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