Isoniazid use, effectiveness, and safety for treatment of latent tuberculosis infection: a systematic review

ABSTRACT Background: The treatment strategy for latent tuberculosis infection is to reduce the number of tuberculosis cases and consequently reduce the transmission of pathogenic bacteria. This study aimed to determine the safety, effectiveness, and adherence of isoniazid use for latent tuberculosis infection treatment. Methods: To identify studies on isoniazid use for latent tuberculosis infection, five electronic databases were searched. The methods and results are presented in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: Most studies (53) used isoniazid for 9 months. The prevalence of use and adherence to treatment varied considerably (18% to 100%), and were evaluated by participant completion of isoniazid treatment for latent tuberculosis infection. The adverse events most frequently reported were hepatotoxicity, gastric intolerance, and neuropathy; the rates of occurrence ranged from < 1% to 48%. In the studies that evaluated the effectiveness of isoniazid for latent tuberculosis infection, the rate varied from 0 to 19.7% for patients who did not have active tuberculosis after the follow-up period. Conclusions: The importance of maintaining follow up for patients using isoniazid should be emphasized due to the risk of developing adverse events. Despite the treatment challenges, the rates of patients who used isoniazid and developed active tuberculosis during the follow-up period were low. We believe that isoniazid continues to contribute to tuberculosis control worldwide, and better care strategies are required.

Mining and analysis for adverse drug event signals of liver failure in underage population based on the FAERS database / 中国药房

OBJECTIVE To conduct data mining on drugs causing liver failure in underage populations based on the FDA Adverse Event Reporting System （FAERS） database， so as to provide reference for clinical use of related drugs. METHODS The data on reported adverse drug event （ADE） of liver failure in this population （under 18 years old） from the first quarter of 2013 to the third quarter of 2022 were retrieved from the FAERS database for mining and analysis； they were divided into infants（≤1 year old）， young children（＞1-＜6 years old）， children（6-＜12 years old） and adolescents（12-＜18 years old） according to the age. The reporting odds ratio （ROR）， proportional reporting ratio and Bayesian confidence propagation neural network of the proportional imbalance method were used to screen ADE signals. RESULTS A total of 1 051 ADE reports of liver failure were collected from the underage population involving 60 drugs. The highest incidence was found in adolescents （410 cases， 39.01%）， followed by young children （297 cases， 28.26%）. The instructions of 14 drugs did not mention hepatobiliary system injury and liver failure risk， including 31 cases of levetiracetam （2.95%），18 cases of metronidazole （1.71%）， 16 cases of each of topiramate and methylprednisolone （1.52% each）， 12 cases of dexamethasone （1.14%）， 11 cases of tisagenlecleucel （1.05%）， 10 cases of each of ferrous sulfate， metformin and busulfan （0.95% each）， 9 cases of propofol （0.86%）， 8 cases of onasemnogene abeparvovec （0.76%）， 5 cases of each of diphenhydramine and omeprazole （0.48% each）， 4 cases of sebeliesterase α （0.38%）， totaling 165 cases， accounting for 15.70% of the total reported cases. Metformin was contrary to the known liver safety， and E-mail：libingchemical@163.com metronidazole and levetiracetam were new risk signals， which caused more serious clinical outcomes. CONCLUSIONS Fourteen new pharmacovigilance signals which cause liver failure in the underage population are found in this study； the liver function of patients should be closely monitored when using these drugs. Among those drugs， metformin neither undergoes liver metabolism nor has been reported in the relevant literature， and the liver-related ADE caused by metformin deserves further attention. The clinical outcomes caused by metronidazole and levetiracetam are relatively serious and need to be given sufficient attention.

