Population Specific Drug Therapies: Dr.Beizer Flashcards
Teratogen defintion
A teratogen is an agent present during critical developmental periods that can cause congenital defects in embryos
developmental Stage Susceptibility
The impact of teratogens depends on the embryo’s developmental stage during exposure.
Maternal Impact
Teratogens might not affect the mother but can cause defects in the developing embryo.
Teratogens and Embryonic Mortality
Agents causing malformations might also increase embryonic mortality.
Congenital Defect Definition
Congenital defects refer to major or minor malformations, deviating from the norm in structure or function.
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 are completely formed
Fetal Vulnerability occurs when?
Weeks 3-8 are the most vulnerable to birth defects; Later exposure might not cause structural defects but can affect organ growth and function.
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
Category A drugs during pregnancy:
FORMER
Adequate studies show no risk to the fetus in the first trimester and no evidence of risk in later trimesters.
Category B drugs during pregnancy
FORMER
Animal studies show no risk, but there are no adequate studies in pregnant women.
Category C drugs during pregnancy
FORMER
Animal studies suggest adverse effects on the fetus, but there are no adequate studies in humans; the benefits might outweigh potential risks for pregnant women.
Category D drugs during pregnancy
FORMER
Positive evidence of human fetal risk exists based on adverse reactions from studies; benefits might still justify use despite potential risks.
Category X
FORMER
Studies in animals or humans have shown fetal abnormalities or positive evidence of human risk based on data; the risks of using the drug in pregnant women outweigh potential benefits.
FDA Labeling Rule Update
NOW
Eliminates letter risk categories, introduces separate sections for pregnancy and lactation in Prescribing Information (PI), and includes contact information for pregnancy registries if available.
Standard risk Statement
The standard statement emphasizes that all pregnancies carry a background risk of birth defects or adverse outcomes, irrespective of drug exposure. The drug’s fetal risk summary describes its potential to elevate developmental abnormality risk above the background level.
Each section contains 3 core elements
Each section comprises three core elements: Risk Summary, Clinical Considerations, and Data.
Risk Summary
: Includes the probability of adverse outcomes; if only animal data are available, risk is categorized as none, low, moderate, high, or unknown.
Clinical Considerations
Provides information for prescribing and outlines the consequences of not treating the mother’s condition.
Data Section
Contains a detailed discussion of clinical trials or studies related to the drug’s effects during pregnancy or lactation
Exception for OTC Products
These rules do not apply to over-the-counter (OTC) products; their labeling might differ in content and structure regarding pregnancy and lactation information.
Lactation Section Format
The format of the lactation section mirrors that of the pregnancy section, detailing specific information.
Required Information
: Details in this section must include the amount of drug in breast milk, potential effects on the infant, and methods to minimize exposure to the breastfed infant.
Labeling for Compatibility
If the drug is undetectable in breast milk or does not affect its quantity or quality, nor adversely impact the breastfed child, the label states: “The use of (name of drug) is compatible with breastfeeding.”
Reproductive Potential Section
Contains necessary information such as the need for pregnancy testing or contraception while on the medication.
Infertility Considerations
Addresses the potential for infertility, both in men and women, if applicable to the drug’s effects.
Example: Pregnancy, Lactation, &
Reproductive Potential Labeling (just to know)
8.1 Pregnancy Risk Summary Based on animal data
showing adverse renal effects, JARDIANCE is not
recommended during the second and third trimesters of
pregnancy.
8.2 Lactation Risk Summary There is no information
regarding the presence of JARDIANCE in human milk, the
effects of JARDIANCE on the breastfed infant or the effects
on milk production. Empagliflozin is present in the milk of
lactating rats [see Data]. Since human kidney maturation
occurs in utero and during the first 2 years of life when
lactational exposure may occur, there may be risk to the
developing human kidney.
Goals of Therapy for Breastfeeding Women
Avoid drug use in nursing women if possible – when
medications are essential then we should consider a few things like
Prefer medications safe for the infant when excreted in breast milk. or
Choose drugs not excreted into breast milk if available.
