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OBJECTIVE To analyze the clinical manifestations and characteristics of adverse drug reactions （ADR） caused by cefotaxime sodium in Shandong province， and to explore the effects of skin test before medication of cefotaxime sodium on serious ADR， so as to provide reference for safe drug use in clinic. METHODS The relevant data of cefotaxime sodium-induced ADR reported by Shandong Province ADR Monitoring Center during December 2019 to December 2021 were collected from National ADR Monitoring System. The ADR classification， age， gender， ADR occurrence time， route of administration， history of allergy， primary diseases， ADR systems/organs involved， clinical manifestations， outcome， skin test or not before medication were statistically analyzed. RESULTS A total of 1 057 ADR reports caused by cefotaxime sodium were included. Among them， there were 867 patients （82.02%） with general ADR and 190 patients （17.98%） with serious ADR. The majority were ＜11 years old （40.30%）. The main route of administration was intravenous drip （96.69%）. A total of 1 033 patients （97.73%） developed ADR 30 min to 24 h after medication. A total of 814 patients （77.01%） had no history of allergy. The primary diseases were respiratory system infection （56.58%）. Main systems/organs involved in ADR were skin and its appendants， digestive system and respiratory system， and its clinical manifestations were rash， pruritus， nausea， vomiting， chest tightness， etc. After withdrawal or symptomatic treatment， 1 050 patients （99.34%） were cured or improved. Before the use of cefotaxime sodium， 850 patients underwent skin test （151 patients occurred serious ADR）； there was no statistical significance in the incidence of serious renzhen202102@163.com ADR， compared with the incidence of serious ADR in 207 patients without skin test （39 patients occurred serious ADR）（P＝0.718）. CONCLUSIONS ADR caused by cefotaxime sodium is mainly seen in patients ＜11 years old， mostly occurring 30 min to 24 h after intravenous drip； skin test before medication of cefotaxime sodium cannot reduce the risk of serious ADR. Before using cefotaxime sodium in clinical practice， patients should be asked about their allergy and medication history in detail. During use， it is important to focus on the patient’s condition within 24 h after medication to prevent serious ADR and ensure the safety of clinical medication.
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OBJECTIVE To analyze the influential factors for potentially inappropriate medication （PIM） in elderly cancer patients. METHODS The data of elderly cancer patients hospitalized in a hospital from January to December 2021 were collected. According to the Beers standard of the American Geriatrics Society in 2019 （hereinafter referred to as the “2019 version of Beers standard”） and Criteria for Potentially Inappropriate Drug Use in Chinese Elderly （2017 version） （hereinafter referred to as the “Chinese PIM standard”）， the PIM status of elderly cancer patients was retrospectively analyzed. Multivariate Logistic regression analysis was used to identify influential factors for PIM. RESULTS A total of 293 patients were included in the study. According to the 2019 version of Beers standard， 211 patients （72.01%） had PIM， of which 204 （69.62%） had PIM related to drugs， 6 （2.05%） had PIM related to diseases or symptoms， 46 （15.70%） had PIM that should be used with caution， 32 （10.92%） had PIM with drug-drug interaction that should be avoided， and 11 （3.75%） had PIM based on renal function； the top 5 drugs in the list of incidence were proton pump inhibitors， metoclopramide， the first-generation antihistamines as promethazine， analgesics as ibuprofen and megestrol. According to the Chinese PIM standard， there were 132 patients （45.05%） with PIM， of which 119 （40.61%） had PIM related to drugs， involving 25 drugs （included 7 high-risk drugs and 18 low-risk drugs）， and 24 （8.19%） with PIM in disease status； top 4 drugs in the list of incidence were promethazine， megestrol， ibuprofen and cimetidine. Multivariate Logistic regression analysis showed that compared with patients with hospital stay≤10 days， patients with hospital 20054） stay between 11 and 30 days had a higher risk of PIM [odds ratio （OR）＝8.836 8， 95% confidence interval （CI） （3.217 8， 31.940 9）， P＝0.000 1]； compared with the patients with the 65895198。E-mail：fjman@cmpt.ac.cn number of clinical disease diagnosed≤5， patients with the number of clinical disease diagnosed≥11 had a higher risk of PIM [OR＝10.930 1， 95%CI （3.000 9， 70.922 9）， P＝0.001 8]； compared with surgical treatment， patients receiving antineoplastic drugs had a higher risk of PIM [OR＝2.209 5， 95%CI （1.180 2， 4.176 9）， P＝0.013 6]. CONCLUSIONS Elderly cancer patients have multiple diseases， complicated medication， and a high incidence of PIM. The length of hospital stay （11-30 d）， the number of clinical disease diagnosed （≥11） and anti-tumor drugs are main influential factors for PIM in patients.