Research hotspots and trends on potentially inappropriate medication from 2012 to 2021 / 中国药房

OBJECTIVE To quantitatively and qualitatively analyze the progress of potentially inappropriate medication （PIM） research by means of bibliometrics， and to predict the hotspots and trends of PIM， so as to provide reference for PIM research in China. METHODS The research literature related to PIM were searched from Web of Science core database， and the publication trend of the literature was analyzed on the bibliometric online analysis platform and CiteSpace 5.8.R3 software. The research results were visualized and analyzed， and the research hotspots of PIM were summarized through gCLUTO. RESULTS About PIM research， the annual number of the literature issued from 2012 to 2021 showed a continuous growth trend totally； the United States had the largest number of literature （241 pieces）； the University of Sydney in Australia was the research institution with the largest number of literature （59 pieces）； O’Mahony D from University College Cork， Ireland， published the most literature （23 pieces）； the research of PIM involved 57 disciplines， among which there was the largest number of literature about gerontology （384 pieces）； International Journal of Clinical Pharmacy was the journal with the largest number of literature （61 pieces）； Journal of the American Geriatrics Society was cited most frequently （1 197 times）. The hotspots of PIM research mainly focused on seven aspects： the standard of PIM， the safety and economy research of PIM， the risk factors research of PIM， the PIM research of chronic patients， the PIM research of antipsychotics， the research of pharmacists’ participation in PIM management， and the PIM research about palliative care of tumor patients. CONCLUSIONS The heat of research on PIM has been on the rise， and there is little cooperation between countries and institutions， and more cooperation is needed. In the future， the focus of Chinese pharmacists’ research on PIM may be on the deep localization of PIM standards， PIM intervention and precise medication guidance， and PIM management of specific diseases and drugs.

Traditional Chinese medicine health care from "long term taking" drugs in Shen Nong's Classic of Materia Medica / 中国中药杂志

"Taking drugs for a long term" is a qualitative expression of medication method based on the efficacy and safety of Chinese medicine, and the study on it is conducive to the full utilization of the efficacy and rational use of drugs. There are 148 drugs that can be taken for a long time recorded in Shen Nong's Classic of Materia Medica, accounting for 41% of the total drugs. This paper analyzed three-grade classification, natural qualities, four properties and five flavors, and efficacy features of the "long-term taking" drugs(LTTD), thus exploring the herbal source of traditional Chinese medicine health care and the rationality of effect accumulation by long-term taking. It was found that there were more than 110 top-grade LTTD in Shen Nong's Classic of Materia Medica, most of which were herbs, with sweet flavor, flat property, and no toxicity. The efficacies were mainly making body feel light and agile(Qingshen) and prolonging life. Eighty-three LTTD were included in the Chinese Pharmacopoeia(2020 edition). In the modern classification, tonic LTTD accounted for the most, followed by damp-draining diuretic LTTD and exterior-releasing LTTD. Twenty LTTD were included in the "List of Medicinal and Edible Products" and 21 were in the "List of Products Used for Health-care Food", involving in various modern health care effects, such as enhancing immunity, assisting in reducing blood lipids, and anti-oxidation. Shen Nong's Classic of Materia Medica is the classic source of traditional Chinese medicine health care, and its medication thought of taking drugs for a long term to accumulate effects has guiding significance for the regulation of sub-health and chronic diseases nowadays. The efficacy and safety of LTTD have been examined in practice for a long time, and some of the drugs are edible, which is unique in the whole cycle of health-care service, especially in line with the health-care needs in the aging society under the concept of Big Health. However, some records in the book are limited by the understanding of the times, which should be scientifically studied according to the Chinese Pharmacopoeia and the related regulations and technical requirements, under the attitude of eliminating falsifications and preserving the truth and keeping the right essence, so as to achieve further improvement, innovation, and development.

Effect of patient engagement on medication safety for chronic disease patients: a systematic review / 中华全科医师杂志

Objective:To explore the effect of patient engagement on medication safety for patients with chronic disease through a systematic review.Methods:Relevant randomized controlled trials of patient engagement on medication safety were searched from PubMed, EMBASE, The Cochrane Library, CNKI, Wanfang and VIP database. The literature was screened according to inclusion and exclusion criteria, and data extraction and literature quality evaluation was conducted on the selected literature.Results:A total of 15 eligible studies was included. Most of the studies occurred in outpatient and home settings, and the subjects were patients with chronic diseases. Patient engagement strategies can be divided into three categories: (1) patient engagement in medical decision-making; (2) patient engagement in medication adjustment; (3) patient engagement in medication management. The outcomes of medication safety included medication adherence, medication knowledge, medication beliefs, adverse events and medication errors. Intervention strategies for patients to actively engage in medication safety significantly improved patients′ medication knowledge and beliefs, but did not improve medication adherence of patients.Conclusion:Promoting patient active engagement is an effective intervention measure to improve patients ′ perception of medication safety. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusions.

