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322 Week 1
322 Exam 1
| Term | Definition |
|---|---|
| phase I clinical trial studies | small group of healthy volunteers that are tightly controlled; goal is to evaluate the safe dosage range and identify side effects through evaluation of drug metabolism, pharmacokinetics and biologic effects |
| phase II clinical trial studies | drugs are tested in patients who have the disease that the drug is designed for; goal is to determine the therapeutic effects, safety and effectiveness |
| phase III clinical trial studies | drug is now used in a vast clinical market and prescribers observe patients very closely to monitor for adverse effects |
| phase IV clinical trial studies | post marketing surveillance; drug is approved by the FDA and continued surveillance occurs, information is collected and side effects assessed |
| categories of controlled substances | five categories labeled with a capital C and roman numeral indicating category, sixth is considered unscheduled |
| controlled drugs discarding | controlled substance waste should be incinerated |
| nurse's responsibilities relating to drug administration | right assessment, documentation, education, evaluation, refusal |
| over the counter drugs | products available to the general public without a perscription for self treatment |
| important to explain regarding over the counter drugs | drugs may mask the signs and symptoms of underlying disease, making diagnosis difficult; beware of drug interactions |
| five plus five rights of medication administration | patient, drug, dose, time, route, assessment, documentation, education, evaluation, refusal |
| four phases of pharmacokinetics | absorption, distribution, metabolism, excretion |
| phase I absorption | movement of the drug from the location of administration into the bloodstream |
| oral drugs require for absorption | disintegration and dissolution |
| dissintegration | breakdown of oral drug form into small particles |
| dissolution | small drug particles mixed with liquid that can be absorbed from the GI tract into the bloodstream |
| first pass | in the liver, some drugs are inactivated on their first pass through and may require a higher dose to achieve a therapeutic effect |
| phase II distribution | drug is delivered to the tissues of the body |
| distribution rate depends on | blood flow to tissues, capillary permeability, protein binding and solubility |
| blood flow to tissues | more blood flow, more of the drug will go there - kidney, brain, liver, heart; slower towards fat skin and muscles |
| capillary permeability | permeability depends on tissue type |
| shock | can cause capillaries to leak and increase medication release, be aware of toxicity |
| distribution rates in CNS | slower due to the tight junctions between capillary endothelial cells and blood brain barrier |
| blood brain barrier | can only receive drugs that are lipid soluble or have a transport system |
| placenta and drugs | very easy for drugs to cross, everything affects fetus and mother |
| protein binding, plasma albumin | most abundant however too large to squeeze through pores, no transport for them to leave so the bound molecules cannot reach site of action |
| solubility | ability of drug to move easily across cell membrane into the organs |
| highly lipid soluble drugs | absorbed more rapidly because they can readily cross membranes that separate them from the blood |
| high distribution | small, lipid soluble, unbound drug |
| lower distribution | water soluble, large, bound |
| phase III metabolism | body's ability to chemically change drugs to be excreted, primary site is liver where enzyme cytochrome P450 converts drugs to metabolites |
| half life | amount of time for the drug in the body to decrease by 50% |
| phase IV excretion | removal of drugs from the body, by the kidneys |
| urine pH influence on excretion | acidic urine promotes elimination of weak based drugs, alkaline promotes elimination of weak acid drugs |
| conditions affect excretion | prerenal, intra renal and postrenal can cause accumulation and adverse reactions |
| therapeutic range | range of doses that produce a response without causing adverse effects, plasma drug levels are drawn and must fall within range |
| onset, peak and duration | assess if causing appropriate response |
| side effects | predictable signs and symptoms that range from inconvenient to severe or life threatening |
| adverse effects | unintentional, unexpected and undesirable reactions to drug therapy that are more severe than side effects |
| client with a brain tumor must be monitored for what aspect of pharmacokinetics | distribution, if there is decreased blood flow, decrease time to get to there, BBB might be an obstacle in therapy |
| phase 4 | unexpected effects identified |
Created by:
ahommel
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