Recommended usability enhancements for
Recording Adverse Reactions in GP software
systems
These recommendations will be made to vendors through the Clinical
Document – My Health Record Usability Recommendations (version 1.3),
following clinical consultation
Clinical Information System (CIS) screens are generic mock-ups and are not
representative of any software vendor system
Contact your software vendor for information on how these enhancements
will be incorporated in the software that you are using
1
National E-Health Transition Authority
www.nehta.gov.au
The following mock-ups are a visual representation of CUP
recommendations for recording adverse reactions. The
enhancements demonstrated include:
1. The minimum data set to be captured for adverse reaction records,
specifically introducing the ‘reaction type’ and ‘date of onset’ data elements
2. Use of standardised clinical terminology when recording adverse
reactions
3. The recording of ‘no known adverse reactions’
2
National E-Health Transition Authority
www.nehta.gov.au
Welcome: Dr Roger Harris
Clinical Information System 1.1
X
_
Last Log In: 04-Jun-2014 10:30
Log out
Select Patient
-
Patient Record
My Health Record
BROWN, David (Mr)
Home Address
Home Phone
Notes
Results
Past Medical
Hx
Requests
(07) 55 66 77 88 99
Forms
Settings
Born 04-Jun-1979 (34y)
212333445 (1)
Medicare #
IHI # prominently8003614455667789
Adverse Reactions are listed
on GP
(07) 22 33 44 55
software systems as per existing implementation
Work Phone
Mobile
20/30 Universal Street,
City East, 4002, QLD
Appointments
Marital Status
Married
i.e. vendors
should
just label
as Allergic
Current
Visitnot
Progress
Notes
reactions OR Allergies
CLD.136 (mandatory)
Allergies and
Adverse
Reactions
Help
Agent
Manifestation
Penicillin
Rash
Reaction Type
+ ADD
A (+) positive
Indigenous Status
My Health Record
weekly
Alcohol
Smoking
Follow up date and time
Messages
Gender Male
Blood Group
Vendors should use one of
the following [email protected]
labels:
Email Address
0404 123 456
Adverse Reactions; OR
View previous
edit
Allergies
and Adverse
Reactions
View previous
edit
Quick Links
InNothis example, the user clicks on
previous
+ADD to add a View
new
Allergyeditor
Adverse Reaction
13-Aug-2014
16.30
Recall / Reminder
Observations /
Examination
General
Cardiovascular
Medicines
Gastrointestinal
Respiratory
Genitourinary
Investigations
Musculoskeletal
ENT
Immunisation
Eye
Skin
Psychiatric
Correspondence
Previous Progress
Notes
Social History
Reason for Visit
HI and My Health Record validation complete
Diagnosis
Management
Reminder
Thursday 05-Jun-2014 12:12
Close
Adding a new adverse reaction…
NOTE: It is the vendor’s discretion on the order
of which to place these fields.
These mock-ups represent the current clinical
workflow for recording an adverse reaction in GP
clinical information systems.
Add Adverse Reaction
* Substance/Agent:
Reaction type:
Adverse reaction
Clinical manifestation:
Not recorded
Date of onset:
dd -- MMM --
yyyy
Not known
* denotes mandatory field
There are four key data fields for capturing an
Adverse Reaction: substance/agent, reaction type,
clinical manifestation and date of onset
CLD.107 (mandatory)
Vendors are not restricted to just these fields and
may/will include additional fields in their systems e.g.
comments field.
CLD.110 (no obligation)
Note that additional fields (and Date of onset) are not
included in clinical document specifications.
Save
Close
The ‘Date of onset’ field is used to capture when the allergy
or adverse reaction happened. It may be a specific date, just
the month and year, just the year only OR identified as ‘not
known’.
CLD.109 (mandatory)
Adding a new adverse reaction…
Each adverse reaction will only
have one reaction type recorded.
