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CHAPTER 8GABBUAT, GALICIA, GANTE,
GONZALES, ISON
CONTROLLED SUBSTANCE
MANAGEMENT
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Introduction
The approach used in examining the
management o contro!!ed su"stances in
the hea!th#s$stem en%ironment is
medication#use s$stem& A!!o's s$stematic examination 'ithin an
organi(ation rom se!ection and
procurement through storage) in%entor$
management) dispensing) administration)sur%ei!!ance and s$stem e%a!uation&
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Introduction
*actors that in!uence the need or hea!th#s$stem
pharmacist in%o!%ement in contro!!ed su"stances
management+
,& -harmacists must ensure that a!! federal and
state law and regulations are o"e$ed.
. Contro!!ed Su"stance Act /CSA0 1 principa! edera!
!a' regu!ation
# Tit!e 22 o the *edera! Comprehensi%e Drug
A"use -re%ention and Contro! Act o ,345) under Tit!e
6, United States Code) starting at Section 74,&
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Introduction
Drug Enorcement Administration /DEA0 1
edera! entit$ charged 'ith enorcing and
imp!ementing the CSA
. Main mission+ to 'or8 in concert 'ithstate agencies and other edera!
agencies to pre%ent the di%ersion o
contro!!ed su"stances or i!!icit reasons
. -ro%ides inormati%e manua! targeted or
pharmacists
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Introduction
DEA is a"!e to carr$ out its mission through
regu!ations contained in the Code o
*edera! Regu!ations /C*R0 1 a set o
genera! or permanent ru!es that arepu"!ished in the *edera! Register "$ the
edera! go%ernment that is di%ided into 94
tit!es encompassing executi%e departments
and agencies co%ering "road areas su":ectto edera! regu!ation&
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Introduction
*actors that in!uence the need or hea!th#s$stem
pharmacist in%o!%ement in contro!!ed su"stances
management+
6& -harmacists need to ensure that contro!!ed
su"stances are used sae!$ 'ith minima! medication
errors resu!ting in ad%erse patient outcomes. and
;& -harmacists must ensure that contro!!ed su"stance
are used appropriate!$ to achie%e optima! hea!th or
patients&
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Patient Safety
2nstitute o Sae Medication -ractices /2SM-0
speciica!!$ opiates in se%era! dosage orms as high alert
medications
medication errors that in%o!%es contro!!ed su"stancesha%e greater ris8 o causing negati%e outcomes or
patients
resu!ts rom medication errors reported nationa!!$
through the US-#2SM- Medication Errors Reporting
-rogram /US-#MEDMAR
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Complexity of Pharmacotherapy
Can !ead to negati%e hea!th outcomes or
patients
Ne' ormu!ations o o!der agents !i8e
morphine in sustained re!ease orms or inno%e! administration orms can !ead to
therapeutic pro"!ems
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Selection of ControlledSubstances
*ormu!ar$
=hen contro!!ed su"stance medication is
considered or inc!usion onto a ormu!ar$) a
detai!ed e%a!uation o the medication isconducted 1 saet$) eicac$) toxicit$)
potentia! or ad%erse e%ents and a"use and
pharmacoeconomics
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Selection of ControlledSubstances
Criteria considered+
Location 'here contro!!ed su"stance 'i!! "e stored
Storage re>uirements or contro!!ed su"stances
-h$sica! securit$ re>uirements at the !ocation to ensure edera! or state
standards are met
Appropriate stoc8ing !e%e!s
Authori(ed access to medication "$ hea!th care sta
Re>uirement or an$ prescri"ing restrictions "ased on pro%iders? scope
o practice
2ncorporation o contro!!ed su"stances into an$ prescri"ing or c!inica!
