Coastal West Sussex
Clinical Commissioning Group
GP Resource Pack
Transdermal opioids / opioid
patches in chronic noncancer pain
Version No.
1
Status
Author
Date
FINAL
Julie Sadler
12/07/2012
Contents
1.
Removed from pack for publishing
Prescribing data for opioid analgesics and transdermal
opioids/ opioid patches in Coastal West Sussex
2.
Guidance for GPs on the prescribing of buprenorphine and
fentanyl patches for patients with chronic non-cancer pain
3.
Patient information leaflet – using opioid medicines for your
chronic pain
4.
Patient/carer information leaflet - safe use of fentanyl
patches for your chronic pain
5.
Patient pain management plan for patients prescribed
medication for chronic non-cancer pain
6.
Audit template - audit of patients prescribed transdermal
opioids / opioid patches in chronic non-cancer pain
7.
Audit data collection form – review of transdermal opioids /
opioid patches in chronic non-cancer pain
8.
Audit results for submission to the Medicines Management
Team
Appendix Fentanyl prescribing – useful sources of information on
1
safety
Page
3
4
7
8
9
11
15
16
18
2
Prescribing data for opioid analgesics and transdermal opioids / opioid
patches in Coastal West Sussex
Data removed prior to sharing outside of Coastal West Sussex
Coastal West Sussex has the highest cost of prescribing for opioid analgesics compared
to PCT, SHA and National costs, with transdermal opioid patches accounting for more
than a third of the total cost of all opioids prescribed.
3
Guidance for GPs on the prescribing of buprenorphine and fentanyl patches
for chronic non-cancer pain
Buprenorphine patches are available as either 4-day (Transtec®) or 7-day (BuTrans®)
patches.
Fentanyl patches are 3-day patches. Various brands including Durogesic DTrans®, Fencino®,
Fentalis®, Matrifen®, Mezolar®, Osmanil®, Tilofyl® and Victanyl® are available. 1
Opioid patches should be reserved for patients with swallowing difficulties.
Heat therapy is often recommended as a non-pharmacological option for treatment of chronic
pain. However, patients should be counselled NOT to use items such as heating pads, electric
blankets and heat lamps on the area where the patch is.
Skin irritation is reported to occur in about 9% of patients using transdermal opioids.2
It is important when using transdermal opioid preparations to be aware of opioid load in terms of
equivalent daily morphine dose.3 Table 1 shows approximate equivalent potencies of commonly
used transdermal opioids.
Table 1: Transdermal opioids: Approximate equivalence with oral morphine 3
10
15
30
45
60
90
120 180 270 360
Oral morphine equivalent (mg/24 hours)
Transdermal buprenorphine (mcg/hr)
5
10
20
35
52.5
70
Transdermal fentanyl (mcg/hr)
12
25
50
75
100
N.B. Published conversion ratios vary and these figures are a guide only. Morphine equivalences for transdermal
opioid preparations have been approximated to allow comparison with available preparations of oral morphine.
Buprenorphine 4-day or 7-day patches
Buprenorphine was commonly used 20 or so years ago in sublingual form, but largely went out of
favour due to its abuse potential and troublesome adverse effect profile — it often causes
nausea and vomiting. It also antagonises the effects of other commonly used opioids. Partly
because it has this dual agonist and antagonist opioid receptor properties, the sublingual form
subsequently re-emerged as a preparation to treat opioid addiction as an alternative to
methadone. In recent years the two transdermal buprenorphine products BuTrans® and
Transtec® were licensed for use. These are said to be better tolerated than the sublingual drug
and one assumes are also not amenable to drug misuse.4
If a patient is started on a transdermal buprenorphine patch, evaluation of the analgesic effect
should not be made before the system has been worn for 72 hours for the 7-day patch and 24
hours for the 4-day patch. This allows for the gradual increase in buprenorphine concentration.
Previous analgesic therapy should be phased out gradually from time of first patch application. 5
1
Opioid analgesics. Rachel SM Ryan, Managing editor (acting), British National Formulary 63rd edition, London: BMJ Group & RPSGB March
2012. Available at: http://www.bnf.org/bnf/index.htm
2
COMPASS Therapeutic Notes on the use of Strong Opioids in Chronic Non-Cancer Pain. January 2011. Available at:
http://www.hscbusiness.hscni.net/pdf/Strong_Opioids_in_Chronic_Non-cancer_Pain.pdf
3
British Pain Society. Opioids for persistent pain: Good practice. Consensus statement 2012. Available at: http://www.britishpainsociety.org/
4
Prescribing opioids in primary care: Following good practice guidelines. Practice based medicines management audit 2010/2011. NHS North
Lancashire.
5