Adverse drug reactions induced by hydroxychloroquine in the treatment of oral lichen planus: a report of 13 cases / 口腔疾病防治

Objective @# To analyze the adverse drug reaction（ADR） reports of hydroxychloroquine for clinical medication safety. @* Methods@#The ADR reports of hydroxychloroquine between May 2019 and May 2021 were analyzed. Age, reasons for drug use, time of ADR, combined drug use, and ADR outcomes were statistically analyzed. @*Results@# No severe ADR was reported. Patients over 60 years old accounted for 53.85% of the total cases, and the time of ADR appearance was significantly earlier among those under 60 years old. A total of 61.54% of ADRs were involved in multiple organs, and optic neurotoxicity was reported in 46.15% of cases. @*Conclusion@# In the treatment of oral lichen planus with hydroxychloroquine, adverse drug reactions should be monitored, and increased attention should be given to patients over 60 years old to ensure the safety of this medication.

Investigation on post classification and personnel qualification of pharmaceutical care in hospitals / 中华医院管理杂志

Objective:To understand the evaluation of 90 pharmaceutical service posts by pharmacists in hospitals, so as to provide basis for rational allocation of pharmaceutical personnel in hospitals.Methods:A questionnaire survey was conducted among 2 582 hospital pharmacists in 31 provinces from August 2019 to April 2020. The survey contents included post classification, staffing qualification and scores related to drug safety.Results:Among the 90 pharmaceutical posts investigated, there were 39 posts with a safety correlation score of 5(the highest score), 36 with 4 and 15 with 3. There were 41 posts in advanced pharmaceutical care and 49 posts in basic pharmaceutical care. The minimum qualifications required was 21 posts with pharmacy related college degree or assistant pharmacist, 61 posts with pharmacy related or clinical pharmacy bachelor degree or pharmacist title, and 8 posts with higher qualification. Advanced pharmaceutical care posts had high drug safety relevance scores and high personnel qualification requirements, mainly involving drug treatment, scientific research and comprehensive management posts.Conclusions:Pharmacists with different qualifications should be allocated according to different levels of pharmaceutical care projects, which can reasonably allocate limited human resources and make the best of their talents.

Analysis of 240 Cases of Medical Damage Liability Disputes Caused by Medication Error / 中国药房

OBJECTIVE：To study general chara cteristics and medication of medical damage liability disputes cases caused by medication error ， and to provide references for related departments and medical staff for preventing and reducing medication-induced medical disputes. METHODS ：A total of 240 cases of medical damage liability disputes cases caused by medication error were collected from Peking University ’s Fabao Law Database during Jan. 2001 to Feb. 2020，and analyzed in terms of general situation ，damage outcome ，level of the hospital involved ，liability judgment and compensation ，types of medication error and drug types. RESULTS ：medication-related medical damage liability disputes accounted for 25.3％ of overall medical damage disputes ；the most damage result of patients was death （68.3％）；medical negligence forensic appraisal was conducted as the main appraisal pattern with a proportion of 57.9％；the average case compensation was 203，000 yuan；the hospitals involved were mainly tertiary hospitals （48.8％）；the main type of medication error involved was prescription error ； chemical medicine was mainly involved ，of which the top three categories were systemic antibacterial ，systemic corticosteroids and antipsychotics. CONCLUSIONS ：ADR caused by medication errors are the common causes of medical disputes. Medical institutions should focus on improving the relevant systems and processes ，strengthen the construction of pharmaceutical information and automation system ，and reduce the probability of medication errors ；at the same time ，great importance should be paid to the cultivation of pharmaceutical talents in hospital ，give full play to the role of pharmacists ，and strengthen the monitoring and intervention of medication errors. Finally ，the relevant national judicial departments should constantly improve the settlement mechanism of medical damage liability disputes to provide reasonable protection for both doctors and patients.

