Signal mining and analysis of adverse drug events of baloxavir marboxil based on American FAERS / 中国药房

OBJECTIVE To mine adverse drug event （ADE） signals related to baloxavir marboxil， and to provide reference for clinically safe drug use. METHODS The ADE signals related to baloxavir marboxil from January 1， 2018 to May 31， 2022 in the US FDA adverse event reporting system （FAERS） were mined using the proportional reporting odds ratio （PRR） method. ADE with report number≥3， PRR≥2 and χ2≥4 was defined as a positive signal， and PRR method was used to analyze the ADE signal. RESULTS A total of 1 424 ADE reports with baloxavir marboxil as the main suspected drug were collected， involving 460 ADE signals. The femininity and patient under 18 years old were reported more， the country with the highest number of reports was the United States， and the main indication of drug reported was influenza. A total of 37 ADE positive signals were obtained after PRR calculation and screening exclusion， the first three ADE signals in the list of the reported number were diarrhea， vomiting and immediate hypersensitivity， and the first three ADE signals in the list of PRR value were febrile delirium， ischaemic colitis and hemorrhagic cystitis. Compared with the instructions of baloxavir marboxil， 18 ADE signals had not yet been included， such as abnormal liver function， hematuria， hemorrhagic cystitis， etc. Five new SOCs were involved， such as kidney and urinary system diseases， hepatobiliary system diseases， investigations， nervous system disorders and musculoskeletal and connective tissue disorders. CONCLUSIONS When clinical application of baloxavir marboxil， in addition to the adverse drug reactions mentioned in the drug instructions， attention should be paid to abnormal liver function， hematuria， hemorrhagic cystitis， etc， so as to guarantee the safety of drug use.

Investigation and Analysis of the Understanding of Pharmacy Practitioners in Retail Pharmacies and Parents to Children’s OTC Drug Knowledge / 中国药房

OBJECTIVE：To standardize the use of children’s over-the-counter（OTC）drugs in China，control the risk of children’s self medication and ensure the safety of children’s medication. METHODS：The questionnaire was randomly distributed to pharmacy practitioners in retail pharmacies in 13/parents in 16 provinces and municipalities directly under the central government. The results of questionnaire survey were analyzed descriptively. The corresponding suggestions were put forward for the problems existing in the use of OTC drugs for children among pharmacy practitioners in retail pharmacies and parents.RESULTS：Totally 5 367 people filled the questionnaire at pharmacies，and 5 353 questionnaires were filled validly with effective rate of 99.74％；the number of consumers（parents）who filled the questionnaires was 6 111，and 5 094 questionnaires were filled validly with effective rate of 83.36％. The results of survey showed that 93.67％ of retail pharmacies were equipped with 1-2licensed pharmacists；most of the employees in pharmacies had college degree（46.59％），and their professional knowledge was relatively weak，and only 30.00％ of them were very familiar with pharmaceutical professional knowledge. Pharmacy practitioners could provide basic pharmaceutical care，but they were not sensitive to the information of children’s age and weight；only 44.11％of the practitioners would approve the dosage according to the age and weight of the children；98.09％ of pharmacies would regularly conduct OTC drugs knowledge training，but they did not pay attention to the knowledge of children related to drug use. About half of the pharmacy practitioners were very clear about the indications，usage and dosage，precautions of OTC drugs forchildren. About 70％ of parents did not fully understand the difference between prescription drugs，green OTC drugs and red OTC drugs，and did not know the risk of home OTC treatment；63.06％ of parents chose OTC drugs according to their previous experience， and 23.05％ of parents relied on drug advertisements to choose OTC drugs； 92.64％ of parents would read the drug instruction carefully before using OTC drugs， but they had blind spots in understanding many contents of the drug instruction. In the process of OTC drug use，46.21％ of parents had used adult OTC drugs for their children，and 41.54％ of parents did not convert the amount of children；52.89％ of parents said that their children suffered from adverse reactions after taking OTC drugs. CONCLUSIONS：The pharmacy practitioners have low education on the whole，professional level needs to be improved，their understanding of children’s OTC drugs is not comprehensive enough，and there is a lack oftraining on children’s medication knowledge. Parents have a poor awareness of children’s OTC drugs，and there are many problems in the process of using children’s OTC drugs，such as inaccurate dosage，using adult’s drugs. It is suggested that we should improve the access standard of pharmacy practitioners and increase the number of licensed pharmacists；organize special training on safe drug use for children to improve the pharmaceutical service ability of pharmacies；strengthen the supervision of retail pharmacies and formulate pharmaceutical care standards for the use of OTC drugs for children；strengthen the publicity and education on rational drug use for children and popularize the knowledge of safe drug use of OTC drugs for children；give full play to the guiding role of pharmacists and pay attention to the medication guidance of parents.

