Exam 1 Flashcards
1
Q
Food & Drug Administration (FDA)
A
- Responsible for protecting public hlth by ensuring safety, efficacy, & security of drugs, biological products & medical devices
- Ensure safety of nation’s food supply, cosmetics, & products tht emit radiation & more
- Drug approval process tightly controlled by FDA; takes several yrs & phases
2
Q
Preclinical Investigational Studies
A
Tested on laboratory animals
3
Q
Phase I Studies of FDA
A
- Tested on hlthy human volunteers
- Dose range & pharmacokinetics
4
Q
Phase II Studies of FDA
A
- Tested on clients w/ disease
- Therapeutic effects & adverse effects
5
Q
Phase III Studies of FDA
A
- Large sample size; placebo and/or blinded studies
> effectiveness, safety, dose - Submission of new drug application; approved by FDA & given name; patent 5-7yrs
6
Q
Phase IV Studies of FDA
A
- Post marketing studies (2+yrs)
- New or severe adverse effects
- Black box or recall
7
Q
Legal Regulation of Drugs: Drug Enforcement Agency (DEA)
A
- Regulates manufacturing, distribution, & dispensing of drugs w/ known abuse potential (controlled substances)
- Anyone convicted of unlawfully manufacturing, distributing, or dispensing of controlled substances faces severe penalties
8
Q
Schedule I Controlled Substance
A
- High abuse potential & no accepted medical use
- Heroin, LSD
9
Q
Schedule II Controlled Substances
A
- High abuse potential w/ severe dependence liability
- Opioids, amphetamines, barbiturates
10
Q
Schedule III Controlled Substances
A
- Less abuse potential & dependence liability than II (moderate)
- Nonamphetamines stimulates, nonbarbiturates sedatives
11
Q
Schedule IV Controlled Substances
A
- Less abuse potential & dependence liability than III (moderate)
- Antianxiety agents, some sedative
12
Q
Schedule V Controlled Substances
A
- Limited abuse potential
- Codeine
13
Q
Pharmacology & the Nursing Process
A
- Assessment
> allergies: ask reaction - true allergy vs. adverse effect
> medications: current & recent past, OTC, herbals, supplements - Diagnosis
- Planning
> expected outcomes SMART - Implementation/Interventions
> administering medication
> pt education - Evaluation
> safe & effective med admin
14
Q
National Coordinating Council for Medication Error Reporting and Prevention definitions
A
- No error, although circumstances or events occurred tht could have led to error
- Medication error caused no harm
- Medication error that causes harm
- Medication error that results in death
15
Q
Most common cause of morbidity and preventable death in hospitals
A
- Medication Errors
- Nurse is last line of defense to prevent errors
16
Q
Errors in Patient Assessment
A
- Most common medication error
- Inadequate medication or medical history
17
Q
Errors in Prescribing
A
- Most common medication error
- Wrong drug, incorrect dose, illegible written order
18
Q
Errors in Administration
A
- Most common medication error
- One of the “rights” of administration compromised
19
Q
Distracting Environmental Factors and Stress
A
- Most common medication error
- Interruptions during preparation or administration
20
Q
Prevention of Medication Errors
A
- Proper assessment, administration, monitoring, evaluation, & documentation
- Question a med order for any reason when in doubt
- Always listen if pt questions drug
- Don’t use med abbreviations & acronyms
- Minimize telephone orders: use “read back” order to prescriber, spell drug name
- Be careful w/ look alike, sound alike drugs
21
Q
Reporting Medication Errors
A
- Student: notify clinical faculty/RN immediately
- Nurse:
> notify PCP for additional orders
> monitor, intervene as prescribed/appropriate
> report (legal & ethical responsibility) - Improve systems & procedures; reduce future errors
22
Q
Possible Consequences of Medication Errors
A
- Psychological impact
- Loss of trust
- Named defendants in malpractice litigation; financial implications
- Administrative response:
> continuing education or refresher
> discipline - suspension or termination - Board of Nursing
> suspend or revoke license
