PHAR5 Chapter 8.pptx

8/17/2019 PHAR5 Chapter 8.pptx

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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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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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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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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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•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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• 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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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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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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!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


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


33/47

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


37/47


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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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The o!!o'ing are examp!es o Board

Regulations "$ DDB!

Ser%e' ./01


42/47


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


44/47

'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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