Opioid analgesics. Rachel SM Ryan, Managing editor (acting), British National Formulary 63rd edition, London: BMJ Group & RPSGB March
2012. Available at: http://www.bnf.org/bnf/index.htm
4
Absorption varies depending on the application site of the patch and the plasma concentration of
buprenorphine can be up to 26% higher when applied to the upper back compared to the side of
the chest. The clinical relevance of this is unknown.2
BuTrans® patches are available in three patch strengths. Their daily dose equivalents to
codeine, dihydrocodeine and tramadol are shown in Table 2.
Table 2: Approximate dose equivalents of buprenorphine patch and oral opioid analgesics
Tramadol
Codeine
Dihydrocodeine
Buprenorphine
5mcg/hour patch
Buprenorphine
10mcg/hour patch
Buprenorphine
20mch/hour patch
<50 milligrams/day
50-100 milligrams/day
100-150 milligrams/day
~30-60 milligrams/day
~60-120 milligrams/day
~120-180 milligrams/day
~60 milligrams/day
~60-120 milligrams/day
~120-180 milligrams/day
N.B. These doses do not imply equi-analgesia; they should be used as a rough guide to estimate a safe starting
dose of buprenorphine. Patients must be treated on an individual basis and carefully titrated to pain control.
The BuTrans® Summary of Product Characteristics6 gives some specific instructions regarding
use of the patch:
 Apply the patch to non-irritated, intact skin of the upper arm, upper chest, upper back or the
side of the chest, but not to any parts of the skin with large scars.
 The site of application should be relatively hairless. If the site is not hairless, the hair should
be cut with scissors, not shaven.
 Do NOT use soaps, alcohol, oils, lotions or abrasive devices to clean the skin prior to
application. The skin must be dry prior to application.
 Apply the patch immediately after it is removed from the sealed sachet.
 The patch should be worn continuously.
 While wearing the patch, patients should be advised to avoid exposing the application site to
external heat sources, such as heating pads, electric blankets, heat lamps, sauna, hot tubs,
and heated water beds, etc., as an increase in absorption of buprenorphine may occur.
 When treating febrile patients, one should be aware that fever may also increase absorption
resulting in increased plasma concentrations of buprenorphine and thereby increased risk of
opioid reactions.
In September 2004 Transtec® was not recommended for use within NHS Scotland for the
licensed indication of “treatment of moderate to severe cancer pain and severe pain that does
not respond to non-opioid analgesics” as, “No comparative data have been provided with
alternative transdermal or oral opioid preparations”.7 A similar review in January 2006 of
BuTrans® also did not recommend use within NHS Scotland for “the treatment of severe opioid
responsive pain conditions which are not adequately responding to non-opioid analgesics” as,
“There was a lack of evidence of comparative efficacy with a clinically relevant treatment for
chronic pain available in the UK. The economic case has not been demonstrated”. 8 SMC
revisited BuTrans in January 2009 and gave similar advice not to recommend the product for use
in NHS Scotland.9
6
Summary of Product Characteristics. BuTrans® (Napp Pharmaceuticals Limited). Last updated: 11/03/2010. Available at:
http://www.medicines.org.uk/EMC/medicine/16787/SPC/BuTrans+5%2c+10+and+20ug+h+Transdermal+Patch/
7
Scottish Medicines Consortium (2004). Buprenorphine (Transtec®) Patch. Available at:
www.scottishmedicines.org.uk/files/buprenorphine__Transtec_matrix_patch_.pdf
8
Scottish Medicines Consortium (2006). Buprenorphine transdermal (BuTrans®) patch, 7 day formulation. Available at:
www.scottishmedicines.org.uk/files/buprenorphine_transdermal_patches_BuTrans__234-06_.pdf
9
Scottish Medicines Consortium (2009). Buprenorphine transdermal (BuTrans®) patch, 7 day formulation: Resubmission. Available at:
www.scottishmedicines.org.uk/files/buprenorphine_transdermal_patch_3rd_Re-Sub_FINAL_DEC_08_for_website.pdf
5
Fentanyl 3-day patches
Fentanyl patches can be used in place of subcutaneous administration of opioids in patients for
whom oral morphine is not suitable or who are unable to take oral medicines. However, their
three-day duration of action means that the patches can be used only for patients who have
stable opioid requirements.10 They are unsuitable for acute pain and fluctuating analgesic
needs due to their slow onset of action, long duration of effect and relatively inflexible dosage.
An effective plasma concentration is usually reached 12–24 hours after the first patch is put on,
but steady-state concentrations may not be reached until the second patch is applied.
Consequently, previous medication should be phased out gradually.10 Each fentanyl patch