Mass Gathering (Hajj) Medication Safety Services: New Initiative in Saudi Arabia

Objective: To demonstrate the mass gathering hajj medication safety as new initiatives in the Kingdom of Saudi Arabia. Methods: It is a new initiative project drove by national mass gathering pharmaceutical programs. The projects drove the mass gathering medicine guidelines and the international business model, pharmacy project guidelines project management institution guidelines of a new project. The initiative project is written through project management professionals and consisted of several parts, including the initial phase, the planning phase, the execution phase and the monitoring and controlling phase. Results: The medication safety services during the mass gathering with a defined vision, mission and goals. The services had multiple benefits, including clinical and economical on patients and healthcare services, as described in the review. The extension of the project assured by risk management elements description. Besides, the monitoring and controlling of the services as illustrated. The conversion of operation project, though closing project stage illustrated in the analysis. Conclusion: The mass gathering medication safety is a new initiative project that is part of the mass gathering medicine. There is various part of medication safety services can be started during the mass gathering; it is highly recommended in Saudi Arabia.

Knowledge, Attitudes, and Practices (KAP) Survey on the Safety of Anti-tumor Drugs in Hospital Discharge among Hospital Pharmacist / 中国药学杂志

OBJECTIVE: To analyze the knowledge, attitude and practice of hospital pharmacists on the safety of patients with anti-tumor drugs discharged from hospitals, explore possible risk factors, and provide reference for targeted guidance and rational medication of tumor patients discharged. METHODS From March 15, 2019 to May 31, 2019, pharmacists at hospitals in 31 provinces (cities) in China conducted a questionnaire survey on the safety of patients with anti-tumor drugs discharged from hospitals. RESULTS: The average score of pharmacists′ knowledges of anti-tumor drugs was 46.7, equivalent to 51.8% of the total score. Most pharmacists (74.5%) are aware of the risks of discharge of antineoplastic agents and are willing (93.9%) to provide medication guidance for cancer patients. However, the pharmacists′ guidance for patients with cancer on the discharge was mostly limited to oral presentation (62.1%), and the accessibility of pharmacists to cancer patients after discharge was generally low (55.6%). CONCLUSION: Drug safety participants pay insufficient attention to the safety risks of patients with anticancer drugs discharged, and hospital pharmacists′ knowledge reserve of anti-tumor drugs has shortcomings, there is no perfect system of medication education for discharged patients, which are all risk factors threatening the safety of medication for cancer patients after discharge. Serious efforts should be made to find solutions to continuously improve the safety of patients with anticancer drugs discharged from hospitals.

Off-label drug use in the treatment of rare diseases:the current situation / 国际药学研究杂志

The diagnosis and treatment of rare diseases are a significant social public health work. Due to the low variety and poor accessibility of orphan drug, off-label use is common in the field of rare diseases at home and abroad. Off-label use may be the effective treatment for life-threatening diseases in patients with rare diseases, but it also raises issues related to drug safety and efficacy, medical liability and drug reimbursement, so the supervision of off-label drug use is of particular importance. This article reviews the current situation of off-label drug use and their application in thefield of rare diseases treatment, hoping to arouse widespread concern in society and ensure medication safety for patients with rare diseases through the joint efforts of medical institutions and regulatory agencies.

Retrospective Analysis of Gestational Adverse Drug Reactions from Sichuan Center for Adverse Drug Reaction Monitoring from Nov. 2016 to Nov. 2017 / 中国药房

