Shared Flashcard Set


General Concepts
Roach Ch 1
Undergraduate 1

Additional Pharmacology Flashcards




  1. higher potential for abuse and phys/phych dependency 

  1. Controlled Substance Act of 1970 – made a schedule/classifications for abuse potential; regulates mnftrdstrbtn and dispensing; are 5 schedules: 

  1. I  -- highest abuse potential, not used for medicine, e.g. heroin and THC 

  2. II – high abuse potential with severe dependency e.g.opioids and even cocaine 

  3. III – moderate dependence; steroids, hydrocodone/anti-inflam 

  4. IV – limited dependence – anxiety agents, non-opioid analgesics 

  5. V – limited abuse e.g.. small amount of codeine as antidiarrheal and LYRICA (pregabalin); some states allow direct purchase of schedule V from pharmacist. 

  1. DEA monitors prescription practices and provider must have a DEA # 

  2. Many facilities counted every shift by 2 people 

  3. Cannot be filled more than 6 months after script and cannot be filled more than 5 times 


Drug Development

Drug dvlp takes 7-12 years with 2 main time frames 

  1. Pre-FDA phase – company researches on non-humans or in vitro then applies to FDA for Investigational New Drug status 

  2. FDA phase – human testing in three phases 

  1. Phase 1 – 20-100 healthy people 

  2. Phase 2 – those with disease are tested 

  3. Phase 3 – larger # of pts to learn about adverse rxs and dosing 

  1. Then co puts in NEW DRUG APPLICATION – FDA decides wheather to approve 

  2. Once drug is released it is further studies in “phase 4” or “postmarketing surveillance.”  

  1. Professionals can help by using MedWatch or Institute of Safe Med Practices (ISMP) Med Error Reporting Program (MERP) 


For faster release or dvlpt of drugs not profitable: 

ORPHAN DUG PROGRAM – Act of 1983 – for rare diseases; provides incentives like grants, credits; if succeed the co gets sole proprietorship for 7 years 

ACCELEATED PROGRAMS – for life saving drugs;become available phase 1 or 2; must continue research and get final approval eventually 

Drug Phases

Oral drugs have 3 phases, liquid and parenteral only last 2 phases.  They are: 

  1. PHARMACEUTICAL PHASE – dissolves in GI tract.  Those with enteric coating dissolve in alkaline small intestine 

  2. PHARMACOKINETIC PHASE – movement of drug, 4 components 

  1. ABSORPTION – moved into body fluids in tissues.  Rate of absorption depends on how administered: IV quickest, oral slowest; fat soluble stay in body longer, more risk for toxicity.   

  2. Water soluble peed out fairly quickly and less chance of toxicity 

  3. Absorption is very individualized 

  1. 3 types of absorption and 1 consideration: 

  1. ACTIVE TRANSPORT – uses cell energy to go from low to high concentrations 

  2. PASSIVE TRANSPORT – no energy, high to low concentrations 

  3. PINOCYTOSIS – cells engulf drug in vescicles to move 

  4. FIRST PASS EFFECT – first use of drug may be met with greater detoxification by liver, so may need a larger dose or more frequent admin; affects absorption 

  1. DISTRIBUTION – through circulation, reacts with receptors;  

  1. depends on proteing binding 

  1. when bound to proteing, loses therapeutic effects 

  2. Only free drug produces effect 

  1. Goes quickly to areas with lots of blood like heart, liver, kidneys 

  2. Affected by SOLUBILITY – ability of drug to cross cell membrane; E.g. a lipid will easily pass through and water soluble doesn’t 

  1. METABOLISM = BIOTRANFORMATION – drug changed to more or less active form for excretion; usually rendered inactive, though sometimes metabolites have activity; done in LIVER mostly, sometimes KIDNEYS, LUNGS, PLASMA, INTESTINAL MUCOSA 

  2. EXCRETION – by kidneys usually, sometimes sweat, breast milk, breath or GI feces 

  1. if there is kidney disease, may need smaller dose and close monitor 

  2. Also children and elderly have less kidney fnx 

  1. PHARMACODYNAMIC PHASE – drug actions, mechanisms, how work 

  1. Most drugs have affinity for target sites, certain tissues 

  2. Drugs do one of two things or both 

  1. ALTERATION OF CELLULAR FUNCTIONING – most drugs do this, by 

  1. RECEPTOR-MEDIATED DRUG ACTION – drug binds to a cell receptor as either an 

  1. AGONIST – stimulates the cell, or 

  2. ANTAGONIST – blocks receptor.  Are 2 kinds of antagonists: 

  1. COMPETATIVE – competes with agoists 

  2. NONCOMPETATIVE – binds receptor and blocks agoists 

  1. RECEPTOR MEDIATED DRUG EFFECTS – depends on # of receptors – the mroereceptors, the greater the response 


  1. physically , e.g. changes osmotic pressure (manitol for brain edema), sunscreen changes lubrication, activated charcoal changes absorption   

  2. chemically; antacids change pH (a chemical change) 

time to eliminate 50% of drug, know this for dosing.  Is increased when liver/kidney fnx is diminished risking toxicity 
  1. ONSET – time between admin and onset of therapeutic effect 