Retrospective Analysis of 530 Cases of New/Severe Pediatric ADR in Shandong Province during 2016-2017 / 中国药房

OBJECTIVE： To analyze the characteristics and regularity of new/severe pediatric ADR in Shandong province， and to promote the safe use of drugs in children. METHODS： A retrospective analysis of new/severe pediatric ADR in the Shandong Provincial ADR database 2016-2017 was conducted in respects of children’s gender and age， primary disease， ADR history， family ADR history， dosage form， route of administration， drug type， systems/organs involved in ADR， clinical manifestations， off-label drug use， drug combination， occurrence time， effects of ADR on primary disease， outcome， etc. RESULTS： A total of 44 742 pediatric ADR cases were collected from Shandong province ADR database from 2016 to 2017， including 27 060 male， 17 664 female and 18 gender unknown. 530 cases were diagnosed as new/severe pediatric ADR， including 334 male and 196 female with ratio of male to female 1.70 ∶ 1. New/severe ADR reports of children aged 1-3 took up the highest proportion （158 cases， 29.81％）. Primary diseases were mainly respiratory disease （190 cases， 25.85％）； there were 10 children with ADR history （1.89％）， 2 with family ADR history （0.38％）. Dosage forms were mainly injection （358 cases， 67.55％）. Route of administration were mainly intravenous drip （431 cases， 81.32％）. The drugs that caused ADR included 20 categories and 162 species， mainly including drug for regulating hydroelectric acid-base balance （148 cases caused by 8 kinds of drugs， 27.92％）， antibiotics （89 cases caused by 33 kinds of drugs， 16.79％）， traditional Chinese medicine and its extract （80 cases caused by 24 kinds of drugs， 15.09％）. The systems/organs involved in ADR were mainly systemic injury （201 cases， 37.92％， main clinical manifestations included chills and fever， etc.）， followed by skin and its appendants （99 cases， 18.68％， mainly clinical manifestations included rash and itching， etc.）， respiratory system （76 cases， 14.43％， main clinical manifestations included dyspnea and cough， etc.）. Off-label drug use were found in 41 cases （7.74％）， including the safety of drug use was not clear in drug instructions （20 cases， 3.77％）； no drug testing was carried out and no reliable references were available （13 cases， 2.45％）， that medicine was prohibited was stated in drug instructions （2 cases， 0.38％）. 106 cases （20.00％） had drug combination， including combined use of two drugs， three drugs and four drugs （62， 36， 8 cases）. ADR occurred mainly within 0-5 min （140 cases， 26.42％）. Among 530 children， ADR had no obvious effect on the outcome of the disease in 457 cases （86.23％）； ADR caused longer course of disease in 57 cases （10.75％）. 278 cases （52.45％） were cured and 243 cases （45.85％） were recovered. CONCLUSIONS： It is necessary to strengthen the monitoring of drug use in children， formulate national standards and relevant laws and regulations for children’s rational drug use， improve the awareness of medical staff to children’s ADR， strengthen the education and publicity of the knowledge about safe drug use in children， and to promote rational drug use.

