Vulnerable Populations …
Are groups of patients with a high risk for
adverse drug effects
Require careful dosing and/or medication
selection
At-Risk Groups Include
Men and women of reproductive age
Pregnant or breastfeeding women
Children and infants
Elderly patients
People with renal or hepatic disease
Obese or underweight patients
Reproductive Age
In women: Drugs can affect fertility or damage
ova
In men: Drugs can alter sperm quality and alter sperm quality and
quantityquantity
Pregnancy
Pregnancy Categories: A, B, C, D, X
A: Studies in pregnant women have not shown a
risk to the fetus
B: Animal studies have not shown harm to fetus
or animal studies have shown fetal harm, but
studies in pregnant women did not show risk
Pregnancy (Cont’d)
Pregnancy Categories (Cont’d)
C: Animal studies show an adverse effect and
there are no adequate studies in pregnant
women or no animal studies have been
conducted and there are no adequate studies in
pregnant women
Many drugs fall into Category C!
Pregnancy (Cont’d)
Pregnancy Categories (Cont’d)
D: Studies in pregnant women have shown a risk
to the fetus; benefits may outweigh potential
risks
X: Studies in animals and pregnant women have
shown evidence of fetal harm; the drug is
contraindicated in women who are or may
become pregnant
Pregnant Women
First TrimesterFirst Trimester
A woman is least likely to know she is
pregnant
Teratogenic drugs may lead to fetal
malformation or miscarriage
Pregnant Women (Cont’d)
Third TrimesterThird Trimester
Drugs may not be safely metabolized and
excreted by the fetus
After DeliveryAfter Delivery
Infants no longer have the placenta to help with
drug excretion, and drugs given before delivery
may cause toxicity
Pregnant Women (Cont’d)
For pregnant women who require medication, both For pregnant women who require medication, both
mother and fetusmother and fetus must be consideredmust be considered
Weigh risks and benefitsWeigh risks and benefits
Rule of thumb:Rule of thumb:
LOWEST EFFECTIVE DOSELOWEST EFFECTIVE DOSE
for thefor the
SHORTEST PERIOD OF TIMESHORTEST PERIOD OF TIME
Lactation
Many drugs are known or thought to be
excreted in breast milk
Dose in breast milk will be low, but still may
cause adverse effects in the infant
Some drugs interfere with milk supply
American Association of Pediatrics (AAP) lists
drugs usually compatible with breastfeeding
http://aappolicy.aappublications.org/cgi/
content/ full/pediatrics;108/3/776
Lactation (Cont’d)
AAP encourages breastfeeding if drug is
unlikely to cause harm
In poorer nations, bottle feeding may not be
an alternative
Research medication at LactMed
http://toxnet.nlm.nih.gov/cgi-bin/sis/
htmlgen?LACT
Pediatrics
Most drugs given to children <18 years have
not been approved by the FDA for children
Must contain information for SAFE SAFE
PEDIATRIC USEPEDIATRIC USE
Pediatrics: Neonates and Preemies
Difficulty in dosing is secondary to
Immature function of body systems
Rapid weight changes
Progressive maturation of hepatic and
renal function
Pediatric Dosing
Doses for children are not automatically less
than those for adults
Higher metabolic rate in children causes
drugs to be processed more quickly
Higher doses are needed to maintain
therapeutic blood levels
Pediatric Dosing (Cont’d)
Medication doses are based on body weight Medication doses are based on body weight
or body surface area (BSA)or body surface area (BSA)
Body weight doses expressed as mg/kgmg/kg
BSA doses expressed as mg/mmg/m
22
Geriatrics
Adults over Adults over 55 55 have have
↑
↑
risk for toxic reactionsrisk for toxic reactions
Age-related changes affectAge-related changes affect pharmacokinetics
Absorption
Distribution
Metabolism
Excretion
Geriatrics (Cont’d)
Changes that affect pharmacokineticsChanges that affect pharmacokinetics
↑ Percentage of body fat
↓ Lean muscle mass
↓ Total body water
↓
Protein
Geriatrics (Cont’d)
↓ GI motility and blood flow delays
absorption and distribution
↓ Hepatic and renal function delays
metabolism and excretion
Leads to greater incidence of toxicity
Prescribe lowest possible dose at initiation
of drug(s)
Geriatrics (Cont’d)
Monitor for
Signs and symptoms of toxicity and side toxicity and side
effectseffects
Drug interactionsDrug interactions
Usage and complications of OTCs and OTCs and
herbal drugsherbal drugs
Effectiveness
Patients with Renal Disease
Kidneys are the mKidneys are the major organ of drug elimination
Failure to account for decreased renal function Failure to account for decreased renal function
is ais a preventablepreventable source of adverse drug reactionssource of adverse drug reactions
AssessAssess
Creatinine clearance
BUN and creatinine
Medication blood levels
Patients with Liver Disease
The liver is the mThe liver is the major organ of metabolism
The liver changes drugs from fat soluble to water The liver changes drugs from fat soluble to water
soluble so that kidneys can excrete themsoluble so that kidneys can excrete them
Liver damage leads to higher levels of active Liver damage leads to higher levels of active
drug and more toxicitydrug and more toxicity
Patients with Liver Disease (Cont’d)
MonitorMonitor
Liver enzymes
Albumin, total protein
Assess patient forAssess patient for
Enlarged liver
Ascites, jaundice
Obese Patients
Drug dosing often based on body weight
Some drugs do not penetrate fatty tissues
To prevent toxicityTo prevent toxicity when giving drugs that do not
penetrate fatty tissue (e.g., digoxin) determine
dose by ideal body weight or estimated lean
body mass
Patients with Extremes of Body SizePatients with Extremes of Body Size
Underweight Patients
Patients likely to be underweight
Chronic alcoholics
Patients with AIDS
Patients terminally ill with cancer and other debilitating
illnesses
Amputations
No standard formula for calculating dose in
underweight patients — watch for toxicity
Patients with Extremes of Body Size Patients with Extremes of Body Size
(Cont’d)(Cont’d)