should provide analgesia for three days once steady state plasma concentrations are reached.
However, if pain recurs during this time, the strength of the patch should be increased when it is
next changed.10 Patients will still need access to analgesia for break-through pain at all times.11
Since the transdermal fentanyl preparations are available as a reservoir or matrix formulation, it
is beat to prescribe the patches by brand as bioavailability may vary between products.
Do not use fentanyl patches in opioid naïve patients because there is an increased risk of toxicity
including fatal respiratory depression.12
The elimination plasma half-life for fentanyl administered via patches is about 17 hours. Patients
should therefore be monitored for side effects for 24 hours after the last patch has been
removed.10 Heat increases the release of fentanyl from patches, so they should not be
applied after a bath or shower. Other heat sources such as hot water bottles, electric
blankets, etc. may also affect drug release. In addition, patients should be monitored for
increased side effects if they develop a fever, as the increased temperature of the skin could
increase the absorption of fentanyl. A rise in body temperature of 3oC will result in an increased
absorption rate of 30%.2
The Medicines and Healthcare Products Regulatory Authority issued safety advice on
fentanyl patches following on from reports of unintentional overdose of fentanyl due to dosing
errors, accidental exposure, and exposure of the patch to a heat source.13
Questions for reflection
1. What is the pattern of transdermal opioid prescribing in my practice?
2. How does this compare with national prescribing patterns, and neighbouring PCTs?
3. Does the pattern of use conform to local pain management guidelines?
4. What barriers prevent it being more appropriate and cost effective?
5. How can I go about improving the appropriateness and cost effectiveness of prescribing?
6. How will I know if the appropriateness and cost effectiveness of prescribing increases?
10
National Prescribing Centre: The use of strong opioids in palliative care. MeReC Briefing 22, 2003. Available at:
http://www.npc.nhs.uk/merec/pain/otherback/resources/merec_briefing_no22.pdf
11
Scottish Intercollegiate Guidelines Network. Control of pain in adults with cancer. SIGN 106, November 2008. Available at:
http://www.sign.ac.uk/guidelines/fulltext/106/index.html
12
National Prescribing Service Limited – an independent, non-profit organisation for quality use of medicines, funded by the Australian
Government Department of Health and Ageing. Clinical audit: review or opioid prescribing in chronic pain. Available at:
http://www.nps.org.au/__data/assets/pdf_file/0006/89160/Clinical_Audit_sample_pack-no_enrolment.pdf
13
Fentanyl patches. Drug Safety Update, Volume2, Issue2. September 2008. MHRA. Available at: http://www.mhra.gov.uk/home/groups/plp/documents/publication/con025632.pdf
6
Patient Information leaflet
Using opioid medicines for your chronic pain
What is chronic pain?
Chronic pain is when pain occurs most days of the week, for at least three months. It is not
always possible to completely relieve chronic pain, however it should be possible to reduce your
pain to an acceptable level, improve your quality of life and increase your activity levels.
How do I assess my pain?
Many things can increase or decrease your pain levels. A pain diary can help you keep track of
your pain and remember how things like medicines, your mood, stress and sleep patterns affect
your pain levels. This information will help you and your healthcare team manage your pain
better. Ask your doctor for a copy of The Pain & Self Care Toolkit available at:
www.orderline.dh.gov.uk (product code = 408678).
What is an opioid medicine?
Opioids refer to morphine and ‘morphine type’ medications. Opioid medicines have been used to
relieve pain for many years and include:
 Weak opioids such as codeine, dihydrocodeine and tramadol
 Strong opioids such as morphine, diamorphine, oxycodone, fentanyl and buprenorphine
Opioid medicines can help manage some but not all types of pain and they will be prescribed by
your doctor if it is felt they are the best treatment for your pain. They are available as tablets,
liquid medicines, suppositories, skin patches and for injection.
Are there side effects from opioid medicines?
Like all medicines, opioids have side effects. The side effects you experience may vary and will
depend on the type of opioid and the dose you take. Some side effects get better after a short
time, but others last longer or can appear after long-term use. Talk to your doctor or pharmacist
about how to manage side effects of opioid medicines,
Common side effects of opioid medicines




