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Pharm1-final 2
Legal/ Safety Issues & Analgesics
| Question | Answer |
|---|---|
| Phase 1 clinical testing | Small number of human volunteers, used to determine pharmacokinetics |
| Phase 2 clinical testing | limited controlled evaluation; in selected individuals with the targeted disease; closely monitored side effects and effectiveness |
| Phase 3 clinical testing | Extended clinical evaluation; tested in various centers in US in large numbers of individuals. Goal:determine clinical effectiveness, drug safety, & est. tolerated dose of rance |
| Phase 4 clinical testing | post marketing surveillance, used by a greater number of clients for a longer period of time; additional effects |
| After phase 3 the new drug application must be what? | Sent to FDA for approval, then marketed for the selected indication and dose and moves onto phase 4 |
| Limitations on drug testing: | number or persons and time allotment, pregnant women, people with multiple disease states, people on multiple meds, children, women, and older adults |
| Preclinical testing on animals to ascertain the following: | Toxicity, acute toxicity-LD50, Subacute toxicity, chronic toxicity |
| Therapeutic index | the ratio of the LD50 to the median effective dose |
| Investigational New Drug Status | application must include evidence of drug safety by providing animal or clinical information, proof of investigator’s qualifications to perform the research, and evidence of the drug product’s proven quality and strength |
| Trade name: | Proprietary or brand name the drug is marketed under. Ex: Tylenol |
| Generic name | Nonproprietary or US adopted name. EX: Acetaminophen |
| Doctors orders trade vs generic | Dr. can opt to have original instead of generic substitution by saying "dispense as written" on order |
| 3 requirements for administering drugs and procedure | 1) Valid med order 2) Prescriber and nurse must be licensed 3) Nurse must know the purpose, actions, effects, and major SE to question any propsed action that is potentially harmful to the client |
| What if the nurse is not familiar with the med? | It can not be relieved by another nurse. LOOK IT UP! |
| 5 rights of med | Right: Patient, Medication, Route, Dose, Time...6: Documentation |
| Controlled Substance Act of 1970 | categorized controlled substances on the basis of their potential for abuse. Schedule I-V with schedule I being the most addictive. Schedule I drugs are not legally marketed in the U.S |
| PQRST | pain, quality, region, severity, time/ duration |
| Telephone orders, procedure | 2 RNs must be present (one is to witness, other to write it down). After writing it down, repeat to dr to verify, physician must sign order within facilities alloted time |
| Rx vs OTC drugs, study: | Study in 1983 found that approx 1/3 OTC were safe and effective for labeled use. The others changed to Rx or were removed from the market. |
| Rx are what? | prescription drugs that can only be obtained with a prescription such as opioids, analgesics, etc. |
| OTC meds are what? | Medications that can be bought Over The Counter and have less potential for sever adverse effects. Ex: Claritin-D |
| Opioid Analgesics-Agonists: | Morphine, Codeine (Paveral), Hydrocodone bitartrate (vicodan), Hydromorphone (Dilaudid), Levorphanol (levo-Dromoran), Oxycodone (Percodan-ASA), Fentanyl (Sublimaze), Methadone (Dolophine, Methadose), Propoxyphene (Darvon), Meperidine (Demerol, Pethidine) |
| Opioid Analgesics--Agonist-Antagonists: | Butorphanol tartrate (Stadol), Dezocine (Dalgan), Pentazocine (Talwin), Nalbuphine (Nubain), Buprenorphine (Buprenex) |
| Opioid Analgesics-Antagonists: | Nalmefene (Revex), Nalonone hydrochloride (Narcan), Naltrexone (ReVia) |
| Nonopioid analgesics | Cyclooxygenase Inhibitors: Cox1 inhibitors(Aspirin) -- Cox2 inhibitors (Celebrex) |
| NSAIDS: | 1st generation: (Aspirin), 2nd generation: (Celebrex), Drugs with anti-inflammatory properties (NSAIDS)—Ibuprofen, Anti-gout meds (colchicines) |
| Meperidine facts | (Demerol, pethidine). AGONIST. Least potent opiod analgesic, largest doses, less apt to release histamine or increase biliary tract pressure, prolonged admin. or use in elderly can lead to neurotoxicity, shorter duration; more frequent dosing |
| Meperidine uses | acute asthma, biliary colicm and pancreatitis |
| Mepreidine SE | tachycardia (d/t vagolytic effect), tissue irritation at IM site (rotate sites), hypotension, behavior change, contraindicated in liver dysfunction, COPD, chronic pain |
| Narcan facts | ANTAGONIST, inactivated PO; very effect parenterally, onset 1-2min (IV), 2-5min (IM, SQ), fast acting, antidote for opiods, withdrawal symptoms in those physically dependent, receptor site: all 3, greater is mu |
| Morphine facts | AGONIST, superior to all analgesics, metabolized in liver; excreted by kidneys, PO, IM, IV, SC, epidural, intrathecally, Rectal, Addiction-common, Schedule II, withdraw gradually |
| Morphine action | Severe pain, CA, depress cough center, pulmonary edema due to periphearl vasodilation effect, MI, antidiarrheal effect (can cause constipation) |
| Morphine SE: | vertigo, faintness, light headedness, fatigue, sleepiness, N/V, sweating, constipation, hypotension, dry mouth, HA, anorexia, abd cramping, nervousness, ^ anxiety, mental confusion, urinary retention, dysuria, visual disturbances, & nightmares |
| Morphine ADR: | seizures, hepatic toxicity, skin rash, facial edema, breathing difficulties/resp. depression, excitability, confusion, tachycardia |
| Signs of OD with Morphine: | cold, clammy skin, drowsiness, dizziness, restlessness, mental confusion, miosis, decreasing pulse rate, coma, resp depression, & pin-point pupils |
| NSAID contraindications | bleeding disorder, 1 week prior to surgery, salicylism, children or teen suspected of having chickenpox, Reye's syndrome, pregnant, hypersensitivity |
| NSAID action | • Suppress inflammation, analgesic, inhibits prostaglandin synthesis, reduces fever, suppresses platelet aggregation |
| NSAID Adverse effects: | GI distress, heartburn, nausea, occult GI bleeding, bleeding, inhibition of kidney function intensifies warfarin therapy, risk of developing gastric ulcers |
| Cox 1 | Good! Aspirin, found in practially all tissues, DO NOT want to INHIBIT Cox 1 |
| Inhibition of Cox 1 action | causes gastric erosion and ulceration, bleeding tendencies, acute renal failure and protection against MI (due to the fact of reduced platelet aggregation |
| Cox 2 | Bad! Celebrex. Found at sites of tissue injury, inflammation, and sensitizes receptors to painful stimuli. You want to inhibit Cox 2. |
| Inhibition of Cox 2 action | suppression of inflammation, alleviation of pain and reduction of fever |
Created by:
Keller_KI
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