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exam 1/ chapters 1-4

Name the five categories of professionals who may be licensed to prescribe drugs in Texas. physicians dentists veterinarians NP PA
Explain why customers may be required to show proof of identification to purchase non-prescription drugs (also called over-the-counter or OTC drugs.) due to abuse of certain non perscription medications such as pseudophedrine, federal state law requires some OTC drugs to be behind the pharmacy counter
The Biologics Control Act of 1902 (a) the events that led to its passage and (b) the main purpose of each: gave the federal gov control over production of vaccines, serums, and other blood products led from a 13 yr old child who died after diphtheria vac. from contaminated horse serum and in NJ 9 children died after receiving contaminated smallpox vac.
The Pure Food and Drug Act of 1906 (a) the events that led to its passage and (b) the main purpose of each: 1. defined adultered foods 2. banned interstate commerce of adultered foods 3. provided for federal inspection of meat products this law passed because of the repugnant practices in meat packing and food manufacturering
The Food, Drug and Cosmetic Act of 1938 (a) the events that led to its passage and (b) the main purpose of each: -mandated evaluation of the safety of drugs, cosmetics and therapeutic devices before the products can be marketed -incident of a physician who prescribed a drug to patients before knowing the toxic addictive and 6 patients died
The Kefauver-Harris Amendment of 1962 (a) the events that led to its passage and (b) the main purpose of each: -passed to make manufacturers prove the efficacy (effectiveness) of new drugs and the safety of drugs -this law was created from the events of the thalidomide tragedies of the 1950s
pharmaceutical companies Describe the role of each of the following in the research, development and approval of new drugs research, development, and testing of new drugs
United States Food and Drug Administration (FDA) Describe the role of each of the following in the research, development and approval of new drugs -agency within the Dept of Health and human services -grant approval before the pharmaceutical companies can market -the agency can take action to restrict sale of the drug
Identify the four stages in the drug approval process 1-pre-clinical evaluation 2-clinical evaluation (clinical trials)/Phase I, II, and III 3-submission of new drug application (NDA) 4-Postmarketing surveillance
Compare and contrast single blind study and double blind study single blind: investigators (but not subjects) know which subjects are receiving a placebo and which are receiving the active drug double blind: neither subjects nor investigators know. Code is held by a 3rd party
priority drugs FDA approval process Anti-cancer and AIDS drugs is when they need less evidence of safety required due to urgent need for new drugs for those diseases
Drug Price Competition and Patent Term Restoration Act of 1984....... FDA approval process established abbreviated approval process for manufacturers who wish to produce generic versions of off-patent, previously approved drugs
Prescription Drug User Fee of 1992 FDA approval process -most significant recent attempt to accelerate approval process -entitles FDA to collect a substantial application fee from drug manufacturers at time of NDA sub -keep receiving fees, FDA is required to comp NDA rev process w/in speeded up time frames
What is the purpose of the USP (United States Pharmacopoeia) -official public standards-setting authority of rx, OTC, dietary sup., and other health products -independent public health org. -standards are enforceable by the FDA
biologics includes hormones and vaccines are derived from animal (including human) sources, or are produced in microorganisms
complementary and alternative medicine (CAM) an extremely diverse set of therapies and healing systems that are considered to be outside of mainstream healthcare
formulary list of drugs and drug recipes commonly used by pharmacists
herbs or botanicals plant w/ a soft stem that is used in healing or as a seasoning
homeopathy treatment of disease by minute doses of natural substances that in a healthy person would produce symptoms of disease
Explain the purpose of the DRI index, and identify its main categories -established 1997 -includes Estimated avg req (EAR),, recommended dietary allowance (RDA), adequate intake (AI), and Tolerable upper intake level (UL)
agonist a drug that binds to a specific receptor site to produce an action or effect ex: levodopa
antagonist drug that binds to the receptor to block or prevent an action or effect ex: benadryl
bioavailability assumed to be equal proportion of a drug or other substance which enters the circulation when introduced to the body and is able to have an active effect