Confusion
Constipation
Dizziness
Drowsiness




Itching
Nausea
Sweating
Vomiting
What is a pain management plan?
A pain management plan is a written ‘plan’ developed by you and your healthcare team. It
details your treatment goals to help manage your pain. Opioid medicines should be used as part
of your pain management plan. Talk to your healthcare team about developing a pain
management plan for you.
What else can I do to help manage my pain?
 Lead a healthy lifestyle (exercise regularly, get adequate sleep, eat a balanced diet)
 Arrange a support network that you can access when you need help (this may include family,
friends or fellow pain sufferers)
 Learn skills to help cope with your pain (set priorities or use relaxation therapies)
 Take your medicines only as prescribed. Never try anyone else’s medicine or give yours to
them: it can be dangerous.
 Reward yourself for each positive step in the management of your pain.
7
Patient/Carer Information leaflet
Safe use of fentanyl patches for your chronic pain
About fentanyl
Fentanyl is a strong painkiller that works by binding to opioid receptors in your brain and spinal
cord. This reduces the pain you feel. For chronic (long-lasting) pain, you will be given a patch
which contains fentanyl to apply to your skin (this is called transdermal fentanyl). Patches
contain the fentanyl in a reservoir and release it gradually over a period of time to give you
continual pain relief.
How to use fentanyl patches
 Open the protective pouch carefully and remove the patch. Check that the patch has not
been damaged in any way as you have opened the pouch.

Place the patch on a dry, non-hairy, healthy area of skin on your upper arm or upper
body. Press it firmly on to your skin for approximately 30 seconds to make sure that it sticks
well, especially around the edges. It is important that you avoid touching the sticky side of the
patch while you do this. After you’ve applied the patch, wash your hands to make sure you
have no fentanyl on your fingers.

When you first use a patch, it may take up to 24 hours for the patch to reach its full
effect; so during this time, you may need alternative pain relief. Your doctor will explain this
to you.

Leave the patch in place for 72 hours (three days), then remove it and apply a new patch
to a different area of skin on your upper arm or body.

Fold the removed patch in half with the stick side inwards and put it back into a
protective pouch. Dispose of the pouch as you have been directed by your doctor, making
sure it is safely out of the reach of any children, or return to your pharmacy.

