Drugs in Special Populations (Pregnancy & Lactation) PDF

Drugs in special population  Drugs and pregnancy No drug should be administered during pregnancy unless it is clearly needed. The rational use of any medication requires a risk versus benefit assessment. All medications should be decreased to the lowest possible effective dose....

Drugs in special population  Drugs and pregnancy No drug should be administered during pregnancy unless it is clearly needed. The rational use of any medication requires a risk versus benefit assessment. All medications should be decreased to the lowest possible effective dose.  Drugs and pregnancy may be one of the following 1. Drug for treatment of the mother 2. Drugs for treatment of fetus during pregnancy. Drugs carry risk for the fetus A. Abortion (loss of fetus). B. Anomalies which may I. Anatomical anomalies: e.g. thalidomide (phocomelia) II. Functional anomalies: e.g. antithyroid drugs causes fetal hypothyroidism.  Medical ethics of prescribing drugs during pregnancy Use well known and proven drug with known side effects. Inform patients about risk of the drug. Avoid polypharmacy Consider benefit risk ratio. Consider risk to the fetus Avoid using drugs during first trimester if possible. Very few drugs are considerably safe and few are definitely teratogenic. When birth defect is observed determine  Pregnancy Categories The FDA-assigned pregnancy categories as used in the Drug Formulary are as follows: Category A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). E.g. folic acid Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in 10/14/2024 6 Category C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. E.g. ciprofloxacin Category D There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits 7 Category X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. E.g. thalidomide 8  Drugs and lactation Factors influencing drug concentration in breast –fed infant 1. Drug related factors – M.W – Lipid solubility – Dose 2. Infant related factors: – Amount of milk ingested (full or partially breast fed). – Decreased hepatic metabolism of drugs. – Greater body water content.  Approach to decrease infant exposure to drugs in breast milk Avoid nursing at times of peak concentration of the drugs in the milk Discontinue nursing for toxic drugs e.g. anticancer drugs Good luck