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NHS ISB – REQUIREMENT SUBMISSION for
OPERATIONAL STANDARD
UKCPRS Programme:
NHS Dosage Syntax
for use with
NHS dictionary of medicines and devices
(NHS dm+d)
submitted by
Emma Madden on behalf of the
UKCPRS Programme Board
re-submission in support of
conversion of
Conditional Approval
to
Approval.
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Document History:
ISB Requirement Submission for Operational Standard —
NHS Dosage Syntax
for use with NHS dictionary of medicines and devices (NHS dm+d)
Document Location
This document is only valid on the day it was printed.
Change History
File name: ISAB Submission-RO_DST-v3-00.rtf
Date Version Changes
(N-NN)
2004/05/27 – 0.01 UKCPRS Internal drafts with file name format: ISAB
2004/06/04 - Submission-RO_MDS-vN-NN.rtf.
0.13 Deletion of most redundant ISB guidance matter.
2004/06/04 0.20 Draft submitted to UKCPRS Project Manager for checking and to ISAB
Manager for information.
2004/06/09 – 0.30 Product name and board members amended in response to comment from
2004/06/10 – UKCPRS Project Manager.
0.37 UKCPRS Project Manager consulted about remaining details of editing.
Completed text, but awaits formal confirmation of Sponsor information (to be
included in final v1.00).
2004/06/10 0.40 Submitted to NHS ISAB Manager for distribution to ISAB for consideration at
meeting 2004-07-07, copied to ISB Manager, ISAB Chairman, UKCPRS
Project Manager, UKCPRS Senior Supplier.
2004/06/24 1.00 Completed text, with confirmed Sponsor information, submitted to NHS ISAB
Manager for distribution to ISAB, copied to ISB Manager, ISAB Chairman,
UKCPRS Project Manager, UKCPRS Senior Supplier. File name amended to
better reflect title: ISAB Submission-RO_DST-v1-00.rtf.
2004/07/14 1.01 Incorporates changes to address ISAB Outcome requested actions Req 1, 2,
— - 3, 4, 5, 6, 7, 8 and Draft 1, (2), (3), 8.; and address Disposition points WQ1, 2,
2004-07-22 1.02 3, 4, 5, 6, 7, 8, 9, (11), 16, VQ1, 2, RQ 2, 3, 4, 5, 6.
Circulated and commented in UKCPRS team.
2004/07/22 2.00 Changes consolidated and submitted to Project Manager for distribution – cc
to ISAB managers for information only.
2004/07/23 2.01 Minor additions and all changes marked in ‘Dark teal‘
2004/07/26 3.00 Accept all changes to document
For further copies of this document, contact Stuart Holtom - stuart.holtom@nhsia.nhs.uk
Programme Manager: David Tutcher david.tutcher@nhsia.nhs.uk
Project Manager: Emma Madden emma.madden@nhsia.nhs.uk
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
NHS ISB – REQUIREMENT SUBMISSION for
OPERATIONAL STANDARD
NAME OF STANDARD
NHS Dosage Syntax
— for use with the NHS dictionary of medicines and devices (NHS dm+d),
is Submitted by Emma Madden on behalf of the UKCPRS Programme
Board
UKCPRS (now NHS dm+d) was approved as a Fundamental Standard in
March 2003.
DEVELOPER
The NHS Dosage Syntax is being implemented and delivered by the NHS
Information Authority within the context of its UKCPRS Programme. For
further information please visit the NHS dictionary of medicines and
devices (dm+d) website: (www.dmd.nhs.uk).
The content is closely, in areas in which NHS staff and contractors have
leadership, related to the provisions of HL7 v3.
SPONSOR
The NHS Dosage Syntax is sponsored as follows;
UKCPRS Programme Sponsor, is:
Mike Bainbridge mike.bainbridge@npfit.nhs.uk
Head of Clinical Application Design,
NPfIT Design Authority
PURPOSE
In order to fully communicate information about administration and/or
supply of a medication to a patient for therapeutic purposes, there must be
a clear and unambiguous description of both the medicine itself, and the
prescriber‘s instructions for its use (as distinct from the
manufacturers/licensees data sheet text).