Try to make sure that any patch you are wearing does not come into contact with
external heat sources such as heating pads or electric blankets, heat or tanning lamps,
saunas, hot tubs and heated water beds. Avoid taking hot baths or sunbathing.
External heat sources like these may increase the amount of fentanyl that is released from
the patch, which increases the risk of overdose.

Let your doctor know if you develop a high temperature at any time, as this also can
increase the amount of fentanyl you absorb from the patch.

Each time you collect your prescription, check to make sure you have been given the
same brand of fentanyl patches as you have had before. This is because different brands
may release different amounts of fentanyl and you should keep to the same brand unless
your doctor has advised you otherwise.

Signs of having too much fentanyl include shallow or weak breathing; feeling very
sleepy; inability to think, talk or walk normally; and feeling faint, dizzy or confused. If
you have any of these effects, remove the patch and contact your doctor straightaway.
8
EXAMPLE
My pain management plan12
Patient name:
Initial pain assessment completed:
/
/
GP name:
Diagnosis:
GP contact details:
After hours details:
Goals of my pain management plan
Goals
(e.g. walk three times a week for half an hour)
1.
Review date
Comments
(including date and progress)
2.
3.
4.
5.
Other health professional assisting my pain management (e.g. physiotherapist)
Professional
(type and details)
Goals of treatment
Action
Review date
Comments
(including date and progress)
9
Pain medicines
Name of medicine
(prescription and
over-the-counter)
1.
Strength
What is the
medicine for?
How much do I
use and when?
Special instructions or
comments (including date
and progress)
2.
3.
4.
5.
Other ways to help manage my pain (non-medicine strategies)
1.___________________________________________________________________________
2.___________________________________________________________________________
3.___________________________________________________________________________
4.___________________________________________________________________________
5.___________________________________________________________________________
If my pain gets worse my doctor recommends
Non-medicine strategies

__________________________________________________________________________

__________________________________________________________________________
Medicines (include details as in the table above)

__________________________________________________________________________

__________________________________________________________________________
To help me manage my pain better (patient to fill out)
What makes my pain worse?
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
What makes my pain better?
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
10
Practice Based Audit Template:
Transdermal Opioids / Opioid Patches in Chronic Non-Cancer Pain
Background Information
The use of strong opioids in the management of cancer pain and palliative care is widely
accepted. The use of opioids to treat moderate to severe acute pain is also widely accepted.
The use of opioids to treat chronic non-cancer pain, however, remains controversial.2 In Coastal
West Sussex there is increasing prescribing of opioid transdermal preparations, which has both
safety and cost implications.
Chronic pain can be treated with a variety of non-pharmacological and pharmacological
measures. Non-pharmacological options include:
 Physiotherapy,
 Heat or cold pack application,
 Graduated exercise programmes,
 Transcutaneous electrical nerve stimulation (TENS), and
 Cognitive behavioural therapy.
These interventions may be difficult to obtain in the primary care setting and so this may be the
reason why, for many patients, the only available option is drug treatment.2
Use of pharmacological options should be based on the analgesic ladder developed by the World
Health Organisation (WHO).14 Treatment should start at the bottom of the ladder and ascend in
accordance with response to medication in terms of both efficacy and side effects.
WHO analgesic ladder for chronic nociceptive pain:
Step 1 = non-opioid +/- adjuvant
Step 2 = weak opioid +/- non-opioid +/- adjuvant
Step 3 = strong opioid +/- non-opioid +/- adjuvant
(Adjuvants include corticosteroids, antidepressants and anticonvulsants)
Opioid patches are available as fentanyl and buprenorphine patches which release a lipidsoluble opioid through the skin into the subcutaneous fat from where it is absorbed into the
systemic circulation. These drugs are very potent but plasma levels take some time to become
therapeutic. Likewise, when the patch is removed, a depot of the drug remains in subcutaneous
fat continuing to have an effect for a further 12-24 hours.2
Buprenorphine patches are available as either 4-day (Transtec®) or 7-day (BuTrans®)
patches.
Fentanyl patches are 3-day patches. Various brands including Durogesic DTrans®, Fencino®,
Fentalis®, Matrifen®, Mezolar®, Osmanil®, Tilofyl® and Victanyl® are available. 5
14
World Health Organisation’s (WHO) Pain Relief Ladder. Available to access via: http://www.who.int/cancer/palliative/painladder/en/
11
The Medicines and Healthcare Products Regulatory Authority issued safety advice on
fentanyl patches following on from reports of unintentional overdose of fentanyl due to dosing
errors, accidental exposure, and exposure of the patch to a heat source: 13