By default, it is set to ‘Adverse
reaction’
CLD.119 (mandatory)
CLD.123 (mandatory)
Add Adverse Reaction
* Substance/Agent:
Reaction type:
The substance/agent field is a
mandatory item when
Clinical manifestation:
incorporating adverse reaction data
in a clinical document.
Date of onset:
Adverse reaction
Not recorded
dd -- MMM --
yyyy
Not known
* denotes mandatory field
Save
It is not mandatory for a user to
enter a clinical manifestation – a
user may choose to set this as ‘Not
recorded’
CLD.125 (mandatory)
Close
Selecting reaction type…
Add Adverse Reaction
* Substance/Agent:
Reaction type:
Adverse reaction
In this example, the user selects a
reaction type from a list of acceptable
items.
This list is sourced from the SNOMED
CT-AU Adverse Reaction Type
reference set.
CLD.120 (mandatory)
CLD.121 (mandatory)
Select a general or specific reaction type (optional):
Clinical manifestation:
Date of onset:
Not recorded
Adverse reaction
dd -- Allergic
MMM --reaction
yyyy
Not known
The list of reaction
types is
* denotes mandatory field
represented as a hierarchy allowing
the user to select a general (e.g. Nonallergic reaction) or more specific (e.g.
Medication side-effect) reaction type
description.
Note that this hierarchy will need to
be manually implemented by vendors.
CLD.122 (mandatory)
Hypersensitivity reaction type I
Close II
Hypersensitivity
Save reaction type
Hypersensitivity reaction type III
Hypersensitivity reaction type IV
Non-allergic reaction
Drug interaction
Drug interaction with drug
Drug interaction with food
Food intolerance
Medication side-effect
Toxicity
Selecting reaction type… ALTERNATIVE REPRESENTATION
Add Adverse Reaction
* Substance/Agent:
Reaction type:
Adverse reaction
Select a general or specific reaction type (optional):
Clinical manifestation:
Date of onset:
Not recorded
Adverse reaction
dd -- Allergic
MMM --reaction
yyyy
Non-allergic reaction
Not known
* denotes mandatory field
ALTERNATIVE
DISPLAY:
Initial list may display just the high
level reaction types.
Save
Close
Selecting reaction type… ALTERNATIVE REPRESENTATION
Add Adverse Reaction
* Substance/Agent:
Reaction type:
Adverse reaction
Select a general or specific reaction type (optional):
Clinical manifestation:
Date of onset:
Not recorded
Adverse reaction
Hypersensitivity reaction type I
dd -- Allergic
MMM --reaction
yyyy
Non-allergic reaction Hypersensitivity reaction type II
Not known
* denotes mandatory field
Save
Hypersensitivity reaction type III
Close
Hypersensitivity reaction type IV
ALTERNATIVE DISPLAY:
Clicking on the arrow next to the high level reaction type
would open up a second list displaying the detailed reaction
types belonging to the higher level reaction type group.
Note – user will still be able to select either the high level
reaction type.
Recording the substance/agent…
Add Adverse Reaction
* Substance/Agent:
Reaction type:
User selects a substance/agent from a list.
parox
Medicine substances/agents are sourced from
SNOMED CT-AU and/or AMT if implemented.
CLD.113 (optional)
Paroxo
Adverse reaction
paroxetine
Clinical manifestation:
Not recorded
Date of onset:
dd -- MMM --
Non-medicinal substances/agents are sourced
from SNOMED CT-AU.
CLD.114 (mandatory) ; CLD.115 (optional)
CLD.116 (mandatory)
yyyy
Not known
* denotes mandatory field
Save
Close
The substance/agent field does not allow free
text entry although the user may add their own
user-defined non-medicinal substances/agents
CLD.118 (mandatory)
CLD.117 (no obligation)
Selecting reaction type…
Illogical pairings of
substance/agent and
reaction type cannot be
recorded.