The first of these is addressed by the NHS dm+d, which provides standard
textual descriptions and electronic identifiers for all medicines used in
healthcare in the realm1.
The second of these, the ―prescriber‘s instructions for use‖ can be termed
the ―dosage‖. It is this that is being addressed in this submission. The
NHS Dosage Syntax will provide a standard grammar (syntax, structure)
and the supporting vocabularies for use in the structure, to describe and
unambiguously communicate dosage instructions for medicines, and to
allow these dosage instructions to be machine readable for electronic
decision support. The Syntax will therefore deal with concepts such as
―how much‖ of the medicine, ―how often‖ to give it, ―where and how‖ to
1
Note that, subject to Editorial policy, anything prescribed more than 3 times in a year will be included in dm+d
as a medicine or device. Recall that the dm+d ISB Requirement submission stated that medicines in this
context are not necessarily licensed as medicinal products.
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
administer it, and for ―how long‖. (See also the high-level draft model
below).
In England, the NHS Dosage Syntax will be used in conjunction with the
dm+d, which will describe the medicinal product itself. However, the
Syntax is being developed so as to take into account both of the variety of
ways that a medicinal product may be described, and of international
requirements and therefore it will not be restricted for use only with the
dm+d as the medication descriptor. It should be suitable for use in any
communication of dosage information.
Thus the NHS Dosage Syntax will therefore be the NHS standard for
communication of dosage information (instructions for use of medicines),
for example as specified in the ETP message specifications accepted by
the NPfIT. It will therefore replace the current practice both for paper and
electronic communication, which is based on the use of text strings or Latin
abbreviations and where each clinical information system supplier
provides their own individual ―proprietary‖ syntax.
Currently, in a text-based environment (including also text where it is
generated electronically), representations of dosage instructions do not
support computational processing and re-use of information across
applications. Consequently, all dosage instructions require human
reading and interpretation, and transcription between different systems;
both of which offer a variety of opportunities for patient-critical error to
occur. The facility to provide decision support into the dosage process is
also unavailable.
Therefore, having a representation of dosage instructions in a format to
support electronic use is a key requirement to enable, e.g.:
§ consistent data entry into prescription, dispensing and medication
administration systems, using the standard syntax and vocabularies;
§ medication dosage decision support systems such as calculation of
expected length of duration of supply, dose range alerts;
§ drug utilisation monitoring, facilitating calculation of supply
amounts/periods, for robotic dispensing, ward re-stocking,
compliance monitoring etc.
It is also fundamental to the building of federated electronic healthcare
records, such as NHSCRS, since information from all authorised sources
must be stored in a format that is both reliably retrievable and useful for the
future.
Many clinical systems managing medicines have local vocabularies to
produce dosage instructions; however these are non-standard in both
content and structure.
In order to reach many of the goals stated above, there is a need for a
standard representation of dosage instructions to be used across all
sectors of care. This need for standardisation is also recognised
internationally, and this project is designed to provide a core part of the
deliverable of an international initiative in this domain (HL7).
Improving Patient Safety is at the heart of all of the NHS IT initiatives being
driven forward by Government. It is estimated that medication errors cost
the NHS about £500 million per year in additional days spent in hospital.
The National Patient Safety Agency (NPSA) has emphasised the
importance of ‗designing solutions that prevent harm‘. Electronic
prescribing and improved computer prescribing and dispensing systems
have a vital part to play in reducing medication errors and transcription
errors by providing clear, unambiguous, timely information.
These technical developments underpin the overall NHS Quality and
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
Safety Agenda. The NHS Dosage Syntax will contribute to the wider
benefits to patients and healthcare professionals through the provision of
consistent textual descriptors and standard electronic codes and structure
for communicating instructions for use for medicines, in prescribing,
dispensing and administration leading to safer systems (less prescribing
and dispensing errors and enhanced decision support).
Until now there has been no common, standardised syntax for medicines
dosage. Clinical applications dealing with medicines, such as GP
systems, Community Pharmacy systems and Hospital Pharmacy systems
have each developed their own patterns, vocabularies and abbreviations,
usually based on the ―historic‖ Latin terms to describe dosage. These
have then been communicated as text strings. This situation does not
allow interoperability between diverse clinical systems, or allow effective
decision support through linkage of knowledge to data. The case for
change is driven at a strategic level by the need to underpin and support
key national initiatives by providing a unique and unambiguous syntax.
