UKMi Executive
U
Proposal for establishment of an
NHS Injectable Medicines Guide
Executive Summary

This paper proposes that the Department of Health support the development of
an NHS Injectable Medicines Guide which will provide an NHS-wide resource
to facilitate implementation of new patient safety initiatives and
recommendations from the National Patient Safety Agency and the Healthcare
Commission relating to injectable medicines.

This project will be led by a joint team from the UK Medicines Information
(UKMi) network, the IV Guide Group and the Royal Pharmaceutical Society of
Great Britain, in partnership with organisations representing the major
pharmacy, nursing and medical professions.

The NHS Injectable Medicines Guide will build on current work and expertise
within the NHS and will be produced on a phased basis, prioritised according to
clinical risk, over 2 years.

All injectable medicines used within the NHS will be covered, including all
routes of administration and whether licensed or not.

The project plan will be to establish a writing and clinical governance
infrastructure and commence production in the first year, and to complete initial
production and implement a review process in Year 2. A robust and
accountable multidisciplinary management and consultative structure will be
established, in addition to new electronic platforms for production and delivery.

A funding requirement of £476K is required over 2 years to achieve this
proposal.

Funding streams to maintain the NHS Injectable Medicines Guide after the
initial 2-year development period will be identified during the project period.
1. Introduction
This paper proposes that the Department of Health supports and facilitates funding for the
development of an NHS Injectable Medicines Guide.
The need for such a development has been highlighted by the recent work of the National
Patient Safety Agency (NPSA) in preparation for a safety alert ‘Patient Safety Alert 20:
Promoting safer use of injectable medicines’’, published in 2007.
This proposal has developed from an approach to UK Medicines Information network (UKMi)
by the NPSA to provide an information resource to front line healthcare staff to minimise the
risk posed by injectable medicines. This approach was made based on a UKMi track record
for delivery of high quality national medicines management initiatives (e.g. national horizon
scanning for the NHS, a training and clinical advisory infrastructure for NHS Direct,
introduction of www.nelm.nhs.uk etc).
This proposal arises from the joint work undertaken by UKMi, the National IV Guide Group
and the Royal Pharmaceutical Society of Great Britain.
Page 1 of 13
The joint group is proposing an NHS Injectable Medicines Guide for the NHS to address the
following unmet needs:

A one-stop quality information resource for frontline NHS staff to enable the safe
prescribing, administration and supply of all injectable medicines.

Provision of information to primary care staff to support implementation of
community initiatives related to injections.

