The National Health (Pharmaceutical Benefits) Amendment Regulations 20194 and the Veterans’ Affairs Pharmaceutical Benefits Amendment Instrument 20195 requires the inclusion of active ingredient name(s) on all RPBS/PBS prescriptions and allow for the identification of a brand if the prescriber deems this to be clinically appropriate for the treatment of their patient.
AIP is the second project under the Electronic Prescribing Initiative aims to increase the uptake of generic and biosimilar medicines. Many patients recognise their medication by the brand name, and there can be a risk of incorrect dosing if they take multiple medicines that contain the same active ingredient. Doctors will still be able to prescribe by Brand (noting the active ingredient must still be on the script) if the doctor considers this necessary for the medical treatment of the patient9.
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1. Inclusion of the Brand as a Default is Prohibited Under Legislation
The regulatory amendments for AIP prohibit prescribing software from automatically including brand names on prescriptions by default, to ensure doctors make a clinical decision regarding the inclusion of the Brand.
The prescriber must make a clinical decision on the application of the brand name for every prescription.
2. Exemptions
The legislative amendments also enable the Secretary of the Department to determine some pharmaceutical benefits as exempt from active ingredient prescribing requirements. These items will be determined by the Department in consultation with the ACSQHC as described in the Guidelines for Active Ingredient Prescribing (See references to "LMBC" and "LEMI" in section 3).
3. Guidelines for Active Ingredient Prescribing
These guidelines will align with existing recommendations for medicines information display such as the Commission’s Recommendations for Terminology, Abbreviations and Symbols used in medicines documentation6 and the electronic display of active ingredient and brand name as described in the National Guidelines for On-Screen Display of Medicines Information7. It will also assist prescribers in making appropriate clinical decisions regarding the specification of the brand name following the active ingredient.
3.1 List of Medicines for Brand Consideration (LMBC)
This list identifies medicines for which prescribers should consider if the inclusion of the brand name on the prescription is necessary for their patient.
The presence of a drug on the RLDBI is intended as a guide only. It is not used as an absolute dictum which prescribers must follow noting that the inclusion of the brand name may apply to any drug and will be driven by the prescriber implementing a decision based upon the appropriate clinical outcome for the patient.
Considerations for prescribing RLDBI Drugs
Where an RLDBI item has been selected:
i. Prescriber Selects the Drug by Active Ingredient:
When prescribing by active ingredient as a specific brand has not been selected, the active ingredient name(s) only would normally be included on the prescription.
However, if the medicine is on the LMBC, the prescribing software can prompt the prescriber "to consider" if the inclusion of the brand is clinically appropriate for their patient.
Figure: Helix prompting for brand inclusion consideration
Figure: Alternate Brands window appears if user selects to include brand name
If the user selects to include the brand along with active ingredient, then the active ingredient and brand will appear in the printout...
...and the medication will be listed by the brand name in the list of patient medications in their Health Summary (in the above example, oxynorm capsule 5mg which is one of the brand options of oxycodone hydrochloride 5mg)
If the user selects to include active ingredient only in the brand consideration, then the only active ingredient will appear in the printout and the Health Summary will just display the active ingredient (in the above example oxycode hydrocholoride 5mg as per existing workflow).
ii. Prescriber Selects the Drug by the Brand:
The prescription must still include the active ingredient name before the brand except for the LEMI items.
In MedicalDirector Helix, the user will be displayed with the warning to consider inclusion of brand where medically necessary with an option to ‘Include brand name on script’ for all LMBC drugs.
Figure: option to ‘Include brand name on script’ for LMBC drugs
The prescriber can then include the brand or just the active ingredient only.
On the relevant selection, the prescription printout will have the active ingredient only or...
...the prescription printout will have active ingredient followed by the brand name in the bracket.
Figure: The active ingredient(s) must appear first when the brand name is included
If the user selects 'Brand substitution not permitted' while prescribing, then the 'Include brand on script' will be automatically selected.
3.2 List of Excluded Medicinal Items (LEMI)
The LEMI identifies drugs which are excluded under the AIP legislation from the mandated requirement to include the active ingredient names(s) on the prescription and which therefore may be prescribed by the brand name only.
On saving the prescription, the Consider Brand Inclusion prompt displays, indicating suggestions for including a brand name.
If you elect to include the brand along with the active ingredient, both will appear on the printout.
As these drugs are specifically nominated by the legislation or identifiable by the classes, general terminology or the scenarios under which their prescribing occurs. The LEMI drugs are not subject to individual MPP identification via an AMT reference set.
5. Situations Excluded Under the AIP Legislation (LEMI)
This section describes the medicines and prescribing events which are excluded under the Active Ingredient Prescribing Legislations where the active ingredient name(s) are NOT mandated thereby allowing the medicinal item to be prescribed by the brand name only.
6. Re-Prescribe or Duplicate Script Functions
This is another common facility provided by some prescribing software systems, whereby the prescriber accesses the patient history and selects a script in the history to create a new prescription identical to the one selected.
Previously in Helix, the script would be directly added to actions in some scenarios. However, with AIP changes, the prescriber editor panel will be displayed to ensure that the re-prescribed item must follow the current AIP rules and not the rules as saved when previously prescribed.
