ABSTRACT
To provide prevention and control strategies of occupational exposure risks to cytotoxic drug in medical institutions， improve the awareness of protection among medical staff，and reduce potential occupational exposure risks，the Guidelines for the Prevention and Control of Occupational Exposure Risk to Cytotoxic Drugs in Medical Institutions is developed. Based on the World Health Organization Guidelines Development Manual，the exposure risk issues of the cytotoxic drug collected from the time that it entered the hospital to the several stages after delivery to hospital，such as transportation，receipt，storage，unpacking，dispensing，use of finished products，and waste disposal. Delphi method is used to construct identification of clinical issues，and evidence-based research method is used to develop relevant evidence. Quality evaluation is conducted by using the recommended GRADE method. The consensus is reached on the recommendation opinions and evidence levels through expert consensus method. By combining engineering controls，administrative controls and personal protective equipment at different levels，a graded control approach is established. A total of 37 clinical issues are identified，resulting in 36 recommendations. This guideline provides reference and supplementation for the formulation of cytotoxic drug prevention and control measures in medical institutions.
ABSTRACT
OBJECTIVE：To investigate the situ ation and characteristics of ADR reports in the elderly patients （≥65 years old ） of Sichuan province ，and to provide reference for guaranteeing the safety of drug use. METHODS ：ADR reporting data of elderly patients collected by spontaneous reporting system of Sichuan ADR monitoring center from 2013 to 2019 were collected ，and then analyzed in respects of report types ，reproting institution ，relationship，patienst’age，gender，nationality，drug type ，organ/system invovled. RESULTS & CONCLUSIONS ：In the past seven years ，175 431 cases spontaneous ADR were collected by Sichuan ADR monitoring center ，and the annual proportion of “general”ADR reports decreased from 78.93％ in 2013 to 60.50％ year by year ； the annual proportion of “new general ”and“serious”ADRs increased year by year ，among which that of “new general ”ADR increased more obviously. The main reporting institutions were medical institutions ，accounting for 92.79％-98.87％ of the total annual reports. The enthusiasm of enterprises and individuals to report ADR needed to be improved ；8 031 cases（4.58％）were “positive”relationship，21 283 cases（12.13％）were“likely”，146 117 cases（83.29％）were“possible”. Except that the gender of 272 cases were not reported ，there were 88 176 male cases and 86 983 female cases ；most of them were 65-74 years old （104 962 cases，59.83％）. The reports covered 19 nationalities，among which the re were 166 752 cases（98.72％）of Han nationality. The distribution of ADR related drug categories in elderly patients of Yi ， Tibetan and Qiang nationalities was significantly different from that of Han nationality （P＜0.01）. The top three drug categories in the total frequency were anti-infective drugs （31.10％），traditional Chinese medicine com （18.27％），and central nervous system drugs （9.99％）. The injection route was the most likely to cause ADR （72.12％）. ADR mainly involved s kin and its appendants （21.47％）， gastrointestinal system （19.61％）and central and peripheral nervous system （18.55％）. Aminophylline injection was the only dr ug in the top 10 drugs leading to “new general ”ADR for consecutive 7 years. Cefotaxime sodium for injection ，Ceftriaxone sodium for injection ，Cefoperazone sodium and sulbactam sodium for injection were the top 10 drugs causing “severe”ADR in consecutive 7 years，which should be paid more attention in clinic.