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.
: Aging Population Trends
Approximately 10,000 baby boomers per day are reaching the age of 65, contributing to the increasing aging population in the US.
Aging in America trends
Seniors 85 years and older are the most rapidly growing age group
Risk Factors for Medication Problems in Older Adults
Presence of comorbid (multiple)
disease states increases vulnerability to medication-related issues.
ex: diabetes, AND high blood pressure.
Sources of Medications in Elderly
Older adults often obtain medications from various sources like mail-order pharmacies, internet sources, OTC products, and herbal/nutritional supplements.
This diverse sourcing heightens the risk of conflicting medications or interactions.
Polypharmacy and Its Risks
- Polypharmacy, or the use of multiple medications, elevates the likelihood of errors like drug-drug or drug-disease interactions.
Patient non-adherence and lack of education
inadequate education about prescribed and over-the-counter medications further contribute to potential issues in this population.
Changes in Aging Bodies
As individuals age, changes in body composition and organ function occur, leading to unpredictable alterations in pharmacokinetics and pharmacodynamics.
Increased Variability with Age
Aging results in greater variability in how medications affect individuals due to physiological changes, making responses to drugs less predictable.
Pharmacokinetic Changes: Absorption
- Gastrointestinal absorption might be delayed in aging; however, the decrease isn’t significant.
Intramuscular absorption
could potentially decrease with age.
transdermal absorption
could potentially decrease with age.
Pharmacokinetic Changes: Distribution
- Fat-soluble medications might exhibit a larger volume of distribution in the elderly.
Protein binding decreases, resulting in an increased free fraction due to reduced albumin levels.
Pharmacokinetic Changes: Metabolism and Elimination
Some metabolic pathways may decrease in efficiency with age.
Renal function
tends to decrease, impacting the elimination of medications in the elderly.
Cockcroft-Gault Equation
Calculation for estimating creatinine clearance:
Cockcroft-Gault Equation For males
CrCl = [(140 - Age) × IBW] / [72 × SCr]
IBW = ideal body weight
CrCl: creatinine clearance
SCr = serum creatinine measured in mg/dL
For females:
CrCl = 0.85 × [(140 - Age) × IBW] / [72 × SCr]
Considerations for Cockcroft-Gault Equation
- Ensure stable renal function for accurate estimation.
If actual body weight (ABW) is less than ideal body weight (IBW), use ABW in the equation.
: Caution in Elderly and Low SCr
Exercise caution in the elderly, particularly if serum creatinine (SCr) is low due to decreased muscle mass, as this may lead to an overestimation of clearance.
What is this patient’s CrCl?
85 yo female, IBW = 141 lbs, Scr = 1.2 mg/dL
CrCl = 0.85 × [(140 - 85) × 141] / [72 × 1.2]
CrCl ≈ 36.2 mL/min
Pharmacodynamics Overview
Pharmacodynamic (P-dynamic) changes are considered when alterations occur despite no explanation from pharmacokinetic changes.
Variability in Pharmacodynamics
P-dynamics exhibit greater variability compared to pharmacokinetics.
Changes in: -Pharmacodynamics
Numbers of receptors
Sensitivity of receptors
Counterregulatory mechanisms are observed.
Prescribing for Older Adults
Consider evidence-based prescribing specifically focusing on research concerning the very old population.
Treatment Evaluation for geriatrics
- Evaluate the risk-benefit ratio of treatment versus watchful waiting or non-pharmacologic approaches.
Functional Changes and Socioeconomic Factors
- Consider functional changes that might affect an older adult’s ability to administer medications or adhere to the prescribed regimen.
: Influence of Advertising
Assess the influence of direct-to-consumer advertising on an older adult’s perception and decisions regarding medications.
Clear Indication for Drug Use; geriatrics
Ensure a precise indication for the medication’s use; consider discontinuation or dose reduction if the indication isn’t clear.
Safety and Efficacy in Older Adults
- Verify if the medication has undergone testing for safety and effectiveness specifically in older adult populations.
