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pht 100-3

chapter 2 part 3

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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