A mechanism by which a consistent, standardised approach to care can be
delivered across the whole of the NHS in this high risk area.
A national initiative has the advantage that it will avoid the duplication of effort, waste of NHS
resource and risk which will be engendered by every Trust writing its own in-house
injectables guide.
The joint group intend to work across the whole UK, utilising appropriately skilled staff to
write material and undertake quality assurance. The proposal is supported by a wide range
of professional groups within the UK, with which continuing partnerships will be developed.
It is proposed that 2 year project funding is made available to establish the NHS Injectable
Medicines Guide.
2. Injectable medicines and risk
Potential risks to patient safety are considerable with injectable medicines, with many reports
in the literature of errors and clinical incidents leading to potentially serious sequelae, and
even death, in patients (1-5).
Although many incidents relate to intravenous (IV) administration because of the high
number of IV administrations used, other routine parenteral routes of administration, e.g.
intramuscular, subcutaneous, intrathecal, epidural etc, also present risks of varying degrees
to patients.
It is incumbent on the NHS and its practitioners (medical, nursing and pharmaceutical) to
minimise risk and potential harm to patients, within a robust clinical governance framework.
Appropriate training, clinical competencies, accountability, standards and guidance, all within
a controlled structure and with a corporate/organisational acceptance of ultimate
responsibility, are essential to minimise risk and harm to patients.
A key tool in achieving this is the provision of credible, accurate, up-to-date and evidencebased clinical guidance, enabling NHS practitioners to work safely when administering
injectable drugs.
In March 2007 the National Patient Safety Agency (NPSA) published a Patient Safety Alert
(Patient Safety Alert 20: Promoting safer use of injectable medicines). One of the
recommendations in the report states “Ensure essential technical information on injectable
medicines is available and accessible to healthcare staff in clinical areas at the point of use.”
This is reinforced in section 3 of the report, underpinning the place of the existing main IV
Guide (see below) as the principal resource to provide compliance with this
recommendation.
At present there is no single source of information, UK or international, that frontline staff can
call upon which provides them with all the essential information required.
Page 2 of 13
3. Current position
There is an array of IV medicines guides produced in-house by NHS Trusts (estimated at 2030). Although some guides are available outside the originating hospital, the principal IV
guide used extensively throughout the NHS is that produced by a National IV Guide Group
with representatives from over 125 UK hospitals, ‘The IV Guide’.
The majority of NHS produced guides, including The IV Guide, focus only on IV
administration and exclude other parenteral routes that also carry significant clinical risk.
No current guide as yet has a national NHS endorsement or provides a nationally approved
standard for production or content of such guides.
Other sources of information on injectable medicines are superficial or non-comprehensive
(e.g. British National Formulary, e-Medicines Compendium) or only provide one part of the
complete information picture required (e.g. Trissel’s IV Incompatibility Guide, the King Guide
to Parenteral Admixtures, UCL Guide). Manufacturers’ information leaflets to support the
prescribing, administration and preparation of injectable medicines are of variable quality
and completeness and not always supplied. For many injectables, the published information
available is of little relevance to clinical practice.
There is, therefore, a need for a single, authoritative, evidence-based, nationally approved
guide to the safe use of all injectable medicines that supports clinical practice in the UK.
4. Proposal
To establish, under the auspices of UKMi, an NHS Injectable Medicines Guide to fully meet
the NPSA’s requirements and the expectations of frontline health professionals.
The NHS Injectable Medicines Guide will ultimately contain a monograph for all injectable
medicines. A separate monograph will be produced for each possible recommended
injectable route. It will be available in both electronic form and as a paper copy.
The achievement of the complete Guide will be through a phased approach, each phase
determined by the relative risk of the product concerned.
The NHS Injectable Medicines Guide will have the following essential features:




Carry multidisciplinary endorsement of national groups which are involved in the
preparation and administration of injectable medicines or are involved with the safe
use of medicines (see Appendix 1)
Build on the current content and reputation of the IV Guide and utilise the expertise
and experience of the IV Guide Group
Adopt a culture of quality and clinical governance to underpin the writing and
maintenance processes and to maximise its uptake and credibility
Be available through a national NHS-wide electronic platform1 which will have
penetration to the point-of care and presents output formats, including hardcopy,
appropriate for different user groups (e.g. pharmacists, nurses and doctors). It is
envisaged that the principal platform will be internet based with a facility to print and
1
The current IV Guide is hosted on an internet platform managed by Health Solutions Wales (HSW)
on behalf of the NHS. Work is currently underway to link the monograph content of the IV Guide to
NeLM. Closer integration with NeLM will be addressed as part of NeLM’s development plan within
this proposal to enable NeLM to deliver the full functionality required of the proposed Injectable
Medicines Guide.
Page 3 of 13



reproduce locally required monographs. Intranet and printed book options will also
be assessed.
Have direct compatibility and integration with the decision support components
Enable links into local guidance if required.
Be free to end users
The initial focus will be on licensed medicines/uses, but will be extended to include
unlicensed products and ‘off-label’ uses.
Prioritisation of monographs required will be through an assessment of potential risk. It is
considered that the priority content of the NHS Injectable Medicines Guide will be:




Commonly used intravenous medicines, especially those in use in general
/multiple clinical areas. It is anticipated that monographs for cytotoxic medicines,
specialised paediatric and neonatal medicines, critical care medicines and HIV
medicines will be reviewed by individuals working in specialist areas.
Epidurals and spinals
Subcutaneous infusions
Medicines commonly used in other high-risk situations or routes of administration
Secondary development will include:
 Drugs administered by specialist routes, e.g. intravitreal, intra-articular
 Blood products which appear in the BNF
 Specialist drugs (e.g. Botox®)
 Lower risk intramuscular and subcutaneous injectables
Planned monograph content (this is dependant on injectable route being described and will
not be relevant for all monographs):








