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17 Cards in this Set
- Front
- Back
- 3rd side (hint)
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Pure food and drug act of 1906 |
Protects public from adulterated or mislabeled drugs. First federal/state drug law. Coca-cola with cocaine caused this to be made. |
Coca-cola |
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1912 Shirley amendment |
Cannot lie about what drugs do. |
Honesty |
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1938 food, drug and cosmetic act |
Drug manufacturers must have complete and accurate labels |
Real deal |
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1952 Durham-Humphrey amendment |
Specified How prescription drugs could be ordered and dispensed. Meds cannot be sold where they are prescribed, must be another area for safety reasons/additional checking. |
Pharmacy |
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1962 Kefauver-Harris amendment |
Require proof of both safety and efficacy(efficiency of drug) prior to approval |
Prove it! |
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Physicians Desk Reference |
Commercially published compilation of manufacturers prescribing info on script drugs, updated annually |
Pharm company info |
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Cochrane library |
Peer-reviewed online publication, uses of drugs, independent from pharmaceutical and government influence. |
No big brother |
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Package insert/drug label |
FDA mandated form, only has FDA approved info, including drug uses, adverse effects. Consumer cannot sue due to this document, considered the communication between drug company and patient. |
Contract |
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American Hospital Formulary Service |
Not limited to just FDA approved info, non-approved doses and uses as well. |
Off-label |
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FDA orange book |
Therapeutic equivalence evaluations for generic medications. Must have AB code to be approved. Using a brand name gives more control over what can be given, since it can only be subbed by something TE. |
Equivalency |
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Drug Price competition and patent term restoration act of 1984 |
Generics can submit an abbreviated NDA (New drug application) as opposed to pioneer/new drug NDA. This made all generics okay to use, so long as pharmaceutical equivalence and bioequivalence exist. This leads to therapeutic equivalence. |
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Therapeutic equivalence |
Proven by pharmaceutical equivalence and bioequivalence. Must lie within 80-125% of pioneer drug by law, but usually within 3-5%. In Texas, there are 0 drugs that cannot have a generic version made. |
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Phase 1 clinical trials vs phase 2 and 3 |
Phase 1 does not involve those afflicted with target disease, phase 2 does, in a small amount, to measure effects and side-effects. Phase 3 is on a larger scale than phase 2 and is very expensive. |
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Schedule 1 drugs vs schedule 2 and 3 |
Schedule 1 have no accepted medical purpose, only for research protocols. Schedule 2 do have a medical purpose/use and can be prescribed for 30 Days with no refills. Schedule 3 have less addictive potential, can have refills for 3 months. |
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Controlled substance act |
Schedule 1-5 of medications, ascending #’s means more availability to it. 1 has no accepted medical use, research protocols only |
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Legend drug |
A drug that requires a script, controlled and non-controlled. |
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OTC vs BTC |
OTC: self-diagnose, low-risk if followed correctly. BTC: schedule V drugs (may not require script.) |
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