Healthcare professionals, particularly those who prescribe and dispense fentanyl patches,
must fully inform patients and caregivers about directions for safe use:
o Follow the prescribed dose
o Follow the correct frequency of patch application
o Ensure that old patches are removed before applying a new one
o Patches must not be cut
o Avoid touching the adhesive side of patches and wash hands after application
o Follow instructions for safe storage and disposal of used or un-needed patches
Increased body temperature, exposure of patches to external heat sources, and concomitant
use of CYP3A4 inhibitors may lead to potentially dangerous rises in serum fentanyl levels.
Concomitant use of other CNS depressants might also potentiate adverse effects from
fentanyl
Healthcare professionals, particularly those who prescribe and dispense fentanyl patches,
should ensure that patients and caregivers are aware of the signs and symptoms of fentanyl
overdose – i.e. trouble breathing or shallow breathing; tiredness; extreme sleepiness or
sedation; inability to think, walk, or talk normally; and feeling faint, dizzy, or confused.
Patients and caregivers should be advised to seek medical attention immediately and should
be monitored for up to 24 hours after patch removal
The aims of this audit are to:




Review the safe and effective prescribing of opioid transdermal patches in line with MHRA
recommendations and agreed audit criteria.
Ensure that patients prescribed an opioid patch have a documented indication recorded.
Ensure that opioid patches are only prescribed for patients with stable pain AND significant
side effects to morphine or when the oral route is unacceptable, e.g. dysphagia.
Formulate and implement an action plan for the prescribing of opioid transdermal patches.
Planning the audit






Discuss the audit guidelines and background and audit criteria at a practice team meeting.
You will also need to discuss the audit standards that are appropriate to you. All prescribers
must be familiar with and agree to the audit; the audit will only be successful in changing
practice if all prescribers are committed.
Decide who should be involved in carrying out the audit (e.g. all partners, practice nurses,
reception staff, practice-based pharmacy teams) and agree what they will be doing as part of
the audit protocol.
Agree timescales and draw up a brief plan.
Prepare the appropriate data collection and audit forms in advance.
Make sure everyone understands how to collect and collate the data that you will produce.
Make sure everyone knows when the audit will start and finish.
12
Audit Criteria and standards
Criteria
Fentanyl
1.
2.
Standard
% of patients
achieving
standard
Patients prescribed fentanyl patches
100%
should have previously been prescribed a
stable dose of another strong opioid,
such as morphine or oxycodone
Patients prescribed fentanyl patches
should also be prescribed a normal
release strong opioid to use when
required for break through pain. (The
dose should be around one sixth of the
equivalent 24 hour total oral morphine
dose)
Buprenorphine
3.
Patients prescribed buprenorphine
patches should have tried other first and
second line treatments which have failed
90%
100%
It is good practice for all medication to be linked to a diagnosis and read-coded on the GP clinical
system.
Method
1. Identify all patients prospectively as they present or retrospectively from a search of your
practice computer system who:
 Are older than 18 years
 Have chronic (≥3 months) non-cancer pain
 Are prescribed an opioid transdermal patch (either an initial prescription or ongoing
supply) for ongoing management of chronic non-cancer pain. Remember to search for
branded products too.
2. Exclude patients:
 Receiving palliative care
 With a history of substance misuse or addiction
3. Review the patients and complete the audit data collection form for each individual patient
4. Complete the final results in the results table and submit to the Medicines Management Team
(along with your supporting evidence) by post to:
1 The Causeway, Goring-by-Sea, Worthing, BN12 6BT, or email to:
ws-pct.CWSMedicinesManagement@nhs.net
13
Results
Share and discuss the results of your baseline audit. Consider these questions:

Are the results what we expected?

