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2021, 23(11)
HighLights More»   
· Pharmacists participate in multidisciplinary team and guard medication safety
· Case analysis of medical disputes related to drug?induced liver injury in Beijing from 2013 to 2019
· Effect of pharmacists′ intervention in therapeutic drug monitoring of voriconazole on medication safety
· Investigation on the use of high?alert medications for children in prescriptions
· Effects of tenofovir alafenamide fumarate and tenofovir disoproxil fumarate on blood lipid: a meta-analysis
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  Adverse Drug Reactions Journal--2021, 23 (11)   Published: 28 November 2021
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Pharmacists participate in multidisciplinary team and guard medication safety Hot!
Liu Fang, Li Yun, Zhao Rongsheng
Adverse Drug Reactions Journal. 2021, 23 (11): 561-563. ;  doi: 10.3760/cma.j.cn114015-20211117-01170
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With the promotion of innovative medical models such as patient-centered multidiscip- linary team (MDT), more and more pharmacists are playing an important role. Owing to their education background, knowledge structure, and professional sensitivity, pharmacists pay more attention to the prevention of the adverse drug reactions/adverse events. They work closely with other medical staffs and support each other in the team to improve the safety of drug therapy in difficult and complex cases through medication reconciliation, participation in development of treatment strategy, carrying out pharmaceutical care, and patient education, etc. Pharmacists should actively participate in MDT, explore and establish standardi- zed pharmaceutical care process and mode, carry out relevant clinical studies, summarize and share experience in time, so as to promote the sustainable development of pharmaceutical care in MDT and give full play to the role in ensuring medication safety in patients.
Case analysis of medical disputes related to drug?induced liver injury in Beijing from 2013 to 2019 Hot!
Mao Lu, Lin Ping, Zhang Wei, Liu Fang
Adverse Drug Reactions Journal. 2021, 23 (11): 564-569. ;  doi: 10.3760/cma.j.cn114015-20210412-00442
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Objective To explore the causes of medical disputes related to drug-induced liver injury (DILI). Methods The Excel data sheet of drug-related medical disputes provided by the Beijing Municipal People′s Mediation Committee for Medical Disputes were searched and data on solved cases of DILI-related medical disputes from 2013 to 2019 were collected. The distribution characteristics, related drugs, and causes of disputes in these cases were analyzed retrospectively. Results A total of 30 cases of DILI-related medical disputes were entered. Among the 30 patients, 23 (76.7%) were female and 7 (23.3%) were male, the age ranged from 3 months to 66 years, and the median age was 37 years; 25 (83.3%) were outpatients and 5 (16.7%) were inpatients. The drugs causing liver injury were traditional Chinese medicine (decoction and/or Chinese patent drugs) in 20 patients (66.7%), western medicine in 6 patients (20.0%), traditional Chinese medicine combined with western medicine in 4 patients (13.3%). Among the hospitals involved, tertiary hospitals accounted for 80.0% (24/30) and specialized hospitals of traditional Chinese medicine accounted for 60.0% (18/30). Of the 30 cases, 19 (63.3%) were judged to be the responsibility of the hospitals and the causes of liver injury were medication defects/errors, in which 17 cases (89.5%) were the responsibility of doctors and 2 cases (10.5%) were of nurses. The main problems were lack of inquiry before medication, lack of monitoring during treatment, illegal prescription, and overdosage due to negligence. Conclusion DILI-related medical disputes often occur in outpatient department, most of the drugs involved were traditional Chinese medicine, which may be related to the lack of understanding of hepatotoxi- city of traditional Chinese medicine in physicians (especially physicians in specialized hospitals of traditional Chinese medicine) and the neglect of management for Chinese medicine prescriptions.
Effect of pharmacists′ intervention in therapeutic drug monitoring of voriconazole on medication safety Hot!