guide!ines
Speciic medication ordering re>uirements "$ prescri"er
@ea!th care sta and patient education re>uirements on the use o the
contro!!ed su"stances
An$ ne' po!icies and procedures that need to "e addressed 'ith the
addition o contro!!ed su"stances
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Selection of ControlledSubstances
Ris8 Assessment
*ai!ure Mode and Eects Ana!$sis /*MEA0
1 useu! 'hen e%a!uating the contro!!ed
su"stances or ormu!ar$ addition) priorprocurement and distri"ution
# examines potentia! or ai!ures "$
identi$ing) c!assi$ing and assessing impact
o ai!ures
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Selection of ControlledSubstances
Ris8 Assessment
*ai!ure Modes 1 an$ errors or deects in a
process) design or item especia!!$ those
aect the patients Eects Ana!$sis 1 stud$ing the
conse>uences o those ai!ures
A critica! ana!$sis o the process can identi$ris8 reduction strategies to enhance patient
saet$
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Procurement of ControlledSubstances
*edera! Registration Re>uirements The hea!th#s$stems pharmac$ must "e registered
'ith the Drug Enorcement Agenc$ /DEA0
The registration is re>uired to "e rene'ed e%er$ ;$ears 'ith "oth the initia! and rene'a! in%o!%ing
ees
The pharmacist in charge o the hea!th s$stem
pharmac$ needs to ac>uire a comp!eteunderstanding o edera! re>uirements or
procurement and processes 'ith the medication#
use s$stme
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INVENTORY AND STORAGEMANAGEMENT
• Inventory n! Re"or!Re#$%re&ent' The pharmacist must assure comp!iance 'ith the
regu!ations pertaining to accounta"i!it$ and
documentation&
Inventory System 1 a!!o' or an audit trai! o comp!ete
and accurate documentation o the contro!!ed
su"stances&
Certain records must "e maintained or 2 years, in
either paper or e!ectronic ormat to "e readi!$ a%ai!a"!e&
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RECORDS TO BE MAITAIED!
Offi"ial order forms /oicia! record o receipt and sa!e0
#ower of Attorney /sign or DEA order orms0
Re"ei$ts and invoi"es Initial inventory /C*R re>uires the date and time o the
initia! in%entor$. name o the drug) strength) and dosage
orms. num"er o units or %o!ume and tota! >uantit$0
Biennial Inventory /conducted o!!o'ing the initia! in%entor$&
E%er$ t'o $ears0 Re"ords of "ontrolled su%stan"e distri%ution and
dis$ensing re"ords /prescription0
Re"ords, if needed, relating to t&eft or loss
Inventory of "ontrolled su%stan"es surrendered for
dis$osal
Re"ords of any transfers
DEA registration "ertifi"ate
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INVENTORY AND STORAGEMANAGEMENT
•P(y'%") Se"$r%ty n! Stor*e *edera! re>uirements or ph$sica! securit$ 1 'se"urely
lo"(ed in a su%stantially "onstru"ted "a%inet) to
deer thet and di%ersion&
=e can consider the o!!o'ing or securit$ measures+
Loc8ed ca"inet 'ith minima! stoc8 !e%e!s and !imited
access
Detection de%ices and a!arm s$stems
*ACTORS TO COSIDER I DETERMI+ TE -E.E-
O* SEC/RIT0 RE1/IRED!
-o"ation of t&e storage site
-evel of a"tivity of t&e storage site
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INVENTORY AND STORAGE
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INVENTORY AND STORAGEMANAGEMENT
• A$to&te! Stor*e n!
D%'tr%+$t%on Dev%"e' Automated Storage and Distri%ution 3 enhance theprocess o contro!!ed medication distri"ution 'ithin hea!th
s$stems
Devi"es 3 permit "etter in%entor$ contro! /e!ectronic
documentation o a!! contro!!ed medication use0
User identiication o access to the storage de%ices
#pro%ides an audit trai! i an$ discrepancies o records
occur
American Societ$ o @ea!th 1 S$stem -harmacists
# o%er%ie' o considerations or re>uirements in
automated storage and distri"ution de%ices
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MANAGEMENT
• D%'o') o- Contro))e! S$+'tn"eMe!%"t%on'
Reasons or disposa!+ due to expiration) damage or or other >ua!it$ contro!
reasons
Must "e segregated and in%entoried separate!$ rom a!!