SCOPE
The NHS Dosage Syntax is required to enable communication of
information about the prescriber‘s instructions for use of medicinal
products in the treatment of human patients.
The NHS Dosage Syntax should cover all domains (primary, secondary,
tertiary care) in which medications are used, including the core clinical
specialties that have particular dosage information requirements
(chemotherapy, child health, anaesthesiology, etc.).
The ―Dosage Syntax‖ should offer support to the scheduling of medicines
administration, as well as the description of dosage information.
A very high-level, and preliminary, model of its scope is given below.
Point and nature of use:
Example uses -
Typical high level uses are as follows:
§ Point of care in support of decision-making, prescribing, clinical
documentation, dispensing and administration;
§ Materials management in support of stock control and costing where
―machine readable‖ dosage information is a requirement;
§ Service management in support of performance improvement and
adverse drug reaction reporting;
§ Electronic data interchange in support of safe interoperability
between computerised information systems.
Users:
Clinical and administrative NHS and DoH users in the context of -
§ Electronic healthcare records;
§ Electronic prescribing;
§ Clinical electronic data interchange;
§ Decision support;
§ Stock control;
§ Costing;
§ Adverse drug reaction reporting;
§ Performance management;
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
§ Care delivery systems.
Community pharmacy users in the context of -
§ Electronic prescribing;
§ Clinical electronic data interchange;
§ Stock control;
§ Costing.
Information systems providers in the context of -
§ Electronic healthcare records;
§ Electronic prescribing;
§ Clinical electronic data interchange;
§ Decision support;
§ Stock control;
§ Care delivery systems.
Distribution:
Current thinking suggests that the vocabularies for NHS Dosage Syntax
will be distributed with the dm+d; these will therefore be routinely available
and have an in-built update facility. The Syntax itself will be described
using appropriate technical documentation. However, once developed, it
is anticipated that the amount of updating required will be limited, since
instructions for medicines use do not change dramatically over time. This
issue will be considered in more depth in Draft standard submission.
Use scenario:
Initial High Level Dose
Syntax Model
Feb 2004
How much to be used
[Quantity; Units]
In that Where, How to
Where to be used
be used
A Medicine
In that When, For how
When to be used
long to be used
Why to be used
Supply Amount
[Quantity; Units]
Primary Care Dosage Syntax Example Storyboard
Justine Thyme goes to see her GP, in Tops Surgery in Toytown,
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
because she has a nasty cough and is producing ill smelling green
phlegm. Dr Indiana Jones, on clinical examination, decides that Justine
has a bacterial chest infection, meriting treatment with antibiotics.
He checks Justine‘s electronic medical record ―Risks and Warnings‖
section for any allergies, but none are present, and he checks with
Justine herself also, but she has never experienced any medication
allergies. He therefore decides to use amoxicillin, and moves to the
―prescribing‖ application in his clinical system, where his initial action is
to select Amoxycillin 250mg capsules. He then moves to the dosage
section, where he is offered a default dosage text that reads ―one
capsule to be taken 3 times daily, for 5 days‖. He accepts this default
and the next default, which suggests a supply quantity of 15 capsules.
The GP clinical system processes the information that Dr Jones has
entered through the prescribing screen and, using SNOMED-CT, the
dm+d, and the Dosage Syntax, it runs its decision support, establishes
both the medication and the dosage is suitable for the patient with this
condition and then it electronically sends the information for the
prescription to Justine‘s nominated high street pharmacy.
Once in town Justine enters the Potions Pharmacy on the High Street
and presents her ‗electronic prescribing token‘. The dispenser scans her
token into the pharmacy‘s local system, which already has her
prescription in it.
The pharmacy system ―reads‖ the coded information in the prescription
and automatically builds a complete ‗patient ready‘ dispensing label for
the item, using the dm+d and the Dosage Syntax. No information
transcription is required.
