| ObjectiveBased on the analysis of the overall quantity and quality of the contraceptive adverse reaction database,the quality of the case report form is further assessed.The research is due to explore the overall availability of the report and the situation of the contraceptive drug monitoring in Jiangsu province during the research period,so that to improve the monitoring level of adverse drug reaction of contraceptive drugs.MethodsAfter the overall analysis and relationship assessment of the 3,384 contraceptive adverse reaction reports collected from the monitoring centre from 2008 to 2016,339(10%)reports were scored by stratified random sampling according to the reporting year,including all serious reports.The adverse event reports were recorded in the Epidata database after scored.And it was analyzed by SAS 9.3 software after double alignment.The distribution of adverse reaction reports from annual,nature,source,adverse reaction type and loss points of the reports were described by the composition ratio index and x~2 test with test level of 0.05.Results1.The overall situation: The monitoring centre collected 3,384 reports of adverse drug reactions from 2008 to 2016 overall,involving a total of 5 categories of 32 contraceptive drugs,39 adverse effects,involving 15 organs or systems.Among them,there were 8 severe adverse reactions,1 new severe adverse reaction,94 new general adverse reactions and 3 general adverse reactions.The proportion of adverse drug reactions of general report was always far higher than serious and new reports from2008 to 2016(x~2=82.99,P<0.001).The proportion of adverse drug reactions from family planning agencies is always far higher than which was from medical institutions from 2008 to 2016(x~2=1193.11,P<0.001).The age group of 30 ~ 39 years old was more likely to get adverse reactions when using contraceptive drugs.There was no significant difference in the number of oral contraceptives and other contraceptive drugs in menstrual problems(c 2=3.484,P>0.05).The proportion of unwanted pregnancies using emergency contraception was significantly higher than that of short-effect oral contraceptives(c 2=2289.647,P < 0.001).The proportion of facial pigmentation and hyperlipidemia using long-acting oral contraceptive is much higher than that of short-effect oral contraceptives(x~2=44.671,P<0.001;x~2=24.025,P<0.001).2.Relationship assessment: There was no significant difference in the relationship assessment between severe and general contraceptive adverse drug reactions(x~2=2.854,P=0.240).The number of adverse reaction reports of the relationship assessment about external anti sperm agent was higher than that of other contraceptive drugs(x~2=122.940,P<0.001).3.Report quality evaluation: The score of 2014 ~ 2016 group is significantly higher than the 2008 ~ 2010 group(c 2=8.691,P=0.013)and 2011 ~ 2013 group(c 2=28.034,P < 0.001).There was no significant difference between the groups of2008 ~ 2010 and 2011 ~ 2013(c 2=4.049,P=0.132).It can be concluded that The quality of contraceptive adverse reaction reports in the past three years(2014~2016)was significantly improved.There was no significant difference between the scores of severe and general contraceptive adverse reaction reports(c 2=1.074,P>0.05).There was no significant difference in the number of forms about normative and integrity scores(c 2=0.894,P>0.05).The main problems in the normative aspects are that the report form exceeds the specified reporting time limit,the batch number and the approval document number are missing,and the drug adverse reaction name is not standardized.The main problem in the aspect of integrity is incomplete description of the adverse drug reaction process,which contains the physical signs of adverse drug reactions,auxiliary examination,gravida and para,follow-up situation and measures to intervene the time of adverse drug reactions.99.12% reported the lack of identity card number,women of childbearing age coding,weight,contact method,hospital name,medical record number,outpatient number and the report person's job or title.Serious and new reports are lack of records of disease course,medical orders,or other relevant medical records.Conclusion1.The proportion of adverse drug reactions of general report was always far higher than serious and new reports from 2008 to 2016.The proportion of adverse drug reactions from family planning agencies is always far higher than which was from medical institutions from 2008 to 2016.2.The proportion of unwanted pregnancies using emergency contraception was significantly higher than that of short-effect oral contraceptives.The proportion of facial pigmentation and hyperlipidemia using long-acting oral contraceptive is much higher than that of short-effect oral contraceptives.3.The number of adverse reaction reports of the relationship assessment about external anti sperm agent was higher than that of other contraceptive drugs.4.The quality of contraceptive adverse reaction reports in the past three years(2014~2016)was significantly improved.5.The quality of contraceptive adverse reaction reports remains to be improved on the normative and integrity aspects. |
PDF Full Text Request