F E N T A N Y L P A T C H E S :ANALYS I S O F I N T ERNAT I ONAL MED I CA T I ON I N C I D EN T S
Authors: Roger Cheng, BScPhm., PharmD., Carol Samples, BGS., Carol Lee, CPhT, CCHRA(A)., David U, BScPhm., MScPhm., Sylvia Hyland, BScPhm., MHSc (Bioethics), Sibylle von Guttenberg, Certina Ho, BScPhm., MISt., MEd.
B A C K G R O U N DEMedication incidents reported around the world with
fentanyl transdermal systems (fentanyl patches)
EMany of these incidents have resulted in patient harm and in some cases, even death
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M E T H O D O L O G YDATA CO L L E CT ION Fentanyl patch incident data received from the participating medication and patient safety centres in the UK, US, Canada and Ireland
QUANT ITAT IV E ANALYS I SEIncidents classified according to:
l Severity / outcome (Figure 1)l Type of incident (Figure 2)l Medication system stages involved (Figure 3)
QUAL I TAT IV E ANALYS I SEIncidents with narrative data fields availableEIncidents reviewed by two analysts to identify main
themesEFurther categorization within each main theme to achieve
homogeneous clustersEClusters studied to identify potential contributing factors
R E C O M M E N D A T I O N SEGreater efforts must be focused on safe guards to ensure
healthcare practit ioners have adequate knowledge and training in the proper use of fentanyl patches.
EEffective strategies should be put in place to ensure patients, care takers and their family are well informed and educated about the use of fentanyl patches.
QUAL I TAT IV E ANALYS I S
F r o m p a t i e n t s ’ p e r s p e c t i v e
4 main themes identified:EToo much, too soon: dose or frequency too highEToo little, too late: dose or frequency too lowEDon’t need (shouldn’t get): Inappropriate patientEOther
21 potential contributing factors identified within each of the main themes
F r o m h e a l t h s y s t e m s p e r s p e c t i v e :
21 potential contributing factors re-grouped to 6 areas of medication systems improvement:
ECritical information (e.g., inadequate knowledge on the part of health care practitioners)EPatient education EComplexities of administrationECommunication
(ordering and transcription) EProduct designEInterfaces of care
(e.g, fentanyl patches not recognized at interfaces of care)
E x a m p l e o f p o t e n t i a l c o n t r i b u t i n g f a c t o r s
EPatient education not provided
“…a patient’s caregiver placed the fentanyl patch on the patient’s buttock, which was the site of her pain. When the patient went to bed, she also used a heating pad at the same place. The patient was discovered dead two days later…neither the prescribing physician nor the pharmacist had counselled her on how to use the patch properly, and they hadn’t told her to avoid applying heat over the patch.”
EPatients with reduced functional status:
“A physician gave a 78 year old patient with chronic pain a prescription for fentanyl patch, with directions to apply on 25mcg patch. The patient was confused and put the patches “wherever it hurt.” She applied 6 patches in all…”
ELack of awareness of indication:
“A 14 year old boy was prescribed duragesic 25 for throat pain due to infectious mononucleosis. He was found in a respiratory arrest 14 hours after the first and only patch was applied. Resuscitative efforts were unsuccessful.”
(
O B J E C T I V E SETo gain an in-depth understanding of fentanyl patch
incidents through the following:l an aggregate analysis of fentanyl patch incidentsl a review of relevant medical literature
ETo present recommendations for medication systems enhancements to ensure the safe use of fentanyl patches
C O N C L U S I O N SEMulti-centered analysis conducted to gain an in-depth
understanding of fentanyl patch-related incidents
E6 areas of medication system improvement identified (21 potential contributing factors)
ERecommendations: Ensure practit ioner knowledge and patient education
EContinued efforts are necessary for the further development of effective systems based solutions targeting the various areas of improvements identified in this analysis
A c k n o w l e d g em e n t s : C a n a d i a n M e d i c a t i o n I n c i d e n t R e p o r t i n g a n d P r e v e n t i o n S y s t em ( CM I RP S ) , I SMP U . S . , Na t i o n a l P a t i e n t S a f e t y A g en c y (NP SA ) , U . K . ; a nd Ad e l a i d e and Mea t h Ho s p i t a l , Dub l i n , I r e l a nd
R E S U L T S
Total number of incidents received
n=3291
Only one form of data n=2235
Both quantitative & qualitative data
n=1056
Quantitative data only n=2215
Qualitative data only n=20
DATA CO L L E CT ION
Fentanyl patch medication incidents classified by severity of outcome (n=3271)
DeathHarmNo HarmNo Error0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
161263
8
2839
F i g u r e 1 S e v e r i t y o f o u t c o m e
QUANT ITAT IV E ANALYS I S
C A N A D A
Fentanyl patch medication incidents: Type of incident (Incidents with outcome of harm or death) (n=271)
F i g u r e 2 T y p e o f I n c i d e n t
0%
5%
15%
25%
35%
45%102
13 12 11 7 6 6 4 3
87
Wrong
dose,
stren
gth o
r qu
antity
Dose
omiss
ion
Incorrec
t drug
Presc
ribing
err
or
Wrong
fre
quen
cy
Incrorre
ct tim
e
Incorrec
t pa
tient
Incorrec
t ad
minis
tratio
n tec
hniqu
e
Contr
aindic
ation
Expir
ed o
r de
terior
ated
drug
QUANT ITAT IV E ANALYS I S Figure 3 M e d i c a t i o n S y s t e m S t a g e s I n v o l v e dFentanyl patch medication incidents classified by stages involved (Incidents with outcome of harm or death only) (n=271)
0%
10%
30%
50%
70%
3817
180
221 6
16
Physi
cian
orde
ring
Orde
r entr
y &
transcri
ption
Prep
aratio
n, dis
pensing
&
delivery
of d
rugs
Admi
nistra
tion
& supp
ly of
a drug
fro
m a clinic
al are
a
Monit
oring
/ fol
low-up
of drug
use N/A
Othe
r
QUANT ITAT IV E ANALYS I S
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