The display and table text for the dosage reads ―Take one capsule three
times a day, at regularly spaced intervals, for the next five days, until all
the medication has been used up.‖
The system also runs a set of clinical checks on the prescription, for
example, a dose range check, again using the Dosage Syntax to
―understand‖ the dosage in a calculable form and compare this to the
information held in its medicines knowledgebase dose check
application.
Peter Potion checks the prescription, then, as he hands her the
medication, checks with Justine that she is both clear about when to take
the medication and that she has no unanswered questions. Justine then
leaves the Pharmacy. She takes the medication and her chest infection
recovers well.
Secondary Care Dosage Syntax Example Storyboard
Mr James Bond has been admitted to Good Health Hospital as an
emergency for pinning of a compound fracture of his left tibia and fibula
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
after a skiing accident. His post-operative pain relief has been
prescribed by the Registrar who orders Aspav tablets (aspirin and
papaveretum), two tablets to be administered regularly every 6 hours to
control the pain adequately with its mixture of NSAID and analgesic.
Aspav Tablets are a ―non-stock‖ item on James‘ ward, so an alert is
generated by the clinical system for pharmacy, which notes that it was
the Registrar ordering the medication, and therefore a non-stock item
can be supplied. Using the dosage information from the prescription, an
initial 5 day supply of 40 tablets is dispensed and sent up to the
Orthopaedic ward.
The nursing system notes the receipt of the Aspav tablets, and the
dosage instructions of the prescription. The next drug round is due at
12.00hrs, which the application has calculated is appropriate for
administration of a ―6 hourly‖ administration regimen. Therefore, the first
administration of James‘ Aspav tablets is shown on the administration
screen for this round, and will then be displayed on the subsequent
appropriate screens for that 6 hourly regimen, until it is discontinued.
The Pharmacy system, that could calculate from the dosage, the
expected duration of the supply quantity that they issued, will ―check‖ in
four days‘ time whether the medication is still current, in which case
further supplies of the medication will be needed for ongoing use.
Performance characteristics:
In order to be a trusted clinical tool the NHS Dosage Syntax must be
accurate.
It must deliver the elements and structures required to communicate
dosage information unambiguously electronically between systems and
into and out of the Electronic Health Record, and to allow electronic
decision support to process this dosage information for the purposes of
safety and suitability checking. It must be applicable for dosage
information in all domains of medicinal product use (primary, secondary
and specialist care).
It is to be expected that 95% of the examples tested be messaged
correctly and consistently by the model. The remaining 5% will take longer
to resolve and will be managed by retaining some support for narrative
dosage in the interim.
One should note that the quantification of percent coded to equate to
success is however, difficult to define. To arbitrarily state 95% of all
examples must ―work‖ is not necessarily a useful exercise, as the easier
95% will be easier to code and by definition these will be the dose
instructions less likely to cause issue. It is the more complicated dose
instructions that will be more prone to produce error and thus more
important to code correctly. If these are the 5% that fail the test process
then even though the 95% threshold would imply success, the workstream
objectives stated above cannot be seen to have been achieved
successfully.
Out of scope:
The NHS Dosage Syntax will not include description of the instructions for
use for medicinal devices, or therapies other than medicinal products (e.g.
radiotherapy dosages).
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
The NHS Dosage Syntax will not ―mandate‖ the use of the core descriptive
concepts from the standard supporting vocabularies in all clinical systems;
some ―synonymy‖ of terms will be allowed to support two particular
business needs:
§ language translation; e.g. dosage entered using a Welsh vocabulary
in a clinical system is communicated electronically and then
displayed in English in the pharmacy system;
§ context translation; e.g. dosage entered using ―clinician
understandable‖ vocabulary (likely to be the one used for the core
descriptive concepts) is communicated electronically and then
displayed using ―Patient Friendly‖ descriptors in the pharmacy
labelling system and on the printed dispensing label.
