NRSE-3010
Chapter 2: Drug Development and Ethical Considerations
Ethical Principles
o Respect (listen to/treat patients equally, even if you disagree; assess cog. ability)
o Beneficence (help, not harm; ex. explaining risks/benefits for research study)
o Autonomy (the patient has the right to self-determination, except when it may harm
others…TB)
o Justice (treat patients equally)
Research subjects should reflect all social/racial groups to ensure medication is
considered across all populations
o Veracity (honest, forthright, factual)
Informed Consent (patient must be competent)
o Voluntary, without coercion, self-determination
o Who is responsible for getting consent/answering client questions?
Physician/person performing procedure explains it, nurse gets consent and
answers questions within her scope
Clinical Research and Study Design
o (Independent variable) causes a change in (Dependent Variable)
o Independent variable (manipulated, ex. time spent studying/medication treatment)
o Dependent variable (result, ex. final test score/clinical effect)
o Control (the standard that the experiment is measured against)
o Placebo (inactive, but looks like experimental option)
o Randomization (to prevent bias)
Blinding (single/double) (who knows who is affected?)
Code of Ethics: Guide for carrying out responsibilities, ethical obligations (ANA pg. 10)
o First duty is to care for the patient! Avoid neglect (illegal)
o Provision 1- the nurse practices with compassion/respect
o Provision 2- the first commitment is to the patient
o Provision 3- the nurse advocates for the patient
Drug Standards
o Food, Drug & Cosmetic Act (first to address food safety)
o All new drugs must undergo testing for toxicity. Results reviewed by FDA
o Drug Schedules:
I (ex. LSD, high potential for abuse)
II (narcotics: opioids/morphine/cocaine; severe risk for dependence)
III (suboxone/narcotic with another drug, ketamine, steroids; risk for dependence)
IV (benzodiazepines, SOMA, phentermine; low risk for dependence)
V (cough medicines with <200 mg codeine, Lyrica, Lomotil)
Drug Names
o Generic (non-proprietary) *only one generic name*
ex. lisinopril, acetaminophen
o Chemical name (long/complex, chemical nomenclature)
ex. N-acetyl-para-aminophenol
, o Brand (trade/proprietary) *easiest to use, may be multiple (different inactive
ingredients/dyes/etc.…)*
ex. Tylenol, Zestril (capitalized!)
o If generic is bioequivalent to brand, it’s therapeutically equivalent (A-rating)
o If < 20% variance in ADME, a generic is equivalent to brand
o OTC (60-95% of initial care includes over the counter)
Includes active/inactive ingredients, purpose/indications, warning/instructions
Average home contains 24 OTC meds…
Few side-effects/interactions/low potential for abuse
Chapter 3: Pharmacokinetics/Pharmacodynamics
Pharmacology: study of drugs/interactions with living system
o Includes all drugs (OTC, vitamins, illegal, prescription)
An ideal drug includes
o Effectiveness (the drug does what it’s supposed to do)
o Safety (no side-effects/adverse effects (no such thing, no drug is 100% safe))
o Selectivity (does only intended response)
Selective BP med affects heart/blood, non-selective may affect lungs too
Pharmacokinetics (what the body does to the drug)
o Absorption: movement of drug into the bloodstream (how will it get in?)
Disintegration (broken into smaller particles after ingestion)
Dissolution (particles and liquid form solution, it can be absorbed)
The rate of dissolution (time needed till drug can be absorbed)
Absorption takes longer in young/old (less gastric acidity)
Enteric-coated drugs (EC, coating allows pill to bypass stomach (acidic) and be
absorbed in intestine(basic)) *don’t crush* *may take longer*
Capsules (not meant to be broken apart)
Sustained release (SR, don’t crush, or all med is delivered at once)
o Factors Affecting Absorption
Blood flow (risk of med lingering or not getting where it needs to go)
May be result of poor circulation to stomach (shock/disease)
Exercise can shunt blood away from GI tract to peripheral muscles
Pain (slowed peristalsis, more med may get absorbed…toxicity risk)
Stress (may increase or decrease peristalsis)
pH: decreases blood flow to gut (less active) thus peristalsis is slowed and causes
more med to be absorbed (stomach pH is 2-4) low pH increases breakdown
Food (solid/hot/fatty foods slow gastric emptying time)
Oral Drugs (variable absorption…)
Mouth-stomach-intestine(absorption)-blood (portal vein)-liver (filtered)-blood-
target tissue
, First-pass effect (first pass metabolism: ONLY ORAL)
In liver, some drugs are metabolized to an inactive form (an oryx) reducing
the amount of active drug available
Bioavailability: amount of drug available after first pass through liver
Only IVs have 100% bioavailability (fastest)
o Factors affecting bioavailability
Drug form (tablet/capsule/SR/liquid/patch…)
Route (inhalation, IV… ex. sublingual/buccal directly enter blood)
Gastric mucosa and motility (villi/peristalsis)
Administration with food or other drugs
Liver function (poor metabolism may cause drug to build up)
o Distribution (how it will get to target)
Affected by circulation, solubility, proteins…
Protein-binding
Drugs in plasma bind with plasma proteins
o The portion bound to the protein is inactive because it is not available to
interact with tissue receptors
Albumin: drugs are inactive if bound
Free drugs
o Free drugs can exit blood vessels in reach their site of action
o Decreased blood flow will affect how the drug gets to target
o Body tissue availability (ex. abscesses have no blood flow)
o Reversible binding of a drug to Albumin
o Retention of protein-bound drug within the vasculature (the protein bound
complex cannot exit as easily as a free drug)
What could increase the risk of drug toxicity?
o When two highly protein-bound drugs are taken together, they compete for
binding sites, leading to an increase in free drug being released into
circulation.
Ex. warfarin (99% protein bound) and Furosemide (95% protein
bound), warfarin (more highly bound) could displace Furosemide from
its binding site, leading to drug accumulation and toxicity
o Low plasma protein levels (fewer binding sites leads to
accumulation/toxicity)
Kidney disease/malnourished/elderly (low albumin levels)
Excess albumin (less free drug to reach target tissues)
o Metabolism (biotransformation via enzymes)
Happens in liver (first-pass effect, some of the med becomes inactive)
What is left over from first-pass is what is “bioavailable” for blood/tissue
Drug metabolism occurs before it enters systemic circulation
Result is decreased bioavailability/therapeutic response
Metabolism may activate inactive forms, watch for toxicity