Experience of Clinical Pharmacists Participte in the Prevention of Drug-induced Epilepsy / 中国药房

OBJECTIVE:To summarize the role of clinical pharmacists on the prevention of medicine-induced epilepsy and common epilepsy-inducing drugs in clinic. METHODS:The role of clinical pharmacists in whole process of pharmaceutical care for an epilepsy patient was introduced,and clinical pharmacists assisted physicians to reduce the risk of drug-induced epilepsy. The role of clinical pharmacists on the prevention of epilepsy-inducing medicine during pharmaceutical care was explored through reviewing literature,summarizing epilepsy-inducing drug and analyzing mechanism. RESULTS:The role of clinical pharmacists in diagnosis and treatment of epilepsy included that analyzing the risk of medicine-induced epilepsy by inquiring about the history of drug use, guiding patients to gradually stop taking risk drugs,participating in the formulation of clinical medication plan and drug risk during diagnosis and treatment,assisting physicians to adjust medication plan,monitoring the change of patient's symptoms after drug,"special medication notification for epilepsy patient",etc. The types of common epilepsy-inducing medicine included antibiotics (fluoroquinolone,β-lactam,etc.),drugs for central nervous system(sedative and antiepileptic drug,mental disorders drug,etc.), Chinese herbal drug,Chinese patent drug,antipyretic- analgesic and anti-inflammatory drug,circulatory system drug and other drugs. The mechanisms of drug effect included entering the brain through the blood cerebrospinal fluid barrier,inhibiting the binding of γ-aminobutyric acid to the receptor site,producing amino or free radicals and affecting a part of the cerebral cortex. CONCLUSIONS:Clinical pharmacists play an irreplaceable role in the safety of drug use in epilepsy patient. Their focuses to epilepsy-inducing drug are of significance to clinical practice.

Classification and Analysis of Set Prescription Preparations Containing Toxic Decoction Pieces in 2015 Edition of Chinese Pharmacopoeia (Part I) / 中国药房

OBJECTIVE: To provide reference for strengthening safe use and supervision of set prescription preparations containing toxic decoction pieces [called "Chinese patent medicine (CPM) containing toxicity" for short] in clinic. METHODS: The CPM containing toxicity in 2015 edition of Chinese Pharmacopoeia (part I) were summarized and analyzed to put forward the suggestion on improving safe use of them in clinic. RESULTS & CONCLUSIONS: A total of 474 CPM containing toxicity are included in 2015 edition of Chinese Pharmacopoeia (part I), accounting for 31. 75％ of set prescription preparations. There are 435 oral preparations (12 preparations both for oral and external use), 38 preparations for external use, one intramuscular injection, accounting for 91. 77％, 8. 02％, 0. 21％ of CPM containing toxicity, respectively. There are 318, 93, 32, 31 set prescription preparations containing 1, 2, 3 or more ingredients toxic decoction pieces, accounting for 67. 09％, 19. 62％, 6. 75％, 6. 54％, respectively. At present, basic research on CPM containing toxicity is weak; the information of the instructions is not perfect; guidance for clinical drug use is absent. It is suggested to strengthen basic research on CPM containing toxicity, develop drug use study among special population, improve rational use of Chinese patent medicine and strengthen post-marketing safety reevaluation so as to guarantee the safety of CPM containing toxicity use in clinic.

Research on high frequency electrotome quality detection method / 中国医学装备

Objective:To analyze the high frequency electric knife detection methods, effective detection methods is used to solve problems in testing, the high frequency electricity knife quality is ensured finally.Methods: According to the national calibration specifications, the high frequency electricity knife analyzer is used to test, the problems are found, the experience is sum up.Results:By using the method of testing for a long time, the hidden danger is eliminated of the high frequency electrical knife, the accuracy of the high frequency electric knife is ensured, so that it is more safe and reliable in clinical.Conclusion: The quality control of high frequency electric knife test is an important part of medical safety, the value of high frequency electric knife is ensured through the tested periodically, so it can better service to patients.

Medication Knowledge, Safe Use of Medicines and Health Literacy in Southern Taiwan: A Cross-section Study.

