Accurate Adverse Drug Reaction (ADR) documentation is important at an individual patient level to ensure that if a patient has had a reaction to any medication or substance, this medication or substance is not administered again inadvertently. Reporting ADRs (where appropriate) to the Therapeutic Goods Administration (TGA), also assists in gathering post-marketing information on the safety profile of that medication.

Clinical staff will document the ADR status of all patients presenting for care at Grampians Health Ballarat

New ADR's are recorded and this information is transferred to other care providers and the patient.

New ADR's are reported to the TGA, where appropriate

Adverse drug reaction (ADR):  A noxious or unintended reaction to a drug or substance which occurs at a dose used in humans for prophylaxis, diagnosis, therapy or for the modification of physiological function. ADRs include allergies (a hypersensitive reaction to common, often intrinsically harmless, substances). This excludes accidental/unintentional overdose.

BPMH: Best Possible Medication History. An accurate list of medications the patient was taking prior to admission that is confirmed using a number of different sources of information.

CAM: Clinical Alerts Manager System used by Grampians Health Ballarat as a source of clinical alerts, including ADR.

Clinicians: Persons involved in the medication management pathway.

Medication: Refers collectively to medications, medicines, drugs or therapeutic agents administered by any route.

Medication chart: Refers to any GH-B form where medications are prescribed, dispensed and/or administered. e.g. National Standard Medication Charts: Medication Chart MR/700.2, Long Term Medication Chart MR/715.2 and MR/715.1, Paediatric Medication Chart MR/700.5.

Prescriber: Any registered health professional who are endorsed to prescribe by their associated Board.

Substances: In this document refers collectively to medications, medicines, drugs or therapeutic agents administered by any route as well as non pharmacological materials.

Therapeutic Goods Administration (TGA): Australian regulatory agency for medicines and medical devices.

At GH-B, the Clinical Alerts Manager (CAM) system is the source of truth for patient ADRs (including allergies) (see Clinical Alerts CPP0657).

 Documenting and Recording of ADR/Allergies

The first treating prescriber, or nurse (where a standing order is used prior to medical officer review - e.g. in the emergency department), must ask the patient (or carer) about previous ADRs (including allergies) and document and verify the patient's ADR/allergy status on the CAM system, and on the Medication Chart as per Medication, Prescribing, Dispensing & Administration POL0048.  This ADR information must match. The ADR status must be completed (and must match CAM) on any form used to prescribe, dispense or administer a medication. It is recommended that two sources are consulted to gather the ADR information (e.g. patient, general practitioner letter, CAM system, previous Clinical Alerts Form, previous medication chart).

A patient identification band must be applied when a patient presents to GH-B for treatment, as per Patient Identification / Name Band CPP0327. If the patient has had a previous ADR, the clinician must apply a red patient identification band (which must replace any white patient identification band that may have previously been applied, e.g. by registration staff).  A red patient identification band indicates that the patient has an ADR alert. The ADRs must be documented on the red patient identification band and must match the CAM system.

Whilst ADR documentation is primarily the responsibility of the first treating prescriber; nursing staff or pharmacists should complete this information on the medication chart and CAM system where it is incomplete. Any medications prescribed must be reviewed in light of the ADR information obtained by the nurse or pharmacist.

Prior to prescribing any medicine, the prescriber must ensure that ADRs are fully recorded in the ADR box on the Medication Chart and ADR stickers are in the appropriate positions as per Medication, Prescribing, Dispensing & Administration POL0048. No medication should be prescribed, administered or dispensed until the ADR section of the medication chart has been completed (i.e. is not blank) as per the example below.

All patients admitted and/or treated within GH-B require a full ADR history documented as a component of the Best Possible Medication History (see Best Possible Medication History - CPP0585). As with a Best Possible Medication History, it is recommended that two sources are consulted to gather this information (e.g. patient, general practitioner letter, CAM system, previous Clinical Alerts Form, previous medication chart).

Nil allergies                                                                                 

Allergy

The prescriber must complete the ADR box (including details of the reaction) on all prescriptions written (see below). The prescription will not be issued to the patient until their allergy status has been confirmed.

The patients alert status is highlighted on their wrist band as per Patient Identification / Name Band - CPP0327. A red wrist band indicates that the patient has an alert.

Prior to administering the drug, the patient's allergy status must be confirmed by asking the patient to verbalise this information (if able) as per Medication Administration - CPP0287. The medication chart must also be checked.

The patients Adverse Drug Reaction status (including allergies) must be communicated at clinical handover as per Clinical Handover - POL0070 and Clinical Handover Protocol - CPP0571.

Electronic prescribing systems, where in use, require ADR information to be recorded before any prescribing can occur. The system must have ADR decision support enacted.

Prescribing a medication to which the patient has a documented ADR

If a prescriber wishes to prescribe a medication to which a patient has a known ADR, this must be recorded in the patient's medical record together with the rationale and any observations that may be required by Nursing Staff.