OBJECTIVE： To investigate the characteristics and regularity of gestational （including perinatal period） adverse drug reactions （ADR） in Sichuan province， and to provide evidence for ensuring the safety and effectiveness of drug use in clinic. METHODS： Gestational ADR reported to Sichuan provincial ADR monitoring center from Nov. 2016 to Nov. 2017 were statistically analyzed in respects of report source， personnel distribution， general information of patients， route of administration， drug types and main drugs， involved system/organ， grading and outcome， etc. RESULTS： A total of 1 309 gestational ADR cases   （1 340 case time） were collected， in which 1 305 were from medical institutions， 3 from enterprises and 1 from manufacturer. There were 986 physicians， 188 nurses， 133 pharmacists and 2 commissioners for drug safety. 859 cases （65.62％） were 21-30 years old， accounting for the largest proportion. 867 case time were caused by intravenous administration （64.70％）. ADR-inducing drug types mainly included reproductive system drugs （491 case time， 36.64％）， antimicrobial drugs （479 case time， 35.75％） and blood system drugs （110 case time， 8.21％）. Main of them were Carboprost tromethamine injection （187 case time， 13.96％）， Cefazolin sodium for injection （122 case time， 9.10％） and Oxytocin injection （105 case time， 7.84％）. ADR mainly involved skin and its appendants （517 case time， 33.95％）， gastrointestinal system （387 case time， 25.41％）， whole body （175 case time， 11.49％）.  In 1 309 gestational ADR， 1 251 cases （95.57％） were general ADR； 58 cases （4.43％） were severe ADR， including 14 life-threatening cases， 7 extended hospital stay and 37 others； 592 （45.22％） patients improved， 716 （54.70％） recovered and 1 （0.08％） did not improve. CONCLUSIONS： In clinical practice， it is necessary to strengthen the monitoring of drug use in patients during gestational， especially monitor ADR of uterine contraction drugs and antimicrobial drugs during gestational， use drug cautiously and promote clinical medication safety in gestational patients.

Investigation and Analysis of Medication Safety among 24 Medical Institutions in Linyi City / 中国药房

OBJECTIVE： To investigate the current situation of medication safety in 24 public medical institutions（referred to as “hospital”） from Linyi city and the differences in medication safety between urban and rural areas. METHODS： ISMP self-assessment scale [including 10 key elements （Ⅰ-Ⅹ，such as “Ⅰ patient’s information” “Ⅱ drug information”）， 20 key characteristics and 270 evaluation projects] developed by Institute of Safe Medication Practices was used to investigate 24 hospitals in Linyi city. The implementation rates of 10 key elements in urban and rural hospitals were analyzed statistically， and the top 10 evaluation projects were listed for the key elements with the lowest implementation rate. The key elements and top 10 evaluation projects with the largest difference in the implementation rate were compared between urban and rural hospitals. Radar maps were used for comparison and analysis intuitively. RESULTS： A total of 24 hospitals were surveyed， including 12 in urban and 12 in rural areas； there were significant differences in the implementation rate of 10 key factors among 24 hospitals； the elements with the highest implementation rate were “Ⅶ environmental factors， workflow and staffing pattern”（56.55％）；the elements with the lowest implementation rate was “Ⅱ drug information” （26.77％）. Among 33 evaluation projects of “Ⅱ drug information”， the implementation rate of No. 36 project （12.50％， related to opioids） was the lowest. Among the implementation rates of 10 key elements in 12 urban hospitals and 12 rural hospitals， the key elements with the greatest difference was “Ⅳ drug label， packaging and naming” （differing by 44.44％，59.72％ vs. 15.28％）； Among“Ⅸ patient education”evaluation project with the greatest gap， there was the greatest difference in No. 199 project （related to patients’ active participation in medication， 58.33％ in urban， 4.17％ in rural）. CONCLUSIONS： The results of medication safety investigation in 24 hospitals from Linyi city show that all the item in each hospital needs to be improved expecially in the implementation of “Ⅱ drug information”. Rural hospitals should strengthen medication education for patients.

Evaluation and Medication Reconciliation of Preoperative Medication in 210 Selective Surgery Elderly Patients / 中国药房