Method of preparation, appropriate dilution and administration method
Specification of infusion pump to use according to therapy category
Example calculation for medicines given by continuous infusion and an electronic
rate of administration calculator
Adverse effects which may occur as a result of the injectable route of administration
used (including consequences of extravasation) and monitoring required
Compatibility information useful in routine clinical practice
Medicine specific factors including pH, sodium content and osmolarity
Special handling precautions
Product risk factor using product risk assessment method described in NPSA Safety
notice
Electronic links to the ‘summary of product characteristics’, patient information leaflet
and relevant entry(ies) in the BNF
Page 4 of 13
5. Project outline
The current IV guide contains about 200 IV monographs which could be utilised within the
NHS Injectable Medicines Guide. Drugs classified as ‘high-risk’ are undergoing extensive
quality assurance to ensure they meet NPSA requirements and to prepare them for inclusion
in a UK wide NHS publication. ‘Lower-risk’ drugs will be updated and assessed as part of
this proposed project. There will remain approximately a further 150 IV medicines for which
new material will need to be written to give the NHS a comprehensive guide to all IV
products.
To develop the completed NHS Injectable Medicines Guide, the NHS will require the de
novo preparation of about 350 new monographs or enhancement to current monographs to
cover all other non-IV routes of injection. All of these will also require quality assurance.
A year by year plan for initiating, delivering, implementing, and maintaining the project is
given below.
Year 1
Create and appoint to a project management/delivery infrastructure. To include a project
board, editorial/operational group, clinical consultation group, regional QA leads and
writers/checkers.
Establish formal lines of communication, including mechanisms for:




Engaging multi-disciplinary stakeholders and partners for clinical advice
Keeping frontline clinical, informatics and NHS IT staff aware that the NHS
Injectable Medicines Guide is in development
Engaging the pharmaceutical industry for information
Providing feedback to the Department(s) of Health and other key stakeholders
on progress
Create an operational plan to deliver the product. This to include:










Planning the management of funding against deliverables
Liaising with stakeholders to finalise monograph templates
Creating a detailed work plan for monograph production and updates
Further developing a style guide and detailed remit for writers, checkers and
clinical experts
Further developing a quality assurance (QA) process
Further developing IT procedures for local web entry
Developing and implementing a training programme for writers and checkers
Accrediting writers and checkers to write and check monographs, add material to
the database, and conduct QA
Further developing a user guide to the database
Promoting local implementation guidance
Develop and deliver the initial outputs and support by::


Completing all IV monographs including cytotoxics and high-priority unlicensed
drugs
Completing monographs for non IV high priority injectable medicines, e.g.
Page 5 of 13
intrathecals and epidurals




Starting update cycle for existing monographs
Considering further IT developments to ensure website meets user need,
especially closer links and integration with NeLM in parallel to the ongoing
development of NeLM.
Establishing a helpline and web support materials for users
Establishing a mechanism for informing users of significant new developments/
updates

Officially launching the NHS Injectable Medicines Guide

Explore sources of funding to maintain the product after the 2-year development
project

Run a series of local multidisciplinary meetings across the UK to ensure that the
product is taken up
Develop an end-user feedback mechanism to inform subsequent development
Review project costs and identify future delivery and funding models
Year 2








Complete all other injectable medicines monographs
Continue update cycle for existing monographs
Conduct user survey
Finalise future funding model
Finalise future delivery platforms and outputs formats
Develop and deliver training materials for NHS implementation of the NHS
Injectable Medicines Guide for each professional group post project.
Page 6 of 13
6
Options appraisal
Option
6.1
6.2
6.3
6.4
+
Retain numerous writers
with ‘free to writers’ access
(subscription to others) with
centralised editing,
consultations and webenabling
Free subscription-linked
writing with some funding
for central functions
Total funding for central
functions. Paid and
employed core writers.
Free Q&A
Total funding for central
functions, writers, checkers
and QA processes

Builds on current product

Cheapest option

Pharmacy-based

Unwieldy process, with barriers
to implementing and
maintaining consistency,
training and quality with a large
group of writers

Relies on voluntary process
with no accountability

Relies on free quality
assurance.