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OBJECTIVE：To provide reference for improving safe drug use in pregnant women. METHODS ：Retrieved from as domestic and foreign literature retrieval platforms as CNKI and Web of Science ，the literatures about drug use in pregnancy period were collected and analyzed by using the literature analysis function provided by the retrieval platform and CiteSpace 5.5R2 software. The collected data of annual volume ，author，organization，keyword co-occurrence and literature co-citation analysis of domestic and foreign literatures are visualized ，and the research focus was analyzed. RESULTS ：A total of 38 946 foreign literatures and 698 domestic literatures were included ，and domestic literatures were less than foreign literatures ；the literature volume on pregnancy drug use were increasing year by year at abroad，but the volume of domestic literatures fluctuates greatly and increased slowly. Foreign institutions and scholars worked closely together ，and built a close cooperation network ，especially in the United States. However ，the author team of domestic research was relatively scattered as a whole ，and the cooperation between researchers was less ，so a large cooperation team had not yet been formed. The most frequently cited literatures in the world were randomized controlled studies and large-scale cohort studies，the keyword “Risk”appears most frequently ，indicating that it focuses on the effects of pregnancy medication on pregnancy outcomes and offspring. The effects of antiepileptic drugs ，antidepressants and opioids used in pregnancy on pregnancy outcomes and child development were currently a research hotspot abroad. However ，there was a lack of large-scale sample and high-quality clinical research in China ，high-frequently keywords in domestic literatures indude “fetus”“hypertension in pregnancy ”etc.，which focused on the treatment of combined diseases in pregnancy and paid little attention to the long-term effects of medication in pregnancy. CONCLUSIONS：More and more attention had been paid to the study of drug use in pregnancy period. Domestic research needs to seize the international cooperation communication ，learns from the excellent experience of foreign research team ，and establishes domestic specific pregnancy medication research team. Relevant departments should introduce measures as soon as possible ，support medical institutions and drug production and developmententerprises to do a good job in the registration of pregnancy medication，establish the database of pregnancy medication inChina as soon as possible ，and improve the medication safety of pregnant patients.
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OBJECTIVE:To provide reference for safe drug use of paclitaxel in clinic. METHODS:The literatures about anaphylactic shock induced by paclitaxel were retrieved from China Hospital Knowledge Database during 2006-2016. After screening literatures which met inclusion criteria,the literatures were analyzed statistically in respects of the distribution of patient's gender and age,primary disease,distribution of occurrence time of anaphylactic shock,prophylactic drug use,route of administration and dosage,combined with chemotherapy drugs,prodromal clinical manifestations,first-aid measures and prognosis,etc. RESULTS:A total of 53 cases of anaphylactic shock induced by paclitaxel were included,among which there were 16 male and 37 female,aged 17-72 years;female patients over 40 year-old took up the highest proportion(30 cases,56.60%). The major primary diseases were lung cancer(15 cases,28.30%),breast cancer(12 cases,22.64%)and ovarian cancer(11 cases,20.75%). Anaphylactic shock mainly occurred within 5 min after intravenous dripping(34 cases,64.15%). 45 cases (84.90%)received antiallergic prophylactic program before using paclitaxel;53 patients were given intravenous dripping with single dose of 30-300 mg. Among 53 patients,25 patients were given paclitaxel alone,and other patients were given paclitaxel combined with chemotherapy drugs. The prodromal clinical symptoms of anaphylactic shock mainly involved cardiovascular system (123 case time,36.07%),skin and mucous membrane system(73 case time,21.41%)and respiratory system(67 case time, 19.64%). 2 patients(3.77%)died after rescue treatment. CONCLUSIONS:More attention must be paid to the occurrence of anaphylactic shock induced by paclitaxel.
