High Alert Medications:

Reliable Methods to Ensure

Safer Use
Christian Hartman, PharmD
Medication Safety fficer
Assistant Professor of Medicine
rgani!ation Profile
"
UMass Memorial Medical Center # $orcester, MA
"
%&' bed academic medical center
"
Multi#cam(us system
"
)e*el + trauma center
"
)e*el & ,-CU
"
.//% $inner 0 -SMP CHEERS A1ard
"
.//% $inner 0 ASHP Affiliate Pharmacy of the 2ear
A1ard
"
)ast 3oint Commission Sur*ey # ,o* .//%
0 ,o Medication Management R4-s
b5ecti*es
"
Define high#alert medications according to
63C, -H-, and -SMP
"
Discuss accreditation and regulatory
re7uirements for high#alert medications
"
utline error (re*ention, identification, and
mitigation strategies and best (ractices
"
8E*erybody gets so much information all
day long that they lose their common
sense9:
# ;ertrude Stein
Statistics

+9< million (re*entable ad*erse drug e*ents =ADEs> occur each year
in the United States9

f ..+,/// medication errors re(orted *ia MEDMAR? +@@%#.//< in

the (erio(erati*e setting:

%/A of the medication errors that result in (atient harm are caused by
./A of medications administered by (ractitioners9

6he leading medications in*ol*ed:

0 -nsulin 0 ++9&A
0 Mor(hine 0 .9&A
0 He(arin 0 &9<A
0 4entanyl 0 .9@A
0 Hydromor(hone 0 .9BA
Committee on -dentifying and Pre*enting Medication Errors9 As(den P, $olcott 3, Cootman 3), Cronen1ett )R, Editors9
Preventing Medication Errors: Quality Chasm Series. $ashington, DC: ,ational Academies PressD 3uly .//E9
Al(habet Sou(F
Definitions
"
-H- # medications that are most liGely to cause
significant harm to the (atient, e*en 1hen used
as intended
"
63C # medications that ha*e the highest risG of
causing in5ury 1hen misused
"
-SMP # mistaGes may not be more common in
the use of these medicationsD 1hen errors occur
the im(act on the (atient can be significant
Standards: -nstitute for Safe
Medication Practices =-SMP>
"
limit access to high#
alert medications
"
auHiliary labels and
automated alerts
"
standardi!e ordering,
storage, (re(aration,
and administration
em(loying
"
redundancies such as
automated or
inde(endent double#
checGs
Standards: 6he -nstitute for
Healthcare -m(ro*ement =-H->
"
< Million )i*es Cam(aign
"
;oal: reduce harm from high#alert
medications by </A by December .//%
"
Aim: Anticoagulants, ,arcotics and
(iates, -nsulin, Sedati*es
Standards: 6he 3oint
Commission =63C>
"
,ational Patient Safety ;oals
0
,PS; &
"
Medication Management
0
MM /+9/+9/&
0
MM /&9/+9/+
0
MM /%9/+9/+
63C Re7uirements: ,PS;
/&9/&9/+
"
6he hos(ital identifies and, at a minimum, annually
re*ie1s a list of looG#aliGeIsound#aliGe medications used
by the hos(ital and taGes action to (re*ent errors
in*ol*ing the interchange of these medications
0 EP+: 6he hos(ital identifies a list of looG#aliGeIsound#aliGe
medications used by the hos(ital9 6he list includes a minimum of
+/ looG#aliGeIsound#aliGe medication
0 EP.: 6he hos(ital re*ie1s the list of looG#aliGeIsound#aliGe
medications at least annually
