly lower in the middle-aged group,the aged group and the super-aged group,whose OR range was 0.30-0.55(P<0.0036),and the OR value gradually decreased with the increase of age.Unlike "an allergic history is a protective factor for cephalosporin positive skin test",an allergic history is not an independent risk factor for penicillin positive skin test.(4)A history of allergy is a protective factor for the development of anaphylaxis in patients receiving antibiotics secondary to negative skin test(OR=0.04,P<0.0001).In patients older than 14 years old,the incidence of anaphylaxis in patients who had a history of allergy and received antibiotics secondary to a negative skin test was significantly higher than that without a history of allergy(P<0.0001),but this phenomenon was not observed in children.(5)In children,age(OR=1.16,P=0.0001)and allergy history(OR=4.80,P<0.0001)were independent risk factors for positive skin test of cephalosporins.The finding that allergy history is an independent risk factor for positive cephalosporin skin test in children is contrary to the conclusion that allergy history is an independent risk factor for negative cephalosporin skin test in patients older than 14 years.Meanwhile,a history of allergy(OR=7.52,P=0.0044)is an independent risk factor for positive penicillin skin test in children.(6)In patients with age 14,or higher,the incidence of drug allergy in patients who received antibiotics secondary to negative penicillin skin test was not statistically significant different from the value in patients who received cephalosporins following negative skin test of cephalosporins.The incidence of allergic reaction after directly using the medicine without cephalosporin skin test was significantly higher than that after negative cephalosporin skin test(0.29%vs 0.066%,OR=6.43,95%CI 4.23-9.79,P<0.0001).However,for cefazolin,ceftizoxime and cefathiamidine,there was no significant difference between the incidence of allergic reaction after directly using the medicine without cephalosporin skin test and that after negative cephalosporin skin test.In children patients,the incidence of drug allergy in patients who received cephalosporins following negative cephalosporin skin test was significantly higher than that in patients with age 14 or higher(0.18%0.066%,=0.0040),but it was not statistically significant different from that in patients who directly received cephalosporins without the need of cephalosporin skin test.Conclusion1.Comprehensive interventions by collaboration among physicians,pharmacists,nurses,information engineers and quality management staff can effectively reduce the occurrence of medication errors related with drug allergy and skin test.2.The skin test results of cephalosporins and penicillin were affected by a variety of factors.However,from the perspective of the final clinical outcome(i.e.,drug allergy),the skin test of cephalosporin for patients aged 14 or older still has certain clinical value,and the incidence of allergic reactions after taking drugs following negative skin test is significantly lower than that without cephalosporin skin test while the extent of allergic reactions is milder in antibiotic treatment following negative skin test.In the case of negative skin test of cephalosporin solution,more attention should be paid to the allergy of children,because the incidence of drug allergy after negative skin test of cephalosporin in children patients is significantly higher than that of patients older than 14 years. |
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