BUSINESS JUSTIFICATION
Strategic Fit
The availability of ‗UKCPRS‘ (now NHS dm+d) and hence the NHS
Dosage Syntax is assumed by NPfIT ICRS-OBS2-2
(www.dh.gov.uk/PolicyAndGuidance/InformationTechnology/NationalITProgramme/NationalITProgra
mmeArticle/fs/en?CONTENT_ID=4071618&chk=FzV2Cm ) which states:
113 – Prescribing and pharmacy
Overview
Prescribing and administering drugs to patients is a key care process. Both processes, if
inadequately informed, can also cause serious risks to patient safety. This module
describes the core functionality required to allow and support the safe prescribing of
drugs by Clinicians, as well as assisting in managing the dispensing and administration
of drugs (mainly in the hospital setting), and monitoring and presenting each patient's
drug history and compliance.
Scope
The scope of this module includes all prescribing and drug use across the NHS: in
Primary Care; in the Acute Care sector; and by community practitioners, as well as
provision of drugs in the community. …
...
Other Requirements
...
A national drug database covering all sectors - The service shall comply with the
UKCPRS (which will be a component of SNOMED CT).
790 – Standards
Overview
The purpose of this module is to document the standards that shall be used in relation to
the NPFIT. These standards have been arrived at through discussion with NDA, NHSIA,
STEP, ISB and third parties. This document has been developed following close
consideration of STEP, ISB and e-GIF and aims, where possible, to strategically align
with the standards certified and documented by the above bodies. The requirements
detailed in this module reflect the need for LSPs and the ICRS NASP to adhere to
current legislation and observe standards as they evolve and emerge. This will include
being able to embrace new legislation and standards and upgrade existing standards
without undue delay as required by the Authority.
...
Detailed Requirements
...
UKCPRS
All new systems shall support the UKCPRS standard.
All existing systems should support UKCPRS.
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
The Overview text in Section 790 of the OBS (see above) explicitly requires integration
of the dm+d into the NHS Business Architecture as it is understood as being critical to
the safe operation of the ICRS. These standards have been taken forward in the
contracts signed with NASP and LSP consortia.
In making the submission of the Requirement for an Operational
standard for NHS dm+d in January 2004 it was stated by Tim Jones
(2004-01-16):
―I would have expected that the DA/TO could not have made a more definite statement
of support than having put it into the OBS and that a further statement is unnecessary.
Regards,
Tim‖
and by Jeremy Thorp (2004-01-30):
―I am writing on behalf of the Design Authority to confirm our support for this work. The
submission already describes how the requirement (expressed using the former title of
UKCPRS) has been incorporated into NHS Care Record Services contracts. It also
describes how dm+d forms an important component of SNOMED CT - together these
will provide the clinical language foundation for the future.
Regards
Jeremy‖
Operational Fit
In all instances the NHS Dosage Syntax will be presented in a NHS dm+d
context that is compatible with that already used by clinical applications in
a manner familiar to the users. Most clinical applications use some form of
proprietary dosage syntax, therefore implementation of a standard syntax
and supporting vocabularies will not be a totally new concept for
developers or users of applications to manage.
It will also be supplied with information on how to use it with the HL7 V3
messaging structures that are required for all National Programme
communications about medicines, including their ―instructions for use‖ or
dosage information.
Similarly, confidentiality, security, legal and professional issues are not
expected to change materially; if anything the improved consistency of
communication could be expected to improve legal and professional
liability matters.
Strengths and Weaknesses
If implemented as described above then the strengths, benefits and
weaknesses are as follows:
Strengths when implemented:
§ Provides a single system of describing medicines dosage;
§ Provides the whole NHS (in hospitals, primary care and the
community) with a means of sharing descriptions of medicines
dosage.
Benefits when implemented:
§ Facilitates structured description of medicines dosage such that the
granularity of description currently used in free-text communication is
fully supported;
§ Enables reduction of medication errors and transcription errors by
providing clear, unambiguous, timely medicines dosage information;
§ Enables point of care support for decision-making, prescribing,
clinical documentation, dispensing and administration;
§ Enables electronic data interchange in support of safe medicines
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
dosage interoperability between computerised information systems;
§ Enables materials management in support of stock control and
costing;
§ Enables service management in support of performance
improvement and adverse drug reaction reporting.