Can we make any improvements?

What might be stopping us getting better?
Identify areas for improvement: formulate an action plan to optimise prescribing

Decide what it is that you want to achieve

Think about how you will know if you are improving or not

Generate ideas for the things that you could do differently. Start with small changes to
begin with and test out your ideas.

Record your progress.
Re-audit
Re-auditing is a key part of the audit cycle. If the first data collection and analysis shows room
for improvement, the audit should be re-run once changes to the service have had time to make
an impact. Depending on the nature of the changes, this could take weeks or months. This
process should be continued until the results of the audit meet the standards. For the purposes
of this scheme, it is suggested that the audit is repeated after 3 months or no later than the end
of February 2013.
Resources
Copies of “The Pain & Self Care Toolkit” for people who live with persistent pain and long-term
health conditions can be ordered from www.orderline.dh.gov.uk and quote 408678/Pain Toolkit.
Telephone: 0300 123 1002. Fax: 01623 724 524.
14
Audit data collection form – Review of transdermal opioids / opioid patches
in chronic non-cancer pain
Your patient code:
Patient details
Gender:
Female Male
Current opioid patch and dose prescribed:
Age (years):
18-34 35-50 51-65
≥66
Diagnosis
Does the patient have: (Mark all that apply)
 neuropathic pain
 osteoarthritis
 other bone, hip, neck or spinal pain
 post-operative pain
 rheumatoid arthritis
 low back pain
 visceral/organ pain
 uncertain diagnosis
 not known
 other_____________________________
How long has the patient had this episode of chronic pain?
 3-6 months
 > 6-12months
 > 12 months
 not known
Drug management
Previous and current non-opioid drug(s) used: (Mark all that apply)
Previous use
Include OTC, prescription and combination use)
None
Paracetamol
Conventional NSAID
COX-2 selective NSAID
Anticonvulsant
Tricyclic antidepressant
Not known
Other
Current use
















Has the patient previously been prescribed a stable dose of another strong opioid?
Yes
No
Current opioid(s) used other than patches: (Mark all that apply)
Which opioid(s) used?
Route
Include OTC, prescription and
Oral
Oral
rectal Injection
combination use
IR
MR
Codeine