  2. PEAK CONCENTRATION – when the absorption rate = elimination rate 

  3. DURATION – how long produces a therapeutic effect 

drugs affect difference genetics differently – stuffy of this, esp. for certain genetic profiles 
Any med carries rist of birth defects, esp 1sttrimester has TERATOGENIC EFFECTS – causing abnormal growth 
5 categories of potential birth defects (A-D, X)


  1. No risk shown in pregnant women 

  2. No risk shown in animals and no good human studies – or – animal studies show risk but human studies do not 

  3. Anuimals studies show adv rxns and no good human studies – or no adequate anumal or human 

  4. Good studies show human risk; may use if benefits outweigh risk 

  5. CATEGORY X = human and anumal studies show risk, contraindicated, never used 

LactMed of National Library of Medicine
free online database with infor on dugs and lactation.  L1 to L5 risk (highest) 
6 types of drug reactions: 


  1. ADVERSE DRUG REACTIONS – include side effects (common) in this book to serious and even fatal. 

  2. ALLERGIC REACTION – an immediate HYPERSENSITIVITY raction – usually begins after more than one dose 

  1. Immune sx responds as if ANTIGEN, forming ANTIBODIES 

  2. Mild to life threatening 

  3. Onset ranges from sedoncds to days – most immediate usually most severe 

  4. ANAPHYLACTIC SHOCK – serious! 

  1. Bronchospasmsdyspenea, wheezing, VERY LOW BP, rapid heart  beat, syncope, cardiac arrest 

  2. Can use EPINEPHRINE for tx and can treat each symptom (like benedryl for itching)\ 

  1. ANGIOEDEMA = ANDIONEUROTIC EDEMA – another rype of allergic drug rxn where fluid collects in subcut tissues – mostly eyelids, lips, nouth, throat – may block airway leading to ASPHYXIA 

  1. DRUG IDIOSYNCRACY- very unusual rxn, or rxn opposite of expected therapeutic rxn – often from a genetic difference 

  1. E.g. those with G6PD deficiency can’t tolerate aspirin and sulfanamides b/c RBS hemolysis (destruction); over 100,000 have this deficiency in US 

  1. DRUG TOLERANCE -  sign of physical dependence 

  2. CUMMLULATIVE DRUG EFFECT – esp those with livier/kidney disease leads to toxicity.  Must give lower dose or not at all. 

  3. TOXIC REACTIONS – most drugs are toxic if too much are given or accumulate from pathology (above) 

  1. Some drugs have narrow margin of safety like LITHIUM so must monitor closely 

  2. e.g. STREPTOMYCIN toxicity can damage 8th cranial nerve leading to permanent hearing loss 

  3. some toxic levels have antidotes like Digibind for digitalis 

  4. seom toxicity from differing genetics 


2 types of drug interactions:



  1. ADDITIVE – additional drug (alcohol) doubles effect of first; 1+1=2 

  2. SYNERGISTIC – produces affect greater than sum of both; 1+1=3 or more; e.g. a hypnotic with alcohol 

  3. ANTAGONISTIC – one frug interferes or cancels other, e.g PROTAMINE blocks HEPARIN 

  1. DRUG – FOOD 

  1. Food can impair or enhance absorption 

  2. Most drugs afster if stomach empty 

  3. Some drugs irritate stomach so give with food, e.g anti-inflam and salicylates 

  4. Some durgs combine with food forming an insoluble mixture e.g. TETRACYCLINE and MILK which disables to drug 

5 factors influencing drug responses


  1. AGE 

  1. Young people have immature ogan fnxso give less 

  2. Elderly may need smaller doses bc pf physo=iologic changes affecting PHARMACOKINETICS 

  3. Elderly may also be POLYPHARMACY – leading to greater chance of interaction and adverse rxn 

  1. WEIGHT – doses are based on average weight of 170 

  2. SEX – women smaller and different body fat to water ration affecting dilution in tissues 

  3. DISEASE – esp hepatic and renal drugs may become toxic 


  1. Fastest is IV 

  2. 2nd is IM 

  3. 3rd is subcut 

  4. orally is usually slowest 

Herbalism/dietary supps


  • are used extensively, 80% of world 

  • in US are regulated as dietary dupps 

  • cannot be patented in US so aren’t too proditale to study and develop as therapy 

  • 1994 Dietary Supp Health and Education Act 

  • defines all herbs as dietary supps 

  • permits health claims as long as says on label not approved by FDA and not intended to treat, cure, etc….. 

  • But, must be truthful and be supported by evidence 

  • NURSES SHOULD KNOW if taking b/ccan interact 

  • Some toxic like COMFREY on LIVER 

  • People may not report these 

  • Not standardized for potency/purity 

  • Also important for drugs with a narrow margain of therapy 

  • APPENDIX C for common herbs/dietary supps 

National Center for Complementary and Alternative Medince (NCCAM) 
part of the NIH – does scientific research and trains scientista and siddeminates info, evalusate safety, efficacy; budget is growing 
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