23
Q
Pharmacokinetics 4 Processes
A
- Absorption: getting drug to blood
- Distribution: getting drug to tissues/organs
- Metabolism: breaking drug down
- Excretion: getting drug out of body
24
Q
Pharmacokinetics
A
What the body does to the drug
25
Absorption - Pharmacokinetics
- Getting drug to blood to be distributed to tissues
- Factors Influencing Absorption:
> Route
> Drug properties: molecular size, lipid solubility, pH
> Pt properties: surface area of absorptive surface, blood flow to site of absorption
26
Oral Route in Absorption
- Some meds absorbed in stomach, most in sm intestine
- Due to first-pass metabolism, the onset of action for most oral drugs is 30-60 mins
- 0-70% bioavailable
27
Factors Affecting Absorption via Oral Route
- Molecular weight: too big, can't pass membrane
- Lipid solubility: sm & highly lipid soluble drugs rapidly thru membrane
- Surface area of gastrointestinal mucosa
- Blood flow to gastrointestinal syst
- Rate of gastric emptying
- Oral preparation
- Admin of mult drugs simultaneously (interaction)
- Foods & fluids admind w/ drugs
28
Distribution - Pharmacokinectics
- Movement of drug to body's tissue
- Results in therapeutic and adverse effects
29
Factors Influencing Distribution
- Blood flow to organs/tissues
> areas of rapid perfusion/distribution: heart, liver, kidney, brain
> Areas of slow distribution: muscle, skin, fat
- Ability to cross blood-brain barrier or fetal/placental barrier
- Drug Properties:
> Protein binding (albumin): highly protein bound = less available for distribution
> Water solubility vs lipid solubility: highly water-soluble drugs stay in blood stream; go more places. highly lipid-soluble drugs more readily pass lipid cell membs & deposit in adipose tissue
30
Metabolism (biotansformation) - Pharmacokinetics
- **Liver** is primary site: hepatic microsomal enzyme syst
- Metabolic activity may be dcrd in some pts
> infants & elderly, genetic disorders, severe liver disease
> dosage reduced in dcrd liver func to prevent toxicity
- Liver transforms some drugs to active form (prodrug)
- Nurse: liver disease is a caution/contraindication when admining certain drugs, moniter liver func to avoid drug toxicity or injury to liver
31
Enzyme Induction
- Incrd activity of enzyme syst by presence of 1st drug; speeds metabolism of 2nd drugs using same enzyme syst; can't reach needed therapeutic lvls
- Why some drugs can't be taken together
32
Enzyme Inhibited
- Some drugs inhibit enzyme syst & make it less effective
- Drug will not be broken down for excretion
- Blood lvl of drug incrs to toxic lvl
33
First Pass Effect
1. Oral drug taken by pt
2. Drug absorbed across the intestinal mucosa
3. Drug enters portal circulation & travels to liver
4. On first pass thru liver, drug is metabolized to less active forms
5. Drug metabolites (less active) leave the liver for distribution to tissues
34
Excretion - Pharmacokinetics
- **Kidneys** are primary organ for excretion of drugs from body
- Liver/bowel are secondary site for excretion
> drugs processed by liver, released into bile, eliminated in feces
- Kidney dysfunc: drugs not excreted effectively, reach toxic lvls
- Nurse: monitor kidney func to avoid drug toxicity or AKI
35
Onset
Time for a drug to elicit a therapeutic response
36
Peak
Time for a drug to reach its maximum therapeutic response
37
Duration
Time for a drug concentration to sufficiently elicit therapeutic response
38
Therapeutic Minimal Effective Concentration (MEC)
- Amnt of a drug tht is needed to cause a therapeutic effect
- Recommended dose of a drug is based on amnt tht must be given to eventually reach therapeutic MEC
- Too much drug = toxic (poisonous) effects
- Too little drug = will not produce desired therapeutic effects
39
Loading Dose
- Higher dose than usually used for treatment to reach therapeutic MEC faster
- Subsequently maintained by using recommended dosing schedule
40
Half-Life
- Time required for one-half (50%) of a given drug to be removed from the body
- Greater half-life, longer it takes to excrete
