Help
Options
Didn't know it?
click below
click below
Knew it?
click below
click below
Don't Know
Remaining cards (0)
Know
retry
shuffle
restart
0:00
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.
Normal Size Small Size show me how
Normal Size Small Size show me how
Pharm Ch. 4
| Question | Answer |
|---|---|
| What is bias? | Any systematic error in a measurment process. one common effort to avoid bias in research studies involves the use of blindid study design |
| What is a black box warning? | A type of warning that appears in a drug's prescribing information, required by th US food and drug administration altering prescribers of swerious adverse events that have occurred witha given drug |
| What is blinded investigational drug strudy? | A research in which the subjects are purposely unaware of whether the substance they are administered is the drug under study or a placebo. this method serves to eliminate bias on the part of research subjects in reporting their body's responses to drugs |
| What are controlled substances? | Any drugs listed on one of the "schedules" of the controlled substance act |
| What is a double blind investigational drug study? | A research design in which both the investigators and the subjects are purposely unaware of whether the substance administered to a give subject is the drug under study or the placebo. eliminates bias on the part of both the investigator and the subject |
| What is drug polymorphism? | variation in response to a drug because of pt's age, gender, size, and body compisition |
| What is expedited drug approval? | Acceleration of the usual investigational new drug approval process by the US food and drug administration and pharmaceutical companies, usually for drugs used to treat life threatening diseases |
| What is Health insurance portability and accoutability act? | An act the protects health insurance covarage for workers and their families when they change jobs. it also protects pt info. if confidentiality of the pt is breached, severe fines may be imposed |
| What is informed consent? | Written permission obtained from a pt consecnting to the performance of a specific procedure, after the pt has been given info. regarding the procedure deemed necessary for the pt to make a sound or informed decision |
| What is investigational new drug? | A drug not approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy |
| What is investigational new drug application? | the type of application tha ta drug manufacturer submits to the FDA following successful completion of required human research studies |
| What is legend drugs? | Another name for prescription drugs |
| What are narcotics? | A legal term established under the harrison antiarcotic act of 1914. it originally applied to drugs that produced insensibility or stupor, especially the opioids |
| What are orphan drugs? | a special category of drugs that have been identified to help treat pt's with rare diseases |
| What are OTC drugs? | drugs available to consumers without a prescription |
| What are placebos? | An inactive substance that is not a drug but is formulated to resemble a drug for research purposes |
| What is ethnopharmacology? | body of knowledge for understanding the specific impact of cultural factos on pt drug response |
| It is impossible to know a pt's genotype by? | physical appearance or health care history |
| You should always except? | a pt's cultural beliefs, values, and customs |
| What factors my effect polymorphism? | Diet and nutritional status, genetic factors |
| Medication working depends greatly on a pt's? | compliance |
| Other than compliance another problem is that some pt's use? | Alternative therapies |
| What can herbal remedies do to prescribed medication? | inhibit or accelerate drug metaboloism and alter a drugs response |
| What can also contribute and effect drug response? | Enviromental and economic factors |
| Malnutrition with deficiencies in ____,____ and ____ may modify the functioning of metabolic enzymes, which may alter the body's ablility to absorb or eliminate meds? | protein, vit. and minerals |
| What people are used for clinical trials? | White college men |
| Europens and african americans are? | Slow acetylators |
| Japanese people metabolize drugs how? | more rapic acetylatos and metabolize quickly |
| levels of _____________ enzyme are also know to vary between ethnic groups? | cytochrome P 450 |
| Where are psychotropic drugs metabolized? | Liver |
| What do african americans believe? | proper diet and rest, teas, laxative, and pretective bracelets |
| What do the chinese believe? | Yin and yang |
| What do native americans believe? | good health=good luck, bad health=bad luck |
