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pharmacology
exam 1/ chapters 1-4
| Question | Answer |
|---|---|
| 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 |
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