New drug comments: aiming to deliver useful, timely, independent information for health professionals

Since 1975, the 'New drugs' section of Australian Prescriber has aimed to provide health professionals with brief, independent, unbiased comments about recently marketed new medicines and vaccines.¹ These new drug comments summarise key information about the new drug (e.g. presentation, indications), the evidence that led to its registration in Australia, and its place in therapy.

New drug comments can be read when they are published in the bimonthly issues of the journal. Or, they can be easily found retrospectively by searching for the drug name and ‘Australian Prescriber’ in any search engine; this can be useful when a brief, independent summary of the medicine is needed, for example, if a patient asks whether a new medicine could be suitable for them.

The Therapeutic Goods Administration (TGA) each year registers approximately 40 new prescription drugs (referred to as ‘new chemical entities’ or ‘new biological entities’).² In the last decade newly approved drugs have changed from being largely traditional small-molecule drugs to often being large-molecule drugs (biologics).³ Australian Prescriber doesn’t aim to comment on every new drug entity. Priority is given to drugs that have a new or unique mechanism of action, provide a significant advance over existing drug therapies, or have specific safety concerns. Drugs for rare diseases or that are highly specialised may not be prioritised.

To enhance readability of new drug comments, Australian Prescriber is introducing changes to the way the comments are presented. Starting with this issue, new drug comments include a summary box and have a structured format with subheadings. The summary box provides basic information including the generic and brand names, sponsor (manufacturer), presentation, route of administration and approved indication. The aim is to enable readers to quickly view key details and decide whether to read the full new drug comment. The structured format of the comment, with subheadings, is intended to make new drug comments easier to read, and help readers find the information they are looking for.

When preparing new drug comments, Australian Prescriber seeks copies of the TGA’s Australian Public Assessment Report (AusPAR) and clinical evaluation report. The AusPAR provides a summary of the information and process that led the TGA to approve or not approve a drug for use in Australia;⁴ it is published on the TGA’s website, but is sometimes not available before the drug is marketed and the new drug comment prepared.^5,6 The TGA’s clinical evaluation report is a document that provides additional, often unpublished, data relating to the safety and efficacy of the product; this is not publicly available, so is requested by Australian Prescriber from the sponsor. Unfortunately, few sponsors provide the clinical evaluation report.

To inform readers about whether these documents were made available by the TGA and the sponsor at the time the new drug comment was prepared, starting with this issue, a transparency statement will be provided at the end of each new drug comment. This statement replaces the ‘transparency score’ (T-score) that previously appeared at the end of each new drug comment. While the T-score served the journal and its readers well over the years,^6-8 the simplified transparency statement will continue to inform readers about the transparency and timeliness of access to information about new drug approval decisions.

When the AusPAR and clinical evaluation report are not available, equivalent documents from the European Medicines Evaluation Agency and the US Food and Drug Administration are reviewed. Other sources of information used when preparing new drug comments include published clinical trials and the approved Australian product information.

New drug comments are a summary, and are not intended to provide all of the information required to prescribe the medicine. Prescribers are encouraged to refer to the approved product information and other high-quality medicines information references for further details about how to use the drug.⁹

The Editorial Advisory Committee welcomes feedback from readers on the new format, and content, of the new drug comments.

Conflicts of interest: none declared

 

References

1. Dowden JS. How we write about new drugs. Aust Prescr 2002;25:120.
2. Therapeutic Goods Administration. Prescription medicines and biologicals: new registrations. Department of Health and Aged Care; 2014. [cited 2024 Nov 11]
3. Martins AC, Oshiro MY, Albericio F, de la Torre BG, Pereira GJV, Gonzaga RV. Trends and perspectives of biological drug approvals by the FDA: a review from 2015 to 2021. Biomedicines 2022;10.
4. Therapeutic Goods Administration. Understanding Australian Public Assessment Reports (AusPARs) for prescription medicines. Department of Health and Aged Care; 2010. [cited 2024 Nov 12]
5. Harvey K. Transparency and the Therapeutic Goods Administration. Aust Prescr 2013;36:110-1.
6. New drugs: transparency. Aust Prescr 2014;37:27.
7. New drugs: transparency. Aust Prescr 2009;32:26-7.
8. New drugs: T-score for transparency. Aust Prescr 2011;34:26-7.
9. Day RO, Snowden L. Where to find information about drugs. Aust Prescr 2016;39:88-95.