Legislative changes that require active ingredients to be included on most PBS and RPBS prescriptions will be mandatory from 1 February 2021
Under new legislative requirements, which are mandatory from 1 February 2021, prescribers must include active ingredient names when preparing prescriptions for Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS (RPBS) medicines.
From this date, all eligible PBS and RPBS prescriptions will need to include the active ingredient, followed by brand if the prescriber believes it is clinically necessary, says the Department of Health.
There are some exceptions—the new regulations do not apply to:
- Handwritten prescriptions;
- Paper-based medication charts in the residential aged care sector;
- Medicines with four or more active ingredients;
- Medicines that have been excluded to protect patient safety or where it is impractical to prescribe the medicine by active ingredient; and
- Prescriptions generated from prescribing software that utilises a free text function.
The changes mean most medicines will be prescribed by their active ingredient, not the brand name, says the Department of Health.
Active ingredient information will not only appear on prescriptions, but on medicines packaging, pharmacy dispensing labels and in My Health Record Shared Summaries.
NPS MedicineWise says this can lead to safer and more appropriate use of medicines by making it easier for patients to:
- check if they are taking the same active ingredient in more than one prescription medicine – to prevent accidental double dosing;
- check that they are not taking an active ingredient they’re allergic to;
- check that the active ingredient can be taken with medicines that have other active ingredients;
- identify suitable alternatives to their usual medicines when travelling overseas.
Research indicates that a substantial number of consumers only know their medicines by their brand name, and can easily double dose if they are inadvertently prescribed two different brands of medicine containing the same active ingredient.
This risk is exacerbated for elderly or chronically ill patients who are often required to take a number of medicines.
In addition to improving patient safety, the Department of Health said active ingredient prescribing should also assist conversations between pharmacists and patients concerning generic alternatives.
It expects that the changes will increase uptake of generic and biosimilar medicines, leading to reduction of out-of-pocket expenses for the consumer.
However it emphasised consumers will still be able to choose the brand they want when they get their medicines from their pharmacy.
“Current pharmacy workflows or processes won’t change,” says NPS MedicineWise.
“Pharmacists are well placed to explain to consumers why their prescriptions may have changed and discuss the benefits of active ingredient prescribing.”
It also advises pharmacists to continue to provide consumers with information about their brand options, and what their medicines will do for them.
“Prescribers will continue to be able to choose a specific brand of medicine for their patient, and can include a brand name on the prescription wherever they believe it is necessary for the treatment of their patient,” says the Department of Health.
Prescribers will also be able to tick the ‘Brand substitution not permitted’ box if necessary. However where a brand name is included on prescriptions, the active ingredient must appear first.
“Continue to discuss generic medicine options with consumers wherever a prescriber has deemed substitution is permitted, whether or not a brand name is on the script,” NPS MedicineWise advises pharmacists.
“The inclusion of a brand on a prescription does not equate to ‘Brand Substitution Not Permitted’ unless the box is ticked.”
Prescribing software is not able to automatically include brand names on prescriptions by default. The Department of Health has been working with the clinical software industry to make appropriate changes to ensure prescribers are using software which generates prescriptions in accordance with these requirements.
This article was updated on 18 January 2021 to provide new information to pharmacists as the mandatory date approaches.