half life the time required for the blood concentration of a drug to fall to half its original level
maintenance dose smaller doses given to maintain a level in the therapeutic range
loading dose an initial higher dose of a drug given to rapidly obtain therapeutic levels
receptor site the site on a cell membrane where a drug may attach to produce an action ex: dopamine receptors, beta receptors
site of action is the location where the drug exerts its therapeutic effect
teratogenic capable of producing developmental abnormalities or death in the fetus
therapeutic index is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity
Explain the dif between a generic version and a trade (brand) version of a medication regarding ingredients, bioavailability, cost and access (i.e., is a prescription required or is it available over-the-counter?) generic versions should share the same active ingredients as the brand the inactive can be different. by law the bioavailability in a generic version is suppose to be identical to the brand the effectiveness are the same but side effects can vary
Explain the patent protections afforded to a trade name medication the initial co developing a new drug applies the protection and it gives them sole rights to market the drug for 17 years after the new drug app submission, and allows them 7-10 years to recoup their research before competitors can market
drug indication a list of conditions or diseases for which the drug has been proven safe and effective
drug contraindication list of conditions for which the drug should NOT be given, usually because the drug can aggravate the existing conditions
drug interaction list of drugs or foods that may alter the effect of the drug and usually should not be given during the same course of therapy
drug mechanism of action refers to how a drug produces its effect ex: antihypertensive med can lower bp by increasing urination
enteral route administered via the digestive tract
parenteral route administered directly into the dermis, subcutaneous tissue, muscles, veins, arteries, bone, body cavities or organs
topical route applied directly onto the skin or associated membranes
Differentiate between therapeutic effect, side effect, adverse effect, and toxic effect therapeutic effect- is an intended or desired effect side effect- unpleasant secondary effects adverse effect- harmful secondary effects toxic effect- life threatening effects
Define “pharmacokinetics”; name and describe the four processes involved in that phase of drug delivery. how drugs move within the body -absorption -distribution -metabolism -excretion
Explain the role of the “first pass effect” in the metabolism of drugs in the body and identify the primary organ of metabolism. is a phenomenon of drug metabolism where the concentration of a drug is greatly reduced before it reaches the systemic circulation. the fraction of drug lost during absorp. and related to the liver and gut wall -hepatic portal circulation -filtration sys
Identify the primary organ involved in excretion of drugs Liver, its main job is to filter toxins from the body, most from indigestible waste
Differentiate between substance abuse and addiction substance abuse is an overuse of a drug for non therapeutic effects and addiction is a compulsive, uncontrollable dependence on a chemical substance, a habit, or a practice to a degree causing harm
Differentiate between tolerance, psychological dependence and physical dependence, and give examples of withdrawal syndrome. tolerance-decreased drug effect after repeated administrations psychological dependence- feeling of strong and compelling need for the drug physical dependence- "withdrawal syndrome" ex: tremors, anxiety, seizures, delirium
Describe the five drug schedules. (For testing purposes, you should be able to recognize some of the drugs in each schedule as examples.) sched I- high tendency for abuse, can't prescibe (ex: heroin) sched II-can produce dependency or addiction (ex: morphine) sched III- less potential for abuse (ex: vicodin) sched IV- low potential for abuse (ex: xanax) sched V-lowest chance (ex: OTC)
Pertaining to the Pregnancy Safety a. state the purpose of this classification system classified according to how safe they are to the developing embryo or fetus when taken by the pregnant woman
Pertaining to the Pregnancy Safety b. state the significance of “Pregnancy Category D” and “Pregnancy Category X” category D- positive evidence pf human fetal risk, ex:tetracycline category X- studies in animals or humans have shown fetal abnormalities and death
Name the legislation that created the Drug Enforcement Agency (DEA) and describe the over-all function of that agency Comprehensive drug abuse prevention and control act (1970) and their job is to enforce the provisions of the law
