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New active ingredient prescribing regulations

New prescribing regulations come into force early next year designed to encourage greater use of generic and biosimilar medicines and improve patient awareness. Find out what these changes are and how they will be embedded in to practice management software.

Prescribing medication by its active ingredient will become mandatory from February 2021. This change is part of the government’s 2018-2019 Electronic Prescribing Budget initiative that was legislated in 2019 under the National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019.

Dr Fabrina Hossain.

The aim of this regulation is to improve patient understanding of the medications they take in addition to promoting the uptake of generic and biosimilar medicines that would support a long term viable and sustainable market for these medications in Australia.

The regulation mandates the inclusion of the active ingredients on all PBS and RPBS prescriptions with the exception of:

  • Handwritten prescriptions.
  • Paper based medication charts in residential aged care settings.
  • Medications with four or more active ingredients.
  • Vaccines.
  • Custom preparations and prescriptions generated through a free text function within prescribing software.
  • Over the counter items.
  • Non-medicinal items such as dressings and food supplements.
  • Medications determined by the Secretary for practicality and safety reasons.

Brand names can be included in the prescription if it is considered to be clinically necessary by the prescriber; however, the active ingredient must be listed first as per the regulation. Furthermore, software is prohibited from automatically including the brand name by default. It is therefore up to the prescriber to include the brand name on the prescription.

Why is this change being implemented?

There are numerous benefits to prescribing by active ingredient rather than brand name. First, generic prescribing enables patients to identify the pharmaceutically active ingredient (the international nonproprietary name) of their drug and thereby have a better understanding about the medications they take.

Second, it will reduce the risk of patients accidentally taking the same medication as a result of a prescribing or dispensing error due to being unaware that the brand name is not a unique identifier of their medication.

The sample script on the left shows the active ingredient and then the brand name in brackets. The script on the right shows the active ingredient only. It will be up to the prescriber to include the brand name on prescriptions under the new regulations.

Third, it will allow the dispensation of any suitable equivalent generic should their brand of medication not be available at the pharmacy and subsequently reduce delays in supplying medication to the patient.

It is envisaged this change will increase the uptake of generic and biosimilar products which would reduce the out-of-pocket cost to the patient and the PBS. 

How might this change the way I prescribe medications?

From a prescriber’s perspective, there are some changes in our workflow. When prescribing a new medication, we can still search by brand name or the active ingredient.

Prescribing a new medication by brand name

If we wish the patient to have a specific brand, then we have to check the “Print brand name on scripts” check-box and un-check the “Allow brand substitution” check box. This will convey to the pharmacist that the brand name on the script is what should be dispensed and brand substitution is not permitted.

Prescribing a new medication by active ingredient name

If we are satisfied that there is no clinical need for the patient to be on a particular brand of medication then we can search and select the drug by the active ingredient name. The options to “Print brand name on scripts” and “Allow brand substitution” will not be selectable as it is superfluous information since we have chosen to prescribe a generic medication.

Providing a prescription for a patient’s existing medication by brand

During the roll out of the software update for active ingredient prescribing, if a patient’s medication has previously been declared as not allowing brand substitution, then it will be set to “Print brand name on scripts”. This is because a prescriber has previously decided and recorded that the patient must be on the recorded brand of medication. In such cases the brand name will be printed on the script and the workflow for the doctor will not change.

However, if “Allow Brand Substitution” is checked (meaning that a generic brand can be dispensed), then the “Print brand name on scripts” will not be flagged. This is because, it has not previously been declared that the patient must be on that brand of medication. As per the regulation, software vendors cannot default to printing brand name on scripts in such cases. This may potentially become an issue to doctors who have, for example, previously prescribed “Micardis”, but have declared that brand substitution is permitted. In these cases, the brand “Micardis” will not be printed on the script and therefore the patient will be dispensed a generic Telmisartan rather than Micardis.

Providing a prescription for a patient’s existing medication by active ingredient

This scenario should not change the workflow of the doctor as the active ingredient will be printed.

How might this change affect my patients?

It is very important that we have a discussion with our patients regarding the upcoming changes and how it can affect their medications. This is especially if they are taking brand medications and we wish them to continue to do so.

ABOUT THE AUTHOR: Dr Fabrina Hossain (MBBS BIT MIT FRACGP), is a Clinical Advisor, General Practice at Best Practice Software. She provides clinical advice to guide the development of products. Fabrina has a background in software development for nine years, before changing her career to study Medicine at the University of Queensland. After working for a few years in the hospital environment, she undertook GP training and obtained her specialist qualification in 2017, and works as a GP in Logan, Queensland.

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