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Practice and Effect Evaluation of Drug Reorganization in Patients with Chronic Obstructive Pulmonary Disease
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作者 Peng Yan Laiji Zhou +1 位作者 Chunwang Hua Ping Gan 《Journal of Clinical and Nursing Research》 2021年第5期130-135,共6页
Objective:To explore the feasibility of drug reorganization in clinical practice through the drug reorganization service of clinical pharmacists for patients with chronic obstructive pulmonary disease(COPD)in respirat... Objective:To explore the feasibility of drug reorganization in clinical practice through the drug reorganization service of clinical pharmacists for patients with chronic obstructive pulmonary disease(COPD)in respiratory and critical care department,and to evaluate the effect of the service in multiple dimensions.Methods:a total of 100 patients with COPD admitted from January to July 2021 were randomly divided into two groups with 50 patients in each group.One group was treated with drug reforming intervention and the other group was not treated with intervention.Statistics and data analysis were carried out from three aspects:patient compliance,satisfaction and medication deviation.Results:(1)compliance:48h after admission,there was no significant difference between the two groups(P>0.05);According to the data statistics on the day of discharge and after one month,the compliance of the two groups was statistically significant(P<0.05),which was higher in the reorganization group.(2)Satisfaction:There was no significant difference between the two groups after admission.However,after drug reforming intervention by pharmaceutical staff,the results of reforming group were better and statistically significant(P<0.05).(3)Medication deviation:There were 50 deviations in the reorganization group,of which drug omission accounted for 52%,which was the main factor.After communicating with clinicians,the clinicians5 acceptance rate of the reorganization scheme reached 94.12%.Conclusion:The implementation of drug reorganization service can effectively prevent the medication deviation of COPD patients,save the cost of patients,improve the satisfaction and compliance,and ensure the medication safety of patients. 展开更多
关键词 drug reforming Compliance SATISFACTION Medication deviation
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Integrating traditional Chinese (herbal) medicines into risk based regulation-With focus on non-clinical requirements to demonstrate safety 被引量:2
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作者 Vivian S.W.Chan Fung 《Journal of Traditional Chinese Medical Sciences》 2020年第2期88-94,共7页
Within the public health sector of Hong Kong(China),there is a consensus around the important role of traditional Chinese medicines.For Hong Kong(China)to play a bridging role to bring Chinese medicines to the global ... Within the public health sector of Hong Kong(China),there is a consensus around the important role of traditional Chinese medicines.For Hong Kong(China)to play a bridging role to bring Chinese medicines to the global market requires a concerted effort from the government,academic institutes and industries.The release of the final version of the European Medicines Agencies guidance document,which details the acceptance of minimum requirements to nonclinical package in bibliographical applications,grants the opportunity for well-established and traditional herbal medicines to demonstrate an‘acceptable safe’status for registration in the European Union.It is anticipated that this minimum nonclinical package can be applied to demonstrate the safe use of many traditional Chinese medicines regardless of their eligibility to be registered under the simplified procedure within the European Union.This paper conceptualizes an integration of a simplified evaluation route for eligible proprietary Chinese medicines(pCm)with long history of use into the existing drug regulatory framework in Hong Kong(China).Such integration utilizing the minimum nonclinical package,based on bibliographical data or expert report,as proof of evidence to demonstrate safety for pCm with long history of use requires less demand in scientific resources.With Hong Kong(China)conducting‘first hand’review for eligible pCm,it provides an option for overseas and local pharmaceutical companies to register their products in Hong Kong(China)without the need to rely on issuance of Certificate of Pharmaceutical Product from other countries.This could bring eligible pCm with long history of use to reach international risk-based standard and to be marketed globally as‘medicines’to reach their full therapeutic potential.An important process to positioning Hong Kong(China)to compete with other countries in promoting importation and exportation of pCm to better serve the global health. 展开更多
关键词 Proprietary and traditional Chinese herbal MEDICINES INTERNATIONALIZATION NONCLINICAL drug regulation and registration reform Certificate of pharmaceutical product
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