Define “pharmacodynamics”; name and describe the five principles involved in that phase of drug delivery. is how the drug exerts its effects -lock and key theory -affinity -efficacy -potency -dose response curve
lock and key theory a drug or natural body substance attahes to its receptor like a lock and key -agonist -antagonist
affinity the extent to which a chemical is capable of binding and remains bound to a receptor -strong bind- less drug needed
efficacy ability of a drug to produce a desired amount of a desired effect
potency strength of a drug required to produce a specific effect drug's strength at a certain concentration or dose
dose-response curve relationship between the dose and the response
Describe the sympathetic nervous system activities known as the flight or fight response adrenergic agonists stimulate or mimics also called sympathomimetics increase HR and adrenaline decrease saliva production and blood flow
Describe the parasympathetic nervous system activities known as the rest and digest response cholinergic blockers or antagonists, inhibit the actions of acetylcholine by blocking acetylcholine receptors rest or digest decrease in HR increase saliva production and blood flow
cholinergic neurons secretes acetylcholine sympathetic postganglion neurons that innervate most sweat glands
adrenergic neurons release norepinephrine
adrenergic agonists (sympathomimetics) stimulates or mimics in the sympathetic nervous system of the fight or flight response
adrenergic antagonists (symptholytics) block adrenergic neurons that release norepinephrine
cholinergic agonists (parasympathomimetics) stimulates cholinergic to increase salvation and contract the ureters
cholinergic antagonists (parasympatholytics) block cholinergic neurons, inhibit the actions of acetylcholine by blocking acetylcholine receptors
Describe why alcohol and other CNS suppressants should not be taken with benzodiazepines. combined effects can over-depress the respiratory center of the brain resulting in respiratory failure can fatally suppress cardiac function
Explain the general pathophysiology of Parkinson’s disease (Parkinsonism) and describe the main treatment goals. a progressive degenerative changes occur due to decrease in # neurons that secrete dopamine treatment goal is to restore balance between dopamine and acetylcholine in the brain
Explain the general pathophysiology of Alzheimer’s disease, and describe the goal of pharmaceutical therapy at this time a neurotransmitter acetylcholine fails to function correctly, leading to progressive loss of nerve condition treatment goal is to increase the effects of acetylcholine in the brain by administering acetylcholine-esterase inhibitors
Explain the general pathophysiology of multiple sclerosis, and describe the three goals of pharmaceutical therapy for that condition. autoimmune disorder resulting in the destruction of the myelin sheath of neurons in the brain treatment goals is decrease frequency and severity or relapses, prevent creation of new plaques, and symptomatic relief of anxiety, pain and insomnia
Explain the three goals of treatment for insomnia to shorten the time required to get to sleep to increase sleep duration and quality to reduce next-day grogginess
anxiolytic anti-depressants, busiprine, and adrenoreceptor antagonists is to encourage calmness
rebound insomnia insomnia that returns when use of sedative is stopped
sedative-hypnotic primary use to produce sleep INDICATIONS: Insomnia Ex: Zolpidem (Ambien), Eszopicione (Lunesta)
TCA Tricyclic antidepressants MECHANISM OF ACTION: Inhibit reuptake of serotonin and norepinephrine Depression, anxiety, panic disorder, phobias, OCD ex: amitriptyline (elavil)
MAOI Monoamine oxidase inhibitors MECHANISM OF ACTION: Increase serotonin and norepinephrine levels Depression, anxiety, panic disorder, phobias, OCD Ex: Phenelzine (Nardil)
SSRI Selective serotonin reuptake inhibitors MECHANISM OF ACTION: Increase serotonin without affecting norepinephrine levels Depression, anxiety, panic disorder, phobias, OCD Ex: Citalopram (celexa)
ADD syndrome that is characterized by short attention span, poor concentration, increased impulsivity and emotional liability
ADHD same as ADD accompanied by hyperactivity
serotonin syndrome caused by drug toxicity in a variety of possible mechanisms can be potentially fatal it's characterized by abrupt increases of serotonin in the body and in the CNS
extrapyramidal syndrome similar to a stroke, with symptoms of impairment of muscle tone (dystonia), restlessness and agitation (akathisia), Parkinsonism, and involuntary movements of face, limbs and trunk (dyskinesia)
neurologic (neuroleptic) malignant syndrome associated with drugs that affect dopamine levels such as antipsychotics and levodopa fatal reaction marked by hyperthermia, renal failure, pulmonary congestion, confusion and seizures, lead to death