Free access only to
contributors

No funding for centralised
functions, development, Health
Solutions Wales (HSW) etc

Builds on current product

Unwieldy process (see above)

Pharmacy-based


Provides some funding
independent of Hammersmith
Hospital with IT/development
potential
Relies on voluntary process
with no accountability

Relies on free Q&A

Free access only to
contributors

Probably insufficient funding for
all centralised functions and
none for development e.g.
HSW

Builds on current product

Requires significant funding

Pharmacy-based

Relies on free Q&A

Limited numbers of writers
employed to undertake task –
accountable, manageable,
easily trained, focussed
expertise, increased process
efficiency and increased
consistency

Free to all NHS users

Facilitates establishing and
maintaining links with experts

Total independence from
current processes and
structures

Expensive

Require large infrastructure

Free to all NHS users

Total freedom to develop as
seen fit
Option 3 is the preferred option as it gives appropriate and managed content, high
quality and quality control processes, manageable structures and processes, utilised
expertise and minimises external funding requirements
Page 7 of 13
7
Management and operational structure
UKMi propose to manage the development of NHS Injectable Medicines Guide ((IMG) via a
decentralised model that combines regional and national level coordination and expertise
with local level production and implementation. Primary responsibility for project
management will rest with a Project Board, whilst control of the project on a day to day basis
will be the responsibility of an Editorial/Operational Group. Both the Project Board and the
Editorial/Operational Group will work in full collaboration with the identified partners and
stakeholders (Appendix 1)
The proposed management and operational structure is:
Project Board
(becomes Steering Group post 2 year project)
Membership:
Remit:
 Editorial Group










representative(s)
UKMi (3)
IV Guide Group (2)
Health Solution Wales
NPSA
Funding body representative
UKCPA
RPSGB
Trust Chief Pharmacist
Connecting for Health
PASA
To provide overall management and
strategic leadership of the project
Including
 allocation of funds
 promoting collaborative team
working
 taking account of
development proposals from
the Clinical Steering Group
Editorial/Operational Group
Clinical Consultation Group
Membership:
Remit:
Membership:
Remit:




To ensure:
 the monographs and
the IMG as a whole
meet the needs of the
users
 The template for each
monograph type is
acceptable for use in
clinical practice.
 Editor/Process
To provide a mechanism
for advising on clinical
content, style, format and
product delivery, and for
implementing pilot
initiatives
Clinical Editor
Process Manager
IT lead
Administrative
support
 Writers/checkers
 QA leads
Manager
 Nurse and
Anaesthetist
advisers
 Professional group
representatives
(pharmacists,
nurses, doctors etc)
 Patient safety
representatives (and
possibly patients)
 Clinical specialist
group
representatives
Effective communication channels will need to be developed between these bodies.
Page 8 of 13
8
Liability
Liability for content, product delivery and staff employment/ management will be met as
follows:
9

The Injectable Medicines Guide will be written as a series of monographs and liability
for content will be held by the ‘lead body’ identified as the ‘publisher’. The Project
Board (subsequently to be the Steering Group post-project) will be responsible for
implementing and monitoring the employment arrangements for staff specifically
employed for this project (writers, editor, process manager) in their professional
capacities as employees of NHS organisations. All writers and checkers will have
their roles in the production of the IMG clearly stated in job descriptions. A rigorous
quality assurance process will be enforced.

Product delivery will be the responsibility of the Process Manager

Staff employment/ management responsibilities will be met by the NHS
organisation(s) for staff specifically employed for this project.

