Chapter 4 pharmacology notes – Flashcards
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a systematic error in a measurement process
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bias
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black box warning
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FDA warnings on drug labels
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double Blind study
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study where neither the investigators nor patient who has the placebo and who has the actually drug
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controlled substances
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listed drugs on schedule of drugs in the Controlled Substances Act
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blind study
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only the participants don't know who is getting the placebo, the investigators do know
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drug polymorphism
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variation in a drugs response due to age, gender, size, and/or body composition
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IND
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investigational new drug not yet approved by the FDA but availble in urgent situations such as aids epidemic and ebola epidemic
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investigational new drug application
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must be submitted to FDA before human trials can begin
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narcotic
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a legal term devised under the Harris Act of 1914 now referring to controlled substances and illegal street drug
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negligence
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failure to act in a reasonable and prudent manner
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orphan drugs
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a category of drugs used to treat people with are diseases
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OTC
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over the counter drugs (non prescription)
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Common African cultural imlicationsespect of others
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folk medicine root healers use herbs, oils androots close extended families getting too personal too fast is intrusive prone to keloids sickle cell anemia lactose intolerance respond better to diuretics than to beta blockers and angiotensin converting enzematic inhibitors respond less effectively to single drug therapy when treating hypertension direct eye contact rude present oriented women as matriarchs
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common Asian cultural implications
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traditional medicine hot/cold acupuncture cupping herbalist high respect for others and authority discomfort w/hand shaking w/opposite sex present oriented close extended families family above individual needs many drug interactions lactose intolerence thalassemia need lower drug dosages such as haloperidol respond ter to lower antidepressant doases req lower doses of antipsychotics]and antimanic drugs yin/yang (female/male) (neg/pos) (dark.light) spiritual grounding of beliefs
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Common Native Americin or First Nations cultural issues
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harmony in nature withevil spirits causing disease medicine man low tone of voice light hand shake, not firm present oriented close extended families emphasis on family lactose intolerance cleftlip and uvula problems spirits can cause disease balance sough
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common, cold, herbs mon Hispanic nuances
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good luck and living right=gd health illness result of bad deeds heat, cold, herb remedies use curandero=spiritualist expressing negative feelingsimpoliet avoiding eye contact respectful and attentive touching in conversationacceptable close extended family ties allfamily member involvedinhealth decisions need lower does of antipsychotics and antimanic drugs
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Pure Food and Drug Act
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drug strength and purity
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Sherley Amendment
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prohibited fraudulent drug claims
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Harrison Narcotic Act
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established the term narcotic reg mfg and sale of habit forming drugs
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Food Drug Cosmetic Act
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drug must be cleared by FDA 1st leg to address drug safety est investigational new drug practice
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Durham Humphrey Amendments
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tightend FDA control by speficying whch drugs need a prescription and which do not legend vs. OTC drugs
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Kefauver Harris Amendments
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req proof of drug efficacy and safety
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Comprehensive Drug Abuse Act (Controlled Substances Act
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est FDA control and enforcement thru the DEA by categorizing drugs by their potential for abuse
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Accelerated Drug Review Reg.
