ABSTRACT
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.
ABSTRACT
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.
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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.