CLD.124 (mandatory))
Add Adverse Reaction
* Substance/Agent:
Reaction type:
paroxetine
Adverse reaction
Select a general or specific reaction type (optional):
Clinical manifestation:
Date of onset:
Not recorded
Adverse reaction
dd -- Allergic
MMM --reaction
yyyy
Not known
* denotes mandatory field
In this example, ‘food intolerance’ is not an
applicable reaction type and therefore not
available for selection, since the agent recorded
is a ‘paroxetine’, a drug.
Note: it is at the vendor’s discretion to choose
how to implement this. Other options include,
for example, disabling the option ‘food
intolerance’ or displaying an error message
when the user attempts to save or close.
Hypersensitivity reaction type I
Hypersensitivity reaction type II
Save
Close
Hypersensitivity reaction type III
Hypersensitivity reaction type IV
Non-allergic reaction
Drug interaction
Drug interaction with drug
Drug interaction with food
Medication side-effect
Toxicity
Recording allergy / adverse reaction manifestation…
Add Adverse Reaction
* Substance/Agent:
Reaction type:
Clinical manifestation:
Date of onset:
paroxetine
Medication side-effect
pal
User selects item from a list.
Paralysis
dd -- MMM -- yyyy
Pale complexion
Not known
Palpitations
* denotes mandatory field
Facial palsy
Cranial neuropathy
Save
Items are sourced from SNOMED CT-AU Clinical
manifestation reference set.
CLD.126Close
(mandatory)
CLD.127 (mandatory)
Recording multiple manifestations…
Add Adverse Reaction
* Substance/Agent:
Reaction type:
Clinical manifestation:
Date of onset:
paroxetine
Medication side-effect
Palpitations
dd -- MMM --
yyyy
User can add multiple
manifestations
CLD.128 (mandatory)
Not known
* denotes mandatory field
Save
Close
Saving an Allergy / Adverse Reaction…
Add Adverse Reaction
* Substance/Agent:
Reaction type:
Clinical manifestation:
paroxetine
Medication side-effect
Palpitations
Nausea
Date of onset:
dd -- MMM --
yyyy
Not known
* denotes mandatory field
Save
Close
ASSUMPTION - date, author ID logged against
Allergy / Adverse Reaction
Welcome: Dr Roger Harris
Clinical Information System 1.1
Pre-existing adverse reactions already recorded are
kept as they are
Select Patient
Patient Record
My Health Record
Requests
e.g. the Reaction
Type fieldAppointments
is left blank if this
is a new
field, or will retain the data from previous entry.
CLD.108
- BROWN, David
(Mr)(mandatory) Born 04-Jun-1979 (34y)
Home Address
20/30 Universal Street,
City East, 4002, QLD
(07) 22 33 44 55
Work Phone
(07) 55 66 77 88 99
0404 123 456
View previous
Notes
Married
Email Address
[email protected]
View previous
Current Visit Progress Notes
Settings
Quick Links
Messages
Help
Gender Male
Agent
Manifestation
Penicillin
Rash
Paroxetine
Palpitations +
Nausea
Reaction Type
Medication side-effect
+ ADD
Marital Status
edit
Log out
Forms
Allergies and
Adverse
Reactions
8003614455667789
IHI #
Home Phone
Mobile
212333445 (1)
Medicare #
X
_
Last Log In: 04-Jun-2014 10:30
edit
Blood Group
A (+) positive
Smoking
Alcohol
Indigenous Status
Follow up date and time
No
13-Aug-2014
My Health Record
weekly
View previous
16.30
edit
Recall / Reminder
Observations /
Examination
Results
Past Medical
Hx
General
Cardiovascular
Medicines
Gastrointestinal
Respiratory
Genitourinary
Investigations
Musculoskeletal
ENT
Immunisation
Eye
Skin
Psychiatric
Correspondence
Previous Progress
Notes
Social History
Reason for Visit
HI and My Health Record validation complete
Diagnosis
Management
Reminder
Thursday 05-Jun-2014 12:12
Close
Welcome: Dr Roger Harris
Clinical Information System 1.1
X
_
Last Log In: 04-Jun-2014 10:30
Log out
Select Patient
-
Patient Record
My Health Record
BROWN, David (Mr)
Home Address
(07) 22 33 44 55
Work Phone
(07) 55 66 77 88 99
Mobile
0404 123 456
View previous
Notes
212333445 (1)
8003614455667789
IHI #
Home Phone
edit
Requests
Forms
Settings
Born 04-Jun-1979 (34y)
Medicare #
20/30 Universal Street,
City East, 4002, QLD
Appointments
Marital Status
Quick Links
Messages
Help
Gender Male
Agent
Allergies and
Adverse
Reactions
Manifestation
Reaction Type
+ ADD
Married
If there are no existing adverse reactions,
the system
Blood Group
Email the
Address
offers
user [email protected]
option to record that there are no
Smoking
known adverse reactions.