OBJECTIVE： To investigate and evaluate perioperative medication in elective surgery elderly patients， and to provide reference for perioperative medication management of clinical pharmacists for elderly patients. METHODS： Totally 210 elective surgery elderly patients were selected from Beijing Tsinghua Chang Gung Hospital during Oct. 2015 to Oct. 2016. Pharmacists carried out drug reconstitution， obtained information about their diseases and medication， analyzed and evaluated perioperative medication （indication， usage and dosage， interaction， drug selection， if these drugs should be stopped before surgery） according to Optimal Guidelines for Preoperative Evaluation of Elderly Patients so as to put forward related medication suggestions. RESULTS： Among 210 patients， there were 132 males （62.86％） and 78 females （37.14％） with an average age of （69.96±7.67） years； 43.81％ of patients had more than 3 kinds of diseases， and 13.33％ of patients suffered from more than 5 kinds of diseases； 31.43％ of patients took more than 5 kinds of drug for long term before surgery； 38.10％ patients had more than 2 drug-induced risks； The preoperative medication of 110 patients （52.38％） included drugs that should be avoided before surgery （such as antiplatelet aggregation agents）， 23 patients （10.95％） had potentially inappropriate medication （such as proton pump inhibitors）， 12 patients （5.71％） should use drugs （such as aspirin） cautiously， 35 patients （16.67％） should use drugs （β receptor blocker） continuously during perioperative period. The pharmacists provided 177 times of medication suggestions such as stopping some medications for patients and physicians through medication reconciliation and preoperative medication evaluation （71 times for patients， 106 times for physicians）； the final adoption rates were 100％ and 95.28％， respectively. CONCLUSIONS： The elderly patients have many preoperative complications， various risk factors， multiple medications， so it is vital for their preoperative medication management. The medication reconciliation is an effective way to evaluate preoperative medication in elderly patients， preoperative medication evaluation and analysis in elderly patients is of great significance to ensure the safety of clinical medication.

IT-based management system for rational drug use in medical alliances: development and application / 中华医院管理杂志

Rational drug use and patient medication safety have always been key to pharmaceutical management.The authors introduced the practice of informationization management of rational drug use in the medical alliance of Luohu Hospital Group.The main measures refer to building an informationization platform for drug purchasing and supply management, dispensing management, medication intervention and medication guidance.This practice can realize closed-loop drug management, achieving full-range supervision and traceability for drugs and higher patient drug use safety.

Development of high-alert medication list based on expert consensus and healthcare workers investigation / 中国药学杂志

OBJECTIVE: To develop high-alert medication list that complies with Chinese medication practice. METHODS: The study was organized by the Group of Medication Safety Experts, Hospital Pharmacy Committee, Chinese Pharmaceutical Association. Selection criteria for high-alert drugs were developed with Delphi consensus among 18 medication safety experts, then two rounds of survey followed. The first round contained open-ended questions, by which the respondents were asked to nominate high-alert medications in addition to ISMP list according to the selection criteria. The new nominations were classified and screened by the experts group to get a preliminary list. The second round was grading scale survey. The healthcare workers who responded to the first round survey were asked to grade on their familiarity to and the risk degree of each medication in the preliminary list. With familiarity as the weight, the weighted risk averages and standard deviations of each medicine were calculated to decide if the medication was included in the high alert medication list or not. RESULTS: Selection criteria of high alert medications were developed, which contains 6 items and were used in the first round survey. Totally 782 healthcare workers in 23 hospitals responded to the survey. Through two rounds of survey, 24 classes and 14 specific medications were included in the final list. Compared with ISMP list, the newly added were two more classes, including reproductive toxic drugs and intravenous theophylline, 4 more specific medications, including topical potassium permanganate, 5 mg•mL-1 atrophine injection, lyophilizing thrombin powder and arsenic trioxide for injection. CONCLUSION: A high-alert medication list is developed with two more classed and four more drugs newly adding to the ISMP list, which complies better with Chinese healthcare practice.

Monthly prescription comment on antimicrobial agents at outpatient and emergency department for 5 years: performance of antimicrobial stewardship / 中华医院管理杂志

Objective To retrospectively analyze the implementation of the antimicrobial agents prescription monthly review at the emergency and outpatient departments for the past five years, for evaluation of its action in promoting rational application of antimicrobial drugs. Methods At the baseline investigation stage, 1780 prescriptions on antibiotics in emergency and outpatient department from June 2012 to November 2012 were randomly selected for centralized evaluation. The period of correction and observation falls into two stages. The first stage ranged from December 2012 to February 2015, when the prescription of antibiotics was sampled manually for monthly review. The second stage ranged from March 2015 to June 2017, when a prescription review software for prescription comment was introduced for the sample purpose. The data so acquired were subject to chi-square test and linear regression analysis using Excel 2010 and SPSS 16. 0. Results The rational rate of prescription for antibiotics at the emergency department increased from 80. 56％ of the baseline stage to 99. 47％ of the second stage (166506/167400), scoring a difference of statistical significance (P<0. 001). With intervention of the prescription review software, the percentage of irrational use of antimicrobial agents dropped by 5. 18％ compared to the baseline stage. Conclusions Monthly prescription review on antimicrobial agents at the outpatient and emergency departments could promote the rational use of antimicrobial agents and play an important role in clinical drug safety. Information system and performance assessment contributed to the effect of prescription review.

