The National Health Act 1953 has been amended to require the inclusion of active ingredient names on prescriptions supplied under the Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS (RPBS).
This amendment, which comes into effect on 1 February 2021, requires the following:
- The active ingredient must be included on all PBS prescriptions (exceptions exist for handwritten prescriptions, paper-based medication charts in the residential aged care setting, medicinal products with four or more active ingredients, and specific items excluded for practicality and safety reasons);
- The brand name may also be included on the prescription if the prescriber considers it clinically necessary (e.g. to ensure continued therapy of the same brand, or when not specifying the brand could pose a potential patient safety risk);
- If the brand name is included on the prescription, the active ingredient(s) must appear first; and
- Prescribing software must not automatically include brand names on prescriptions by default.
This legislation forms part of a broader government initiative to standardise medication information and support the safe use of medicines. A range of supporting material has been developed to ensure that healthcare professionals and patients are adequately informed of these changes. These include:
- Amended packaging and labelling requirements by the Therapeutic Goods Administration (TGA);
- Development of the National Guidelines for On-Screen Display of Medicines Information which states that the active ingredient should be displayed before the brand name; and
- Shared health summaries on the My Health Record system display active ingredient before brand name.
It is anticipated that active ingredient prescribing will increase patient understanding of their medications and increase the uptake of generic and biosimilar medicines. It is important that patients are aware of the active ingredients of their medicines as the brand name is not always a unique identifier. Many medications are available in multiple different brand names which can be confusing. For patients who are not aware of the active ingredient, there is a risk of accidentally doubling up on a medicine or even failing to take a medicine if the name on the package does not match the name on the prescription. Active ingredient prescribing may also promote the use of generic medicines. Increased uptake of generic medicines will provide patients with immediate cost savings, while also helping to ensure the long-term sustainability of the PBS.
The Australian Commission on Safety and Quality in Healthcare (the Commission) has published the Active Ingredient Prescribing User Guide to assist prescribers in prescribing by active ingredient. It also contains the following lists to provide guidance on when a brand name should be included on a prescription: the ‘List of Medicines for Brand Consideration’ and the ‘List of Excluded Medicinal Items’. These two lists will be reviewed by the Commission at least twice a year.
The List of Medicines for Brand Consideration contains medicines that prescribers may consider prescribing by brand as well as active ingredient. Clinical software systems will alert prescribers when a medicine is on this list and provide a hyperlink to the List of Medicines for Brand Consideration. Medications on the list are annotated with detailed reasoning for their inclusion. For example, insulin is included as it is a high-risk medication that is available in many different presentations with the same or very similar active ingredient name. This list is not intended to be prescriptive or exhaustive. The choice to specify a brand remains that of the prescriber and should be documented in the patient’s record.
In contrast, the List of Excluded Medicinal Items contains medicines that should be prescribed by brand only for practical and safety purposes. Selected products from the following categories are included in this list:
- Products containing four or more active ingredients (e.g. Restore O.R.S);
- Vaccines and allergenic extracts (e.g. ADT™ Booster);
- Ocular lubricants and ophthalmologicals (e.g. Refresh Tears Plus®);
- Dermatological preparations – topical emollients and washes (e.g. EgoPsoryl-TA™);
- Treatments for haemorrhoids and constipation (e.g. Micolette®);
- Diagnostic tools (e.g. Keto-Diastix®);
- Iron preparations (e.g. Ferro-tab®);
- Vitamins, minerals and trace elements (e.g. Paediatric Seravit®);
- Various general nutrients, other nutrients (e.g. Chlorvescent®);
- Triple therapy to treat Helicobacter pylori (e.g. Nexium® Hp7®); and
- Some non-medicinal items (e.g. Iodosorb® Powder).
Active ingredient prescribing does not affect a patient’s ability to choose the brand they prefer or a prescriber’s clinical decision making. Patients will still be able to request their brand of choice, and prescribers will retain the option to specify that brand substitution is not permitted. While active ingredient prescribing is only mandated for PBS and RPBS prescriptions, the same principles extend to private prescriptions.
- Australian Commission on Safety and Quality in Health Care. Active ingredient prescribing – User guide for Australian prescribers. Sydney: ACSQHC; 2020
- Australian Government. Explanatory Statement: National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2020. Canberra: Australian Government; 2020.
- Pharmaceutical Benefits Scheme. Active Ingredient Prescribing. Canberra: Department of Health; 2020.