flashcards pharmac CH 1.txt

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teloff
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84538
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flashcards pharmac CH 1.txt
Updated:
2011-05-08 14:54:51
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medical coding pharmacology unit1 chap
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Pharmcology Unit 1 Chapter 1
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  1. drug standards
    "all preparations called by the same drug name must be of uniform strength, quality and purity"
  2. 1906 Pure Food and Drug Act
    • first gov attempt to establish consumer protection in the mfg of food & drugs
    • "req'd uniform strength, quality and purity"
    • req'd dangerous ingredients be on label
    • established the US Pharmacopeia and Nat'l Formulary; specified the official US standards for making each drug
  3. "1938 Fed Food, Drug and Cosmetic Act and Amendments of 1951 & 1962"
    • established food & drug admn
    • "est more specific regulations to prevent tampering with drugs, food & cosmetics"
    • : all labels must be accurate and include list of all active and inactive ingredients
    • : all new products must be approved by the FDA before public release
    • : warning labels must be present on certain preparations (ie may cause drowsiness)
    • ": created ""legend drugs"" - those drugs that cannot be sold w/o a prescription"
    • : also designated which drugs did not need prescriptions
    • : both prescr and non prescr drugs must be shown to be EFFECTIVE and SAFE
  4. 1970 Controlled Substances Act
    • est the Drug Enforcement Admin (DEA) to enforce provisions of the act
    • set much tighter controls on specific drugs that needed to be controlled: ie drugs being abused by society
    • : assigned abused and addicting drugs into five schedules: C1 (most addictive) - C5 (least addictive)
    • : specified handling regs for controlled substances; records to be held for 2 years
    • : set limitations on the use of prescription drugs; ie how many refills etc
    • ": reqd prescribers to register with DEA for license; includes mfg, vets, pharmacists, physicians"
  5. SCHEDULE 1 OF CONTROLLED SUBSTANCES
    • high abuse potential
    • not approved for use in US
    • "ie heroin, LSD, mescaline, ecstasy"
  6. SCHEDULE 2 OF CONTROLLED SUBSTANCES
    • high abuse potential; may lead to severe dependence
    • written prescription only; cannot be phoned in; new prescription every refill
    • "can be faxed, but original must be presented when picking up med"
    • "in an emergency, dr can phone in, but handwritten prescr must be presented at pharmacy within 7 days"
    • "ie morphine, codeine, methadone, Percocet, Tylox, Dilaudid, Ritalin, cocaine, Oxycontin, meperidine (Demerol)"
  7. SCHEDULE 3 OF CONTROLLED SUBSTANCES
    • may lead to limited dependence
    • written faxed or verbal prescriptions by physician only
    • may be refilled up to five times in 6 months
    • "ie codeine and hydrocodone w/ aspirin or tylenol, anabolic steroids"
  8. SCHEDULE 4 OF CONTROLLED SUBSTANCES
    • lower abuse potential
    • "prescription can be written out by health care practitioner, but must be signed by the physician"
    • prescription may be phoned in or faxed by health care practitioner
    • may be refilled up to five times in 6 months
    • "ie valium, ativan, xanax, phenobarbital, librium, darvocet, ristoril, ambien"
  9. SCHEDULE 5 OF CONTROLLED SUBSTANCES
    • low abuse potential
    • primarily for preparations for cough suppressants containing codeine and preparations for diarrhea (ie diphenoxylate)
    • "ie Promethazine w codeine, Cheratussin AC, Lomotil"
  10. 1983 Orphan Drug Act
    give pharmaceutical companies financial incentives to develop medications for diseases that affect only a small number of people
  11. Omnibus Budget Reconciliation Act (OBRA) of 1990
    • mandates that all Otc drugs a patient is taking must be documented as part of the medical record
    • pharmacists provide drug use review and patient counseling before dispensing prescriptions to a patient
  12. FDA
    • oversees testing of all proposed drugs before public release
    • "inspect plants where foods, drugs, medical devices or cosmetics are made"
    • review new drug applications and petitions for food additives
    • investigate and remove unsafe drugs from the market
    • "ensure proper labeling of foods, cosmetics and drugs"
  13. DEA
    • established in 1970 to enforce the drug laws
    • works with controlled substances only
    • separate agency from FDA
    • monitors need to move a drug from one schedule to another
  14. Withdrawing a drug from public
    • FDA recommends withdrawal when risks outweigh the benefits
    • FDA has no authority to remove from market
    • FDA can recommend to the manufacturer that it be pulled
  15. healthcare practitioners and the law
    • keep current drug reference book
    • double lock controlled substances
    • conceal & secure drug prescription pads
    • "keep accurate records of contolled substances dispensed, received or destroyed. Keep records for 2 years."
    • keep up to date with current news from FDA and DEA and controlled substances
    • establish a working rapport with a pharmacist
    • maintain a professional rapport with the pharmaceutical reps

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