Introduction: There was a high prevalence of non-prescribed medicine usage in Taiwan the reasons for this phenomenon may be the false advertisements on underground radio programs that exaggerate the efficacy of non-prescribed medicines combined with inadequate medication knowledge and the high prevalence of adverse self-medication of Taiwanese people. As the result, it is critical to investigate the health literacy in Taiwan. The aim of this study was to investigate the relationship between medication knowledge, safe use of medicines and health literacy in southern Taiwan. Methodology: A cross-sectional survey was used in the study. A total of 513 residents were recruited and 87 of these were excluded because of invalid data, giving a response rate of 83.0%. Data were collected from February to August 2013. Results: From 426 residents who participated in the study, 60.6% were women. The mean age of study participants was 45.8±5.2 years and the majority of them (38.7%, N=165) were between 31-50 years old. Health literacy was positively associated with medication knowledge (r =.520, p<.01) and safe use of medicines (r =.643, p<.01). Medication knowledge was positively related to safe use of medicines (r =.378, p<.01). Conclusion: Medical knowledge and safe use of medicines affect health literacy. Residents with appropriate medical knowledge, reduce adverse self medication behaviors, and promote health literacy.

Study of deltamethrin detection method and its residual dynamics in Loincerae Japonicae Flos / 中国中药杂志

This paper reports the residual dynamics of deltamethrin and detection method in Loincerae Japonicae Flos to provide scientific basis for safe and appropriate use of deltamethrin. A field experiment was conducted in Fengqiu, Henan Province China. The field plots were sprayed with deltamethrin at the recommended dose and a high dose, respectively, and a control was set up, totally being 3 treatments with 3 replications. The flowers were picked at 2 hours, 1, 2, 3, 4, 5, 7, 9, 11, 13 and 15 days after pesticide application and then dried. The residue of deltamethrin was determined by gas chromatography method with electron capture detector for the above samples. Results showed that recoveries of deltamethrin ranged from 76.4% to 86.9%,and the relative standard deviation was below 11%,Linearity was observed over a range of 5-500 μg•L ⁻¹ with correlation coefficient was 0. 999 2. The established method meets the requirements of pesticide residue analytical methods. The degradation of deltamethrin followed the first order dynamics. The residue dynamic equation of the high dose and recommended dose deltamethrin were C=5.992 2e-0.338t and C=1.536 9e-0.31t respectively, and the half-life of deltamethrin in Loincerae Japonicae Flos was 2.09-2.24 days, which indicates that deltamethrin is an easily degradable pesticide. It is concluded that deltamethrin should be used in aphids occurring period and the safety interval was more than 7 days to ensure the safety of Loincerae Japonicae Flos consuming.

Analysis of 1 372 Cases of Adverse Drug Reaction Reports in 36 Hospitals in Xi’an / 中国药房

OBJECTIVE:To investigate the characteristics and regularity of ADR in secondary-level hospitals and above in Xi’an in order to provide reference for clinical drug use. METHODS:During Oct. 2012-Jun. 2014,1 372 ADR cases reported in 36 hospitals at secondary-level or above in Xi’an were analyzed retrospectively. RESULTS:Among 1 372 cases of ADR reports,the incidence of ADR in the above 60 age group occupied the highest percentage,being 29.67%(407 cases);ADR reports were most likely caused by antibacterial drugs,accounting for 45.77%,followed by TCM injections(15.82%)and circulatory system drugs(9.55%);the largest number of ADR reports was caused by injections(1 210 cases,88.19%);the main types of ADR were lesion of skin and its appen-dents,accounting for 44.16%. The most number of ADR was induced by Levofloxacin injection,involving 95 cases. CONCLU-SIONS:Mastering the characteristics and regularity of ADR help managers to standardize clinical rational drug use and ensure patients’ medication safety.

Importancia de la vigilancia sanitaria de los parásitos en la calidad del agua, según su uso / Importance of health surveillance of parasites in water quality according to use

El agua contaminada puede transmitir infinidad de patógenos con comportamientos y resistencias diversas. Dentro de los patógenos a determinar los parásitos son de especial relevancia pues se destacan por su alta resistencia a los diversos factores ambientales además se encuentran relacionados con altos índices de morbilidad y mortalidad en los países en desarrollo, especialmente en la población infantil. El objetivo de este trabajo es destacar la importancia de la vigilancia sanitaria de los parásitos en la calidad del agua según su uso y en su relación con el ambiente. Los huevos de helmintos son el principal riesgo a la salud debido al uso seguro del agua residual o lodos en la agricultura. Los quistes de los protozoarios como Giardia y Cryptosporidium, son difíciles de eliminar del agua de consumo sin tratar, debido a su pequeño tamaño y resistencia a oxidantes usados comúnmente como el cloro. Aunque no se recomienda su monitoreo de rutina en el agua, sí es necesario realizar investigaciones para detectar su presencia y establecer normativas propias adecuadas a nuestras condiciones(AU)