other drugs& CODE O* *EDERAL REGULAT2ON /C*R0
in%entor$ detai!s+ in%entor$ date) drug name) strength and
dosage orm) tota! >uantit$ /%o!ume or num"er o units0)
reason or disposa!) i it is capa"!e to "e used ormanuacturing other contro!!ed medications&
Re%erse Distri"utor
compan$ that disposes o expired medications
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Ordering and Dispensing ofControlled Substances
Medication Orders 1 co%ered under the
Tit!e 6, C*R) Section ,;44& 2t deines a
prescription as a means o ordering
medication is intended to "e dispensed ora patient 'ho is the u!timate user&
This regu!ation does not co%er medication
orders that are 'ritten or the purpose o
"eing dispensed or immediateadministration
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Ordering and Dispensing ofControlled Substances
Electronic Prescribing
# =ith the ad%ent o ph$sician computer
order#entr$ and the strong mo%ement 'ithin
hea!th s$stems across the nation to adopt thistechno!og$) "oth edera! and and state !a's
and regu!ations 'i!! need to address the
e!ectronic transmission o medication orders
in the a"sence o paper
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Ordering and Dispensing ofControlled Substances
The %endor must ha%e a
current cop$ o $our DEA
!icense on i!e& The drug can on!$ "e
shipped to the address on$our !icense&
Shipment trac8ing must "e
used&
Once $ou ta8e possession othe su"stance) $ou are
responsi"!e or its hand!ing& Schedu!es 2 22 re>uire an
order orm
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Administration of ControlledSubstances
; -rimar$ actors re>uiring increased
scrutin$ o contro!!ed su"stances
Attri"uta"!e to edera! and state !a's and
regu!ations
-atient saet$
Comp!exit$ o pharmacotherap$
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Patient Safety
-harmacist must ta8e an acti%e ro!e in
'or8ing primari!$ 'ith the nursing sta to
reduce the ris8 o contro!!ed su"stances
di%ersion at the point o administration
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Complexity of Pharmacotherapy
Contri"utor$ to the en%ironment oincreasing the potentia! or medication
errors) 'ith mu!tip!e medications and
dosage orms) medications 'ith !oo8#a#!i8e
and sound#a#!i8e names) and the increaseduti!i(ation o inusion de%ices&
Risk Reduction Strategies
Minimi(ing medication errors prior to
administration on patient care units
Ealuation of Controlled Substances
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Ealuation of Controlled Substances
!edication "tili#ation Ealuation
$!"E% Program Examining uti!i(ation o contro!!ed
su"stances 'ithin the hea!th s$stem
Examines the uti!i(ation o a medication
and its eects on patient outcomes
Can "e a too! to stud$ the use o contro!!ed
su"stances throughout the medication
s$stem or to ocus on one particu!arprocess o the s$stem
a ua on o on ro e u s ances
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Contro!!ed su"stances 1 medications
that ha%e %arious potentia! or a"use
and di%ersion 'ithin medica! s$stem
This program ocuses on contro!!edsu"stances di%ersion and su"se>uent
a"use
Re>uired program that e%er$ pharmacistmust acti%e!$ engaged in
a ua on o on ro e u s ances
Controlled Substances Sureillance
Program
l i f ll d b
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-ro%ides the opportunit$ to impro%e the
>ua!it$ o patient care through
appropriate use o contro!!ed su"stances
Theses guide!ines are part o an$ MUEprogram that stri%es to ensure
appropriate uti!i(ation o medication
Can a!so "e used as a too! in acontro!!ed su"stances sur%ei!!ance
program
Ealuation of Controlled Substances
Clinical Practice &uidelines
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-rocesses 'ithin the Medication
Use S$stem
2t is o %ita! importance that po!icies and
procedures or contro!!ed su"stances
management "e de%e!oped and instituted
'ithin the organi(ation& This is "ecause othe o!!o'ing+
Ris8s associated 'ith contro!!ed
su"stances are too great to a!!o' much
!exi"i!it$ in the process
-oses rea! ris8s to patients
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A pharmacist?s career is at ris8 i he or
she is care!ess in hand!ing or recording
su"stances
Being !ax 'ith one?s responsi"i!it$ inmanaging contro!!ed su"stances is one o
the >uic8est 'a$s to get ired rom a
pharmac$
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Policies and Procedures
ita! too! in the management o a pharmac$ in
a hea!th s$stem&
E%ident in the management o contro!!ed
su"stances Needs to address the entire medication
s$stem 'hich inc!udes the o!!o'ing+
Se!ection
-rocurement and Storage
Ordering
Distri"ution and -reparation
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Policies and Procedures
Administration and Monitoring 1
essentia! to address the entire
medication management s$stem
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Controlled Substance
!anagement in the Philippines #&ili$$ine Drug Enfor"ement Agen"y /#DEA0
2s the !ead anti#drug !a' enorcement#agenc$)
responsi"!e or pre%enting) in%estigating andcom"ating an$ dangerous drugs)
contro!!ed precursors and essentia!