0 EP&: 6he hos(ital taGes action to (re*ent errors in*ol*ing the
interchange of the medications on the list of looG#aliGeIsound#
aliGe medications
3oint Commission: .//@ Hos(ital Accreditation Manual9
63C Re7uirements:
MM /+9/+9/&
"
6he hos(ital safety manages high#alert and
ha!ardous medication
0
EP+ # 6he hos(ital identifies, in 1riting, its high#alert
medications
0
EP. # 6he hos(ital has a (rocess for managing
high#alert medications
0
EP& # 6he hos(ital im(lements its (rocess for
managing high#alert medications
0
EP' # 6he hos(ital minimi!es risGs associated 1ith
managing ha!ardous medications
3oint Commission: .//@ Hos(ital Accreditation Manual9
63C Re7uirements:
MM /&9/+9/+
"
6he hos(ital safety stores medications
0
EP@ # 6he hos(ital Gee(s concentrated electrolytes
(resent in (atient care areas only 1hen (atient
safety necessitates their immediate use and
(recautions are used to (re*ent inad*ertent
administration
3oint Commission: .//@ Hos(ital Accreditation Manual9
63C Re7uirements:
MM /%9/+9/+
"
6he hos(ital e*aluates the effecti*eness
of its medication management system9
0 EP< # Cased on analysis of its data, as 1ell as re*ie1 of the
literature for ne1 technologies and best (ractices, the hos(ital
identifies o((ortunities for im(ro*ement in its medication
management system
0 EP% # 6he hos(ital taGes action 1hen (lanned im(ro*ements
for its medication management (rocesses are either not
achie*ed or not sustained
3oint Commission: .//@ Hos(ital Accreditation Manual9
63C Sentinel E*ent Alerts
" -ssue '+ 0 Se(tember .', .//%: Pre*enting errors relating to commonly
used anticoagulants
" -ssue &@ # A(ril ++, .//%: Pre*enting (ediatric medication errors
" -ssue &' # 3uly +', .//<: Pre*enting *incristine administration errors
" -ssue && # December ./, .//': Patient controlled analgesia =PCA> by
(roHy
" -ssue .& # Se(tember +, .//+: Medication errors related to (otentially
dangerous abbre*iations
"
-ssue +@ May +, .//+: )ooG#aliGe, sound#aliGe drug names
$here do 1e beginJ
"
S(ecific medications
"
;eneral drug classes
"
S(ecific (rocesses
"
S(ecific (atient (o(ulations
S(ecific Medications: -nsulin
"
MEDMAR? # @,+&< errors in (erio(erati*e
settingD '9. A causing harm
"
Problem#
0
Multi(le (roducts a*ailable
0
)ooG aliGe sound aliGe names and (roducts
0
Abbre*iations =)antus +<Units>
0
Difficult dosing regimens
HicGs R$, CecGer SC, Cousins DD9 MEDMAR? Data Re(ort: A ChartbooG of Medication
Error 4indings from the Perio(erati*e Setting from +@@%#.//<9 RocG*ille, MD: USP Center for
the Ad*ancement of Patient Safety9
S(ecific Medications: (iates
"
)argest category of drugs associated 1ith
error related deaths
"
Problem#
0
,ame confusion =oHycodone *s oHycontin>
0
Dose con*ersion =mor(hine *s9 dilaudid>
0
*erla((ing regimens
0
Multi(le dosage forms =P, -K, 6D, etc>
Loc!mara C, Hyland S99 Pre*enting narcotic associated ad*erse e*ents in critical care units9
Dynamics +<:B#+/, 4all .//'9
S(ecific Medications:
Anticoagulants