A number of benefits of having a standard dosage representation available
can therefore be expected:
§ Standard representation of medicines information in health records;
§ A reduction in errors from interpretation of dosage information; all
clinicians will become familiar with the standard, full documentation
will be available to support any queries;
§ A reduction in errors from transcription and calculation of dosage
information; systems will be able to communicate seamlessly,
therefore transcription should not be required; this includes
communication from clinical application to administration devices
and systems such as infusion pumps etc.
§ A reduction in clinical errors in the medication process as decision
support can perform checks on dosage information;
§ Efficiency improvements in medication processes due to seamless
information transfer.
Weaknesses when implemented:
None identified if implemented as planned.
NOTE:
Except for availability of medication information when a social services
professional has appropriate clearance to access health records there is
no anticipated use for the NHS Dosage Syntax in the Social Care sector.
Risks
Development:
§ Software Development Effort Higher than Expected:
Software development has a propensity to require more effort than
expected.
§ Test Case Examples Inadequate:
This can be mitigated by widely circulating a list of categories of
dosage information, and soliciting ―difficult cases‖. This may be
through the NHS-IA UKCPRS programme website but may also
involve the professional literature.
§ Timescales, Availability and Operational Requirements:
The requirements for this work are urgent, since a significant amount
of Phase 1 implementation in the National Programme requires this
to be in place.
Due to other pressures from other projects, reasonable staff
availability cannot be taken as a given. In the Project Plan, the
availability is generally minimised in an attempt to give realistic
delivery timescales.
Risks when not implemented:
Note that these are shared with the same risks for dm+d itself.
§ No common, standardised vocabulary for clinical products;
§ No interoperability between clinical systems;
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
§ No consistent decision support possible;
§ No exchange of comparable information on medicines and devices;
§ No consistent reduction in medication errors and transcription errors
by providing clear, unambiguous, timely information;
§ No widespread support of materials management in stock control
and costing;
§ No common service management in support of performance
improvement and adverse drug reaction reporting possible.
Issues when implemented:
§ Migration from existing fragmented systems could be hampered by
commercial will, cost, complexity and availability issues. These have
the following mitigation aspects.
1. Commercial will
a The use of the (UKCPRS) NHS dm+d, in total, is mandated
by the NSP and LSP contracts for ICRS service provision;
b Costs of system integration will be reduced by availability of a
common standard NHS Dosage Syntax.
2. Cost
a The NHS dm+d and the NHS Dosage Syntax is freely
available to registered (free) systems suppliers, service providers
and users;
b Costs of system integration will be reduced by availability of a
common standard NHS Dosage Syntax.
3. Complexity
a The complexity of the NHS Dosage Syntax is no greater than
that the variety of existing ad hoc systems and indeed the
selection methods are directly comparable with those in current
use – even to the number of ‗levels‘ of granularity;
b No supplier/ service-provider maintenance (other than
enabling pass-through updating) is required. By having the NHS
Dosage Syntax standard, costly and risky mapping of proprietary
systems between each other is avoided.
4. Availability
The NHS Dosage Syntax structure, vocabulary and technical
documentation will be freely available via the NHS dm+d website.
Vocabulary will also be available from standard terminology
services.
§ Use (widely in both primary and secondary care) by clinical
professionals could be perceived as ‗slow‘ when compared with
current hand-written free-text documentation (but no worse than with
current use of proprietary computerised systems). The mitigation for
this is that ‗whole-task‘ (selection, prescription, dispensing,
administration, contraindication checking and logistics) use of the
structured NHS Dosage Syntax requires less interpretation and is
hence prone to error – reducing both risks of harm to patients and
direct and indirect costs to the NHS.
KNOWN STANDARDS
Existing work by the NHS IA, the literature in this area, (both in the UK and
internationally (e.g. ENV 13697, NCPDP, G-Standard)) has been reviewed
and while previous the work done is of great interest, no work has been
identified that meets all the requirements of this project.
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
Analysis of dosage syntax in existing clinical systems, such as in primary
care and community pharmacies revealed no consistency or
standardisation. The majority are text format, even if using ―codes or
abbreviations‖ (e.g. t.d.s).
During the Literary Review stage existing standards were considered and
rejected primarily because of their development for mainly Primary Care
requirements, making them not suitable for all Secondary Care
requirements.
