Kee: Pharmacology, 8th Edition

Chapter 2: The Drug Approval Process

Downloadale Key Points
The U.S. Food and Drug Administration (FDA) averages 23 drug approvals per year.
The FDA Critical ath !nitiative is a national strategy "to drive innovation in the
scienti#ic processes through $hich medical products are developed% evaluated% and
manu#actured.&
D!"# $TA%DA!D$ A%D &E#'$&AT'(%
The com'ination o# drug discovery and manu#acturing ta(es )2 to 2* years% $ith a cost o#
more than +) 'illion. ,nly a small percentage o# drugs are approved.
The United States Pharmacopeia National Formulary (USP-NF) is the authoritative
source #or drug standards.
Drugs included in the US-.F have met high standards #or therapeutic use% patient
sa#ety% /uality% purity% strength% pac(aging sa#ety% and dosage #orm.
The International Pharmacopeia% #irst pu'lished in )01) 'y the 2orld 3ealth
,rgani4ation (23,)% provides a 'asis #or standards in strength and composition o# drugs
#or use throughout the $orld. Through #ederal legislation% the pu'lic is protected #rom
drugs that are impure% to5ic% ine##ective% or not tested 'e#ore pu'lic sale.
The Food% Drug% and Cosmetic Act o# )036 empo$ered the FDA to ensure drug sa#ety 'y
monitoring and regulating the manu#acture and mar(eting o# drugs. !t is the FDA7s
responsi'ility to ensure that all drugs are tested #or harm#ul e##ects% have la'els $ith
accurate in#ormation% and enclose detailed literature in the drug pac(aging that e5plains
adverse e##ects.
The Durham-3umphrey Amendment to the Food% Drug% and Cosmetic Act o# )036
distinguished 'et$een drugs that can 'e sold $ith or $ithout prescription and those that
should not 'e re#illed $ithout a ne$ prescription.
The 8e#auver-3arris Amendment o# )092 tightened controls on drug sa#ety% especially
e5perimental drugs% and re/uired that adverse reactions and contraindications must 'e
la'eled and included in the literature.
The Controlled Su'stances Act o# )0:*% designed to remedy the escalating pro'lem o#
drug a'use% included several provisions; ()) the promotion o# drug education and research
into the prevention and treatment o# drug dependence% (2) the strengthening o#
en#orcement authority% (3) the esta'lishment o# treatment and reha'ilitation #acilities% and
(<) the designation o# schedules% or categories% #or controlled su'stances according to
a'use lia'ility.
Schedule ! drugs are not approved #or medical use= schedule !! through > drugs have
accepted medical use. The a'use potential and e5tent o# physical and psychological
dependence are greatest $ith schedule ! drugs. This dependency decreases as one moves
through the schedule% $ith schedule > drugs having only limited a'use potential.
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The ,rphan Drug Act o# )063 promoted the development and manu#acture o# drugs used
to treat rare diseases through ()) #ederal #unding o# grants and contracts to per#orm
clinical trials o# orphan products% (2) 1*A ta5 credit #or costs o# clinical testing% and (3)
e5clusive right to mar(et the drug #or : years #rom the mar(eting approval date.
There are #ive provisions o# the )00: Food and Drug Administration Boderni4ation Act;
()) revie$ and use o# ne$ drugs is accelerated= (2) drugs can 'e tested in children 'e#ore
mar(eting= (3) clinical trial data are necessary #or e5perimental drug use #or serious or
li#e-threatening health conditions= (<) drug companies are re/uired to give in#ormation on
"o##-la'el& drugs (nonCFDA-approved drugs) and their uses and costs= and (1) drug
companies that plan to discontinue drugs must in#orm health pro#essionals and patients at
least 9 months 'e#ore stopping drug production.
The 3ealth !nsurance orta'ility and Accounta'ility Act (3!AA) o# 2**3 set the
standards #or the privacy o# individually identi#ia'le health in#ormation.
@ssential components o# the 2*)* atient rotection and A##orda'le Care Act include ())
/uality% a##orda'le health care #or all Americans= (2) improved /uality and e##iciency o#
health care= (3) prevention o# chronic disease and improved pu'lic health= (<) improved
access to innovative medical therapies% and (1) community living services and supports.
%"!$E P!ACT'CE ACT$
@very state has its o$n la$s regarding drug administration 'y nurses= generally% nurses
cannot prescri'e or administer drugs $ithout a health care provider7s order.
!n a civil court% the nurse can 'e prosecuted #or giving the $rong drug or dosage% omitting
a drug dose% or giving the drug 'y the $rong route.
CA%AD'A% D!"# !E#"&AT'(%
!n Canada% the 3ealth rotection Dranch% Department o# .ational 3ealth and 2el#are% is
responsi'le #or the administration o# the t$o acts that are the #oundation o# national drug
la$s.
The manu#acture% distri'ution% and sale o# drugs (e5cept narcotics) are controlled 'y the
Canadian Food and Drug Act% amended in )013.
The manu#acture% distri'ution% and sale o# narcotic drugs are controlled 'y the )009
Controlled Drugs and Su'stances Act.
.onprescription drugs are administered 'y the pharmacy acts o# the respective Canadian
provinces that identi#y the place and conditions o# sale.
'%'T'AT')E$ T( C(*+AT D!"# C("%TE!,E'T'%#
Bedication sa#ety may 'e a##ected 'y counter#eit drugs and adulterated prescription
drugs.
Use o# counter#eit and adulterated prescription drugs is on the rise.
The role o# the nurse is critical in consumer education= nurses must advise patients to
report any di##erences in taste or appearance o# a drug or in its pac(aging.
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D!"# %A*E$
@ach drug may have several di##erent names; the chemical name% the generic name% and
the trade or 'rand name.
The chemical name o# a drug descri'es the chemical structure o# the drug.
The generic name is the o##icial% nonproprietary name #or the drug.
The generic name al$ays 'egins $ith lo$ercase letters.
Eeneric drugs must 'e approved 'y the FDA 'e#ore they can 'e mar(eted.
Eeneric drugs have the same active ingredients as 'rand-name drugs.
Some generic drugs have inert #illers and 'inders that may result in variations o# drug
e##ectiveness.
The 'rand (trade) name% also (no$n as the proprietary name% is chosen 'y the drug
company and is usually a registered trademar( o$ned 'y that speci#ic company.
Drand names al$ays 'egin $ith a capital letter.
D!"# !E$("!CE$
Bany drug re#erences are availa'le% including nursing te5ts that identi#y related nursing
interventions and areas #or health teaching.
American Hospital Formulary Service (AHFS) Drug Inormation is pu'lished 'y the
American Society o# 3ealth-System harmacists in Dethesda% Baryland. !t provides
accurate and complete drug in#ormation on nearly all prescription drugs mar(eted in the
United States.
The United States Pharmacopeia!Drug Inormation (USP-DI) is a three-volume set that
is availa'le in most hospitals and pharmacies and supplies monthly supplements. The #irst
t$o volumes% >olumes !A and !D% provide drug in#ormation #or the health care provider.
Bedlinelus is a service o# the U.S. .ational Fi'rary o# Bedicine. Availa'le at
http;GG$$$.nlm.nih.govGmedlineplusGdrugin#ormation% it o##ers e5tensive in#ormation on
prescri'ed drugs as $ell as her's and supplements% inde5ed 'y generic and 'rand names.
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