Cates and colleagues re(ort that anticoagulants

accounted for 'A of (re*entable ADEs and +/A
of (otential ADEs9
"
Problem#
0
Multi(le (roducts =He(arin>
0
Difficult dosing regimens
0
Abbre*iations =He(arin <///Units>
0
)ooG aliGe sound aliGe names and (roducts =He(arin
*s9 Hes(an>
Cates D$, Cullen D3, )aird ,, et al9 -ncidence of ad*erse drug e*ents and (otential ad*erse
drug e*ents: -m(lications for (re*ention9 ADE Pre*ention Study ;rou(9 JAMA9 +@@<D.B':.@#
&'9
S(ecific Medications:
Concentrated Electrolytes
"
< to +/ (atients die annually due to
concentrated LCl in the United States
"
Re*ersal is difficult
"
Problem#
0
Access and storage
0
Procurement
3oint Commission Resources: Reducing the risG of errors associated 1ith concentrated
electrolyte solutions9 3oint Commission: 6he Source E:+#., Mar9 .//%9
S(ecific Medications: Sedation
"
Sedation is a continuum and often difficult to
(redict (atient res(onseD ty(es =+> minimal, =.>
moderate, =&> dee(, ='> anesthesia
"
Problem#
0
Dosing confusion =ie mida!olam onset of
action>
0
-na((ro(riate monitoring
0
EH(ertise, 7ualification, and credentialing of
staff
High#Alert Medications: Strategies for -m(ro*ing Safety9 3oint Commission 3oint Commission
Resources9
S(ecific Medications: ,MC
"
According to USP, there ha*e been more
than </ re(orts of significant misuse of
,MC
"
Problem#
0
-m(ro(er storage =-CU *s floor>
0
)ooG aliGe sound aliGe =Kanco *s Kec>
0
-na((ro(riate monitoring
0
Medication use (rocess
Smet!er 3)9 Pre*enting errors 1ith neuromuscular blocGing agents9 3t Comm 3 Mual Patient
Saf &.: <E#<@, 3an9 .//E9
S(ecific Medications:
Adrenergic Agents
"
Cen Lolb # syringe that 1as su((osed to
contain lidocaine actually contained
e(ine(hrine
"
Problem#
0
)ooG aliGe sound aliGe names and (acGaging
0
Multi(le manufacturers
0
)arge *ial si!es
High RisG Processes: ncology
"
-n the US, +9. million are diagnosed 1ith
cancer each yearD '%,/// eH(erience
some ty(e of ad*erse e*ent
"
Problem#
0
SelectionI(rocurementIstorage
0
rdering and monitoring
0
6ranscribing
0
Pre(aration and administration
3oint Commission Resources: Medication safety 1ith the use of chemothera(y agents9 3oint
Commission Pers(ecti*es on Patient Safety9 %:+#<, Mar9 .//%
High RisG Processes: Pediatrics
"
Similar medication error rates as adults butFthree times
the (otential to cause harm
"
*er </A of ne1 a((ro*ed medications ha*e not had
sufficient (edi research
"
Problem#
0 Com(leH regimens and dosing
0 Medication (re(aration
0 -mmature ability to metaboli!e
0 )acG of communication
3oint Commission Resources: Pre*enting (ediatric medication errors9 3oint Commission
Pers(ecti*es on Patient Safety9 B:<#E, Se(t9 .//B
High RisG Processes: Elderly
"
-nsulin, 1arfarin, and digoHin 1ere im(licated in one in
e*ery three estimated ADEs treated in ED and '+9<A of
estimated hos(itali!ations
"
Problem#
0 Altered metabolism
0 Decreased renal function
0 Poly(harmacy
0 Communication and technology
Cudnit! DS, PollocG DA, $eidenbach L,, et al9 ,ational sur*eillance of emergency
de(artment *isits for out(atient ad*erse drug e*ents9 JAMA9 .//ED.@E:+%<%#+%EE9
Strategies for Success
"
NAnyone can maGe the sim(le
com(licated9 Creati*ity is maGing the
com(licated sim(le9N
# Charles Mingus
Strategies for Success
"
;eneral recommendations for all
medications and (rocesses
"
S(ecific recommendations for select
medications
"
Additional recommendations
;eneral Recommendations
"
Design (rocesses to prevent errors and
harm9
"
Design methods to identify errors and
harm 1hen they occur9
"
Design methods to mitigate the harm
that may result from the error9
< Million )i*es Cam(aign9 ;etting Started Lit: Pre*enting Harm from High#Alert Medications9
Cambridge, MA: -nstitute for Healthcare -m(ro*ementD .//%9
Design Process to Prevent
Errors and Harm
"
Standardi!e order sets, (re(rinted order forms,
clinical (ath1ays
"
Standardi!e concentrations and dose strengths
"
Reminders about a((ro(riate monitoring
(arameters
"
Consider (rotocols for *ulnerable (o(ulations
such as the elderly, (ediatric, and obese
(atients
< Million )i*es Cam(aign9 ;etting Started Lit: Pre*enting Harm from High#Alert Medications9
Cambridge, MA: -nstitute for Healthcare -m(ro*ementD .//%9
Design Methods to -dentify
Errors and Harm
"
Ensure that critical lab information is a*ailable to those
