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Pharmacology Ch 3
Pharmacology
| Question | Answer |
|---|---|
| Federal Pure Food & Drug Act, 1906 | Drugs must be free of adulterants |
| Food, Drug, & Cosmetic Act, 1938 | 1st to regulate drug safety - tested by FDA for toxicity |
| Harris-Kefauver Amendments, 1962 | Drugs must have some proven benefit (must be proven effective) |
| Controlled Substances Act, 1970 | Set rules for the manufacture and distribution of drugs considered to have potential for abuse |
| Drug Schedule (I-V) | I: Drugs have no accepted medical use in the U.S. (ex. heroin, mescaline, LSD) II-IV: have accepted use but potential for abuse V: least potential for abuse |
| Permission of Accelerated Drug Approval, 1992 | Gets needed AIDS & cancer drugs to market faster . . . there are drawbacks |
| Prescription Drug User Fee Act, 1992 | Companies can pay the FDA to review drugs faster |
| FDA Modernization Act, 1997 | 1) fast-track now includes other serious/life-threatening illnesses 2) Give pts 6m notice b/4 stop making drug 3) Clinical trial database for serious/life-threatening illness drugs 4) Companies can give out journal articles about off-label uses |
| Best Pharmaceuticals for Children Act, 2002 Pediatric Research Equity Act, 2003 | Test drug efficacy & safety in kids |
| FDA Amendments Act, 2007 | Expanded the mission of the FDA to include rigorous oversight of drug safety AFTER drug is on the market |
| 3 Benefits of Randomized Control Trials | Randomized control trials minimize personal bias on results 1) Use of Controls 2) Randomization 3) Blinding |
| Use of controls | See how drug compares to either standard Tx or no Tx for same disorder - tests safety & effectiveness |
| Randomization | Avoids allocation bias |
| Blinding | People involved don't know which group subject are in: single blind (subjects only), double blind (everyone) |
| Stages of New Drug Development | Preclinical testing Clinical testing (Phase I-IV) |
| Preclinical Testing | Required before a new drug may be tested in humans (1-5y). Evaluate for toxicity, pharmacokinetic properties, & potentially useful biologic effects |
| Clinical Testing | Can begin when drug is awarded Investigational Drug Status by the FDA (2-10y) |
| Phase I | Trials in HEALTHY volunteers unless drug likely to have severe SE's - then done in target disease population. Tests metabolism, pharmacokinetics, & bio effects. |
| Phase II & III | Trials in patients - tests therapeutic effects, dosage range, safety, effectiveness |
| Phase IV | If granted conditional approval of new drug (by applying to FDA) - released for general use permitting observation of effects on large population. |
| Limitations of the Testing Procedure (2) | 1) Limited information for women & children 2) Failure to detect all adverse effects |
| Things We Don't Know About How Most Drugs Affect Women & Children | 1) Are effects & SE's same as in men? 2) Effects of menstrual cycle on drugs? 3) Absorption, distribution, metabolism, excretion same? 4) Saftey during PG? |
| Why can't we detect all adverse effects in clinical trials? | 1) small # subjects in clinical trials 2) subjects don't represent entire population (carefully selected) 3) drugs taken for relatively short time (3-6m) |
| Discretion Regarding New Drugs | 1) Don't be the first or last to try it 2) Balance risks & benefits 3) New drugs generally riskier (don't know all SE's) |
| Nurses with Patients Taking New Drugs | Watch for unusual SE's - if pt shows unusual Sx, it's prudent to suspect the new drug even if Sx not mentioned in literature |
| 3 Types of Drug Names | Chemical Name Generic Name Trade Name |
| Chemical Name | What you learned in organic - too long & complicated to use |
| Generic Name (Non-Proprietary Name) | Assigned by US Adopted Names Council - each drug only has 1 - less complex than chemical name; more complex than trade name |
| Trade Name (Proprietary or Brand Name) | Name under which the drug is marketed. Created by drug companies to be easy to say. Can have MANY trade names. Must be FDA-approved. |
| Why should the generic name be used? | Name recognition would be facilitated through universal use of generic names. Use of multiple trade names can lead to "double medication". |
| Problems with Trade Names | 1) Too many! 2) Drugs w/ same name may have different active ingredients (Monistat vs. Monistat 1) 3) Manufacturers can reformulate brand-name products w/o changing trade name (Kaopectate & salicylates) |
| Trade Names Outside US | Products with IDENTICAL trade names may have different active ingredients. Traveler is exposed to all the risks of the medicine, but no needed benefits. |
| What is the only real concern with generic formulations? | Their rate and extent of absorption. |
| Good Sources of Drug Information | 1) Clinicians & Pharmacists 2) Poison Control Centers 3) Drug Reps - be careful . . . they won't volunteer negative info about drug 4) Goodman & Gilman's |
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