Safety issues with transdermal opioid medications - Australian and ...
Safety issues with transdermal opioid medications - Australian and ...
Safety issues with transdermal opioid medications - Australian and ...
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<strong>Safety</strong> <strong>issues</strong> <strong>with</strong> <strong>transdermal</strong><br />
<strong>opioid</strong> <strong>medications</strong> – do they<br />
matter?<br />
Diane Reeves<br />
Medication safety officer, NSCCH
Are patches a problem?<br />
By 2005 the FDA reported 230 patients had died from using<br />
Fentanyl patches in North America, 127 probably from<br />
accidental overdose. However, there were numerous<br />
deaths in California alone in that year.<br />
<strong>Australian</strong> deaths <strong>and</strong> near misses have been reported<br />
Ongoing legal action commonplace in the US<br />
• Birth Control Patch Law Firm – “News about our Class<br />
Action Lawsuit <strong>and</strong> Ortho Evra® Dangers”<br />
• FDA Issues Warning About Ortho Evra® Birth Control<br />
Patch<br />
• Contact us for Fentanyl Duragesic Patch Lawyer<br />
Representation in …
An example<br />
• Patient arrived in ED from ….. With a GCS<br />
of 3 <strong>and</strong> a respiratory rate of 6 <strong>with</strong> pin<br />
point pupils.
History<br />
• 1982 - Glyceryl trinitrate<br />
• 1994 – Fentanyl<br />
• 2002 – contraceptive patch<br />
• 2004 – Buprenorphine<br />
• Also <strong>transdermal</strong> <strong>medications</strong> for urinary<br />
incontinence, Parkinson’s, s, Alzheimer’s<br />
• In progress - for ADHD <strong>and</strong> oxycodone
Cross section of a Norspan<br />
<strong>transdermal</strong> patch
IIMS NOTIFICATIONS – A SIGNAL<br />
• Notification to the NSW incident database<br />
is voluntary. Culture <strong>and</strong> enthusiasm<br />
varies amongst <strong>and</strong> <strong>with</strong>in the Areas.<br />
• Quality of data entry varies <strong>with</strong> notifier,<br />
but qualitative data can be very useful.<br />
• The notifications are useful for emerging<br />
trends – a signal but not reliable for<br />
quantitative reporting.
New South Wales IIMS data<br />
1. - Medications<br />
Transdermal <strong>medications</strong> reported to NSW IIMS July 06 to June 07 ( 330)<br />
Frequency<br />
350<br />
300<br />
250<br />
200<br />
150<br />
100<br />
50<br />
0<br />
Medication<br />
GTN<br />
Fentanyl<br />
Buprenorphine<br />
Nicotine<br />
Fent/bup<br />
Unknown<br />
Hyoscine<br />
Emla<br />
HRT<br />
Frequency 128 108 49 28 9 4 3 1 1<br />
Percent 38.7 32.6 14.8 8.5 2.7 1.2 0.9 0.3 0.3<br />
Cum % 38.7 71.3 86.1 94.6 97.3 98.5 99.4 99.7 100.0<br />
100<br />
80<br />
60<br />
40<br />
20<br />
0<br />
Percent
What exactly is the problem?
Well, this doesn’t t appear to be one!<br />
Not one report of an illegible order
But definitely about ambiguity<br />
It’s s all about communication - 1
And again – a common notification
New South Wales IIMS data<br />
2 - Type of notification<br />
NSW IIMS Transdermal medication <strong>issues</strong> ( all meds) July 06 to June 07<br />
350<br />
100<br />
300<br />
250<br />
80<br />
Frequency<br />
200<br />
150<br />
60<br />
40<br />
Percent<br />
100<br />
50<br />
20<br />
0<br />
Issue Admin Presc Other S8 <strong>issues</strong> Disp<br />
Frequency 197 67 43 19 4<br />
Percent 59.7 20.3 13.0 5.8 1.2<br />
Cum % 59.7 80.0 93.0 98.8 100.0<br />
0
Perceived problems <strong>with</strong> patches<br />
Perceived problems <strong>with</strong> patches<br />
Pareto Chart of Voting on Issues of Transdermal Medications<br />
Vote<br />
Percent<br />
Medication chart needs On <strong>and</strong> O ff charted<br />
Patch es no t visible designed to be discreet<br />
No process for documenting patch location<br />