| The nurse should always consult with the pt never ____ | assume |
| What are the barriers to adequate health? | language, poverty, access, pride and beliefs |
| What is included in a cultural assessment? | language, health beliefs, past use of medicine, herbal treatment, OTC, usual response to illness, support, and dietary habits |
| What is diethylene glycol? | Antifreeze |
| What is the thalidomide tragedy? | pregnant women took sedative hypnotic drugs and gave birth to deformed babies |
| What is HIPPA? | requires all health care providers, health and life insurance companies, public health authorities, employers and schools to maintain pt privacy regarding protected health info. |
| Drug companies must develop new drugs to? | keep a competitive edge |
| The research for new drugs may take? | several years |
| Drug companies must follow a ? | very regulated, systematic process before the drug can be released |
| The process of drug acceptance is regulated by? | The FDA |
| What is the primary purpose of the FDA? | to protect the pt and ensure drug effectiveness |
| T or F: many drugs are used in other coutries unmarked before here? | TRUE |
| The FDA has less authority with? | vitamin, herbal, and homeopathic preparations |
| Who is responsible for approving drugs? | FDA |
| expedited drug approval= | "fast track" |
| What was the first fast track drugs for? | AIDS |
| What are the schedule categories? | CI, CII, CIII, CIV, CV |
| CI and CII? | can be abused |
| CI can only be obtained how? | approved protocol |
| CII can only be obtained how? | Written prescription only, no refills, warning label |
| CIII can only be obtained how? | Written or oral prescription, no more than 5 refills, warning label |
| CIV can only be obtained how? | Written or oral prescription, no more than 5 refills, warning label |
| CV can only be obtained how? | Written perscription or OTC |
| How does the drug approval process begin? | preclinical |
| Preclinical phase includes? | vitro studies and animal studies |
| What follows preclinical? | clinical phase |
| How many clinical phases are there? | 4 |
| When can the drug be put on the market? | after phase 3 is complete only if the FDA accepts it |
| What does phase IV consist of? | postmarketing studies |
| What is the goal of phase IV? | to provide information on the safety, toxicity, efficacy, potency, bioavailability, and purity of the new drug |
| In the preclinical phase what tissues are collected? | human and animal, live and dead |
| What do invitro studies provide researchers? | to determine early on if a substance might be too toxic for human pts |
| How must the consent form be written? | in their language , must be dated, signed and have at least one witness |
| informed consent is always _______ | Voluntary |
| What is phase one of drug studies? | usually involves small numbers of healthy sujects rather than those who have disease |
| What is the purpose of phase 1? | to determine the optimal dosage range and the pharmacokinetics of the drug and to see if further testing is needed |
| What is phase 3 of drug studies? | invole large numbers of pts who are followed by medical research centers and other types of health care facilities |
| What is the purpose of phase 3? | to provide info about infrequent or rare adverse effects they may not yet have been observed during previous smaller studies |
| a study with a placebo is called? | placebo controlled study |
| What does phase 2 involve? | small numbers of volumteers who have the disease that the drug treats |
| What is refined during phase 2? | therapeutic dosage ranges |
| What are the 3 objectives of phase 3? | to establish effectiveness, safety and dosage |
| When is the application given to the FDA? | phase 3 |
| What is phase 4? | postmarketing studies conducted by companies to obtain further proof of the drug effectiveness |
| What is class one of drug recall? | the most serious, bad side effects or death |
| What is class two of drug recall? | temporary effects but long effect risks are low |
| What is class three of drug recall? | least severe not likely to cause serious problems |
| The joint commission requires? | must have written policies and procedures |
| Ethical nursing practice is based on what principles? | beneficence, autonomy, justice, varacity, and confidentiality |
| What does the nurse have the right to refuse? | any treatment |
| Why do facilities limit the use of placebos? | Deceit and mistrust |
| during a clinical trial the pt must be informed that? | they can leave at any time without consequences to medical care, full info. about the study, be aware of alternet options |
Created by:
alicia.rennaker
Popular Nursing sets