Diamorphine


Dihydrocodeine



Dipipanone

Hydromorphone


Meptazinol


Methadone


Morphine




Oxycodone



Pethidine


Tramadol



Not known
Current dosing schedule
Regularly As
Not
each day
needed
known

































Abbreviations: IR = immediate release (includes buccal, lozenge and liquid preparations), MR = modified release (includes controlled- and
sustained-release preparations)
15
Results for submission to the Medicines Management Team - Transdermal
opioids / opioid patches in chronic non-cancer pain
Please use the following forms to submit your evidence to the Medicines Management Team
by 31st March 2013
These forms have been emailed to you separately so you can fill them in electronically; in
addition they can be found on the Medicines Management pages of the GP website
(www.westsussexgp.com). Click in the text boxes to add your comments. If you prefer to
hand write them, please expand the boxes before printing out. Please ensure you also
include the results table at the end.
You may also submit further supporting evidence. For example, this may include:
 Minutes of a practice meeting where the audit was discussed
 A practice protocol which has been created or amended as a result of your findings
Method:
Please describe who was involved in carrying out the audit and what was done. Give
dates and attendees of any practice meetings where the audit was discussed:
Findings:
Please describe the findings from the base line audit. Were the findings what you
expected or did they come as a surprise? Which criteria standards were not met and
why do you think this was? You can describe individual patient findings however do
not include any patient identifiable information.
16
Action taken:
Please describe what actions were taken as a result of the baseline findings. How
has practice changed? What will be done differently in the future? Are there any
barriers to improving? You can describe individual patient findings however do not
include any patient identifiable information.
Re-audit: (Encouraged but not mandatory)
Please describe your findings from the re-audit. Has an improvement been found?
If not what action do you now intend to take to ensure an improvement in the
future?
Criteria
Criterion 1
Patients prescribed fentanyl patches should
have previously been prescribed a stable
dose of another strong opioid, such as
morphine or oxycodone.
Criterion 2
Patients prescribed fentanyl patches should
also be prescribed a normal release strong
opioid to use when required for break through
pain. (The dose should be around one sixth
of the equivalent 24 hour total oral morphine
dose).
Criterion 3
Patients prescribed buprenorphine patches
should have tried other first and second line
treatments which have failed.
Standard
% of patients
achieving
standard at
baseline
% of patients
achieving
standard at reaudit
100%
90%
100%
17
Appendix 1
Fentanyl prescribing - Useful Sources of information on safety
Source
Web link
Fentanyl SPC and
PILs
http://www.medicines.org.uk/EMC/searc
hresults.aspx?term=fentanyl&searchtyp
e=QuickSearch
Latest approved prescribing information and patient
information leaflets for fentanyl from the
manufacturer.
FDA Alerts
http://www.fda.gov/ForConsumers/Cons
umerUpdates/ucm300803.htm
United States Food and Drug Administration alerts –
provides information for consumers and health
professionals on new drug warnings and other safety
information, drug label changes, and shortages of
medically necessary drug products.
http://www.fda.gov/Drugs/DrugSafety/P
ostmarketDrugSafetyInformationforPati
entsandProviders/DrugSafetyInformatio
nforHeathcareProfessionals/PublicHealt
hAdvisories/ucm048721.htm
Description
Fife Fentanyl
Prescribing
guidelines
http://www.fifeadtc.scot.nhs.uk/support/
Fentanyl%20palliative%20care.pdf
Document approved on behalf of NHS Fife Board by
the Fife Area Drug and Therapeutics Committee
August 2009.
MHRA
http://www.mhra.gov.uk/Safetyinformati
on/DrugSafetyUpdate/CON087796
The Medicines and Healthcare products Regulatory
Agency (an executive agency of the Department of
Health) responsible for ensuring that medicines and
medical devices work, and are acceptably safe.
Medsafe
http://www.medsafe.govt.nz/profs/PUArt
icles/FentanylPatchesSept10.htm
New Zealand medicines and medical devices safety
authority.
Medscape
http://www.medscape.org/viewarticle/76
2637
Robust and integrated medical information and
educational tools for specialists, primary care
physicians, and other health professionals.
National Institutes
of Health
http://www.ncbi.nlm.nih.gov/pmc/articles
/PMC3008378/
United States National Library of Medicines.
NPSA
http://www.nrls.npsa.nhs.uk/resources/?
entryid45=59888
National Patient Safety Agency – contributes to
improved, safe patient care by informing, supporting
and influencing organisations and people working in
the health sector.
Sheffield APC
http://www.sheffield.nhs.uk/professional
s/resources/formulary/transdermalpatch
esguidelines.pdf
Guidelines on the use of opioid transdermal patches
in a primary care setting approved by the Sheffield
Area Prescribing Committee (April 2011).
US Institute of
Safe Medication
Practice
http://www.ismp.org/newsletters/acutec
are/articles/20070628.asp
A non profit organisation educating the healthcare
community and consumers about safe medication
practices.
US Patient Safety
Solutions
http://www.patientsafetysolutions.com/d
ocs/May_2012_Another_Fentanyl_Patc
h_Warning_from_FDA.htm
Healthcare consulting services with a focus on
patient safety solutions and quality improvement
across the health care continuum.
Wales ABHB
http://www.wales.nhs.uk/sites3/Docume
nts/814/ABHBprescribingGuidanceFENTANYLpatchesMay2011Update.pdf
ABHB prescribing guideline on the use of
transdermal fentanyl patches (May 2011).
18