Treatment of Children Rhinitis from Spleen / 中国中医药信息杂志

Rhinitis is a common disease with high incidence in children. Wind is the cause of the disease, and weakness of spleen and lung is the root of the disease. Therefore, this article proposed that the treatment principle of this disease is to clear heat and remove toxicity in the acute stage, and to strengthen spleen and tonify lung in relief period. Medicines are selected with the same origins of food to ensure medication safety.

Ethical Reflections on the Enlightenment of American Off-Label Drug Use to Our Country / 中国医学伦理学

Off-label drug use to some extent meets the clinical medication,achieves the most needed treat-ment of patients and promotes the development of medicine,but there exists certain risks at the same time.Through the analysis of the phenomenon of off-label drug use,from the perspective of medical ethics,this paper proposed that it should adhere to the principles of beneficence and respect,specifically,correcting the motives of off-label drug use,strict review of supporting evidence,ensuring patient's informed consent,strengthening ethical review andintroducing the insurance sharing mechanism,so as to achieve both the guarantee of patient's medication safety and the aversion of medical personnel's practice risks.

Investigation and Analysis of Parents’Cognition,Attitude and Behavior on Pediatric Medication Safety in Part of Urban Area of Fujian Province / 中国药房

OBJECTIVE:To provide reference for guaranteeing safety and rationality of pediatric medication. METHODS:Questionnaire survey was designed to investigate and analyze the cognition,attitude and behavior of parents on pediatric medication safety in urban area of Fujian province. RESULTS:Totally 1 405 questionnaires were sent out,and 1 326 were effectively received with effective rate of 94.38%. The education level of the respondents was high,and the respondents with college degree or above accounted for 57.92%. The total monthly income was also high,the respondents with monthly income of 4 000 yuan or above accounted for 61.61%. The correct answer rates of the respondents about pediatric medication safety was above 55%,but the lowest correct rate of 3 questions was only 13.73%,14.25% and 23.83%,respectively. The average score of cognition was (13.92 ± 2.80). The scores of low educational background,low monthly income and farmers were relatively low (P＜0.01). 97.06% of the respondents had trouble or difficulty in giving children drugs;the frequency of choice for children who didn’t cooperate with medication due to the taste or dosage was 29.83%;14.58% of the respondents didn’t know the accurate dosage;12.13% lacked of pediatric medication guide. 11.37%of the respondents thought that there was no drug for child specific use or not enough child-specific varieties;when children suffered from common diseases,the majority of respondents would choose municipal level or above hospitals and community health service,accounting for 49.55% and 15.46%. 85.22% of respondents had the experience of giving drug to their children by themselves. As to medication information,10.94% of respondents hold that"wanted to know but did not have the channel"and 47.66%"would read when had opportunity". 40.05% of the respondents sometimes took the initiative to consult doctor or pharmacist about pediatric medication attention,but 19.60% of respondents took little or no initiative to that. For main sources of the respondents accessing to pediatric medication guidance,the frequency of choosing doctors was 65.53%,and that of choosing pharmacists was 20.31%. 61.09% of respondents wanted to get the medication education from doctors,while 19.76% from pharmacist. Information on pediatric medication information when the respondents visited doctors and purchased drugs were also relatively simple,and were mainly about the usage and dosage. CONCLUSIONS:At present,it is common for parents to give drug to children by themselves in Fujian province. But the cognition,attitude and behavior on medication safety of children still remain to be improved. There are shortcomings in the publicity and education of knowledge and information,and the pediatric pharmaceutical care functions of pharmacists have not been fully embodied. At the same time,the development and production of children specific drugs need to be strengthened,and the information about pediatric medication in drug instructions should be standardized and improved.