Safety issues with transdermal opioid medications - Australian and ...

Safety issues with transdermal
opioid medications – do they
matter?
Diane Reeves
Medication safety officer, NSCCH

Are patches a problem?
By 2005 the FDA reported 230 patients had died from using
Fentanyl patches in North America, 127 probably from
accidental overdose. However, there were numerous
deaths in California alone in that year.
Australian deaths and near misses have been reported
Ongoing legal action commonplace in the US
• Birth Control Patch Law Firm – “News about our Class
Action Lawsuit and Ortho Evra® Dangers”
• FDA Issues Warning About Ortho Evra® Birth Control
Patch
• Contact us for Fentanyl Duragesic Patch Lawyer
Representation in …

An example
• Patient arrived in ED from ….. With a GCS
of 3 and a respiratory rate of 6 with pin
point pupils.

History
• 1982 - Glyceryl trinitrate
• 1994 – Fentanyl
• 2002 – contraceptive patch
• 2004 – Buprenorphine
• Also transdermal medications for urinary
incontinence, Parkinson’s, s, Alzheimer’s
• In progress - for ADHD and oxycodone

Cross section of a Norspan
transdermal patch

IIMS NOTIFICATIONS – A SIGNAL
• Notification to the NSW incident database
is voluntary. Culture and enthusiasm
varies amongst and within the Areas.
• Quality of data entry varies with notifier,
but qualitative data can be very useful.
• The notifications are useful for emerging
trends – a signal but not reliable for
quantitative reporting.

New South Wales IIMS data
1. - Medications
Transdermal medications reported to NSW IIMS July 06 to June 07 ( 330)
Frequency
350
300
250
200
150
100
50
0
Medication
GTN
Fentanyl
Buprenorphine
Nicotine
Fent/bup
Unknown
Hyoscine
Emla
HRT
Frequency 128 108 49 28 9 4 3 1 1
Percent 38.7 32.6 14.8 8.5 2.7 1.2 0.9 0.3 0.3
Cum % 38.7 71.3 86.1 94.6 97.3 98.5 99.4 99.7 100.0
100
80
60
40
20
0
Percent

What exactly is the problem?

Well, this doesn’t t appear to be one!
Not one report of an illegible order

But definitely about ambiguity
It’s s all about communication - 1

And again – a common notification

New South Wales IIMS data
2 - Type of notification
NSW IIMS Transdermal medication issues ( all meds) July 06 to June 07
350
100
300
250
80
Frequency
200
150
60
40
Percent
100
50
20
0
Issue Admin Presc Other S8 issues Disp
Frequency 197 67 43 19 4
Percent 59.7 20.3 13.0 5.8 1.2
Cum % 59.7 80.0 93.0 98.8 100.0
0

Perceived problems with patches
Perceived problems with patches
Pareto Chart of Voting on Issues of Transdermal Medications
Vote
Percent
Medication chart needs On and O ff charted
Patch es no t visible designed to be discreet
No process for documenting patch location
Education of Doctors
Staff working too fast. Put o n & no t remove
Patient education
Other
Issue
40
30
20
10
0
100
80
60
40
20
0
Count 7 7 6 4 4 3 6
Percent 18.9 18.9 16.2 10.8 10.8 8.1 16.2
Cum % 18.9 37.8 54.1 64.9 75.7 83.8 100.0

Fishbone diagram of patch issues
Environment
Staff working too fast.
Policy and
Procedure
Staff
Education of Doctors
Education of nurses
Signed and then was distracted
Forgot to sign
Forgot to remove
Medication chart needs On
and Off charted
No process for documenting
patch location
Wrong patch applied
Not physically examining patient
Education pharmacist
Nurses inexperienced with patches
Not aware of implication of errors
Perceptions that patches are safe
Equipment
Still active after "replace time"
Safe disposal important
Different patches expire different times
Patches fall off
M ultiple patches to make up dose
Differing duration of action/dwell time
Not enough pharmacists
Dispensed wrong patch
Cutting patches
Can't find patch, too small
Patch put on in ED, not handed over
Not visible designed to be discreet
Patient
Doctors unaware different
Hairy skin requires special prep
Patient tells staff incorrect
information
Drug absorption varies with age
Body temperature affects
absorption
Patient removes patch
Patient doesn't perceive patch as
medication
Patient telling nurse patch is
removed
Patient education
Unintended
outcome to
patient

And the culprits are?
100
95
Notifications to IIMS Database by NSCCH
Jul-06
Feb-08
80
Number e
60
40
20
0
54
44
19
13
13 15
2
1 2
GTN Fentanyl Buprenorphine Nicotine HRT
Medication

