Prescription Analysis and Risk Category Assessment of Drugs Prescribed during Pregnancy in a Tertiary Care Center as per USFDA Classification

摘要

Objective:To carry out prescription analysis and assign risk category as per USFDA(United States Food and Drug Administration)to prescribed drug during pregnancy in a tertiary health care center at Raipur,Chhattisgarh.Method:This cross-sectional study was carried out over the period of 2 months in obstetric OPD(outpatient department)at tertiary health care center Raipur.Pregnant woman of any trimester was recruited from ANC(antenatal clinic)after obtaining informed written consent.Important information collected was demography,gravida,parity,trimester of pregnancy,reason for visit to clinic,history of any chronic illness,names of drugs prescribed with their doses and frequency of administration.Prescription analysis was carried out and USFDA risk category had been assigned to each of the drug.Results:Total 340 drugs were prescribed for 75 patients.And 51.43%pregnant women were from 3rd trimester of pregnancy.Most of pregnant women(92.86%)reported to OPD for regular ANC checkup.Prescription analysis shows that average number of drugs prescribed during pregnancy was 4.52 per prescription.Average FDCs(fixed dose combinations)prescribed were 1.64 per prescription.Vitamins and minerals FDCs(82.4%)were commonly prescribed FDCs.As per USFDA risk category,prescribed drugs were A(73.83%),B(18.82%),C(7.06%)and D(0.29%)respectively.Antimicrobials were prescribed in 25%pregnant women and commonly prescribed antimicrobial was nitrofurantoin(13.33%)for urinary tract infection.Conclusions:More than four drugs are prescribed in pregnancy.Drugs required to specifically treat associated health problems belong to category B which can be considered safe in pregnancy.Different class of drug though not labelled indication(off-label)needs to be prescribed as per treatment guideline to prevent the pregnancy loss and prevent post-partum complications.