Population Specific Considerations in Drug Therapy Flashcards
Specific Populations
-Racial & Ethnic Minorities
-Transgender & Gender-Diverse Persons
-Rural Americans
-People with Limited English Proficiency
-Military Veterans
-Pediatrics
-Geriatrics
congenital defects
refers to the major and minor malformations either in structure OR in function that deviate from the norm
may be genetic, unknown factors, environmental ( 3% drugs and chemicals) - Prevalence depends on how the data is collected and reported.
Teratogen
an agent that is present during critical periods of development and is able to produce a congenital defect.
These can include chemicals, medications, infections, and physical agents.
-Susceptibility to the embryo depends upon the developmental stage
-Teratogens may not affect the maternal organism
-Agents that may cause malformations may also increase embryonic mortality
stages of pregnancy
First Trimester 0 – 12 weeks
Week 5 – development of neural tube
Week 6 – development of heart & major blood vessels
Week 7 – development of arms & legs
Week 9 – Bones and muscles form; Face & neck develop, brain waves detected; skeleton formed, fingers and toes fully defined
Week 10 – Kidneys begin to function; almost all organs completely formed;
- Week 3-8 fetus is most vulnerable to birth defects.
Drugs taken after organs are formed may not cause defects, but may alter growth and function of organ
what weeks is baby most vulnerable to birth defects
3-8 weeks
Second Trimester 13-24 weeks
Week 14 – fetus can hear
Week 16 – fingers can grasp; body begins to fill out as fat is deposited beneath skin; hair appears on head and skin; eyebrows and eyelashes present
Week 20 – placenta fully formed
Week 24 – fetus has a chance of survival outside of uterus
Third Trimester 25 weeks to delivery
Week 25 – lungs continue to mature;
Delivery - 37 to 42 weeks
blood transfer to fetus from mother
Some of the fetus’s blood vessels are contained in tiny hairlike projections (villi) of the placenta that extend into the wall of the uterus.
The mother’s blood passes through the space surrounding the villi (intervillous space).
Only a thin membrane (placental membrane) separates the mother’s blood in the intervillous space from the fetus’s blood in the villi.
Drugs in the mother’s blood can cross this membrane into blood vessels in the villi and pass through the umbilical cord to the fetus.
Category A –
(SAFE)
Adequate and well CONTROLLED studies have FAILED to demonstrate a risk to the fetus in the FIRST trimester and no evidence of risk in later trimesters
NO FETAL RISKS
CATEGORIES ARE THE FORMER USE BY FDA
Category B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are NO adequate and well-controlled studies in pregnant women
animal studies show NO RISK TO FETUS
NO human studies done
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
-animals study show RISK
-NO human studies
-only use if the potential benefits is greater than the potential risks
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 may warrant use of the drug in pregnant women despite potential risks
- there is evidence of risk of human fetal risk, only use if the potential benefits is greater than the potential risks
Category X –
Studies in animals or humans have demonstrated fetal abnormalities and/or there positive evidence of human 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 the potential benefits
-animal or human studies show risk of fetal human develop
-risks outweighs benefits
Current FDA Pregnancy & Lactation: Labeling Rule
no risk categories
PI sections for: pregnancy and lactation
CONTACT INFO on pregnancy registry
All pregnancies have a background risk of birth defect, loss, or other adverse outcome regardless of drug exposure. The fetal statement risk summary below describes (name of drug) potential to increase the risk of developmental abnormalities above the background risk.”
current rule: 3 sections
Risk Summary:
-Probability of adverse outcome
-If only animal data are available, risk is categorized as none, low, moderate, high or unknown.
- Clinical Considerations
-Information for prescribing
-Consequences of not treating the mother’s condition
3.Data
-Detailed discussion of clinical trials or studies
current lactation section
Same format as pregnancy section
Must state information such as:
-Amount of drug in breast milk and potential effect on infant
-Ways to minimize exposure in the breast-fed infant
If drug is undetectable in breast milk and doesn’t affect the quantity or quality of breast milk or does not adversely affect the breastfed child, then the label states:
“The use of (name of drug) is compatible with breastfeeding.”
New/Current Section on Reproductive Potential
-Need for pregnancy testing or contraception when on the medication
-Potential for infertility both for men and women
Lactation/ Breast-Feeding WomenGoals of Therapy
Avoid drug use in nursing women if possible – when medications are essential then:
Generally if the medication is safe for use in the infant it can usually be administered to the mother
Choose a drug that is not excreted into the breast milk
Alter time of drug regimen to allow mother to nurse BEFORE taking medications – and or allow large amounts of time between medications and nursing
If mother must discontinue nursing for a limited time- breast milk can be extracted before starting treatment and stored for use during treatment period.
Pregnancy & Lactation Resources
TEXTBOOKS:
Briggs: drugs on pregnancy and lactation
Shepard: Catalog of Teratogenic Agents
DATABASES:
TERIS – (Teratogen Information System) online version of Shepard’s book
LactMed -– free, online, reputable, data US NLM/TOXNET
Journals/ Case reports
Motherrisk – website/ hotline
FDA reports/ Drug
Manufacturers
LexiComp
General Pediatric Pharmacy Objectives
Understand how children differ from adults
Importance of clinical presentation
Pharmacokinetic / pharmacodynamic differences
Dosing strategies
Appropriate medication formulations
Medication administration devices
Counseling parents
Clinical presentation
Children may not be able to talk or describe their symptoms thus we should be familiar with clinical presentation for common pediatric disorders
Sepsis/Meningitis:
- temperature instability, feeding intoleranace, lethargy, grunting, flaring, retractions, bulging fonatnelle, seizures
RSV infection:
- wheezing, lethargy, irritability, poor feeding, apnea
Otitis Media: ear pain,
-inflammation of middle ear with or without bulging tympanic membrane, purulent fluid within middle ear
Pediatric Considerations
Pharmacokinetic and pharmacodynamics of medications differ in children vs. adults
Absorption, distribution, metabolism and elimination vary with age
Body composition changes with age
As a result of these differences, dosing strategies for children are different from adults
Pediatric Dosing
dosing in children less than 12 yo (function of age and body weight)
Dosing is predominantly weight based (mg/kg)
General Rule: use weight based dosing up to 40kg
If weight based dosing exceeds adult dosing, defer to adult dosing
Do NOT confuse mg/kg/DOSE versus mg/kg/DAY
Remember to convert pounds (lbs) into kg
2.2lbs = 1 kg
Dose frequency in children may not be the same as in adults
Certain medications should be avoided in Children
Reye’s syndrome is sudden brain damage:
(encephalopathy) and liver function problems of unknown cause
Reye’s has occurred with the use of aspirin to treat chickenpox or the flu in children, therefore
Aspirin is no longer recommended for routine use in children especially with flu or viral like symptoms
Anti-Infective Drugs Advisory Committee that the fluoroquinolones (ex. Ciprofloxacin) cause irreversible joint damage in the pediatric population
