New regulations for e-prescribing and their impact on patent litigation in Australia
- All electronic PBS prescriptions must include the name of the active ingredient.
- The regulations do not apply to handwritten prescriptions, paper-based medication charts in the residential aged-care setting, and prescriptions for medicines with four or more active ingredients, and items determined by the Secretary to be excluded for practicality and safety reasons.
- Prescribers can still prescribe by brand where clinically necessary, including where the medication prescribed may pose a potential patient safety risk if the brand is not specified, or to promote patient compliance where a patient is familiar with a particular brand.
- Where the prescriber nevertheless makes a clinical decision to specify a brand name on the electronic prescription, the name of the active ingredient must appear first.
- Prescribing software must not default to include brand names on prescriptions. In this way the regulations compel doctors to make a clinical decision regarding inclusion of a brand name.
- Following the 31 October 2019 commencement date, there is a 12 month transition period to ensure that prescribers have sufficient time to update their prescribing software to comply with the new requirements.
There is similar legal coverage here: