Download Reducing the risk of harm when administering intravenous fluids to

National Patient Agency
Stakeholder Consultation Summary
Safer Use of Epidural Medicines
Consultation Process
The consultation period ran from 1st March to 31st March 2006.
Documentation was distributed electronically to a list of stakeholders and more widely to
organisations in England, Northern Ireland, Wales and Scotland via direct distribution
and by NPSA Patient Safety Managers.
98 responses were received by 6th July 2006
Analysis of respondents
Table 1. Responses by country
Country
England
Wales
Northern Ireland
Scotland
UK
Other
Total
Number of
Responses
67 ( 69%)
6 (6%)
1 (1%)
14 (14%)
7 (7%)
3 (3%)
98
Table 2. Responses by respondent type
Type of
Response
Hospital Trusts
Individual
healthcare
practitioners
Organisations
Total
Number of
Responses
38 (39%)
49 (50%)
11 (11%)
98
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Table 3. List of organisation contributing responses
Royal College of Anaesthetists
Obstetric Anaesthetist Association
Paediatric Chief Pharmacists Group
Royal College of Paediatrics and Child Health
Guild of Healthcare Pharmacists
Royal College of Physicians Faculty of
Pharmaceutical of Occupational Medicine
Department of Health, England
MHRA
Healthcare commission
Nuffield Hospitals Group
Independent Healthcare Advisory Forum
Response themes
Question 1. Risk factors

67 (68%) responses agreed with the patient safety risks identified for epidural
infusions in the draft alert.

31 (32%) either made no comment or identified additional risks.

Some of the hospital Trusts indicated that they had already identified the risks and
implemented actions similar to those recommended by the Patient Safety Alert.
Additional risks
Response
Absence of a specific connector for the
epidural/spinal route that cannot be connected
to the intravenous route.
Inadequate training and competency of
healthcare staff involved in epidural therapy.
Errors in prescribing, preparation and
administration of epidural infusions
Single or multiple boluses of strong solution
(e.g. for surgery) are much more hazardous
Include reference to epidural prefilled syringes
and syringe drivers.
Recommendations do not easily fit with the
practices of palliative care medicines
Include information in the Patient Safety Alert to
indicate that the Department of Health is progressing
work to introduce a new spinal connector into practice.
Include guidance on training and competency in the
Patient Safety Alert.
Provide guidance on these topics in the Patient Safety
Alert on Safer Practice with Injectable medicines.
Provide guidance on these topics in the Patient Safety
Alert on Safer Practice with Injectable medicines.
Include guidance on this in the Patient Safety Alert.
Users may use colour and design of infusions
and not read the label
Since bupivacaine toxicity is equally or more
likely to occur from overdose via the intended
route, or from migration of an epidural catheter
intravenously, consideration should be given to
a resuscitation protocol wherever bupivacaine is
being administered. .
Define scope for recommendations. Clarify that
recommendations only apply to palliative medicine
where applicable.
The Department of Health, MHRA, NPSA and others
have all supported the use of colour and design to
enhance safe product selection.
Include in Patient Safety Alert.
2
Question 2. Judicious use of colour and design in the labelling and packaging
of epidural infusions




67 (68%) responses supported the judicious use of labelling an packaging of
infusions
15 (16%) partially supported this approach – but identified other measures that
were required as well.
12 (12%) no comment.
4 (4%) not supported – as concern was expressed that this would encourage
practitioners not to read the label of infusions.
Additional issues
Response
Support for the use of colour and design for
syringes used for epidural bolus and infusion
therapy
Include a recommendation in the Patient Safety
Alert for the use of colour and design to help
differentiate syringes for epidural bolus and
infusion therapy
Include recommendation in the Patient Safety
Alert for the development of a standard or
template by the standard setting bodies
Need for consistency; the anaesthetic syringe label
guideline uses grey for local anaesthetics, but does
not distinguish the route of administration. The
colour yellow has been adopted by some infusion,
device and pump manufacturers
Any colour and design convention must include
epidural bolus dose syringes
Use of colour and design for medicines
administered via different sites e.g. Paravertebral,
stump infusions etc
Outside the scope of this work.
Question 3. Can purchasing for safety policies be implemented to ensure
epidural infusions with safer designs are used?




71 (72%) responses supported the use of purchasing for safety policies.
4 (4%)responses partial support
20 (21%) no comment .
3 (3%) not supported
Responses indicated that many Trusts were already implementing purchasing for
safety policies. Other had tried to implement policies using new products and had
failed due no industry standard or lack of a co-ordinated approach leading to
industry being not being willing to make the investment to supply new and
modified devices.
‘Indeed we had a system made as a trial for us by a supplier which reversed the
luer connections in the system. This prevented 2 incidents of wrong infusate or
route being used. As there is no industry standard and volume of sales small it
was not financially viable and they would not continue to manufacture them.’
3
Additional issues
Response
Industry will need to introduce new and modified
products to meet the Patient Safety Alert
recommendations.
The NPSA has been in contact with the medical
device manufacturers since the beginning of the
year. Many suppliers have already changed the
labelling of their infusions. New licensed and
unlicensed products will be introduced subject
to demand from the NHS. The NHS Medicines
Manufacturing and Preparation Modernisation
Board is interested in co-ordinating the supply of
unlicensed medicines produced in NHS and
commercial specials manufacturing units.
Provide for information concerning purchasing
for safety in the Patient Safety Alert.
Include an overview of the likely economic
impact on healthcare organisations.
The term purchasing for safety may not be fully
understood.
Some economic analysis is needed to indicate the
cost differences and likely impact on healthcare
organisations
Would not support unless the purchasing for safety
policy included the procurement of devices that had
unique spinal connectors
Agree a process of risk assessment can be used
to guide procurement
Include a note to indicate the Department of
Health is progressing work to introduce a new
spinal connector into practice.
Provide guidance on risk assessment in the
Patient Safety Alert on Safer Practice with
Injectable medicines.
No specific action that can be taken by the
NPSA over this. We are satisfied that there will
be sufficient alternative and traditional products
available to safely manage the recommended
change over.
Include reference to the NPSA guidance on
infusion pumps.
Include information about these local
anaesthetics. However, using these agents
does not substitute the requirement for the other
safer practice recommendations.
Problems include manufacturers stopping producing
one preparation & another one having to be sourced
(maybe different strength etc)
Support for a centralised storage and supply area
for infusion pumps
Consideration should be given to the use of other
less cardio toxic local anaesthetic infusions used for
epidural infusion
Question 4. Review procedures for the preparation of epidural infusions in
hospital pharmacies and clinical areas of the hospital to ensure effective use of
labelling and design to minimise mis-selection errors?




51 (52%) responses supported this recommendation
7 (7 %) responses indicated partial support
39 (40%) responses gave no comment on this recommendation
1 (1%)responses did not support this recommendation
4
Additional issues
Response
Less helpful for intrathecal infusions used for
analgesia
Individual titration at the outset can require dose
and drug changes daily or twice daily, necessitating
that these are made up on the inpatient units. Once
stabilised, however, supply of infusions from
hospital pharmacies is practical, and particularly
useful when patients go home with their intrathecal
lines.
Outside of the scope of this work – clarify scope
in Patient Safety Alert.
Where-ever possible standard strength ready to
use and ready to administer infusions are
recommended – and individual dose adjustment
is achieve by adjusting the rate of infusion
rather that frequent changes in the
concentration. This may not be possible in
palliative care which is outside the scope of this
work.
The guidance does not recommend that all
epidural infusions are made in the hospital
pharmacy – it does promote ready to
use/administer products and safe labelling and
design – many of these products can be
obtained commercially
The use of infusion volume is one element of
design that can be used to help different
epidural products.
The guidance is not recommending central
preparation of all epidurals – it is recommending
the use of ready to use and ready to administer
products were possible – these products can be
made available as ward stock in appropriate
areas and can be available for immediate use.
Acknowledged, but many of the other safer
practice recommendations described can be
applied to diamorphine infusions
For inclusion in local policies – may not be
practical in all clinical settings.
All epidural infusions should be prepared in the
hospital pharmacy – funding and resources for this.
The use of 250ml infusion bags is reserved for
epidural use in some Trusts
Some time delay could result in risks to patient care
if all epidurals were centrally prepared
Due to short shelf life diamorphine infusions for
epidural use have to be prepared in the clinical area
and cannot be prepared centrally.
An epidural infusion must be connected to the
epidural immediately so that a bag of bupivicaine
does not sit on a bench,
Question 5. Can the range of epidural infusions used in healthcare organisation be
simplified to help minimise confusion and mis-selection?




54 (55%) supported simplification of the range
14 (14%)indicated partial support for range simplification
4 (4%)do not support the simplification of the range
26 (27%) no comment
Many healthcare organisations indicated that they had already made good progress
in rationalising the range, others indicated more could be done
Additional issues
Response
A range is needed for different circumstances
(anaesthesia vs post op analgesia vs long term pain
problems vs terminal care, patients with particular
allergies/ drug sensitivities/ needs etc
Agreed
There needs to be full involvement of prescribers/
clinical staff/professional organisations
Not for intrathecal infusions used for analgesia.The
regimen for each patient has to be individually
adjusted - there are no standard infusions.
Outside scope of this work
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Question 6. How effective will the recommendation to store epidural infusion
products in separate locked cupboards or refrigerators to those used for
intravenous infusion be in improving patient safety?




55 (56%) supported this recommendations
17 (17%) indicated partial support
7 (7%) not supported
19 (20%) no comment
Additional issues
Response
Limited space for additional cupboards – additional
cost.
Additional cupboards only required if there is
large numbers of infusions to be used –
controlled drug cupboard or refrigerator could
be used otherwise.
Many healthcare organisations have reported
they have already implemented this solution.
Local risk assessment required
Include in local policies
Not practical and could delay care
Supply chain issues – ensure delivery of the correct
epidural infusion to the correct clinical storage
location.
Not for intrathecal infusions
Unless there is a requirement to register all usage
when taken out from the locked cupboards, staff
may remove more infusion products than needed at
one time. This may lead to infusion products being
left on the bench – which may be a cause of misselection.
Outside the scope of this work
Documentation requirements not included in
recommendations
Question 7. Can purchasing for safety policies be implemented to ensure
special epidural administration sets, with safe designs and labelling, are used
in preference to devices intended for intravenous use?



63 (64%) responses supported this recommendation
6 responses indicated partial support
29 (30%) no comment
A substantial number of healthcare organisations reported that they had already
implemented this recommendation.
Additional issues
Response
Support from industry required to provide new and
amended products with safer designs
The NPSA have been keeping industry informed
and with further clarification what constitutes
safe practice – it is expected that industry will
make devices with safer designs available
The total cost of using medicine products in
practice should be considered during
procurement.
Include recommendation for development of
international or national standard or template in
the Patient Safety Alert.
New products with safer designs may be more
costly than the traditional devices
An industry standard is required for the design,
colour and labelling of epidural infusion sets
6
Question 8. How effective will the recommendation to use different types of
infusion pumps and syringe drivers for epidural use be in further minimising
risk?




65 (66%) responses supported this recommendation
15 (15%) responses indicated partial support
2 (2%) not supported
16 (17%) no comment
21 responses indicated that their organisation had already implemented this
recommendation
Additional issues
Response
The costs of purchasing dedicated epidural pumps
would be a barrier to successful implementation
Amend Alert so that there is no longer an
absolute requirement for dedicated epidural
devices. Include new ‘low cost’ recommendation
that all devices when being used for epidural
infusions should be labelled.
This risk can be reduced by implementing a
pump equipment library and planning the
number of dedicated pumps required to meet
clinical demands.
Emphasise the need for training for epidural
practice.
Analysis of risks vs benefits of dedicated
epidural pumps indicates the overall benefit of
using dedicated pumps as evidenced by the
number of Trusts that have already
implemented this recommendation
Include reference to dedicated epidural syringe
driver pumps will be included in the Patient
Safety Alert
Recommend that standard setting organisations
address this issue
Dedicated epidural pumps could lead to shortages of
pump equipment
Staff will need additional training on these pumps.
Dedicated epidural pumps may add further complexity
and risk
Benefits in having dedicated epidural syringe drivers
for those areas that do not use infusion pumps
There would be benefits in having a industry standard
for the colour and design of epidural infusion pumps
and syringe drivers
Question 9. How easy will these recommendations be to implement in the
NHS?
33 (34%) relatively easy to implement
31 (32%) moderately easy to implement. The major issues being the additional costs
for safer designed infusions and devices and the provision of specialist training
4 difficult to implement
30 (30%) no comment
Dependant upon the systems already in place and the culture for pt safety within the
area.
7
Question 10. What are the barriers that may prevent the successful
implementation of this guidance? Will any new risks be introduced by
implementation?
74 of responses identified barriers to successful implementation
24 had no comment
The following barriers to successful implementation were identified:
Additional issues
Response
Additional cost for safer designed infusions, administration sets,
pumps and storage.
Additional training for staff providing epidural therapy – now
addressed.
Absence of an industry standard for colour and design on
epidural infusions and devices.
Availability of infusions and devices from industry that match the
NPSA recommendations.
Poor risk awareness of some of individuals, departments and
organisations.
Lack of support for the recommendations from the clinical staff.
Workload issues for the hospital pharmacy service to produce
ready to administer epidural infusions.
Difficulty in rationalising range of epidural products –.
8
Now addressed - dedicated devices not
essential provided all devices are clearly
labelled when used for epidural use
Now addressed
Difficult to address for medicines – new
European Standards for epidural infusion
devices in a few years
Already addressed
Being addressed via the Patient Safety
Alert
Additional communication and
stakeholder involvement from
anaesthetic professional groups.
Addressed by suggesting the use of
industry prepared products.
Responsibility of Drugs and Therapeutics
Committee who develop consensus and
make decisions concerning medicine
products that are included on medicine
formularies
Question 11. How could the presentation of the final Patient Safety Alert be
improved?
76 were positive about the design of the Alert or had no comment
22 provided suggestions on how the presentation could be improved
The following suggestions were made:
Additional issues
Response
Change the title ‘epidural infusions’ to ‘spinal infusions
Keep short and concise – use bullet points.
Use colour photographs and use a yellow colour to signify
epidural.
Improve wording
Include details of beacon sites that have already implemented
these changes.
Include posters and promotional material.
More detail, use of FAQ’s.
Outside of scope of work
Now addressed
Not in accordance with NPSA house
style
Now addressed
Develop materials in saferhealthcare
website
Considered but not supported.
Include on Saferhealthcare/NPSA web
site.
Addressed
Focus on the crucial risk of local anaesthetic solution being
administered intravenously.
Use of posters and promotional materials
More detail, use of FAQ's
Restrict to 500ml infusion bags this reduces the number of
times the bags have to be changed by the ward nurses
decreases the risk of putting the incorrect drug up and also the
risk of infection.
9
Noted – share locally produced
posters and promotional material via
saferhealthcare web site
Share this information via
saferhealthcare web site
Noted – decision for local procedures
Question 12 Do you have any other comments concerning the draft Safer
Practice Alert?
65 No comment or no new comment not mentioned elsewhere
The following suggestions were made:
Additional issues
Response
Include guidance on monitoring and clinical observations
Draw attention to risks of all types of epidural infusions
Concerned that by focusing on one area of care will
detract from improving the importance of a safety culture
when handling medications at all junctures of treatment.
Labelling patients access lines
There should be consistent use of terminology. The terms
hazard and risk should be used in preference to the less
specific term “danger.
Less cardiotoxic solutions.
Dangers from the use of 3 way taps
Competency based training.
Audit
Include as part of Trust’s epidural procedures
Addressed
Mention broader guidance on safer practice with
injectable medicines in PATIENT SAFETY ALERT
Supply problems of getting ready to use products
Syringes with colour plunger
Include reference to report on Good practice in the
management of continuous epidural analgesia in the
hospital setting’ published 2004
Treat as controlled drug
Inclusion of advice relating to corrective action that should
be taken if epidural solutions are administered
intravenously in error.
Danger of using standard IV sets and pumps
The NHS has very limited capacity to implement changes
especially now so many jobs are being cut: the service is
in a state of flux. Only one alert should be issued at a
time with realistic times allowed to achieve
implementation. The timing of the release of each alert
should be prioritised and scheduled so as not to overlap
unless a more long term programme is needed for a
particular alert.
Ensure wording and advice appropriate for the
independent sector
Of obvious concern is that some other drug may be put
into the epidural space.
Role of the Acute Pain Service. The implementation of this
safety alert, and ongoing training, supervision and audit
can only occur if a health care organisation has an
adequately funded and resourced acute pain service,
capable of maintaining the standards defined by the
professional bodies.
10
Include in Patient Safety Alert
There is consistent use of terminology
Addressed
Outside scope of work
Addressed
Include in Patient Safety Alert and support
materials
Outside of scope of work
Good idea will take some time to implement –
keep idea in reserve if other measures do not
achieve improvement in safety
Include in Patient Safety Alert
No considered practical for all epidural infusions
Include in Patient Safety Alert.
Addressed
Noted
Wording modified to be more appropriate for
independent sector
Addressed
Noted. The NPSA recommendations are intended
for all clinical services not just the Acute Pain
Service. Health care organisations will be required
to address the risks and implement risk
management initiatives appropriate to local
assessment.