Xiao Guirong, Zhang Weidong, Liu Yixian, Fan Ping, Hu Ming, Xu Ting
Adverse Drug Reactions Journal. 2021, 23 (11): 570-576. ;  doi: 10.3760/cma.j.cn114015-20210407-00425
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Objective To explore the effect of clinical pharmacists′ intervention in therapeutic drug monitoring (TDM) of voriconazole on medication safety. Methods The study subjects were inpatients with fungal infection, admitted from January 2019 to June 2020 in the Department of Infectious Diseases, West China Hospital, Sichuan University, who were scheduled to be treated with voriconazole. Using random-cluster method, patients were divided into intervention group and control group based on their doctor medical groups. In the intervention group, clinical pharmacists participated in the whole process of voricona- zole TDM and provided pharmaceutical care, while in the control group, no clinical pharmacists participated in TDM. The percentage of voriconazole-treated patients achieved target trough concentration(1.5-5.5-mg/L), the incidence of adverse reactions, and clinical cure rate between the 2 groups were compared. The timely (within 24-hours) management rate of medication orders containing drugs with interaction by doctors and the detection frequency of blood drug concentration were compared between the 2 groups. Results A total of 303 patients were enrolled in the analysis, including 166 in the intervention group and 137 in the control group. There was no significant difference between the 2 groups in demographic characteristics, liver function indexes, types of fungal diseases, main combined diseases, and the use of drugs with interactions with voriconazole before voriconazole treatment (all P>0.05). After receiving voriconazole, percentage of patients achieved target trough concentration in the intervention group was similar to that in the control group in the first detection [55% (91/166) vs. 50% (69/137), P=0.440] while significantly higher in the last detection[81% (134/166) vs. 47% (65/137), P<0.001]. The total frequency of trough concentration detection in the intervention group and the control group were 403 and 244 respectively. Percentage of detection values consisted with target trough concentration was significantly higher, while percentage of detection values exceeding target trough concentration (>5.5-mg/L) was significantly lower in the intervention group than those in the control group, respectively [63% (254/403) vs. 44% (107/244), P<0.001; 19% (63/403) vs. 22% (54/244), P=0.037)]. The total incidence of voriconazole-related adverse reactions [14% (23/166) vs. 23% (31/137)], the incidence of severe adverse reactions [2% (4/166) vs. 8% (11/137)], and incidence of liver injury [Council for International Organizations of Medical Sciences standard: 8% (13/166) vs. 15% (21/137); International Drug-induced Liver Injury Expert Working Group standard: 2% (4/166) vs. 7% (10/137)] in the intervention group were significantly lower than those in the control group (all P<0.05), and the clinical cure rate was similar in the 2 groups [86% (142/166) vs. 81% (111/137), P=0.291]. In the intervention and control groups, some patients were using drugs which had interactions with voriconazole when starting voriconazole treatment, and the timely management rates of these medication orders were 71% (24/17) and 18% (3/17) respectively, with a statistically significant difference between the 2 groups (P=0.001). The detection frequency of voriconazole trough concentration in the intervention group (2.4 times per patient) was higher than that in the control group (1.8 times per patient), and the proportion of patients with ≥3 detection was significantly higher [38% (63/166) vs. 23% (32/137), P=0.006]. Conclusion The involvement of clinical pharmacists in voriconazole TDM can enlarge the percentage of patients who achieve target trough concentration, improve the timely management rate of medication orders containing drugs with interactions with voriconazole, reduce the incidence of voriconazole-related adverse reactions, and improve medication safety.
Investigation on the use of high?alert medications for children in prescriptions Hot!
Wang Chunxiang, Hu Xuelian, Li Zhenzhi, Liu Shujie, Liu Yuling, Meng Chunming, Xue Gang
Adverse Drug Reactions Journal. 2021, 23 (11): 577-583. ;  doi: 10.3760/cma.j.cn114015-20211008-01046
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Objective To understand the usage status of high-alert medicines (HAM) for children in outpatient and emergency prescriptions and inpatient medication orders at department of pediatric. Methods All outpatient and emergency prescriptions and inpatient medication orders in patients with an age of <18 years between July 1, 2016 and June 30, 2018 in Huairou Maternal and Child Health Hospital Affiliated to Beijing Obstetrics and Gynecology Hospital, Capital Medical University were collected. According to the List of High-Alert Medications for the Chinese Children, the use of HAM for children in prescriptions and medication orders was analyzed retrospectively. Results A total of 297-968 prescriptions and medication orders were collected in the study, including 270-024 outpatient and emergency prescriptions (90.62%) and 27-944 inpatient medication orders (9.38%). There were 162-521 prescriptions (54.54%) involving male children and 135-447 (45.46%) involving female children with an age of (4±3) years, ranged 0-17 years. The number of drugs included in each prescription was (2±1), ranged 1-9. Of the 297-968 prescriptions and medication orders, 23-476 (7.88%) involved HAM for children. The proportion of prescriptions containing HAM for children in outpatient and emergency prescriptions was significantly higher than that in inpatient medication orders [7.92% (21-381/270-024) vs. 7.50% (2-095/27-944), P=0.013]; the proportion of prescriptions and medication orders containing HAM for children in Surgery Department [32.84% (1-220/3-715)] was significantly higher than that in Medicine Department [8.17% (22-043/269-777)] and other departments [0.87% (213/24-476)], and the difference was statistically significant (all P<0.001). The 23-476 prescriptions involved 13 categories and 42 kinds of HAM for children and the total frequency of HAM for children was 26-084. The top 3 drug categories that most frequently used were traditional Chinese medicine injections (8-694, 33.33%), antipyretic analgesic and anti-inflammatory drugs (7-505, 28.77%), and anti-infective drugs (4-011, 15.38%); the top 10 HAM for children that most frequently used were paracetamol, Yanhuning injection (炎琥宁注射液), Xiyanping injection (喜炎平注射液), vitamin K1, vidarabine, tetanus antitoxin, penicillins, phenobarbital, promethazine injections, and heparin. Adverse events occurred in 9 children due to medication errors of HAM for children, which were all grade E, and the drugs involved were Xiyanping injection, paracetamol, and vitamin K1 injection. Conclusions HAM for children was commonly used, among which the traditional Chinese medicine injection-related HAM was used more, and the proportion of prescriptions containing HAM for children was higher in departments of outpatient, emergency, and surgery. Medication errors related to HAM for children may lead to serious adverse events, so the management of HAM for children should be strengthened.