If a patient is prescribed a medication that has previously been associated with an ADR, and:

• there is no documented reason for prescribing AND

• a satisfactory explanation has not been provided after discussion with the prescriber and/or treating team. 

the medication must be withheld, and clinical escalation enacted as per Escalation of Patient Safety Concerns - CPP0231

Reporting inadvertent prescribing, dispensing or administration of a medication to which the patient has an ADR

In the event of unintentional prescribing, dispensing and/or administration of a medication to a patient with an ADR to the substance, a Riskman report must be completed. The treating team must be contacted, any reaction treated accordingly, and appropriate monitoring commenced.

If not previously documented, the ADR must be recorded as soon as possible on the medication chart and/or CAM by the treating team, pharmacist and nurse.

If the patient is administered a medication to which they had a documented ADR but no reaction has occurred, the treating medical officer may determine that the patient no longer has an ADR to the medication. The treating medical officer can also choose to leave the alert in place if the reaction is such that one dose without a reaction does not mean a reaction will not occur (e.g. delayed allergic reactions).

To remove the alert, draw a single line through the alert (if the ADR is recorded on a document such as a medication chart).  Date, sign and add your designation. Detail the reason for the alert cessation in the progress notes. ADRs can also be revoked by the authorised medical and pharmacy staff in the CAM system, if it is deemed clinically appropriate and with discussion with the consultant. The consultant's name must be documented. See section below regarding removal of CAM alerts.

Documentation and recording of new ADRs (See appendix 1 for flow chart)

If patient has experienced a new ADR at GH-B or is admitted with a new ADR, the patient must be assessed by a medical officer and have the reaction reviewed and any sequelae treated appropriately. The ADR must be recorded as per procedure (i.e. on medication charts, CAM system). This process includes reactions detected or treated by GH-B staff from medications that may have been prescribed by another care provider.

All new ADRs (even if only suspected) must be documented using Grampians Health Ballarat CAM system (as per Clinical Alerts- CPP0657) and the Riskman system.

The nurse caring for the patient must be made aware of the new ADR. If the patient is wearing a white identification band, the nurse is to organise for it to be replaced with a red identification band. The patient must be made aware of their changed allergy status associated with the new ADR and given appropriate counselling regarding future precautions by the treating medical officer or pharmacist. This discussion must be documented in the patients' medical record by the staff who were involved in discussing the new ADR or changed allergy status with the patient.

The treating medical officer must ensure the next care provider (e.g. patients' general practitioner, residential care facility) is made aware of any new ADRs. This must be documented on the discharge summary as per the Inpatient Discharge Summary - CPP0206. The patient's local pharmacy may also be contacted (e.g. if the patient has a Dose Administration Aid which contains the medication to which an ADR has been reported).

A VHIMS (Riskman report) must be completed by the medical/nursing or pharmacy staff caring for the patient.

The treating team's medical officer or pharmacist will complete:

1. An "Adverse Drug Reaction (ADR) Advice Letter"
   
   The patient must also receive a copy of the e-form "Adverse Drug Reaction (ADR) Advice Letter" (available in Opal) if a new significant drug reaction (in particular drug allergies) occurs in hospital or their admission is the result of a significant drug reaction. The letter will highlight the drug(s) involved and nature of the adverse drug reaction. A copy of the e-form must be forwarded to the patient's GP either via fax or mail. When the GP's details are not available an additional copy must be given to the patient. Consideration must be given to:
   (i) the reaction is most likely an adverse drug reaction
   (ii) the drugs(s) associated with the ADR
   (iii) the reaction is significant enough to advise the patient.

2. TGA report. The ADRs to be reported to the TGA include:

   • All suspected reactions to new medicines and vaccines.

   • All suspected drug interactions.

   • Unexpected reactions, that is not consistent with product information or labelling.

   • Serious reactions which are suspected of significantly affecting a patients management including reactions suspected of causing death, danger to life, admission to hospital, prolongation of hospitalisation, absence from productive activity, increased investigational or treatment costs, and birth defects.

More information and the reporting form can be accessed from the TGA website.

Removal of allergy information from CAM

Removal of allergy information from CAM, maybe appropriate based on a patient's history.

Where it is believed appropriate documented allergies may be removed from CAM by either the medical officer or pharmacist looking after the patient but must be discussed with the consultant involved in the patients care. The consultants name must be noted. In some cases, it may be appropriate to not fully remove the allergy but provide an update e.g. " Penicillin- nausea/vomiting, updated to Penicillin nausea/vomiting- tolerated IV flucloxacillin 2.6.22". The updater should include the date, name and role in the updated entry.

For patients involved in the penicillin delabelling process refer to Appendix 2: Penicillin Allergy Delabelling. For patients involved with the delabelling process a consultant is not required to endorse the penicillin allergy being revoked.

Reporting and monitoring
A summary of the number of Riskman reports relating to ADRs will be reported at the Medication Safety Governance Committee (MSGC) and significant reports discussed in detail. Each month the number of new ADR's is reported to the MSGC, based on Riskman reports.