Further legal advice will be sought to clarify and confirm the liability and associated
issues.
Intellectual Property Rights
A named Trust will assume copyright and Intellectual Property Rights on behalf of the NHS
as a whole and the Secretary of State to protect the contents from being used without
permission outside the NHS.
Copyright will not be enforced to the detriment of any potential users within the NHS or
Departments of Health for the tenure of this 2 year project.
10 Funding
To establish the NHS Injectable Medicines Guide a funding requirements to be £420K the 2year life span of the project has been identified.
The funding will be used in part to establish central editorial and IT support teams but will
mainly be used to commission writing and QA from pharmacists based in NHS Trusts, multidisciplinary expert advice and review from multidisciplinary experts.
Funding
Year 1
Funding
Year 2
Editorial and administrative team
£64.4K
£66.0K
IT support (Band 6 0.6 wte)
£24.7K
£25.3K
£122.3K
£125.4K
£15.8K
£16.1K
£8.0K
£8.2K
£235K
£241K
Writing (2.5 pharmacists/others)
Specialist advice and review –
Anaesthetist 0.1 wte and Nurse Advisor
0.1 wte
Quality assurance
Total
Page 9 of 13
Continued funding for maintaining and further developing the Injectable Medicines Guide will
be addressed as a matter of critical importance in the early stages of the project plan.
Maintenance costs are anticipated to be less that the development costs identified above.
NHS and external funding sources (or a combination), including commercial potential, will be
explored to ensure a revenue stream to maintain the IMG free at the point of use within the
NHS.
The Department of Health will advise on whether this proposed project falls within OJEU
commissioning/tendering or whether it is managed as an internal NHS development.
11 Recommendation
That the Department of Health facilitates the establishment of a funding stream of £476K for
the development of the NHS Injectable Medicines Guide over a 2-year period, as outlined in
the proposal.
Lack of development of the NHS Injectable Medicines Guide has consequences of:

The NHS as a whole will be unable to meet the requirements of the NPSA regarding
the safe administration of injectable medicines to patients.

There will be inappropriate use of NHS resources as a result of increasing duplication
of effort as Trusts locally try to meet the requirements of the NPSA

Proliferation of ‘local’ guides will lead to inconsistency and lack of robust clinical
governance frameworks for this crucial high-risk area of patient safety.