Effects of tenofovir alafenamide fumarate and tenofovir disoproxil fumarate on blood lipid: a meta-analysis Hot!
Wu Xiaoyan, Yu Hao, Zhou Yang, Cai Haodong, Jiang Yuyong
Adverse Drug Reactions Journal. 2021, 23 (11): 584-581. ;  doi: 10.3760/cma.j.cn114015-20211013-01064
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Objective To explore the effects of tenofovir alafenamide fumarate (TAF) and tenofovir disoproxil fumarate (TDF) on blood lipid. Methods The relevant databases (up to August 31, 2021) were searched. The data of dyslipidemia in treatment of hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection with TAF (trial group) and TDF (control group) in randomized controlled trials (RCTs) were collected. Methodological quality was evaluated by bias risk assessment tool of Cochrane collaborative network, and the meta-analysis was conducted using RevMan 5.3-software. The effect value was the risk ratio (RR) and its 95% confidence interval (CI). Results A total of 11 RCTs were enrolled in the analysis, including 4 on the treatment of hepatitis B (HBV subgroup) and 7 on the treatment of AIDS (HIV subgroup), and the methodological quality evaluation results showed low risk of bias for all. Eleven thousand eight hundred and eighty-eight patients were involved in the 11 RCTs, of which 6-273 were in the trial group and 5-615 in the control group. The results of meta-analysis showed that the incidences of increased low density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and triglyceride (TG) with the severity of ≥3 grade were higher in the trial group than those in the control group and the differences of incidences in LDL-C and TC increase were significant between the 2 groups [LDL-C: 2.9% (157/5-347) vs. 0.8% (37/4-727), RR=3.39, 95%CI: 2.35-4.89, P=0.001; TC: 0.7% (36/4-880) vs. 0.1% (6/4-397), RR=4.25, 95%CI: 1.91-9.45, P<0.001; TG: 0.5%(16/3-157) vs. 0.3%(8/3-102),RR=1.83,95%CI:0.81-4.15, P=0.140]. The changes of blood lipid after treatment were compared and the results showed that the increase of LDL-C was higher in the trial group (14.00-mg/dl) than that in the control group (4.00-mg/dl), and the difference was statistically significant (P=0.004). Conclusion TAF can significantly increase the levels of LDL-C and TC in patients.
Research status of coronavirus disease 2019 mRNA vaccine?associated lymphadenopathy Hot!
Yue Xiaolin, Wang Yawei, Wang Xin
Adverse Drug Reactions Journal. 2021, 23 (11): 592-596. ;  doi: 10.3760/cma.j.cn114015-20210906-00969
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After administration of coronavirus disease 2019 (COVID-19) mRNA vaccine (BNT162b2 vaccine of Pfizer/BioNTech incorporation and mRNA-1273 vaccine of Moderna incorporation), some vaccinators develop vaccination-associated lymphadenopathy (VAL). VAL usually occurs 2 to 4 days after vaccination, or 2 weeks later. The incidence of VAL after the second dose of vaccine is higher than that after the first dose. Some vaccinators develop VAL after both the first and second doses of vaccination. The clinical manifestations of VAL are enlarged lymph nodes with pain in axilla, supraclavicular, neck, and inguen on the same side of the inoculation site. Imaging examination shows enlarged lymph nodes with diffuse or focal cortical thickening, etc. The pathological diagnosis is benign reactive lymphadenopathy. VAL does not need treatment and generally subsides spontaneously 5 to 16 days after onset. The mechanism of lymphadenopathy after administration of COVID-19 mRNA vaccine is unclear.