Polluted water can transmit lots of pathogens with various behaviors and resistances. Among the pathogens, the parasites are particularly important since they stand out for their high resistance to various environmental factors in addition to being associated to high morbidity and mortality rates in the developing countries, particularly children. The objective of this paper was to highlight the importance of health surveillance of parasites in water quality according to use and its relationship with the environment. The helminth eggs are the main health risk due to the safe use of wastewater or sludge in agriculture. Protozoan cysts like Cryptosporidium and Giardia, are difficult to remove from untreated drinking water due to its small size and resistance to commonly used oxidants such as chlorine. Although the routine monitoring of these cysts in water is not recommended, it is necessary to conduct research to detect its presence and to establish suitable guidelines according to our conditions(AU)

National policies for safety of medicines in the Asia Pacific region.

National medicines policies can aid the safe use of medicines by ensuring availability of quality products, appropriate information for prescribers and consumers, strengthening the national medicines regulatory capacity and improving access to expert advice and authoritative laboratory testing. We report the findings of a workshop on medicines safety, which focused on the Asia Pacific region. Participants noted that external support is needed for resource‑poor countries and that national medicines policies should include surveillance on problems with medicines, rather than the more limited monitoring of adverse drug reactions. The latter approach may be the only sensible option in countries in the Asia Pacific with very small populations.

The Origin, Principles of Intense Pulsed Light and Its Proper Application in Clinical Practice / 대한피부과학회지

Intense pulsed light (IPL) is a high-intensity polychromatic incoherent light of a determined wavelength spectrum, fluence, and pulse duration. Clinicians can combine these variable factors of IPL for the purpose of selective destruction of target chromophores. Due to these properties, IPL has been widely used for numerous indications including hair removal and treatment of vascular or pigmented lesions. For skilled and experienced clinicians, IPL is a great treatment modality; however it can be a source of serious adverse effects when performed by untrained clinicians. Thus, to promote the proper and safe use of IPL, we summarized the origin, history, basic principles, and clinical application of IPL and discussed qualification factors needed for clinicians who use IPL.

Awareness of chilli (Capsicum Annuam L.) farmers on safe use of pesticides: a case of crop life India (CLI) project farmers from Guntur District of Andhra Pradesh.

A survey was conducted in six villages in three mandals viz., Tadikonda, Medikonduru and Pedanandipadu in Guntur district of Andhra Pradesh. All the 150 chilli farmers participating in Crop Life India (CLI) sponsored safe use of pesticides and Integrated Pest Management project were taken as sample for the study. It was expressed all the respondent farmers purchasing pesticides from authorised dealers. It was observed from the responses that all the respondents used face/nose mask and about 80 per cent used head dress. No one used hand gloves and shoes. It is interesting to note that no one used recommended personal protection equipment. Recommended personal protection equipments (PPEs) were not used by the farmers but expressed strong desire to use them if available at affordable cost and fit to local environment. Regarding the disposal empty pesticide containers 50 per cent of them bury these in the field and rest are either buried or crushed and thrown in the field. Re-use of empty pesticide bottles was not in practice. About 80 per cent of the respondents used Taiwan sprayers. About 82 per cent of the respondents took bath and 74 per cent changed clothes after spraying pesticide and 82.67 per cent were aware of the colour triangle indication on the pesticide bottles. About 53.33 per cent expressed that they have knowledge on upkeep of the sprayers.

Management of Oxygen and Clinical Safe Use in Our Hospital / 医疗卫生装备

Standardized management and safe-supply system can be enhanced by oxygen chamber management rules,oxygen safe -supply management,daily maintenance of oxygen supply,solutions on common malfunctions and the management of oxygen humidifier. The importance of the management of oxygen is discussed and the regulations should be strictly abided to reduce accident. The oxygen used on clinic can be standardized to ensure the safe-supply.