Title: Drug safety in pregnancy: Assessment by FDA Safety Rating system and WHO prescribing Indicators
Authors: Arun Paul, Femy Varghese, Mariyet C.J, Nancy Varghese, Meppil Baby
DOI: https://dx.doi.org/10.18535/jmscr/v6i7.91
Abstract
Objectives: To determine the safety, extent of drug use, management of diseases in pregnancy with regard to the WHO prescribing indicators and US FDA safety rating system.
Methodology: A prospective observational study was conducted in St James Hospital, Chalakudy, Thrissur by collecting inpatient’s medical data in the obstetrics and gynaecology departmentover 100 patients for a period of 6 months. Datas were collected by using “Patient data collection proforma” and results were statistically analysed by Pearson chi square test and simple graphical methods.
Results: Majority of the drugs are Category B(50.9%) and C (33.4%).The average number of drugs per prescription was 5.74 (polypharmacy) and percentage of encounters with injections and antibiotics were 76% and 44% respectively.
Conclusion: Drug use was safe and rational as per FDA safety rating and WHO prescribing indicators except for high incidence of Category C drugs, polypharmacy, and increased number of antibiotics and injection per prescription.
Keywords: Pregnancy, US FDA safety rating system, PIH ,GDM, Pregnancy trimesters, WHO indicators
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