| ABSTRACT Objective:To understand the relationship between the drugs produced in Shaanxi province and its adverse drug reactions and the variation tendency in 2012 2014. Which provided proof for drugs production, drugs surveillance and clinical rational drug use. Methods:Analyse 81 585 adverse drug reaction reports of the drugs produced by the drug manufacturers in Shaanxi province during 2012 to 2014 from the basic situation, severity, sources of the report, gender and age, involving system, etc. Results:214 pharmaceutical production enterprises and about 1 500 drugs were involved in all reports: ①The drug combination reports increased apparently. ②The new and severe reports increased rapidity. ③There were more female patients and the quantity of female reports to be rising, and the patients 0 to 6 increased slightly and 50 years of age or older increased rapidity. ④Adverse drug reactions mainly do harm to gastrointestinal system, skin and its accessories, central and peripheral nervous system, etc. ⑤Chemicals drugs accounted for more than 80%, Chinese patent drugs accounted for more than 17%. The proportion of anti infective agents among chemicals decreased year by year; the dosage forms are mainly tablet, injection and capsule, its administration route is mainly orally, injection and drug delivery. Conclusion:The quantity of adverse reactions reported increased with good overall situation. The trend of rising of the “new” and “serious” report number was obvious. But there were still some shortcomings: The “new” and “serious” report number was not meeting the requirements of the WHO. The number of ADR reported by the enterprise had a strikingly low proportion. The sex ratiowere similar and population of aging was growing. A few large and medium enterprise had a high proportion of ADR report. The oral and injection were the main cause of the route of medication of ADR. And the injected might be associated with the usage of the antibiotic. |