100
80
Percent
60
Fentanyl
Fentanyl Transdermal Notifications 2005 to 2008
60
50
40
20
0
40
30
20
10
Prescribing issues
Multiple patches in place
Not put on
Missed off med history/error
Not changed on expiry
Not taken Patch fell off/missing
Taken off after procedures
Wrong timing
Wrong strength
Dispensing error
Other
Medication
0
Frequency 14 5 4 3 3 3 3 3 3 2 1 10
Percent 25.9 9.3 7.4 5.6 5.6 5.6 5.6 5.6 5.6 3.7 1.9 18.5
Cum % 25.9 35.2 42.6 48.1 53.7 59.3 64.8 70.4 75.9 79.6 81.5100.0
Frequency

100
80
Percent
60
Buprenorphine
Buprenorphine Transdermal Notifications 2005 to 2008
20
15
10
40
20
5
0
Missed off med history/error
Patch fell off/missing
Prescribing issues
Taken off after procedures
Clerical error
Not changed on expiry
Not put on
Other
Medication
0
Frequency 2 2 2 2 1 1 1 8
Percent 10.5 10.5 10.5 10.5 5.3 5.3 5.3 42.1
Cum % 10.5 21.1 31.6 42.1 47.4 52.6 57.9 100.0
Frequency

• FDA ALERT 7/15/2005;
“Fentanyl Transdermal System (marketed
as Duragesic) Information”
• Then
Update 12/21/2007: This update
highlights important information on
appropriate prescribing, dose
selection, and the safe use of the
fentanyl transdermal system.

Did the Alert make a difference?
• “Despite these efforts FDA has continued
to receive reports of death and life-
threatening adverse events .. when the
fentanyl patch was:
• used to treat pain in opioid-na
naïve patients
• opioid-tolerant patients have applied more
patches than prescribed,
• changed the patch too frequently,
• and exposed the patch to a heat source. “

Australian Adverse Drug Reactions Bulletin
Volume 26, Number 6, December 2007
• Transdermal medications - look for the
patch
• Despite a thorough medical history……
• the patient omitted to tell the anaesthetist and
other medical staff that she was using Norspan
patches, and she had applied a fresh patch on
the day of surgery. Medical staff discovered the
patch when the patient became comatose with
significant respiratory depression after the
conventional dose of morphine was given.

Warnings at Home

Problems and potential solutions -
Operational
• Medication needs On and Off charted
• No process for documenting patch location
Solution: - Have uniform policy re signing and dating
patch
Solution: - Work on hospital policy
Solution: - Patch NIMC (unlikely)
Solution: - Wipeable chart, X marks the spot
Solution: - Have a patch location chart
Solution: - Include on handover chart
• Patch too small
Solution: - Colour spot the patch whilst in hospital or
care facility

MIMS Prescribing information also confusing
Medication Trade name Listed as
Glyceryl
Trinitrate
Nicotine
Nitro-Dur
Transiderm
- Nitro
Nicorette
QuitX
Nicabate
Pack 5mg/24hours (10cm 2 ), 10mg/24 hours
(20cm 2 ), 15mg/24hours (30cm 2 )
Pack 5mg/24hours (25mg)Pack 10mg/24 hours
(50mg)
Nicotine 0.83mg/cm 2 , 15mg/16 hours,
10mg/16 hours, 5mg/16 hours
52.5mg delivers 21mg/24hours,
35mg -14mg in 24 hours,
17.5mg - 7mg in 24 hours
114mg (21mg/day),
78mg (14mg/day),
36mg (7mg/day)
Buprenorphine Norspan 10
and 20
Buprenorphine = 10mcg/hr. Patch 10mg.
And 20mg
Fentanyl Durogesic Pack 12mcg/hr(2.1mg) Pack 25mcg/hr (4.2mg)
Pack 50mcg/hr (8.4mg) Pack 75mcg/hr (12.6mg)
Pack 100mcg/hr (16.8mg)

The Way Forward
• Acknowledge that this is a
multidisciplinary issue, not any one group
of staff
• Realise that transdermal technology is on
the move and the number of medications
is only going to increase ( there’s s an
oxycodone patch en route too..)

What can you do as pain specialists
and prescribers
• Realise that patients don’t t always understand
what we may think as straightforward.
• Ensure that both the medical officers in your
team and the nursing staff at ward level,
appreciate the importance of orders being
prescribed and administered as expected
• Ensure that you are advised of any
deviations from your intended treatment
plan.
• Pharmacist available for patient counselling?

Don’t t forget the patient
• Educate the patient and their carers about
their patches.
• Patches are often forgotten both in their
medication history and subsequent
prescribing and administration.
• Prompt the patient as for other frequently
omitted medications, Eye drops?
Complementary medications? Patches?

All about communication - 2

Acknowledgments
• Clinical governance unit, NSCCH
• The Patch Project Team, RNSH
• Kai Zhang IIMS Project officer at the
Clinical Excellence Commission
• Charles Brooker for inviting me
And lastly but not least
• The staff at NSCCH who took the time to
enter notifications into the IIMS database