Education of Doctors<br />
Staff working too fast. Put o n & no t remove<br />
Patient education<br />
Other<br />
Issue<br />
40<br />
30<br />
20<br />
10<br />
0<br />
100<br />
80<br />
60<br />
40<br />
20<br />
0<br />
Count 7 7 6 4 4 3 6<br />
Percent 18.9 18.9 16.2 10.8 10.8 8.1 16.2<br />
Cum % 18.9 37.8 54.1 64.9 75.7 83.8 100.0
Fishbone diagram of patch <strong>issues</strong><br />
Environment<br />
Staff working too fast.<br />
Policy <strong>and</strong><br />
Procedure<br />
Staff<br />
Education of Doctors<br />
Education of nurses<br />
Signed <strong>and</strong> then was distracted<br />
Forgot to sign<br />
Forgot to remove<br />
Medication chart needs On<br />
<strong>and</strong> Off charted<br />
No process for documenting<br />
patch location<br />
Wrong patch applied<br />
Not physically examining patient<br />
Education pharmacist<br />
Nurses inexperienced <strong>with</strong> patches<br />
Not aware of implication of errors<br />
Perceptions that patches are safe<br />
Equipment<br />
Still active after "replace time"<br />
Safe disposal important<br />
Different patches expire different times<br />
Patches fall off<br />
M ultiple patches to make up dose<br />
Differing duration of action/dwell time<br />
Not enough pharmacists<br />
Dispensed wrong patch<br />
Cutting patches<br />
Can't find patch, too small<br />
Patch put on in ED, not h<strong>and</strong>ed over<br />
Not visible designed to be discreet<br />
Patient<br />
Doctors unaware different<br />
Hairy skin requires special prep<br />
Patient tells staff incorrect<br />
information<br />
Drug absorption varies <strong>with</strong> age<br />
Body temperature affects<br />
absorption<br />
Patient removes patch<br />
Patient doesn't perceive patch as<br />
medication<br />
Patient telling nurse patch is<br />
removed<br />
Patient education<br />
Unintended<br />
outcome to<br />
patient
And the culprits are?<br />
100<br />
95<br />
Notifications to IIMS Database by NSCCH<br />
Jul-06<br />
Feb-08<br />
80<br />
Number e<br />
60<br />
40<br />
20<br />
0<br />
54<br />
44<br />
19<br />
13<br />
13 15<br />
2<br />
1 2<br />
GTN Fentanyl Buprenorphine Nicotine HRT<br />
Medication
100<br />
80<br />
Percent<br />
60<br />
Fentanyl<br />
Fentanyl Transdermal Notifications 2005 to 2008<br />
60<br />
50<br />
40<br />
20<br />
0<br />
40<br />
30<br />
20<br />
10<br />
Prescribing <strong>issues</strong><br />
Multiple patches in place<br />
Not put on<br />
Missed off med history/error<br />
Not changed on expiry<br />
Not taken Patch fell off/missing<br />
Taken off after procedures<br />
Wrong timing<br />
Wrong strength<br />
Dispensing error<br />
Other<br />
Medication<br />
0<br />
Frequency 14 5 4 3 3 3 3 3 3 2 1 10<br />
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<br />
Cum % 25.9 35.2 42.6 48.1 53.7 59.3 64.8 70.4 75.9 79.6 81.5100.0<br />
Frequency
100<br />
80<br />
Percent<br />
60<br />
Buprenorphine<br />
Buprenorphine Transdermal Notifications 2005 to 2008<br />
20<br />
15<br />
10<br />
40<br />
20<br />
5<br />
0<br />
Missed off med history/error<br />
Patch fell off/missing<br />
Prescribing <strong>issues</strong><br />
Taken off after procedures<br />
Clerical error<br />
Not changed on expiry<br />
Not put on<br />
Other<br />
Medication<br />
0<br />
Frequency 2 2 2 2 1 1 1 8<br />
Percent 10.5 10.5 10.5 10.5 5.3 5.3 5.3 42.1<br />
Cum % 10.5 21.1 31.6 42.1 47.4 52.6 57.9 100.0<br />
Frequency
• FDA ALERT 7/15/2005;<br />
“Fentanyl Transdermal System (marketed<br />
as Duragesic) Information”<br />
• Then<br />
Update 12/21/2007: This update<br />
highlights important information on<br />
appropriate prescribing, dose<br />
selection, <strong>and</strong> the safe use of the<br />
fentanyl <strong>transdermal</strong> system.