1ho need the information and can taGe action
"
-m(lement inde(endent double#checGs 1here
a((ro(riate
"
-nstruct (atients on sym(toms to monitor and 1hen to
contact a health care (ro*ider for assistance
< Million )i*es Cam(aign9 ;etting Started Lit: Pre*enting Harm from High#Alert Medications9
Cambridge, MA: -nstitute for Healthcare -m(ro*ementD .//%9
Methods to Mitigate Harm
"
De*elo( (rotocols allo1ing for the
administration of re*ersal agents 1ithout
ha*ing to contact the (hysician
"
Ensure that antidotes and re*ersal agents
are readily a*ailable
"
Ha*e rescue (rotocols a*ailable
< Million )i*es Cam(aign9 ;etting Started Lit: Pre*enting Harm from High#Alert Medications9
Cambridge, MA: -nstitute for Healthcare -m(ro*ementD .//%9
Ho1 do 1e maGe mistaGesJ
#EHercise
"
61o teams
"
6eam + 0 count bounce (asses for
(layers in $H-6E shirts
"
6eam . 0 count chest (asses for (layers
in $H-6E shirts
http://viscog.beckman.uiuc.edu/flashmovie/15.php
Changing PracticeICeha*ior
"
4orced 4unctions
"
Constraints
"
ChecG listsI(ath1ays
"
Policy
"
;uidelines
"
Education
;eneral Recommendations:
Anticoagulants
"
4ormat anticoagulation orders to follo1 the (atient
through transitions of care
"
Use an anticoagulant dosing ser*ice or NclinicN in
in(atient and out(atient settings
"
Use ,)2 oral unit#dose (roducts and (re#miHed
infusions as a*ailable
"
Staff training and com(etency assessment
"
Conduct an Antithrombotic 6hera(y Self#assessment or
4MEA htt(:II1119ism(9orgIselfassessmentsIasa.//EI-ntro9as(
< Million )i*es Cam(aign9 ;etting Started Lit: Pre*enting Harm from High#Alert Medications9
Cambridge, MA: -nstitute for Healthcare -m(ro*ementD .//%9
" Patient -nformation
" Drug -nformation
" Communication of rders
" Storage
" De*ice Use
" Staff Com(etency
" Patient Education
" RisG Assessment
S(ecific Recommendations:
He(arin
"
$eight#based he(arin (rotocolInomogram
"
Pre(rinted order forms or ordering (rotocols
"
Account for the use of thrombolytics and ;--gI---a
inhibitors
"
)M$H and He(arin con*ersion standards
"
Standard concentrations
"
Se(arate liGe (roducts
"
He(#flush ordered and a*ailable in syringe
"
Monitoring (arameters are im(lemented
< Million )i*es Cam(aign9 ;etting Started Lit: Pre*enting Harm from High#Alert Medications9
Cambridge, MA: -nstitute for Healthcare -m(ro*ementD .//%9
S(ecific Recommendations:
$arfarin
"
,arro1 thera(eutic indeH # centrali!ed dosing
and monitoring ser*ice
"
Standardi!e dosing, monitoring, re*ersal
"
Minimi!e a*ailable strengthsD no tablet s(litting
"
,utrition consult for (atients on 1arfarin to a*oid
drugIfood interactions
"
Patient education and follo1#u(
< Million )i*es Cam(aign9 ;etting Started Lit: Pre*enting Harm from High#Alert Medications9
Cambridge, MA: -nstitute for Healthcare -m(ro*ementD .//%9
;eneral Recommendations:
(iate and ,arcotics
"
Standardi!e (rotocols
"
Monitoring for ad*erse effects of narcotics and
o(iates
"
Protocols for re*ersal agents
"
Centrali!ed (ain ser*ices
"
-nde(endent double#checGs
"
Minimi!e multi(le drug strengths and
concentrations 1here (ossible
"
Mutual (ain assessment and toileting
< Million )i*es Cam(aign9 ;etting Started Lit: Pre*enting Harm from High#Alert Medications9
Cambridge, MA: -nstitute for Healthcare -m(ro*ementD .//%9
S(ecific Recommendations:
-nsulin
"
Eliminate or standardi!e sliding scales
"
-nde(endent double#checG
"
Pre#(rinted insulin infusion orders and flo1sheets
"
Se(arate )ASAD standardi!e manufacturer
"
Pre(are all infusions in the (harmacy
"
Standardi!e to a single concentration for -K
"
Safeguards on high#dose insulin concentrationD re*ersal
(rotocols
< Million )i*es Cam(aign9 ;etting Started Lit: Pre*enting Harm from High#Alert Medications9
Cambridge, MA: -nstitute for Healthcare -m(ro*ementD .//%9
S(ecific Recommendations:
Concentrated Electrolytes
"
Eliminate storage on (atient care units 1hen
(ossible
"
Segregate bulG su((lies 1ithin the (harmacy
"
Secure after hours access to medication
su((lies
"
Utili!e (remiHI(re#(acGaged 1here feasible
"
AuHiliary labeling and (acGaging
"
Po(#u( 1arningsIalerts in ADM
High#Alert Medications: Strategies for -m(ro*ing Safety9 3oint Commission 3oint Commission
Resources9
S(ecific Recommendations:
Sedation
"
StocG only one concentration of moderate sedation
agents
"
Pre(rinted order formsIsets
"
Monitor all children on chloral hydrate
