Medicines Australia CEO sheds light on the new active ingredient prescribing

Pharma News: The Government announced the implementation of active ingredient prescribing, a joint commitment in the Department of Health’s 2017 Strategic Agreements with the Generic and Biosimilar Medicines Association and Medicines Australia, during the 2018-19 Budget to promote the uptake of generic and biosimilar medicines as part of a $1.8 billion investment to reduce the drugs bill over five years.

Active ingredient prescribing became law on 1 November 2019 with a 12-month grace period to ease its introduction. The upheaval due to the COVID-19 pandemic brought an extension of that grace period. Effective 1 February 2021, it is mandatory to include active ingredients on most PBS and RPBS  prescriptions.

In an interview with Health Industry Hub, Elizabeth de Somer, CEO of Medicines Australia said “We were happy to agree to the notion of active ingredient prescribing because understanding your active ingredient is an important part of quality use of medicines. However, it was contingent on the ability of the prescriber and patient to maintain choice, so that if the patient had a particular brand of medicine that they were familiar with and needed to stay on from a clinical perspective or wished to to stay on, that it would be easy for the prescriber to add the brand name to the script.

“There is a need for the Australian Government to invest in innovation and ensure that the latest technologies, the newest medicines and the greatest health advances can be paid for. One of the ways of doing that is to increase the savings derived from the off-patent market. We saw a similar scenario with the price disclosure mechanism where post-patent medicines moved to below the co-pay price range to make PBS funds available for innovation,” she added.

The additional goal of the active ingredient prescribing initiative is to help patients understand what medicines they are taking and to reduce the risk of people accidentally taking multiple doses of the same medicine under different brand names. This is especially important for patients who move from hospital care back to the community, or vice versa.

Although there are benefits to patients, there seem to be some complexities regarding the practicalities of the roll-out which need careful consideration.

Active ingredient names are complex and difficult to say or remember. There is the potential for confusion, especially for patients who may only be familiar with the brand name of their medication. Some patients may feel loyal to their particular brand and be anxious about changing or using an alternative brand. It is important that patients are made aware they do not have to change, they can still request their particular brand when they go to their pharmacist or doctor.

“The brand name is still an important descriptor of a medicine, even in the generic market. If you are taking a new and innovative treatment, although it may have the same active ingredient it may also have key differences that are really important to consider in patient care. These include how the medicine is administered, the device by which the treatment is delivered or how it is formulated. These items need to be carefully addressed to ensure quality use of medicines,” noted Ms de Somer.

With any change of this magnitude, a robust education and health literacy program is key for patients and clinicians.

The Australian Commission on Safety and Quality in Health Care and the National Prescribing Service (NPS) are responsible for clinician and patient education of this initiative, in addition to the resources and training provided by the relevant professional bodies.

Review of several clinical information softwares (CIS) used by clinicians indicates changes to the prescribing workflow with slight differences between the different softwares. For example, in the commonly used Best Practice software, when prescribing a new medication the clinician can search by brand name or the active ingredient. If the clinician wishes the patient to have a specific brand, then he/she has to check the “Print brand name on scripts” check-box and un-check the “Allow brand substitution” check box – adding extra steps to their workflow. This will convey to the pharmacist that the brand name on the script is what should be dispensed and brand substitution is not permitted.

Ms de Somer said “There needs to be some focus on the quality use of medicines aspects of active ingredient prescribing. Whilst the benefit of understanding the active ingredient is valuable for patients, the confusion that could be generated by having a different brand of medicine dispensed every month when you go to the pharmacy is a concern that needs to be addressed satisfactorily. There is potential for prescriber choice to be eroded if it is difficult for them to navigate to a brand name where they think a brand is important.”

It will be imperative for marketing, medical and commercial teams in the pharmaceutical industry to work collaboratively on an education and communication strategy that ensures GPs and specialists are aware of the practicalities of the changes with their prescribing software and that both patients and clinicians maintain the choice of branded medicines, where appropriate.

Medicines Australia is keen to be more involved in the roll-out of the active ingredient prescribing initiative and the review of health outcomes.

“We have received updates from the Department of Health but we have not been very strongly consulted on the implementation. Monitoring health outcomes will also be an important part of this initiative. A more mature electronic health record system would facilitate this,” said Ms de Somer.

The decisions by pharmaceutical companies to register and launch innovative medicines in Australia is impacted by a range of factors. Delays to registration and reimbursement, and international reference pricing policies make it challenging for Australia to attract the launch of innovative medicines.

Medicines Australia and the pharmaceutical industry is keen to see whether the new medicines funding guarantee that has been promised in the 2020 October Budget translates into increased expenditure on innovative medicines. The industry is eager to see a positive change to the PBS expenditure that has been flat or in decline in the last decade.

“Active ingredient prescribing has been agreed to by the pharmaceutical industry on the basis of reinvestment in innovative medicines. We now have to work towards ensuring that Australia remains an attractive destination for launching innovative products because these are the game-changers in enhancing patient outcomes,” concludes Ms de Somer.