Both the US NCPDP Script Standard and the Dutch G-Standaard are also
primary care based dosage descriptions.
ENV 13607, ―Health informatics - Messages for the exchange of
information on medicine prescriptions‖ which includes structured dosage
information, was reviewed. Regrettably it was concluded that as it was
also developed for mainly for Primary Care and therefore does not meet
Secondary care requirements. Of particular concern was the lack of
supporting vocabulary accompanying ENV 13607, therefore it was unclear
―how‖ the structure proposed by the standard might be implemented in
practice, particularly for more ―complicated‖ phrases.
The NHS Dosage Syntax is based upon the provisions of NHS dm+d and
is linked to SNOMED CT and integrated with HL7 v3.
Thus, there is no known national or international alternative to the
proposed UKCPRS NHS Dosage Syntax approach.2
INTERDEPENDENCIES
Since all messaging of medication information will be using HL7 V3, and it
will be this messaging that will provide information into the NHSCRS, there
is a functional requirement to ensure that the structure and vocabulary
map into the V3 Medication messaging model.
The mapping of the elements of the dosage syntax model to the
appropriate structures in the V3 Domain Message Information Model
(DMIM) is therefore a requirement. This will be a ―field to field‖ and
―definition to definition‖ mapping. It is envisaged that this will be delivered
in a similar manner to the HL7 V3 ballot package and consist of a ―Dosage
DMIM‖ (a specific subset from the Pharmacy DMIM) with textual
walk-through and supporting vocabulary tables, and one or more RMIMs
(Refined Message Information Models) and schemas for specific example
patterns.
The dm+d is related to (but not dependent on) the SNOMED-CT Core, and
the provisions of the HL7 v3 Reference Information Model, as contributed
by HL7-UK and the HL7 Pharmacy Special Interest Group.
As illustrated in the section on ‗Strategic Fit‘ the establishment of a
clinically safe integrated care record service (ICRS) is dependent on the
ability of contributing applications to populate record components from a
single unambiguous terminological source.
The identified interdependencies do not impose critical path limitations
upon development of the NHS Dosage Syntax; so tight integration of time
scales is not an issue.
DEVELOPMENT PLAN
The core deliverables of the NHS Dosage Syntax will consist of:
2
Literature Review Document can be made available to ISB if required.
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
§ an information model describing dosage information;
§ this is then translated into a physical deliverable;
§ that is initially populated with suitable vocabularies.
These are to be supported by documentation that includes formal
definitions and concept population policy (―Editorial Policy‖).
Existing functionality of systems migrating to NHS Dosage Syntax will be
reviewed prior to Draft Standard submission. A decision has been made
that legacy data will not be translated into the NHS Dosage Syntax due to
the number of varying methods of noting dosage, which would make it
clinically unsafe to do so.
Once NHS Dosage Syntax is introduced for ETP and PSIS records, all
existing proprietary and informal dose syntaxes will be superseded.
The deliverables can then be validated against the needs and
requirements.
The budget for this work has been identified within UKCPRS Budget
2004/2005, which will adequately cover the development of this standard.
The Pharmacy Team at NHS IA will undertake any maintenance under
funding arrangements already in place through the business case for the
maintenance of the dm+d.
The proposed (and subject to refinement) test plan is as follows:
The testing process should investigate both the model and the vocabulary for fitness for
purpose.
Testing should be conducted in two initial stages, alpha and beta, with some
development of testing tools in between.
The alpha testing will involve the collection of a relatively small number of sample
dosage instructions to use in building the model and initial population of the vocabulary.
A structure and vocabulary that can support these examples will then exist.
From this, and having completed the mapping of the structure and vocabulary to the HL7
V3 messaging, an information entry interface should be developed. This will allow entry
of dosage data into a piece of test software, which will use the structure and vocabulary
and ―translate‖ the information through into the V3 schema (xsd). This can be ―sent‖ as if
it were a message, to a second piece of test software, which receives the information,
then displays it back as information on screen (or writes it to a results sheet). This is the
equivalent of writing information to an EHR or sending it to another medication system.
The input information and the output information must then be compared and analysed
by a domain expert, external to the project team.