"
AgeIsi!e a((ro(riate resuscitation e7ui(ment
"
Ade7uately trained (ersonnel
"
4all (re*ention (rogram
High#Alert Medications: Strategies for -m(ro*ing Safety9 3oint Commission 3oint Commission
Resources9
S(ecific Recommendations:
,MC
"
SecureIsegregate storage
"
Restrict access to -CU, ED, R only
"
AuHiliary labeling and (acGaging
"
Alerts and (o(#u( 1arnings
"
Do not store on unit dose cartIADM matriH
dra1erD ADM single item only
"
Standardi!e formulary and (rescribing
"
Prom(t remo*al of (roduct after DIC
High#Alert Medications: Strategies for -m(ro*ing Safety9 3oint Commission 3oint Commission
Resources9
htt(:II1119ism(#canada9orgIdo1nloadIcaccnICACC,#S(ring/B9(df
S(ecific Recommendations:
Adrenergic Agents
"
PremiHed solutions and (refilled syringes 1hen
feasible
"
Standardi!e concentrations
"
A((ly )ASA standards
"
Standardi!e ordering =ie do not use 8titrate to
effect:>
"
EHtra*asation (olicy and Git
"
Utili!e different manufacturers 1hen feasible to
ensure (acGaging looGs different
High#Alert Medications: Strategies for -m(ro*ing Safety9 3oint Commission 3oint Commission
Resources9
S(ecific Recommendations:
ncology
"
ProcurementIDis(ensing # standardi!e
"
Storage # (hysical se(aration, negati*e (ressure room,
)ASA
"
rdering # standard order sets, CPE, ordering (olicy,
dose limits, (air 1ith (rotocols, forced # 1eight, blood
counts
"
6ranscribing # (rohibit *erbals if (ossible, transcri(tion
(olicy, inde(endent *erification
High#Alert Medications: Strategies for -m(ro*ing Safety9 3oint Commission 3oint Commission
Resources9
S(ecific Recommendations:
ncology
" Pre(arationIDis(ensing # inde(endent *erification, checG offs, staff
(rotection =USP B@B, closed systems, etc>, labeling
" Administration # inde(endent *erification of ne1 startsIrate
changesIetc, smart (um(s, clearly marGed catheters
" Monitoring # interdisci(linary monitoring, standard orders for
laboratory monitoring, cumulati*e dose
High#Alert Medications: Strategies for -m(ro*ing Safety9 3oint Commission 3oint Commission
Resources9
S(ecific Recommendations:
Pediatric
"
Segregate medications from adult storage areas
"
Standardi!e concentrations
"
Com(ounding and dilutions should occur 1ithin the
(harmacy
"
ral syringes for oral li7uids
"
Patient s(ecific unit dosing (ro*ided by (harmacy
"
Mandatory 1eights and ongoing assessment
"
Pediatric PO6 Committee and formulary
"
rdered using 1eight based formula =mgIGg>
"
Kisual cues for (ediatric orders and records
High#Alert Medications: Strategies for -m(ro*ing Safety9 3oint Commission 3oint Commission
Resources9
S(ecific Recommendations:
Elderly
"
Poly(harmacy assessment
"
Concurrent renal dosing monitoring
(rogram
"
Com(rehensi*e falls risG assessment
"
Ado(tion of Ceers criteria and mitigation
strategies
High#Alert Medications: Strategies for -m(ro*ing Safety9 3oint Commission 3oint Commission
Resources9
Ceers )ist
Donna M9 4icG, 3ames $9 Coo(er, $illiam E9 $ade, 3ennifer )9 $aller, 39 Ross Maclean, and MarG H9 Ceers9 U(dating the Ceers
Criteria for Potentially -na((ro(riate Medication Use in lder Adults: Results of a US Consensus Panel of EH(erts9 Arch -ntern Med,
Dec .//&D +E&: .B+E # .B.'9
Additional Recommendations:
Dedicated 6eams
"
Anticoagulation management team
"
-nterdisci(linary (ain management team
"
Dedicated (ediatric and oncology
co*erage
"
Annual risG assessment team # 4ailure
Mode and Effect Analysis
Additional Recommendations:
Patient Education
"
Engage (atient in*ol*ement
0
Pain management
0
Anticoagulation
"
Sim(le, *isual information
0
EHam(le: 1arfarin education
Additional Recommendations:
6echnology
"
Com(uteri!ed Practioner rder EntryIePrecribing
"
Car Coded Medication Administration =CCMA>
"
Dis(ensing *erification
"
R4-D
"
Smart Pum(s
"
Medication carousel
"
Electronic, real#time sur*eillance of trigger drugs, labs,
etc
Clinical Sur*eillance
A Robust ProgramF
"
Analy!es medications and (rocesses
"
A((lies standards and regulations
"
De*elo(s strategies to (re*ent, -dentify,
and mitigate errors and harm
"
Utili!es technology 1hen feasible
"
Engages the (atient and family
"
Design is not 5ust 1hat it looGs liGe and
feels liGe9 Design is ho1 it 1orGs9:
# Ste*e 3obs
Contact -nformation
Christian9HartmanPasmso9org
6he American Society of Medication Safety fficers
1119asmso9org
1119t1itter9comIChrisHartman