chemica!s 'ithin the -hi!ippines&
2s the imp!ementing arm o the Dangerous Drugs
Board 4DDB5&
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The agenc$ is tas8ed 'ith the enorcement o the
pena! and regu!ator$ pro%isions o Repu"!ic
Act No& 3,9 /R6A6 789:0) other'ise 8no'n as
the Com$re&ensive Dangerous Drugs A"t of
2;;2&
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Controlled Substance
!anagement in the PhilippinesDangerous Drug Board 4DDB5
is the po!ic$#ma8ing and strateg$#
ormu!ating "od$ in the p!anning andormu!ation o po!icies and programs on
drug pre%ention and contro!& #DEA and
DDB are "oth under the super%ision o
the Offi"e of t&e #resident&
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Controlled Substance !anagementin the Philippines
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Controlled Substance!anagement in the Philippines
Can dangerous drugs %e $res"ri%ed for
t&era$euti" $ur$oses=
A !icensed practitioner cou!d prescri"e) administer) ordispense dangerous drugs or therapeutic purpose to
a person diagnosed and treated or a condition
resu!ting in intracta"!e pain pro%ided that this
diagnosis and treatment ha%e "een documented in
the practitioner?s record& The prescription cannot
exceed ,44 dosage units or a ;,#da$ supp!$)
'hiche%er is higher&
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*orm 'A) and &ow s&all it
%e used=
The Annex *orm FA can "e used "$ pharmacists
in hospita!s and simi!ar institutions to 8eep
records o dangerous drugs dispensed in the in#
patient 'ards& On!$ a !icensed pharmacist or a
!icensed practitioner in a dispensar$ o an
institution sha!! issue a re>uisition or dangerous
drugs or drug preparations&
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Controlled Substance!anagement in the Philippines Can a $erson travelling to t&e #&ili$$ines %e allowed to
%ring in dangerous drugs or drug $re$arations for t&eir
medi"al use?treatment=
2nternationa! tra%e!ers are a!!o'ed to carr$ >uantities o
dangerous drugs or drug preparations or their medica! useand treatment) pro%ided that the$ ha%e the o!!o'ing
documents+
Origina! cop$ o a Certiication rom the attending
ph$sician that the patient needs the drug or themedication&
Speciic dates o arri%a! and departure rom the
-hi!ippines&
Origina! cop$ o prescription issued "$ the du!$ !icensed
attendin h sicianH doctor&
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Controlled Substance!anagement in the Philippines
The o!!o'ing are examp!es o Board
Regulations "$ DDB!
Ser%e' ./01
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Controlled Substance!anagement in the Philippines
Ser%e' ./02
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'ui#
,& An$ errors or deects in a process) design or
item especia!!$ those that aect patients&
A& *ai!ure Modes
B& Eects Ana!$sisC& Critica! Ana!$sis
6& 2t is the principa! edera! !a' regu!ation&
A& DEA
B& C*R
C& CSA
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'ui#;& 2t is useu! 'hen e%a!uating the contro!!ed su"stances or
ormu!ar$ addition and prior to procurement and distri"ution'ithin hea!th s$stem
A& Medication Uti!i(ation E%a!uation
B& *ai!ure Mode and Eects Ana!$sis
C& 2nstitute o Sae Medication -ractice
I& An$ errors or deects in process) design) or item)
especia!!$ those that aect the customer
A& Stop orders
B& Eect ana!$sis
C& *ai!ure modes
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'ui#
9& 2t enhances the process o contro!!ed
medication distri"ution hea!th s$stems
A& De%ices
B& Automated storage and distri"ution
C& User identiication
& Certain records must "e maintained "$J
A& 6 $earsB& I $ears
C& ; $ears
'ui
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'ui#5& 2t is a ita! too! in the management o a
pharmac$ in a hea!th s$stem& A&Medication Use S$stems
B& -o!icies and -rocedures
C& Administration and Monitoring
7& 2t is the !ead anti##drug !a' enorcement agenc$
in the -hi!ippines&
A& Dangerous Drug Board /DDB0 B&
Oice o the -residentC& -hi!ippine Drug Enorcement Agenc$ /-DEA0
' i
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'ui#3& 2t is contri"utor$ to the en%ironment o increasing the
potentia! or medication errors) 'ith mu!tip!e medications anddosage orms) medications 'ith !oo8#a#!i8e and sound#a#!i8e
names) and the increased uti!i(ation o inusion de%ices&
A& Comp!exit$ o -harmacotherap$
B& -atient Saet$C& Ris8 Reduction Strateg$
,4& This program ocuses on contro!!ed su"stances di%ersion
and su"se>uent a"use A& -atient Saet$
B& Medication Uti!i(ation E%a!uation /MUE0 -rogram
C& Contro!!ed Su"stances Sur%ei!!ance -rogram
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