This process can be shown diagrammatically as follows:
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
Dosage Model and
Syntax Testing Model and
Process Diagram Vocabulary
Data Entry Web-based HL7 V3 Translation Display Text Data Out
Text Data In Interface
Interface Software Software
Domain Expert
Comparison
The beta testing will therefore involve taking a larger sample of dosage information and
putting it through this process, and analysing the results obtained.
All of this testing process should be web based to enable widespread access and
testing.
The results of initial testing should be available in a format of ―text in‖ and ―text out‖ to
allow comparison by a domain expert. An example of input and output might be ―Give
exotocillin 400micrograms/kg/hour over 6 hours by Intravenous infusion‖ and
―Exotocillin - 400microgram per kg per hour - for 6 hours duration - by infusion
intravenous‖; these would be judged to be clinically equivalent, and therefore a
successful use of the model.
To avoid bias in interpretation of the results, a domain expert external to the project (a
member of the NHS-IA Pharmacy authoring team) will undertake the analysis of the
results of the beta testing.
The analysis will involve comparison of input and output text strings, and judging
whether they are semantically identical in content and meaning.
If the results of the analysis are positive the model and vocabulary are judged initially fit
for purpose, and the project board will decide what if any next steps are required. By
using a web-based data entry interface, it will be possible to offer the package for wider
(beta) testing by the clinical community, with the resultant feedback enriching the project
outcomes.
If the results of the analysis reveal deficiencies in the model and vocabulary further
development of the model to accommodate the areas of deficiency can be undertaken.
It is not anticipated that the introduction of NHS Dosage Syntax will raise
new training or human and behavioural issues but because it will, at the
point of use, replace an existing ad hoc analogue of the new syntax, a risk
assessment will be undertaken.
The importance of maintaining the accuracy of the prime resource and
ensuring end-to-end audit to assure and maintain accurate and full
implementation has been considered and will be addressed when the
maintenance plans are drawn up prior to the Draft Standard submission.
Depending on the outcome of this application for approval of a
Requirement, and within the scope of the UKCPRS Strategic Framework
Standard already approved, a Draft Standard submission of NHS Dosage
Syntax as an Operational Reference Source Standard is anticipated in Q3
2004.
SUPPORT
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NHS Information Standards Board Requirement Submission for Operational Standard NHS Dose Syntax
In addition to the support of the DoH Information Policy Unit and the
Prescription Pricing Authority, the UKCPRS and resulting NHS dm+d
(including NHS Dosage Syntax), have the active support of the following:
Senior Suppliers
Paul Frosdick, Head of Professional Networks,
NHS Information Authority
Christine Dalton, Director of Pharmaceutical Policy and Services,
NHS Prescription Pricing Authority
Senior Users
Dr. Colin Price, Assistant Director Healthcare Networks,
NHS Information Authority
Nick Scholte, Chief Executive Officer,
NHS Prescription Pricing Authority
Ian Arrowsmith Consultant - Health Information Design,
NPfIT Design Authority
Dr Felicity Harvey Head of Medicines, Pharmacy & Industry Group,
Department of Health
These individuals are all members of the Programme Board and as such
ensure that the Programme is aligned with the requirements of the ICRS
Programme.
The Senior Users, as UKCPRS Board members, represent the views of
the primary users of this standard, i.e. the clinical and administrative NHS
and DH staff and system providers. Editorial Board members also
represent the interests of the Royal Colleges.
Other sources of support include;
Medicines and Healthcare Product Regulatory Authority – for recording
information on product safety and adverse events;
National Patient Safety Agency – for recording information on medication
errors and mishaps, and to minimise errors in clinical practice;
Purchasing and Supply Agency – to move forward the eCommerce
agenda.
FDB (Decision Support Supplier to BT NASP) have volunteered their
support and will be involved throughout the development of the NHS
Dosage Syntax. In addition the NHS Dosage Syntax is represented at and
receives feedback from NPfIT Terminology Meetings (chaired by Mike
Cooke) and at a sub group - the Medicines Terminology Sub-Group
Meetings (chaired by Mike Bainbridge). The NASP and LSPs are actively
represented at both these meetings.
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