Side Effects, Interactions, and Dosage
Consider potential side effects and drug interactions when prescribing for older adults.
Assess if the dosage is appropriate considering an older individual’s physiology.
Establishing Therapeutic Goals for geriatrics
- Define clear therapeutic endpoints for the medication’s use in older adults.
Involvement of Geriatric Pharmacists
- Consider engaging a Board-Certified Geriatric Pharmacist (BCGP) to optimize medication management for older adults.
Beers Criteria
Identifies potentially inappropriate medications for older adults.
explicit criteria
STOPP and START
- STOPP: Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions.
START: Screening Tool to Alert Doctors to Right Treatment.
explicit criteria
Efficacy- geriatric
Evaluate the medication’s effectiveness in older adults.
Side Effects
Consider potential side effects specific to older adults.
: Drug Interactions fro
Assess potential drug interactions with other medications an older adult may be taking.
Disease Interactions for geriatrics-
Evaluate how the medication may interact with specific diseases or conditions present in older adults.
Ease of Administration: geriatrics
Consider the convenience and simplicity of administering the medication to older adults.
Quality of Life
Assess how the medication impacts an older adult’s overall quality of life.
Cost for geriatrics
Consider the affordability and cost-effectiveness of the medication for older adults.
Dosing in Older Adults
“Start low and go slow” approach to dosing is advisable in older adults due to potential sensitivity to medications.
Medication Administration in geriatrics
Avoid extended-release products in patients who can’t swallow whole tablets or need medications crushed due to dysphagia.
Personal Medication Log for geriatrics
Encourage patients to maintain a personal medication log and share it with each of their physicians for better coordination of care.
risk factors for nonadherence:
Prolonged therapy
Need for prolonged therapy for chronic diseases increases the risk of nonadherence.
Multiple Pharmacies
Using multiple pharmacies can contribute to nonadherence due to fragmented medication management.
Dexterity & Sensory Issues
Issues with dexterity or sensory impairments may hinder proper medication administration, impacting adherence.
Cognitive Impairment & Psychiatric Illness
Cognitive impairment or psychiatric illnesses can affect an individual’s ability to adhere to medication regimens.
Multiple Physicians
- Consulting multiple physicians can lead to conflicting medication recommendations, affecting adherence.
Multiple Medications
- Managing multiple medications increases the complexity of the regimen, leading to nonadherence.
: Complicated Dosing Regimens
Complex or multi-step dosing regimens can be challenging to follow, impacting adherence.
: Adverse Effects
Experiencing adverse effects from medications may lead to nonadherence.
Communication with Healthcare Professionals
Ineffective communication with healthcare professionals can lead to misunderstandings affecting medication adherence.
Involving Caregivers/Family
Involving caregivers or family members in education can enhance adherence by ensuring a supportive environment.
: Clear Treatment Goals
Clearly establish treatment goals that the patient comprehends and agrees with to enhance adherence.
Detailed Medication Schedule
- Providing a detailed medication schedule helps patients understand and adhere to their medication regimen.
: Written and Verbal Information
- Providing both written and verbal information about medications aids in better understanding and adherence.
Impairments in dexterity
can be caused by:
Osteoarthritis
Rheumatoid Arthritis
Stroke
Paralysis
Parkinson’s Disease
Peripheral Neuropathy
Amputation
Adaptive Devices for Opening
Medications
like putting the cap on upside-down or a pill bottle opener
R CAP
Traditional push-down-and-turn child-resistant cap.
SNAP CAP
Updated design on the traditional non-lock snap cap, includes an enhanced push-tab.
FUAL-PURPOSE CAP
Can be used as both a push-down-and-turn child-resistant cap and a non-child-resistant cap when turned over. Red liner indicates non-C/R mode.