complex sleep-related behaviors an adverse affect to a sedative hypnotic drug patients experience such as driving, while not fully awake
Describe the adverse effects of sedative-hypnotics that caused the FDA to recommend a warning label on those products. due to the medication, people are not aware they are partially asleep the FDA requested warning labels and medication guides
dopaminergics MECHANISM OF ACTION: Supply dopamine in the nerve terminals to restore the balance between dopamine and acetylcholine
cholinergic blockers MECHANISM OF ACTION: Balance dopamine and acetylcholine by Inhibiting acetylcholine activity
acetylcholinesterase inhibitors MECHANISM OF ACTION: Increase the effects of acetylcholine
anxiolytic benzodiazepines INDICATIONS: Anxiety, panic disorder, phobias, OCD Ex: Alprazolam
amnesic benzodiazepines INDICATIONS: To induce memory loss during surgery Ex: Midazolam
hypnotic benzodiazepines INDICATIONS: Insomnia Ex: Flurazepam
barbiturates INDICATIONS: Sedation (during surgery); treatment of seizures; treatment of multiple sclerosis symptoms Ex: Phenobarbital
mood stabilizers INDICATIONS: Bipolar disorder Ex: Lithium
central nervous system (CNS) stimulants INDICATIONS: ADD & ADHD Ex: methylphenidate (Ritalin)
non-stimulants such as atomoxetine INDICATIONS: ADD & ADHD Ex: amomoxetine (Strattera)
antipsychotics INDICATIONS: Schizophrenia and other psychoses Ex: Risperidone (Risperdal)
dopaminergics INDICATIONS: Parkinsonism Ex: Levodopa (L-dopa)
cholinergic blockers INDICATIONS: Parkinsonism Ex: Benztropine mesylate (Cogentin)
acetylcholinesterase inhibitors INDICATIONS: Alzheimer’s disease Ex: Donepezil (Aricept)
Differentiate between analgesia and anesthesia analgesia is the use of medications to reduce pain w/out loss of consciousness and anesthesia is the use of medications to reduce pain with loss of consciousness
Differentiate between local and general anesthesia. local is used for one particular area and general is loss of sensation for the whole body with unconsciousness
Explain the difference between non-selective COX inhibitors and COX2 inhibitors COX1 cause platelet aggregation COX2 cause pain stimulation and inflammation
main potential adverse effect(s) of: aspirin and other non-selective COX-inhibitors bleeding bruising stomach upset
main potential adverse effect(s) of: acetaminophen can cause liver damage if used in excess
main potential adverse effect(s) of: COX2 inhibitors increased incidence of myocardial infarction and liver failure reported
main potential adverse effect(s) of: opioids sedation and respiratory depression decreased GI motility decreased cough reflex dependency euphoria
main potential adverse effect(s) of: general anesthetics headache fatigue irritability nausea vomiting
Describe the properties of acetaminophen its a non-opioid analgesic medication its an antipyretic- acts directly on the hypothalamus and causes dilation of blood vessels
routes of administration of local anesthetics: topical spray or cream applied to the skin, mucus, cornea treats minor burns, abrasions and inflammation can be a single agent or mixture
routes of administration of local anesthetics: infiltration drugs are injected into the selected tissue diffuses to sensory nerve endings within the tissue
routes of administration of local anesthetics: spinal nerve block local anesthesia into the CSF in the subarachnoid space, used for surgery of the lower abdomen and below
routes of administration of local anesthetics: epidural nerve block two locations are the cranial at the lumbosacral junction between L6 and S1 caudal between S5 and C1 or C1 and C2
general uses of: preoperative adjunctive medications sedation and antianxiety
general uses of: intraoperative and postoperative adjunctive medications control of nausea and vomiting
Explain why most patients undergoing general anesthesia are now placed on a mechanical ventilator prior to induction. to prevent death from respiratory paralysis
induction in anesthesia the administration of a drug or combination of drugs at the beginning of an anesthetic that results in a state of general anesthesia
maintenance in anesthesia administering a continuous level of inhalation and/or IV anesthetic to sustain general anesthesia until the procedure is complete
conscious sedation in anesthesia combination of medicines to help you relax and to block pain during a medical or dental procedure
Describe the two methods of delivering general anesthesia. IV medications and inhalation medications
Explain why for most purposes, amide-type local anesthetics are preferable to ester-type local anesthetics there are less allergic reactions due to PABA with amide-type
