How we write about new drugs
- J.S. Dowden
- Aust Prescr 2002;25:120
- 1 October 2002
- DOI: 10.18773/austprescr.2002.116
The 'New drugs' section of Australian Prescriber has been a consistent feature of the journal since 1975. Health professionals value its brief, unbiased comments about recently marketed products. These comments will continue to be published, but following the acquisition of Australian Prescriber by the National Prescribing Service1,2 there have been some changes in the way the 'New drugs' section is prepared.
When the journal was published by the Department of Health, the editors had access to the drug evaluations prepared by the Therapeutic Goods Administration. As the editors were usually senior medical advisers to the Drug Evaluation Branch they were able to see all the (published and unpublished) research evidence submitted by pharmaceutical companies applying to have their drugs approved for use in Australia.
As the National Prescribing Service operates independently of the Department of Health and Ageing, it does not have access to the research evidence held by the Therapeutic Goods Administration. This is because the applications containing the evidence are considered to be 'commercial-in-confidence'.3
To overcome this barrier Australian Prescriber is increasingly using information published by the European Medicines Evaluation Agency and the US Food and Drug Administration. Although it would be better to have access to Australian assessments of new drugs, these overseas regulatory authorities currently have less restriction on making information available.
The 'New drugs' comments in Australian Prescriber continue to draw information from the medical literature and databases such as the Cochrane Collaboration. Although only a few key references are published in the 'New drugs' section many more are considered when preparing the comments. When dealing with published clinical trials there is, however, a risk that only the trials with positive results have been published.4
Sometimes the results of an unpublished trial can appear in the product information for the drug. The product information also contains helpful information about a drug's pharmacology and adverse effects.
The Editor prepares draft 'New drugs' comments using the available sources of information. These drafts are then considered by the Editorial Executive Committee. This peer-review process helps to ensure the comments are correct and relevant to clinicians. The 'New drugs' comments are not intended to be a comprehensive review of a product, but should help health professionals decide if they need to find out more information for their own practices.
Now that new drugs are often reported by the general media before health professionals are informed about them, Australian Prescriber is speeding up the dissemination of its 'New drugs' comments. Instead of waiting for the next issue to review a new product, a 'New drug' comment will be published on the Australian Prescriber web site as soon as the drug is marketed. This will help to ensure Australian Prescriber remains a helpful and trusted source of drug information.
Editor, Australian Prescriber