Management of insulin switching in diabetes mellitus treatment: an overview of domestic and foreign guidelines Hot!
Meng Simeng, Zhang Ling, Jiang Rong, Shao Rong
Adverse Drug Reactions Journal. 2021, 23 (11): 597-602. ;  doi: 10.3760/cma.j.cn114015-20210519-00593
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Insulin switching is very common in the treatment of diabetes mellitus, which is an important link that affects the safe use of insulin. At present, insulin switching, including selection of different insulin products, dosage adjustment, and patient education has been explained in the guidelines issued by the United States, the United Kingdom, Canada, and China. Relevant information on insulin switching is various and scattered and there is a lack of systemicity and comprehensiveness. It is suggested to refer to the guidelines of other countries, fully analyze the clinical characteristics of diabetes mellitus in China, and base on the real-world research data to formulate a systematic insulin switching guideline in line with China′s national conditions, in which the selection of insulin products, dose adjustment, patient education, dietary advice, and blood glucose monitoring, etc. can be described in detail. In addition, strengthening patient tracking and medication monitoring is also a necessary mean to ensure the safety in insulin switching.
Anaphylaxis induced by Lanqin oral solution (蓝芩口服液)
Xu Lu
Adverse Drug Reactions Journal. 2021, 23 (11): 603-604. ;  doi: 10.3760/cma.j.cn114015 20210106 00020
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A 46 year old female patient with primary biliary cholangitis received Lanqin oral solution (蓝芩口服液) 10 ml orally thrice daily because of pharyngeal pain due to cold. About 20 minutes after taking the first dose of the drug, the patient suddenly felt general discomfort and numbness of mouth and tongue, followed by vomiting, sweating, pale complexion, dyspnea (27 times per minute), and hypotension (104/56 mmHg). Anaphylaxis induced by Lanqin oral solution was considered, the drug was discontinued and the liquid supplement to expand the blood volume and chlorphenamine maleate for anti allergy were given. One hour later, the patient′s symptoms disappeared and the blood pressure returned to 124/76 mmHg. The next day, the patient did not follow the doctor′s advice and took Lanqin oral liquid 10 ml again by herself. A few minutes later, she developed nausea and abdominal pain. The fluid infusion and symptomatic treatment were given immediately, and the symptoms disappeared 20 minutes later.
Delirium induced by dexmedetomidine
Qiu Zhihong, Peng Longxi, Li Xiaoming
Adverse Drug Reactions Journal. 2021, 23 (11): 605-606. ;  doi: 10.3760/cma.j.cn114015-20210120-00085
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An 81-year-old male patient with bipedal blue toe syndrome received IV pumping of dexmedetomidine 0.2-mg dissolved in 0.9% sodium chloride injection 48-ml at the rate of 4-ml/h once daily because of severe pain in his left toe. The patient developed irritability and delirium about 6 hours after the 3rd IV pumping. The next day, the pain was relieved and dexmedetomidine was stopped. After drug withdrawal, the patient occasionally had delirium. Due to difficulty in falling asleep, the same dose of dexmedetomidine was given again on the 3rd day of drug withdrawal. The same dose of dexmedetomidine was given twice the next day and obvious delirium and irritability occurred 2-3 hours after drug administration of each time. Delirium was suspected to be related to dexmedetomidine. Dexmedetomidine was stopped again and replaced by tramadol and midazolam. On the 6th day of drug withdrawal, the patient′s consciousness turned clear, and no delirium recured.
Bilateral choroidal detachment induced by topiramate
Zhao Zhenhuan, Li Lei, Liang Yu, Fu Lei, Jing Fanbo, Qu Haijun
Adverse Drug Reactions Journal. 2021, 23 (11): 607-608. ;  doi: 10.3760/cma.j.cn114015-20210524-00603
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A 57-year-old male patient with epilepsy was additionally given topiramate 25-mg orally once at night because of poor curative effect of sodium valproate. Seven days later, the patient developed vision loss with eye pain and swelling. Ocular ultrasonography showed bilateral choroidal detachment, which was considered to be related to topiramate. Topiramate was discontinued and prednisone acetate 60-mg once daily was given, and 8 days later, the patient′s eye pain and swelling were improved. Ocular ultrasonography showed that choroidal detachment disappeared. Fifteen days after drug withdrawal, his ocular symptoms disappeared.
