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
Q
Absorption - Pharmacokinetics
A
- 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
Q
Oral Route in Absorption
A
- 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
Q
Factors Affecting Absorption via Oral Route
A
- 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
