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pht 100-3
chapter 2 part 3
| Question | Answer |
|---|---|
| the drug listing act of 1972 gave the fda authority to | compile a list of currently marketed drugs that have ndc's |
| NDC means | nat'l drug code |
| a database of drugs kept by the fda is by | use, manufacturer, & ingredients |
| the orphan drug act of 1983, is for rare disease treatment drugs that are | approved by the fda which is prohibitively expensive to make & market |
| the orphan drug act of 1983, encourages their development by | giving tax incentive, granting exclusive license, & allowing expedited review & approval |
| the brand name is the | trade name under which the manufacturer markets the drug |
| a generic name sometimes denotes a drug | unprotected by trade mark |
| the drug price competition & patent restoration act of 1984 responded to pressure to | reduce drug costs, encouraged need for generics, & extended patent license to allow manufacturers to recoup research & development costs |
| brand & generics are compared by | form, safety, strength, quality, & performance |
| generics must demonstrate | bioequivalent to brand name product |
| over 60% of rx's are filled with | generics in community pharm] |
| the rx drug marketing act of 1987, keeps non-manufacturers from | re-importing drugs into the u.s. |
| the rx drug marketing act of 1987, responded to safety & competition issues & has major issues as | seniors go to canada for rx's or mail orders them |
| the anabolic steroid act of 1990, identifies steroids as | a CIII drug |
| steroids are | synthetic testosterone which gives serious effects when abused. |
| the omnibus budget act of 1990 requires | state standards of practice for drug use reviews |
| pharmacists must screen for | therapeutic duplications, drug disease contraindication, drug to drug interactions, incorrect dosage/duration of treatment, & clinical abuse/misuse |
| possibility of medicaid reimbursement loss | used to enforce rules |
| the omnibus budget reconciliation act of 1990, requires pharmacists to discuss with patients the | interactions & therapeutic contraindications such as the way to prevent them & what to do if they happen |
| the omnibus budget act of 1990, also wants pharmacists to tell patients how to | self-monitor drug therapy,refill info, proper storage, directed usage, & warnings |
| dietary supplement health & education act of 1994 says that manufacturers don't have to | prove safety, effectiveness, or standardization of products |
Created by:
frescah
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