Chp 3-4 Infants & Elderly/Cultural, Legal, Ethical Flashcards
During pregnancy, how do drugs cross the placenta?
by diffusion
When is drug transfer to the fetus most likely to occur?
during the last trimester of pregnancy
When is exposure of the fetus to drugs most detrimental?
during the first trimester of pregnancy
When is the fetus at greatest risk for drug-induced developmental defects?
during the first trimester of pregnancy
Can/should a women take high blood pressure medication during pregnancy?
Yes women need to take medications to control situations such as high blood pressure.
A patient younger than 38 weeks gestation is classified as what?
premature or preterm infant
A patient younger than 1 month is classified as what?
neonate or newborn infant
A patient age 1 month up to 1 year is classified as what?
infant
A patient age 1 year up to 12 years is classified as what?
child
Neonatal/pediatric Pharmacokinetics - Absorption considerations:
- gastric pH less acidic
- gastric emptying slowed
- intramuscular absorption faster and irregular
Neonatal/pediatric Pharmacokinetics - Distribution considerations:
- greater total body water means lower fat content
- decreased level of protein binding
- immature blood-brain barrier (more drugs enter the brain)
Neonatal/pediatric Pharmacokinetics - Metabolism considerations:
- liver immature, does not produce enough microsomal enzymes
- older children may have increased metabolism, requiring higher doses than infants
- other factors such as status of liver enzyme production, genetic differences, and substances to which the mother was exposed during pregnancy.
Neonatal/pediatric Pharmacokinetics - Excretion considerations:
- kidney immaturity affects glomerular filtration rate and tubular secretion
- decreased perfusion rate of the kidneys may reduce excretion of drugs
What are the factors that affect pediatric drug dosage?
- skin is thin and permeable
- stomach lacks acid to kill bacteria
- lungs have weaker mucus barriers
- body temp less well regulated, and dehydration occurs easily
- liver and kidneys are immature, impairing drug metabolism and excretion
What are the methods of dosage calculation for pediatric patients?
- body surface area method (uses West nomogram)
- always use weight in kilograms, not pounds
- body weight dosage calculations (uses mg/kg)
When prescribing medications, what are the considerations for elderly patients (over 65)?
- high use of medications
- polypharmacy
- noncompliance, nonadherence
- increased incidence of chronic illnesses
- sensory and motor deficits
What is polypharmacy?
the use of a large number of medications, commonly considered to be the use of five or more.
Elderly Pharmacokinetics - Absorption considerations:
- gastric pH less acidic
- gastric emptying slowed
- movement through GI tract slowed
- blood flow to GI tract reduced
- use of laxatives may accelerate GI motility
Elderly Pharmacokinetics - Distribution considerations:
- lower total body water percentages
- increased fat content
- decreased production of proteins by the liver, resulting in decreased protein binding of drugs (and increased circulation of free drugs)
Elderly Pharmacokinetics - Metabolism considerations:
- aging liver produces fewer microsomal enzymes, affecting drug metabolism
- reduced blood flow to the liver
Elderly Pharmacokinetics - Excretion considerations:
- decreased glomerular filtration rate
- decreased number of intact nephrons
What are problematic medications for the elderly? (8)
- analgesics, including NSAIDs and opioids
- anticoagulants
- anticholinergics
- antidepressants
- antihypertensives
- cardiac glycosides (digoxin)
- sedatives and hypnotics, CNS depressants
- thiazide diuretics
What three areas can the factors that contribute to the safety or potential harm of drug therapy during pregnancy be broken down into?
- drug properties
- fetal gestational age
- maternal factors
drug polymorphism
the effect of a patient’s age, gender, size, body composition, and other characteristics on the pharmacokinetics of specific drugs.
What factors need to be considered when making a cultural assessment? (9)
- language spoken
- health beliefs and practices
- past uses of medicine
- herbal treatments, folk remedies, home remedies
- OTC drugs and treatments
- usual response to illness
- responsiveness to medical treatment
- religious practices and beliefs
- support from the patient’s cultural community
dietary habits
What are legal nursing considerations?
- State and federal legislation (dictate the boundaries for professional nursing practice)
- Nurse practice acts (identify the definition of the scope and role of the professional nurse)
- Guidelines from professional nursing groups (American Nurses Association AMA); Institutional policies and procedures; State and federal hospital licensing (help to identify the legal boundaries of nursing practice.)
- Case law or common law (prior court rulings that affect professional nursing practice)
- HIPAA (legal-ethical dimensions of professional nursing care)
What are the nurse practice acts?
state laws that are instrumental in defining the scope of nursing practice and protect public health, safety, and welfare. Acts define and identify:
- scope of nursing practice
- expanded nursing roles
- educational requirements
- standards of care
- minimally safe nursing practice
- differences between nursing and medical practice
What does HIPPA stand for?
Health Insurance Portability and Accountability Act
expedited drug approval
“fast track” approval - allows pharmaceutical manufacturers to shorten the approval process and allows prescribers to give medications that showed promise during early phase I and II clinical trials to qualified patients.
What is the drug approval process?
- preclinical testing phases (in vitro studies using tissue samples and cell cultures, and animal studies)
- clinical (human) studies - 4 phases
in vitro
performed or taking place in a test tube, culture dish, or elsewhere outside a living organism.
When is a drug put on the market?
after phase III is completed if an investigational new drug application submitted by the manufacturer is approved by the FDA.
What is the collective goal of the drug approval process phases?
to provide info on the safety, toxicity, efficacy, potency, bioavailability, and purity of the new drug.
What must be obtained from patients before they can be enrolled in an investigational new drug (IND) study during the clinical phase?
informed consent
What happens during phase I of the clinical drug study?
Studies involve small numbers of healthy subjects rather than those who have the disease that the drug is intended to treat.
Purpose - to determine the optimal dosage range and pharmacokinetics of the drug and ascertain if further testing is needed.
(includes blood tests, urinalyses, assessments of vital signs, and specific monitoring tests)
What happens during phase II of the clinical drug study?
Studies include a small number of volunteers who have the disease.
Purpose - to determine the drug’s effectiveness and identify any adverse effects.
(therapeutic dosage ranges are refined)
What happens during phase III of the clinical drug study?
Studies involve large number of patients who are followed by medical research centers and other types of health care entities.
Purpose - to provide info about infrequent or rare adverse effects that may not yet have been observed during previous smaller studies.
What are the objectives of phase III of the clinical drug study?
to establish the drug’s clinical effectiveness, safety, and dosage range.
What happens during phase IV of the clinical drug study?
postmarketing studies that are voluntarily conducted by pharmaceutical companies to obtain further proof of the therapeutic and adverse effects of the new drug.
(Data gathered for at least 2 years after the drug’s release)