Ultimately this will also lead to poor and inappropriate information available at the
bedside, in clinics and in community and home-care settings.
The importance of the development of an NHS Injectable Medicines Guide to improve
patient safety and to meet the requirements laid down by the NPSA cannot be overstated,
and must not be underestimated.
References:
1.
2.
3.
4.
5.
6.
Clark CM, Bailie GR, Whitaker AM and Goldberg LA. Intravenous medicine delivery - value for money?.
Pharm J 1986; 236:452-455
Hartley GM and Dhillon S. An observational study of the prescribing and administration of intravenous
medicines in a general hospital. Int J Pharm Pract 1998; 6:38-45
Taxis K, Barber N. Ethnographic study of incidence and severity of intravenous drug errors. Br Med J
2003;326:684-7
Cousins DH, Sabatier B, Begue D, Schmitt C and Hoppe-Tichy T. Medication errors in intravenous drug
preparation and administration: a multicentre audit in the UK, Germany and France. Qual Saf Health Care
2005,14:190-195.
Taxis K. and Barber N. Causes of intravenous medication errors: an ethnographic study. Qual Saf Health
Care 2003; 12:343-348
Development of an intravenous drug administration guide. Pharm J 2002; 269:366
Peter Golightly
Fiona Woods
Chris Proudlove
Eilish Smith
On behalf of UKMi Executive
Meghna Joshi
Susan Keeling
Beryl Langfield
Robin Burfield
Anne Jacklin
On behalf of the IV Drug Guide Group
On behalf of the Royal Pharmaceutical Society of Great Britain
Version 4 (final) January 2008
Page 10 of 13
Appendix 1
Partner and Stakeholder Groups/Organisations
The Organisations listed are those which have already expressed support for, and/or been
actively been involved with, consultation on this proposed NHS Injectable Medicines Guide.
Other professional organisations which will have a strategic or user interest in the proposed
guide will be engaged where possible. The MHRA and the pharmaceutical industry (ethical
and generic), including umbrella bodies such as ABPI, BGA, PIPA etc, will also be engaged
in the development of the IMG.
British Association of Critical Care Nurses
British Oncology Pharmacy Association (BOPA)
Cerner Corporation
Chief Pharmacists’ Group for Wales
College of Pharmacy Practice (CPP)
Critical Care Patient Liaison Group
Critical Care Pharmacists Group
Department of Heath
First DataBank
Guild of Healthcare Pharmacists (GHP)
Hospital Pharmacists Group, RPSGB
Intensive Care Society
London Deanery for Medicine
National Knowledge Service (NKS)
National Library for Health (NLH)
National Patient Safety Agency (NPSA)
National Quality Assurance Pharmacists’ Group
National Technical Services Group
Neonatal and Paediatric Pharmacists Group (NPPG)
Nursing and Midwifery Council
Paediatric IICU Group (PICU)
Primary Care Pharmacists Association (PCPA)
Royal College of Anaesthetists
Royal College of Nursing – IV Forum
Royal Pharmaceutical Society of Great Britain (RPSGB)
UK Association of Teaching Hospitals Pharmacists
UK Clinical Pharmacists Association (UKCPA)
UK Medicines Information network (UKMi)
Page 11 of 13
Appendix 2
Appendix 2
Funding Options
Requirement
Notes
Total Cost (£000)
(incl. employer’s contrib. if approp)
Year 1
Year 2
Editorial & Admin Team
Clinical Editor
0.3 wte (8b mid-scale)
17.2
17.6
Process Manager
0.7wte (band 8a/b mid-scale)
40.2
41.2
Administration/secretarial
0.2 wte (band 3)
4.0
3.8
Editorial team non-staff costs
Consumables, travel,
office furniture, PCs,
information resources etc
3.0
3.1
20.7
21.2
4.0
4.1
122.3
125.4
8.0
8.2
10.1
10.3
5.7
5.8
235
241
[It is assumed that a trust will
provide office space for free]
IT Support
0.6 wte (band 6 mid-scale)
Non-staff IT costs
Writers and Quality
Assurance
Pay 2.5 (up to 3) employed
writers to write (and check each
other)
Quality assurance
Specialist Input & Network
Support
To review individual
monographs and to sit on the
Clinical Sub-group to advise the
Project Board and support costs
for network support.
2.5 max 3) band 8a (max)
mid-scale
Up to 8 regional MICs
providing service-funded
support – working
towards random checking
only
1 session (0.1) Consultant
Anaesthetist
1 session (0.1) senior Nurse
Advisor
Page 12 of 13
Appendix 3
IT developments
Some short-term changes will be needed to convert the existing IV Guide website into the Injectable
Medicines Guide website. These changes are needed to support the new ways of working that are
envisaged with the new UKMi co-ordinators and to support new types of monograph for the new
routes of administration to be added.
Aim of the website
To provide an electronic platform to deliver the Injectable Medicines Guide to the end-user that is
available through a national NHS-wide electronic platform which has penetration to the point-of care
and presents output formats appropriate for different user groups.
Changes required
1. It is envisaged that the way monographs are produced will change:
 Monograph authors will write and edit monographs online.
 With the introduction of UKMi co-ordinators with some editorial functions, a more formal
process of quality assurance will be adopted.
 The role of the central Editor will change.
The website will need to be developed to support these changes and to meet the requirements for
the new workflow with new editing functions and changes to the security and access
arrangements.
2. The introduction of the Editorial Board and also specialist monographs, e.g. Paediatrics, Oncology
and other routes of admin, will require changes to the format of the monographs online.
3. Enable links into local guidance and policy and add local Trust Guides to the website so that the
Injectable Medicines Guide and local practice can be accessed as a single combined source of
information.
4. Provide access to the guide from other computer systems such as electronic prescribing and the
National electronic Library of Medicine (NeLM) so that the Injectable Medicines Guide can provide
the decision support needed on injectable medicines within these systems.
5. Provide access to the guide via other types of media including PDAs and mobile phones in
formats appropriate to the user’s requirements.
6. Improve the decision support for dose and infusion rate calculation with formulae, example tables
and a pop-up calculator.
Page 13 of 13