goal(s) of pharmaceutical treatment for: seizures the treatment goal is to suppress the neuronal activity sufficiently to prevent abnormal or repetitive firing
goal(s) of pharmaceutical treatment for: migraine headache treatment goal involves 2 approaches -stopping the current migraine -preventing further migraines
Opioids MECHANISM OF ACTION: bind to receptors in the CNS and alter the reaction to pain receptors INDICATIONS analgesia, sedation, cough, diarrhea suppression Ex: codeine, morphine, hydrocodone (Vicodin), hydromorphone (Dilaudid)
NSAIDS MECHANISM OF ACTION: non steroidal anti-inflammatory drug
hydantoins and hydantoin-like medications INDICATIONS: seizures, hypotension, hyperglycemia, headache, and slurred speech Ex: Phenytoin (Dilantin), Carbamazepine (Tegretol)
succinimides INDICATIONS: absence (petit mal) seizures Ex: Ethosuximide (Zarontin)
opioid antagonists INDICATIONS: overdoses of narcotics, competes for the same receptor sites, reverses the narcotic overdose and narcotic depression Ex: Naloxone hydrochloride
non-selective NSAIDS INDICATIONS: pain and inflammation Ex: aspirin, ibuprofen (advil, Motrin), Naproxen sodium (Naprosyn)
COX-2 inhibitor NSAIDS INDICATIONS: reduces the risk of peptic ulceration, inflammation, and pain Ex: Celecoxib (Celebrex), Rofecoxib (Vioxx)
acetaminophen INDICATIONS: pain control and fever Ex: Tylenol
triptans INDICATIONS: treating migraines Ex: Sumatriptan (Imitrex)
midazolam INDICATIONS: status epilepticus, conscious sedation , insomnia Ex: Versed
What are the facts for the types of professionals who can prescribe medications within state of TX law MDs but NPs and PAs can also write prescriptions under physician approved protocols and function under the delegated authority of a licensed physician
What are the 5 main laws regarding drug control in the U.S Biologics Control Act of 1902 Pure Food and Drug Act of 1906 Food, Drug, and Cosmetic Act of 1938 Kefauver-Harris Drug Amendments of 1962 Bioterrorism Act of 2002
Through the years, several governmental divisions and departments were responsible for enforcing the provisions of the Food, Drug and Cosmetic Act of 1938. That responsibility currently falls to who? Kefauver-Harris Drug Amendments of 1962
What does the FDA DOES NOT mandate the testing of for safety and efficacy? They DO NOT mandate the safety and efficacy of meat processing plants and meat products. That is the USDA
Who is responsible for approving new prescription/non-prescription drugs and for testing it? What are the 3 stages? FDA the Food and Drug Administration stage 1- pre-clinical evaluation (testing on cultures then animals) stage 2-clinical evaluation ( clinical trials on humans) stage 3-submission of new drug application, which is a request for approval to market
Postmarketing surveillance is what phase IV clinical trials that take place after FDA approval
The drug approval process can be accelerated under what 3 circumstances? 1- drug under review is urgently needed (ex: treat cancer) 2-drug is generic version of an already approved brand name 3-drug company has paid a fee to the FDA to guarantee an accelerated process
Hospitals cannot afford to stock multiple brands of the same drug. Therefore, each hospital pharmacy maintains what? How does the hospital pharmacy function with this? maintains a formulary, which is a category of its available drugs and physicians must prescribe from the formulary
What did the federal government established recommended dosages for vitamins and minerals. DRI- Dietary Reference Intakes
What are the three phases of drug delivery and define each.. drug administration- routes of administration pharmacokinetics phase- how drugs move within the body pharmacodynamic phase-how the drug exerts its effect
Pregnancy Safety Categories were established to identify a drug’s potential teratogenic effects. Drugs are classified as Category A, B, C, D or X, explain each. A-no risk to the fetus B/C-risk not established in humans D- positive evidence pf human fetal risk, ex:tetracycline X- studies in animals or humans have shown fetal abnormalities and death
Drug Schedules refers to a drug’s legality. Drug schedules were established by and are enforced by who? Explain the five schedules Comprehensive Drug Abuse Prevention and Control Act of 1970 sch 1-high tendency for abuse and dependence (heroin) sch 2- cocaine, morphine sch 3- vicodin, codeine sch 4-valium, klopin sch 5-lowest chance of abuse and dependence (OTC)
Pain can be controlled by what type of meds? non-opioid analgesics like NSAIDS centrally-acting drugs acetaminophen
The goal of general anesthesia is what? achieve complete loss of sensation throughout the entire body with loss of consciousness
Seizures result from what in the brain? abnormal electrical activity
Created by: vtlove116



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