Drug Regulation, Development, Names and Information

Drug
Regulation,
Development,
Names and
Information
1. Drug
Regulation, Development, Names and Information
1.1. Landmark drug legislation
1.2. New drug development
1.3. Drug names
1.4. Over the counter drugs
1.5. Sources o drug inormation
2. Landmark Drug Legislation
2.1. Federal Pure Food and Drug Act, 1!"
2.2. Food, Drug, and #osmetic Act, 1$%
2.$. &arris'(efauver Amendments, 1"2
2.). #ontrolled *u+stances Act, 1,!
2.-. Permission of accelerated drug approval, 12
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Drug Regulation, Development, Names and Information
2.". Prescription Drug .ser Fee Act, 12
2.,. Food and Drug Administration /oderni0ation Act, 1,
2.%. 1est p2armaceutical for #2ildren Act, 2!!2
2.. Pediatric Researc2 34uit5 Act, 2!!$,
2.1!. FDA Amendments A#6 2!!,
$. Ne7 Drug Development
$.1. 62e randomi0ed controlled trial
3.1.1. !ontrol use
3.1.2. "andomi#ation
3.1.3. $linding
$.2. *tages of ne7 Drug Development
3.2.1. %reclinical testing
3.2.2. !linical testing
3.2.2.1. %hase &
3.2.2.2. %hase && and &&&
3.2.2.3. %hase &'( %ost)marketing surveillance
$.$. Limitations of t2e 6esting Procedure
3.3.1. Limited inormation or women and children
3.3.1.1. *omen
3.3.1.2. !hildren
3.3.2. +ailure to detect all adverse eects
$.). 38ercising Discretion Regarding Ne7 Drugs
3.4.1. $e neither the irst to adopt the new nor the last to a,andon the old.
3.4.2. $alance potential ,eneits against inherent risk.
3.4.3. New drugs generall- present greater risks than old ones.
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Drug Regulation, Development, Names and Information
). Drug Names
4.1. *hich name to use( .eneric or /rade0
4.1.1. 1se o drug names
4.1.1.1. *ritten and oral communication a,out medicines
4.1.1.2. La,eling medication containers
4.1.2. /he little pro,lems with generic names
4.1.2.1. 2ore complicated than trade names
4.1.3. /he ,ig pro,lems with trade names
4.1.3.1. Single drug can have multiple trade names
4.1.3.2. 1.S. drugs and drugs outside the 1.S. ma- have dierent active
ingredients.
4.1.3.3. %roducts with the same trade name ma- have dierent active
ingredients
4.1.3.3.1. 2onistat and kaopectate
4.1.4.
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Drug Regulation, Development, Names and Information
4.1.5.
).1.". 9eneric products versus +rand'name products
4.1.3.1. 4re generic products and ,rand name products therapeuticall-
e5uivalent0
4.1.3.2. *ould a dierence ,etween ,rand name and generic products
6usti- the o trade names
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Drug Regulation, Development, Names and Information
).2. :ver't2e'counter Drugs
).2.1. Americans spend a+out ;2! +illion annuall5 on :6# drugs
).2.2. :6# drugs account for "!< of all doses administered
).2.$. )!< of Americans take at least one :6# drug ever5 2 da5s
).2.). Four times as man5 illnesses are treated +5 a consumer using an
:6# drug as +5 a consumer visiting a p25sician.
).2.-. =it2 most illnesses >"!<'-<?, initial t2erap5 consists of self'care,
including self'medication 7it2 :6# drug.
).2.". 62e average 2ome medicine ca+inet contains 2) :6# preparations
).$. *ources of Drug information
).$.1. People
4.3.1.1. !linicians and pharmacists
4.3.1.2. %oison control centers
4.3.1.3. %harmaceutical sales representatives
).$.2. Pu+lis2ed information
4.3.2.1. /est)like ,ooks
4.3.2.1.1. .oodman7 .ilman8s /he %harmacological $asis o
/herapeutics
4.3.2.1.2. %harmacotherap-( 4 %athoph-siologic 4pproach
4.3.2.1.3. 4pplied /herapeutics( /he clinical 1se o Drugs
).$.2.2. Ne7sletters
4.3.2.2.1. /he medical letter on Drugs and /herapeutics
4.3.2.2.2. %rescri,er8s letter
4.3.2.3. "eerence $ooks
4.3.2.3.1. %h-sicians8 Desk "eerence
4.3.2.3.2. Drug acts and !omparisons
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Drug Regulation, Development, Names and Information
4.3.2.3.3. Nursing drug reerences
).$.2.). 62e Internet
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