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Nurs 572A Pharm
Chapters 1-3
| Question | Answer |
|---|---|
| drug | chemical that affects living processes |
| pharmacology | study of drugs + interactions with living systems pharmacokinetics + pharmacodynamics |
| clinical pharmacology | study of drugs in humans |
| pharmacotherapeutics | choosing the right drug for right purpose; use of drugs to diagnose, prevent & treat disease; use of drugs to prevent/induce pregnancy |
| properties of ideal drug "ess" | effectiveness - does what it should, better than no drug safety - no universally safe drug selectivity - no universally selective drug |
| properties of ideal drug - other desirable properties "rpe ml ch" | reversible action predictability ease of administration minimal drug interactions low cost chemical stability simple generic name |
| therapeutic objective | maximum benefit with minimal harm |
| intensity of drug response determined by | concentration of the drug, in its active form, at site of action |
| factors influencing drug response "appi" | administration pharmacokinetics pharmacodynamics individual variations |
| drug response factor - administration | dosage size route timing patient compliance controlled med errors |
| drug response factor - pharmacokinetics 'adme' | what body does with drug - absorb, distribute, metabolize, excrete |
| drug response factor - pharmacodynamics | impact of drug on the body when at site of action |
| nurse must anticipate . . . | side effects and drug interactions |
| General steps in nursing process "papie" | pre-administration assessment analysis/nursing diagnosis planning implementation/intervention evaluation |
| Nursing process: Pre-Admin assessment "cia" | collect baseline data identify high risk patients assess pt self care capacity |
| Nursing Process: analysis/nursing diagnosis | drug appropriateness response to prior tx drug choice, dose, route precautions/contraindications statements about pt actual/potential problems, probable causes, risk factors |
| Nursing process: planning | individualized problem solving plan based on analysis *defined goals - max benefit/min harm *identify interventions *establish criteria for evaluation |
| Nursing process: implementation | *prescriber order drug *independent intervention (pt. comfort/adherence, social aspect, etc) *same 4 aspects = *** drug admin ***enhancing benefit ***minimize size effects/interactio ***pt ed *may require coordination with other members of healthca |
| Nursing process: evaluation | *determine degree of success *therapeutic response *absence of side effects, adverse interactions *promote optimal compliance *pt satisfaction |
| Nursing process: other components | *promote non-drug options *pt ed - disease/tx *minimize side effects - anticipate s/e by monitoring s/s *appropriate prn decisions *manage side effects/toxicities |
| Federal Pure Food & Drug Act 1906 | free of adulterants, nothing about efficacy or safety |
| Food, Drug & Cosmetic Act 1938 | *all new drugs tested for safety *bwo sulfonamide incident *FDA responsible for evaluating safety tests |
| Kefauver-Harris amendment 1962 | *drugs proven effective compared to placebo *established rigorous testing for new drugs |
| Controlled Substance Act 1970 | schedules of drugs I-V in decreasing order of potential addiction/abuse |
| FDA Fast Track 1992 | *accelerated approval (antiretroviral, cancer chemo) *marketing could precede completion of phase III trials |
| PDUFA - prescription drug user fee act 1992 | mfg pay fees for application/services FDA use fees to hire reviewers, assess applications |
| FDA guidelines revised 1990s | studies must include women/minority populations |
| FDA Modernization Act 1997 | *expand fast tract *plan for drug discontinuation *some drugs must be tested in children *database for life-threatening diseases to facilitate pt enrollment in trials *off-label promotion & research agreement *renewed PDUFA |
| Best pharmaceutical for Children Act 2002 | 6 month patent extension (drugs already on market) for ped research |
| Pediatric Research Equity Act 2003 | gives FDA authority to require peds research on certain drugs |
| FDA Amendments Act 2007 | *post-marketing phase regulations *FDA can monitor drug safety *FDA can require post market studies *FDA can require additional safety labeling |
| New Drug Development - Preclinical testing | 1-5 years on animals to evaluate *toxicity *pharmacokinetic properties *biologically useful effect |
| New Drug Development - Clinical Testing Phase I | *normal volunteers *evaluation of drug metabolism *effects on humans |
| New Drug Development - Clinical Testing Phase II | *tested on patients (500-5000) *therapeutic effects |
| How long is phase II & phase III new drug development | 3-6 months, after phase III application for conditional approval is made |
| New Drug Development - Clinical Testing Phase III | patient safety and effectiveness |
| New Drug Development - Clinical Testing Phase IV | *begins with conditional approval from FDA *post-marketing surveillance *usage for general population *new side effects may be discovered *voluntary reporting by HCPs essential |
| types of drugs by regulatory authority | *legend/rx --> FDA *OTC --> FDA *BTC behind the counter - smoking cessation, emergency contraception, pseudoephedrine products --> FDA nutritional/dietary --> DSHEA |
| DSHEA = Dietary supplement Health and Education act 1994 | *FDA limited authority *unregulated sale of supplements with restrictive labeling *no health/disease claims *allowed claims about 'structure/function on bdy *no proof of safety/efficacy |
| CGMP = Current good manufacturing practices | FDA proposed standards to improve quality, labeling and quality control practices |
| Drug can have 5 names, starting with Phase I investigational number | *investigational number *chemical name *generic name *abbreviation *trade name |
| FDA Orange Book | *lists TE=therapeutic equivalency of generics *if TE begins with letter "A" then product shown to have no problem with bioequivalency |
| Monoclonal antibody nomenclature | system to classify monoclonal antibodies (often reproduced artificially)that share same target *Ends in -mab |
| MAB system | * end in -mab *preceded by abbreviation related to source (human, rat, etc) *preceded by 2-3 letter abbreviation relating to clinical application *prefix is unique to drug product *if product radio labeled or has toxin attached, a separate word used |
| MAB system Source codes Human = humanized = chimeric (fusion protein)= primate = mouse = rat = hamster = | =u =zu =xi =I =o =a =e |
| MAB disease or targets colon tumor = melanoma = breast tumor = testicular tumor = ovarian tumor = prostate tumor = misc. tumor = viral = bacterial = infectious lesion = immune = cardiovascular = | =col =mel =mar =got =gov =pro =tum =vir =bac =les =lim =cir |
| MAB example - Infliximab = Remicade -mab = -xi = li(m) = -inf = | =monoclonal antibody =chimeric (human + mouse) =immune target used for RA) =unique targe |
| MAB example Abciximab = Reopro ci(r) = | cardiovascular target (antiplatelet agent) |
| MAB example Palivizumab = Synagis -vi(r)= -zu = | viral (used to tx/prevent RSV humanized |
| MAB example certuximab = Erbitux tu(m)= | misc tumor (used for several types of cancer) |
| Drug development takes how many years | 6-12 |
| Drug development costs approximately | $800 million |
| Percentage of drugs in trials that gain approval | 20% |
| most reliable way to assess drug therapies | randomized controlled trials |
| what is tested during pre-clinical phase | *kinetics *toxicity *effectiveness |
| True statements regarding OTCs | *most illness initially treated with OTC *more rx drugs than OTC drugs administered annually in U.S. *average home has 5-10 OTC drugs *40% of Americans take one OTC q2d *some drugs sold by rx now available OTC |
| Classic text/reference on pharmacology | Goodman & Gilman's The Pharmacological Basis of Therapeutics |
Created by:
lorrelaws
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