Pseudoaldosteronism complicated with hypokalemic rhabdomyolysis induced by longterm use of oral glycyrrhizic acid preparations
Sun Xue, Zeng Hua, Cidan Zhuoga, Deji, Zebi, Zuo Wei, Cidan Zhuoga
Adverse Drug Reactions Journal. 2021, 23 (11): 609-611. ;  doi: 10.3760/cma.j.cn1140152021022200194
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A 50yearold female patient was treated with diammonium glycyrrhizinate enteric coated capsules for about 22 months irregularly due to repeated abnormal liver function, which was changed to compound glycyrrhizin 3 tablets thrice daily later. After 4 months of treatment with compound glycyrrhizin, the patient developed myalgia with fatigue and the symptoms gradually aggravated, resulting in weakness of limbs and difficulty in walking. Compound glycyrrhizin were stopped for 1 week, but the symptoms were not improved, with a blood pressure of 160/100mmHg. Laboratory tests showed blood potassium 1.9mmol/L, alanine aminotransferase (ALT) 54U/L, aspartate aminotransferase (AST) 104U/L, creatine kinase (CK) >2200U/L, myoglobin 542.1μg/L, and blood pH 7.56. Intravenous and oral potassium supplementation and symptomatic treatments were given. Three days later, the symptoms of myalgia and fatigue were markedly improved and the blood potassium returned to 3.5mmol/L. Two weeks later, the patient′s muscle strength recovered and the blood pressure was 100/71mmHg. Laboratory tests showed blood potassium 4.2mmol/L, ALT 45U/L, AST 38U/L, and CK 44U/L. Aldosterone postural stimulation test and captopril challenge test were performed for definite diagnosis, showing normal aldosterone level and decreased renin concentration. Pseudoaldosteronism complicated with hypokalemic rhabdomyolysis was diagnosed, which was considered to be related to longterm administration of glycyrrhizic acid preparations.
Acute poisoning caused by largedose of phenobarbital and scopolamine hydrobromide
Sun Bo, Liu Xun, Zhang Erfeng, Ma Huanqing
Adverse Drug Reactions Journal. 2021, 23 (11): 612-614. ;  doi: 10.3760/cma.j.cn1140152021051500581
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A 25yearold male patient took about 60 tablets of phenobarbital and scopolamine hydrobromide by himself (each tablet contains 30mg phenobarbital and 0.2mg scopolamine hydrobromide). About 1 hour later, he developed coma with paroxysmal limb convulsions. Drug poisoning was diagnosed. The patient received gastric lavage, catharsis, and intravenous injection of midazolam 10mg for epilepsy. Six hours later, his heart rate was 53 beats/min, breathing rate was 11 times/min, and occasional convulsions and hematuria occurred. Laboratory tests showed indirect bilirubin 16.97μmol/L, total protein 54g/L, albumin 27.6g/L, and thrombin time 25.0s. Multiple organ injury was considered and blood purification treatment was given. One day later, the patient′s consciousness was restored, heart rate was 68 beats/min, breathing rate was 16 times/min, and no convulsion occurred. Laboratory tests showed indirect bilirubin 8.69μmol/L, total protein 54.7g/L, albumin 34.0g/L, and thrombin time 16.7s.
Contrast encephalopathy induced by iodixanol
Ye Chao, Wang Zhaohui
Adverse Drug Reactions Journal. 2021, 23 (11): 614-616. ;  doi: 10.3760/cma.j.cn114015-20210118-00074
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A 74 year old female patient underwent percutaneous coronary intervention due to acute non ST segment elevation myocardial infarction. Iodixanol 160 ml was injected intravenously during the operation. Angiography showed that coronary artery disease was type B and and no drug adverse reactions occurred during the operation. About 12 hours after the operation, the patient developed nausea, vomiting, and blindness; about 30 hours after the operation, she developed memory decline, irritability, and anxiety with a serum creatinine of 174 μmol/L. Her serum creatinine was 134 μmol/L before operation. After consultation with the ophthalmologists and neurologists and the cranial CT examination (showing increased density of the tentacles, a small amount of suspected subarachnoid hemorrhage, and softening lesions in bilateral basal ganglia) during disease progression, it was considered to be contrast encephalopathy. Symptomatic treatments such as IV infusions of methylprednisolone 80 mg twice daily and torasemide 10 mg once daily and fluid replacement were given. Two days later, the patient had improved vision and memory and consciousness recovered; 3 days later, her vision and spirit returned to normal.
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