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enabled faster approval by FDA for drugs to treat life threatening diseases like cancer,aids, ebola
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HIPPA act
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privacy of protected health info
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Medicare Prescription Drug Act
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prescription coverage for seniors and disabled
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Are med errors preventable
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yes
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Errors in medication can occur
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in procuring, prescribing, dispending,administering, transcribing, and monitoring
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Schedule 1 drugs
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high abuse potential no accepted med use lsd, heroin, pot
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Schedule II drugs
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current accepted med use high abuse potential physical or psych addiction possible new Rx must be written for each 30 day supply no verbal orders allowed morphine, codine, methadone, oxycodine, pentbarbital, cocaine
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Schedule III drugs
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lower abuse potential RXreq,after 6 mo. or after five rfills new script needed each time tylenol 3, butabrbital, steroids
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Schedule IV drugs
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some abuse potential, Rx 6 mos or after five refills tranq and anianxiety drugs
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Schedule V drugs
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lowest abuse potential no RX needed OTC drugs
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FDA Modernization Act
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fast track for life threatening illnesses,children included intesting, off label info my mfg must be provided
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theraputic objective of drug therapy
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to provide most amt of benefit w/least amt of harm
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a drug that has a good efficacy
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does what it is supposed to do
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a selective drug
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does what it is suppose to do and nothing else
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an ideal drug is
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safe, effective, selective
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are there any idea drugs
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no
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are nephrons increased or decreased in the elderly
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decreased
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nearly everything is decreased in elderly except what
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body fat
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if a person wants to drop out of a drug trial can they
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yes
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if someone in a drug trial wants out can you try to talk them out of to dropping out
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no
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what is involved in preclinical drug development
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in vitro and animal studies
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phase I of drug development does what
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sets optimal dose range and pharmacokenetics involves healthy volunteers unless effect SE (severe) small group
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phase II of drug dev
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theses utility (effectiveness) tests dose response tests adverse effecs diseased population smallnumbers of people
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phase III of drug dev
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safety and effeciveness broader range of tonxicity may include placebos multi center broad populatin base blnd or double blind studies
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phase IV of drug dev
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post marketing studies safety monitored under actual usage conditins drug canbe pulled
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what culture has the greatest participation in healh care and demands the greates explanations
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western
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NPA
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nurse practice acts==state lawthat define nursing practice
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autonomy
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the ability to act onyour own
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benefencne
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doing good; how the patient is best served
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noncemalfeasence
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doing no harm
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veracity
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telling the truth
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should a nurse have her own malpractice insurance
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not req'd but a good idea
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three areas where nurses face potential liability
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failure to assess or evaluate failure to insure safety medication errors
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a nurse says to a student nurse, I have drawn up this syringe, i will let you give it to the patient. what should the student nurse do?
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refuse to give it since the student didnot draw it up herself
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how many times should you ck a med before you give it.
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at least three times
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A patient is undergoing major surgery and asks the nurse about a living will. He states, "I don't want anyone making decisions for me.And I don't want to prolong my life.: the patient is demonstrating?
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autonomy
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When caring for an elderly Chinese patient, the nurse recognizes that which of these cultural issues may influence the care of this patient?
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the use of heat may be an important practice for this patient
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A patient is being counseled for possible participation in a clinical trial for a new med. After the patient meets with the physician, the nurse is asked to obtain the ctient's signature on the consent forms. The nurse knowns that this informed consent indicates?
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the patient has been informed of all thepotential hazards and benefits of the therapy
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A new drug has been approved for use,and the drug mfg has made it available for sale. During the first few months the FDA receives reports of severe adverse effects that were not discovered during the testing and is considering withdrawing the drug. This is part of what phase of the drug studies process?
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phase IV
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A patient of Japanese descent describes a family trait that manefests frequently. She says that members of her family often have strong reactions after taking certain medications but her white friends don't seem to have the problem. The nurse regonizes the implication of this stmt to be?
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she may need lower doses of certainmeds
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When evaluating polymorphism and medication administration the nurse should consider all f the following except: a. nutritional status b. drug route c. patient's ethniciity d. cultural beliefs e. patients age
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b. drug route, all others can effect polymorphic results
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what must the nurse do when taking a verbal order:
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1. only cn be used in emergency 2. write down order completely 3. read back to prescriber 4. provider verifies correctness 5. write time and date on order, also dose rate route 6. nurse signs 7. make sure you put the docs name who gave order and that doc must come in in sign the order w/n 24 hrs.
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can all drug order be given verbally?
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no, cancer drugs and certain controlled drugs cannot
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what do you do if an order is wrong or unsafe
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1. inform provider 2. record notification and their response 3. notify supervisor 4. refuse to carry it out and document why
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what do you din poor judgemento when an order is simply
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1. notify provider 2. if order stays the same, you must carry it out
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what is the antidote for acetaminphen toxicity
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acetylcyeteine
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what is the antidote for benzodiazephrine toxicity
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flumazenil
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what is the antidote fo opiate toxicity
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naloxne
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when are animal studies done on new drugs
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in the pre clinical stage