Time Alteration Strategy
Adjust the drug regimen timing to allow the mother to nurse before taking medications or create a substantial time gap between medication and nursing sessions.
Temporary Discontinuation
If nursing must cease temporarily, extract breast milk before starting treatment and store it for later use during the treatment period.
Pregnancy and lactation resources (mostly vibes)
Briggs – Drugs on Pregnancy & Lactation (*Updated quarterly)
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
Children’s 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
Pharmacokinetic Differences for children vs adults
absorption, distribution, metabolism, and elimination of medications vary with age, impacting drug effects in children compared to adults.
Body Composition Changes for dosing
Changes in body composition with age influence how drugs are processed and utilized in children versus adults.
Dosing Strategies for children
Due to these differences, dosing strategies for children differ significantly from those for adults to ensure appropriate medication effects and safety.
Babies and children have more ___ than adults and elders?
More water
Pediatric Dosing
dosing in children under 12 years depends on age, body weight, or both.
Weight-Based Dosing
A general rule: use weight-based dosing up to 40kg.
If weight-based dosing exceeds adult dosing, rely on adult dosing instead.
Clarity in Dosage
caution: differentiate between mg/kg/dose and mg/kg/day.
Remember to convert pounds (lbs) to kilograms (kg) (1 kg = 2.2 lbs).
Dose Frequency Variations
- Dose frequency in children might differ from that in adults due to age-related factors or physiological differences.
(math lowkey makes no sense)
beizer said no math or dosing questions are coming from her slides #hope thats true
Pediatric Dosage Forms
Children may struggle to swallow tablets; consider using liquids, solutions, or ODTs for easier administration.
Flavors can be added to liquid medications for improved palatability using products like Flavor RX or Tasty Meds.
Medication Administration Devices
Utilize appropriate medication administration devices suitable for pediatric use to ensure accurate dosing and administration.
Sometimes, it may be necessary to compound a liquid formulation from tablets to suit the child’s needs.
Pediatric Medication Administration Devices
Measuring spoons, oral syringes, and droppers are commonly used for accurate dosing in children
Dosing Errors in Parents
in a study, 83.5% of parents made at least one dosing error in selecting the correct syringe size is crucial for accurate dosing.
Use of Pictograms
Pictograms significantly assisted parents in accurately measuring medication doses for their children.
Advice for Counseling Parents
- When discussing liquid medications, describe doses in milliliters (mL) rather than teaspoons or tablespoons for accuracy.
Why are crushed medications not favored?
Crushed tablets can have an unpleasant taste.
advice for parents administering their children medication
When mixing with applesauce or pudding, ensure only a spoonful is used to guarantee complete administration.
Avoid referring to medicine as candy or playing with it to prevent confusion.
Address what to do if a child spits out or vomits the medication.
Safety Tips for Administering Medications
Avoid administering medications in the dark to ensure accuracy and safety.
Instructing Caregivers with dosing
never estimate a dose or perform conversions; seek guidance from a pharmacist for accuracy.
Record Keeping
Patient should maintain a medication administration record to track when doses were given, avoiding the risk of overdosing or underdosing.
- The Poison Prevention Act of 1970
mandated child-resistant closures on medications, enhancing safety for children.
Since 2011, over-the-counter (OTC) acetaminophen and prescription liquids are equipped with ___ to prevent overdoses?
“flow restrictors” for safer dosing to prevent accidental overdoses.
How to explain doses?
Avoid the terms teaspoon or tablespoon. Use mL for
doses.
Safe Medication Storage
Emphasize safe storage of medications at home.
“keep it stored Up and Away”
Healthy People 2030 goal ?
35% reduction in
pediatric medication overdoses
Age Categories in Geriatrics
- Older adults/elderly are typically individuals aged 65 years or older.
Subcategories include young-old (65-74 years), old-old (75-84 years), and very-old old (85+ years).
what is the Geriatric Population in the US
Currently, there are over 54 million individuals aged 65 years or older in the United States.
Projections estimate that by 2030, nearly 1 in 5 residents in the US will be aged over 65.