Add Adverse Reactions

Record an Adverse Reaction for a reaction a patient has to a substance of any sort.

All users will be able to view a patient's reactions, and will receive a warning if prescribing medication for which a patient has a recorded allergic adverse reaction. However, only users who belong to a user group with the Common viewing right will be able to add adverse reaction information to a user's clinical record.

Only users who belong to a user group with the Adverse Reaction Administration system right can delete or update adverse reactions.

Definitions of clinical terms provided by NEHTA Adverse Reactions Data Specfications v1.1 29/02/2008.

To add a new adverse reaction to a patient's clinical record:

In the clinical record, on the Main Summary, click New Adverse Reaction.
In the New Adverse Reaction window, from the Information Provided By list, select a category for the source of the adverse reaction health information.
Select the agent or substance that causes the adverse reaction:
1. Select the tab for the type of allergy.
2. Scroll and select the allergen from the list or in the Search field enter a search term.
The agent type is identified as a Generic, a Drug brand, or a Non-Drug allergy. Drug allergies provide extra checking beyond the chosen drug. Include other drugs of the same substance class for warnings? is set by default. When set, any drug that is in the same substance class as that chosen also generates an alert. Alerts are also based on any drugs that have cross sensitivities.

The Non-Drug tab lists all active, non-medicinal concepts from the SNOMED CT-AU terminology. If you view or edit a non-drug adverse reaction added before SNOMED CT-AU terminology was implemented, the substance or agent is listed using old terminology, which includes Animal, Chemical, Environment and Food agents.
From the Certainty list, select the degree of confidence that you have that the selected agent or substance caused the adverse reaction.
Select from:
- Certain - a clinical event, including laboratory test abnormality, occurring in a plausible time relationship to agent exposure or administration, and which cannot be explained by concurrent disease or other agents or chemicals. The response to withdrawal of the agent (dechallenge) should be clinically plausible. The event must be definitive pharmacologically or phenomenologically, using a satisfactory rechallenge procedure if necessary.
- Probably/Likely - a clinical event, including laboratory test abnormality, with a reasonable time relationship to agent exposure or administration, unlikely to be attributed to concurrent disease or other agents or chemicals, and which follows a clinically reasonable response on withdrawal (dechallenge). Rechallenge information is not required to fulfil this definition.
- Possible - a clinical event, including laboratory test abnormality, with a reasonable time time relationship to agent exposure or administration, but which could also be explained by concurrent disease or other agents or chemicals. Information on agent withdrawal may be lacking or unclear.
- Unlikely - a clinical event, including laboratory test abnormality, with a temporal relationship to agent exposure or administration which makes a causal relationship improbable, and in which other agents, chemicals or underlying disease provide plausible explanations.
From the Date of Exposure calendar, select the date or date and time that the exposure to the agent or substance occurred.
From the Date of Onset fields, select the date when the adverse reaction first occurred or started showing symptoms or signs. Set the year, month and day if known. Otherwise, set the year and month, or only the year. If the patient doesn't know when the adverse reaction started, set Not Known.
In the Reaction Type pane, select the reaction type.
Reaction types are taken from SNOMED CT-AU terminology and are arranged in a hierarchy, from least to most specific reaction type. Select the most appropriate reaction type:
- Adverse reaction - the default option and least specific reaction type. The WHO in 1972 defined an adverse reaction as 'a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function'.
- Allergic reaction - Allergies are an overreaction of the immune system to substances that generally do not affect other individuals (from US Centre for Disease Control). Allergic reactions range from merely bothersome to life-threatening.
  - Hypersensitivity reaction type I - immediate hypersensitivity reaction or anaphylaxis, the most severe reaction
  - Hypersensitivity reaction type II - cytotoxic or cytolytic antibody reactions, e.g. transfusion reaction
  - Hypersensitivity reaction type III - immune-complex reactions, e.g. serum sickness
  - Hypersensitivity reaction type IV - delayed T cell mediated reactions, e.g. poison ivy
- Non-allergic reaction - the immune system is not involved with non-allergic reactions
  - Drug interaction - a substance (usually another drug) affects the activity of a drug when both are administered together.
    - Drug interaction with drug - one drug alters the pharmacological effect of another drug. The pharmacological effect of one or both drugs may be increased or decreased, or a new and unanticipated adverse effect may be produced.
    - Drug interaction with food - the food a person eats affects the ingredients in a drug so it doesn't work the way it should. Drug-food interactions can happen with both prescription and over-the-counter medicines, including antacids, vitamins and iron pills.
  - Food intolerance - occurs when the body has a chemical reaction to eating a particular food or drink. The symptoms for mild to moderate food allergy or intolerance may sometimes be similar, but food intolerance do not cause severe allergic reactions (anaphylaxis).
  - Medication side-effect - adverse drug reactions which do not depend on an immunological reaction against the drug, but on its pharmacological effects.
  - Toxicity - the degree to which a substance (a toxin or poison) can harm humans or animals. Acute toxicity involves harmful effects in an organism through a single or short-term exposure.
In the Clinical Manifestation(s) pane, select one or more signs and symptoms of the adverse reaction manifested by the patient. Where required, from the Severity list, select the severity of the symptoms.
In the Reaction Status pane, set the whether the adverse reaction is considered an active or inactive health challenge.
Select from:
- Active - no rechallenge performed - the adverse reaction is considered an ongoing health issue, e.g. active allergy to penicillin or bee sting
- Inactive - no rechallenge performed - the adverse reaction is not considered an ongoing health issue, e.g. intolerance to lactose was suspected, but this now does not appear to be the case
- Rechallenge outcome - active - a rechallenge of the adverse reaction has occurred and it is still considered an ongoing health issue, e.g. an adverse reaction to penicillin was reported. A clinically controlled rechallenge was performed, resulting in symptoms and signs of continuing allergy.
- Rechallenge outcome - inactive - a rechallenge of the adverse reaction has occurred and it is no longer considered an ongoing health issue, e.g. the subject of care had a reported adverse event to bee sting. After a course of desensitisation, a rechallenge produced no reaction - the problem determined now as inactive.
Click Save.

The new adverse reaction is listed in the patient's clinical record:

On the Main Summary, in the Adverse Reaction Summary panes. Reactions to drugs are listed in the left pane; reactions to other substances such as bee venom are listed in the right pane.
In the Action Banner

Tip: Newly added reactions can be deleted or updated within 24 hours if required.

When prescribing, clinicians will receive a warning if prescribing medication which contains a drug for which a patient has a recorded allergic adverse reaction.

If enabled, clinicians will be required to enter their password to proceed with a prescription for which the patient has a recorded allergic adverse reaction. The Require password on adverse reaction prescribing option is set by default. To turn off this feature, deselect it in File > System Parameters > Clinical tab.