Indigenous
Status
View previous
edit
CLD.111 (mandatory)
Current Visit Progress Notes
Follow up date and time
A (+) positive
No
13-Aug-2014
My Health Record
weekly
Alcohol
View previous
16.30
edit
Recall / Reminder
Observations /
Examination
Results
Past Medical
Hx
General
Cardiovascular
Medicines
Gastrointestinal
Respiratory
Genitourinary
Investigations
Musculoskeletal
ENT
Immunisation
Eye
Skin
Psychiatric
Correspondence
Previous Progress
Notes
Social History
Reason for Visit
HI and My Health Record validation complete
Diagnosis
Management
Reminder
Thursday 05-Jun-2014 12:12
Close
Recording ‘no known adverse reaction’…
Add Adverse Reaction
* Substance/Agent:
Reaction type:
Adverse reaction
Clinical manifestation:
Not recorded
Date of onset:
dd -- MMM --
yyyy
Not known
* denotes mandatory field
None known
The user can record that there are no known adverse
reactions if the patient’s record does not have any
existing adverse reactions recorded.
CLD.111 (mandatory)
Save
Close
Welcome: Dr Roger Harris
Clinical Information System 1.1
X
_
Last Log In: 04-Jun-2014 10:30
Log out
Select Patient
-
Patient Record
My Health Record
BROWN, David (Mr)
Home Address
20/30 Universal Street,
City East, 4002, QLD
(07) 22 33 44 55
Work Phone
(07) 55 66 77 88 99
Mobile
Notes
0404 123 456
Requests
Forms
Born 04-Jun-1979 (34y)
Medicare #
IHI #
Home Phone
Appointments
212333445 (1)
8003614455667789
Allergies and
Adverse
Reactions
Settings
Quick Links
Messages
Help
Gender Male
Agent
Manifestation
Reaction Type
+ ADD
No known adverse reactions (recorded 23-Jan 2013)
Marital Status
Married
Email Address
[email protected]
Blood Group
Smoking
If the user has recorded that there are no known
No
Indigenous
Status
View
previous
edit and displays the
adverse reactions, the system records
View previous
edit
day, month and year it was recorded.
CLD.112
(mandatory)
Current Visit
Progress
Notes
13-Aug-2014
Follow up date and time
A (+) positive
My Health Record
weekly
Alcohol
View previous
16.30
edit
Recall / Reminder
Observations /
Examination
Results
Past Medical
Hx
General
Cardiovascular
Medicines
Gastrointestinal
Respiratory
Genitourinary
Investigations
Musculoskeletal
ENT
Immunisation
Eye
Skin
Psychiatric
Correspondence
Previous Progress
Notes
Social History
Reason for Visit
HI and My Health Record validation complete
Diagnosis
Management
Reminder
Thursday 05-Jun-2014 12:12
Close
References
Name & Version
Release Date
Clinical Document – My Health Record Usability Recommendations v1.3 [NEHTA-2210:2016]
29 Jan 2016
18
National E-Health Transition Authority
www.nehta.gov.au