Did the Alert make a difference?<br />
• “Despite these efforts FDA has continued<br />
to receive reports of death <strong>and</strong> life-<br />
threatening adverse events .. when the<br />
fentanyl patch was:<br />
• used to treat pain in <strong>opioid</strong>-na<br />
naïve patients<br />
• <strong>opioid</strong>-tolerant patients have applied more<br />
patches than prescribed,<br />
• changed the patch too frequently,<br />
• <strong>and</strong> exposed the patch to a heat source. “
<strong>Australian</strong> Adverse Drug Reactions Bulletin<br />
Volume 26, Number 6, December 2007<br />
• Transdermal <strong>medications</strong> - look for the<br />
patch<br />
• Despite a thorough medical history……<br />
• the patient omitted to tell the anaesthetist <strong>and</strong><br />
other medical staff that she was using Norspan<br />
patches, <strong>and</strong> she had applied a fresh patch on<br />
the day of surgery. Medical staff discovered the<br />
patch when the patient became comatose <strong>with</strong><br />
significant respiratory depression after the<br />
conventional dose of morphine was given.
Warnings at Home
Problems <strong>and</strong> potential solutions -<br />
Operational<br />
• Medication needs On <strong>and</strong> Off charted<br />
• No process for documenting patch location<br />
Solution: - Have uniform policy re signing <strong>and</strong> dating<br />
patch<br />
Solution: - Work on hospital policy<br />
Solution: - Patch NIMC (unlikely)<br />
Solution: - Wipeable chart, X marks the spot<br />
Solution: - Have a patch location chart<br />
Solution: - Include on h<strong>and</strong>over chart<br />
• Patch too small<br />
Solution: - Colour spot the patch whilst in hospital or<br />
care facility
MIMS Prescribing information also confusing<br />
Medication Trade name Listed as<br />
Glyceryl<br />
Trinitrate<br />
Nicotine<br />
Nitro-Dur<br />
Transiderm<br />
- Nitro<br />
Nicorette<br />
QuitX<br />
Nicabate<br />
Pack 5mg/24hours (10cm 2 ), 10mg/24 hours<br />
(20cm 2 ), 15mg/24hours (30cm 2 )<br />
Pack 5mg/24hours (25mg)Pack 10mg/24 hours<br />
(50mg)<br />
Nicotine 0.83mg/cm 2 , 15mg/16 hours,<br />
10mg/16 hours, 5mg/16 hours<br />
52.5mg delivers 21mg/24hours,<br />
35mg -14mg in 24 hours,<br />
17.5mg - 7mg in 24 hours<br />
114mg (21mg/day),<br />
78mg (14mg/day),<br />
36mg (7mg/day)<br />
Buprenorphine Norspan 10<br />
<strong>and</strong> 20<br />
Buprenorphine = 10mcg/hr. Patch 10mg.<br />
And 20mg<br />
Fentanyl Durogesic Pack 12mcg/hr(2.1mg) Pack 25mcg/hr (4.2mg)<br />
Pack 50mcg/hr (8.4mg) Pack 75mcg/hr (12.6mg)<br />
Pack 100mcg/hr (16.8mg)
The Way Forward<br />
• Acknowledge that this is a<br />
multidisciplinary issue, not any one group<br />
of staff<br />
• Realise that <strong>transdermal</strong> technology is on<br />
the move <strong>and</strong> the number of <strong>medications</strong><br />
is only going to increase ( there’s s an<br />
oxycodone patch en route too..)
What can you do as pain specialists<br />
<strong>and</strong> prescribers<br />
• Realise that patients don’t t always underst<strong>and</strong><br />
what we may think as straightforward.<br />
• Ensure that both the medical officers in your<br />
team <strong>and</strong> the nursing staff at ward level,<br />
appreciate the importance of orders being<br />
prescribed <strong>and</strong> administered as expected<br />
• Ensure that you are advised of any<br />
deviations from your intended treatment<br />
plan.<br />
• Pharmacist available for patient counselling?
Don’t t forget the patient<br />
• Educate the patient <strong>and</strong> their carers about<br />
their patches.<br />
• Patches are often forgotten both in their<br />
medication history <strong>and</strong> subsequent<br />
prescribing <strong>and</strong> administration.<br />
• Prompt the patient as for other frequently<br />
omitted <strong>medications</strong>, Eye drops?<br />
Complementary <strong>medications</strong>? Patches?
All about communication - 2
Acknowledgments<br />
• Clinical governance unit, NSCCH<br />
• The Patch Project Team, RNSH<br />
• Kai Zhang IIMS Project officer at the<br />
Clinical Excellence Commission<br />
• Charles Brooker for inviting me<br />
And lastly but not least<br />
• The staff at NSCCH who took the time to<br />
enter notifications into the IIMS database