- Determines frequency & dosage
41
How Drug Attains & Maintains Therapeutic Range (steady state)
- Repeated doses of a drug are given
- Drug accumulated in bloodstream
- Plateau is reached
- Amnt admind equals amnt eliminated
42
Therapeutic Drug Monitoring
- Blood test performed to determine lvls of drugs
> Determine therapeutic range & avoid toxicity
- Peak & Trough
> Tests to determine highest & lowest blood lvl of drug
43
Trough (Peak&Trough)
Lowest drug lvl needed to reach therapeutic range drawn 1 hr prior to start of next infusion
44
Peak (Peak&Trough)
Highest lvl of the drug in the bloodstream drawn 1 hr after infusion completed
45
Factors Influencing Drugs Effects
- Age
- Gender
> men more vascular muscles
> women more fat cells; slow release
- Physiological: hydration, acid-base, electrolytes
- Pathological: disorders change conditions for drug (vascular, GI, liver, kidney disease)
- Genetic: lack enzymes, cultural diffs
- Psychological: attitude; placebo effect, trust in HCP
- Environmental: temp, relaxed
- Tolerance: larger dose needed
- Interactions: two or more drugs
46
Drug-Drug Interactions
- Site of absorption: one drug prevents or accelerate absorption of another drug
- During distribution/site of action
> drugs compete for binding site of another, one drug gets bumped off
> opposing mechanisms of actions
> drugs w/ similar adverse effects
- During metabolism: one drug stimulated or block metabolism of another
- During excretion: one drug competes for other to be excreted. leads to accumulation/toxicity
47
Drug-Food Interactions
- Prevent absorption (oral route)
> incrd acid production, speeds breakdown of drug
> milk products: calcium binds drug, dcrd absorption
> chemical reaction
- Incr or dcr drug's effect (any route)
> food affects liver enzyme: grapefruit juice inhibits liver enzymes leading to toxic effects
48
Types of Adverse Effects/Reactions
- Primary actions (pharmacological)
> overdose; extension of desired effect (antihypertensive, hypotension) - dose adjustments
- Secondary actions
> undesired effects produced in addition to pharmacologic effect (antihypertensive, nausea, diarrhea, rash) - undesired effect must be tolerated
- Toxicity
- Allergic reactions
49
Allergic Reactions: Nursing Intervention
- 1st:
> stop admind of med immediately
> apply oxygen if needed
- Next:
> call rapid response team if severe
> notify PCP
> Admin IV fluids as ordered
> Admin antihistamines as ordered
50
Pharmacodynamics
- How the medication affects the body
- Drugs act at specific areas on cell membs called receptor sites
> normally bind hormones, neurotransmitters, growth factors
- Drugs change existing physiological & biochemical processes
51
Medications work in 1 of 4 ways (pharmacodynamics)
1. To replace or act as substitutes for missing chemicals
2. To incr or stimulate certain cellular activities
3. To depress or slow cellular activities
4. To interfere w/ the funcing of foreign cells, such as invading microorganisms or neoplasms lead to cell death
52
Agonist (Receptor Theory Type)
- Drugs interact directly w/ receptor sites
- Cause same activity of natural chemicals would case at tht site
- EX: insulin; beta-agonist
53
Antagonist (Receptor Theory Type)
- Competitive: block normal stimulation of receptor
- Noncompetitive: prevent reaction of another chemical w/ a diff receptor site on cell
- EX: beta-blockers; anti-histamines
54
Cholinergic Agonist
- Parasympathetic branch
- Mimics acetylcholine
- Incrs saliva production
- Slows HR
- Constricts bronchioles
- Stims digestive process
- Incrs urination
- Common use: Alzheimer's disease
55
Cholinergic-Blocking
- Parasympathetic branch
- Anti-cholinergic
- Dcrs saliva/secretion
- Incrs HR
- Relaxes bronchioles
- Dcrd GI motility & peristalsis
- Urinary retention
- Drowsiness, disorientation
- Uses: bowel & bladder disorder, Parkinson's disease, asthma
56
Cholinergic Mnemonic - SLUDGE
S = salivation
L = lacrimation
U = urination
D = diaphoresis (sweating)
G = GI upset
E = emesis (vomiting)
57