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OBJECTIVE: To probe into the cognition of the elderly to the safety of drug use and their demand for pharmaceutical care,and to improve pharmaceutical care in the hospital and guarantee the safety of drug use.METHODS: Questionnaires about medication information were designed.315 elderly patients,who were collected from 10 old-age homes of Liaocheng,domestic sickbed department and 5 community medical service stations of Liaocheng Municipal People's Hospital from Oct.2008 to Mar.2009,were involved in study.Investigation data were analyzed statistically using SPSS17.0 software.RESULTS & CONCLUSIONS: Results of study showed that the elderly had not sufficient knowledge towards the safety of drug use,especially drug allergies,side effects of drugs and special population medication.There was significant difference in the understanding of the safety of drug use among the elderly with different education levels,different occupations and different medical insurance patterns.The potential danger of medication is present.They are desirous of acquiring pharmaceutical care.Pharmacists should carry out medicine consultation and popularize pharmaceutical knowledge.They also should provide a comprehensive pharmaceutical care for the elderly people to ensure the safety of drug use in the elderly.
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OBJECTIVE:To provide reference and suggestion for the implementation of patient safety goal and safety improvement of drug use in primary health care institutions.METHODS:With the concrete practice of pharmacy and work experience,problems about safety of drug use in outpatient and inpatient department of primary hospital were investigated to put forward countermeasures.RESULTS & CONCLUSION:At present irrational use of drug appeared in medical institutions in China generally.The drug use of patients suffered from threatens.It is expected that safety of drug use is confirmed by formulating policies and performing their function of Pharmacy Administration Committee and perfecting training system of licensed pharmacist.
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OBJECTIVE:To analyze relevant regulations in Drug Administration Law and to study the safety of drug use. METHODS:The key points of the safety of drug use were analyzed through reasoning analysis. RESULTS&CONCLUSION:The safety of drug use was the core of medicine legislation while there were still some problems on law execution and blind spots in legislation. It is suggested to standardize the research and development of drug and purchase channel,improve system for safety of drug use and role of clinical pharmacists so as to guarantee the safety of drug use.
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OBJECTIVE: To survey the habits of public drug use in China and its reasons and to put forward countermeasures so as to provide reference for government and decision-making department. METHODS: From Nov. 2008 to Feb. 2009, questionnaire survey was adopted in 31 provincial administrative regions except for Hong Kong, Macao and Taiwan. 26 000 questionnaires were collected and 1 100 physicians were interviewed. SPSS17.0 software was used to analyze 11 796 valid questionnaires statistically. The frequency of words used by physicians was counted. RESULTS: The residents don’t have enough knowledge to support them to use medicine rationally. And they are not compliant with prescription but take medicine by arbitrariness. 44.88% of residents don’t buy medicines according to prescriptions and 74.39% don’t take medicine following treatment course, stop taking medicine once symptom relieve or change the category of drugs frequently. CONCLUSION: The improvement of pharmaceutical market environment, enhancement of medication guide and popularization of medication knowledge can promote rational use of drug.
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OBJECTIVE: To investigate the tagging condition in medication of special population in package inserts in order to give reference for rational drug use of special population. METHODS: 389 pieces of common Chinese and western medicine package inserts of our inpatient and out-patient dispensaries were randomly collected and analyzed statistically in terms of the content of package inserts for special population, including pregnant and lactant women, children and the aged. RESULTS: A part of medication items of special population in package inserts had deficiency. According to the classification of dosage form, the tagging rate of injection exceeded other dosage forms reached to more than 90%, except of medication items for children. The tagging rate of oral formulation arrived at more than 90% only in terms of contraindications and cautions. According to the classification of manufacturer, the tagging rate of domestic drugs was kept at the low level while that of imported drugs exceeded 90%. CONCLUSIONS: Package inserts need to be improved with the effort of drug supervision management department, drug production department and population of using drugs to guarantee the safety of drug use in special population.
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OBJECTIVE: To study relation between the packaging of pharmaceutical products and the safety of drug use. METHODS: Analysis was based on the relevant documents, and combined with the actual situations in China. RESULTS & CONCLUSION: Only by selecting the appropriate packaging materials, controlling the packaging process effectively and man- aging the package labels, will the safety of drug use be ensured.