NON-LOCK TWIST CAP
Taller cap with large indents for easy gripping. It’s a twist-on cap, the easiest non-lock cap available
Devices to help open bottles
Bottle and cap openers
Adherence Aids
dosing boxes, beepers and timers, medication calendars, Administration aids
Dosing Boxes
SMTWRFS boxes
Timers
dispense pills at a certain times
or go off at a certain time
Eye drop guide
rubber stopper sits on the eye
PERSONAL MEDICATION CALENDAR
keep track in a written schedule
common age-related impairments in vision:
Presbyopia
Cataracts
Macular degeneration
Retinopathy
Glaucoma
Detached Retina
Which tablet is orange?
if a patient has an vision impairment, they may not be able to tell the diff. between their pills
Large print
manufacturers can increase the font size of warnings
Blood glucose monitors
prick test to test for blood sugar
blood pressure
cuff to test blood pressure
Talking Prescription Vials & Labels:
Spoken Rx & Scriptalk
There is a voice instructing the patient to take their meds
TTDs (Telecommunication Devices for the Deaf)
Devices that enable individuals with hearing impairments to communicate over the phone through text.
TTYs (Text Telephones)
Also known as text telephones, these devices allow individuals with hearing loss to communicate by typing and reading text on a screen.
Sign Language Interpreters
Professionals who facilitate communication between deaf/hearing-impaired individuals and others by interpreting spoken language into sign language and vice versa.
Texting
Written communication via mobile phones or other devices, enabling quick and effective interaction for individuals with hearing impairments.
Lip Reading
Technique used by individuals with hearing impairments to understand speech by observing the speaker’s lip movements and facial expressions.
Pocket Talkers
- Portable amplification devices that assist hearing-impaired individuals in hearing speech more clearly by amplifying sound
ethnic Factors in Drug Response
Understand how ethnicity influences drug metabolism, responses, lifestyle practices, and health care attitudes among different ethnic subgroups.
Cultural Competence
strategies and awareness aimed at understanding and respecting diverse cultural backgrounds, fostering sensitivity, and showing humility in interactions.
interaction with Diverse Colleagues & Patients
Enhancing communication and understanding while interacting with colleagues and patients from diverse ethnic backgrounds.
Health Equity and Disparity Reduction
Increasing awareness of health disparities among various ethnic groups and striving to reduce these disparities to promote health equity for all.
Cultural Awareness in Pharmacy
Recognizing ethnic differences is vital for pharmacists to optimize drug selection, adjust dosages, provide effective adherence counseling, and monitor for potential adverse effects.
Polymorphism
genetic factors which determine
normal differences in drug response
Gender-Affirming Hormone Therapy
When dealing with patients on gender-affirming hormone therapy for over six months, consider calculating creatinine clearance (CrCl) and ideal body weight (IBW) based on their gender identity for appropriate medication dosing.
Cultural Competence
Cultural competence in healthcare involves recognizing, understanding, and respecting differences without stereotyping, requiring a blend of knowledge, attitude, and skills for effective patient care.
Communication
pharmacists can enhance communication by learning basic phrases in languages common among clients, fostering understanding and demonstrating interest. Knowing phrases like “I don’t understand” or “speak slower please” can aid communication. Awareness of community resources allows for effective referrals when needed.
Non-Verbal Communication
Understanding cultural differences in nonverbal cues like eye contact, personal space, and facial expressions can prevent misinterpretation and help avoid judgment during interactions with clients from diverse backgrounds.
Cultural Variations in Facial Expressions
In certain cultures, nodding or saying “yes” may signify politeness, not necessarily agreement or comprehension. Encouraging patients to reiterate information ensures mutual understanding despite potential cultural differences in nonverbal cues.
Strategies for Cultural Competence / Sensitivity
Understand your own culture. 2. Learn about the cultures you serve. 3. Show genuine interest through open-ended questions. 4. Acknowledge differences without stereotyping. 5. Create a welcoming environment reflective of clients’ cultures. 6. Collaborate to tailor treatments to cultural beliefs and needs.
Enhancing Cultural Competence
- Employ culturally sensitive educational tools. 2. Learn key phrases from predominant non-English speaking groups. 3. Recognize community-specific resources. 4. Offer referral materials. 5. Use trained interpreters for language barriers. 6. Utilize pictograms for clearer communication.