Anticholinergic Mnemonic
- Can't SEE / dry eyes, blurred vision
- Can't PEE / urinary retention
- Can't SPIT / dry mouth
- Can't SHIT / constipation
58
Adrenergic Agonist
- Sympathetic branch
- Tachycardia & vasoconstriction
- Bronchodilation
- Dcrd GI motility
- Glycogenolysis (incrd bld glucose)
- Constricts bladder sphincter
- Uses: cardiac & respiratory
- Sympathomimetic
(think of switching the fight or flight ON)
59
Adrenergic Antagonist (adrenergic-blocking)
- Sympathetic branch
- Slows HR
- Lowers BP
- Bronchoconstriction
- Masks s/s hypoglycemia
- Urinary incontinence
- Uses: HTN, BPH
- alpha-, beta- blocker
60
Anti-Inflammatory Drugs
- Fluticasone (inhaler/nasal)
- Montelukast
61
Bronchodilator Drugs
- Albuterol (inhaler)
- Salmeterol (inhaler)
- Ipratropium (inhaler)
- Theophylline/aminophylline
62
Inhaler Education
- Correct administration procedure & return demonstration
- Clean delivery devices weekly
- Rinse mouth after inhaler use
> esp w/ inhaled corticosteroid
- Timing of ad ministration
> prior to exercise, acute attack, daily use
- Adverse effects of inhaled medication
63
Sequencing of Multiple Inhalers
1. Bronchodilators
- Beta agonist agents
> wat 1 min btwn puffs for mult inhalation of same med
> wait 2-5 mins before administering next med
- Anticholingeric agents
> scheduled administration only (not rescue inhaler)
2. Corticosteroids
- Administer after bronchodilators
- Wait 1 min btwn puffs for mult inhalations of same med
- Rinse mouth following use (don't swallow water) to prevent oropharyngeal fungal infection
64
Albuterol
MOA: Beta2 selective adrenergic agonist; bronchodilator (SABA)
INDICATIONS: Acute bronchospasm (asthma attack, COPD exacerbation, pneumonia), prevention of exercise induced asthma
ROUTE: inhaler, nebulizer; onset 5-15 mins
CONTRAINDICATIONS: conditions exacerbated by sympathymimetic effects
DRUG-DRUG: beta adrenergic antagonist
AE: sympathomimetic stimulation; cardiac arrhythmias, HTN, sweating, tremors; worsened bronchospasm
NURSING: admin for symps or scheduled; overuse incrs AE; use 30-60 min prior to exercise
65
Salmeterol (Servant Diskus)
MOA: Beta2 selective adrenergic agonist; bronchodilation (LABA)
INDICATIONS: prevent exercise induced bronchospasm; COPD, asthma (maintenance)
ROUTE: inhaler
CONTRAINDICATIONS: condition exacerbation by sympathomimetic effects
BLACK BOX: incrd risk of asthma-related deaths; use inhaled corticosteroid to dcr risk
DRUG-DRUG: beta-adrenergic antagonists
AE: same as SABA
NURSING: NOT a rescue inhaler; admin on schedule
66
Ipratropium (Atrovent)
(resp anticholinergic)
MOA: blocks acetylcholine (PSNS); airway dilation
INDICATION: prevention of bronchospasm (maintenance)
ROUTE: inhaler
AE: dry mouth, nasal congestion, heart palpitations; other systemic anticholinergic effects rare
NURSING: NOT a rescue inhaler
67
Fluticason (Flovent)
(inhaled corticosteroid)
MOA: dcr inflammatory response in airways
INDICATIONS: prevention and treatment of asthma (maintenance)
ROUTE: inhaler
AE: sore throat, hoarseness, coughing, dry mouth, pharyngeal & laryngeal fungal infections; systemic rare
NURSING: assess mucous membs-fungal infection; educate pt: rinse mouth after, NOT a rescue inhaler
68
Montelukast (Singulair)
(leukotriene receptor antagonist)
MOA: selectively block receptors for production of leukotrienes; reduces inflammation
INDICATIONS: prophylaxis for asthma in adults & children
ROUTE: oral
AE: mood & behavior changes
NURSING: NOT a rescue med; approved for use in children 1+
69
Theophylline/Aminophylline
(xanthine derivatives)
MOA: direct effect on smooth muscles of respiratory tract. both in bronchi & bad vessels (metabolized to caffeine)
INDICATIONS: prevention (theophylline) or reversal of bronchospasm (aminophylline)
ROUTE: oral (theophylline) or IV (aminophylline)
CONTRAINDICATIONS: cardiovascular disease
AE: related to blood lvls: GI upset, nausea, irritability, & tachycardia to seizure, brain damage, & death
NURSING: narrow therapeutic window, monitor lvls; smoking incrs metabolism (lowers lvls)
